Donesyn

Package leaflet: Information for the patient

Donesyn, 5 mg, film-coated tablets
Donepezili hydrochloridum
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• 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 a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Donesyn is and what it is used for
2. Important information before taking Donesyn
3. How to take Donesyn
4. Possible side effects
5. How to store Donesyn
6. Contents of the pack and other information

1. What Donesyn is and what it is used for

Donesyn contains donepezil hydrochloride as the active substance, which belongs to a group of medicines called acetylcholinesterase inhibitors.
Donesyn is indicated for the symptomatic treatment of mild to moderate dementia in Alzheimer's disease. Donesyn can be used in adult patients.

2. Important information before using Donesyn

When not to use Donesyn

• If the patient is allergic to donepezil or to any piperidine derivatives, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Donesyn, discuss with your doctor or pharmacist if any of the following situations apply to the patient:

• If the patient has or has ever had heart problems (particularly sick sinus syndrome or similar conditions such as irregular or very slow heartbeat, heart failure, myocardial infarction). Donepezil may slow heart rate;
• If the patient has a heart condition known as "prolonged QT interval" or has previously been diagnosed with certain heart rhythm disorders called torsade de pointes, or has a history of "prolonged QT interval";
• If the patient has low levels of magnesium or potassium in the blood;
• If the patient has ever had stomach or duodenal ulcers, or if the patient is taking a specific type of pain medication (non-steroidal anti-inflammatory drugs - NSAIDs). The doctor should monitor symptoms;
• If the patient has difficulty urinating. The doctor should monitor symptoms;
• If the patient has ever had seizures. Donepezil may trigger a new seizure. The doctor should monitor symptoms;
• If the patient has asthma or another chronic lung disease. Symptoms may worsen;
• If the doctor has informed the patient about intolerance to certain sugars, such as lactose.

Donesyn may be used in patients with kidney disease or mild to moderate liver disease. The doctor should be informed first about kidney or liver disease. Patients with severe liver disease should not take Donesyn.

Children and adolescents
Donesyn is not indicated for use in children and adolescents (under 18 years of age).

Donesyn and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform the doctor if the patient is taking any of the following medicines:

• General anaesthetics. If undergoing surgery requiring general anaesthesia, inform the doctor and anaesthesiologist that the patient is taking Donesyn, as this medicine may affect the amount of anaesthetic required.
• Medicines used to control heart rhythm (quinidine), antifungal medicines (ketoconazole and itraconazole), certain types of antibiotics (erythromycin), and medicines used to treat depression (e.g. fluoxetine). These medicines may enhance the effect of Donesyn.
• Medicines used to treat tuberculosis (rifampicin), medicines used to treat epilepsy (phenytoin and carbamazepine). These medicines may reduce the effect of Donesyn.
• Medicines used for short-term muscle relaxation during anaesthesia and intensive care (succinylcholine), other muscle relaxants, medicines stimulating a specific part of the nervous system (cholinergic agonists), and certain blood pressure-lowering medicines (beta-blockers). The effect of both medicines is increased.
• Medicines that inhibit a specific part of the nervous system (anticholinergic medicines).
• Painkillers or medicines for joint inflammation, such as acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac.
• Other medicines for Alzheimer's disease, e.g. galantamine.
• Over-the-counter medicines, e.g. herbal remedies.
• Medicines used to treat heart rhythm disorders (e.g. amiodarone, sotalol, quinidine).
• Medicines used to treat depression (e.g. citalopram, escitalopram, amitriptyline), medicines used to treat psychosis (e.g. pimozide, sertindole, ziprasidone), medicines used to treat bacterial infections (such as clarithromycin, erythromycin, levofloxacin, moxifloxacin).

Taking Donesyn with food, drink and alcohol
Food does not affect the action of the medicine.
Alcohol should not be consumed while taking Donesyn, as alcohol may alter the effect of the medicine.

Pregnancy, breastfeeding and fertility
Women taking Donesyn should not breastfeed.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Driving and using machines
Dementia in Alzheimer's disease may impair the ability to drive or operate machinery. Therefore, these activities should not be performed until the doctor assesses that it is safe for the patient.
Additionally, Donesyn may cause fatigue, dizziness, and muscle cramps. If any of these effects occur, the patient should not drive or operate machinery.

Donesyn contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

Donesyn contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to take Donesyn
This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult the doctor or pharmacist.
The patient should inform the doctor or pharmacist of the name of their caregiver. The caregiver will assist the patient in taking the prescribed medicine.
The dose of Donesyn may change depending on the duration of treatment and the recommendations of the treating doctor.
The recommended initial dose is one 5 mg tablet of Donesyn (5 mg of donepezil hydrochloride) taken in the evening. After one month, the doctor may increase the dose to two 5 mg tablets of Donesyn (10 mg of donepezil hydrochloride) taken in the evening.
The maximum recommended daily dose is 10 mg.
If doses cannot be achieved with this strength, other strengths of this medicinal product are available.
Dose adjustment is not required in patients with impaired kidney function.
In patients with mild to moderate liver impairment, dose escalation should be based on individual patient tolerance. Donesyn should not be taken in patients with severe liver impairment (see section 2, before taking Donesyn). If unexplained liver disease occurs, the doctor may decide to discontinue Donesyn treatment completely.
Donesyn tablet(s) should be taken orally with water in the evening, before going to bed.
If the patient experiences unusual dreams, nightmares, or difficulty sleeping (see section 4), the doctor may recommend taking Donesyn in the morning.
The doctor will inform the patient how long Donesyn should be taken. Regular contact with the doctor should be maintained to review treatment and assess symptoms.

Taking more Donesyn than recommended
Symptoms of overdose may include: severe nausea, vomiting, salivation, excessive sweating, bradycardia (slowing of the heart), hypotension, respiratory depression. Muscle weakness (collapse) and involuntary muscle contractions (seizures) may occur, as well as progressive muscle weakness which may be life-threatening.
If more Donesyn than recommended has been taken, contact a doctor immediately or go to the nearest hospital. Bring this leaflet and the medicine packaging with you.

If a dose of Donesyn is missed
Do not take a double dose to make up for a missed dose.
Take the next dose at the usual time.
If Donesyn has not been taken for longer than one week, contact the treating doctor before resuming treatment.

Stopping the medicine
Do not stop taking the medicine, even if the patient feels well, unless advised by the doctor.
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 listed below occur, seek medical advice immediately, as urgent medical treatment may be required.

• Liver function disorders, including hepatitis. Symptoms of hepatitis include nausea or vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), dark-coloured urine (may affect up to 1 in 1,000 people)
• Gastric or duodenal ulcers. Symptoms of ulcers include abdominal pain and discomfort in the upper abdomen (dyspepsia) (may affect up to 1 in 100 people)
• Bleeding from the stomach or intestines. This may cause black, tarry stools or the presence of blood from the rectum (may affect up to 1 in 100 people)
• Seizures or convulsions (may affect up to 1 in 100 people)
• Fever with muscle stiffness, sweating, or reduced level of consciousness (a condition known as neuroleptic malignant syndrome) (may affect up to 1 in 10,000 people)
• Weakness, tenderness or muscle pain, especially when accompanied by malaise, high temperature or dark urine. These symptoms may be caused by abnormal breakdown of muscle cells, which can be life-threatening and lead to kidney dysfunction (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 people)

Very common (may affect more than 1 in 10 people):

• Diarrhoea
• Nausea
• Headache

Common (may affect less than 1 in 10 people):

• Cold-like symptoms
• Loss of appetite (anorexia)
• Seeing or hearing things that are not there (hallucinations)
• Restlessness
• Aggressive behaviour
• Unusual dreams, including nightmares
• Fainting
• Dizziness
• Sleep problems (insomnia)
• Vomiting
• Stomach discomfort
• Rash
• Fatigue
• Sleep problems (insomnia)
• Itching
• Muscle cramps
• Urinary incontinence
• Accidents (patients may be more prone to falls and accidental injuries)
• Pain

Uncommon (may affect more than 1 in 100 people):

• Bradycardia (slowing of the heart rate)
• Slight increase in blood levels of creatine kinase (an enzyme found in muscle)

Rare (may affect less than 1 in 1,000 people):

• Involuntary movements of the body and face (extrapyramidal symptoms)
• Certain heart conduction disorders leading to irregular heart rhythms (sinoatrial block, atrioventricular block)

Frequency not known (frequency cannot be estimated from the available data):

• Changes in heart function seen on ECG known as "prolongation of the QT interval"
• Fast, irregular heartbeat, fainting, which may be symptoms of a potentially life-threatening condition called torsade de pointes
• Increased libido, hypersexuality
• "Leaning Tower of Pisa" sign (involuntary muscle contractions causing abnormal twisting of the body and head to one side)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for 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
Adverse reactions can also be reported to the marketing authorisation holder or its representative.

5. How to store Donesyn

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the stated month.
Store below 30°C.
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 Donesyn contains
The active substance is donepezil hydrochloride.
Each Donesyn 5 mg film-coated tablet contains 5.22 mg of donepezil hydrochloride monohydrate,
corresponding to 5 mg of donepezil hydrochloride, equivalent to 4.56 mg of donepezil.
The other ingredients of the tablet core are: lactose monohydrate, microcrystalline cellulose (E460),
sodium carboxymethyl starch (type A), hydroxypropyl cellulose (E463), magnesium stearate (E470b).
The ingredients of the tablet coating are: hypromellose (E464), lactose monohydrate, macrogol 4000,
titanium dioxide (E171).

What Donesyn looks like and contents of the pack
Donesyn 5 mg film-coated tablets are white, round, biconvex tablets, with the engraved code "D9EI" on one side and the number "5" on the other side.
Film-coated tablets are available in blister packs containing 7, 28, 30, 50, 56, 60, 84, 98, 100, 120 film-coated tablets, and in unit-dose blisters containing 50 film-coated tablets (for hospital use only).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
Poland

Manufacturers:
Synthon BV
Microweg 22
6545 CM, Nijmegen
The Netherlands
Synthon Hispania S.L.
Castelló 1, Polígono Las Salinas
08830 San Boi de Llobregat
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany Donesyn 5 mg Filmtabletten
Bulgaria Donesyn 5 mg Филмирана таблетка
Czech Republic Donpethon 5 mg, potahovaná tableta
Estonia Donesyn 5 mg
Greece Donepezil Synthon Hispania 5 mg
Finland Donesyn 5 mg tabletti
Hungary Donesyn 5 mg filmtabletta
Ireland Donesyn 5 mg film-coated tablets
Iceland Donesyn 5 mg filmuhúðaðar töflur
Lithuania Donesyn 5 mg plėvele dengtos tabletės
Latvia Donesyn 5 mg apvalkotās tabletes
Norway Donesyn 5 mg tablett
Poland Donesyn
Portugal Dosylien 5 mg comprimidos revestidos por película
Romania Donesyn 5 mg
Slovenia Donesyn 5 mg filmsko obložene tablete
Slovakia Donesyn 5 mg