Product Information for the User

Donepezilo Teva 10 mg Film-Coated Tablets

donepezilo, hydrochloride(as monohydrate)

Read this entire product information carefully before starting to take this medicine, as it contains important information for you

- Keep this product information, as you may need to read it again.- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed to you alone and should not be given to others, even if they have the same symptoms, as it may harm them.

- If you experience any adverse effects, consult your doctor or pharmacist or nurse, even if they are not listed in this product information. See section 4

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

2. What you need to know before starting to take Donepezilo Teva

3. How to take Donepezilo Teva

4. Possible adverse effects

5. Storage of Donepezilo Teva

6. Contents of the pack and additional information

Donepezilo (donepezil hydrochloride) belongs to a group of medicines called cholinesterase 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. Symptoms include increased loss of memory, confusion, and changes in behavior. As a result, patients with Alzheimer's find it increasingly difficult to carry out their normal daily activities. It is for use only in adult patients.

Do not take Donepezilo Teva

- if you are allergic (hypersensitive) to donepezil hydrochloride or derivatives of piperidina or to any of the other components of this medication (listed in section 6).

Inform your doctor if any of these situations affect you.

Warnings and precautions

Donepezilo Teva treatment should only be initiated and monitored by a doctor with experience in the diagnosis and treatment of Alzheimer's disease.

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

- stomach or duodenal ulcers

- a seizure or convulsion

- a heart condition (such as irregular or very slow heartbeats, heart failure, myocardial infarction)

- if you have or have had a heart condition called "prolongation of the QT interval" or a history of certain abnormal heart rhythms called torsade de pointes or if someone in your family 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 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

Donepezilo Teva is not recommended for use in children and adolescents under 18 years old.

Other medications and Donepezilo Teva

Inform your doctor or pharmacist if you are using or have used recently 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 Donepezilo Teva. This is because these medications may weaken or strengthen the effects of Donepezilo Teva.

Especially inform your doctor if you are taking any of the following medications:

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

other medications for Alzheimer's disease, for example galantamine

sedatives or treatment for arthritis, for example Aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium

anticholinergics, for example Tolterodina

anticonvulsants, for example phenytoin, carbamazepine

• medications for a heart condition, for example quinidine, beta-blockers (propranolol and atenolol)

muscle relaxants, for example diazepam, succinylcholine

general anesthetics

over-the-counter medications, for example, plant-based medications.

If you are to undergo surgery that requires general anesthesia, inform your doctor and the anesthesiologist that you are taking Donepezilo Teva. This is because your medication may affect the amount of anesthetic needed.

Donepezilo Teva may be used in patients with mild to moderate kidney or liver disease.

Inform your doctor that you have kidney or liver disease. Patients with severe liver disease should not take Donepezilo Teva.

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

Taking Donepezilo Teva with food, drinks, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Donepezilo Teva should not be used during breastfeeding.

Driving and operating machinery

Alzheimer's disease may affect your ability to drive or operate machinery and should not engage in these activities unless your doctor indicates it is safe to do so.

It may also cause fatigue, dizziness, or muscle cramps mainly at the beginning of treatment or when changing the dose. If you experience these effects while taking Donepezilo Teva tablets, do not drive or operate machinery.

Donepezilo Teva contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Donepezilo Teva contains sodium

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

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

Donepezilo Teva Dose Taking

The initial recommended dose is 5 mg (one white tablet) each night before going to bed. After a 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 modify 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 that you take donepezilo in the morning.

Use in children and adolescents

Donepezilo Teva is not recommended for use in children and adolescents under 18 years old.

If you take more Donepezilo 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Bring the tablets and the packaging to the hospital, so the doctor will know what you have taken.

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

If you forgot to take Donepezilo Teva

If you forgot to take your medication, take the next dose at the usual time. Do not take a double dose to compensate for the missed doses. If you forgot to take your medication for more than a week, call your doctor before taking more.

If you interrupt treatment with Donepezilo Teva

Do not stop taking the tablets unless your doctor has told you to. Your doctor or pharmacist will indicate for how long you should continue taking the tablets. You will need to see your doctor from time to time to review your treatment and evaluate your symptoms.

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

How long should you take Donepezilo Teva

Your doctor or pharmacist will advise you on how long you should continue taking the tablets.

You will need to visit your doctor from time to time to review your treatment and evaluate your symptoms.

Like all medicines, Donepezilo Teva may cause side effects, although not everyone will experience them.

People who took Donepezilo Teva have reported the following side effects.

Inform your doctor if you experience any of these side effects while taking Donepezilo Teva.

Severe side effects:

Consult your doctor immediately if you notice any of the following side effects. You may need urgent medical treatment.

• Liver damage, for example, hepatitis. Hepatitis symptoms include nausea (feeling unwell) or vomiting (being sick), loss of appetite, general discomfort, fever, itching, yellowing of the skin and eyes, and dark-colored urine (may affect up to 1 in 1,000 people).

• Stomach or duodenal ulcers. Ulcer symptoms include stomach pain and discomfort (indigestion), general discomfort between the navel and sternum (may affect up to 1 in 100 people).

• Bleeding in the stomach or intestines. This may cause your stools to turn from tar-black to 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 level of consciousness (a condition called "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people).

•Weakness, sensitivity, or muscle pain, particularly if you are feeling unwell, have a fever, or have dark-colored urine. This may be due to abnormal muscle destruction that can be fatal 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,

• Restlessness,

• Aggressive behavior,

• Fainting,

• Dizziness,

• Uncomfortable stomach sensation,

• 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)

• Rigidity, tremors, or uncontrollable movements, especially of the face and tongue but also of the limbs.

Frequency not known:cannot be estimated from available data

• 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children

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

No special storage conditions are required.

Do not dispose of the medication through the drains or in the trash. Dispose of the packaging andthe medication that you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask yourpharmacist how to dispose of the packaging and the medication that you no longer need. By doing so, you willhelp protect the environment.

Composition of Donepezilo Teva 10 mg film-coated tablets.

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

- The other components are:

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

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

Appearance of the product and contents of the package

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

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

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas, Madrid (Spain)

Responsible 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 medicinal product is authorized in the Member States of the European Economic Area with the following names:

BélgicaDonepezil Teva 10 mg filmomhulde tabletten

AlemaniaDonepezil-HCl AbZ10 mg Filmtabletten

FranciaDonépézil TEVA 10 mg comprimé pelliculé

IrlandaDonepezil Teva 10 mg film-coated tablets

ItaliaDonepezil Teva

PortugalDonepezilo Teva

EsloveniaDonepezil Pliva 10 mg filmsko obložene tablete

EspañaDonepezilo Teva 10 mg comprimidos recubiertos con película EFG

This leaflet was approved in November 2022

Detailed and updated information on this medicinal product is availableon the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/