DONEPEZIL TARBIS 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Donepezil Tarbis 10 mg Film-Coated Tablets EFG

Donepezil Hydrochloride Monohydrate

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

Contents of the Package Leaflet

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

1. What is Donepezil Tarbis 10 mg Film-Coated Tablets and what is it used for

Donepezil Tarbis belongs to a group of medicines called specific and reversible inhibitors of acetylcholinesterase, the predominant cholinesterase in the brain.

It is used in the symptomatic treatment of mild to moderately severe Alzheimer's disease.

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

Do not take Donepezil Tarbis

• If you are allergic to donepezil or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other medicines containing piperidine derivatives.
• If you are pregnant or breastfeeding.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Donepezil Tarbis.

• Before initiating treatment with Donepezil Tarbis 10 mg film-coated tablets, you should inform your doctor if you have or have a history of stomach ulcers, heart disease, seizures, asthma, chronic pulmonary disease, or difficulty urinating.
• In case of surgery with general anesthesia, you should inform your doctor that you are taking Donepezil Tarbis 10 mg film-coated tablets.
• The use of Donepezil Tarbis 10 mg film-coated tablets is not recommended in children.
• You should avoid taking Donepezil Tarbis 10 mg film-coated tablets 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).

• If you have a heart condition (such as irregular or very slow heartbeats, heart failure, myocardial infarction).
• If you have a heart condition called "prolongation of the QT interval" or a history of abnormal heart rhythm intervals called torsades de pointes, or if a family member has "prolongation of the QT interval".
• If you have low levels of magnesium or potassium in the blood.

Using Donepezil Tarbis with other medicines

In particular, it is important that you inform your doctor if you are taking any of the following types of medicines:

• medicines for heart rhythm problems, such as amiodarone or sotalol
• medicines for depression, such as citalopram, escitalopram, amitriptyline, fluoxetine
• medicines for psychosis, such as pimozide, sertindole, or ziprasidone
• medicines for bacterial infections, such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungal medicines, such as ketoconazole
• other medicines for Alzheimer's disease, such as galantamine
• analgesics or treatments for arthritis, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or diclofenac sodium
• anticholinergic medicines, such as tolterodine
• antibiotics, such as erythromycin or rifampicin
• antifungal medicine, such as ketoconazole
• antidepressants, such as fluoxetine
• anticonvulsants, such as phenytoin, carbamazepine
• medicines for heart conditions, such as quinidine, beta-blockers (propranolol and atenolol)
• muscle relaxants, such as diazepam, succinylcholine
• general anesthetics
• medicines obtained without a prescription, such as herbal remedies

The individual effect of donepezil cannot be predicted, and the effect of treatment should be regularly evaluated by your doctor.

Taking Donepezil Tarbis with food, drinks, and alcohol

Taking donepezil with alcohol may reduce the absorption of this medicine. You should avoid drinking alcohol while being treated with donepezil.

Children:

The use of donepezil is not recommended in children.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Donepezil Tarbis if you are pregnant.

Do not take Donepezil Tarbis if you are breastfeeding.

Driving and using machines

Your illness 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. Donepezil may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or use machines.

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

3. How to take Donepezil Tarbis

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist. The recommended normal dose is described below.

Donepezil is administered orally.

You should take donepezil once a day, orally with a glass of water, at night, immediately 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.

The dose you take may vary depending on the time you have been taking the medicine and what your doctor recommends. Usually, treatment is started with a 5 mg tablet taken once a day with a little water, at night. After a month of treatment, your doctor may indicate an increase in the dose to 10 mg once a day and at night. The maximum recommended dose is 10 mg per day.

Both you and your caregivers should be aware of the doctor's instructions.

If you have mild or moderate hepatic insufficiency (a disease that affects the liver) or renal insufficiency (a disease that affects the kidneys), you may follow a similar dosing schedule as indicated above.

If you take more Donepezil Tarbis than you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone (91) 562 04 20, indicating the medicine and the amount ingested.

At high doses (overdose), the adverse effects (see section 4 Possible side effects) may worsen. In particular, nausea, vomiting, salivation, sweating, slow heart rate, low blood pressure, difficulty breathing, collapse, seizures, and muscle weakness may occur.

If you forget to take Donepezil Tarbis:

If you forget to take a dose, take the forgotten dose as soon as possible. Unless it is time for the next dose.

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

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

4. Possible side effects

Like all medicines, Donepezil Tarbis 10 mg film-coated tablets can cause side effects, although not everybody gets them. The estimated frequency of their occurrence is as follows:

Serious side effects:

You should inform your doctor immediately if you observe any of the following serious side effects, as you may need urgent medical treatment.

• Fever with muscle stiffness, sweating, or a decrease in the level of consciousness (symptoms of a disorder known as "Neuroleptic Malignant Syndrome").
• Weakness, sensitivity, or muscle pain, particularly if you feel unwell, have a fever, or your urine is dark. This may be due to abnormal muscle destruction, which can be fatal and cause kidney problems (a disease called rhabdomyolysis).

The most common side effects can affect more than 1 in 10 patients and are:

• Diarrhea
• Nausea
• Headache

Common side effects can affect between 1 and 10 in 100 patients and are:

• 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 side effects can affect between 1 and 10 in 1,000 patients and are:

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

Rare side effects can affect between 1 and 10 in 10,000 patients and are:

• Extrapyramidal symptoms (such as tremor or rigidity of the hands or feet)
• Conduction disorders
• Liver function disorders, including hepatitis

Side effects with unknown frequency (cannot be estimated from available data) are:

• Changes in cardiac activity that can be seen in an electrocardiogram (ECG) called "prolongation of the QT interval"
• Rapid and irregular heartbeat, fainting that can be symptoms of a potentially fatal disorder known as torsades de pointes.
• 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, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Donepezil Tarbis

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Donepezil Tarbis 10 mg film-coated tablets

The active substance is donepezil hydrochloride monohydrate. Each film-coated tablet contains 10 mg of donepezil hydrochloride equivalent to 9.12 mg of donepezil base.

The other ingredients are:

Core of the tablet

Lactose monohydrate

Microcrystalline cellulose

Corn starch

Magnesium stearate.

Coating

Polyvinyl alcohol

Titanium dioxide (E171)

Macrogol 3350

Talc

Yellow iron oxide (synthetic).

Appearance of the product and contents of the pack

Donepezil Tarbis 10 mg film-coated tablets are yellow, round, biconvex tablets marked 'DZ10'.

Each pack contains 28 and 50 (clinical pack) film-coated tablets in aluminum-PVC blisters or a PE bottle.

Donepezil Tarbis is also available in 5 mg film-coated tablets in packs of 28 and 50 (clinical pack) film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer:

Actavis Limited

BLB016 Bulebel Industrial Estate

Zejtun, ZTN 3000

Malta

Date of the last revision of this leaflet: October 2022

"Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/"