Donepezil Flas CINFA 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Donepezilo flas cinfa 10 mg orodispersible tablets EFG

Donepezil hydrochloride

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Donepezilo flas cinfa is and what it is used for
2. What you need to know before taking Donepezilo flas cinfa
3. How to take Donepezilo flas cinfa
4. Possible side effects
5. How to store Donepezilo flas cinfa
6. Contents of the pack and other information

1. What is Donepezilo flas cinfa and what is it used for

Donepezilo 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 rate at which this substance is broken down.

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

2. What you need to know before taking Donepezilo flas cinfa

Do not take Donepezilo flas cinfa

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Donepezilo flas cinfa if you have or have had:

• A history of stomach or duodenal ulcer

• Heart disease (such as irregular or very slow heartbeats, heart failure, myocardial infarction)

• A heart condition known as "prolongation of the QT interval", or a history of certain abnormal heart rhythms called torsade de pointes, or if anyone 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 should avoid taking donepezilo flas together with other acetylcholinesterase inhibitors and other cholinergic agonists or antagonists.

Children and adolescents

Donepezilo flas is not recommended for use in children.

Taking Donepezilo flas cinfa with other medicines

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

Especially if you are taking any of the following:

• Medicines for heart rhythm problems, for example amiodarone or sotalol
• Medicines for depression, for example citalopram, escitalopram, amitriptyline, fluoxetine
• Medicines for psychosis, e.g., pimozide, sertindole, or ziprasidone
• Medicines for bacterial infections, for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• Antifungal medicines, such as ketoconazole
• Other medicines for treating Alzheimer's disease, for example galantamine
• Painkillers or treatments for arthritis such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac
• Anticholinergic medicines, e.g., tolterodine
• Anticonvulsants, e.g., phenytoin, carbamazepine
• Medication for heart disease, for example quinidine, beta-blockers (propranolol and atenolol)
• Muscle relaxants, e.g., diazepam, succinylcholine
• General anaesthetic
• Herbal remedies or over-the-counter medicines

If you require surgery under general anaesthesia, you must inform your doctor that you are taking donepezilo flas, as this may affect the amount of anaesthetic needed.

Donepezilo flas may be used in patients with mild to moderate renal or hepatic impairment. Inform your doctor if you have any kidney or liver disease. Patients with severe hepatic impairment should not take donepezilo flas.

Taking Donepezilo flas cinfa with food, drinks, and alcohol

Place the tablet on the tongue and allow it to dissolve. Swallow with or without water. Donepezilo flas should not be taken with alcohol, as alcohol may alter the effect of this medicine.

Pregnancy, breastfeeding, and fertility

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

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

Do not take donepezilo flas if you are breastfeeding your child.

Driving and using machines

Your condition may affect your ability to drive or operate machinery, and you should not perform these activities unless your doctor has advised you it is safe to do so. Donepezilo flas may cause fatigue, dizziness, somnolence, and muscle cramps, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you should not drive or operate machinery.

Donepezilo flas cinfa contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Donepezilo flas cinfa contains sodium. This medicine contains less than 23 mg of sodium (1 mmol) per orodispersible tablet; hence, it is essentially "sodium-free".

Donepezilo flas cinfa contains aspartame (E-951). This medicine contains 10 mg of aspartame in each orodispersible tablet, equivalent to 5.613 mg of phenylalanine. Aspartame contains a source of phenylalanine which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

3. How to take Donepezil flas cinfa

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in 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 prevent crushing the orodispersible tablet, do not press on the blister (Figure 1).

1. Separate one blister

Each blister contains fourteen blisters separated by perforations. Separate one blister along the perforated lines, where "fold" is indicated (Figure 2).

1. Remove the foil

Carefully peel off the foil, starting from the corner marked with an arrow and where "pull here" is indicated (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 rapidly, and once dissolved, it may be swallowed with or without water, according to your preference.

Treatment with donepezil flas starts with one 5 mg tablet taken once daily at night, immediately before going to bed. After one month of treatment, your doctor may instruct you to increase the dose to 10 mg once daily at night. The maximum recommended dose is 10 mg per day.

If you experience 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 hepatic insufficiency (liver disease) or renal insufficiency (kidney disease), you may take donepezil. Inform your doctor before starting treatment if you have liver or kidney problems. Patients with severe hepatic insufficiency (liver disease) must not take donepezil.

Use in children and adolescents

The use of donepezil flas is not recommended 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 at 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the package leaflet and the medicine container to the healthcare professional.

Symptoms of overdose may include nausea (feeling sick), vomiting, salivation, sweating, slowed heart rate, low blood pressure (dizziness or lightheadedness upon standing), breathing difficulties, 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 treatment with donepezil unless instructed by your doctor. If you stop taking donepezil flas, the benefits of treatment will gradually disappear.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported in people taking donepezilo flas. Contact your doctor if you experience any of these effects during treatment with donepezilo flas.

Serious adverse effects:

You must inform your doctor immediately if you notice any of the following serious adverse effects, as you may require urgent medical treatment.

• Liver damage, for example, hepatitis. Symptoms of hepatitis include feeling sick or being sick, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), and dark-colored urine (very rare adverse effects (may affect up to 1 in 10,000 patients)).
• Stomach or duodenal ulcers. Symptoms of ulcers include stomach pain and discomfort (indigestion) between the navel and the sternum (rare adverse 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 rectal bleeding (rare adverse effects (may affect up to 1 in 1,000 patients)).
• Dizziness (attacks) or seizures (rare adverse effects (may affect up to 1 in 1,000 patients)).
• Fever with muscle rigidity, sweating, and decreased level of consciousness (these may be symptoms of a disorder called "Neuroleptic Malignant Syndrome") (very rare adverse effects (may affect up to 1 in 10,000 patients)).
• Muscle weakness, tenderness, or pain, particularly if you also feel unwell, have a fever, or have dark-colored urine. This may be due to abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis).

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

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

• Diarrhea
• Malaise
• Headache

Common (may affect up to 1 in 10 patients)

• Cold symptoms
• 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
• Slowing of the heart rate (bradycardia)
• Gastrointestinal bleeding, stomach and duodenal ulcers (a part of the intestine)
• Increase in a type of enzyme (muscle creatine kinase) in the blood

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

• Extrapyramidal symptoms (such as tremor or stiffness in the hands or legs)
• Cardiac conduction disturbances
• Impaired liver function, including hepatitis

Frequency not known (cannot be estimated from available data)

• Changes in heart activity that may be seen on an electrocardiogram (ECG), known as "QT interval prolongation"
• Fast and irregular heartbeat, fainting, which may be symptoms of a potentially life-threatening disorder known as torsade de pointes
• Increased libido, hypersexuality
• Pisa syndrome (a condition involving involuntary muscle contraction with abnormal bending of the body and head to one side)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This 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 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, colloidal anhydrous silica, magnesium stearate, hydrochloric acid, purified water.

Appearance of the medicinal product and contents of the pack

Donepezil flas cinfa is available as orodispersible tablets, i.e. tablets that dissolve in the mouth. The orodispersible tablets of Donepezil flas cinfa 10 mg are flat, round, bevel-edged tablets, white or almost white in colour, marked with "10" on one side and plain on the other.

Donepezil flas cinfa 10 mg is available in PVC/PCTFE (Aclar)/aluminum and aluminum/aluminum blister packs containing 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 Avenue, 15351 Pallini, Greece

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10, Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent revision of this leaflet: October 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Medical Devices (AEMPS): http://www.aemps.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. 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