Donepezil

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Donecept, 10 mg, coated tablets
Donepezil hydrochloride
Please read the entire leaflet carefully before using 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 other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Donecept is and what it is used for
2. Important information before taking Donecept
3. How to take Donecept
4. Possible side effects
5. How to store Donecept
6. Contents of the package 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. The 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 Alzheimer's disease dementia.
Before starting Donecept, discuss the following with your doctor or pharmacist:

• if the patient has ever suffered from gastric or duodenal ulcer disease, 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 a history of certain abnormal heart rhythms called torsade de pointes, or if someone in your family has a "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 ever had liver disease in the past
• if the patient has difficulty urinating
• if the patient is to undergo surgery under general anesthesia, as the dose of anesthetic 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, has recently taken, or plans to take, including medicines obtained without a prescription.
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)
• antibiotics 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. suxamethonium
• antiepileptic medicines, e.g. phenytoin or carbamazepine
• heart or antihypertensive medicines, 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 diarrhea, Parkinson's disease, or asthma
• medicines used for general anesthesia.

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 baby, she should consult her doctor or pharmacist before using this medicine.
Donecept must not be used by breastfeeding patients.
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 lactose monohydrate
If the patient has been previously diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Donecept

This medicine should always be taken as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
Donecept is available in the following strengths: 5 mg and 10 mg.
The tablet strength taken by the patient may vary depending on the duration of treatment and the doctor's recommendations.
Treatment usually starts with 5 mg of donepezil hydrochloride taken once daily in the evening. After approximately one month, the doctor may recommend switching to the coated tablets at a dose of 10 mg of donepezil hydrochloride, taken in the evening. The maximum recommended dose is 10 mg 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 stop taking the tablets unless instructed by your doctor.
How long to take Donecept
Your doctor will inform you how long you should take the medicine. You will need regular visits to your doctor to assess the effectiveness of treatment and disease symptoms.
Taking more Donecept than recommended
Do not take more medicine than prescribed by your doctor. Contact your doctor or hospital immediately if you have taken more than the prescribed dose. Always bring the medicine in its original packaging so the doctor knows which medicine has been taken.
Symptoms of overdose may include nausea, vomiting, salivation, sweating, slow heart rate, breathing difficulties, muscle weakness, fainting, and seizures.
Missed 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 decides otherwise.
If you have any further questions 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, contact a doctor immediately.
The patient may require urgent medical attention.

• Liver damage, for example hepatitis. Symptoms of hepatitis include: feeling sick or vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, darkening of the 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 the urine. These symptoms may be due to abnormal muscle breakdown. This condition can be life-threatening and may lead to kidney dysfunction (a condition known as rhabdomyolysis)
• Fast 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 people):

• Diarrhoea
• Nausea
• Headache.

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

• 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 people):

• Slowing of heart function
• Slight increase in serum creatine kinase activity.

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

• Stiffness or involuntary movements, particularly affecting the face and tongue, but also limbs
• Heart disorders. Unknown (frequency cannot be determined from available data):
• Changes in heart function visible 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 a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of 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 provide more information on the safety of the 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 apply for this medicinal product.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 10 mg of donepezil hydrochloride.
• Other ingredients are:
  Tablet core: monohydrate lactose, corn starch, microcrystalline cellulose, magnesium stearate.
  Tablet coating: Opadry II 85F32120 Yellow: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), iron oxide yellow (E 172).

What Donecept looks like and contents of the pack
A coated tablet, pale yellow, round and biconvex, with the imprint “DZ10” on one side.
Pack sizes:
Blister pack: 28 coated tablets.
For more detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing Authorization Holder in Romania, country of export:
Teva B.V.
Swensweg 5, 2031 GA Haarlem
The Netherlands
Manufacturer:
Actavis Ltd.
BLB 016 Bulebel Industrial Estate, Zejtun ZTN 3000, Malta
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorization Number in Romania, country of export: 7005/2014/02
Parallel Import License Number: 328/21