DONEPEZIL FLAS CINFA 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Donepezil Flas Cinfa 5 mg Orodispersible Tablets EFG

Donepezil, Hydrochloride

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this 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 you take Donepezil Flas Cinfa
3. How to take Donepezil Flas Cinfa
4. Possible side effects
5. Storage of Donepezil Flas Cinfa
6. Contents of the pack and other information

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

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

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

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

Do not take Donepezil Flas Cinfa

• If you are allergic to donepezil hydrochloride, piperidine derivatives, or any of the other ingredients of this medicine (listed in section 6)
• If you are pregnant, think you may be pregnant, or are breast-feeding.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Donepezil Flas 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 torsades 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 pulmonary 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 medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, 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
• other medicines for treating Alzheimer's disease, such as galantamine
• analgesics or treatments for arthritis such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium
• anticholinergic medicines, such as tolterodine
• anticonvulsants, such as phenytoin, carbamazepine
• medicines for heart disease, such as quinidine, beta-blockers (propranolol and atenolol)
• muscle relaxants, such as diazepam, succinylcholine
• general anesthetics
• medicines obtained without a prescription, such as herbal remedies

In case 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 medicine.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Do not take donepezil flas if you are breast-feeding.

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. 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, you should not drive or use machines.

Donepezil Flas Cinfa contains Lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Donepezil Flas Cinfa contains Sodium. This medicine contains less than 23 mg of sodium (1 mmol) per orodispersible tablet; this is essentially "sodium-free".

Donepezil Flas Cinfa contains Aspartame (E-951). This medicine contains 5 mg of aspartame in each orodispersible tablet, equivalent to 2.80 mg of phenylalanine. Aspartame is a source of phenylalanine, which may be harmful in people with phenylketonuria (a rare genetic disorder in which phenylalanine accumulates in the body because it cannot be eliminated properly).

3. How to take Donepezil Flas Cinfa

Follow exactly the instructions of administration of this medicine given to you by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Take the orodispersible tablet as follows:

Donepezil flas is administered orally.

1. Do not crush the orodispersible tablet

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

1. Separate a blister

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

1. Remove the foil

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

1. Remove the orodispersible tablet

Remove the orodispersible 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, as you prefer.

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 that you take donepezil in the morning.

If you have mild or moderate liver or kidney disease, 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 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, telephone 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the package leaflet and the medicine packaging to the healthcare professional.

Symptoms of overdose may include nausea (feeling sick), vomiting (being sick), 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 unless your doctor tells you to. If you stop taking donepezil flas, the benefits of treatment will gradually disappear.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported by people taking donepezil flas. Contact your doctor if you have 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, for example, 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 (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)).
• Dizziness (fits) or seizures (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-colored urine. This may be due to an abnormal destruction of muscle that 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 (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 tremor or rigidity of the hands or feet)
• Conduction disorders
• Liver function disorders, including hepatitis

Frequency Not Known (cannot be estimated from the available data)

• Changes in heart 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 that involves involuntary muscle contraction with abnormal flexion of the body and head to one side)

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's website: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Donepezil Flas Cinfa

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

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. Contents of the Pack and Other Information

Composition of Donepezil Flas Cinfa

• The active substance is donepezil hydrochloride. Each orodispersible tablet contains 5 mg of donepezil hydrochloride, equivalent to 4.56 mg of donepezil.
• The other ingredients 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 Packaging

Donepezil Flas Cinfa is presented in orodispersible tablets, which dissolve in the mouth. The orodispersible tablets of Donepezil Flas Cinfa 5 mg are flat, round, with beveled edges, and white or almost white, engraved with "5" on one face and flat on the other.

Donepezil Flas Cinfa 5 mg is available in PVC/PCTFE (Aclar)/Aluminum blister packs and in Aluminum/Aluminum blister packs with 28 orodispersible 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 Av. 15351 Pallini Attikis - Greece

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of Last Revision of this Leaflet:October 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/

You can access detailed and up-to-date information about this medicine 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/74998/P_74998.html

QR code to: https://cima.aemps.es/cima/dochtml/p/74998/P_74998.html