DONEPEZIL TECNIGEN 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Donepezil TecniGen 5 mg film-coated tablets EFG

Donepezil hydrochloride

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:

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

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

Donepezil TecniGen (donepezil hydrochloride) belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil increases the levels of a substance (acetylcholine) in the brain involved in memory function, making the breakdown of acetylcholine slower.

It is used to treat the symptoms of dementia in people diagnosed with mild to moderately severe Alzheimer's disease. The symptoms include increased memory loss, confusion, and changes in behavior. As a result, patients with Alzheimer's disease have increasing difficulties performing their normal daily activities.

It is a medicine for use only in adult patients.

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

Do not take Donepezil TecniGen

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

Warnings and precautions

Tell your doctor or pharmacist before you start taking Donepezil TecniGen.

Tell your doctor if you have or have had:

• Stomach or duodenal ulcer.
• Fainting or seizures.
• Heart disease (such as irregular heartbeat or very slow, heart failure, myocardial infarction).
• A heart condition called "prolongation of the QT interval" or a history of certain abnormal heart rhythms called torsades de pointes or if someone 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.

Tell your doctor if you are pregnant or think you may be pregnant.

Interaction of Donepezil TecniGen with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take other medicines. This includes medicines that your doctor has not prescribed but that you may have bought yourself at the pharmacy. It also applies to medicines that you may need to take in the future if you continue to take Donepezil TecniGen. These medicines may weaken or enhance the effects of Donepezil TecniGen.

In particular, it is important to tell your doctor or pharmacist 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, such as 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.
• Pain relievers or arthritis treatment, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or diclofenac sodium.
• Anticholinergic medicines, such as tolterodine.
• Anticonvulsants, such as phenytoin, carbamazepine.
• Medicines for heart disease, such as quinidine, beta-blockers (propranolol and atenolol).
• Muscle relaxants, such as diazepam, succinylcholine.
• General anesthetic.
• Medicines obtained without a prescription, such as herbal remedies.

If you are going to have surgery with general anesthesia, you must tell your doctor and anesthesiologist that you are taking Donepezil TecniGen, as this medicine may affect the amount of anesthetic needed.

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

Tell your doctor or pharmacist about the name of your caregiver. Your caregiver can 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 change its effect.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Donepezil TecniGen should not be used during breastfeeding.

Donepezil TecniGen should not be used during pregnancy unless clearly necessary.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Your illness may affect your ability to drive or use machines, and you should not perform 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 TecniGen 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 TecniGen

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

How much Donepezil TecniGen should you take?

Normally, you will start taking 5 mg (1 white tablet) each night. After a month, your doctor may tell 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 have 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 the recommendations of your doctor or pharmacist on how and when to take your medicine. Do not change the dose yourself without your doctor's advice.

How long should you take Donepezil TecniGen?

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

If you stop taking Donepezil TecniGen

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

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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken. Always carry the tablets and packaging with you so that the doctor knows what you are taking.

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

If you forget to take Donepezil TecniGen

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

If you forget to take the medicine for more than a week, before taking the medicine again, consult your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported in people taking Donepezil TecniGen. Tell your doctor if you have any of these side effects while taking Donepezil TecniGen.

Serious side effects

You should tell your doctor immediately if you notice any of these serious side effects. You may need urgent medical treatment.

• Weakness, sensitivity, or muscle pain, especially if you also feel unwell, have a fever, or your urine is dark. This can be due to abnormal muscle destruction that can be life-threatening and cause kidney problems (a disease called rhabdomyolysis).
• Liver damage, for example, hepatitis. The symptoms of hepatitis are: feeling unwell, loss of appetite, general malaise, fever, itching, yellow color in skin and eyes, dark urine (affects 1 to 10 people in every 10,000).
• Stomach and duodenal ulcers. The symptoms of ulcers are: stomach pain, feeling of indigestion between the navel and the back (affects 1 to 10 people in every 1,000).
• Bleeding in the stomach or intestine. This can cause black stools or visible blood in the rectum (affects 1 to 10 people in every 1,000).
• Seizures (affects 1 to 10 people in every 1,000).

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

• Diarrhea.
• Feeling unwell.
• Headache.

Common side 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.
• Feeling unwell in the stomach.
• Skin rash.
• Itching.
• Urinary incontinence.
• Pain.
• Accidents (patients are more prone to falling or accidentally harming themselves).

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

• Slow heart rate.

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

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

Frequency not known

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

Frequency not known (cannot be estimated from the available data)

• 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 or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 which is stated on the packaging. The expiry date is the last day of the month stated.

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 TecniGen

The active substance is donepezil hydrochloride.

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

The other ingredients are: Core:Lactose monohydrate, Microcrystalline cellulose, Corn starch, Hydroxypropylcellulose, Magnesium stearate. Coating:Hypromellose, Titanium dioxide, Macrogol 400, and Talc.

Appearance of the product and pack size

White, round, convex, film-coated tablets.

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

Not all pack sizes may be marketed.

Other presentations:

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

Marketing authorization holder and manufacturer:

Marketing authorization 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 last revision of this leaflet: March 2023

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/