Donesin

Package Leaflet: Information for the Patient

Donesyn, 5 mg, 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 medication 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Donesyn and What is it 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 is Donesyn and What is it Used For

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

2. Important Information Before Taking Donesyn

When Not to Take Donesyn

• If you are 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 taking Donesyn, discuss with your doctor or pharmacist if any of the following apply to you:
if you have or have had heart problems (especially sick sinus syndrome or other supraventricular conduction disturbances, e.g. atrioventricular block, bradycardia, heart failure, myocardial infarction). Donepezil may slow the heart rate;
if you have or have had a condition where the heart beats too slowly (prolonged QT interval) or have had certain types of irregular heart rhythms (e.g. torsade de pointes) or have had a prolonged QT interval in the past;
if you have low levels of magnesium or potassium in the blood.
if you have or have had stomach ulcers or bleeding in the stomach or duodenum, or if you are taking non-steroidal anti-inflammatory drugs (NSAIDs). Your doctor should monitor you;
if you have difficulty urinating. Your doctor should monitor you;
if you have ever had seizures. Donepezil may cause a new seizure.
Your doctor should monitor you;
if you have asthma or other chronic lung disease. Symptoms may worsen;
if your doctor has told you that you have an intolerance to some sugars, such as lactose.
Donesyn can be used in patients with kidney or mild to moderate liver disease. However, you should tell your doctor if you have kidney or liver disease. Patients with severe liver disease should not take Donesyn.

Children and Adolescents

Donesyn is not recommended for use in children and adolescents (under 18 years).

Donesyn and Other Medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
Tell your doctor if you are taking any of the following medicines:

• general anesthetics. If you are going to have surgery requiring general anesthesia, tell your doctor and anesthesiologist that you are taking Donesyn. This is because the medicine may affect the amount of anesthetic needed.
• medicines used to control heart rhythm (quinidine), antifungal medicines (ketoconazole and itraconazole), certain antibiotics (erythromycin), and medicines used to treat depression (e.g. fluoxetine). These medicines may increase the effects of Donesyn.
• medicines used to treat tuberculosis (rifampicin), medicines used to treat epilepsy (phenytoin and carbamazepine). These medicines may decrease the effects of Donesyn.
• medicines used for short-term muscle relaxation during anesthesia and intensive care (succinylcholine), other muscle relaxants, medicines that stimulate a certain area of the nervous system (cholinergic agonists), and certain medicines that lower blood pressure (beta-blockers). The effects of both medicines are increased.
• medicines that inhibit a certain area of the nervous system (anticholinergic medicines).
• pain relievers or anti-inflammatory medicines, such as acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac.
• other medicines for Alzheimer's disease, such as galantamine.
• over-the-counter medicines, such as herbal medicines.
• medicines used to treat irregular heart rhythms (e.g. amiodarone, sotalol, and quinidine).
• medicines used to treat depression (e.g. citalopram, escitalopram, amitriptyline), medicines used to treat psychosis (e.g. pimozide, sertindol, 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.
Do not drink alcohol while taking Donesyn, as alcohol may change the effect of the medicine.

Pregnancy, Breastfeeding, and Fertility

Women taking Donesyn should not breastfeed.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and Using Machines

Alzheimer's disease may impair your ability to drive or operate machinery, so do not perform these activities until your doctor has deemed it safe for you to do so.
Additionally, Donesyn may cause drowsiness, dizziness, and muscle cramps. If you experience any of these effects, do not drive or operate machinery.

Donesyn Contains Lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Donesyn Contains Sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to Take Donesyn

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Tell your doctor or pharmacist the name of your caregiver. Your caregiver will help you take the prescribed medicine.
The dose of Donesyn may change depending on the duration of treatment and your doctor's recommendations.
The recommended starting dose is one 5 mg tablet of Donesyn (5 mg donepezil hydrochloride) taken in the evening. After one month, your doctor may increase the dose of Donesyn to two 5 mg tablets of Donesyn (10 mg donepezil hydrochloride) taken in the evening.
The maximum recommended daily dose is 10 mg.
If doses are not possible with this strength, other strengths of this medicinal product are available.
In patients with impaired renal function, dose adjustment is not necessary.
In patients with mild to moderate liver impairment, dose increases should be based on individual tolerance. In case of severe liver impairment, do not take Donesyn (see section 2, before taking Donesyn). In case of unexplained liver disease, your doctor may decide to discontinue treatment with Donesyn.
Take the Donesyn tablet(s) orally, with water, in the evening, before bedtime.
If you experience unusual dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend taking Donesyn in the morning.
Your doctor will tell you how long to take Donesyn. Keep regular contact with your doctor to verify treatment and assess symptoms.

Taking More Donesyn Than Prescribed

Symptoms of overdose may include: severe nausea, vomiting, salivation, sweating, bradycardia (slow heart rate), hypotension, respiratory depression. Muscle weakness (collapse) and involuntary muscle contractions (seizures) may also occur, as well as progressive muscle weakness that can be life-threatening.
If you have taken more Donesyn than prescribed, contact your doctor or go to the nearest hospital immediately. Bring this leaflet and the packaging of the medicine with you.

Missing a Dose of Donesyn

Do not take a double dose to make up for a forgotten dose.
Take the next dose at the usual time.
If you have missed taking Donesyn for more than one week, consult your doctor before taking the medicine again.

Stopping Donesyn Treatment

Do not stop taking Donesyn, even if you feel better, unless your doctor tells you to.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Donesyn can cause side effects, although not everybody gets them.
Severe side effects:
If you experience any of the following severe side effects, contact your doctor immediately, as you may need urgent medical attention.

• liver problems, including hepatitis. Symptoms of hepatitis are nausea or vomiting, loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin and eyes, dark urine (may affect up to 1 in 1,000 people)
• stomach or duodenal ulcers. Symptoms of ulcers are stomach pain and discomfort in the upper abdomen (indigestion) (may affect up to 1 in 100 people)
• bleeding from the stomach or intestines. This may cause black tarry stools or blood in the stool (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 decreased consciousness (a condition called neuroleptic malignant syndrome) (may affect up to 1 in 10,000 people)
• weakness, tenderness, or pain in the muscles, especially if accompanied by feeling unwell, 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 problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 people)

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

• diarrhea
• nausea
• headache

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

• cold
• loss of appetite (anorexia)
• hallucinations
• agitation
• aggressive behavior
• unusual dreams, including nightmares
• fainting
• dizziness
• sleep disturbances (insomnia)
• vomiting
• stomach upset
• rash
• fatigue
• sleep disturbances (insomnia)
• itching
• muscle cramps
• incontinence
• accidents (patients may be more prone to falls and accidental injuries)
• pain

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

• bradycardia (slow heart rate)
• mild increase in muscle enzyme levels in the blood

Rare(may affect up to 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 an electrocardiogram known as "prolonged QT interval"
• fast, irregular heartbeat, fainting, which can be symptoms of a life-threatening condition called torsade de pointes
• increased libido, hypersexuality
• a condition called torticollis (involuntary muscle contraction with abnormal twisting of the head and neck to one side).

Reporting Side Effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety 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
Side effects can also be reported to the marketing authorization holder or its representative.

5. How to Store Donesyn

Keep this medicine out of the 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 that month.
Store in a temperature 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 5 mg coated tablet of Donesyn contains 5.22 mg of donepezil hydrochloride monohydrate, equivalent 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 carboxymethylcellulose (type A), hydroxypropylcellulose (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, coated tablets are white, round, and biconvex tablets with a debossed "D9EI" on one side and "5" on the other side.
The coated tablets are available in blisters of 7, 28, 30, 50, 56, 60, 84, 98, 100, 120 coated tablets and in single-dose blisters of 50 coated tablets (for hospital use only).
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

Manufacturers:

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

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

Germany
Donesyn 5 mg Film-Coated Tablets
Bulgaria
Donesyn 5 mg Film-Coated Tablets
Czech Republic
Donpethon 5 mg, Coated Tablets
Estonia
Donesyn 5 mg
Greece
Donepezil Synthon Hispania 5 mg
Finland
Donesyn 5 mg Tablets
Hungary
Donesyn 5 mg Film-Coated Tablets
Ireland
Donesyn 5 mg Film-Coated Tablets
Iceland
Donesyn 5 mg Film-Coated Tablets
Lithuania
Donesyn 5 mg Coated Tablets
Latvia
Donesyn 5 mg Coated Tablets
Norway
Donesyn 5 mg Tablets
Poland
Donesyn
Portugal
Dosylien 5 mg Film-Coated Tablets
Romania
Donesyn 5 mg
Slovenia
Donesyn 5 mg Film-Coated Tablets
Slovakia
Donesyn 5 mg
Date of Approval of the Leaflet:01.11.2022