Donepezil TecniGen 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Donepezil TecniGen 5 mg film-coated tablets EFG

Donepezil hydrochloride

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, 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 or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Donepezilo TecniGen (donepezil hydrochloride) belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil increases the levels of a substance in the brain (acetylcholine) involved in memory function, by slowing down 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 behavioural changes. As a result, patients with Alzheimer's disease have increasing difficulty performing their usual daily activities.

This medicine is intended for use only in adult patients.

2. What you need to know before starting to take Donepezil TecniGen

Do not take Donepezil TecniGen

• if you are allergic to donepezil hydrochloride, to piperidine derivatives, or to any of the other ingredients of Donepezil TecniGen listed in section 6 of this leaflet.

Warnings and precautions

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

Inform your doctor if you have or have had:

• Stomach or duodenal ulcer.
• Fainting or seizures.
• Heart disease (such as irregular or very slow heartbeat, heart failure, myocardial infarction).
• A heart condition known as "prolongation of the QT interval" or a history of certain abnormal heart rhythms called torsade de pointes, or if anyone in your family has "prolongation of the QT interval".
• Low levels of magnesium or potassium in the blood.
• Asthma or other lung disease.
• Liver disease or hepatitis.
• Difficulty urinating or mild kidney disease.

Also inform your doctor if you are pregnant or think you may be pregnant.

Interaction of Donepezil TecniGen with other medicines

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 which you may have obtained on your own from a pharmacy. It also applies to medicines you may need to take in the future while continuing to take Donepezil TecniGen. These medicines may weaken or intensify the effects of Donepezil TecniGen.

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

• Medicines for heart rhythm problems, for example amiodarone or sotalol.
• Medicines for depression, for example citalopram, escitalopram, amitriptyline, fluoxetine.
• Medicines for psychosis, e.g., pimozide, sertindole, or ziprasidone.
• Medicines for bacterial infections, for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin.
• Antifungal medicines, such as ketoconazole.
• Other medicines for Alzheimer's disease, for example galantamine.
• Painkillers or arthritis treatment, for example, aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac.
• Anticholinergic medicines, e.g., tolterodine.
• Anticonvulsants, e.g., phenytoin, carbamazepine.
• Medicines for heart disease, for example quinidine, beta-blockers (propranolol and atenolol).
• Muscle relaxants, e.g., diazepam, succinylcholine.
• General anaesthetic.
• Medicines obtained without a prescription, for example, herbal remedies.

If you are going to undergo surgery under general anaesthesia, you must inform your doctor and anaesthetist that you are taking Donepezil TecniGen, as this medicine may affect the amount of anaesthetic required.

Inform your doctor if you have any kidney or liver disease. Patients with severe liver disease should not take Donepezil TecniGen. Donepezil TecniGen can be used in patients with renal impairment and mild to moderate liver disease.

Inform your doctor or pharmacist of your caregiver's name. Your caregiver may help you take the medicine prescribed by your doctor.

Donepezil TecniGen with food, drink, and alcohol

Food does not affect the absorption of Donepezil TecniGen.

Donepezil TecniGen should not be taken with alcohol, as alcohol may alter its effect.

Pregnancy, breastfeeding, and fertility

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 TecniGen must not be used during breastfeeding.

Donepezil TecniGen must not be used during pregnancy except in clearly necessary cases.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Your medical condition may affect your ability to drive or operate machinery, and you should not perform these activities unless your doctor has advised you that it is safe to do so. Donepezil may cause dizziness and drowsiness, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you should not drive or operate machinery.

Donepezil TecniGen contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Donepezil TecniGen

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

How much Donepezil TecniGen should you take?

Normally, you will start by taking 5 mg (1 white tablet) each night. After one month, your doctor may instruct you to take 10 mg (1 yellow tablet) each night.

Swallow the tablet with water or another drink before going to bed at night. If you experience abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend that you take donepezil in the morning. The dose may change depending on the duration of treatment or your doctor's recommendation. The maximum recommended dose is 10 mg each night.

Always follow your doctor’s or pharmacist’s instructions regarding how and when to take your medicine. Do not change the dose yourself without consulting your doctor.

How long should you take Donepezil TecniGen?

Your doctor or pharmacist will tell you how long you should take the tablets. You will need to visit your doctor periodically to review your treatment and assess your symptoms.

If you stop taking Donepezil TecniGen

Do not stop taking the tablets unless your doctor tells you to do so. When treatment with Donepezil TecniGen is interrupted, the benefits of treatment gradually disappear.

If you take more Donepezil TecniGen than you should

Do not take more than one tablet per day. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medication and the amount ingested. Always bring the tablets and the packaging with you so the doctor knows what you have taken.

If you take more Donepezil TecniGen than you should, symptoms such as feeling unwell, salivation, sweating, slow heart rate, low blood pressure (dizziness upon standing), breathing difficulties, loss of consciousness, epileptic seizures, or convulsions may occur.

If you forget to take Donepezil TecniGen

If you forget to take a dose, take only one dose the following day at your usual time. Do not take a double dose to make up for missed doses.

If you have forgotten to take the medicine for more than one week, consult your doctor before resuming treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported in people who have taken Donepezil TecniGen. Inform your doctor if you experience any of these effects while taking Donepezil TecniGen.

Serious adverse effects

You must inform your doctor immediately if you notice any of the serious adverse effects listed below. You may require urgent medical treatment.

• Muscle weakness, tenderness, or pain, particularly if you also feel unwell, have a fever, or your urine is dark-colored. This may be due to abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition known as rhabdomyolysis).
• Liver damage, for example hepatitis. Symptoms of hepatitis include: feeling unwell, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), and dark urine (occurs in 1 to 10 people out of 10,000).
• Stomach and duodenal ulcers. Ulcer symptoms include: stomach pain, indigestion-like discomfort between the navel and the back (occurs in 1 to 10 people out of 1,000).
• Bleeding in the stomach or intestine. This may cause black stools or visible rectal bleeding (occurs in 1 to 10 people out of 1,000).
• Seizures (occurs in 1 to 10 people out of 1,000).

Very common adverse effects (may affect more than 1 in 10 people)

• Diarrhea.
• Feeling unwell.
• Headache.

Common adverse effects (may affect up to 1 in 10 people)

• Muscle cramps.
• Fatigue.
• Difficulty sleeping (insomnia).
• Common cold.
• Loss of appetite.
• Hallucinations (seeing or hearing things that are not real).
• Unusual dreams including nightmares.
• Agitation.
• Aggressive behavior.
• Fainting.
• Dizziness.
• Stomach discomfort.
• Skin rash.
• Itching.
• Urinary incontinence.
• Pain.
• Accidents (patients are more likely to fall or suffer accidental injuries).

Uncommon adverse effects (may affect up to 1 in 100 people)

• Slow heart rate.

Rare adverse effects (may affect up to 1 in 1,000 people)

• Stiffness, tremor, or uncontrollable movements, especially of the face, tongue, hands, or legs.

Frequency not known

• Changes in heart activity that may be seen on an electrocardiogram (ECG), known as "QT interval prolongation".
• Fast and irregular heartbeat, fainting, which may be symptoms of a potentially life-threatening condition called torsade de pointes.

Frequency not known (cannot be estimated from available data)

• Increased libido, hypersexuality.
• Pisa syndrome (a condition involving involuntary muscle contractions with abnormal sideways flexion of the body and head).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Donepezil TecniGen

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

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Donepezilo TecniGen

The active substance is donepezil hydrochloride.

Each tablet contains 5 mg of donepezil hydrochloride (equivalent to 4.56 mg of donepezil).

The other components are: Core: Lactose monohydrate, microcrystalline cellulose, corn starch, hydroxypropylcellulose, magnesium stearate. Coating: hypromellose, titanium dioxide, macrogol 400, talc.

Appearance of the product and pack sizes

Film-coated tablets, round, convex, and white in colour.

Available in blister packs containing 28 or 56 film-coated tablets.

Only certain pack sizes may be marketed.

Other presentations:

Donepezilo TecniGen 10 mg film-coated tablets EFG. Packs of 28 tablets.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

Tecnimede España Industria Farmacéutica, S.A.
Avda. de Bruselas, 13, 3º D.
28108 Alcobendas (Madrid) SPAIN

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas SA
Rua da Tapada Grande, 2, Abrunheira, 2710–089 Sintra
Portugal

Date of the most recent review of this leaflet: March 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/