Package leaflet: Information for the patient

Donesyn, 10 mg, film-coated tablets
Donepezili hydrochloridum
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Table of contents of the leaflet

What is Donesyn and what is it used for
Important information before taking Donesyn
How to take Donesyn
Possible side effects
How to store Donesyn
Contents of the pack and other information

1. What is Donesyn and what is it 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 may 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 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 apply to the patient:
if the patient has or has ever had heart problems (particularly sick sinus syndrome or a similar condition 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 passing urine. 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. However, the doctor should first be informed 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 anaesthetist that the patient is taking Donesyn. This is because the 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 and 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.
While taking Donesyn, alcohol should not be consumed, 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 whether it is safe for the patient.
In addition, 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 their doctor before taking this medicine.
Donesyn contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Donesyn
This medicine should always be taken 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 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 donepezil hydrochloride taken in the evening.
After one month, the doctor may increase the dose to one Donesyn 10 mg tablet (10 mg donepezil hydrochloride) taken in the evening.
The maximum recommended daily dose is 10 mg.
If a dose cannot be achieved with the available strengths, other strengths of this medicinal product are available.
In patients with impaired kidney function, no dose adjustment is necessary.
In patients with mild to moderate liver impairment, dose escalation should be based on individual patient tolerance. Donesyn should not be taken in cases of severe liver impairment (see section 2, Before taking Donesyn). In cases of unexplained liver disease, 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 prescribed
Symptoms of overdose may include: severe nausea, vomiting, salivation, excessive sweating, bradycardia (slowed heart rate), hypotension, respiratory depression. Muscle weakness (flaccidity) and involuntary muscle contractions (seizures) may occur, as well as progressive muscle weakness which may be life-threatening.
If more Donesyn has been taken than prescribed, contact a doctor immediately or go to the nearest hospital. Bring this leaflet and the medicine packaging with you.
Missing a dose of Donesyn
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 Donesyn
Do not stop taking Donesyn, even if the patient feels well, unless advised by the doctor.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Severe adverse reactions:
If any of the following severe adverse reactions occur, consult a doctor 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)
Stomach 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 called neuroleptic malignant syndrome) (may affect up to 1 in 10,000 people)
Weakness, tenderness or pain in muscles, especially when accompanied by malaise, high temperature or dark urine. These symptoms may be due to abnormal breakdown of muscle cells, which can be life-threatening and lead to kidney dysfunction (a condition known as 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)
Imagining 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 heartbeat)
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 disturbances in heart conduction leading to heart rhythm disorders (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
Pisa syndrome (characterized by 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, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring 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 the representative of the marketing authorisation holder.

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 30ºC.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Package contents and other information

What Donesyn contains
The active substance is donepezil hydrochloride.
Each Donesyn 10 mg film-coated tablet contains 10.44 mg of donepezil hydrochloride monohydrate, corresponding to 10 mg of donepezil hydrochloride, equivalent to 9.12 mg of donepezil.
Other ingredients of the tablet core are: monohydrate lactose, microcrystalline cellulose (E460),
sodium carboxymethyl starch (type A), hydroxypropyl cellulose (E463), magnesium stearate (E470b).
Ingredients of the tablet coating: hypromellose (E464), monohydrate lactose, macrogol 4000, titanium dioxide (E171) and yellow iron oxide (E172).

What Donesyn looks like and contents of the pack
Donesyn 10 mg film-coated tablets are yellow, round, biconvex tablets with the engraved code "D9EI" on one side and the number "10" on the other side.
Film-coated tablets are available in blisters of 7, 28, 30, 50, 56, 60, 84, 98, 100, 120 film-coated tablets and in unit-dose divisible blisters containing 50 film-coated tablets (for hospital use only).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
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 10 mg Filmtabletten
Bulgaria Donesyn 10 mg Филмирана таблетка
Czech Republic Donpethon 10 mg, potahovaná tableta
Estonia Donesyn 10 mg
Greece Donepezil Synthon Hispania 10 mg
Finland Donesyn 10 mg tabletti
Hungary Donesyn 10 mg filmtabletta
Ireland Donesyn 10 mg film-coated tablets
Iceland Donesyn 10 mg filmuhúðaðar töflur
Lithuania Donesyn 10 mg plėvele dengtos tabletės
Latvia Donesyn 10 mg apvalkotās tabletes
Norway Donesyn 10 mg tablett
Poland Donesyn
Portugal Dosylien 10 mg comprimidos revestidos por película
Romania Donesyn 10 mg
Slovenia Donesyn 10 mg filmsko obložene tablete
Slovakia Donesyn 10 mg