Summary of Product Characteristics: Information for the User

Donepezilo Cinfa 5 mg TabletsEFG

Donezepilo Hydrochloride

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is donepezilo cinfa and what it is used for.

2.What you need to know before starting to take donepezilo cinfa.

3.How to take donepezilo cinfa.

4.Possible side effects.

5Storage of donepezilo cinfa.

6.Contents of the pack and additional information.

Donepezilo cinfa belongs to a group of medicines called cholinesterase inhibitors. Hydrochloride of donepezilo increases the levels in the brain of a substance related to memory (acetylcholine), through the reduction of the speed of decomposition of this substance.

It is used for the treatment of the symptoms of mild to moderately severe Alzheimer's disease. Symptoms include increased loss of memory, confusion, and changes in behavior.

Do not take Donepezil Cinfa

• If you are allergic to hydrochloride of donepezil, to piperidina derivatives or to any of the other components of this medication (listed in section 6).

-If you are pregnant, think you may be pregnant or are breastfeeding.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take donepezil cinfa if you have or have had:

• History of stomach or duodenal ulcers
• Heart disease (such as irregular or very slow heartbeats, heart failure, myocardial infarction)
• A heart condition called “prolongation of the QT interval” or a history of certain abnormal heart rhythms called torsade de pointes or if someone in your family has “prolongation of the QT interval”
• Low levels of magnesium or potassium in the blood
• Seizures
• Asthma or chronic lung disease
• Difficulty urinating or mild kidney disease.

You must avoid takingdonepezilwith other acetylcholinesterase inhibitors and other cholinergic agonists or antagonists.

Children and Adolescents

Donepezil is not recommended for use in children.

Taking Donepezil Cinfa with Other Medications

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

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
• Other medications for treating Alzheimer's disease, for example galantamine
• Pain relievers or treatments for arthritis such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium
• Anticholinergic medications, for example tolterodine
• Anticonvulsants, for example, phenytoin, carbamazepine
• Medications for heart disease, for example quinidine, beta blockers (propranolol and atenolol)
• Muscle relaxants, for example, diazepam, succinylcholine
• General anesthetic
• Over-the-counter medications, for example, herbal remedies

You must inform your doctor that you are taking donepezil before undergoing surgery with general anesthesia as this may affect the amount of anesthetic needed.

Donepezil may be used in patients with mild to moderate kidney or liver disease. Inform your doctor if you have any kidney or liver disease. Patients with severe liver disease should not take donepezil.

Taking Donepezil Cinfa with Food, Drinks, and Alcohol

This medication should be taken with a little water.

Donepezil should not be taken with alcohol as alcohol may modify the effect of this medication.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Do not take donepezil if you are pregnant or think you may be pregnant.

Do not take donepezil if you are breastfeeding.

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. Donepezil may cause fatigue, dizziness, drowsiness, and muscle cramps, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or operate machinery.

Donepezil Cinfa Contains Lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Donepezil is administered orally.

Donepezil treatmentbegins 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 (2 tablets) once a day and at night. The maximum recommended dose is 10 mg (2 tablets) per day.

If you have abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend that you take donepezil 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 take donepezil. Inform your doctor before starting treatment if you have liver or kidney problems. Patients with severe liver disease should not take donepezil.

Use in children

Donepezil is not recommended for use in children.

If you take more donepezil cinfa 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 medication and the amount ingested. It is recommended to bring the package insert and the medication packaging to the healthcare professional.

The symptoms of overdose may include nausea (feeling sick), vomiting (being sick), drooling, sweating, decreased heart rate, low blood pressure (dizziness or dizziness when standing up), breathing problems, loss of consciousness, and seizures.

If you forgot to take donepezil cinfa

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

If you interrupt the treatment with donepezil cinfa

Do not stop taking donepezil unless your doctor tells you to. If you stop taking donepezil, the benefits of treatment will gradually disappear.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them

The following side effects have been reported by people taking donepezil. Contact your doctor if you experience any of these side effects during treatment with donepezil.

Severe side effects

You should inform your doctor immediately if you notice any of the following severe side effects mentioned, as you may need urgent medical treatment.

• Liver damage, for example, hepatitis. The symptoms of hepatitis are feeling or being sick, loss of appetite, general discomfort, fever, itching, yellowing of the skin and eyes, and dark-colored urine (very rare side effects (may affect up to 1 in 10,000 patients)).
• Ulcers in the stomach or duodenum. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the breastbone (rare side effects (may affect up to 1 in 1,000 patients)).
• Bleeding in the stomach or intestines. This may cause you to have black, tar-like stools or visible blood from the rectum (rare side effects (may affect up to 1 in 1,000 patients)).
• Dizziness (attacks) or convulsions (rare side effects (may affect up to 1 in 1,000 patients)).
• Fever with muscle stiffness, sweating, decreased level of consciousness (may be symptoms of a condition called "Neuroleptic Malignant Syndrome") (very rare side effects (may affect up to 1 in 10,000 patients)).
• Weakness, sensitivity, or muscle pain, particularly if you are also feeling unwell, have a fever, or your urine is dark. This may be due to abnormal muscle destruction that can be fatal and cause kidney problems (a condition called rhabdomyolysis).

The estimated frequency of side effects is as follows:

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

• Diarrhea
• Discomfort
• Headache

Common (may affect up to 1 in 10 patients)

• Common cold

• Loss of appetite
• Illusions
• Agitation
• Aggressive behavior
• Abnormal dreams and nightmares
• Fainting
• Dizziness
• Difficulty sleeping
• Vomiting
• Abdominal discomfort
• Urinary incontinence
• Rash
• Itching
• Muscle cramps
• Fatigue
• Pain
• Accidents (patients may be more prone to falls and accidental injuries)

Uncommon (may affect up to 1 in 100 patients)

Rare (may affect up to 1 in 1,000 patients)

Frequency not known (cannot be estimated from available data)

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy.at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of donepezil cinfa

• The active ingredient is donepezil hydrochloride. Each tablet contains 5 mg of donepezil hydrochloride equivalent to 4.56 mg of donepezil.
• The other components are: lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate.

Appearance of the product and contents of the packaging

White, cylindrical, biconvex tablets marked with the code “DL”.

Each package contains 28 or 50 (clinical package) tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:October 2022

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

You can access detailed and updated information on this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/73153/P_73153.html

QR code to:https://cima.aemps.es/cima/dochtml/p/73153/P_73153.html