DONEPEZIL CINFA 5 mg TABLETS

2. What you need to know before taking donepezil cinfa

Do not take donepezil cinfa

• If you are allergic to donepezil hydrochloride, piperidine derivatives, or 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:

• a history of stomach or duodenal ulcers
• heart disease (such as irregular or slow heartbeats, heart failure, myocardial infarction)
• a heart condition called "prolongation of the QT interval" or a history of certain abnormal heart rhythms called torsades de pointes, or if a family member has "prolongation of the QT interval"
• low magnesium or potassium levels in the blood
• seizures
• asthma or chronic pulmonary disease
• difficulty urinating or mild kidney disease.

You should avoid taking donepezil with other acetylcholinesterase inhibitors and other agonists or antagonists of the cholinergic system.

Children and Adolescents

Donepezil is not recommended for use in children.

Taking donepezil cinfa with other medications

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

Especially if you are taking any of the following medications:

• medications for heart rhythm problems, such as amiodarone or sotalol
• medications for depression, such as citalopram, escitalopram, amitriptyline, fluoxetine
• medications for psychosis, such as pimozide, sertindole, or ziprasidone
• medications for bacterial infections, such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungal medications, such as ketoconazole
• other medications for treating Alzheimer's disease, such as galantamine
• analgesics or treatments for arthritis, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or diclofenac sodium
• anticholinergic medications, such as tolterodine
• anticonvulsants, such as phenytoin, carbamazepine
• medications for heart disease, such as quinidine, beta-blockers (propranolol and atenolol)
• muscle relaxants, such as diazepam, succinylcholine
• general anesthetics
• over-the-counter medications, such as herbal remedies

In the event of surgical intervention with general anesthesia, you should inform your doctor that you are taking donepezil, as this may affect the amount of anesthetic needed.

Donepezil can be used in patients with mild to moderate kidney or liver disease. Inform your doctor before starting treatment if you have kidney or liver problems. 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 alter the effect of this medication.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 Using Machines

Your illness may affect your ability to drive or operate machinery, and you should not engage in these activities unless your doctor indicates that it is safe to do so. Donepezil may cause fatigue, dizziness, somnolence, 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 them before taking this medication.

3. How to take donepezil cinfa

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

Donepezil is administered orally.

Treatment with donepezil starts with one 5 mg tablet, taken once a day with a little water, at night immediately before bedtime.

After one month of treatment, your doctor may indicate an increase in the dose to 10 mg (2 tablets) once a day, 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 taking donepezil in the morning.

If you have mild or moderate liver or kidney impairment, you can take donepezil. Inform your doctor before starting treatment if you have liver or kidney problems. Patients with severe liver impairment 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 leaflet and the medication packaging to the healthcare professional.

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

If you forget to take donepezil cinfa

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

If you stop taking 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.

4. Possible Side Effects

Like all medications, this medication can 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.

Serious Side Effects

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

• Liver damage, such as hepatitis. The symptoms of hepatitis are feeling or being sick, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and dark-colored urine (very rare side effects, affecting 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 sternum (rare side effects, affecting up to 1 in 1,000 patients).
• Bleeding in the stomach or intestine. This can cause you to have black, tarry stools or visible blood from the rectum (rare side effects, affecting up to 1 in 1,000 patients).
• Seizures or convulsions (rare side effects, affecting 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, affecting up to 1 in 10,000 patients).
• Weakness, sensitivity, or muscle pain, particularly if you also feel unwell, have a fever, or have dark-colored urine. This may be due to abnormal muscle destruction, which can be life-threatening and cause kidney problems (a condition called rhabdomyolysis).

The estimated frequency of occurrence of side effects is as follows:

Very Common (affecting more than 1 in 10 patients)

• Diarrhea
• Nausea
• Headache

Common (affecting up to 1 in 10 patients)

• Cold

• Loss of appetite
• Hallucinations
• 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 (affecting up to 1 in 100 patients)

• Seizures
• Decreased heart rate (bradycardia)
• Gastrointestinal bleeding, ulcers in the stomach and duodenum (a part of the intestine)
• Increased levels of a type of enzyme (creatinine kinase) in the blood

Rare (affecting up to 1 in 1,000 patients)

• Extrapyramidal symptoms (such as tremors or rigidity of the hands or feet)
• Changes in cardiac conduction
• Liver function changes, including hepatitis

Frequency Not Known (cannot be estimated from available data)

• Changes in cardiac activity that can be seen on an electrocardiogram (ECG) called "prolongation of the QT interval"
• Fast and irregular heartbeat, fainting that can be symptoms of a potentially life-threatening condition called torsades de pointes
• Increased libido, hypersexuality.
• Pisa syndrome (a condition involving involuntary muscle contraction with abnormal flexion of the body and head to one side)

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) online system: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of donepezil cinfa

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

Do not use this medication after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medications should not be disposed of through wastewater or household waste. Dispose of the packaging and any unused medication in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

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 ingredients are: lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate.

Appearance of the Product and Package Contents

White, cylindrical, biconvex tablets marked with the code "DL".

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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Dates of the Last Revision of this Package Leaflet:October 2022

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

You can access detailed and updated information about this medication by scanning the QR code included in the package 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