DONEPEZIL FLAS CINFA 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Donepezil Flas Cinfa 10 mg Oral Disintegrating Tablets EFG

Donepezil Hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is Donepezil Flas Cinfa and what is it used for
2. What you need to know before taking Donepezil Flas Cinfa
3. How to take Donepezil Flas Cinfa
4. Possible side effects
5. Storage of Donepezil Flas Cinfa
6. Package contents and additional information

1. What is Donepezil Flas Cinfa and what is it used for

Donepezil Flas Cinfa belongs to a group of medications called acetylcholinesterase inhibitors. Donepezil hydrochloride increases the levels in the brain of a substance related to memory (acetylcholine) by decreasing the breakdown of this substance.

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

2. What you need to know before taking Donepezil Flas Cinfa

Do not take Donepezil Flas 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 Flas 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 cardiac condition called "prolonged QT interval" or a history of certain abnormal heart rhythms called torsades de pointes, or if a family member has "prolonged QT interval"
• low levels of magnesium or potassium in the blood

• seizures
• asthma or chronic lung disease
• difficulty urinating or mild kidney disease.

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

Children and Adolescents

Donepezil flas is not recommended for use in children.

Taking Donepezil Flas Cinfa with Other Medications

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

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 flas, as this may affect the amount of anesthetic needed.

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

Taking Donepezil Flas Cinfa with Food, Drinks, and Alcohol

Place the tablet on the tongue and let it dissolve. Swallow with or without water. Donepezil flas 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 flas if you are pregnant or think you may be pregnant.

Do not take donepezil flas if you are breastfeeding.

Driving and Using Machines

Your illness may affect your ability to drive or operate machinery, and you should not perform these activities unless your doctor indicates that it is safe to do so. Donepezil flas can 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 Flas Cinfa Contains Lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Donepezil Flas Cinfa Contains Sodium. This medication contains less than 23 mg of sodium (1 mmol) per oral disintegrating tablet; it is essentially "sodium-free".

Donepezil Flas Cinfa Contains Aspartame (E-951). This medication contains 10 mg of aspartame in each oral disintegrating tablet, equivalent to 5.613 mg of phenylalanine. Aspartame is a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

3. How to Take Donepezil Flas Cinfa

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

Take the oral disintegrating tablet as follows:

Donepezil flas is administered orally.

1. Do not crush the oral disintegrating tablet

To avoid crushing the oral disintegrating tablet, do not press the blister (Figure 1).

1. Separate a blister

Each blister pack contains fourteen blisters, separated by perforations. Separate a blister by following the perforated lines, where indicated "fold" (Figure 2).

1. Remove the foil

Carefully remove the foil, starting from the corner marked with an arrow and where indicated "pull here" (Figures 3 and 4).

1. Remove the oral disintegrating tablet

Remove the oral disintegrating tablet with dry hands and place it on the tongue (Figure 5).

The tablet will dissolve quickly, and once dissolved, it can be swallowed with or without water, according to your preference.

Treatment with donepezil flas starts with a 5 mg tablet, taken once a day, at night, immediately before bedtime. After one month of treatment, your doctor may indicate an increase in the dose to 10 mg, once a day, at night. The maximum recommended dose is 10 mg 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 and Adolescents

Donepezil flas is not recommended for use in children or adolescents.

If You Take More Donepezil Flas 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 Flas Cinfa

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

If You Stop Taking Donepezil Flas Cinfa

Do not stop taking donepezil flas unless your doctor indicates that you should. If you stop taking donepezil flas, 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 flas. Contact your doctor if you experience any of these side effects during treatment with donepezil flas.

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 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 sternum (rare side effects, may affect 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, may affect up to 1 in 1,000 patients).
• Seizures 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 also feel unwell, have a fever, or have dark urine. This may be due to abnormal muscle destruction that can be life-threatening 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
• Nausea
• Headache

Common (may affect 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 (may affect 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 (creatine kinase) in the blood

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

• Extrapyramidal symptoms (such as tremors or rigidity of the hands or feet)
• Conduction disorders
• Liver function disorders, including hepatitis

Frequency Not Known (cannot be estimated from available data)

• Changes in heart activity that can be seen on an electrocardiogram (ECG) called "prolonged QT interval"
• Rapid and irregular heartbeat, fainting that can be symptoms of a potentially life-threatening disorder known as torsades de pointes
• Increased libido, hypersexuality.
• Pisa syndrome (a condition that involves 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 Medication Surveillance System for Human Use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Donepezil Flas 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.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Donepezil Flas Cinfa

• The active ingredient is donepezil hydrochloride. Each oral disintegrating tablet contains 10 mg of donepezil hydrochloride, equivalent to 9.12 mg of donepezil.
• The other components are: polacrilin potassium, microcrystalline cellulose, lactose monohydrate, anhydrous monosodium citrate, aspartame (E-951), sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, hydrochloric acid, purified water.

Appearance of the Product and Package Contents

Donepezil Flas Cinfa is presented in oral disintegrating tablets, which dissolve in the mouth. The oral disintegrating tablets of Donepezil Flas Cinfa 10 mg are flat, round, with beveled edges, and white or almost white in color, engraved with "10" on one face and flat on the other.

Donepezil Flas Cinfa 10 mg is available in PVC/PCTFE (Aclar)/Aluminum blister packs and Aluminum/Aluminum blister packs with 28 oral disintegrating tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Genepharm S.A.

18 Km Marathon Avenue, 15351 Pallini Greece

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10, Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date 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 Health Products (AEMPS) http://www.aemps.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/75000/P_75000.html

QR code to: https://cima.aemps.es/cima/dochtml/p/75000/P_75000.html