Donecept

Package Leaflet: Information for the Patient

Donecept, 5 mg, Film-Coated Tablets

Donecept, 10 mg, Film-Coated Tablets

Donepezil Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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. Donepezil increases the concentration of a substance (acetylcholine) involved in memory function by slowing down the breakdown of acetylcholine.
This medicine is used to treat the symptoms of dementia in patients who have been diagnosed with mild to moderate Alzheimer's disease. The symptoms of the disease may include increasing memory loss, feeling disoriented, and changes in behavior. As a result, people with Alzheimer's disease may find it increasingly difficult to perform their daily tasks.
The medicine is intended for use only in adult patients.

2. Important Information Before Taking Donecept

When Not to Take Donecept

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

Warnings and Precautions

Before Starting Donecept, Discuss with Your Doctor or Pharmacist if You Have or Have Had:

• stomach or duodenal ulcer,
• seizures
• heart diseases (such as irregular or very slow heartbeat, heart failure, heart attack)
• a heart condition called "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 magnesium or potassium levels in the blood
• asthma or other chronic lung disease
• liver disease or hepatitis
• difficulty urinating or mild kidney disease

You should also inform your doctor if you are pregnant or think you may be pregnant.

Children and Adolescents

Donecept is not recommended for use in children and adolescents (under 18 years of age).

Donecept and Other Medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take. This includes medicines that have not been prescribed by a doctor, which you have bought yourself in a pharmacy. It also includes medicines that you plan to take in the future with Donecept. This is important because these medicines may weaken or strengthen the effect of Donecept.
It is especially important to tell your doctor if you are taking any of the following types of medicines:

• medicines used to treat irregular heart rhythms (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
• other medicines used to treat Alzheimer's disease, e.g., galantamine
• painkillers or medicines used to treat arthritis, e.g., acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen or diclofenac sodium
• anticholinergic medicines, e.g., tolterodine
• antiepileptic medicines, e.g., phenytoin, carbamazepine
• medicines used to treat heart diseases, e.g., quinidine, beta-blockers (propranolol and atenolol)
• muscle relaxants, e.g., diazepam, succinylcholine
• general anesthetics.
• over-the-counter medicines, e.g., herbal medicines.

A patient who is to undergo surgery requiring general anesthesia should inform the doctor that they are taking Donecept. Donecept may affect the amount of anesthetic needed.
Donecept can be used in patients with kidney and mild to moderate liver impairment. You should inform your doctor about kidney or liver disease. Patients with severe liver impairment should not take Donecept.
You should indicate to your doctor or pharmacist who is your caregiver. The caregiver will help the patient take the medicines as prescribed.

Donecept with Food, Drink, and Alcohol

Food does not affect the action of Donecept.
During treatment with Donecept, you should not consume alcohol, as alcohol may alter the effect of the medicine.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking any medicine.
Donecept should not be used during breastfeeding.

Driving and Using Machines

Alzheimer's disease may impair your ability to drive or operate machinery.
You should not perform these activities unless your doctor considers it safe for you to do so. The medicine may cause fatigue, dizziness, and muscle cramps. If you experience these symptoms, you should not drive or operate machinery.

Donecept Contains Lactose

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to Take Donecept

What Dose of Donecept Should You Take

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The recommended starting dose is 5 mg (one white tablet) taken once daily in the evening before bedtime. After one month, your doctor may increase the dose to 10 mg (one yellow tablet) taken once daily in the evening before bedtime.
If you experience unusual dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend taking Donecept in the morning.
The dose of the tablet you take may change depending on the duration of treatment and your doctor's recommendations. The maximum recommended daily dose is 10 mg taken in the evening.
Always follow the instructions of your doctor or pharmacist regarding the method and time of taking the medicine. Do not change the dose yourself without consulting your doctor.

How to Take the Medicine

Donecept is taken orally with a glass of water, in the evening, immediately before bedtime.

Use in Children and Adolescents

Donepezil is not recommended for use in children and adolescents (under 18 years of age).

Overdose of Donecept

In case of overdose, contact your doctor or hospital immediately. Take the package leaflet and any remaining tablets with you.
Symptoms of overdose may include nausea, vomiting, salivation, sweating, slow heartbeat, low blood pressure (dizziness when standing), difficulty breathing, loss of consciousness, and seizures.

Missed Dose of Donecept

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

Stopping Treatment with Donecept

Do not stop taking the tablets unless your doctor tells you to. If you stop treatment, the benefits of donepezil will gradually fade away.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

How Long to Take Donecept

Your doctor or pharmacist will inform you how long to continue taking the tablets.
Regular check-ups with your doctor will be necessary to assess your treatment and symptoms.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Donecept can cause side effects, although not everybody gets them.
The following side effects have been reported in patients taking Donecept.
If any of the following side effects occur while taking Donecept, you should consult your doctor.

Serious Side Effects

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

• liver damage, e.g., hepatitis. Symptoms of hepatitis are nausea (feeling sick) or vomiting, loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin and eyes, dark urine (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 (may occur in less than 1 in 100 patients)
• bleeding from the stomach or intestines. It may appear as black, tarry stools or visible blood in the stool (may occur in less than 1 in 100 patients)
• seizures (may occur in less than 1 in 100 patients)
• fever with muscle stiffness, sweating, or decreased consciousness (a condition called "neuroleptic malignant syndrome") (may occur in less than 1 in 10,000 patients)
• muscle weakness, tenderness, or pain, especially if you also feel tired, have a 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 (a condition called rhabdomyolysis) (may occur in less than 1 in 10,000 patients)
• fast, irregular heartbeat and fainting, which can be symptoms of a life-threatening condition called torsade de pointes(frequency cannot be estimated from the available data).

Other Side Effects

Very Common: may affect more than 1 in 10 patients:

• diarrhea
• headache.

Common: may affect up to 1 in 10 patients:

• -muscle cramps
• -fatigue
• -sleep problems (insomnia)
• common cold
• hallucinations, (seeing and hearing things that are not there)
• unusual dreams, including nightmares
• agitation
• aggressive behavior
• fainting
• dizziness,
• discomfort in the stomach
• rash,
• incontinence
• pain
• accidents (patients may be more prone to falls and accidental injuries)

Uncommon: may affect up to 1 in 100 patients:

• slow heart rate
• increased salivation

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

• stiffness, trembling, or involuntary movements, especially in the face and tongue, but also affecting the limbs

Unknown: frequency cannot be estimated from the available data

• changes in heart function visible on an electrocardiogram (ECG) called "prolonged QT interval"
• increased libido, hypersexuality
• a condition called "Pisa syndrome" (involuntary muscle contraction with abnormal twisting of the body and head to one side).
• changes in heart function visible on an electrocardiogram (ECG) called "prolonged -

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You can also report side effects 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. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help 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 blister pack and carton after EXP. The expiry date refers to the last day of the month.
There are no special storage precautions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Donecept Contains

• The active substance is donepezil hydrochloride. Each film-coated tablet contains donepezil hydrochloride monohydrate equivalent to 5 mg or 10 mg of donepezil hydrochloride.
• The other ingredients are: tablet core: lactose monohydrate, maize starch, microcrystalline cellulose, magnesium stearate. coating 5 mg: Opadry II 85F18378 White: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171) 10 mg: Opadry II 85F32120 Yellow: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171), yellow iron oxide (E172)

What Donecept Looks Like and Contents of the Pack

Donecept, 5 mg, film-coated tablet, white, round, and biconvex with "DZ5" engraved on one side.
Donecept, 10 mg, film-coated tablet, pale yellow, round, and biconvex with "DZ10" engraved on one side.
Pack sizes: Blister: 28, 30, 56, and 60 film-coated tablets.

Marketing Authorization Holder

Actavis Group PTC ehf.
Dalshraun 1, 220 Hafnarfjörður, Iceland

Manufacturer

Actavis Ltd.
BLB 016 Bulebel Industrial Estate
Zejtun ZTN 3000, Malta
Actavis Group PTC ehf.
Dalshraun 1, IS-220 Hafnarfjörður, Iceland
Balkanpharma-Dupnitsa AD
3 Samokovska Shosse Str.
2600, Dupnitsa, Bulgaria

For Further Information on This Medicine, Please Contact the Marketing Authorization Holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names

Estonia
Donepezil Actavis
Austria
Donepezil Actavis 5 mg Filmtabletten
Donepezil Actavis 10 mg Filmtabletten
Czech Republic
Donepezil Actavis
Iceland
Donepezil Actavis
Lithuania
Donepezil Actavis 5 mg plėvele dengtos tabletės
Donepezil Actavis 10 mg plėvele dengtos tabletės
Malta
Donecept
Norway
Donepezil Actavis
Poland
Donecept
Romania
Donecept 5 mg, comprimate filmate
Donecept 10 mg, comprimate filmate
Sweden
Donepezil Actavis
Date of Last Revision of the Leaflet:January 2024