DONEPEZIL TEVA 5 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Donepezil Teva 5 mg film-coated tablets EFG

donepezil, hydrochloride (as monohydrate)

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult 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 it may harm them.
• If you experience side effects, consult your doctor or pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Donepezil Teva and what is it used for
2. What you need to know before taking Donepezil Teva
3. How to take Donepezil Teva
4. Possible side effects
5. Storage of Donepezil Teva
6. Package contents and additional information

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

Donepezil (donepezil hydrochloride) belongs to a group of medications 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 increased 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 taking Donepezil Teva

Do not take Donepezil Teva

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

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

Warnings and precautions

Treatment with Donepezil Teva should only be initiated 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
• a heart condition (such as irregular or very slow heartbeats, heart failure, myocardial infarction)
• a heart condition called "prolonged QT interval" or a history of certain abnormal heart rhythms called torsades de pointes or if a family member has "prolonged QT interval"
• low magnesium or potassium levels in the blood
• asthma or other long-term lung diseases
• liver problems or hepatitis
• difficulty urinating or mild kidney disease.

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

Use in children and adolescents

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

Other medications and Donepezil Teva

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medication.

This includes medications that your doctor has not prescribed but that you have purchased from a pharmacist. It also applies to medications that you may take in the future if you continue to take Donepezil Teva. This is because these medications can weaken or strengthen the effects of Donepezil Teva.

In particular, it is important to inform your doctor if you are taking any of the following 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, or ziprasidone
• medications for bacterial infections, such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungal medications, such as ketoconazole
• other medications for Alzheimer's disease, such as galantamine.
• sedatives or treatment for arthritis, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium

• anticholinergics, such as tolterodine
• anticonvulsants, such as phenytoin, carbamazepine
• medication for a heart condition, such as quinidine, beta-blockers (propranolol and

atenolol)

• muscle relaxants, such as diazepam, succinylcholine
• general anesthetics
• over-the-counter medications, such as herbal remedies.

If you are going to undergo surgery that requires general anesthesia, you should inform your doctor and anesthesiologist that you are taking Donepezil Teva. This is because your medication 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 the medication as prescribed.

Taking Donepezil Teva with food and alcohol

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 may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Donepezil Teva should not be used during breastfeeding.

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 tells you it is safe to do so.

It can also cause fatigue, dizziness, or muscle cramps, especially when starting treatment or changing the dose. If you experience these effects while taking Donepezil Teva tablets, you should not drive or use machinery.

Donepezil Teva contains lactose

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

Donepezil Teva contains sodium

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

3. How to take Donepezil Teva

Follow the instructions for taking this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Taking the dose of Donepezil Teva

Initially, the recommended dose is 5 mg (one white tablet) each night before bedtime. 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 medication 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 medication. Do not change the dose yourself without consulting your doctor.

How to take your medication

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 taking 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 immediately, or go to the hospital or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken. Bring the tablets and 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 convulsions.

If you forget to take Donepezil Teva

If you forget to take your medication, 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 one week, call your doctor before taking more.

If you stop taking Donepezil Teva

Do not stop taking the tablets unless your doctor has told you to do so. Your doctor or pharmacist will tell you how long you should continue taking 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 other 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 medications, Donepezil Teva can cause side effects, although not everyone 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, such as hepatitis. The symptoms of hepatitis are nausea (feeling unwell) or vomiting (being sick), loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and dark 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 sternum (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 visible blood in 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 condition called "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people).
• Weakness, sensitivity, or muscle pain, especially if you are also feeling unwell, have a fever, or have dark urine. This may be due to abnormal muscle destruction, 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 stomach feeling,
• 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
• increased 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.
• increased libido, hypersexuality
• Syndrome of Pisa (a condition that involves involuntary muscle contraction with an abnormal flexion of the body and head to one side).

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this 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 contribute to providing more information on the safety of this medication.

5. Storage of Donepezil Teva

Keep out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Donepezil Teva 5 mg film-coated tablets EFG.

• The active ingredient is donepezil hydrochloride. Each tablet contains 5 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), and macrogol 4000.

Appearance of the product and package contents

Donepezil Teva 5 mg: film-coated tablets, white or almost white, round, biconvex, and marked with "DN 5" 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

or

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

Belgium Donepezil Teva 5 mg film-coated tablets

Germany Donepezil-HCl AbZ 5 mg film-coated tablets

France Donépézil TEVA 5 mg film-coated tablets

Ireland Donepezil Teva 5 mg film-coated tablets

Italy Donepezil Teva

Portugal Donepezilo Teva

Slovenia Donepezil Pliva 5 mg film-coated tablets

Spain Donepezilo Teva 5 mg film-coated tablets EFG

This leaflet was approved in November 2022

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/