


Ask a doctor about a prescription for DONEPEZIL COMBIX 10 mg FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
DONEPEZILO COMBIX 10 mg film-coated tablets EFG
Donepezil hydrochloride
Read all of this leaflet carefully before you start taking this medicine.
Contents of the pack:
Donepezilo Combix belongs to a group of medicines called acetylcholinesterase inhibitors. They are used to treat the symptoms of Alzheimer's disease of mild to moderate severity. It should only be used in adult patients.
Do not take DONEPEZILO COMBIX
Take special care with DONEPEZILO COMBIX
Using other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, and especially if you are taking any of the following medicines:
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 little water.
Paediatric population:
Donepezilo Combix is not recommended for use in children.
Pregnancy and breastfeeding
Do not take Donepezilo Combix if you are pregnant.
Do not take Donepezilo Combix if you are breastfeeding.
Driving and using machines
Your illness may affect your ability to drive or use machines, and you should not carry out these activities unless your doctor tells you it is safe to do so. Donepezilo may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or use machines.
Important information about some of the ingredients of DONEPEZILO COMBIX
Donepezilo Combix contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.
Follow exactly the administration instructions of Donepezilo Combix given by your doctor. Ask your doctor or pharmacist if you have any doubts.
Donepezilo Combix is administered orally.
Treatment with Donepezilo Combix is started with a 5 mg tablet, taken once a day with a little water, at night immediately before bedtime. After a month of treatment, your doctor may indicate an increase in the dose to 10 mg, once a day and at night. The maximum recommended dose is 10 mg/day.
If you have 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 insufficiency (disease affecting the liver) or renal insufficiency (disease affecting the kidney), you may follow a similar dosing schedule as indicated above.
If you take more DONEPEZILO COMBIX than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take DONEPEZILO COMBIX
Do not take a double dose to make up for the forgotten dose.
Like all medicines, Donepezilo Combix can cause side effects, although not everybody gets them.
Serious side effects
Tell your doctor immediately if you notice any of these serious side effects. You may need urgent medical treatment.
Very common side effects (may affect more than 1 in 10 patients):
Common side effects (may affect between 1 and 10 in 100 patients):
Uncommon side effects (may affect between 1 and 10 in 1,000 patients):
Rare side effects (may affect between 1 and 10 in 10,000 patients):
Frequency not known:
Reporting of side effects
If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
Keep out of the reach and sight of children.
Do not use Donepezilo Combix after the expiry date which is stated on the blister and carton. The expiry date is the last day of the month stated.
Store below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
Composition of DONEPEZILO COMBIX
Appearance and packaging of the product
Donepezilo Combix 10 mg is presented in packs containing 28 film-coated tablets, white or almost white, round, biconvex, marked with "ZF10" on one side and smooth on the other.
Donepezilo Combix is also available in 5 mg film-coated tablets, in packs of 28 tablets.
Marketing authorisation 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 last revision of this leaflet:November 2022
Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es
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Discuss dosage, side effects, interactions, contraindications, and prescription renewal for DONEPEZIL COMBIX 10 mg FILM-COATED TABLETS – subject to medical assessment and local rules.