Donepezil Teva-Ratio 5 mg film-coated tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Donepezil Teva-ratio 5 mg film-coated tablets EFG
donepezil, hydrochloride (as monohydrate)
Read the entire 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, consult your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
- If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Donepezil Teva-ratio is and what it is used for
- What you need to know before taking Donepezil Teva-ratio
- How to take Donepezil Teva-ratio
- Possible side effects
- How to store Donepezil Teva-ratio
- Contents of the pack and other information
1. What Donepezilo Teva-ratio is and what it is used for
Donepezil (donepezil hydrochloride) belongs to a group of medicines 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 increasing memory loss, confusion, and changes in behaviour. As a result, patients suffering from Alzheimer's disease find it increasingly difficult to carry out their normal daily activities. It is for use in adult patients only.
2. What you need to know before taking Donepezilo Teva-ratio
Do not take Donepezilo Teva-ratio
- if you are allergic (hypersensitive) to donepezil hydrochloride or piperidine derivatives, or to any of the other ingredients of this medicine (listed in section 6).
Inform your doctor if any of the following situations apply to you.
Warnings and precautions
Treatment with Donepezilo Teva-ratio should only be initiated and supervised by a physician experienced 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
- stroke or seizures
- a heart condition (such as irregular or very slow heartbeat, heart failure, myocardial infarction)
- a heart condition called "QT interval prolongation" or a history of certain abnormal heart rhythms known as torsade de pointes, or if anyone in your family has "QT interval prolongation"
- 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.
You should also inform your doctor if you are pregnant or think you might be pregnant.
Use in children and adolescents
Donepezilo Teva-ratio is not recommended for use in children and adolescents under 18 years of age.
Other medicines and Donepezilo Teva-ratio
Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.
This includes medicines not prescribed by your doctor but which you have obtained over-the-counter from a pharmacist. It also applies to medicines you might take in the future while continuing to take Donepezilo Teva-ratio. This is because these medicines may weaken or enhance the effects of Donepezilo Teva-ratio.
It is especially important to inform your doctor if you are taking any of the following medicines:
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medicines for heart rhythm problems, for example amiodarone or sotalol
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medicines for depression, for example citalopram, escitalopram, amitriptyline, fluoxetine
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medicines for psychosis, e.g. pimozide, sertindole or ziprasidone
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medicines for bacterial infections, for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
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antifungal medicines, such as ketoconazole
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other medicines for Alzheimer's disease, e.g. galantamine
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painkillers or treatment for arthritis, e.g. Aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac
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anticholinergics, e.g. Tolterodine
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anticonvulsants, e.g. phenytoin, carbamazepine
- medication for heart disease, e.g. quinidine, beta-blockers (propranolol and atenolol)
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muscle relaxants, e.g. diazepam, succinylcholine
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general anesthetics
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over-the-counter medicines, e.g. herbal remedies.
If you are undergoing surgery requiring general anesthesia, you must inform your doctor and anesthetist that you are taking Donepezilo Teva-ratio. This is because your medicine may affect the amount of anesthetic required.
Donepezilo Teva-ratio can be used in patients with mild to moderate renal or hepatic impairment.
Inform your doctor if you have kidney or liver disease. Patients with severe hepatic impairment should not take Donepezilo Teva-ratio.
Tell your doctor or pharmacist the name of your caregiver. Your caregiver will help you take the medicine as prescribed.
Taking Donepezilo Teva-ratio with food and alcohol
Food does not affect the absorption of donepezil hydrochloride. You should not drink alcohol while taking Donepezilo Teva-ratio, as alcohol may alter its effect.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Donepezilo Teva-ratio must not be used during breastfeeding.
Driving and using machines
Alzheimer's disease can impair your ability to drive or operate machinery, and you should not engage in these activities unless your doctor tells you it is safe to do so.
Donepezilo Teva-ratio may also cause fatigue, dizziness, or muscle cramps, especially at the beginning of treatment or when the dose is changed. If you experience these effects while taking Donepezilo Teva-ratio tablets, you should not drive or operate machinery.
Donepezilo Teva-ratio contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
Donepezilo Teva-ratio contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".
3. How to take Donepezil Teva-ratio
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Taking the dose of Donepezil Teva-ratio
Initially, the recommended dose is 5 mg (one white tablet) each night before going to bed. After one month, your doctor may instruct you to take 10 mg (one yellow tablet) each night. The tablet dose you take may vary depending on how long you have been taking this medicine and your doctor's recommendation. The maximum recommended dose is 10 mg each night. Always follow your doctor’s or pharmacist’s advice on how and when to take your medicine. Do not change the dose yourself without consulting your doctor.
How to take your medicine
Swallow your tablet with a little water at night before going to bed. If you experience abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend that you take donepezil in the morning.
Use in children and adolescents
Donepezil Teva-ratio is not recommended for use in children and adolescents under 18 years of age.
If you take more Donepezil Teva-ratio than you should
In case of overdose or accidental ingestion, contact your doctor, pharmacist, or hospital immediately, or call the Toxicology Information Service at telephone: 91 562 04 20, stating the medicine and the amount ingested. Take the tablets and packaging with you to the hospital so the doctor knows what you have taken.
Symptoms of overdose may include nausea and vomiting, drooling, sweating, slowed heart rate, low blood pressure (dizziness or lightheadedness upon standing), breathing difficulties, loss of consciousness, and seizures or convulsions.
If you forget to take Donepezil Teva-ratio
If you forget to take your medicine, take the next dose at the usual time. Do not take a double dose to make up for missed doses. If you have forgotten to take your medicine for more than one week, contact your doctor before taking any more.
If you stop taking Donepezil Teva-ratio
Do not stop taking the tablets unless your doctor tells you to. Your doctor or pharmacist will advise you on 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 further questions about the use of this product, ask your doctor or pharmacist.
How long should you take Donepezil Teva-ratio
Your doctor or pharmacist will advise you on how long you should continue taking the tablets.
You should visit your doctor from time to time to review your treatment and evaluate your symptoms.
4. Possible adverse effects
Like all medicines, Donepezil Teva-ratio can cause adverse effects, although not everyone experiences them.
The following adverse effects have been reported by people taking Donepezil Teva-ratio.
Inform your doctor if you experience any of these effects while taking Donepezil Teva-ratio.
Serious adverse effects:
Contact your doctor immediately if you notice any of the following adverse effects. You may require urgent medical treatment.
- Liver damage, for example, hepatitis. Symptoms of hepatitis include nausea (feeling unwell) or vomiting, loss of appetite, general malaise, 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. Symptoms of ulcers include stomach pain and discomfort (indigestion), and discomfort between the navel and the breastbone (may affect up to 1 in 100 people).
- Bleeding in the stomach or intestines. This may cause your stools to turn black and tarry or visible blood to appear in the rectum (may affect up to 1 in 100 people).
- Seizures or fits (may affect up to 1 in 100 people).
- Fever with muscle rigidity, sweating, or decreased level of consciousness (a disorder called "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people).
- Muscle weakness, sensitivity, or pain, particularly if you also feel unwell, have a fever, or have dark-colored urine. This may be due to abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 people).
Other adverse effects
Very common (may affect more than 1 in 10 people)
- Diarrhea,
- Headache,
Common (may affect up to 1 in 10 people)
- Inability to sleep (insomnia)
- Common cold
- Loss of appetite
- Hallucinations (seeing or hearing things that are not real)
- Unusual dreams and nightmares
- Agitation
- Aggressive behaviour
- Fainting
- Dizziness
- Uncomfortable feeling in the stomach
- Muscle cramps
- Urinary incontinence
- Pain
- Accidents (patients more prone to falls and accidents)
Uncommon (may affect up to 1 in 100 people)
- Slowing of the heartbeat
- Excessive salivation
Rare (may affect up to 1 in 1,000 people)
- Stiffness, tremors, or uncontrollable movements, especially of the face and tongue, but also of the limbs.
- Increased libido, hypersexuality
- Pisa syndrome (a condition involving involuntary muscle contractions with abnormal bending of the body and head to one side).
Reporting of adverse effects:
If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines:
https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Donepezil Teva-ratio
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation EXP. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Package contents and other information
Composition of Donepezilo Teva-ratio 5 mg film-coated tablets EFG
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The active substance is donepezil hydrochloride. Each tablet contains 5 mg of donepezil hydrochloride.
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The other components are:
Core: maize starch, monohydrate lactose, microcrystalline cellulose, sodium starch glycolate type A, colloidal anhydrous silica, magnesium stearate.
Coating: monohydrate lactose, hypromellose 15cp, titanium dioxide (E-171) and macrogol 4000.
Appearance of the product and contents of the pack
Donepezilo Teva-ratio 5 mg: film-coated tablets, white or almost white, round, biconvex, marked with "DN 5" 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 also supplied in calendar blister packs of 7, 28, 56, 84 or 98 film-coated tablets.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Pharma, S.L.U.
Anabel Segura 11, Edificio Albatros B, 1st floor
28108 Alcobendas, Madrid (Spain)
Manufacturer
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31-456 Kraków
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 medicinal product is authorised in the European Economic Area Member States under the following names:
Belgium: Donepezil Teva 5 mg filmomhulde tabletten
Germany: Donepezil-HCl AbZ 5 mg Filmtabletten
France: Donépézil TEVA 5 mg comprimé pelliculé
Ireland: Donepezil Teva 5 mg film-coated tablets
Italy: Donepezil Teva
Portugal: Donepezilo Teva
Slovenia: Donepezil Pliva 5 mg filmsko obložene tablete
Spain: Donepezilo Teva-ratio 5 mg comprimidos recubiertos con película EFG
This leaflet was approved in November 2022
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75249/P_75249.html
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