Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Donecept
10 mg, coated tablets
Donepezil hydrochloride
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Donecept is and what it is used for
Important information before taking Donecept
How to take Donecept
Possible side effects
How to store Donecept
Contents of the pack and other information

1. What Donecept is and what it is used for

Donecept belongs to a group of medicines called acetylcholinesterase inhibitors. It is a medicine
used to treat symptoms of dementia in patients diagnosed with mild to moderate
Alzheimer's disease. This medicine is intended for use only in adult patients.

2. Important information before using Donecept

When not to use Donecept

if the patient is allergic to donepezil hydrochloride, piperidine derivatives, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Treatment with Donecept should be initiated and supervised by a physician experienced in the diagnosis and treatment of dementia in Alzheimer's disease.
Before starting Donecept, discuss this with your doctor or pharmacist:

if the patient has ever suffered from peptic ulcer disease of the stomach or duodenum, or if they are taking nonsteroidal anti-inflammatory drugs (NSAIDs);
if the patient has ever had seizures. Donepezil may potentially increase the risk of seizures. The doctor will monitor symptoms occurring in the patient;
if the patient has heart diseases (such as irregular or very slow heartbeat, heart failure, myocardial infarction);
a heart condition known as "prolonged QT interval" or history of certain abnormal heart rhythms called torsade de pointes, or if someone in your family has "prolonged QT interval";
low levels of magnesium or potassium in the blood;
if the patient suffers from asthma or another chronic lung disease;
if the patient has previously had liver disease;
if the patient has difficulty urinating;
if the patient is to undergo surgery under general anaesthesia, as the dose of anaesthetic drugs may require adjustment.

Children and adolescents
Donecept must not be used in children and adolescents under 18 years of age.
Donecept with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take, including over-the-counter medicines.
This is particularly important for:

medicines used to treat heart rhythm disorders (e.g. amiodarone, sotalol);
antidepressants, e.g. citalopram, escitalopram, amitriptyline, fluoxetine;
antipsychotics (e.g. pimozide, sertindole, ziprasidone);
medicines used for bacterial infections (such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin);
antifungal medicines, e.g. ketoconazole;
medicines used to treat pain and inflammation (nonsteroidal anti-inflammatory drugs, NSAIDs);
muscle relaxants, e.g. succinylcholine;
anticonvulsants, e.g. phenytoin or carbamazepine;
heart medicines or antihypertensives, e.g. beta-blockers;
other medicines that work in a similar way to donepezil (e.g. galantamine or rivastigmine) and certain medicines used to treat diarrhoea, Parkinson's disease, or asthma;
medicines used for general anaesthesia.

Donecept and alcohol
Alcohol should be avoided during treatment with donepezil, as alcohol may reduce the effectiveness of the medicine.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Donecept must not be used by breastfeeding women.
Driving and operating machinery
Donecept and the underlying disease may impair the ability to drive and operate machinery. The medicine may cause fatigue, dizziness, and muscle cramps, especially at the beginning of treatment. If such symptoms occur, the patient must not drive or operate machinery. Consult your doctor before engaging in such activities.
Donecept contains monohydrate lactose
If the patient has been previously diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Donecept

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Donecept is available in 5 mg and 10 mg strengths.
The tablet dose taken by the patient may vary depending on the duration of treatment and the doctor's instructions.
Treatment is usually initiated with a single daily dose of 5 mg of donepezil hydrochloride taken in the evening. After approximately 1 month, the doctor may recommend switching to the 10 mg coated tablets of donepezil hydrochloride taken in the evening. The maximum recommended dose is 10 mg taken every evening.
Donecept should be taken orally with a glass of water, in the evening just before bedtime.
Dose adjustment is not required in patients with renal impairment.
In adult patients with mild or moderate hepatic impairment, the doctor may adjust the dose of the medicine. There is no data available for patients with severe hepatic impairment.
Use in children and adolescents
Donepezil is not recommended for use in children and adolescents.
If you have any doubts regarding the use of this medicine, consult your doctor or pharmacist.
Do not change the dose of the medicine without consulting your doctor. Do not discontinue taking the tablets unless instructed by your doctor.
How long to use Donecept
Your doctor will inform you how long you should take this medicine. You will need regular visits to your doctor to assess the effectiveness of treatment and disease symptoms.
Taking more Donecept than prescribed
Do not take more medicine than prescribed by your doctor. If you take more than the prescribed dose, contact your doctor or nearest hospital immediately. Always bring the medicine in its original packaging so the doctor knows which medicine was taken.
Symptoms of overdose may include nausea, vomiting, salivation, sweating, slow heartbeat, breathing difficulties, muscle weakness, fainting, and seizures.
If you miss a dose of Donecept
Do not take a double dose to make up for a missed dose.
If you miss a tablet, take the next dose at the usual time. If treatment has been interrupted for more than one week, contact your doctor before taking the next dose.
Stopping Donecept
If treatment is discontinued, the benefits of donepezil will gradually diminish. Do not stop taking the tablets, even if you feel well, unless your doctor advises otherwise.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Serious adverse reactions
If any of the serious adverse reactions described below occur in a patient, contact a doctor immediately.
The patient may require urgent medical attention.

Liver damage, for example hepatitis. Symptoms of hepatitis include: nausea or vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, darkening of urine (Rare: may occur in no more than 1 in 1,000 patients).
Gastric or duodenal ulceration. Symptoms of ulceration include stomach pain and discomfort (dyspepsia) in the area between the navel and the breastbone (Uncommon: may occur in no more than 1 in 100 patients).
Bleeding from the stomach or intestines. This may present as black stools or visible blood from the anus (Uncommon: may occur in no more than 1 in 100 patients).
Seizures or convulsions (Uncommon: may occur in no more than 1 in 100 patients).
Fever with muscle stiffness, sweating, or reduced level of consciousness (a condition known as "neuroleptic malignant syndrome") (Very rare: may occur in no more than 1 in 10,000 patients).
Muscle weakness, tenderness or pain, especially if accompanied by a feeling of fatigue, high fever, or darkening of urine. These symptoms may be caused by abnormal muscle breakdown. This condition may be life-threatening and may lead to kidney dysfunction (a condition called rhabdomyolysis).
Rapid or irregular heartbeat, fainting, which may be symptoms of a life-threatening condition known as torsade de pointes (frequency cannot be determined from available data).

Other adverse reactions
Very common (may affect more than 1 in 10 patients):

diarrhoea
nausea
headache.

Common (may affect up to 1 in 10 patients):

colds
loss of appetite
hallucinations, aggressive behaviour, agitation, which resolve after dose reduction or discontinuation of treatment
dizziness, insomnia, fainting
vomiting, gastric disturbances
rash, itching
muscle cramps
urinary incontinence
feeling of fatigue, pain
accidents (patients may be more prone to falls and accidental injuries)
unusual dreams, nightmares.

Uncommon (may affect up to 1 in 100 patients):

slowing of heart rate
slight increase in serum creatine kinase activity.

Rare (may affect up to 1 in 1,000 patients):

stiffness or involuntary movements, particularly affecting the face and tongue, but also limbs
heart disorders.

Not known (frequency cannot be determined from available data):

changes in heart function seen on electrocardiogram (ECG) known as "prolonged QT interval".

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Donecept

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Donecept contains

The active substance is donepezil hydrochloride. Each coated tablet contains donepezil hydrochloride monohydrate equivalent to 10 mg of donepezil hydrochloride.
Other ingredients: monohydrate lactose, corn starch, microcrystalline cellulose, magnesium stearate. Coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), yellow iron oxide (E 172).

What Donecept looks like and contents of the pack
Coated tablet, pale yellow, round and biconvex, with the imprint "DZ10" on one side.
Pack sizes: 28, 56 coated tablets.
For more detailed information, please contact the responsible entity or the parallel importer.
Marketing Authorisation Holder in Romania, country of export:
Teva B.V.
Swensweg 5, 2031 GA Haarlem, The Netherlands
Manufacturer:
Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000, Malta
Actavis Group PTC ehf.
Reykjavíkurvegur 76-78, IS-220 Hafnarfjörður
Iceland
BALKANPHARMA-DUPNITSA AD
3 Samakovsko Shosse
Str. Dupnitsa, 2600, Bulgaria
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in Romania, country of export: 7005/2014/02
Parallel Import Licence Number: 125/22