Donepezil Kern Pharma 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Donepezil Kern Pharma 5 mg film-coated tablets EFG

Donepezil hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as 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 adverse effects not listed in this leaflet.

Leaflet contents:

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

1. What Donepezil Kern Pharma is and what it is used for

Donepezil 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 taking Donepezil Kern Pharma

Do not take Donepezil Kern Pharma

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

Warnings and precautions

• Before starting treatment with Donepezil 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.
• The use of Donepezil is not recommended in children.
• You should avoid taking Donepezil 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 a family member has "QT interval prolongation".
• Low levels of magnesium or potassium in the blood.

Children and adolescents

The use of donepezil is not recommended in children.

Taking Donepezil Kern Pharma with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take 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, amitriptiline), medicines for psychosis (e.g., pimozide, sertindole, ziprasidone), medicines for bacterial infections (such as clarithromycin, erythromycin, levofloxacin, moxifloxacin).

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

Taking Donepezil Kern Pharma with food, drinks, and alcohol

This medicine should be taken with a glass of water.

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

Pregnancy, breastfeeding, and fertility

Do not take Donepezil if you are pregnant.

Do not take Donepezil if you are breastfeeding.

Driving and using machines

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

Donepezil Kern Pharma contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Donepezilo Kern Pharma

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

Donepezilo Kern Pharma is administered orally.

Treatment with Donepezilo Kern Pharma begins with one 5 mg tablet taken once daily with 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 Donepezilo 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 Donepezilo Kern Pharma than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Donepezilo Kern Pharma

Do not take a double dose to make up for missed 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 Kern Pharma may produce 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 people, are:

• Common cold
• 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 people, are:

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

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

• Extrapyramidal symptoms (such as tremor or stiffness in 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 condition 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:

Contact your doctor immediately if you experience any of the following serious adverse effects. You may require urgent medical treatment.

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

5. Storage of Donepezil Kern Pharma

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

No special storage conditions are required.

Do not use Donepezil Kern Pharma after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Donepezil Kern Pharma

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

• The other components are: monohydrate lactose, microcrystalline cellulose (E-460i), anhydrous colloidal silica, corn starch, sodium starch glycolate (potato starch), talc (E-553b), magnesium stearate, polyvinyl alcohol, titanium dioxide (E-171), and polyethylene glycol.

Appearance of the product and contents of the pack

White, round, biconvex, flat coated tablets.

The tablets are packaged in blisters within cartons containing 28 or 56 tablets (retail pack) and 50 tablets (hospital pack).

Marketing Authorization Holder and Manufacturer Responsible

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the 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 Health Products (AEMPS) http://www.aemps.gob.es/.