Package Leaflet: Information for the User

Donepezilo Tarbis 10 mg Film-Coated Tablets EFG

Donepezil Hydrochloride Monohydrate

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Donepezilo Tarbis

3. How to take Donepezilo Tarbis

4. Possible side effects

5. Storage of Donepezilo Tarbis

6. Contents of the pack and additional information

Donepezilo 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.

Do not take Donepezilo Tarbis

• If you are allergic to donepezilo or any of the other components of this medication (listed in section 6).
• If you are allergic to other medications that contain piperidina derivatives.
• If you are pregnant or breastfeeding.

Warnings and precautions

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

• Before starting treatment with Donepezilo Tarbis 10 mg film-coated tablets, you must inform your doctor if you have or have a history of stomach ulcers, heart disease, seizures, asthma, chronic lung disease, or difficulty urinating.
• In the event of surgery under general anesthesia, you must inform your doctor that you are taking Donepezilo Tarbis 10 mg film-coated tablets.
• Donepezilo Tarbis 10 mg film-coated tablets are not recommended for use in children.
• You should avoid taking Donepezilo Tarbis 10 mg film-coated tablets with other acetylcholinesterase inhibitors and other cholinergic agonists or antagonists.
• 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 <> or have a history of abnormal heart rhythm intervals called torsade de pointes or if someone in your family has <>.

-If you have low levels of magnesium or potassium in your blood.

Use of Donepezilo Tarbis with other medications

Especially, you should inform your doctor if you are taking any of the following types of 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

-Pain relievers or arthritis treatment, for example, aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium

-Anticholinergic medications, for example, tolterodine

-Antibiotics, for example, erythromycin or rifampicin

-Antifungal medication, for example, ketoconazole

-Antidepressants, for example, fluoxetine

-Anticonvulsants, for example, phenytoin, carbamazepine

-Medications for heart disease, for example quinidine, beta blockers (propranolol and atenolol)

-Muscle relaxants, for example, diazepam, succinylcholine

-General anesthetic

-Over-the-counter medications, for example, herbal remedies

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

Taking Donepezilo Tarbis with food, drinks, and alcohol

Taking donepezilo with alcohol may reduce the absorption of this medication. You should avoid drinking alcohol while taking donepezilo.

Children:

Donepezilo is not recommended for use in children.

Pregnancy, lactation, and fertility

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

Do not take Donepezilo Tarbis if you are pregnant.

Do not take Donepezilo Tarbis if you are breastfeeding.

Driving and operating machinery

Your condition may affect your ability to drive or operate machinery, and you should not do so unless your doctor tells you it is safe to do so. Donepezilo may cause dizziness and drowsiness, mainly at the start of treatment or when increasing the dose. If you experience these effects, you should not drive or operate machinery.

Donepezilo Tarbis contains lactose. If your doctor has told you that you have intolerance to certain sugars, consult with them before taking it.

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

Donepezilo is administered orally.

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

The dose you take may vary depending on how long you have been taking the medication and what your doctor recommends. Typically, treatment begins 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 know the doctor's instructions.

If you have mild or moderate liver disease (a disease that affects the liver) or kidney disease (a disease that affects the kidney), you can follow a similar dosing schedule as indicated above.

If you take more Donepezilo 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 medication and the amount ingested.

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

If you forgot to take Donepezilo Tarbis:

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

Do not take a double dose to compensate for missed doses.

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

Like all medicines, Donepezilo Tarbis 10 mg film-coated tablets may cause side effects, although not everyone will experience them. The estimated frequency of their occurrence is as follows:

Severe side effects:

Inform your doctor immediately if you observe the following severe side effects, as you may need urgent medical treatment.

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

The most frequent side effects may affect more than 1 in 10 patients and are:

• Diarrhea
• Nausea
• Headache

Frequent side effects may affect between 1 and 10 in 100 patients and are:

• Cold
• Loss of appetite
• Illusions, agitation, aggressive behavior
• Fainting, dizziness, difficulty sleeping
• Vomiting, abdominal discomfort
• Urinary incontinence
• Rash, itching
• Muscle cramps
• Fatigue, pain
• Accidents

Rare side effects may 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 (creatine kinase muscle) in the blood

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

• Extrapyramidal symptoms (such as tremors or stiffness of the hands or legs)
• Alterations in cardiac conduction
• Liver function alteration, including hepatitis

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

• Changes in cardiac activity that can be observed on an electrocardiogram (ECG) called <>
• Fast and irregular heartbeat, fainting that may be symptoms of a potentially fatal condition known as torsade 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 type of side effect, consult your doctor or pharmacist or nurse, 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 of 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 this medication out of the sight and reach of children.

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Donepezilo Tarbis10 mg film-coated tablets

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

The other components are:

Tablet core

monohydrate lactose

microcrystalline cellulose

cornstarch

magnesium stearate.

Coating

polyvinyl alcohol

titanium dioxide (E171)

macrogol 3350

talco

yellow iron oxide (synthetic).

Appearance of the product and content of the container

Donepezilo Tarbis 10 mg film-coated tablets are yellowish clear film-coated tablets of round, biconvex shape, marked ‘DZ10’.

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

Donepezilo Tarbis is also available in 5 mg film-coated tablets in containers of28 and 50 (clinical pack) film-coated tablets.

Only some container sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Responsible manufacturer:

Actavis Limited

BLB016 Bulebel Industrial Estate

Zejtun, ZTN 3000

Malta

Last review date of this leaflet: October 2022

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”