DONEPEZIL STADA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Donepezil Stada 10 mg film-coated 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, ask 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 side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Donepezil Stada and what is it used for

1. What you need to know before taking Donepezil Stada

1. How to take Donepezil Stada

1. Possible side effects

1. Storage of Donepezil Stada
2. Contents of the pack and further information

1. What is Donepezil Stada and what is it used for

Donepezil Stada belongs to a group of medications called acetylcholinesterase inhibitors. Donepezil increases the levels in the brain of a substance related to memory (acetylcholine) by reducing the speed of its breakdown.

Donepezil Stada is used to treat the symptoms of dementia in people with Alzheimer's diseaseof mild to moderate severity. The symptoms include increased memory loss, confusion, and changes in behavior. As a result, it becomes increasingly difficult for patients with Alzheimer's disease to continue with their daily activities.

Donepezil is indicated only for adult patients.

2. What you need to know before taking Donepezil Stada

Do not take Donepezil Stada:

• if you are allergic to donepezil hydrochloride or similar medications (known as "piperidine derivatives") or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take donepezil if you have or have had:

• stomach ulcersor duodenal ulcers
• seizuresor convulsions

• a heart condition(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 Pointesor if a family member has "prolongation of the QT interval".
• asthmaor other long-term lung disease
• liver problemsor hepatitis
• difficulty urinatingor mild kidney disease.
• low levels of magnesium or potassiumin the blood.

Also, inform your doctor if you are pregnant or think you may be pregnant.

Children and adolescents

Donepezil is not indicated for use in children and adolescents (young people under 18 years of age).

Other medications and Donepezil Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medications, including those without a prescription. This also includes medications that you may take in the future if you continue to take donepezil. This is because these medications can weaken or enhance the effects of donepezil.

It is particularly important to inform your doctor if you are taking any of the following types of 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, ziprasidone
• medications for bacterial infections, such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungals, such as ketoconazole
• other medications for Alzheimer's disease, such as galantamine

• pain relievers or treatment for arthritis, such as acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or diclofenac sodium
• anticholinergics, such as tolterodine
• anticonvulsants, such as phenytoin and carbamazepine
• medications for heart conditions, such as quinidine, beta-blockers(propranolol and atenolol)
• muscle relaxants, such as diazepam, succinylcholine
• general anesthesia
• medications obtained without a prescription, such as herbal-based medications

In the event of surgical intervention with general anesthesia, you should inform your doctor and anesthesiologist that you are taking donepezil, as your medication may affect the amount of anesthesia needed.

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

Tell your doctor or pharmacist the name of the person in charge of your care. This person will help you take your medication as indicated.

Taking Donepezil Stada with food, drinks, and alcohol

Food does not interfere with the effect of this medication.

Donepezil should not be taken with alcohol, as alcohol may alter its effects.

Pregnancy and breastfeeding

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.

There is not enough experience with the use of donepezil in pregnant women. Do not take donepezil if you are pregnantor plan to become pregnant, unless your doctor considers it absolutely necessary, taking into account the clinical benefit-risk balance for you.

The available data are insufficient to assess the safety of donepezil during breastfeeding. You should not breastfeedwhile taking donepezil.

Driving and using machines

Alzheimer's disease may affect your ability to drive or use machinery, and you should not perform these activities unless your doctor indicates that it is safe to do so.

Additionally, this medication may cause fatigue, dizziness, and muscle cramps. If you experience any of these symptoms, you should not drive or operate machinery.

Donepezil Stada contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medication.

3. How to take Donepezil Stada

How much Donepezil Stada to take

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

The recommended dose is:

Usually, you will start taking 5 mg of donepezil hydrochloride each night before bedtime.

After a month, your doctor may indicate that you take 1 film-coated tablet (10 mg of donepezil hydrochloride) each night before bedtime.

The concentration of the tablet you take may change depending on the time you have been taking the medication and what your doctor recommends.

The maximum recommended dose is 1 film-coated tablet (10 mg of donepezil hydrochloride) each night.

For doses that cannot be administered with this presentation, other doses of this medication are available.

Always follow the instructions of your doctor or pharmacist on how and when to take this medication.

Do not change the dose on your ownwithout consulting your doctor.

No dose adjustment is necessary if you have kidney problems.

If you have liver problemsof mild to moderate severity, a dose adjustment may be necessary by your doctor. If you have severe liver problems, you should not take donepezil (see section 2, "Warnings and precautions"). If you have unexplained liver disease, your doctor may decide to completely interrupt your treatment with donepezil.

How to take this medication

Take your tablet with a glass of water at night before bedtime. If you have abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend that you take donepezil in the morning.

Use in children and adolescents

This medication is not recommendedin children and adolescents (under 18 years of age).

If you take more Donepezil Stada than you should

Contact your doctor or the emergency department of the nearest hospital immediately if you take more medication than you should. Bring this package leaflet and the remaining tablets with you.

The symptoms of overdose are, among others, feeling unwell or vomiting, drooling, sweating, slow heartbeat, low blood pressure (dizziness or fainting when standing), respiratory problems, loss of consciousness, and seizures or convulsions.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 5620420, indicating the medication and the amount ingested.

If you forget to take Donepezil Stada

If you forget to take a tablet, take the next dose at the usual time.

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

If you forget to take your medication for more than a week, consult your doctor before taking more medication.

If you stop taking Donepezil Stada

Do not stop taking the tablets unless your doctor tells you to. If you stop taking donepezil, the benefits of treatment will gradually disappear.

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

How long to take Donepezil Stada

Your doctor or pharmacist will advise you how long to take these tablets. You will need to visit your doctor from time to time to review your treatment and assess your symptoms.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

The following side effects have been reported by people taking donepezil.

Contact your doctor if you have any of these side effects during treatment with donepezil.

Serious side effects:

You should inform your doctor immediately if you notice the following serious side effects. You may need urgent medical treatment.

• liver disorder, such as hepatitis. The symptoms of hepatitis are nausea (feeling sick), vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and dark urine (may affect up to 1 in 1,000 people).
• stomach ulcers and duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the sternum (may affect up to 1 in 100 people).
• bleeding in the stomach or intestine. This can produce black, tar-like stools or visible blood from the rectum (may affect up to 1 in 100 people).
• seizures or convulsions (may affect up to 1 in 100 people).

• fever with muscle stiffness, sweating, or a decrease in the level of consciousness (a disorder called "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people)
• weakness, sensitivity, or muscle pain, especially if you feel unwell, have a fever, or your urine is dark. This may be due to abnormal muscle destruction, which can be life-threatening and cause kidney problems (a disease called "rhabdomyolysis") (may affect up to 1 in 10,000 people).
• rapid and irregular heartbeat, fainting that can be symptoms of a potentially life-threatening disorder known as Torsades de Pointes (the frequency cannot be estimated from the available data).

Other side effects

Very common (may affect more than 1 in 10 people):

• diarrhea
• nausea (feeling sick)
• headache

Common (may affect up to 1 in 10 people):

• common cold
• vomiting (feeling sick)
• abdominal discomfort
• muscle cramps
• fatigue
• fainting
• dizziness
• difficulty sleeping (insomnia)
• pain
• loss of appetite
• itching
• rash
• hallucinations (seeing or hearing things that do not really exist)
• unusual dreams, including nightmares
• agitation
• aggressive behavior
• urinary incontinence
• accidents (patients may be more prone to falls and injuries from accidents)

Uncommon (may affect up to 1 in 100 people):

• slow heartbeat
• excessive salivation

Rare (may affect up to 1 in 1,000 people):

• stiffness, tremors, or uncontrolled movements, especially of the face and tongue, as well as the limbs (extrapyramidal symptoms)

Not known (frequency 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"
• 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, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Donepezil Stada

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

Do not use this medication after the expiration date shown on the packaging and blister. The expiration date is the last day of the month indicated.

Do not store above 30°C.

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 the 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. Contents of the pack and further information

Composition of Donepezil Stada

• The active ingredient is donepezil hydrochloride.

Each film-coated tablet contains 10 mg of donepezil hydrochloride, equivalent to 9.12 mg of donepezil.

• The other components are:

Core of the tablet:

Anhydrous lactose

Pregelatinized corn starch

Dihydrate calcium hydrogen phosphate

Talc

Magnesium stearate

Anhydrous colloidal silica

Coating of the tablet:

Hypromellose

Hydroxypropylcellulose

Talc

Titanium dioxide (E171)

Yellow iron oxide (E172)

Appearance of Donepezil Stada and contents of the pack

Film-coated tablets, yellow, round, and biconvex, 9.1 mm in diameter.

Packaging of 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112, 120, 126, 154, 182, 196 film-coated tablets in PVC/Aluminum blisters.

HDPE bottle (100 ml) with a polypropylene cap with integrated silica gel, containing 250 film-coated tablets, only for dispensing by dose in pharmacies.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio Stada, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Clonmel Healthcare Ltd.

Waterford Road, Clonmel,

Co. Tipperary

Ireland

or

• A. Eurogenerics N.V.

Heizel Esplanade Heysel b 22,

B-1020 Brussels

Belgium

or

STADA Arzneimittel AG

Stadastr. 2-18,

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2,

A-1190 Wien

Austria

This medication is authorized in the Member States of the European Economic Area under the following names:

AT Donepezil STADA 10 mg Filmtabletten

BE Donepezil EG 10 mg filmomhulde tabletten

DE Donepezil STADA 10 mg Filmtabletten

DK Donepezil STADA

ES Donepezilo Stada 10 mg comprimidos recubiertos con película EFG

FR Donepezil EG 10 mg comprimés pelliculés

HU Donestad 10 mg filmtabletta

LU Donepezil EG 10 mg comprimés pelliculés

PL Donestad

PT Donepezilio Ciclum

RO Donepezil STADA 10 mg comprimate filmate

SE Donepezil STADA 10 mg filmdragerade tabletter

Date of the last revision of this package leaflet:May 2025

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.gob.es/)