Donepezil Zentiva

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Donepezil Zentiva 5 mg film-coated tablets, 10 mg film-coated tablets

Generic medicine
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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Donepezil Zentiva is and what it is used for

Donepezil Zentiva (donepezil hydrochloride) belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil increases the levels of a substance (acetylcholine) present in the brain that is involved in memory function, as it slows down the breakdown of acetylcholine.
It is used to treat the symptoms of dementia in people who have been diagnosed with mild to moderate Alzheimer's disease. Symptoms include increasing memory loss, confusion, and changes in behaviour. As a result, individuals affected by Alzheimer's disease find it increasingly difficult to carry out normal daily activities.
Donepezil Zentiva is for use in adult patients only.

2. What you need to know before taking Donepezil Zentiva

Do not take Donepezil Zentiva

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Donepezil Zentiva, especially if you have or have previously had:

• gastric or duodenal ulcer;
• epileptic seizures or convulsions;
• heart conditions (irregular or very slow heartbeat);
• asthma or other chronic lung diseases;
• liver problems or hepatitis;
• difficulty passing urine or mild kidney disease;
• any involuntary or abnormal movements of the tongue, face, or body (extrapyramidal symptoms). Donepezil Zentiva may cause or worsen extrapyramidal symptoms.

Also inform your doctor if you are pregnant or suspect you may be pregnant.
Children and adolescents
The use of Donepezil Zentiva in children and adolescents (under 18 years of age) is not recommended.
Other medicines and Donepezil Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because these medicines may weaken or strengthen the effects of Donepezil Zentiva.
In particular, it is important to inform your doctor if you are taking any of the following medicines:

• other medicines for Alzheimer's disease, such as galantamine;
• painkillers or medicines for arthritis, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or sodium diclofenac;
• anticholinergic medicines, such as tolterodine;
• antibiotics such as erythromycin, rifampicin;
• antifungal medicines such as ketoconazole;
• antidepressants such as fluoxetine;
• anticonvulsants such as phenytoin, carbamazepine;
• medicines for heart conditions such as quinidine, beta-blockers (propranolol and atenolol);
• muscle relaxants such as diazepam, succinylcholine;
• general anaesthetics;
• over-the-counter medicines, including herbal remedies. If you are due to have surgery requiring general anaesthesia, you must inform your doctor and anaesthetist that you are taking Donepezil Zentiva. This is because this medicine may affect the amount of anaesthetic required.

Donepezil Zentiva can be used in patients with mild or moderate kidney or liver disease. If you have kidney or liver disease, inform your doctor before starting treatment. Patients with severe liver disease must not take Donepezil Zentiva.
Inform your doctor or pharmacist about the name of the person who cares for you. This person will help you take the medicine as prescribed by your doctor.
Donepezil Zentiva with food, drinks, and alcohol
Food does not affect the action of Donepezil Zentiva. Donepezil Zentiva should not be taken with alcohol, as this may alter the effect of the medicine.
Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, inform your doctor or pharmacist before taking any medicine.
Donepezil Zentiva must not be taken during breastfeeding.
Driving and using machines
Alzheimer's disease may impair your ability to drive or operate machinery, and you should not perform these activities unless your doctor has told you it is safe to do so.
In addition, this medicine may cause tiredness, dizziness, and muscle cramps. If you experience any of these effects, do not drive or operate machinery.
Donepezil Zentiva contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Donepezil Zentiva

Take this medicine exactly as your doctor or pharmacist has told you. If you are
unsure, consult your doctor or pharmacist.
Initially, the recommended dose is 5 mg (one white tablet) every evening before going to bed. After
one month, your doctor may instruct you to take 10 mg (two white tablets) every evening before going to bed.
Donepezil Zentiva 10 mg
Initially, the recommended dose is 5 mg (one half of a yellow tablet) every evening before going to bed. After
one month, your doctor may instruct you to take 10 mg (one yellow tablet) every evening before going to bed.
Your tablet dosage may change depending on when you started treatment and on your doctor's recommendations.
The maximum recommended dose is 10 mg every evening.
Always follow your doctor’s or pharmacist’s advice regarding how and when to take your medicine.
Do not change the dose without consulting your doctor.
Use in children and adolescents
This medicine is not recommended for use in children and adolescents (under 18 years of age).
How to take Donepezil Zentiva
Swallow the Donepezil Zentiva tablets with water before going to bed in the evening.
How long should you take Donepezil Zentiva
Your doctor or pharmacist will tell you how long you should continue taking the tablets. You will need to see your doctor periodically to reassess your treatment and symptoms.
If you take more Donepezil Zentiva than you should
DO NOT take more than the recommended dose each day. Contact your doctor immediately if you take more than you should. If you cannot reach your doctor, go immediately to the nearest hospital emergency department. Always take the tablets and the packaging with you to hospital so the doctor knows what you have taken.
Symptoms of overdose include feeling unwell or nausea, drooling, sweating, slowed heartbeat, low blood pressure (dizziness or lightheadedness when standing), breathing difficulties, loss of consciousness, and epileptic seizures or convulsions.
If you forget to take Donepezil Zentiva
If you forget to take a dose of the medicine, take the recommended dose at the usual time the next day.
Do not take a double dose to make up for the missed dose. If you forget to take the tablet for more than one week, speak with your doctor before taking any further medicine.
If you stop taking Donepezil Zentiva
Do not stop taking Donepezil Zentiva unless your doctor tells you to. If you stop taking Donepezil Zentiva, the benefits of treatment will gradually decrease.
For further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported in people who have taken Donepezil Zentiva.
Tell your doctor if any of the side effects listed below occur while taking Donepezil Zentiva.
Serious side effects
You must speak to your doctor immediately if you experience any of the serious side effects listed below.
You may urgently require medical treatment.

• Liver damage, such as hepatitis. Symptoms of hepatitis include feeling unwell or malaise, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), and dark-coloured urine (may affect up to 1 in 1,000 people).
• Gastric or duodenal ulcer. Symptoms of ulcer include stomach pain and discomfort (indigestion) felt between the navel and the breastbone (may affect up to 1 in 100 patients).
• Bleeding in the stomach or intestines. This may cause passage of black, tarry stools or visible rectal bleeding (may affect up to 1 in 100 people).
• Epileptic seizures or convulsions (may affect up to 1 in 100 people).
• Fever with muscle rigidity, sweating, or reduced level of consciousness – a condition called "Neuroleptic Malignant Syndrome" (may affect up to 1 in 10,000 people).
• Weakness, hypotonia, or muscle pain, particularly if accompanied by feeling unwell, high fever, or dark urine. These symptoms could be due to abnormal muscle breakdown, which can be life-threatening and may lead to kidney problems (a condition known as rhabdomyolysis) (may affect up to 1 in 10,000 people).

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

• Diarrhoea, feeling unwell or nausea.
• Headache.

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

• Cold symptoms.
• Loss of appetite.
• Hallucinations (seeing or hearing things that are not real), agitation, aggressive behaviour, abnormal dreams and nightmares.
• Fatigue, dizziness, difficulty sleeping (insomnia).
• Vomiting, stomach discomfort.
• Rash, itching.
• Muscle cramps.
• Involuntary urination.
• Tiredness, pain.
• Accidents (patients may be more prone to falls and accidental injuries).

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

• Slowed heart rate.
• Hypersalivation (increased saliva production).
• Minor changes in the concentration of certain enzymes.

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

• Stiffness, tremor, or uncontrolled movements, especially of the face and tongue, but also of the limbs.
• Irregular heartbeat.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Donepezil Zentiva

Keep out of the sight and reach of children.
Do not use Donepezil Zentiva after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the Pack and Other Information

What Donepezil Zentiva Contains
The active substance is donepezil hydrochloride. Each 5 mg film-coated tablet contains 5 mg of
donepezil hydrochloride, equivalent to 4.56 mg of donepezil.
The active substance is donepezil hydrochloride. Each 10 mg film-coated tablet contains 10 mg of
donepezil hydrochloride, equivalent to 9.12 mg of donepezil.
The other ingredients (excipients) are lactose monohydrate, microcrystalline cellulose, magnesium stearate,
potassium acesulfame, hypromellose, talc, macrogol, titanium dioxide (E171).
In addition, the 10 mg tablets contain synthetic yellow iron oxide (E172).

Description of the Appearance of Donepezil Zentiva and Contents of the Pack

• Round, biconvex film-coated tablets, white to off-white in colour, approximately 6.7 mm in diameter, marked with "5" on one side and plain on the other side.
• Round, biconvex film-coated tablets, yellow in colour, approximately 8.8 mm in diameter, marked with "10" on one side and a breakline on the other side. The tablets can be divided into two equal doses.
  Blister (polyamide/Alu/PVC/Alu).
  Pack sizes: 7, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112, 120 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder:
Zentiva Italia S.r.l.
Viale L. Bodio, 37/b
20158 Milano
Italy

Manufacturer Responsible for Batch Release:
ZENTIVA, k.s.
U kabelovny 130, Dolní Měcholupy, 102 37 Praha 10
Czech Republic

This medicinal product is authorized in the European Economic Area member states under the following names:

This leaflet was last updated on: