Donecept

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Donecept, 10 mg, film-coated tablets

Donepezil hydrochloride

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

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient 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 disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 packaging 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 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 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, the patient should discuss the following with their doctor or pharmacist:

• if the patient has ever suffered from 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 patient's symptoms
• 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 pointes, or if someone in the patient's 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 the age of 18.

Donecept and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan 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, such as 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, such as ketoconazole
• medicines used to treat pain and inflammation (non-steroidal anti-inflammatory drugs - NSAIDs)
• muscle relaxants, such as succinylcholine
• antiepileptic medicines, such as phenytoin or carbamazepine
• heart medicines or blood pressure medicines, such as 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 and alcohol

The patient should avoid drinking alcohol during treatment with 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 patient's 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, the patient should not drive or operate machines. Before performing such activities, the patient should consult their 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 according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
Donecept is available in the following strengths: 5 mg and 10 mg.
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 once daily in the 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 patients with kidney problems.
In adult patients with mild or moderate liver impairment, the doctor may adjust the dose of the medicine. There are no data available for patients with severe liver impairment.

Use in children and adolescents

Donepezil is not recommended for use in children and adolescents.
In case of doubts about the use of the medicine, the patient should consult their doctor or pharmacist.
The patient should not change the dose of the medicine without consulting their doctor. The patient should not stop taking the tablets unless their doctor decides to do so.

How long to take Donecept

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

Taking more than the recommended dose of Donecept

The patient should not take more than the recommended dose of the medicine. If they take more than the recommended dose, they should immediately contact their doctor or hospital. The patient should always take the medicine packaging with them so that the doctor knows what medicine was taken.
Symptoms of overdose may include nausea, vomiting, salivation, sweating, slow heart rate, breathing difficulties, muscle weakness, fainting, and seizures.

Missing a dose of Donecept

The patient should not take a double dose to make up for a missed dose.
If the patient misses a tablet, they should take the next dose at the usual time. If the treatment has been interrupted for more than one week, the patient should consult their doctor before taking the next dose.

Stopping treatment with Donecept

If the treatment is stopped, the benefits of donepezil will gradually decrease. The patient should not stop taking the tablets, even if they feel well, unless their doctor decides to do so.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

Severe side effects

If the patient experiences any of the following severe side effects, they should immediately contact their doctor. The patient may need urgent medical attention.

• liver damage, such as hepatitis. Symptoms of hepatitis include: feeling sick or vomiting, loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin and eyes, dark urine (Rare: may affect up to 1 in 1,000 people)
• stomach or duodenal ulcers. Symptoms of ulcers include stomach pain and discomfort (indigestion) in the area between the navel and the breastbone (Uncommon: may affect up to 1 in 100 people)
• bleeding from the stomach or intestines. This may be indicated by black stools or visible blood in the stool (Uncommon: may affect up to 1 in 100 people)
• seizures or convulsions (Uncommon: may affect up to 1 in 100 people)
• fever with muscle stiffness, sweating, or decreased consciousness (a condition called "neuroleptic malignant syndrome") (Very rare: may affect up to 1 in 10,000 people)
• muscle weakness, tenderness, or pain, especially if accompanied by feeling unwell, high fever, or dark urine. These symptoms may be caused by abnormal muscle breakdown. This condition can be life-threatening and may lead to kidney problems (rhabdomyolysis)
• rapid, 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 affect more than 1 in 10 people):

• diarrhea
• nausea
• headache.

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

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

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

• slow heart rate
• mild increase in muscle creatine kinase activity in the blood.

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

• stiffness or involuntary movements, 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Donecept

The medicine should be stored out of sight and reach of children.
The medicine should not be used 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 the storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Donecept contains

• The active substance of the medicine is donepezil hydrochloride. Each film-coated tablet contains 10 mg of donepezil hydrochloride.
• The other ingredients are: tablet core: lactose monohydrate, corn starch, microcrystalline cellulose, magnesium stearate. tablet coating: Opadry II 85F32120 Yellow: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), yellow iron oxide (E 172).

What Donecept looks like and contents of the pack

Film-coated tablet, pale yellow, round, and biconvex with the inscription "DZ10" on one side.
Pack sizes:
Blister: 28 film-coated tablets.
For more detailed information, the patient 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.
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 by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Authorization number in Romania, the country of export: 7005/2014/02

Parallel import authorization number: 328/21

Date of leaflet approval:16.08.2022
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