DONEPEZIL TEVA 10 MG

Israel - English - Ministry of Health

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Active ingredient:
DONEPEZIL HYDROCHLORIDE
Available from:
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
ATC code:
N06DA02
Pharmaceutical form:
TABLETS
Composition:
DONEPEZIL HYDROCHLORIDE 10 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
Therapeutic group:
DONEPEZIL
Therapeutic area:
DONEPEZIL
Therapeutic indications:
Treatment of mild to moderately severe Alzheimer's dementia.
Authorization number:
141 26 31461 00
Authorization date:
2014-07-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Hebrew

17-08-2016

PATIENT PACKAGE INSERT

IN ACCORDANCE WITH THE

PHARMACISTS’ REGULATIONS

(PREPARATIONS) - 1986

The medicine is dispensed with

a doctor’s prescription only

Donepezil Teva

®

5 mg

Tablets

Each tablet contains:

Donepezil HCl 5 mg

Donepezil Teva

®

10 mg

Tablets

Each tablet contains:

Donepezil HCl 10 mg

For the list of inactive ingredients

in the preparation, see section 6 -

"Further Information".

Read this leaflet carefully in its

entirety before using this 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

for the treatment of your ailment. 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 not intended for

children.

1. WHAT

IS

THE

MEDICINE

INTENDED FOR?

For treatment of mild to moderate

dementia of Alzheimer’s disease.

Therapeutic group:

Inhibitors

enzyme

acetylcholinesterase.

2. B E F O R E

U S I N G

T H E

MEDICINE

Do not use the medicine if:

there is a known sensitivity to any

of its ingredients or to piperidine

derivatives.

Special warnings regarding use of

the medicine

Inform the doctor before starting

treatment if you are suffering, or

have suffered in the past, from:

a stomach or duodenal ulcer

convulsions or seizures (epilepsy)

any heart problem, including

irregular, slow or fast heartbeat

asthma or other chronic pulmonary

disease

liver inflammation (hepatitis)

impaired kidney function

difficulty passing urine

If you are about to undergo surgery

(including dental surgery), or any

procedure requiring anesthesia,

inform the anesthesiologist that

you are taking this medicine,

because it may increase the

activity of the anesthetic.

Additional warnings

If you are sensitive to any food

or medicine, inform the doctor

before taking this medicine.

The preparation contains lactose

and may cause allergy in people

sensitive to lactose.

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

if you are taking the following

medicines:

Other

medicines

treat

Alzheimer’s disease, such as

galantamine

Antidepressants (e.g., fluoxetine)

Anticholinergics or medicines

with anticholinergic activity (e.g.,

antispasmodics)

Neuromuscular blockers (such as

succinylcholine in surgery)

Analgesics, such as aspirin and

non-steroidal anti-inflammatory

drugs (NSAIDs) (such as ibuprofen

or diclofenac)

Medicines to treat heart function

(e.g.,

antiarrhythmics,

beta

blockers)

Antiepileptics (e.g., carbamazepine,

phenobarbitone, phenytoin)

Antifungals (e.g., ketoconazole)

Rifampicin (for tuberculosis)

Antibiotics (such as erythromycin)

General anesthetics – see special

warnings in this section

Use of the medicine and food

This medicine can be taken with or

without food.

Use of the medicine and alcohol

consumption

Do not drink wine or alcoholic

beverages during the course of

treatment with this medicine, since

it may change the effect of the

medicine.

Pregnancy and breastfeeding

If you are pregnant, planning

become

pregnant,

breastfeeding, consult the doctor

before using the medicine.

Use in children

This medicine is not intended for

children.

Driving and use of machinery

Use of this medicine may impair

alertness, cause dizziness, tiredness

or muscle cramps, and therefore

requires that caution be exercised

when driving a car, operating

complicated machinery and in any

activity that requires alertness.

3. HOW SHOULD YOU USE THE

MEDICINE?

Always use the medicine according

to the doctor’s instructions. Check

with the doctor or pharmacist if you

are uncertain.

The

dosage

and

treatment

regimen will be determined by the

doctor only.

The usual initial dosage is generally:

one 5 mg tablet in the evening at

bedtime. After approximately one

month, the doctor will consider

administration of one 10 mg tablet

in the evening.

Use this medicine at specified time

intervals as determined by the

attending doctor.

The tablet cannot be halved, as

there is no score line.

Do not exceed the recommended

dose.

If you took an overdose, 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.

Do not induce vomiting without

explicit instruction from the doctor!

Symptoms of overdose: nausea,

drooling, sweating, slow heartbeat,

low blood pressure (manifested by

dizziness when switching from a

sitting to standing position), breathing

problems, loss of consciousness,

seizures or convulsions.

If you forgot to take this medicine

at the designated time, take the next

dose at the usual time. Do not take

two doses together to compensate

for a forgotten dose.

Adhere

treatment

recommended by the doctor, even

if there is an improvement in your

health condition. Do not stop

treatment without consulting the

doctor or pharmacist.

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 this

medicine can 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.

Severe side effects

Refer to a doctor immediately if

you experience any of the following

effects - you may need urgent

medical treatment:

liver damage e.g., hepatitis,

manifested by: nausea, lack of

appetite, feeling generally unwell,

fever, itching, yellow skin and

eyes, dark urine (affect 1 to 10 in

10,000 users)

duodenal or stomach ulcer,

manifested by: stomach pains,

indigestion (affect 1 to 10 in 1,000

users)

bleeding in the stomach or

intestines, manifested by bloody

or black stools (affect 1 to 10 in

1,000 users)

seizures or convulsions (affect 1

to 10 in 1,000 users)

fever, muscle stiffness, sweating,

loss of consciousness (affect less

than 1 in 10,000 users)

Muscle

weakness,

muscle

tenderness or pain, particularly if

at the same time you feel unwell,

have high fever or dark urine.

These effects may be caused

by an abnormal muscle tissue

breakdown (a condition called

rhabdomyolysis), which can be

life-threatening and lead to kidney

damage.

Very common side effects – effects

that occur in more than one user

in ten:

diarrhea

nausea

headaches

Common side effects – effects that

occur in 1-10 users in 100:

muscle cramps

tiredness

insomnia

the common cold

lack of appetite

hallucinations

nightmares

aggressive behavior

agitation

fainting

dizziness

abdominal discomfort

rash

itching

lack of control in passing urine

pains

tendency to have accidents

(tendency to fall and get hurt)

Uncommon side effects – effects

that occur in 1-10 users in 1,000:

slow heartbeat

Rare side effects – effects that

occur in 1-10 users in 10,000:

stiffness, shaking and lack of

control in body movements,

especially of the face and tongue,

and also of the limbs

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.

Reporting side effects

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/get

sequence/getsequence.aspx?form

Type=AdversEffectMedic@moh.gov

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 of

children and/or infants to avoid

poisoning.

Do not use the medicine after the

expiry date that appears on the

package. The expiry date refers to

the last day of that month.

Store in a dry place, below 25°C.

Do not discard medicines in the

wastewater or waste bin. Ask

the pharmacist how to dispose

of medicines that are not in use.

These measures will help protect

the environment.

6. FURTHER INFORMATION

In addition to the active ingredient,

the medicine also contains:

Lactose anhydrous, microcrystalline

cellulose, pregelatinized starch,

hypromellose, magnesium stearate,

purified water, polyvinyl alcohol,

titanium dioxide, macrogol/PEG,

talc, iron oxide yellow (only in the

10 mg).

Each Donepezil Teva 5 mg tablet

contains 128.2 mg lactose.

Each Donepezil Teva 10 mg tablet

contains 256.4 mg lactose.

What the medicine looks like and

the contents of the package

Donepezil Teva 5 mg: White,

film-coated, oval-shaped tablet,

debossed with “93” on one side and

“7320” on the other.

Donepezil Teva 10 mg: Yellow,

film-coated, oval-shaped tablet,

debossed with “93” on one side and

“7321” on the other.

The package contains 30 film-

coated tablets.

Manufacturer and license holder

Teva Pharmaceutical Industries Ltd.,

P.O.B. 3190, Petach Tikva.

This leaflet was checked and

approved by the Ministry of Health

in 03/2016

Registration numbers of the

medicine in the National Drug

Registry

of

the

Ministry

of

Health:

Donepezil Teva 5 mg:

141.25.31460

Donepezil Teva 10 mg:

141.26.31461

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