Prospect: Information for the User

Donepezilo TecniGen 5 mg Film-Coated Tablets

Donepezil Hydrochloride

Read this prospect carefully before starting to take this medicine, as it contains important information for you:

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they present the same symptoms of illness as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Donepezilo TecniGen (donepezil hydrochloride) belongs to a group of medications called acetylcholinesterase inhibitors. Donepezilo increases the levels of a substance (acetylcholine) in the brain involved in memory function, slowing down the breakdown of acetylcholine.

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

It is a medication for use only in adult patients.

Do not take Donepezilo TecniGen

• if you are allergic to hydrochloride of donepezilo, to piperidina derivatives or to any other component of Donepezilo TecniGen listed in section 6 of this prospectus.

Warnings and precautions

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

Inform your doctor if you have or have had:

• Stomach or duodenal ulcer.
• Syncope or convulsions.
• Heart disease (such as irregular or very slow heart rhythm, heart failure, myocardial infarction).
• A heart condition called "prolongation of the QT interval" or a history of certain abnormal heart rhythms called torsade 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.

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

Interaction of Donepezilo TecniGen with other medications

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

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

• Medications for heart rhythm problems, for example amiodarone or sotalol.
• Medications for depression, for example citalopram, escitalopram, amitriptyline, fluoxetine.
• Medications for psychosis, for example pimozide, sertindole or ziprasidone.
• Medications for bacterial infections, for example clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin.
• Antifungal medications, such as ketoconazole.
• Other medications for Alzheimer's disease, for example galantamine.
• Pain relievers or arthritis treatment, for example aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium.
• Anticholinergic medications, for example tolterodine.
• Anticonvulsants, for example phenytoin, carbamazepine.
• Medications for heart disease, for example quinidine, beta-blockers (propranolol and atenolol).
• Muscle relaxants, for example diazepam, succinylcholine.
• General anesthetic.
• Over-the-counter medications, for example herbal remedies.

If you are to be operated on with general anesthesia, you must inform your doctor and anesthesiologist that you are taking Donepezilo TecniGen, as this medication may affect the amount of anesthetic needed.

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

Inform your doctor or pharmacist about the name of your caregiver. Your caregiver may help you take the medication prescribed by your doctor.

Donepezilo TecniGen with food, drink and alcohol

Food does not affect the absorption of Donepezilo TecniGen.

Donepezilo 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Donepezilo TecniGen should not be used during breastfeeding.

Donepezilo TecniGen should not be used during pregnancy except in clearly necessary cases.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

Your condition may affect 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 may cause dizziness and drowsiness, mainly at the start of treatment or when increasing the dose. If you experience these effects, you should not drive or operate machinery.

Donepezilo TecniGen contains lactose

If your doctor has told you that you have intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much Donepezilo TecniGen should you take?

You will usually start taking 5 mg (1 white tablet) at night. After a month, your doctor may tell you to take 10 mg (1 yellow tablet) at 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 donepezilo 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 at night.

Always follow the recommendations of your doctor or pharmacist on how and when to take your medication. Do not change the dose yourself without consulting your doctor.

For how long should you take Donepezilo TecniGen?

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

If you interrupt treatment with Donepezilo TecniGen

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

If you take more Donepezilo TecniGen than you should

Do not take more than one tablet a 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 medication and the amount ingested. Always carry the tablets and packaging with you so that the doctor knows what you are taking.

If you take more Donepezilo 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 difficulties, loss of consciousness, seizures, or convulsions.

If you forgot to take Donepezilo TecniGen

If you forgot to take a dose, take only one dose the next day at the usual time. Do not take a double dose to compensate for missed doses.

If you forgot to take the medication for more than a week, consult your doctor before resuming the medication.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

Severe side effects

You must inform your doctor immediately if you observe the mentioned severe side effects. You may need urgent medical treatment.

• Weakness, sensitivity, or muscle pain, particularly if you also 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 condition called rhabdomyolysis).
• Liver damage, for example hepatitis. The symptoms of hepatitis are: feeling unwell, loss of appetite, general discomfort, fever, itching, yellow skin and eyes, dark urine (affects 1 to 10 people out of 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 out of 1,000).
• Bleeding in the stomach or intestines. This can cause black stools or visible blood in the rectum (affects 1 to 10 people out of 1,000).
• Seizures (affects 1 to 10 people out of 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.
• Tiredness.
• 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.
• Discomfort in the stomach.
• Skin rash.
• Itching.
• Urinary incontinence.
• Pain.
• Accidents (patients are more prone to falling or accidentally injuring themselves).

Rare 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)

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

Unknown frequency

• Changes in heart activity that can be seen on an electrocardiogram (ECG) called "prolongation of the QT interval."
• Fast and irregular heartbeat, fainting that may be a symptom of a potentially fatal condition called torsade de pointes.

Unknown frequency (cannot be estimated from 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Donepezilo TecniGen

The active ingredient is donepezilo hydrochloride.

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

The other components are:Core:Lactose monohydrate, Microcrystalline cellulose, Cornstarch, Hydroxypropyl cellulose, Magnesium stearate.Covering:Hydroxypropyl methylcellulose, Titanium dioxide, Macrogol 400, and Talc.

Appearance of the product and packaging size

Coated tablets, round, convex, and white in color.

Available in blisters in packaging of 28 or 56 coated tablets.

Only some packaging sizes may be commercially available.

Other presentations:

Donepezilo TecniGen 10 mg coated tablets. Packaging of 28 tablets.

Marketing Authorization Holder and Responsible for Manufacturing:

Marketing Authorization Holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd Floor.

28108 Alcobendas (Madrid) SPAIN

Responsible for Manufacturing:

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande, 2, Abrunheira, 2710 – 089 Sintra

Portugal

Last review date of this leaflet: March 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/