Donecept

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Donecept

10 mg, coated tablets

Donepezil hydrochloride

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Donecept and what is it 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 pack and other information

1. What is Donecept and what is it used for

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

2. Important information before taking Donecept

When not to take 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 doctor experienced in the diagnosis and treatment of dementia in Alzheimer's disease.

Before starting treatment with Donecept, you should discuss it with your doctor or pharmacist:

• if the patient has ever had stomach or duodenal ulcers, or if they are taking non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient has ever had seizures. Donepezil may potentially cause a tendency to seizures. The doctor will monitor the symptoms that occur in the patient;
• if the patient has heart disease (such as irregular or very slow heartbeat, heart failure, myocardial infarction);
• heart disease called "prolonged QT interval" or a history of certain abnormal heart rhythms, called torsades de pointesor if someone in your family has a "prolonged QT interval";
• low magnesium or potassium levels in the blood;
• if the patient has asthma or other 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 the anesthetic may need to be adjusted.

Children and adolescents

Donecept should not be used in children and adolescents under 18 years of age.

Donecept and other medicines

You should tell your doctor or pharmacist about all medicines the patient is taking, or has recently taken, and about medicines the patient plans to take, including those available without a prescription.
This is especially important in the case of:

• 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 to treat bacterial infections (such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin)
• antifungal medicines, e.g. ketoconazole
• medicines used to treat pain and inflammation (non-steroidal anti-inflammatory drugs, NSAIDs)
• muscle relaxants, e.g. succinylcholine
• antiepileptic drugs, e.g. phenytoin or carbamazepine
• cardiac or antihypertensive medicines, e.g. beta-blockers
• other medicines that work in the same way as donepezil (e.g. galantamine or rivastigmine) and some medicines used to treat diarrhea, Parkinson's disease, or asthma
• general anesthetics.

Donecept with alcohol

You should avoid drinking alcohol while taking donepezil, as alcohol may reduce the effect of the medicine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Donecept should not be used by breastfeeding women.

Driving and using machines

Donecept and the underlying disease may impair the ability to drive and use machines. The medicine may cause fatigue, dizziness, and muscle cramps, especially at the beginning of treatment. If such symptoms occur, you should not drive or operate machinery. Before starting such activities, you should consult your doctor.

Donecept contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Donecept

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Donecept is available in 5 mg and 10 mg doses.
The dose of the tablet taken by the patient may change 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 a period of 1 month, the doctor may recommend taking 10 mg of donepezil hydrochloride, once daily, in the evening. The maximum recommended dose is 10 mg each evening.
Donecept should be taken orally, with a glass of water, in the evening, immediately before bedtime.
There is no need to adjust the dose in case of kidney problems.
In adult patients with mild or moderate liver impairment, the doctor may adjust the dose of the medicine. There is no data on patients with severe liver impairment.

Use in children and adolescents

Donepezil is not recommended for use in children and adolescents.
If you have any doubts about taking the medicine, you should consult your doctor or pharmacist.
You should not change the dose of the medicine without consulting your doctor. You should not stop taking the tablets unless your doctor decides to.

How long to take Donecept

The doctor will inform you how long you should take the medicine. You will need regular check-ups with your doctor to assess the effectiveness of the treatment and the symptoms of the disease.

Taking more than the recommended dose of Donecept

You should not take more than the recommended dose of the medicine. You should immediately contact your doctor or hospital if you have taken more than the recommended dose. You should always take the medicine in its packaging, so that the doctor knows what medicine has been taken.
Symptoms of overdose may include nausea, vomiting, salivation, sweating, slow heartbeat, breathing difficulties, muscle weakness, fainting, and seizures.

Missing a dose of Donecept

You should not take a double dose to make up for a missed dose.
If you miss a tablet, you should take the next dose at the usual time. If the treatment has been interrupted for more than one week, you should consult your doctor before taking the next dose.

Stopping treatment with Donecept

If the treatment is stopped, the benefits of donepezil will gradually decrease. You should not stop taking the tablets, even if you feel well, unless your doctor decides to.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe side effects

If you experience any of the following severe side effects, you should immediately contact your doctor. You may need urgent medical attention.

• Liver damage, e.g. hepatitis. Symptoms of hepatitis are: feeling sick or vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, dark urine (Rare: may occur in less than 1 in 1,000 patients).
• Stomach and duodenal ulcers. Symptoms of ulcers are stomach pain and discomfort (indigestion) in the area between the navel and the breastbone (Uncommon: may occur in less than 1 in 100 patients).
• Bleeding from the stomach or intestines. It may be manifested by black stools or visible blood from the anus (Uncommon: may occur in less than 1 in 100 patients).
• Seizures or convulsions (Uncommon: may occur in less than 1 in 100 patients).
• Fever with muscle stiffness, sweating, or decreased consciousness (a condition called "malignant neuroleptic syndrome") (Very rare: may occur in less than 1 in 10,000 patients).
• Muscle weakness, tenderness, or pain, especially if accompanied by feeling tired, high fever, or dark urine. These symptoms may be caused by abnormal muscle breakdown. This condition can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis).
• Fast, irregular heartbeat, fainting, which can be symptoms of a life-threatening condition called torsades de pointes(frequency cannot be estimated from the available data).

Other side effects

Very common (may occur in more than 1 in 10 patients):

• diarrhea
• nausea
• headache.

Common (may occur in less than 1 in 10 patients):

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

Uncommon (may occur in less than 1 in 100 patients):

• slow heart rate
• mild increase in creatine kinase activity in serum.

Rare (may occur in less than 1 in 1,000 patients):

• stiffness or involuntary movements, occurring especially in the face and tongue, but also affecting the limbs
• heart disorders.

Unknown (frequency cannot be estimated from the available data):

• changes in heart function visible on an electrocardiogram (ECG) called "prolonged QT interval".

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Donecept

The medicine should be stored out of sight and reach of children.
You should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Donecept contains

• The active substance of the medicine is donepezil hydrochloride. Each coated tablet contains donepezil hydrochloride monohydrate equivalent to 10 mg of donepezil hydrochloride.
• The other ingredients are: lactose monohydrate, maize 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 inscription "DZ10" on one side.
Pack sizes: 28, 56 coated tablets.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

Teva B.V.
Swensweg 5, 2031 GA Haarlem, 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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Romania, the country of export:7005/2014/02

Parallel import authorization number: 125/22 Date of approval of the leaflet: 11.03.2022

[Information about the trademark]