DONEPEZIL TEVA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Donepezil Teva 10 mg film-coated tablets EFG

donepezil, hydrochloride (as monohydrochloride)

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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Donepezil (donepezil hydrochloride) belongs to a group of medicines called acetylcholinesterase inhibitors.

Donepezil hydrochloride increases the levels in the brain of a substance (acetylcholine) involved in memory function by reducing the breakdown of acetylcholine.

It is used to treat the symptoms of dementia in people diagnosed with mild to moderately severe Alzheimer's disease. The symptoms include increasing memory loss, confusion, and changes in behavior. As a result, patients with Alzheimer's disease find it increasingly difficult to carry out their normal daily activities. It is for use only in adult patients.

2. What you need to know before you take Donepezil Teva

Do not take Donepezil Teva

• if you are allergic (hypersensitive) to donepezil hydrochloride or piperidine derivatives or any of the other ingredients of this medicine (listed in section 6).

Tell your doctor if any of these conditions apply to you.

Warnings and precautions

Treatment with Donepezil Teva should only be started and supervised by a doctor with experience in the diagnosis and treatment of Alzheimer's disease.

Consult your doctor or pharmacist before taking donepezil hydrochloride if you have or have had:

• stomach or duodenal ulcer
• seizures or fits
• a heart condition (such as irregular or very slow heart beats, heart failure, heart attack)
• if you have or have had a heart condition called "prolongation of the QT interval" or a history of certain abnormal heart rhythms called torsades de pointes or if a family member has "prolongation of the QT interval"
• if you have or have had low levels of magnesium or potassium in the blood
• asthma or other long-term lung diseases
• liver or hepatitis problems
• difficulty urinating or mild kidney disease.

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

Use in children and adolescents

Donepezil Teva is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Donepezil Teva

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

This includes medicines that your doctor has not prescribed but that you have bought yourself from a pharmacist. It also applies to medicines that you might take in the future while you are still taking Donepezil Teva. This is because these medicines may weaken or strengthen the effects of Donepezil Teva.

In particular, it is important to tell your doctor if you are taking any of the following medicines:

• medicines for heart rhythm problems, for example, amiodarone or sotalol
• medicines for depression, for example, citalopram, escitalopram, amitriptyline, fluoxetine
• medicines for psychosis, for example, pimozide, sertindole, or ziprasidone
• medicines for bacterial infections, for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungal medicines, such as ketoconazole

• other medicines for Alzheimer's disease, for example, galantamine
• sedatives or treatments for arthritis, for example, aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium
• anticholinergics, for example, tolterodine
• anticonvulsants, for example, phenytoin, carbamazepine
• heart medication, for example, quinidine, beta-blockers (propranolol and atenolol)

• muscle relaxants, for example, diazepam, succinylcholine
• general anesthetics
• over-the-counter medicines, for example, herbal remedies.

If you are going to have an operation that requires general anesthesia, you must inform your doctor and anesthetist that you are taking Donepezil Teva. This is because your medicine may affect the amount of anesthetic needed.

Donepezil Teva can be used in patients with mild to moderate kidney or liver disease.

Tell your doctor if you have kidney or liver disease. Patients with severe liver disease should not take Donepezil Teva.

Tell your doctor or pharmacist the name of your caregiver. Your caregiver will help you take your medicine as prescribed.

Taking Donepezil Teva with food, drinks, and alcohol

Donepezil Teva should be taken with water. Food does not affect the absorption of donepezil hydrochloride. You should not drink alcohol while taking Donepezil Teva because alcohol may change its effect.

Pregnancy and breastfeeding

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

Donepezil Teva should not be used during breastfeeding.

Driving and using machines

Alzheimer's disease 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.

It can also cause tiredness, dizziness, or muscle cramps, mainly at the start of treatment or when changing the dose. If you experience these effects while taking Donepezil Teva tablets, you should not drive or use machines.

Donepezil Teva contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Donepezil Teva contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to take Donepezil Teva

Follow exactly the instructions given to you by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Taking the dose of Donepezil Teva

The recommended starting dose is 5 mg (one white tablet) each night before going to bed. After one month, your doctor may tell you to take 10 mg (one yellow tablet) each night. The dose of the tablet you take may vary depending on how long you have been taking this medicine and what your doctor recommends. The maximum recommended dose is 10 mg each night. Always follow the advice of your doctor or pharmacist on how and when to take your medicine. Do not change the dose yourself without consulting your doctor.

How to take your medicine

Swallow your tablet with a little water at night before going to bed. 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

Donepezil Teva is not recommended for use in children and adolescents under 18 years of age.

If you take more Donepezil Teva than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or hospital immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken. Take the tablets and the packaging to the hospital, so the doctor knows what you have taken.

The symptoms of overdose may include nausea and vomiting, drooling, sweating, decreased heart rate, low blood pressure (dizziness or fainting when standing up), breathing problems, loss of consciousness, and seizures or fits.

If you forget to take Donepezil Teva

If you forget to take your medicine, 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 medicine for more than one week, call your doctor before taking any more.

If you stop taking Donepezil Teva

Do not stop taking the tablets unless your doctor tells you to do so. Your doctor or pharmacist will tell you for how long you should continue to take the tablets. You will need to see your doctor from time to time to review your treatment and assess your symptoms.

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

How long to take Donepezil Teva

Your doctor or pharmacist will advise you on how long to continue taking the 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 medicines, Donepezil Teva can cause side effects, although not everybody gets them.

People taking Donepezil Teva have reported the following side effects.

Tell your doctor if you experience any of these side effects while taking Donepezil Teva.

Serious side effects:

Consult your doctor immediately if you notice these side effects. You may need urgent medical treatment.

• Liver damage, for example, hepatitis. The symptoms of hepatitis are nausea (feeling sick) or vomiting (being sick), loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin and eyes, and dark-colored urine (may affect up to 1 in 1000 people).
• Stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion), discomfort between the navel and the breastbone (may affect up to 1 in 100 people).
• Bleeding in the stomach or intestines. This can cause your stools to turn from black to tar-like or for visible blood to appear in the rectum (may affect up to 1 in 100 people).
• Seizures or fits (may affect up to 1 in 100 people).
• Fever with stiff muscles, sweating, or a decreased level of consciousness (a condition called "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people).
• Weakness, sensitivity, or pain in the muscles, particularly if you also feel unwell, have a fever, or have dark-colored urine. This can be due to abnormal muscle breakdown, which can be life-threatening and cause kidney problems (a condition called "rhabdomyolysis") (may affect up to 1 in 10,000 people).

Other side effects

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

• Diarrhea,
• Headache,

Common (may affect up to 1 in 10 people)

• Insomnia (difficulty sleeping),
• Common cold,
• Loss of appetite,
• Hallucinations (seeing or hearing things that are not real),
• Unusual dreams and nightmares,
• Agitation,
• Aggressive behavior,
• Fainting,
• Dizziness,
• Uncomfortable feeling in the stomach,
• Muscle cramps,
• Urinary incontinence,
• Pain,
• Accidents (patients are more prone to falls and accidents).

Uncommon (may affect up to 1 in 100 people)

• Decreased heart rate
• Excessive salivation

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

• Stiffness, tremors, or uncontrolled movements, especially of the face and tongue but also of the limbs.

Frequency not known: cannot be estimated from the available data

• Increased libido, hypersexuality
• Pisa syndrome (a condition involving 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 or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Donepezil Teva

Keep out of the sight and reach of children

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Donepezil Teva 10 mg film-coated tablets EFG.

• The active ingredient is donepezil hydrochloride. Each tablet contains 10 mg of donepezil hydrochloride.

• The other ingredients are:

Core: cornstarch, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, type A, anhydrous colloidal silica, magnesium stearate.

Coating: lactose monohydrate, hypromellose 15cp, titanium dioxide (E-171), macrogol 4000, and yellow iron oxide (E-172).

Appearance of the product and contents of the pack

Donepezil Teva 10 mg: film-coated tablets, yellow, round, biconvex, and marked with "DN 10" on one side.

The film-coated tablets are supplied in blister packs of 7, 28, 30, 50, 56, 60, 84, 90, 98, or 120 film-coated tablets.

The film-coated tablets are supplied in calendar blister packs of 7, 28, 56, 84, or 98 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B 1ª planta

28108 Alcobendas, Madrid (Spain)

Manufacturer

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80, 31-456, Cracow

Poland

PLIVA CROATIA LIMITED (PLIVA KRVATSKA D.O.O.)

Prilaz Baruna Filipovica, 25

10000 Zagreb, Croatia

or

Merckle GmbH

Ludwig-Merckle-Str. 3,

89143 Blaubeuren

Germany

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

Belgium Donepezil Teva 10 mg filmomhulde tabletten

Germany Donepezil-HCl AbZ 10 mg Filmtabletten

France Donépézil TEVA 10 mg comprimé pelliculé

Ireland Donepezil Teva 10 mg film-coated tablets

Italy Donepezil Teva

Portugal Donepezilo Teva

Slovenia Donepezil Pliva 10 mg filmsko obložene tablete

Spain Donepezilo Teva 10 mg comprimidos recubiertos con película EFG

This leaflet was approved in November 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.gob.es/