GABAPENTIN

Main information

  • Trade name:
  • GABAPENTIN GH gabapentin 400 mg capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GABAPENTIN GH gabapentin 400 mg capsule blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219922
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219922

GABAPENTIN GH gabapentin 400 mg capsule blister pack

ARTG entry for

Medicine Registered

Sponsor

Sandoz Pty Ltd

Postal Address

54 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

24/11/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. GABAPENTIN GH gabapentin 400 mg capsule blister pack

Product Type

Single Medicine Product

Effective date

15/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults and children age 3 years and

above who have not achieved adequate control with standard antiepileptic medicines. Treatment of neuropathic pain.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PE/PVDC/Al

24 Months

Store below 30

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

100 capsules

(S4) Prescription Only Medicine

Components

1. GABAPENTIN GH gabapentin 400 mg capsule blister pack

Dosage Form

Capsule

Route of Administration

Oral

Visual Identification

Capsule with brown body & cap

Active Ingredients

Gabapentin

400 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 03:12:54 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

GABAPENTIN GH

CONSUMER MEDICINE INFORMATION

Gabapentin GH

gabapentin capsules

WHAT IS IN THIS

LEAFLET

This leaflet answers some common

questions about Gabapentin GH.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risk of you taking this medicine

against the benefits they expect it

will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

WHAT GABAPENTIN

GH IS USED FOR

This medicine is used to control

epilepsy. Epilepsy is a condition

where you have repeated seizures

(fits). There are many different types

of seizures, ranging from mild to

severe.

It contains the active ingredient

gabapentin and belongs to a group of

medicines called anticonvulsants.

It is thought to work by controlling

brain chemicals which send signals

to nerves to help control seizures or

neuropathic pain.

This medicine may also be used to

treat neuropathic pain (pain due to

nerves being damaged or affected).

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed it

for another reason.

Gabapentin GH also has analgesic

effects.

This medicine is not addictive.

This medicine is available only with

a doctor's prescription.

Gabapentin GH is not recommended

for the use in children under the age

of 3 years to control epilepsy, or in

children under the age of 18 years for

the treatment of neuropathic pain.

The safety and effectiveness of

Gabapentin GH in these age groups

have not been established.

BEFORE YOU TAKE

GABAPENTIN GH

When you must not take it

Do not take this medicine if you

have an allergy to:

gabapentin, the active ingredient,

or to any of the other ingredients

listed at the end of this leaflet

under Product Description.

any other similar medicines

especially barbiturates or any

other anticonvulsant medicines.

Some of the symptoms of an allergic

reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the skin.

Do not take this medicine after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

If it has expired or is damaged, return

it to your pharmacist for disposal.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to take it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

kidney problems

mixed seizure disorders that

include absence seizures.

Tell your doctor if you are

pregnant or intend to become

pregnant.

Gabapentin GH may affect your

developing baby if you take it during

pregnancy. However, it is very

important to control your fits while

you are pregnant. If it is necessary

for you to take this medicine, your

GABAPENTIN GH

doctor will discuss with you the risks

and benefits involved.

Tell your doctor if you are

breastfeeding or plan to

breastfeed.

Your doctor will discuss the possible

risks and benefits of using this

medicine during breastfeeding.

Gabapentin Sandoz passes into breast

milk. The effect on your breast-fed

baby is unknown.

If you do breastfeed, watch your

baby carefully. If your baby

develops a skin rash or has unusual

symptoms, don't breastfeed again

until you speak to your doctor.

If you have not told your doctor

about any of the above, tell

him/her before you start taking

Gabapentin GH.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines and Gabapentin

GH may interfere with each other.

These include:

cimetidine, a medicine used to

treat stomach or duodenal ulcers

or reflux

antacids, medicines used to treat

heartburn or reflux

morphine, a medicine used to

control pain.

These medicines may be affected by

Gabapentin GH, or may affect how

well it works. You may need

different amounts of your medicines,

or you may need to take different

medicines.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

this medicine.

HOW TO TAKE

GABAPENTIN GH

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions, ask your doctor or

pharmacist for help.

How much to take

Your doctor will tell you how many

capsules you will need to take each

day. This may depend on your age,

your condition and whether or not

you are taking any other medicines.

Your doctor may recommend that

you start with a low dose of

Gabapentin GH and slowly increase

the dose to the lowest amount needed

to control your epilepsy or

neuropathic pain.

Ask your doctor or pharmacist if

you are unsure of the correct dose

for you.

They will tell you exactly how much

to take.

Follow the instructions they give

you.

If you take the wrong dose,

Gabapentin GH may not work as

well and your problem may not

improve.

How to take it

Swallow the capsules whole with a

full glass of water.

When to take Gabapentin

GH

Take your medicine at about the

same time each day.

Taking it at the same time each day

will have the best effect. It will also

help you remember when to take it.

It does not matter if you take this

medicine before or after food.

If you need to take an antacid, take

it at least 2 hours before or 2 hours

after your dose of Gabapentin GH.

How long to take it

Continue taking your medicine for

as long as your doctor tells you.

This medicine helps control your

condition, but does not cure it. It is

important to keep taking your

medicine even if you feel well.

If you forget to take it

Take your dose as soon as you

remember, and continue to take it as

you would normally.

If you have missed a dose by more

than 4 hours, skip the dose you

missed and take your next dose when

you are meant to.

Do not take a double dose to make

up for the dose you missed.

This may increase the chance of you

getting an unwanted side effect.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

when to take your medicine, ask your

pharmacist for some hints.

If you take too much

(Overdose)

Immediately telephone your

doctor, or the Poisons Information

Centre (telephone 13 11 26) for

advice or go to Accident and

Emergency at your nearest

hospital, if you think you or

anyone else has taken too much

Gabapentin GH. Do this even if

there are no signs of discomfort or

poisoning.

You may need urgent medical

attention.

Symptoms of an overdose may

include drowsiness, unsteadiness,

dizziness, double vision, slurred

speech, lethargy, low blood pressure

or diarrhoea.

GABAPENTIN GH

WHILE YOU ARE

TAKING GABAPENTIN

GH

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking Gabapentin GH.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are taking this medicine.

If you are going to have surgery,

tell the surgeon or anaesthetist that

you are taking this medicine.

It may affect other medicines used

during surgery.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

If you are about to have any blood

tests, tell your doctor that you are

taking this medicine.

It may interfere with the results of

some tests.

Keep all of your doctor's

appointments so that your progress

can be checked.

Tell your doctor if you feel that

Gabapentin GH is not helping your

condition.

Tell your doctor if for any reason you

have not taken this medicine as

prescribed. Otherwise, your doctor

may change your treatment

unnecessarily.

Persons taking Gabapentin GH

may be more likely to think about

killing themselves or actually

trying to do so, especially when

Gabapentin GH is first started or

the dose is changed. Tell your

doctor immediately if you have

thoughts about killing yourself or

if you are close to or care for

someone using Gabapentin GH

who talks about or shows signs of

killing him or herself.

All mentions of suicide or violence

must be taken seriously.

Patient and care givers should pay

attention for any of the following

warning signs of suicide-related

behaviour while taking

Gabapentin GH. Contact a health

care provider immediately, or even

go to the nearest hospital for

treatment:

thoughts or talk of death or

suicide

thoughts or talk of self-harm or

harm to others

any recent attempts of self-harm

increase in aggressive behaviour,

irritability or agitation.

Things you must not do

Do not take Gabapentin GH to

treat any other complaints unless

your doctor tells you to.

Do not give your medicine to

anyone else, even if they have the

same condition as you.

Do not stop taking your medicine

or lower the dosage without

checking with your doctor.

Things to be careful of

Be careful driving or operating

machinery until you know how

Gabapentin GH affects you.

This medicine may cause dizziness

or light-headedness in some people,

especially after the first dose.

Be careful when drinking alcohol

while you are taking this medicine.

If you drink alcohol, it may worsen

your dizziness, light-headedness or

drowsiness. Your doctor may suggest

you avoid alcohol while you are

being treated with Gabapentin GH.

Children should not ride a bike,

climb trees or do anything else that

could be dangerous if they are

feeling drowsy or sleepy.

SIDE EFFECTS

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

Gabapentin GH.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical attention if you get some of

the side effects.

If you are over 65 years of age you

may have an increased chance of

getting side effects.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

dizziness* or light-headedness

feeling tired or drowsy*

unfriendliness*

being unusually overactive*

forgetfulness, loss of

concentration or confusion

difficulty speaking

changes in your weight*

constipation or diarrhoea

nausea and/or vomiting*,

indigestion

dry mouth, red swollen gums

muscle pain or cramps

back pain

swelling of hands, ankles or feet

runny or blocked nose

fever*

bronchitis*, lung infection*

sore throat and discomfort when

swallowing, coughing.

Tell your doctor as soon as possible

if you notice any of the following:

weakness, unsteadiness when

walking, including falling,

reduced coordination or slowed

reactions

mood changes* such as

restlessness, agitation,

nervousness, irritability or

GABAPENTIN GH

excitement, depression, seeing or

hearing things that are not there,

irrational thinking

blurred or double vision,

uncontrollable jerky eye

movements, or difficulty seeing

signs of frequent infections such

as fever, severe chills, sore throat

or mouth ulcers.

The side effects marked * have been

especially reported in children taking

gabapentin.

If any of the following happen, tell

your doctor immediately, or go to

Accident and Emergency at your

nearest hospital:

sudden signs of allergy such as

rash, itching or hives, fever,

swollen lymph glands, swelling

of the face, lips, mouth, tongue or

throat or other parts of the body,

shortness of breath, wheezing or

which may cause difficulty in

swallowing or breathing

more frequent or more severe

seizures (fits)

chest pain

fast or irregular heart beats.

The above list includes very serious

side effects. You may need urgent

medical attention or hospitalisation.

All of these side effects are very rare.

Tell your doctor or pharmacist if

you notice anything else that is

making you feel unwell.

Other side effects not listed above

may also occur in some people.

Some of these side effects (for

example, changes in thyroid function,

structures of bones, high cholesterol,

levels of sugar in your blood or blood

pressure) can only be found when

your doctor does blood tests from

time to time to check your progress.

AFTER TAKING

GABAPENTIN GH

Storage

Keep your medicine in the original

container.

If you take it out of its original

container it may not keep well.

Keep your medicine in a cool dry

place where the temperature stays

below 30°C.

Do not store Gabapentin GH or any

other medicine in the bathroom or

near a sink. Do not leave it on a

window sill or in the car.

Heat and dampness can destroy some

medicines.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop taking

this medicine or the expiry date has

passed, ask your pharmacist what to

do with any medicine that is left

over.

PRODUCT

DESCRIPTION

What it looks like

Gabapentin GH 300mg are yellow

capsules, available in blister packs of

100 capsules.

Gabapentin GH 400mg are brown

capsules, available in blister packs of

100 capsules.

Ingredients

Active ingredient:

Gabapentin GH 300mg - 300mg

gabapentin.

Gabapentin GH 400mg - 400mg

gabapentin.

Inactive ingredients:

starch pregelatinised

maize starch

talc

anhydrous colloidal silica

titanium dioxide

sodium lauryl sulphate

gelatin

iron oxide yellow

iron oxide red 400mg capsule

only.

This medicine does not contain

lactose, sucrose, gluten, tartrazine or

any other azo dyes.

Distributor

Generic Health Pty Ltd

Level 1, 1102 Toorak Road

Camberwell VIC 3124

Australia

This leaflet was revised in February

2016.

Australian Register Numbers

300mg capsules: AUST R 219923

(blisters)

400mg capsules: AUST R 219922

(blisters)

15-5-2018

May 7, 2018: Abingdon Nurse Practitioner Pleads Guilty to Conspiring to Illegally Prescribe Buprenorphine, Clonazepam, and Gabapentin at Substance Abuse Treatment Program

May 7, 2018: Abingdon Nurse Practitioner Pleads Guilty to Conspiring to Illegally Prescribe Buprenorphine, Clonazepam, and Gabapentin at Substance Abuse Treatment Program

May 7, 2018: Abingdon Nurse Practitioner Pleads Guilty to Conspiring to Illegally Prescribe Buprenorphine, Clonazepam, and Gabapentin at Substance Abuse Treatment Program

FDA - U.S. Food and Drug Administration

There are no news related to this product.