DONEPEZIL FLAS KERN PHARMA 5 MG ORODISPERSIBLE TABLETS EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Donepezil Flas Kern Pharma 5 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 effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Contents of the leaflet:

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

1. What Donepezilo Flas Kern Pharma is and what it is used for

Donepezilo Flas is a specific and reversible inhibitor of acetylcholinesterase, the predominant cholinesterase in the brain.

It is used for the symptomatic treatment of mild to moderately severe Alzheimer's disease.

2. What you need to know before starting to take Donepezil Flas Kern Pharma

Do not take Donepezil Flas Kern Pharma

• If you are allergic to donepezil hydrochloride or to any of the components of Donepezil Flas Kern Pharma.
• If you are pregnant or breastfeeding.

Warnings and precautions

• Before starting treatment with Donepezil Flas Kern Pharma, you must inform your doctor if you have or have a history of stomach ulcer, heart disease, seizures, asthma, chronic lung disease, or difficulty urinating.
• If you require surgery under general anesthesia, you must inform your doctor that you are taking Donepezil Flas.
• The use of Donepezil Flas is not recommended in children.
• You should avoid taking Donepezil Flas together with other acetylcholinesterase inhibitors and other agonists or antagonists of the cholinergic system.
• If you have vascular dementia (loss of brain function due to a series of small strokes).
• A heart condition (such as irregular or very slow heartbeats, heart failure, myocardial infarction).
• A heart condition known as "QT interval prolongation" or a history of certain abnormal heart rhythms called torsade de pointes, or if someone in your family has "QT interval prolongation".
• Low levels of magnesium or potassium in the blood.

Use of Donepezil Flas Kern Pharma with other medicines

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription, and especially if you are taking any of the following:

• Ketoconazole and itraconazole (used to treat fungal infections).
• Quinidine and beta-blockers (used to treat irregular heartbeats).
• Erythromycin (used to treat bacterial infections).
• Fluoxetine (used to treat depression).
• Rifampicin (used to treat bacterial infections and tuberculosis).
• Phenytoin and carbamazepine (used to treat epilepsy).
• Cholinergic agonists and medicines with anticholinergic activity (acting on the central nervous system).
• Succinylcholine and other neuromuscular blockers (used to produce muscle relaxation).
• Medicines for heart rhythm problems (e.g., amiodarone, sotalol, and quinidine).
• Medicines for depression (e.g., citalopram, escitalopram, amitriptyline), medicines for psychosis (e.g., pimozide, sertindole, ziprasidone), medicines for bacterial infections (such as clarithromycin, erythromycin, levofloxacin, moxifloxacin).

Use of Donepezil Flas Kern Pharma with food, drink, and alcohol

Place the tablet on the tongue and allow it to dissolve. Swallow with or without water.

Taking Donepezil with alcohol may reduce the absorption of this medicine.

Pregnancy, breastfeeding, and fertility

Do not take Donepezil Flas if you are pregnant.

Do not take Donepezil Flas if you are breastfeeding your child.

Driving and use of machines

Your illness may affect your ability to drive or operate machinery, and you should not perform these activities unless your doctor tells you it is safe to do so. Donepezil may cause dizziness and drowsiness, mainly at the beginning of treatment or when the dose is increased. If you experience these effects, you must not drive or operate machinery.

Donepezil Flas Kern Pharma contains aspartame. This medicine may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

3. How to take Donepezil Flas Kern Pharma

Follow your doctor's instructions for taking Donepezil Flas Kern Pharma exactly. If you have any doubts, consult your doctor or pharmacist.

Donepezil Flas Kern Pharma is administered orally. The tablet should be placed on the tongue and allowed to dissolve before swallowing, with or without water.

Treatment with Donepezil Flas Kern Pharma starts with one 5 mg tablet taken once daily with a little water, 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/day.

If you experience abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend that you take Donepezil Flas Kern Pharma in the morning.

If you have mild or moderate hepatic impairment (liver disease) or renal impairment (kidney disease), you may follow a dosing regimen similar to that described above.

If you take more Donepezil Flas Kern Pharma than you should

If you have taken more Donepezil Flas Kern Pharma than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medication and amount taken.

If you forget to take Donepezil Flas Kern Pharma

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

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

4. Possible adverse effects

Like all medicines, Donepezil Flas Kern Pharma can cause adverse effects, although not everyone experiences them. The estimated frequency of occurrence is as follows:

The most common adverse effects, which may affect at least 1 in 10 patients, are:

• Diarrhea
• Nausea
• Headache

Frequent adverse effects, which may affect more than 1 in 100 but less than 1 in 10 patients, are:

• Cold symptoms
• Loss of appetite
• Hallucinations, agitation, aggressive behavior
• Fainting, dizziness, difficulty sleeping
• Vomiting, abdominal discomfort
• Urinary incontinence
• Rash, itching
• Muscle cramps
• Fatigue, pain
• Accidents

Uncommon adverse effects, which may affect more than 1 in 1,000 but less than 1 in 100 patients, are:

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

Rare adverse effects, which may affect less than 1 in 1,000 patients, are:

• Extrapyramidal symptoms (such as tremor or stiffness of the hands or legs)
• Disorders of cardiac conduction
• Liver function abnormalities, including hepatitis

Adverse effects with unknown frequency:

• Changes in heart activity that may be seen on an electrocardiogram (ECG), known as "QT interval prolongation"
• Rapid 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 contractions with abnormal bending of the body and head to one side)

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Serious adverse effects:

Seek immediate medical advice if you experience any of the following serious adverse effects. You may require urgent medical treatment.

• Muscle weakness, tenderness or pain, especially if accompanied by feeling unwell, fever, or dark-colored urine. This may be due to abnormal muscle breakdown, which can be life-threatening and may lead to kidney problems (a condition called rhabdomyolysis).

5. Storage of Donepezil Flas Kern Pharma

Keep out of sight and reach of children.

No special storage conditions are required.

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.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Donepezil Flas Kern Pharma

• The active substance is donepezil. Each tablet contains 5 mg of donepezil hydrochloride (equivalent to 4.56 mg of donepezil).

• The other components are: mannitol (E-421), microcrystalline cellulose (E-460i), guar gum, crospovidone, aspartame (E-951) and magnesium stearate.

Appearance of the product and contents of the pack

Round, white tablets with a score line on one side and the letter "K" on the other. The score line is intended to facilitate breaking the tablet and swallowing, but not for dividing the tablet into equal doses.

The tablets are packaged in blisters within cartons containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of most recent revision of this leaflet: November 2022.

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