DONEPEZILO 10 mg Film-Coated Tablets

2. Before taking Donepezilo Combix

Do not take DONEPEZILO COMBIX

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

Take special care with DONEPEZILO COMBIX

• Before starting treatment with Donepezilo Combix, you should tell your doctor if you have or have had stomach ulcers, heart disease (such as irregular heartbeats, heart failure, myocardial infarction), seizures, asthma, chronic pulmonary disease, or difficulty urinating, a heart condition called "prolonged QT interval" or a history of certain abnormal heart rhythms called torsades de pointes, or if someone in your family has "prolonged QT interval", or low levels of magnesium or potassium in the blood.
• In case of surgery with general anesthesia, you should inform your doctor that you are taking Donepezilo Combix.
• Donepezilo Combix is not recommended for use in children.
• You should avoid taking Donepezilo Combix with other acetylcholinesterase inhibitors and other agonists or antagonists of the cholinergic system.
• If you have vascular dementia (loss of brain function due to a series of small strokes).

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:

• Medicines for heart rhythm problems, such as amiodarone or sotalol
• Medicines for depression, such as citalopram, escitalopram, amitriptyline, fluoxetine
• Medicines for psychosis, such as pimozide, sertindole, or ziprasidone
• Medicines for bacterial infections, such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• Antifungal medicines, such as ketoconazole
• Quinidine and beta-blockers (for irregular heartbeats)
• Erythromycin (for bacterial infections)
• Phenytoin and carbamazepine (for epilepsy)
• Cholinergic agonists and medicines with anticholinergic activity (with action 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 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.

3. How to take Donepezilo Combix

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.

4. Possible side effects

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.

• Weakness, sensitivity, or muscle pain, especially if you feel unwell, have a fever, or your urine is dark. This can be due to abnormal muscle destruction that can be fatal and cause kidney problems (a disease called rhabdomyolysis).

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

• diarrhea.
• nausea.
• headache.

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

• common cold.
• loss of appetite.
• hallucinations, aggressive behavior, restlessness, which have been resolved by decreasing the dose or interrupting treatment.
• dizziness, insomnia, fainting.
• vomiting, abdominal discomfort.
• itching, rash.
• muscle cramps.
• urinary incontinence.
• fatigue, pain.
• accidents.

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

• seizures.
• slow heart rate.
• gastrointestinal bleeding, stomach and duodenal ulcers.
• in blood tests, a slight increase in the muscle enzyme creatine kinase.

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

• stiffness or uncontrolled movements, especially of the face and tongue, but also of the limbs.
• heart problems.
• liver problems, including hepatitis.

Frequency not known:

• changes in heart activity that can be seen on an electrocardiogram (ECG) called "prolonged QT interval"
• fast and irregular heartbeat, fainting that can be symptoms of a potentially fatal disorder known as torsades de pointes
• Pisa syndrome (a condition that involves involuntary muscle contraction with abnormal flexion of the body and head to one side)
• increased libido, hypersexuality.

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.

5. Storage of Donepezilo Combix

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.

6. Further information

Composition of DONEPEZILO COMBIX

• The active substance is donepezil hydrochloride. Each film-coated tablet contains 10 mg of donepezil hydrochloride.
• The other ingredients are: Tablet core: lactose monohydrate, corn starch, hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate. Tablet coating: hypromellose, titanium dioxide E171, macrogol 400, talc E553b.

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