Donepesan

Package Leaflet: Information for the User

Donepesan, 5 mg, film-coated tablets

Donepesan, 10 mg, film-coated tablets

Donepezil hydrochloride

Read the package leaflet carefully before taking the medicine, 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 Donepesan and what is it used for
• 2. Important information before taking Donepesan
• 3. How to take Donepesan
• 4. Possible side effects
• 5. How to store Donepesan
• 6. Contents of the pack and other information

1. What is Donepesan and what is it used for

Donepesan belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil increases the levels of a substance (acetylcholine) in the brain involved in memory function, by inhibiting the breakdown of acetylcholine. The medicine is used to treat symptomatic dementia in patients with a diagnosed mild or moderate Alzheimer's disease. Symptoms include increasing memory loss, confusion, and changes in behavior. As a result, patients with Alzheimer's disease find it increasingly difficult to perform everyday activities. Donepesan is indicated for use only in adults.

2. Important information before taking Donepesan

When not to take Donepesan

• if you are allergic to donepezil hydrochloride, piperidine derivatives (used to treat various mental disorders, bone diseases, hypertension, and others) or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take Donepesan, you should discuss with your doctor or pharmacist if you have or have had:

• stomach or duodenal ulcers,
• seizures or convulsions,
• heart disease (such as irregular or very slow heart rhythm, heart failure, heart attack),
• a heart condition called "prolonged QT interval" or have been diagnosed with certain heart rhythm disorders, called torsades de pointes, or have a history of "QT interval prolongation",
• low magnesium or potassium levels in the blood,
• asthma or other chronic lung disease,
• liver disease or hepatitis,
• difficulty urinating or mild kidney disease,
• intolerance to some sugars,
• if you are pregnant or think you may be pregnant, or if you plan to become pregnant.

Donepesan can be used in patients with kidney or mild to moderate liver impairment. If you have kidney or liver impairment, you should inform your doctor before starting treatment. Patients with severe liver impairment should not take Donepesan. You should give your doctor or pharmacist the name of your caregiver. The caregiver will help you take the medicine as prescribed by your doctor.

Donepesan and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take, as they may reduce or increase the effectiveness of Donepesan. In particular, you should inform your doctor if you are taking any of the following medicines:

• medicines used to treat heart rhythm disorders, such as amiodarone, sotalol,
• medicines used to treat depression, such as citalopram, escitalopram, amitriptyline, fluoxetine, antipsychotic medicines, such as pimozide, sertindole, ziprasidone,
• medicines used to treat bacterial infections, such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin,
• antifungal medicines, such as ketoconazole,
• other medicines for the treatment of Alzheimer's disease, such as galantamine,
• analgesics or medicines used to treat arthritis, such as acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium,
• medicines with anticholinergic activity, such as tolterodine,
• antiepileptic medicines, such as phenytoin, carbamazepine (antiepileptic medicines),
• medicines used to treat heart disease, such as quinidine, beta-adrenergic blockers (such as propranolol and atenolol),
• muscle relaxants, such as diazepam, succinylcholine,
• general anesthetics,
• over-the-counter medicines, such as herbal products.

In case of planned surgery requiring general anesthesia, you should inform your doctor and anesthesiologist about taking Donepesan, as this medicine may affect the amount of anesthetic needed during surgery.

Donepesan with food, drink, and alcohol

Food does not affect the action of the medicine. Donepesan should not be taken with alcohol, as alcohol may change its action.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine. Donepesan should not be taken during breastfeeding.

Driving and using machines

The disease may impair the patient's ability to drive, operate machinery, or work in difficult conditions. You should not perform these activities unless your doctor considers it safe. The medicine may also cause fatigue, dizziness, and muscle cramps. If you experience any of these symptoms, you should not drive, operate machinery, or work in difficult conditions.

Donepesan contains lactose

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking Donepesan.

3. How to take Donepesan

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist. The usual starting dose is 5 mg (one white Donepesan tablet, 5 mg) once a day. After one month, your doctor may recommend taking 10 mg (one yellow Donepesan tablet, 10 mg or two white Donepesan tablets, 5 mg) once a day. The Donepesan tablet should be taken orally, with water, in the evening before bedtime. The dose taken may change depending on the duration of treatment and your doctor's recommendations. Do not change the dose without consulting your doctor. The maximum recommended daily dose is 10 mg. Your doctor will advise how long to take the tablets. You will need to consult your doctor from time to time to assess the effectiveness of the treatment and symptoms.

Use in children and adolescents

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

Taking more than the recommended dose of Donepesan

DO NOT take more than one dose per day. If you have taken more than the recommended dose, contact your doctor immediately. If this is not possible, go to the emergency room at the nearest hospital, always taking the tablets and packaging with you, so the doctor knows what medicine you have taken. Symptoms suggesting an overdose may include nausea, vomiting, salivation, sweating, slow heart rate, low blood pressure (dizziness or fainting when standing up), respiratory depression, collapse, and seizures or convulsions.

Missing a dose of Donepesan

If you forget to take a dose, take one dose the next day at the usual time. Do not take a double dose to make up for a missed dose. If you forget to take the medicine for a period longer than one week, consult your doctor before taking the medicine again.

Stopping treatment with Donepesan

Do not stop taking the medicine unless your doctor advises you to. If you stop taking Donepesan, the beneficial effects of the treatment will gradually disappear. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Donepesan can cause side effects, although not everybody gets them. The following side effects have been reported by people taking donepezil hydrochloride.

Severe side effects:

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

• Rapid, irregular heartbeat, fainting, which can be symptoms of a life-threatening condition called torsades de pointes (frequency not known).
• Liver damage, such as hepatitis. Symptoms of hepatitis are nausea or vomiting, loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin and eyes, and dark urine (may occur in up to 1 in 1,000 people).
• Stomach and duodenal ulcers. Symptoms of ulcers are stomach pain and discomfort (indigestion) felt between the navel and the breastbone (may occur in up to 1 in 100 people).
• Bleeding in the stomach or intestines. This can cause black, tarry stools or visible bleeding from the anus (may occur in up to 1 in 100 people).
• Seizures or convulsions (may occur in up to 1 in 100 people).
• Fever combined with muscle stiffness, sweating, or decreased level of consciousness (a condition called neuroleptic malignant syndrome) (may occur in up to 1 in 10,000 people).
• Muscle weakness, tenderness, or pain, especially occurring at the same time as feeling unwell, high fever, or dark urine. This can be caused by abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (may occur in up to 1 in 10,000 people).

Very common side effects(may occur in more than 1 in 10 people):

• diarrhea,
• nausea or vomiting,
• headache.

Common side effects(may occur in up to 1 in 10 people):

• muscle cramps,
• fatigue,
• difficulty sleeping (insomnia),
• cold,
• loss of appetite,
• hallucinations (the patient sees or hears things that do not exist),
• unusual dreams, including nightmares,
• agitation,
• aggressive behavior,
• fainting,
• dizziness,
• stomach upset, vomiting,
• rash,
• itching,
• incontinence,
• pain,
• accidents (patients may be more prone to falls and accidental injuries).

Uncommon side effects(may occur in up to 1 in 100 people):

• slow heart rate,
• excessive salivation.

Rare side effects(may occur in up to 1 in 1,000 people):

• muscle stiffness, tremor, or uncontrolled movements, especially of the face and tongue, but also of the limbs,
• heart problems, such as irregular heartbeat.

Frequency not known:

• changes in heart function visible on an ECG called "QT interval prolongation",

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported 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 Donepesan

The medicine should be stored out of sight and reach of children. There are no special precautions for storage of the medicinal product. Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of the month stated. 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 Donepesan contains

• The active substance is donepezil hydrochloride. Donepesan, 5 mg: each tablet contains 5 mg of donepezil hydrochloride, equivalent to 4.56 mg of free donepezil. Donepesan, 10 mg: each tablet contains 10 mg of donepezil hydrochloride, equivalent to 9.12 mg of free donepezil.
• The other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, corn starch, magnesium stearate. Tablet coating: titanium dioxide (E171), triacetin, lactose monohydrate, hypromellose, macrogol 3350. Yellow iron oxide (E172) - only Donepesan 10 mg.
• Yellow iron oxide (E172) – only Donepesan 10 mg.

What Donepesan looks like and contents of the pack

Donepesan, 5 mg: white, round, biconvex, film-coated tablets with a diameter of 7.1 mm. Donepesan, 10 mg: yellow, round, biconvex, film-coated tablets with a diameter of 9.1 mm. Donepesan, film-coated tablets are available in blisters containing 7, 10, 20, 28, 30, 50, 56, 60, 84, 98, 100, or 120 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

PRO.MED.CS Praha a.s. Telčská 377/1 Michle 140 00 Praha 4 Czech Republic

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic Donepezil PMCS 5 mg Donepezil PMCS 10 mg Poland Donepesan Romania DONEPESAN 5 mg film-coated tablets DONEPESAN 10 mg film-coated tablets Date of last revision of the leaflet:20.12.2021