GABAPENTIN TEVA 300 MG

Israel - English - Ministry of Health

Buy It Now

Active ingredient:
GABAPENTIN
Available from:
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
ATC code:
N03AX12
Pharmaceutical form:
CAPSULES
Composition:
GABAPENTIN 300 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
Therapeutic group:
GABAPENTIN
Therapeutic area:
GABAPENTIN
Therapeutic indications:
Epilepsy :- Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents ( age 12 and up ) with epilepsy.- Treatment of neuropathic pain- Gabapentin is indicated for the treatment of neuropathic pain in diabetic neuropathy or postherpetic neuropathy(neuralgia) in adults.
Authorization number:
119 46 29956 00
Authorization date:
2020-07-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

24-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

23-04-2017

PATIENT PACKAGE INSERT IN

ACCORDANCE WITH THE PHARMACISTS’

REGULATIONS (PREPARATIONS) - 1986

The medicine is dispensed with

a doctor’s prescription only

Gabapentin Teva

®

300 mg

Capsules

The active ingredient and its quantity:

Each capsule contains:

Gabapentin 300 mg

Gabapentin Teva

®

400 mg

Capsules

The active ingredient and its quantity:

Each capsule contains:

Gabapentin 400 mg

For the list of inactive ingredients, please see

section 6.

Read this leaflet carefully in its entirety before

using the medicine. This leaflet contains concise

information about the medicine. If you have further

questions, refer to the doctor or pharmacist.

This medicine has been prescribed to treat you.

Do not pass it on to others. It may harm them

even if it seems to you that their medical condition

is similar.

This medicine is intended for treatment of

epilepsy in adults and adolescents above 12

years of age.

This medicine is intended to treat neuropathic

pain in adults from 18 years of age and

above.

1. WHAT IS THE MEDICINE INTENDED FOR?

∙ For treatment of various forms of epilepsy

(seizures that are initially limited to certain parts

of the brain, whether they spread to other parts

of the brain or not). The doctor will prescribe

gabapentin for you to help treat your epilepsy

when your current treatment does not provide

full control of your condition.

∙ For treatment of neuropathic pain (prolonged

pain caused by nerve damage) after herpes

or due to diabetes. Pain sensations may be

described as hot, burning, throbbing, shooting,

stabbing, sharp, cramping, tingling, numbing,

pins and needles and the like.

Therapeutic group:

Anticonvulsants.

2. BEFORE USING THE MEDICINE:

Do not use the medicine if:

∙ There is a known sensitivity to gabapentin or

to any of the other ingredients (see section 6

“Further Information”).

Special warnings regarding use of the

medicine:

∙ A small number of people being treated with

anti-epileptics, such as gabapentin, had suicidal

thoughts or thoughts of harming themselves.

You and your family members must pay attention

to changes in mood and behavior patterns.

Monitor signs that indicate risk of suicide, such

- Talking or thinking about wanting to harm

yourself.

- Introversion and withdrawal from family and

friends.

- Depression

worsening

existing

depression.

- Preoccupation with death.

- Relinquishing

giving

away

prized

possessions.

In the event of appearance of one or more of

these signs, or any other worrisome behavior

pattern – refer to the doctor immediately!

∙ A small number of people taking gabapentin

suffer from an allergic reaction or serious skin

reaction, which may develop into more serious

problems if they are not treated. You need to

pay attention to all of the symptoms detailed

below and inform the doctor immediately upon

their appearance:

Muscle weakness, tenderness or pain and

particularly, if at the same time, you feel unwell

or have a high fever that may be caused by

abnormal muscle breakdown, which can be

life-threatening and lead to kidney problems.

There may also be a discoloration of your urine,

and a change in blood test results (mainly

increased blood creatine phosphokinase

levels).

Before treatment with Gabapentin Teva

®

, tell

the doctor if:

∙ You are pregnant, planning a pregnancy or are

breastfeeding.

∙ You are suffering, or have suffered in the past,

from impaired kidney function. The doctor may

prescribe a different dosage regimen for you.

∙ You are being treated with hemodialysis; tell

your doctor if you develop muscle pain and/or

weakness.

∙ You develop symptoms such as persistent

abdominal pains, nausea and vomiting; contact

your doctor immediately, as these symptoms

may indicate acute pancreatitis.

You are suffering from a disturbance of various

types of seizures, including “absence” seizures.

From the experience gained since marketing

this preparation, incidents of gabapentin abuse

and dependence have been reported. Inform the

attending doctor if you have a history of abuse

or dependence.

If you are taking, or have recently taken,

other medicines, including non-prescription

medicines and nutritional supplements, tell the

doctor or pharmacist. In particular, inform the

doctor or pharmacist if you are taking:

∙ Medicines containing opioids, such as morphine.

Morphine may increase the effect of gabapentin.

In addition, the combination of gabapentin

with opioids may cause symptoms such as

sleepiness and/or respiratory depression.

∙ Antacids for digestion problems. When taking

gabapentin concomitantly with antacids

containing

aluminum

magnesium,

absorption of gabapentin from the stomach

may be reduced. Therefore, it is recommended

that gabapentin be taken at least two hours after

taking an antacid.

∙ Gabapentin is not expected to interact with

other anti-epileptics or with oral contraceptive

pills.

Gabapentin can interfere with the results of some

laboratory tests. If you have to undergo a urine

test, tell your doctor that you are taking this

medicine.

Use of the medicine and food:

The capsules can be taken with or without food.

Use

of

the

medicine

and

alcohol

consumption:

Do not drink wines or alcoholic beverages during

the course of treatment with the medicine.

Pregnancy and breastfeeding:

It is not recommended to take the medicine during

pregnancy, unless your doctor has determined that

it can be taken. Women of child-bearing age must

use effective contraceptives during the course of

treatment with the medicine.

Studies on use of this medicine in pregnant women

have not been conducted; however, an increased

risk of harm to the developing baby has been

observed upon use of other medicines to treat

seizures in pregnant women, especially if more

than one medicine to prevent seizures was used

at the same time. Therefore, if possible, try to

take only one medicine to prevent seizures during

pregnancy, and only as advised by your doctor.

Refer to the doctor immediately if you are

pregnant, think you may be pregnant or are

planning to become pregnant while taking the

preparation. Do not stop taking the medicine

suddenly, as discontinuing use of the medicine

may lead to an epileptic attack, which may have

severe consequences on your health and on the

health of the unborn baby.

Gabapentin, the active ingredient in the medicine,

passes through breast milk. Since the effect on

the baby is unknown, it is not recommended to

breastfeed while using the medicine.

Driving and use of machinery:

Use of this medicine may cause dizziness and

tiredness and therefore, requires that caution be

exercised when driving a vehicle, when operating

dangerous machinery and when engaging in any

activity that requires alertness until you know

whether the medicine affects your ability to

perform these activities.

3. HOW SHOULD yOU USE THE MEDICINE?

∙ Always use according to the doctor’s instructions.

If the effect of gabapentin is too strong or too

weak or if you are uncertain, check, as soon as

possible, with the doctor or pharmacist.

∙ The dosage and treatment regimen will be

determined by the doctor only.

Do not exceed the recommended dose.

This medicine is intended to treat epilepsy in

adults and adolescents above 12 years of age.

This medicine is intended to treat neuropathic

pain in adults from 18 years of age and above.

∙ The attending doctor will usually increase the

dosage gradually.

∙ The starting dosage will usually be between

300 mg and 900 mg per day.

∙ After that, the dose can be increased as per the

doctor’s instruction, up to the maximum daily

dosage of 3600 mg, and the doctor will instruct

you to take it in 3 separate doses, i.e., once

in the morning, once at noon and once in the

evening.

∙ Use this medicine at specified time intervals, as

determined by the attending doctor.

∙ Do not chew! Swallow the capsules with a lot

of water.

The effect of opening and dispersing the

contents of the capsule has not been tested.

∙ It is recommended that Gabapentin Teva

taken at least two hours after taking antacids.

∙ Continue taking the preparation until the doctor

tells you to stop.

∙ If you are suffering from kidney problems or are

being treated with hemodialysis, the doctor may

prescribe a different dosage regimen or dose for

you.

∙ If you are over the age of 65, take a regular dose

of gabapentin, unless you are suffering from

kidney problems. The doctor may prescribe you

a different dosage regimen or dose if you are

suffering from kidney problems.

If you accidentally took a higher dosage or if

a child accidentally swallowed the medicine,

immediately refer to a doctor or proceed to a

hospital emergency room and bring the package

of the medicine with you.

An overdose may cause an increase in side effects,

including: loss of consciousness, dizziness, double

vision, unclear speech, drowsiness and diarrhea.

Do not induce vomiting without explicit instruction

from a doctor!

If you forgot to take this medicine at the

scheduled time, take a dose as soon as you

remember, unless it is time for the next dose.

Never take two doses together to compensate

for a forgotten dose!

Adhere to the treatment as recommended by the

doctor.

If you stop taking the medicine suddenly

or without consulting the doctor, there is an

increased risk of seizures. Do not stop treatment

with the medicine without consulting the doctor.

Discontinuation of treatment, lowering the

treatment dosage or switching this medicine for

another medicine should be done gradually, over

at least one week, as per the doctor’s instructions.

(See section 4 in this leaflet – Side effects due to

sudden discontinuation of treatment).

∙ Do not take medicines in the dark! Check the

label and dose each time you take medicine.

Wear glasses if you need them.

∙ If you have further questions regarding use of the

medicine, consult the doctor or pharmacist.

4. SIDE EFFECTS:

As with any medicine, use of Gabapentin Teva

may cause side effects in some users. Do not be

alarmed when reading the list of side effects. You

may not suffer from any of them.

Side effects that require special attention; if

the following effects occur, refer to the doctor

immediately:

∙ Severe skin reactions, including signs such

as: itching, skin rash, redness and/or hair loss,

swelling of the lips and face, may be symptoms

of a serious allergic reaction

∙ Persistent stomach pain, nausea and vomiting,

may be symptoms of acute pancreatitis

∙ Gabapentin

cause

serious

life-threatening allergic reaction that may affect

the skin or other parts of the body, such as the

liver or blood cells. You may have a rash as

part of this reaction. The serious reaction may

cause you to be hospitalized or you may be

forced to stop taking gabapentin (at the doctor’s

discretion). Contact your doctor immediately if

you have any of the following symptoms:

- skin rash

- urticaria

- fever

- swollen glands that do not go away

(e.g., lymph nodes)

- swelling of the lips and tongue

- yellowing of the skin or of the whites of the

eyes

- occurrence of unusual bruising or bleeding

- severe fatigue or weakness

- unexpected muscle pain

- frequent infections

∙ If you are being treated with hemodialysis, refer

to the doctor upon occurrence of muscle pain

and/or weakness

∙ Muscle weakness, tenderness or pain,

especially if accompanied by an unwell feeling

or fever; these may be signs of unusual muscle

breakdown that can be life-threatening and

lead to kidney problems. In addition, your urine

may be colorless and there may be changes in

blood test results (increase in blood creatine

phosphokinase levels) – refer to the doctor

immediately!

∙ Worsened seizures – refer to the doctor

immediately!

∙ Involuntary

movements,

mainly

face, tongue or limbs – refer to the doctor

immediately!

Very common side effects (may occur in more

than 1 in 10 patients):

∙ Viral infection

∙ Drowsiness, lack of coordination (ataxia),

dizziness

∙ Fatigue, fever

Common side effects (may occur in more than

1 in 100 patients):

∙ Pneumonia, respiratory tract infections, urinary

tract infections, inflammation of the ears or other

types of infections

∙ Low white blood cell count

∙ Anorexia, increased appetite

∙ Confusion, difficulty thinking, mood changes,

depression, anxiety, nervousness, anger

towards others – refer to the doctor immediately!

(See “Special warnings regarding use of the

medicine” in section 2 of this leaflet)

∙ Convulsions, spastic movements (jerky

movements), difficulty with speech, memory

loss, tremor, difficulty sleeping, headache, skin

sensitivity, decreased sensation (numbness),

difficulty with coordination, unusual eye

movements, increased, decreased or absence

of reflexes – refer to the doctor immediately!

Forgetfulness, reduced sensitivity to touch

(dullness)

∙ Blurred vision or double vision – refer to the

doctor immediately!

∙ Dizziness/vertigo – refer to the doctor

immediately!

∙ Hypertension, flushing or dilation of blood

vessels

∙ Breathing difficulties – refer to the doctor

immediately! Bronchitis (inflammation of the

pharynx or bronchi). Sore throat – refer to the

doctor immediately! Cough, dry nose

∙ Vomiting, nausea – refer to the doctor

immediately! Problems with teeth, inflamed

gums

∙ Diarrhea,

stomach

pain,

indigestion,

constipation, flatulence, dry throat or mouth

∙ Facial swelling, bruises, rash, itch, acne,

stinging

∙ Joint pain, muscle pain – refer to the doctor

immediately! Back pain, twitching

∙ Impotence in men

∙ Swelling in the legs and arms, difficulty with

walking, weakness, pain, feeling unwell,

flu-like symptoms

∙ Decrease in white blood cell count, increase in

weight

∙ Accidental injury, fracture, abrasion/erosion

∙ Additionally, in clinical studies in children, reports

of aggressive behavior and jerky movements

were common

Uncommon side effects (may occur in more

than 1 in 1,000 patients):

∙ Allergic reaction such as hives

∙ Decreased movement

∙ Rapid

heartbeat

refer

doctor

immediately!

∙ Abnormal laboratory test results, indicating

problems with the liver

∙ Mental impairments

∙ Falls

∙ Increased blood sugar levels (generally observed

in patients with diabetes)

Rare side effects (may occur in more than 1 in

10,000 patients):

∙ Loss of consciousness

∙ Decreased blood sugar levels (generally

observed in patients with diabetes)

Since introduction of gabapentin to the

market, the following side effects have been

reported:

∙ Decreased level of blood platelets (which help

with clotting)

∙ Hallucinations

refer

doctor

immediately!

∙ Problems of abnormal movements such as

writhing, jerky movements and stiffness

∙ Ringing in the ears

∙ A group of side effects that could include swollen

lymph nodes (isolated small, raised lumps under

the skin), fever, rash and inflammation of liver

occurring together

∙ Jaundice (yellowing of the skin and eyes),

inflammation of the liver

∙ Acute kidney failure, urinary incontinence

∙ Increased breast tissue, breast enlargement

∙ Side effects due to sudden discontinuation of

treatment: anxiety, difficulty sleeping, nausea,

pain, sweating. Chest pain – refer to the doctor

immediately!

∙ Blood glucose level fluctuations in patients with

diabetes

∙ Signs

breakdown

muscle

fibers

(rhabdomyolysis) – sudden muscle pains,

muscle tenderness or weakness. Refer to the

doctor immediately!

∙ Change in blood test results – increase in blood

levels of CPK (creatine phosphokinase), an

enzyme released as a result of muscle injury or

damage – refer to the doctor immediately!

∙ Stevens-Johnson syndrome (may be manifested

by blistering, peeling or bleeding of the skin

around the lips, eyes, mouth, nose and genitals,

flu-like symptoms and high fever) – refer to the

doctor immediately!

∙ Sexual function problems, including inability to

reach orgasm, delayed ejaculation

∙ Decrease in blood sodium level

If a side effect occurs, if any of the side effects

worsen, or if you are suffering from a side

effect not mentioned in the leaflet, consult the

doctor.

Side effects can be reported to the Ministry of

Health by clicking on the link “Report Side Effects

of Drug Treatment” found on the Ministry of Health

homepage (www.health.gov.il) that directs you to

the online form for reporting side effects, or by

entering the link:

https://forms.gov.il/globaldata/getsequence/get

sequence.aspx?formType=AdversEffectMedic@

moh.gov.il

5. HOW

SHOULD

THE

MEDICINE

BE

STORED?

∙ Avoid poisoning! This medicine and any other

medicine must be kept in a safe place out of

the reach and sight of children and/or infants in

order to avoid poisoning. Do not induce vomiting

without explicit instruction from the doctor.

∙ Do not use the medicine after the expiry date

(exp. date) that appears on the package/blister.

The expiry date refers to the last day of that

month. In any case of doubt, consult the

pharmacist who dispensed the medicine to

you.

Store this medicine in a dry place, below 25ºC.

6. FURTHER INFORMATION

In addition to the active ingredient, the

medicine also contains:

Gabapentin Teva

300 mg

Talc, pregelatinized starch, FD&C red 3, FD&C

yellow 6, titanium dioxide, gelatin, printing ink.

Gabapentin Teva

400 mg

Talc, pregelatinized starch, red iron oxide, yellow

iron oxide, black iron oxide, titanium dioxide,

gelatin, printing ink.

What the medicine looks like and the contents

of the package:

Gabapentin Teva

300 mg

An orange hard gelatin capsule, filled with a white

to off-white powder with small agglomerates.

The capsule body and cap are imprinted with:

Gabapentin Teva

400 mg

A brown hard gelatin capsule, filled with a white

to off-white powder with small agglomerates.

The capsule body and cap are imprinted with:

The medicine is packaged in a tray (blister), in a

package containing 100 capsules.

License Holder and its Address, Name

of Manufacturer and its Address: Teva

Pharmaceutical Industries Ltd., P.O.B. 3190,

Petach-Tikva

∙ This leaflet was checked and approved by the

Ministry of Health in 12.2016

Registration number of the medicine in the

National Drug Registry of the Ministry of

Health:

Gabapentin Teva

300 mg: 119.46.29956

Gabapentin Teva

400 mg: 119.47.29937

GABA CAPS PL SH 221216

GABA CAPS PL SH 221216

Gabapentin Teva, 16. 7. 2015 , RH

."רשואו קדבנ ונכותו תואירבה דרשמ י"ע עבקנ הז ןולע טמרופ"

ילוי :רשואמ ןולע

2015

“This leaflet format has been determined by the Ministry of Health and the content thereof has been

checked and approved.” Date of approval: July 2015.

GABAPENTIN TEVA

CAPSULES

TABLETS

Composition

Gabapentin Teva 300 mg Capsules

Each capsule contains

Active Ingredient

Gabapentin

300 mg

Other Ingredients

Talc, pregelatinized starch (from corn origin).

Capsule Shell

FD&C Red No.3, FD&C Yellow No.6, titanium dioxide, gelatin, printing ink.

Gabapentin Teva 400 mg Capsules

Each capsule contains

Active Ingredient

Gabapentin

400 mg

Other Ingredients

Talc, pregelatinized starch (from corn origin).

Capsule Shell

Red iron oxide, yellow iron oxide, black iron oxide, titanium dioxide, gelatin, printing

ink.

Gabapentin Teva 600 mg Tablets

Each tablet contains

Active Ingredient

Gabapentin

600 mg

Other Ingredients

Microcrystalline

cellulose,

povidone,

hydrogenated

vegetable

type

talc,

crospovidone, HPMC 2910/hypromellose, titanium dioxide, macrogol/PEG 400.

Gabapentin Teva 800 mg Tablets

Each tablet contains

Active Ingredient

Gabapentin

800 mg

Other Ingredients

Microcrystalline

cellulose,

povidone,

hydrogenated

vegetable

type

talc,

crospovidone, HPMC 2910/hypromellose, titanium dioxide, macrogol/PEG 400.

Gabapentin Teva, 16. 7. 2015 , RH

Mechanism of Action

Gabapentin is an oral anticonvulsant agent structurally related to the inhibitory CNS

neurotransmitter

gama-amino-butyric

acid

(GABA).

Although

Gabapentin

developed as a structural analog of GABA, it does not interact with GABA receptors,

it is not metabolized to GABA or to GABA agonists, and it is not an inhibitor of GABA

uptake or degradation, Gabapentin does not exhibit affinity for a number of other

common receptor sites. In vitro studies have revealed a gabapentin binding site in

areas of rat brain including neocortex and hippocampus. The identity and function of

this binding site remain to be elucidated.

The mechanism by which gabapentin exerts its anticonvulsant action is unknown

but in animals it has properties in common with other anticonvulsants. Gabapentin

exhibits antiseizure activity in mice and rats in both the maximal electroshock and

pentylenetetrazole seizure models and other preclinical models (e.g., strains with

genetic epilepsy). The relevance of these models to human epilepsy is not known.

Analgesic

activity

been

shown

animal

models

inflammatory

neuropathic pain.

All pharmacological actions following gabapentin administration are due to the

activity of the parent compound; gabapentin is not appreciably metabolized.

Pharmacokinetics

Absorption

Gabapentin bioavailability is not dose-proportional (i.e., as dose in increased,

bioavailability

decreases).

dose,

example,

about

less

bioavailable than a 100 mg dose. Over the recommended dose range of 300 to

600 mg 3 times daily, however, the differences in bioavailability are not large, and

bioavailability is about 60%. Food has no effect on the rate and extent of absorption.

Distribution

Gabapentin circulates largely unbound (less than 3%) to plasma protein.

The apparent volume of distribution after 1 mg I.V. administration is 58

6L. In

patients with epilepsy, steady-state pre-dose (C

) concentrations of gabapentin in

cerebrospinal fluid (CSF) were approximately equal to 20% of the corresponding

plasma concentrations.

Metabolism/Excretion

Gabapentin is eliminated from the systemic circulation by renal excretion as

unchanged drug; it is not appreciably metabolized.

Gabapentin elimination half-life is 5 to 7 hours and is unaltered by dose or following

multiple dosing. Elimination rate constant, plasma clearance and renal clearance are

directly proportional to creatinine clearance (Ccr). In elderly patients and in patients

with impaired renal function, gabapentin plasma clearance is reduced. Gabapentin

can be removed from plasma by hemodialysis.

Pharmacokinetics in Patients with Renal Insufficiency

When subjects with renal insufficiency were administered single 400 mg oral doses,

the mean half-life ranged from about 6.5 hours (patients with Ccr less than 60

ml/min) to 52 hours (Ccr less than 30 ml/min) and renal clearance from about

90 ml/min to about 10 ml/min. Mean plasma clearance decreased from about 190 to

20 ml/min. Therefore dosage adjustment is necessary in patients with compromised

renal function (see Dosage and Administration).

Gabapentin Teva, 16. 7. 2015 , RH

Hemodialysis

In a study in anuric subjects, the apparent elimination half-life of gabapentin on

nondialysis days was about 132 hours; dialysis 3 times a week (4 hours duration)

lowered the apparent half-life of gabapentin by about 60% form 132 to 51 hours.

Hemodialysis

thus

significant

effect

gabapentin

elimination

anuric

subjects. Dosage adjustment in patients undergoing hemodialysis is necessary (see

Administration and Dosage).

Effect of Age

The effect of age was studied in subjects 20 to 80 years of age. Apparent oral

clearance of gabapentin decreased as age increased, from approximately equal to

225 ml/min in those less than 30 years of age to approximately equal to 125 ml/min

in those more than 70 years of age. Renal clearance also declined with age;

however, the decline in the renal clearance of gabapentin with age can largely be

explained by the decline in renal function. Reduction of gabapentin dose may be

required

patients

have

age-related

compromised

renal

function

(see

Administration and Dosage).

Indications

Epilepsy

Gabapentin Teva is indicated as adjunctive therapy in the treatment of partial

seizures with and without secondary generalization in adults with epilepsy.

Neuropathic Pain

Gabapentin Teva is also indicated for the treatment of neuropathic pain in diabetic

neuropathy or postherpetic neuropathy (neuralgia).

Contraindications

Known hypersensitivity to gabapentin or to any other ingredient of the preparation.

Warnings

General

Although

there

evidence

rebound

seizures

with

gabapentin,

abrupt

withdrawal of anticonvulsants in epileptic patients may precipitate status epilepticus.

with

other

antiepileptics,

attempts

withdraw

concomitant

antiepileptics

treatment refractive patients on more than one antiepileptic, in order to reach

gabapentin monotherapy have a low success rate.

When

judgment

clinician

there

need

dose

reduction,

discontinuation, or substitution of alternative anticonvulsant medication, this should

be done gradually over a minimum of one week.

Gabapentin is not generally considered effective in the treatment of absence

seizures

exacerbate

these

seizures

some

patients.

Consequently,

gabapentin

should

used

with

caution

patients

have

mixed

seizure

disorders that include absence seizures.

Patients

require

concomitant

treatment

with

morphine

experience

increases in gabapentin concentrations. Patients should be carefully observed for

signs of CNS depression, such as somnolence, and the dose of gabapentinor

morphine should be reduced appropriately (see Drug Interactions).

Drug Rash with Eosinophilia and Systemic Symptoms (DRESS)

Severe, life-threatening, systemic hypersensitivity reactions such as Drug rash with

eosinophilia and systemic symptoms (DRESS) have been reported in patients taking

antiepileptic drugs including gabapentin.

Gabapentin Teva, 16. 7. 2015 , RH

It is important to note that early manifestations of hypersensitivity, such as fever or

lymphadenopathy, may be present even though rash is not evident. If such signs or

symptoms are present, the patient should be evaluated immediately. Gabapentin

should be discontinued if an alternative etiology for the signs or symptoms cannot be

established.

Suicidal Ideation and Behavior

Suicidal ideation and behavior have been reported in patients treated with anti-

epileptic drugs (AED) in several indications. A meta-analysis of randomised placebo

controlled trials of anti-epileptic drugs has also shown a small increased risk of

suicidal ideation and behavior. The mechanism of this risk is not known and the

available data do not exclude the possibility of an increased risk for gabapentin.

Pooled analyses of 199 placebo-controlled clinical trials of 11 different AEDs

showed that patients randomized to one of the AEDs had approximately twice the

risk of suicidal thinking or behavior compared to patients randomized to placebo. The

increased risk of suicidal thoughts or behavior with AEDs was observed as early as

one week after starting drug treatment with AEDs and persisted for the duration of

treatment assessed.

The risk of suicidal thoughts or behavior was generally consistent among drugs in

the data analyzed. The finding of increased risk with AEDs of varying mechanisms of

action and across a range of indications suggests that the risk applies to all AEDs

used for any indication. The risk did not vary substantially by age (5-100 years)in the

clinical trials analyzed.

Therefore patients should be monitored for signs of suicidal ideation and behaviors

appropriate

treatment

should

considered.

Patients

(and

caregivers

patients) should be advised to seek medical advice should signs of suicidal ideation

or behavior emerge.

Increase in Seizure Frequency

As with other antiepileptic medicinal products, some patients may experience an

increase in seizure frequency or the onset of new types of seizures with gabapentin

Withdrawal-precipitated seizure

Antiepileptic drugs should not be abruptly discontinued because of the possibility of

increasing seizure frequency and the precipitation of status epilepticus.

When

judgment

clinician

there

need

dose

reduction,

discontinuation or substitution of alternative anticonvulsant medication, this should be

done gradually over a minimum of one week.

Status Epilepticus

In the placebo controlled studies, the incidence of status epilepticus in patients

receiving gabapentin was 0.6% vs. 0.5% with placebo. Among the patients treated

with gabapentin, 1.5% of the patients had status epilepticus. 45% of these patients

had no prior history of status epilepticus either before treatment or while on other

medications. Because adequate historical data are not available, it is impossible to

say whether or not treatment with gabapentin is associated with a higher or lower

rate of status epilepticus than would be expected to occur in a similar population not

treated with gabapentin.

Sudden and Unexplained Deaths

During the course of premarketing development of gabapentin, 8 sudden and

unexplained deaths were recorded among 2203 patients. Some of these could

represent seizure-related deaths in which the seizure was not observed (e.g., at

night).

Gabapentin Teva, 16. 7. 2015 , RH

This represents an incidence of 0.0038 deaths per patient-year. Although this rate

exceeds that expected in a healthy population matched for age and sex, it is within

the range of estimates for the incidence of sudden unexplained deaths in patients

with epilepsy not receiving gabapentin.

Long Term Effects

The effects of long-term (greater than 36 weeks) gabapentin therapy on learning,

intelligence, and development in children and adolescents have not been adequately

studied. The benefits of prolonged therapy must therefore be weighed against the

potential risks of such therapy.

Other

patient

develops

acute

pancreatitis

under

treatment

with

gabapentin,

discontinuation of gabapentin should be considered

Mutagenicity

Gabapentin did not demonstrate mutagenic or genotoxic potential in 3 in vitro and 2

in vivo assays. It was negative in the Ames test and the in vitro HGPRT forward

mutation assay in Chinese hamster lung cells; it did not produce significant increases

in chromosomal aberrations in the in vitro Chinese hamster lung cell assay; it was

negative in the in vivo chromosomal aberration assay and in the in vivo micronucleus

test in Chinese hamster bone marrow.

Carcinogenicity

Gabapentin was given in the diet to mice at 200, 600 and 2000 mg/kg/day and to

rats at 250, 1000 and 2000 mg/kg/day for 2 years. A statistically significant increase

in the incidence of pancreatic acinar cell adenomas and carcinomas was found in

male

rats

receiving

high

dose;

no-effect

dose

occurrence

carcinomas was 1000 mg/kg/day.

Peak plasma concentrations of gabapentin in rats receiving the high dose of

2000 mg/kg were 10 times higher than plasma concentrations in humans receiving

3600 mg per day, and in rats receiving 1000 mg//kg/day peak plasma concentrations

were 6.5 times higher than in humans receiving 3600 mg/day. The pancreatic acinar

cell carcinomas did not affect survival, did not metastasize and were not locally

invasive. Studies to attempt to define a mechanism by which this relatively rare tumor

type is occurring are in progress. The relevance of this finding to carcinogenic risk in

humans in unclear.

Teratogenicity

Gabapentin is fetotoxic in rodents, causing delayed ossification of several bones in

the skull, vertebrae, forelimbs and hindlimbs. These effects occurred when pregnant

mice

received

oral

doses

1000

3000

mg/kg/day

during

period

organogenesis, or approximately 1 to 4 times the maximum dose of 3600 mg/day.

When rats were dosed prior to and during mating, and throughout gestation, pups

from all dose groups (500, 1000 and 2000 mg/kg/day) were affected. These doses

are equivalent to approximately to 1 to 5 times the maximum human dose. There was

an increased incidence of hydroureter or hydronephrosis in rats. The doses at which

the effects occurred are approximately equal to1 to 5 times the maximum human

dose of 3600 mg/day.

In rabbits, an increased incidence of postimplantation fetal loss occurred in dams

exposed to 60, 300 and 1500 mg/kg/day, or less than approximately equal to

to 8

times the maximum human dose.

Gabapentin Teva, 16. 7. 2015 , RH

Effect on Fertility and Reproduction

No adverse effects on fertility or reproduction were observed in rats at doses up to

2000 mg/kg (approximately 5 times the maximum recommended human dose on a

mg/m

basis).

Use in Pregnancy

Risk related to epilepsy and antiepileptic medicinal products in general

The risk of birth defects is increased by a factor of 2 – 3 in the offspring of mothers

treated with an antiepileptic medicinal product. Most frequently reported are cleft lip,

cardiovascular malformations and neural tube defects. Multiple antiepileptic drug

therapy may be associated with a higher risk of congenital malformations than

monotherapy, therefore it is important that monotherapy is practised whenever

possible.

Specialist advice should be given to women who are likely to become pregnant or

who are of childbearing potential and the need for antiepileptic treatment should be

reviewed when a woman is planning to become pregnant. No sudden discontinuation

of antiepileptic therapy should be undertaken as this may lead to breakthrough

seizures,

which

could

have

serious

consequences

both

mother

child.

Developmental delay in children of mothers with epilepsy has been observed rarely.

It is not possible to differentiate if the developmental delay is caused by genetic,

social factors, maternal epilepsy or the antiepileptic therapy.

Risk related to gabapentin

There are no adequate data from the use of gabapentin in pregnant women.

Studies in animals have shown reproductive toxicity. The potential risk for humans is

unknown. Gabapentin should not be used during pregnancy unless the potential

benefit to the mother clearly outweighs the potential risk to the foetus.

No definite conclusion can be made as to whether gabapentin is associated with an

increased risk of congenital malformations when taken during pregnancy, because of

epilepsy itself and the presence of concomitant antiepileptic medicinal products

during each reported pregnancy.

Use during Lactation

Gabapentin is secreted into human milk following oral administration. A nursed

infant could be exposed to a maximum dose of approximately 1 mg/kg/day of

gabapentin. Because the effect on the nursing infant is unknown, gabapentin should

be used in women who are nursing only if the benefits clearly outweigh the risks.

Use in Pediatrics

Safety and effectiveness in pediatric patients below the age of 12 years in epilepsy

have not been established.

Use in the indication for neuropathic pain is for adults over the age of 18 years.

Use in the Elderly

Safety and efficacy of gabapentin in geriatric patients have not been evaluated

systematically and clinical trials did not include sufficient number of patients older

than 65 years of age to determine whether they respond differently than do younger

patients. However, in clinical studies of the drug in patients ranging from 20-80 years

of age, gabapentin plasma clearance, renal clearance, and renal clearance adjusted

for body surface area declined with age. If gabapentin is used in geriatric patients,

the initial dosage may need to be reduced and caution should be exercised since

renal, hepatic and cardiovascular dysfunction and concomitant disease or other drug

therapy is more common in this age group than in younger patients.

Gabapentin Teva, 16. 7. 2015 , RH

Use

in

Patients

with

Impairment

of

Renal

Function

or

those

undergoing

Hemodialysis.

Mean plasma clearance of gabapentin decreases when administered to patients

with impaired

renal function. Therefore dosage

adjustment

is recommended in

patients with compromised renal function or those undergoing hemodialysis

Adverse Reactions

List of Compiled Adverse Reactions in Epilepsy (adjunctive and monotherapy) and

Neuropathic pain

The adverse reactions observed during clinical studies conducted in epilepsy (adjunctive and

monotherapy) and neuropathic pain have been provided in a single list below by class and

frequency: very common (≥ 1/10); common (≥ 1/100 to< 1/10); uncommon (≥ 1/1,000 to <

1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000). Where an adverse reaction was

seen at different frequencies in clinical studies, it was assigned to the highest frequency

reported.

Additional reactions reported from post-marketing experience are included as frequency Not

known (cannot be estimated from the available data) in italics in the list below.

Within each frequency grouping, undesirable effects are presented in order of decreasing

seriousness.

Body System

Adverse drug reactions

Infections and infestations

Very Common

viral infection

Common

pneumonia, respiratory infection, urinary tract infection, infection, otitis media

Blood and the lymphatic system disorders

Common

leucopenia

Not known

thrombocytopenia

Immune system disorders

Uncommon

allergic reactions (e.g. urticaria)

Not known

hypersensitivity syndrome, a systemic reaction with a variable presentation that can include

fever, rash, hepatitis, lymphadenopathy, eosinophilia, and sometimes other signs

and symptoms

Metabolism and Nutrition Disorders

Common

anorexia, increased appetite

Uncommon

hyperglycemia (most often observed in patients with diabetes)

Rare

hypoglycaemia (most often observed in patients with diabetes)

Not known

hyponatraemia

Psychiatric disorders

Common

hostility, confusion and emotional lability, depression, anxiety, nervousness,

thinking abnormal

Not known

hallucinations

Gabapentin Teva, 16. 7. 2015 , RH

Nervous system disorders

Very Common

somnolence, dizziness, ataxia

Common

convulsions, hyperkinesias, dysarthria, amnesia, tremor, insomnia, headache, sensations

such as paresthesia, hypaesthesia, coordination abnormal, nystagmus, increased,

decreased, or absent reflexes

Uncommon

hypokinesia, mental impairment

Rare

loss of consciousness

Not known

other movement disorders (e.g. choreoathetosis, dyskinesia, dystonia)

Eye disorders

Common

visual disturbances such as amblyopia, diplopia

Ear and Labyrinth disorders

Common

vertigo

Not known

tinnitus

Cardiac disorders

Uncommon

palpitations

Vascular disorders

Common

hypertension, vasodilatation

Respiratory, thoracic and mediastinal disorders

Common

dyspnoea, bronchitis, pharyngitis, cough, rhinitis

Gastrointestinal disorders

Common

vomiting, nausea, dental abnormalities, gingivitis, diarrhoea, abdominal pain, dyspepsia,

constipation, dry mouth or throat, flatulence

Not known

pancreatitis

Hepatobiliary disorders

Not known

hepatitis, jaundice

Skin and subcutaneous tissue disorders

Common

facial oedema, purpura most often described as bruises resulting from physical trauma,

rash, pruritus, acne

Not known

Stevens-Johnson syndrome, angioedema, erythema multiforme, alopecia, drug rash with

eosinophilia and systemic symptoms (see section 4.4)

Musculoskeletal and connective tissue disorders

Common

arthralgia, myalgia, back pain, twitching

Not known

rhabdomyolysis, myoclonus

Renal and urinary disorder

Not known

acute renal failure, incontinence

Reproductive system and breast disorders

Common

impotence

Not known

breast hypertrophy, gynaecomastia, sexual dysfunction (including changes in libido,

ejaculation disorders and anorgasmia)

Gabapentin Teva, 16. 7. 2015 , RH

General disorders and administration site conditions

Very Common

fatigue, fever

Common

peripheral oedema, abnormal gait, asthenia, pain, malaise, flu syndrome

Uncommon

generalized oedema

Not known

withdrawal reactions (mostly anxiety, insomnia, nausea, pains, sweating), chest pain.

Sudden unexplained deaths have been reported where a causal relationship to treatment

with gabapentin has not been established.

Investigations

Common

WBC (white blood cell count) decreased, weight gain

Uncommon

elevated liver function tests SGOT (AST), SGPT (ALT) and bilirubin

Not known

blood creatine phosphokinase increased

Injury and poisoning

Common

accidental injury, fracture, abrasion

Uncommon

fall

Under treatment with gabapentin cases of acute pancreatitis were reported. Causality

with gabapentin is unclear.

In patients on haemodialysis due to end-stage renal failure, myopathy with elevated

creatine kinase levels has been reported.

Respiratory tract infections, otitis media, convulsions and bronchitis were reported

only

clinical

studies

children.

Additionally,

clinical

studies

children,

aggressive behaviour and hyperkinesias were reported commonly.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is

important. It allows continued monitoring of the benefit/risk balance of the medicinal

product. Healthcare professionals are asked to report any suspected adverse

reactions to the Ministry of Health according to the National Regulation by using an

online form

(http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffe

ctMedic@moh.health.gov.il ) or by email (adr@MOH.HEALTH.GOV.IL ).

Postmarketing and Other Experience

addition

adverse

experiences

reported

during

clinical

testing

gabapentin,

following

adverse

experiences

have

been

reported

patients

receiving marketed gabapentin. These adverse experiences have not been listed

above and data are insufficient to support an estimate of their incidence or to

establish

causation.

listing

alphabetized:

angioedema,

blood

glucose

fluctuation, breast hypertrophy, erythema multiforme, elevated liver function tests,

fever, hyponatremia, jaundice, movement disorder, Stevens-Johnson syndrome.

Gabapentin Teva, 16. 7. 2015 , RH

Sudden, unexplained deaths have been reported where a causal relationship to

treatment

with

gabapentin

been

established.

Additional

post-marketing

adverse

effects

reported

include

blood

creatine

phosphokinase

increased,

rhabdomyolysis, acute kidney failure, renal impairment, allergic reaction including

urticaria, alopecia,a naemia, angioedema, convulsions, depersonalisation, urinary

incontinence, pancreatitis, erythema multiforme,*hypersensitivity including systemic

reactions, jaundice, movement disorders such as choreoathetosis, dyskinesia and

dystonia, myoclonus, speech disorder, sexual dysfunction, palpitation, tachycardia,

Stevens-Johnson syndrome, thrombocytopenia, tinnitus, blood glucose fluctuations in

patients with diabetes, breast hypertrophy, gynaecomastia,c ardiac arrest, chest

pain,

abnormal

liver

function

symptoms

psychosis

such

delusions,

hallucinations, and thinking abnormal.

Generalised edema, hepatitis, hypotension, neuropathy/peripheral neuropathy and

syncope have been rarely reported.

Adverse events following the abrupt discontinuation of gabapentin have also been

reported. The most frequently reported events were: anxiety, insomnia, nausea, pain

and sweating.

Sensory neuropathy has also been reported in a single patient being treated with

gabapentin .

Some cases of hypomania have been reported after commencement of gabapentin.

In each case, other anticonvulsants had been used concurrently, and symptoms of

hypomania resolved following a reduction in dosage or cessation of the drug.

*The following adverse effects have not been identified as specific to gabapentin.

However, antiepileptic drugs have been associated with an increased risk of suicidal

behavior, suicidal ideation and emergence or worsening of existing depression.

Precautions

(See also Warnings)

Because of the possibility of increased seizure frequency, anticonvulsant drugs,

including gabapentin, should not be discontinued suddenly. In controlled studies, the

incidence of status epilepticus was 0.6% in patients receiving gabapentin and 0.5%

in those receiving placebo. In all (uncontrolled and controlled) clinical studies of

gabapentin therapy, the incidence of status epilepticus was 1.5%. Because adequate

historical data are unavailable for comparison, it has not been established whether

the incidence of status epilepticus in patients treated with gabapentin is higher or

lower than would be expected in a similar population of patients not treated with the

drug. Discontinuance of gabapentin and/or addition of an alternative anticonvulsant

drug to existing therapy should be done gradually over a minimum of 1 week.

Effect on Ability to Drive and Operate Machinery

Gabapentin can produce drowsiness and dizziness, as well as possible blurred or

double vision. Therefore patients should be cautioned that the drug may impair their

ability

perform

hazardous

activities

requiring

mental

alertness

physical

coordination (e.g., operating machinery, driving a motor vehicle).

Drug Abuse and Dependence

The abuse and dependence potential of gabapentin has not been evaluated in

human studies.

Gabapentin Teva, 16. 7. 2015 , RH

Drug Interactions

Note

In vitro studies were conducted to investigate the potential of gabapentin to inhibit

the major cytochrome P450 enzymes (CYP1A2, CYP2A6, CYP2C9, CYP2C19,

CYP2D6, CYP2E1, and CYP3A4) that mediate drug and xenobiotic metabolism

using isoform selective marker substrates and human liver microsomal preparations.

Only at the highest concentration tested (171 µg/mL; 1 mM) was a slight degree of

inhibition (14%-30%) of isoform CYP2A6 observed. No inhibition of any of the other

isoforms

tested

observed

gabapentin

concentrations

µg/mL

(approximately 15 times the C

at 3600 mg/day).

Gabapentin is not appreciably metabolized nor does it interfere with the metabolism

of commonly coadministered antiepileptic drugs. Thus gabapentin may be used in

combination with other antiepileptic drugs without concern for alteration of the blood

concentrations of gabapentin or of other antiepileptic drugs

Gabapentin

steady-state

pharmacokinetics

similar

healthy

subjects

patients with epilepsy receiving these antiepileptic agents.

Gabapentin/Phenytoin/Carbamazepine/Valproic

Acid/Phenobarbital:

There

interaction between gabapentin and phenytoin, valproic acid, carbamazepine or

phenobarbital. Gabapentin steady-state pharmacokinetics are similar for healthy

subjects and patients with epilepsy receiving antiepileptic agents.

Gabapentin/Central Nervous System Depressants/Alcohol

: Concomitant administration

may lead to increased CNS depression.

Gabapentin/OpioidsMorphine

: There are spontaneous and literature case reports of

respiratory depression and/or sedation associated with gabapentin and opioid use. In

some of these reports, the authors considered this a particular concern with the

combination of gabapentin and opioids, especially in elderly patients.

In a study involving healthy volunteers, when a 60 mg controlled-release morphine

capsule was administered 2 hours prior to a 600

mg gabapentin capsule, mean

gabapentin AUC increased by 44% compared to gabapentin administered without

morphine.

Therefore,

patients

should

carefully

observed

signs

depression, such as somnolence, and the dose of gabapentin or morphine should be

reduced appropriately.

Gabapentin//Naproxen:

:

Coadministration)of naproxen sodium capsules (250 mg)

with gabapentin (125 mg) appears to increase the amount of gabapentin absorbed by

12%to 15%.Gabapentin had no effect on naproxen pharmacokinetic parameters.

These doses are lower than the therapeutic doses for both drugs. The magnitude of

interaction within the recommended dose ranges of either drug is not known.

Gabapentin/Hydrocodone

:

Coadministration

gabapentin

(125

decreases hydrocodone (10 mg) Cmax and AUC

values

in a dose-dependent

manner relative to administration of hydrocodone alone; Cmax and AUC values are

3%to 4% lower, respectively, after administration of 125 mg gabapentin and 21% to

22% lower, respectively, after administration of 500 mg gabapentin. The mechanism

for this interaction is unknown. Hydrocodone increases gabapentin AUC values by

14%.The magnitude of interaction at other doses is not known.

Gabapentin/Oral

Contraceptives:

Co-administration

gabapentin

with

oral

contraceptives including norethisterone and/or ethinyl estradiol does not influence the

steady-state pharmacokinetics of either component.

Gabapentin/Antacids:

In a clinical study where gabapentin and an aluminium and

magnesium

containing

antacid

were

given

same

time,

gabapentin’s

bioavailability

reduced

24%.

therefore

recommended

that

gabapentin be taken about two hours following any such antacid administration.

Gabapentin Teva, 16. 7. 2015 , RH

Gabapentin/Probenecid:

Renal excretion of gabapentin is unaltered by probenecid.

Gabapentin/Cimetidine

slight

decrease

renal

excretion

gabapentin

observed when co-administered with cimetidine is not expected to be of clinical

importance.

Drug/Food Interactions:

Food has no effect on gabapentin pharmacokinetics.

Effects on Ability to Drive and Use Machines

Gabapentin may have minor or moderate influence on the ability to drive and use

machines.

Gabapentin

acts

central

nervous

system

cause

drowsiness, dizziness or other related symptoms. Even, if they were only of mild or

moderate

degree,

these

undesirable

effects

could

potentially

dangerous

patients driving or operating machinery. This is especially true at the beginning of the

treatment and after increase in dose.

Drug Abuse and Dependence

Cases

abuse

dependence

have

been

reported

post-marketing

database. Carefully evaluate patients for a history of drug abuse and observe them

for possible signs of gabapentin abuse e.g. drug-seeking behaviour, dose escalation,

development of tolerance.

Diagnostic Interference

Because false positive readings were reported with the Ames N-Multistix SG,

dipstick test when gabapentin or placebo was added to other anticonvulsant drugs,

the more specific sulphosalicylic acid precipitation procedure is recommended to

determine urine protein.

Laboratory Tests

Clinical trials data do not indicate that routine monitoring of clinical laboratory

parameters is necessary for the safe use of gabapentin. The value of monitoring

blood concentrations has not been established..

False positive readings may be obtained in the semi-quantitative determination of

total urine protein by dipstick tests. It is therefore recommended to verify such a

positive dipstick test result by methods based on a different analytical principle such

Biuret

method,

turbidimetric

dye-binding

methods,

these

alternative methods from the beginning.

Information for Patients

Patients should be instructed to take gabapentin only as prescribed.

Patients

should

inform

physician

about

prescription

non-

prescription medications, alcohol, or drugs they are taking or plan to take

during their treatment with gabapentin.

Patients, their caregivers, and families should be counseled that AEDs,

including gabapentin ,

increase the risk of suicidal thoughts and behavior

and should be advised of the need to be alert for the emergence or worsening

of symptoms of depression, any unusual changes in mood or behavior, or the

emergence

suicidal

thoughts,

behavior,

thoughts

about

self-harm.

Behaviors of concern should be reported immediately to healthcare providers.

Patients

should

advised

that

gabapentin

cause

dizziness,

somnolence and other symptoms and signs of CNS depression. Accordingly,

they should be advised neither to drive a car nor to operate machinery until

they have gained sufficient experience on gabapentin to gauge whether or not

it affects their mental and/or motor performance adversely.

Gabapentin Teva, 16. 7. 2015 , RH

Patients who require concomitant treatment with morphine may experience

increases

gabapentin

concentrations.

Patients

should

carefully

observed for signs of CNS depression, such as somnolence, and the dose of

gabapentin or morphine should be reduced appropriately (see Warnings,

Drug Interactions).

Patients should inform the physician if they are pregnant, plan to become

pregnant, or if they become pregnant while you are taking gabapentin.

Gabapentin is excreted in human milk, and the effect on the nursing infant is

unknown. The patient should inform the physician in case she is breast

feeding an infant.

Gabapentin may impair your ability to drive a car or operate potentially

dangerous machinery. Until it is known that this medication does not affect

the patient’s ability to engage in these activities, the patient should not drive a

car or operate potentially dangerous machinery.

You should not allow more than 12 hours between gabapentin doses to

prevent breakthrough convulsions.

Prior

initiation

treatment

with

gabapentin,

patient

should

instructed that a rash or other signs or symptoms of hypersensitivity such as

fever or lymphadenopathy may herald a serious medical event and that the

patient should report any such occurrence to a physician immediately.

Drug abuse and dependence

The abuse and dependence potential of gabapentin has not been evaluated in

human studies.

Dosage and Administration

Gabapentin is given orally with or without food.

Epilepsy

Gabapentin Teva is recommended for add-on therapy in patients over 12 years of

age. Evidence bearing on its safety and effectiveness in children is not available.

When

judgment

clinician

there

need

dose

reduction,

discontinuation, or substitution with an alternative medication, this should be done

gradually over a minimum of one week.

Adults and pediatric patients over 12 years of age:

In clinical trials, the effective dosing range was 900 to 3600 mg/day. Therapy may

be initiated by administering 300 mg three times a day (TID) on Day 1, or by titrating

the dose as described in the Table Thereafter, the dose can be increased in three

equally divided doses up to a maximum dose of 3600 mg/day. Dosages up to 4800

mg/day

have

been

well

tolerated

long-term

open-label

clinical

studies.

maximum time between doses in the three times a day (TID) schedule should not

exceed 12 hours to prevent breakthrough convulsions.

Dosing Chart- Initial Titration

Dose

Day 1

Day 2

Day 3

900mg

300 mg QD

300 mgBID

300 mg TID

QD = once a day

BID = two times a day

TID = three times a day

Gabapentin Teva, 16. 7. 2015 , RH

necessary

monitor

gabapentin

plasma

concentrations

optimize

gabapentin therapy. Further, gabapentin may be used in combination with other

antiepileptic drugs without concern for alteration of the plasma concentrations of

gabapentin or serum concentrations of other antiepileptic drugs.

Neuropathic Pain

Peripheral neuropathic pain

Adults (over the age of 18)

Gabapentin should be titrated to a maximum dose of 1800 mg per day.

Titration to an effective dose can progress rapidly and can be accomplished over a

few days by administering 300 mg once a day on day 1, 300mg twice a day on day 2

and 300 mg three times a day on day 3, as described in the following table.

DOSING CHART - INITIAL TITRATION

Dose

Day 1

Day 2

Day 3

900mg

300mg

once a day

300mg

two times a day

300mg

three times a day

Thereafter, the dose can be increased using increments of 300 mg per day given in

three divided doses to a maximum of 1800 mg per day. It is not necessary to divide

the doses equally when titrating gabapentin.

necessary

monitor

gabapentin

plasma

concentrations

optimize

gabapentin therapy.

The maximum time between doses in a three times daily schedule should not exceed

12 hours. Gabapentin may be given orally with or without food.

If gabapentin is discontinued, or the dose reduced or substituted with an alternative

medication, this should be done gradually over a minimum of one week.

Dosage adjustment in impaired renal function for patients with epilepsy:

Dosage adjustment is recommended in patients with compromised renal function as

described in Table 2 and/or those undergoing hemodialysis.

Dosage of Gabapentin in Adults Based on Renal Function

Creatinine Clearance (mL/min)

Total Daily Dose

(mg/day)

≥ 80

900-3600

50-79

600-1800

30-49

300-900

15-29

-600

Total daily dose should be administered as a TID regimen. Doses used to treat patients with

normal renal function (creatinine clearance >80 mL/min) range from 900 to 3600 mg/day.

Reduced dosages are for patients with renal impairment (creatinine clearance < 79 mL/min).

To be administered as 300 mg every other day.

Dosage adjustment in patients undergoing hemodialysis:

For patients undergoing hemodialysis who have never received gabapentin, a

loading dose of 300 to 400 mg is recommended, then 200 to 300 mg of gabapentin

following each 4 hours of hemodialysis is recommended. On dialysis-free days, there

should be no treatment with gabapentin.

Gabapentin Teva, 16. 7. 2015 , RH

For renally impaired patients undergoing haemodialysis, the maintenance dose of

gabapentin should be based on the dosing recommendations found in Table 2. In

addition to the maintenance dose, an additional 200 to 300 mg dose following each

4-hour haemodialysis treatment is recommended.

Elderly

Elderly patients may require dosage adjustment because of declining renal function

with age.

Overdosage

A lethal dose of gabapentin was not identified in mice and rats receiving single oral

doses as high as 8000 mg/kg.

Manifestations

Signs

acute

toxicity

animals

included

ataxia,

labored

breathing,

ptosis,

sedation, hypoactivity, or excitation.

Acute oral overdose of gabapentin up to 49 grams have been reported. In these

cases,

double

vision,

slurred

speech,

drowsiness,

lethargy

diarrhea

were

observed.

patients

recovered

with

supportive

care.

Reduced

absorption

gabapentin at higher doses may limit drug absorption at the time of overdosing and,

hence, minimize toxicity from overdoses.

Treatment

Gabapentin can be removed by hemodialysis. Although hemodialysis has not been

performed in the few overdose cases reported, based on prior experience it is usually

not required .It may be indicated by the patient’s clinical state or in patients with

significant renal impairment.

An oral lethal dose of gabapentin was not identified in mice and rats given doses as

high as 8000 mg/kg. Signs of acute toxicity in animals included ataxia, labored

breathing, ptosis, hypoactivity, or excitation.

Registration Nos:

Gabapentin Teva Capsules 300 mg: 119.46.29956.00; 119 46 29956 01

Gabapentin Teva Capsules 400 mg: 119.47.29937.00; 119 47 29937 01

Gabapentin Teva Tablets 600 mg; 146.53.32979.00; 146.53.32979.01

Gabapentin Teva Tablets 800 mg; 146.54.32980.00; 146.54.32980.01

Storage

Gabapentin 300, 400 mg capsules

Store in a dry place below 25

Gabapentin 600, 800 mg Tablets

Store in a dry and dark place below 25

C. Store in the original pack.

Presentation

300 and 400 mg: Packs of 100 capsules.

600 and 800 mg: Packs of 60 tablets.

Manufacturer

Teva Pharmaceuticals Industries Ltd.

P.O.Box 3190, Petach Tikva.

העדוה העדוה

לע לע

הרמחה הרמחה

עדימ ( עדימ (

ןולעב )תוחיטב ןולעב )תוחיטב

ןכרצל ןכרצל

:ךיראת

19/02/2014

רישכת םש

:םושירה רפסמו תילגנאב

GABAPENTIN TEVA

Capsules300 mg: 119 46 29956 00; 119 46

29956 01

GABAPENTIN TEVA Capsules 400 mg: 119 47 29937 00; 119 47

29937 01

םושירה לעב םש

:

מ"עב תויטבצמרפ תוישעת עבט

ספוט

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תורמחהה

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יחכונ טסקט

שדח תורהזא תודחוימ תועגונה שומישל :הפורתב

/דמוע ךניה םא אפורל חוודל ךילע רחאמ תויתדבעמ תוקידב רובעל ת .תואצותל עירפהל לולע וז הפורתב לופיטו

רובעל דמוע ךניה םא אפורל חוודל ךילע לולע וז הפורתב לופיטו רחאמ תויתדבעמ תוקידב .תואצותל עירפהל תקידב רובעל דמוע ךנה םא .הפורתה תליטנ לע אפורל חוודל שי -ןתש שמשתהל ןיא ילבמ הפורתב ץעווהל ינפל אפורב תלחתה :לופיטה וא הקינמ וא ןוירהב ךניה םא ךניה םא דוקפיתב יוקילמ רבעב תלבס וא ת/לבוס ת/לבוס ךניה םא ,ןתשה תכרעמ/הילכה תוללוכה תותיווע יגוס המכ לש הערפהמ " ( "תורדעה" גוסמ תותיווע

absence

) "

הקינמ וא

הזילאידומהב לפוטמ ךניה םא

רפס השלוח וא/ו םירירש באכ חתפת םא ךאפורל

,םיפלוח אלש ןטב יבאכמ לבוס ךניה םא

תוליחב

תקלד לע עיבצהל םילולעה תואקהמ בלבלב ןכש ךלש אפורה םע ידיימ רשק רוצ

תקלד לע עיבצהל םילולע וליא םימוטפמיס בלבלב ןיב תובוגת תויתפורת הצמוח ירתוס, ןיפרומ יבגל דחוימב ,)םויזנגמו םוינימולא םיליכמה אמגודל( לוכיעה תכרעמב ביכב לופיטל תופורת לע תועיפשמה תופורת ,ןידיטמיס ןוגכ תופורת :ןוגכ( תיזכרמה םיבצעה תכרעמ .)ןוסניקרפ ,הנישל ,העגרהל

תוליכמה תופורת . ןיפרומ ןיפרומהש ןכתי עבט ןיטנפאבאג לש העפשהה תא לידגי

םיליכמה אמגודל( הצמוח ירתוס )םויזנגמו םוינימולא לוכיע תויעבל

יכ ץלמומ. רחאל םייתעש תוחפל חקלת עבט ןיטנפאבאג רתוס תליטנ

הצמוח

)לוכיעה תכרעמב ביכב לופיטל( ןידיטמיס הקנהו ןוירה

:

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תוירופה ליגב םישנ לע לופיטה תעב םיליעי העינמ יעצמאב שמתשהל הפורתב ברקב וז הפורתב שומישה לע םירקחמ ושענ אל תורחא תופורתב שומישב לבא ,תורה םישנ וע יפקתהב לופיטל יו תורה םישנ ברקב תוית ,קוניתה תוחפתהל קזנל ןוכיסב הילע התפצנ תחא הפורתמ רתויב היה שומישה םע דחוימב ע יפקתה תעינמל

,ןתינ םאב ,ןכל .תינמז וב תותיו ת קר לוטל יסנ

יפקתה תעינמל תחא הפו ועה יו אפורה תצעל םאתהב קרו ןוירהה ךשמב תוית ךלש ןכתייש תבשוח ,ןוירהב תאו הדימב דימ אפורל ינפ רישכתה תליטנ ןמזב ןוירה תננכתמ וא ןוירהב תאו

הפורתה תא לוטל יקיספת לא

ןכש תקספה הפורתב שומישה לולע

יטפליפא ףקתהל ליבוהל

ל םורגל לולעה תוכלשה רומח תו לע ךתואירב לעו רבועה

ךרד רבוע ,הפורתה לש ליעפה רמוחה ,ןיטנפאבאג הניא קוניתה לע היפשההש םושמ .םאה בלח הפורתב שומישה ןמזב קינהל ץלמומ אל ,העודי שמתשת דציכ הפורתב

?

ןיא ,ךתואירב בצמב רופיש לח םא םג אלל הפורתב לופיטה תא קיספהל .אפורה םע תוצעייתה םאתהב תיתגרדה היהת לופיטה תקספה .אפורה תוארוהל רתוי הובג ןונימ תועטב תלטנ םא ,הרכה ןדבוא :לולכל םילולע רתי ןונימ ינימסת םונמנ ,רורב אל רוביד ,הלופכ היאר ,תרוחרחס לושלשו

הפורתה תליטנ קיספמ התא םא ןפואב ןוכיסה ,אפור םע תוצעייתה אלל וא ,ימואתפ .רבגומ תותיוועל

הפורתב לופיטה תא קיספהל ןיא , לופיטה תקספה .אפורה םע תוצעייתה אלל וז הפורת הפלחה וא לופיטה לש ןונימב הדרוה תרחא הפורתב

תיתגרדה היהת

תוחפל ךשמב עובש

. .אפורה תוארוהל םאתהב ףיעסב האר(

תימואתפ הקספה בקע יאוול תועפות -הז ןולעב לופיטב

תועפות יאוול

:

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.!דימ אפורל הנפ- תותיוועב הרמחה

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העדוה העדוה

לע לע

הרמחה הרמחה

עדימ ( עדימ (

ןולעב )תוחיטב ןולעב )תוחיטב

ןכרצל ןכרצל

:ךיראת

19/02/2014

רישכת םש

:םושירה רפסמו תילגנאב

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םושירה לעב םש

:

מ"עב תויטבצמרפ תוישעת עבט

ספוט

הז

דעוימ

טוריפל

תורמחהה

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תורמחהה

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יחכונ טסקט

שדח תורהזא תודחוימ תועגונה שומישל :הפורתב

שמתשהל תוירופה ליגב םישנ לע לופיטה תעב םיליעי העינמ יעצמאב תאו הדימב דימ אפורל ינפ הפורתב וא ןוירהב תאו ןכתייש תבשוח ,ןוירהב רישכתה תליטנ ןמזב ןוירה תננכתמ

לע

םישנ

ליגב

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שמתשהל יעצמאב

העינמ

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לופיטה הפורתב תאו הדימב דימ אפורל ינפ וא ןוירהב תאו ןכתייש תבשוח ,ןוירהב רישכתה תליטנ ןמזב ןוירה תננכתמ ןיא שמשתהל הפורתב ץעווהל ילבמ ינפל אפורב תלחתה :לופיטה ,הקינמ ,ןוירה תננכתמ ,ןוירהב ךניה םא יוקילמ רבעב תלבס וא ת/לבוס ךניה םא ךנה םא ,ןתשה תכרעמ/הילכה דוקפיתב ת/לבוס ךניה םא ,הזילאידומהב ת/לפוטמ תוליחבמ ,םיפלוח אלש ןטב יבאכמ תקלד לע עיבצהל םילולעה תואקהמו גוסמ תותיוועמ ת/לבוס ךנה םא ,בלבלב "( "תורדעה"

absence

.)"

הקינמ וא

יוקילמ רבעב תלבס וא לבוס ךניה םא

ןתשה תכרעמ/הילכה דוקפיתב

הזילאידומהב לפוטמ ךניה םא רפס. וא/ו םירירש באכ חתפת םא ךאפורל השלוח

םא

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ןטב

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"

absence

) "

ןיב תובוגת :תויתפורת םיבצעה תכרעמ לע תועיפשמה תופורת ,הנישל ,העגרהל תופורת :ןוגכ( תיזכרמה הצמוח ירתוס ,ןידיטמיס ,)ןוסניקרפל ,)םויזנגמו םוינימולא םיליכמה אמגודל( .ןיפרומ תוליכמה תופורת

תוליכמה תופורת ןיפרומ

ןיפרומהש ןכתי עבט ןיטנפאבאג לש העפשהה תא לידגי

םיליכמה אמגודל( הצמוח ירתוס )םויזנגמו םוינימולא

לוכיע תויעבל

ץלמומ. םייתעש תוחפל חקלת עבט ןיטנפאבאג יכ הצמוח רתוס תליטנ רחאל

ןידיטמיס

)לוכיעה תכרעמב ביכב לופיטל(

םיבצעה תכרעמ לע תועיפשמה תופורת ,הנישל ,העגרהל תופורת :ןוגכ( תיזכרמה .)ןוסניקרפ ןוירה הקנהו

:

,ןוירהב תאו הדימב דימ אפורל ינפ תננכתמ וא ןוירהב תאו ןכתייש תבשוח רישכתה תליטנ ןמזב ןוירה ןכ םא אלא ,ןוירהה ךלהמב הפורתה תא לוטל ןיא התחקל ןתינש עבק ךאפור

ליגב םישנ לע תעב םיליעי העינמ יעצמאב שמתשהל תוירופה הפורתב לופיטה ברקב וז הפורתב שומישה לע םירקחמ ושענ אל תורחא תופורתב שומישב לבא ,תורה םישנ התפצנ תורה םישנ ברקב תויתוע יפקתהב לופיטל םע דחוימב ,קוניתה תוחפתהל קזנל ןוכיסב הילע יפקתה תעינמל תחא הפורתמ רתויב היה שומישה קר לוטל יסנ ,ןתינ םאב ,ןכל .תינמז וב תותיוע ךשמב תויתועה יפקתה תעינמל תחא הפוקת ךלש אפורה תצעל םאתהב קרו ןוירהה

ןכתייש תבשוח ,ןוירהב תאו הדימב דימ אפורל ינפ רישכתה תליטנ ןמזב ןוירה תננכתמ וא ןוירהב תאו

ליבוהל לולע הז ןכש הפורתה תא לוטל יקיספת לא הרומח האצותל םורגל לולעה יטפליפא ףקתהל ךקונית לעו ךילע

ךרד רבוע ,הפורתה לש ליעפה רמוחה ,ןיטנפאבאג הניא קוניתה לע העפשההש םושמ .םאה בלח הפורתב שומישה ןמזב קינהל ץלמומ אל ,העודי

דציכ שמתשת הפורתב

?

שי בוצק ןמזב וז הפורת לוטיל תחכש םא ןפוא םושב ךא ;תרכזנשכ דימ הנמ לוטיל .דחיב תונמ יתש לוטיל ןיא י"ע ץלמוהש לופיטה תא םילשהל ךילע .אפורה ןיא ךתואירב בצמב רופיש לח םא םג אלל הפורתב לופיטה תא קיספהל לופיטה תקספה.אפורה םע תוצעייתה .אפורה תוארוהל םאתהב תיתגרדה היהת ןיא

רובעל

לע

הנמה

תצלמומה

םא

תחכש

לוטיל

הפורת

וז

ןמזב

שי ,בוצקה לוטיל

הנמ

דימ

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ךא

םושב

ןפוא

ןיא לוטל

יתש

תונמ

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דימתהל

לופיטב

יפכ

ץלמוהש

י"ע

אפורה

םא

תלטנ

תועטב

ןונימ

הובג

רתוי

ינימסת

ןונימ

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םילולע

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,הרכה היאר ,תרוחרחס

רוביד ,הלופכ

אל

,רורב םונמנ/תופייע

,לושלשו הנפ

דימ

אפורל

וא רדחל

ןוימ

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תזירא

הפורתה

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םא

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תליטנ

הפורתה

ןפואב

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םע

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תותיוועל רבגומ

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הפורתב

אלל תוצעייתה

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הדרוה ןונימב

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לופיטה

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הפלחה

הפורת

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הפורתב תרחא

היהת

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ךשמב

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ףיעסב

ןולעב תועפות -הז

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תולולע( דאמ תוצופנ -מ רתויב עיפוהל

ךותמ

:)םישנא רסוח ,רורחס ,תוינונשי ,ילאריו םוהיז .םוח ,תופייע ,היצנידרואוק עיפוהל תולולע( תוצופנ יאוול תועפות -מ רתויב

ךותמ

תקלד :)םישנא םימוהיז ,המישנה יכרדב םימוהיז ,תואיר םימוהיז וא םיינזוא תקלד ,ןתשה יכרדב רחא גוסמ

הכומנ םינבל םד יאת תריפס

רבגומ ןובאית ,היסקרונא

יפלכ סעכ ,חורה בצמב םייוניש ,לובלב ,םירחא בושחל ישוק ,תונבצע ,הדרח ,ןואכיד

,רוביד יישק ,תויתיווע תועונת ,תויוצווכתה רוע ,שאר באכ ,הניש יישק ,דער ,החכש יישק ,)תוהק( תושיגרב התחפה ,שיגר ,תוליגר אל םייניע תועונת ,היצנידרואוק םיסקלפר רסוח וא השלחה וא הרבגה

הלופכ היאר ,תשטשוטמ היאר

תרוחרחס

ילכ לש הבחרה וא הקמסה ,םד ץחל רתי םד

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תויעב ,הליחב ,האקה ,ןטב באכ ,לושלש ,םייכינח תקלד ,םייניש ,ןורגב וא הפב שבוי ,תוריצע ,לוכיע יישק תוחיפנ

,תורובח ,םינפה תוחפנתה תועפות

יאוול

תובייחמה

תוסחיתה

,תדחוימ הדימב

תועפותהו

תואבה

תושחרתמ

הנפ

דימ :אפורל

תובוגת

תורומח

רועב

תוללוכה

םינמיס

:ןוגכ ,דרג תוימומדא

וא/ו

תרישנ

רעיש

תוחפנתה לש

םייתפש

הו םינפ םילולע ,

תויהל

םינימסת לש

הבוגת

תיגרלא

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באכ

ןטב

ךשמתמ

תוליחב ,

םילולע ,תואקהו תויהל

םינימסת

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תקלד

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הבוגתל

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רשק

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דחאמ

םימוטפמיסה

םיאבה

החירפ

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רועב

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הנקא ,ץוצקע

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םירבגב תונוא ןיא

,הכילה יישק ,תועורזו םיילגר תוחפנתה םינימסת ,ילוח תשגרה ,באכ ,השלוח תעפש ייומד

םד יאת תומכב הדירי לקשמב הילע ,םינבל

,תירקמ העיצפ ףושפש ,רבש

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ךותמ

1000

הבוגת :)םישנא קפוד ,העונתב הדירי ,תלרח ןוגכ תיגרלא לולכל הלולעה תוחפנתה ,ריהמ

תא לש תוגירח תואצות ,םייפגהו ףוגה ,םינפה תויעב לע תועיבצמה הדבעמ תוקידב .דבכב תועפות וחווד הפורתה קוויש תליחת זאמ השירק תויסטב הדירי :תואבה יאוולה תוגירח תועונת לש תויעב ,תויזה ,םדב ,תושקונו תויתיווע תועונת ,תולתפתה ןוגכ יאוול תועפות תצובק ,םיינזואב םילוצלצ ,תוחופנ הפמיל תוטולב לולכל הלוכיה ,דחי םיעיפומה דבכ תקלדו החירפ ,םוח תחירב ,יתיילכ לשכ ,דבכ תקלד ,תבהצ ,םיידש תלדגה ,דש תמקר תלדגה ,ןתש תימואתפ הקספה בקע יאוול תועפות ,באכ ,הליחב ,הניש יישק ,הדרח( לופיטב רכוסה תמרב תודונת ,הזחב באכ ,)העזה .תרכס ילוחב םדב :תדחוימ תוסחייתה תובייחמה תועפות תימומדאו החירפ ,רועב תורומח תובוגת תוחפנתה ,רעיש דוביא ,דרג ,רועב !דימ אפורל י/הנפ – םינפהו םייתפשה תויהל םילולע תואקהו תוליחב ,ןטב באכ אפורל י/הנפ - בלבלב תקלד לש םינמיס !דימ ,תוחופנ תוטולב ,םוח ,רועב החירפ ,םימומיד וא תוירוע תורובח תעפוה רועה תבהצה ,ןושלהו םייתפשה תוחפנתה השלוח וא תופייע ,םייניעהו ,םירומח םילולע – תורזוח תוקלד ,םירירש באכ י/הנפ -תיגרלא הבוגת לש םינמיס תויהל !דימ אפורל לש היצנידרואוקב ישוק( היסקטא יתלב תועונת ,)תוביצי רסוח ,םירירשה חורה בצמב םייוניש ,םייניעה לש תוינוצר האר – תונבצעו הדרח ,ןואכיד :ןוגכ( תינפקות תוגהנתה ינמיס ,)תורהזא !דימ אפורל י/הנפ :)רידנ( ,םינפה לש רקיעב ,תוינוצר אל תועונת :תותיוועב הרמחה וא ,םייפגה וא ןושלה .דימ אפורל י/הנפ וא רצוק ,ריהמ קפוד ,תויזה ,הזחב באכ תדרגמ החירפ( תדפרס וא/ו המישנ יישק .דימ אפורל י/הנפ ,)רועב דחוימב( השלוח וא/ו םירירש יבאכ תעפוה י/הנפ :)הזילאידב ת/לפוטמ ךנה םא .אפורל תימצע העיגפ לע וא תוינדבוא תובשחמ

תוחפנתה

םייתפשה

ןושלהו

תבהצה

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הדירי

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לקשמב

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אל

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Stevens-Johnson

לולע( אטבתהל

ףוליק ,תויחופלשב

וא

םומיד

לש רועה

ביבסמ

ףא ,הפ ,םייניע ,םייתפשל ירבאו

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ייומד

תעפש

םוחו )הובג שי -

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אפורל

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םדב

םא דחוימב באכ וא תושיגר ,םירירש תשלוח םניהש ןכתי םוחב וא הבוט אל השגרהב הוולמ לולעש ליגר יתלב רירש קוריפ לש םינמיס תויתפורת ןיב תובוגתו יאוול תועפות תוקוניתבו םידליב לכ לע לפטמה אפורל חוודל םירוהה לע תפסונ הפורת לכ לע ןכו יאוול תועפות .ה/דליל תנתינה ןכתי .הילכב תויעבל ליבוהלו םייח ןכסל ויהיו עבצ רסח היהי ךלש ןתשה ףסונבש תומרב היילע( םד תקידב תואצותב םייוניש !דימ אפורל הנפ -)םדב זאניקופסופ ןיטארק

.!דימ אפורל הנפ- תותיוועב הרמחה

וא ןושלה ,םינפה לש רקיעב ,תוינוצר אל תועונת םייפגה

!דימ אפורל תונפל שי :)רידנ(

העדוה העדוה

לע לע

הרמחה הרמחה

(

(

עדימ עדימ

ןולעב )תוחיטב ןולעב )תוחיטב

ל

ל

אפור אפור

ןכדועמ( ןכדועמ(

05.2013

05.2013

ךיראת

________

February 19, 2014

____

םש

רישכת

תילגנאב

רפסמו

םושירה

GABAPENTIN TEVA Capsules300 mg: 119 46 29956 00; 119

46 29956 01

GABAPENTIN TEVA Capsules 400 mg: 119 47 29937 00; 119

47 29937 01

GABAPENTIN TEVA Tablets 600 mg:

146.53.32979.00; 146.53.32979.01

GABAPENTIN TEVA Tablets 800 mg:

146.54.32980.00; 146.54.32980.01

םושירה לעב םש

:

מ"עב תויטבצמרפ תוישעת עבט

ספוט

הז

דעוימ

טורפל

תורמחהה

דבלב

תורמחהה

תושקובמה קרפ

ןולעב טסקט

יחכונ טסקט

שדח

Posology, dosage &

administration

Epilepsy

Gabapentin Teva is recommended for add-on

therapy in patients over 12 years of age.

Evidence bearing on its safety and effectiveness

in children is not available.

The effective dose of gabapentin is 900 to

1800 mg/day and may be given in divided doses

(3 times a day) using 300 mg or 400-mg

capsules. Titration to an effective dose can take

place rapidly over a few days, giving 300 mg on

Day 1, 300 mg twice a day on Day 2, and

300 mg three times a day on Day 3. To minimize

potential side effects, especially somnolence,

dizziness, fatigue, and ataxia, the first dose on

Day 1 may be administered at bedtime. If

necessary, the dose may be increased 3 times a

1800 mg/day.

Dosage

Epilepsy

Gabapentin Teva is recommended for add-on therapy in

patients over 12 years of age. Evidence bearing on its

safety and effectiveness in children is not available.

When in the judgment of the clinician there is a need for

dose reduction, discontinuation, or substitution with an

alternative medication, this should be done gradually over

a minimum of one week.

Adults and pediatric patients over 12 years of age:

In clinical trials, the effective dosing range was 900 to

3600 mg/day. Therapy may be initiated by administering

300 mg three times a day (TID) on Day 1, or by titrating

the dose as described in Table 1. Thereafter, the dose can

be increased in three equally divided doses up to a

maximum dose of 3600 mg/day. Dosages up to 4800

mg/day have been well tolerated in long-term open-label

clinical studies. The maximum time between doses in the

2400 mg/day have been well tolerated in long-

term clinical studies. Doses of 3600 mg/day have

also been administered to a small number of

patients for a relatively short duration, and have

been well tolerated. The maximum time between

doses in the t.i.d. schedule should not exceed

12 hours.

necessary

monitor

gabapentin plasma concentrations to optimize

gabapentin therapy. Further, because there are no

significant pharmacokinetic interactions among

gabapentin

other

commonly

used

antiepileptic drugs, the addition of gabapentin

does not alter the plasma level of these drugs

appreciably.

If gabapentin is discontinued and/or an

alternate anticonvulsant medication is added to

the therapy, this should be done gradually over a

minimum of 1 week.

Dosage adjustment in patients with

compromised renal function or undergoing

hemodialysis is recommended as follows:

The effective dose of gabapentin is 900 to

1800 mg/day and may be given in divided doses

(3 times a day) using 300 mg or 400-mg

capsules. Titration to an effective dose can take

place rapidly over a few days, giving 300 mg on

Day 1, 300 mg twice a day on Day 2, and

300 mg three times a day on Day 3. To minimize

potential side effects, especially somnolence,

dizziness, fatigue, and ataxia, the first dose on

Day 1 may be administered at bedtime. If

necessary, the dose may be increased 3 times a

day up to 1800 mg/day. Dosage up to

2400 mg/day have been well tolerated in long-

term clinical studies. Doses of 3600 mg/day have

also been administered to a small number of

patients for a relatively short duration, and have

been well tolerated. The maximum time between

doses in the t.i.d. schedule should not exceed

12 hours. It is not necessary to monitor

gabapentin plasma concentrations to optimize

gabapentin therapy. Further, because there are no

significant pharmacokinetic interactions among

gabapentin and other commonly used

antiepileptic drugs, the addition of gabapentin

does not alter the plasma level of these drugs

appreciably.

If gabapentin is discontinued and/or an

alternate anticonvulsant medication is added to

the therapy, this should be done gradually over a

minimum of 1 week.

Dosage adjustment in patients with

compromised renal function or undergoing

hemodialysis is recommended as follows:

Gabapentin Teva Dosage Based on Renal Function

Renal Function

Creatinine

Clearance

(ml/min)

Total Daily Dose

(mg/day)

Dose Regimen

(mg)

>60

1200

400 t.i.d..

30-60

300 b.i.d..

15-30

300 O.D.

<15

300 Q.O.D.*

Hemodialysis

200-300**

Every other day.

three times a day (TID) schedule should not exceed 12

hours to prevent breakthrough convulsions.

Dosing Chart- Initial Titration

Dose

Day 1

Day 2

Day 3

900 mg

300 mg QD

300 mg BID

300 mg TID

QD = once a day

BID = two times a day

TID = three times a day

It is not necessary to monitor gabapentin plasma concentrations to

optimize gabapentin therapy. Further, gabapentin may be used in

combination with other antiepileptic drugs without concern for

alteration of the plasma concentrations of gabapentin or serum

concentrations of other antiepileptic drugs.

Dosage adjustment in impaired renal function for patients with

epilepsy:

1

Dosage adjustment is recommended in patients with compromised

renal function as described in Table 2 and/or those undergoing

hemodialysis.

Dosage of Gabapentin in Adults Based on Renal Function

Creatinine Clearance (mL/min)

Total Daily Dose

(mg/day)

≥ 80

900-3600

50-79

600-1800

30-49

300-900

15-29

-600

-300

Creatinine Clearance (mL/min)

Total Daily Dose

(mg/day)

≥ 80

900-3600

50-79

600-1800

30-49

300-900

15-29

-600

-300

Total daily dose should be administered as a TID regimen.

Doses used to treat patients with normal renal function

(creatinine clearance >80 mL/min) range from 900 to 3600

mg/day. Reduced dosages are for patients with renal

impairment (creatinine clearance < 79 mL/min).

To be administered as 300 mg every other day.

Dosage adjustment in patients undergoing

hemodialysis:

For patients undergoing hemodialysis who have never

received gabapentin, a loading dose of 300 to 400 mg is

recommended, then 200 to 300 mg of gabapentin following

each 4 hours of hemodialysis.

Loading dose of 300 to 400 mg in patients who

have never received gabapentin, then 200 to 300 mg

gabapentin following each 4 hours of hemodialysis.

Special Warnings

and Special

Precautions for Use

Drug Rash with Eosinophilia and Systemic Symptoms

(DRESS)

Severe,

life-threatening,

systemic

hypersensitivity

reactions such as Drug rash with eosinophilia and systemic

symptoms (DRESS) have been reported in patients taking

antiepileptic drugs including gabapentin.

It is important to note that early manifestations of

hypersensitivity, such as fever or lymphadenopathy, may

be present even though rash is not evident. If such signs or

symptoms are present, the patient should be evaluated

immediately. Gabapentin should be discontinued if an

alternative etiology for the signs or symptoms cannot be

established.

Information for

patients

Patients should inform the physician if they are pregnant,

plan to become pregnant, or if they become pregnant while

you are taking gabapentin.

You should not allow more than 12 hours between

gabapentin doses to prevent breakthrough convulsions.

Prior to initiation of treatment with gabapentin, the patient

should be instructed that a rash or other signs or symptoms

of hypersensitivity such as fever or lymphadenopathy may

herald a serious medical event and that the patient should

report any such occurrence to a physician immediately

Overdosage

A lethal dose of gabapentin was not identified in mice

and rats receiving single oral doses as high as

8000 mg/kg.

Manifestations

Signs of acute toxicity in animals included ataxia,

labored breathing, ptosis, sedation, hypoactivity, or

excitation.

Acute oral overdose of gabapentin up to 49 grams

have been reported. In these cases, double vision,

slurred speech, drowsiness, lethargy and diarrhea were

observed. All patients recovered with supportive care.

Treatment

Gabapentin can be removed by hemodialysis.

Although hemodialysis has not been performed in the

few overdose cases reported, .It may be indicated by

the patient’s clinical state or in patients with significant

renal impairment.

A lethal dose of gabapentin was not identified in mice and rats

receiving single oral doses as high as 8000 mg/kg.

Manifestations

Signs of acute toxicity in animals included ataxia, labored

breathing, ptosis, sedation, hypoactivity, or excitation.

Acute oral overdose of gabapentin up to 49 grams have been

reported. In these cases, double vision, slurred speech, drowsiness,

lethargy and diarrhea were observed. All patients recovered with

supportive care. Reduced absorption of gabapentin at higher doses

may limit drug absorption at the time of overdosing and, hence,

minimize toxicity from overdoses.

Treatment

Gabapentin can be removed by hemodialysis. Although

hemodialysis has not been performed in the few overdose cases

reported, based on prior experience it is usually not required

may be indicated by the patient’s clinical state or in patients with

significant renal impairment.

An oral lethal dose of gabapentin was not identified in mice and

rats given doses as high as 8000 mg/kg. Signs of acute toxicity in

animals included ataxia, labored breathing, ptosis, hypoactivity, or

excitation.

Drug abuse and

dependence

The abuse and dependence potential of gabapentin has not

been evaluated in human studies

Interaction with

Other Medicaments

and Other Forms of

Interaction

In vitro studies were conducted to investigate the potential

of gabapentin to inhibit the major cytochrome P450

enzymes

(CYP1A2,

CYP2A6,

CYP2C9,

CYP2C19,

CYP2D6, CYP2E1, and CYP3A4) that mediate drug and

xenobiotic metabolism using isoform selective marker

substrates and human liver microsomal preparations.

Only at the highest concentration tested (171 µg/mL; 1

mM) was a slight degree of inhibition (14%-30%) of

isoform CYP2A6 observed. No inhibition of any of the

other

isoforms

tested

observed

gabapentin

concentrations up to 171 µg/mL (approximately 15 times

the Cmax at 3600 mg/day).

Fertility,

pregnancy and

Lactation

Adverse events

Postmarketing and Other Experience

In addition to the adverse experiences reported

during clinical testing of gabapentin, the

following adverse experiences have been

reported in patients receiving marketed

gabapentin. These adverse experiences have not

been listed above and data are insufficient to

support an estimate of their incidence or to

establish causation. The listing is alphabetized:

angioedema, blood glucose fluctuation, breast

hypertrophy, erythema multiforme, elevated liver

function tests, fever, hyponatremia, jaundice,

movement disorder, Stevens-Johnson syndrome.

Sudden, unexplained deaths have been reported

where a causal relationship to treatment with

gabapentin has not been established. Additional

post-marketing adverse effects reported include

acute kidney failure, renal impairment, allergic

reaction including urticaria, alopecia,a naemia,

angioedema, convulsions, depersonalisation,

urinary incontinence, pancreatitis, erythema

multiforme,*hypersensitivity including systemic

reactions, jaundice, movement disorders such as

choreoathetosis, dyskinesia and dystonia,

myoclonus, speech disorder, sexual dysfunction,

palpitation, tachycardia, Stevens-Johnson

syndrome, thrombocytopenia, tinnitus, blood

glucose fluctuations in patients with diabetes,

breast hypertrophy, gynaecomastia,c ardiac

arrest, chest pain, abnormal liver function and

symptoms of psychosis such as delusions,

hallucinations, and thinking abnormal.

Generalised edema, hepatitis, hypotension,

neuropathy/peripheral neuropathy and syncope

have been rarely reported.

Withdrawal from treatment due to adverse events:

1

Adjunctive therapy:

Approximately 7% of the more than 2000 healthy

volunteers and patients with epilepsy, spasticity, or

migraine who received gabapentin in clinical studies

withdrew due to adverse events.

In all clinical studies, the most frequently occurring

events that contributed to discontinuation of gabapentin

included somnolence, ataxia, dizziness, fatigue, nausea

and/or vomiting. Almost all participants had multiple

complaints, none of which could be characterized as

primary.

Monotherapy:

Approximately 8% of the 659 patients who received

gabapentin as monotherapy or conversion to monotherapy

in pre-marketing trials discontinued treatment because of

an adverse event. The adverse events most somnolence.

Pediatric:

Approximately 8% of the 292 children age 3 to 12 years

who received gabapentin in clinical trials discontinued

treatment because of an adverse event. The adverse events

most commonly associated with withdrawal in children

were somnolence, hyperkinesia, and hostility.

Neuropathic pain:

Summary of Treatment-Emergent Signs and Symptoms

in ≥1% of Gabapentin-Treated Patients in Neuropathic

Pain Placebo-Controlled Studies

COSTART

Body System

Adverse Event

Gabapentin

N=821

N

of

Pts

(%)

Placebo

N=537

N

of

Pts

(%)

Body as

a Whole

Abdomi

nal Pain

Accident

al Injury

Asthenia

Back

Pain

Syndrom

Headach

Infection

Pain

Digestiv

e System

Constipa

tion

Diarrhea

Mouth

Dyspeps

Flatulen

Nausea

Vomitin

Metaboli

Nutrition

Peripher

Edema

Weight

Gain

Nervous

System

Abnorm

al Gait

Amnesia

Ataxia

Confusio

Dizzines

Hypesth

esia

Somnole

Thinking

Abnorm

Tremor

Vertigo

21.1

16.1

Respirat

System

Dyspnea

Pharyngi

Skin and

Appenda

Rash

Special

Senses

Ambylo

Postmarketing and Other Experience

In addition to the adverse experiences reported during

clinical testing of gabapentin, the following adverse

experiences have been reported in patients receiving

marketed gabapentin. These adverse experiences have not

been listed above and data are insufficient to support an

estimate of their incidence or to establish causation. The

listing is alphabetized: angioedema, blood glucose

fluctuation, breast hypertrophy, erythema multiforme,

elevated liver function tests, fever, hyponatremia, jaundice,

movement disorder, Stevens-Johnson syndrome.

Sudden, unexplained deaths have been reported where a

causal relationship to treatment with gabapentin has not

been established. Additional post-marketing adverse

effects reported include blood creatine phosphokinase

increased, rhabdomyolysis,

acute kidney failure, renal

impairment, allergic reaction including urticaria, alopecia,a

naemia, angioedema, convulsions, depersonalisation,

urinary incontinence, pancreatitis, erythema

multiforme,*hypersensitivity including systemic reactions,

jaundice, movement disorders such as choreoathetosis,

dyskinesia and dystonia, myoclonus, speech disorder,

sexual dysfunction, palpitation, tachycardia, Stevens-

Johnson syndrome, thrombocytopenia, tinnitus, blood

glucose fluctuations in patients with diabetes, breast

hypertrophy, gynaecomastia,c ardiac arrest, chest pain,

abnormal liver function and symptoms of psychosis such

as delusions, hallucinations, and thinking abnormal.

Generalised edema, hepatitis, hypotension,

neuropathy/peripheral neuropathy and syncope have been

rarely reported.

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