Donepezil Combix 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

DONEPEZIL COMBIX 5 mg film-coated tablets EFG

donepezil, hydrochloride

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you; do not give it to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What DONEPEZIL COMBIX is and what it is used for
2. Before you take DONEPEZIL COMBIX
3. How to take DONEPEZIL COMBIX
4. Possible side effects
5. How to store DONEPEZIL COMBIX
6. Further information

1. What Donepezilo Combix is and what it is used for

Donepezilo Combix belongs to a group of medicines called acetylcholinesterase inhibitors. It is used to treat the symptoms of mild to moderately severe Alzheimer's disease. It should only be used in adult patients.

2. Before taking Donepezilo Combix

Do not take DONEPEZILO COMBIX

• If you are allergic to donepezil hydrochloride or any of the components of Donepezilo Combix.
• If you are pregnant or breastfeeding.

Take special care with DONEPEZILO COMBIX

• Before starting treatment with Donepezilo Combix, you must inform your doctor if you have or have had stomach ulcer, heart disease (such as irregular or very slow heartbeats, heart failure, myocardial infarction), seizures, asthma, chronic lung disease or difficulty urinating, a heart condition called "QT interval prolongation" or a history of certain abnormal heart rhythms known as torsade de pointes, or if anyone in your family has "QT interval prolongation" or low levels of magnesium or potassium in the blood.
• If you are undergoing surgery with general anesthesia, you must inform your doctor that you are taking Donepezilo Combix.
• The use of Donepezilo Combix is not recommended in children.
• You should avoid taking Donepezilo Combix together with other acetylcholinesterase inhibitors and other agonists or antagonists of the cholinergic system.
• If you suffer from vascular dementia (loss of brain function due to a series of small strokes).

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription, and especially if you are taking any of the following medicines:

• Medicines for heart rhythm problems, for example amiodarone or sotalol
• Medicines for depression, for example citalopram, escitalopram, amitriptyline, fluoxetine
• Medicines for psychosis, e.g. pimozide, sertindole or ziprasidone
• Medicines for bacterial infections, for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• Antifungal medicines, such as ketoconazole
• Quinidine and beta-blockers (for treating irregular heartbeats)
• Rifampicin (for treating bacterial infections and tuberculosis)
• Phenytoin and carbamazepine (for treating epilepsy)
• Cholinergic agonists and medicines with anticholinergic activity (acting on the central nervous system).
• Succinylcholine and other neuromuscular blockers (to produce muscle relaxation)

Taking Donepezilo Combix with alcohol may reduce the absorption of this medicine.

Taking DONEPEZILO COMBIX with food and drinks

This medicine should be taken with a glass of water.

Paediatric population:

The use of Donepezilo Combix is not recommended in children.

Pregnancy and breastfeeding

Do not take Donepezilo Combix if you are pregnant.

Do not take Donepezilo Combix if you are breastfeeding your baby.

Driving and using machines

Your condition may affect your ability to drive or operate machinery, and you should not engage in these activities unless your doctor tells you it is safe to do so. Donepezil may cause dizziness and drowsiness, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you should not drive or operate machinery.

Important information about some of the components of DONEPEZILO COMBIX

Donepezilo Combix contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Donepezilo Combix

Follow exactly the instructions for taking Donepezilo Combix as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

Donepezilo Combix is administered orally.

Treatment with Donepezilo Combix starts with one 5 mg tablet taken once daily with water, at night immediately before going to bed. After one month of treatment, your doctor may instruct you to increase the dose to 10 mg once daily at night. The maximum recommended dose is 10 mg/day.

If you experience abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend that you take Donepezilo Combix in the morning.

If you have mild or moderate hepatic impairment (liver disease) or renal impairment (kidney disease), you may follow a dosing regimen similar to that described above.

If you take more DONEPEZILO COMBIX than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take DONEPEZILO COMBIX

Do not take a double dose to make up for the missed dose.

4. Possible adverse effects

Like all medicines, Donepezil Combix may cause adverse effects, although not everyone experiences them.

Serious adverse effects

Inform your doctor immediately if you notice any of these serious effects listed below. You may require urgent medical treatment.

• Muscle weakness, tenderness or pain, particularly if you also feel unwell, have a fever, or your urine is dark-colored. This may be due to abnormal muscle breakdown which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis).

Very common adverse effects (may affect more than 1 in 10 patients):

• Diarrhea.
• Nausea.
• Headache.

Common adverse effects (may affect between 1 and 10 in every 100 patients):

• Common cold.
• Loss of appetite.
• Hallucinations, aggressive behavior, restlessness, which resolved when the dose was reduced or treatment discontinued.
• Dizziness, insomnia, fainting.
• Vomiting, abdominal discomfort.
• Itching, rash.
• Muscle cramps.
• Urinary incontinence.
• Fatigue, pain.
• Accidents.

Uncommon adverse effects (may affect between 1 and 10 in every 1,000 patients):

• Seizures.
• Slow heartbeat.
• Gastrointestinal bleeding, stomach and duodenal ulcers.
• In blood tests, slight increase in the muscle enzyme creatine kinase.

Rare adverse effects (may affect between 1 and 10 in every 10,000 patients):

• Stiffness or uncontrollable movements, especially of the face and tongue, but also of the limbs.
• Heart disorders.
• Liver disorders, including hepatitis.

Frequency not known

• Changes in heart activity that may be seen on an electrocardiogram (ECG), known as "QT interval prolongation".
• Rapid and irregular heartbeat, fainting, which may be symptoms of a potentially life-threatening disorder known as torsade de pointes.
• Pisa syndrome (a condition involving involuntary muscle contractions with abnormal lateral flexion of the body and head).
• Increased libido, hypersexuality.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Donepezil Combix

Keep out of the reach and sight of children.

Do not use Donepezil Combix after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month indicated.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Additional Information

Composition of DONEPEZIL COMBIX

• The active substance is donepezil hydrochloride. Each film-coated tablet contains 5 mg of donepezil hydrochloride.
• The other components are:

Tablet core: lactose monohydrate, corn starch, hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate.

Tablet coating: hypromellose, titanium dioxide E171, macrogol 400, talc E553b.

Appearance of the product and contents of the container

Donepezil Combix 5 mg is presented in packs containing 28, 50 or 56 film-coated tablets, white or almost white, round, biconvex, marked with "ZF9" on one side and smooth on the other.

Donepezil Combix is also available as 10 mg film-coated tablets, in packs of 28, 50 or 56 tablets.

Marketing Authorization Holder

LABORATORIOS COMBIX, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid), Spain

Manufacturer

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 Rue de la Chapelle

63450 Saint Amant Tallende

France

or

Zydus France

ZAC Les Hautes Patures

25 Rue des Peupliers

92000 Nanterre

France

Date of the most recent review of this leaflet: November 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es