DONEPEZIL TARBIS 5 mg FILM-COATED TABLETS
Ask a doctor about a prescription for DONEPEZIL TARBIS 5 mg FILM-COATED TABLETS
How to use DONEPEZIL TARBIS 5 mg FILM-COATED TABLETS
Introduction
Package Leaflet: Information for the User
Donepezil Tarbis 5 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 pack
- What is Donepezil Tarbis and what is it used for
- What you need to know before you take Donepezil Tarbis
- How to take Donepezil Tarbis
- Possible side effects
- Storage of Donepezil Tarbis
- Contents of the pack and other information
1. What is Donepezil Tarbis 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 (hypersensitive) 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 starting treatment with Donepezil Tarbis 5mg film-coated tablets, you should inform your doctor if you have or have had 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 5mg film-coated tablets.
- The use of Donepezil Tarbis 5 mg film-coated tablets is not recommended in children.
- You should avoid taking Donepezil Tarbis 5mg 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 <
> or a history of abnormal heart rhythm intervals called torsades de pointes or if someone in your family has < >. - 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, e.g. 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, e.g. tolterodine
- antibiotics, such as erythromycin or rifampicin
- antifungal medicine, e.g. ketoconazole
- antidepressants, e.g. fluoxetine
- anticonvulsants, e.g. phenytoin, carbamazepine
- medicines for heart conditions, such as quinidine, beta-blockers (propranolol and atenolol)
- muscle relaxants, e.g. diazepam, succinylcholine
- general anesthetic
- medicines obtained without a prescription, such as herbal remedies
The individual effect of donepezil cannot be predicted, so 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. If you are unsure, consult your doctor or pharmacist again. The recommended dose is described below.
Donepezil is administered orally.
You should take donepezil once a day, orally with a glass of water in the evening, 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 how long 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, in the evening. After one month of treatment, your doctor may indicate an increase in the dose to 10 mg once a day and in the evening. 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 hepatic insufficiency (a disease that affects the liver) or renal insufficiency (a disease that affects the kidneys), you may follow a similar dosage regimen 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 Toxicology Information Service, telephone (91) 562 04 20, indicating the medicine and the amount ingested.
At high doses (overdose), 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 5mg 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 notice 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 that can be fatal and cause kidney problems (a disease called rhabdomyolysis).
Very common side effects may affect more than 1 in 10 patients and are:
- Diarrhea
- Nausea
- Headache
Common side effects may affect up to 1 in 10 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 may affect up to 1 in 100 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) in the blood
Rare side effects may affect up to 1 in 1,000 patients and are:
- Extrapyramidal symptoms (such as tremor or rigidity of the hands or feet)
- Conduction disorders
- Liver function disorders, including hepatitis
Side effects of unknown frequency (cannot be estimated from the available data) are:
- Changes in heart activity that can be seen in an electrocardiogram (ECG) called <
> - Fast 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 shown.
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 5 mg film-coated tablets
The active substance is donepezil hydrochloride monohydrate. Each film-coated tablet contains 5mg of donepezil hydrochloride equivalent to 4.56 mg of donepezil base.
The other ingredients are:
Core of the tablet
Coating
Appearance of the product and contents of the pack
Donepezil Tarbis 5 mg film-coated tablets are white, round, biconvex tablets marked 'DZ5'.
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 10 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
Barcelona (Spain)
Manufacturer:
Actavis Limited
BLB016 Bulebel Industrial Estate
Zejtun, ZTN 3000
Malta
Date of 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/”
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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