Donepezil Teva-Ratio 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Donepezil Teva-ratio 10 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; 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Donepezil 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 usual daily activities. It is for use in adult patients only.

2. What you need to know before starting to take Donepezil Teva-ratio

Do not take Donepezil 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).

Tell your doctor if any of the following apply to you.

Warnings and precautions

Treatment with Donepezil 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)
• if you have or have had a heart condition known as "QT interval prolongation" or a history of certain abnormal heart rhythms called torsade de pointes, or if anyone in your family has "QT interval prolongation"
• 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.

You should also inform your doctor if you are pregnant or think you might be pregnant.

Use in children and adolescents

Donepezil Teva-ratio is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Donepezil Teva-ratio

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

This includes medicines not prescribed by your doctor but obtained over-the-counter from a pharmacist. It also applies to medicines you may take in the future while continuing to take Donepezil Teva-ratio. This is because these medicines may weaken or strengthen the effects of Donepezil Teva-ratio.

It is especially important to inform your doctor if you are taking any of the following medicines:

• medicines for heart rhythm problems, e.g. amiodarone or sotalol

  • medicines for depression, e.g. citalopram, escitalopram, amitriptyline, fluoxetine
  • medicines for psychosis, e.g. pimozide, sertindole or ziprasidone
  • medicines for bacterial infections, e.g. clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
  • antifungal medicines, such as ketoconazole

• other medicines for Alzheimer's disease, e.g. galantamine

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

• anticholinergics, e.g. tolterodine

• anticonvulsants, e.g. phenytoin, carbamazepine

  • medicines for heart disease, e.g. quinidine, beta-blockers (propranolol and atenolol)

• muscle relaxants, e.g. diazepam, succinylcholine

• general anaesthetics

• over-the-counter medicines, e.g. herbal remedies.

If you are undergoing surgery requiring general anaesthesia, you must inform your doctor and anaesthetist that you are taking Donepezil Teva-ratio. This is because your medicine may affect the amount of anaesthetic required.

Donepezil 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 liver disease should not take Donepezil Teva-ratio.

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

medicine as prescribed.

Taking Donepezil Teva-ratio with food, drinks and alcohol

Donepezil Teva-ratio should be taken with water. Food does not affect the absorption of donepezil hydrochloride. You should not drink alcohol while taking Donepezil Teva-ratio, as alcohol may alter its effect.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Donepezil 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.

It may also cause fatigue, dizziness, or muscle cramps, mainly at the beginning of treatment or when the dose is changed. If you experience these effects while taking Donepezil Teva-ratio tablets, you should not drive or operate machinery.

Donepezil 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.

Donepezil Teva-ratio contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; that is, essentially “sodium-free”.

3. How to take Donepezil Teva-ratio

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Taking the dose of Donepezil Teva-ratio

The initial 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 91 562 04 20, indicating 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, salivation, sweating, slowed heart rate, low blood pressure (dizziness or fainting upon standing), breathing difficulties, loss of consciousness, and seizures.

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 forgotten doses. If you have missed taking 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 using this product, ask your doctor or pharmacist.

How long to 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, Donepezilo Teva-ratio can cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported by people taking Donepezilo Teva-ratio.

Inform your doctor if you experience any of these effects while taking Donepezilo 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 (jaundice), 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), 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 become black and tarry or visible blood to appear 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 rigidity, sweating, or decreased level of consciousness (a disorder known as "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people).
• Weakness, tenderness, or muscle 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 behavior,
• 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)

• Decreased heart rate,
• Increased 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 the available data

• 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 type of adverse effect, 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 Teva-ratio 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 empty containers and unused medicines at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Donepezilo Teva-ratio 10 mg film-coated tablets EFG

• The active substance is donepezil hydrochloride. Each tablet contains 10 mg of donepezil hydrochloride.

• The other components are:

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

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

Appearance of the product and contents of the pack

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

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

Film-coated tablets are also supplied in calendar blister packs containing 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

PLIVA CROATIA LIMITED (PLIVA HRVATSKA D.O.O.)
Prilaz Baruna Filipovica 25
10000 Zagreb, Croatia

or

Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren
Germany

This medicine is authorised in the Member States of the European Economic Area under the following names:

Belgium: Donepezil Teva 10 mg filmomhulde tabletten
Germany: Donepezil-HCl AbZ 10 mg Filmtabletten
France: Donépézil TEVA 10 mg comprimé pelliculé
Ireland: Donepezil Teva 10 mg film-coated tablets
Italy: Donepezil Teva
Portugal: Donepezilo Teva
Slovenia: Donepezil Pliva 10 mg filmsko obložene tablete
Spain: Donepezilo Teva-ratio 10 mg comprimidos recubiertos con película EFG

This leaflet was last approved in November 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75250/P_75250.html