PATIENT INFORMATION LEAFLET

DONEPEZIL COMBIX 5 mg film-coated tablets

Donepezil hydrochloride

Read this leaflet carefully before you start taking the 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 pass it on to others even if their symptoms are the same. It may harm them.
• If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.See section 4.

1. What DONEPEZIL COMBIX is and what it is used for

2. Before taking DONEPEZIL COMBIX

3. How to take DONEPEZIL COMBIX

4. Possible side effects

5. Storage of DONEPEZIL COMBIX

6. Further information

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

Do not take DONEPEZILO COMBIX

- If you are allergic to hydrochloride donepezilo or any of the components of Donepezilo Combix.

- If you are pregnant or breastfeeding.

Be especially careful with DONEPEZILO COMBIX

- Before starting treatment with Donepezilo Combix, you must inform your doctor if you have or have a history of stomach ulcers, 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 "prolongation of the QT interval" or a family history of "prolongation of the QT interval", or low levels of magnesium or potassium in the blood.

- In case of surgical intervention with general anesthesia, you must inform your doctor that you are taking Donepezilo Combix.

- Do not recommend the use of Donepezilo Combix in children.

- You should avoid taking Donepezilo Combix with other acetylcholinesterase inhibitors and other cholinergic agonists or antagonists.

- If you have vascular dementia (loss of brain function due to a series of small strokes).

Use of other medications

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

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

The consumption of Donepezilo Combix with alcohol may reduce the absorption of this medication.

Taking DONEPEZILO COMBIX with food and beverages

This medication should be taken with a little water.

Pediatric population:

Do not recommend the use of Donepezilo Combix in children.

Pregnancy and lactation

Do not take Donepezilo Combix if you are pregnant.

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

Driving and operating machinery

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

Important information about one of the components of DONEPEZILO COMBIX

Donepezilo Combix contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Follow exactly the administration instructions for Donepezilo Combix as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Donepezilo Combix is administered orally.

The treatment with Donepezilo Combix starts with a 5 mg tablet, taken once a day with a little water, at night immediately before going to bed. After a month of treatment, your doctor may recommend an increase in the dose to 10 mg, once a day and 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 liver disease (a disease that affects the liver) or kidney disease (a disease that affects the kidney), you can 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take DONEPEZILO COMBIX

Do not take a double dose to compensate for the missed dose.

Like all medicines, Donepezilo Combix can cause side effects, although not everyone will experience them.

Severe side effects

Inform your doctor immediately if you notice any of these severe side effects mentioned. You may need urgent medical treatment.

• Muscle weakness, sensitivity, or pain, particularly if you are feeling unwell, have a fever, or your urine is dark in color. This can be due to abnormal muscle destruction that can be fatal and cause kidney problems (a condition known as 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 resolved by reducing the dose or discontinuing 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.

- Mild increase in muscle creatine kinase enzyme in blood tests.

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

- Rigidity or uncontrolled movements, especially of the face and tongue, but also of the limbs.

- Cardiac abnormalities.

- Liver abnormalities, including hepatitis.

Unknown frequency

- Changes in heart activity that can be seen on an electrocardiogram (ECG) called "prolongation of the QT interval"

- Rapid and irregular heart rate, fainting that may be symptoms of a potentially fatal condition known as torsade 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 side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the reach and sight of children.

Do not use Donepezilo Combix after the expiration date that appears on the blister and on the box. The expiration date is the last day of the month indicated.

Store below25°C.

Medicines should not be thrown into the drains or into the trash. Dispose ofthe packaging and the medicines that you do not need at the SIGRE collection pointofthe pharmacy. Incase of doubt, ask your pharmacist how to dispose of the packaging and the medicines that you do not need. By doing so, you will help protect the environment.

Composition of DONEPEZILO COMBIX

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

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

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

Appearance of the product and contents of the package

Donepezilo Combix 5 mgis presented in packages containing 28 film-coated tablets, ofwhite or almost white color, round, biconvex, marked with“ZF9”on one side and smooth on the other.

Donepezilo Combix is also available in 10 mg film-coated tablets, in packages of 28 tablets.

Marketing Authorization Holder

LABORATORIOS COMBIX, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid), Spain

Responsible for Manufacturing

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 Rue de la Chapelle

63450 Saint Amant Tallende

France

Last review date of this leaflet:November 2022

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es