PATIENT INFORMATION LEAFLET

Donepezilo Flas TecniGen 10 mg buccal tablets EFG

Donepezilo hydrochloride

Read this 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. Do not give it to others even if they have the same symptoms of disease as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Donepezilo Flas TecniGen belongs to a group of medications known as acetylcholinesterase inhibitors. Donepezilo increases the levels of a substance (acetylcholine) in the brain involved in memory function as it decreases the degradation of acetylcholine.

Donepezilo Flas TecniGen is used to treat the symptoms of dementia in individuals diagnosed with mild to moderately severe Alzheimer's disease..The symptoms include memory loss, confusion, and changes in behavior. As a result, individuals with Alzheimer's find it increasingly difficult to perform their normal daily activities.

Donepezilo hydrochloride is for use only in adult patients.

Do not take Donepezilo Flas TecniGen

• if you are allergic (hypersensitive) to hydrochloride of donepezilo, to derivatives of piperidina or to any of the other components of Donepezilo Flas TecniGen buccal dispersible tablets (including those listed in section 6).

Warnings and precautions

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

Inform your doctor if you have or have had:

• Stomach or duodenal ulcers.
• Attacks or convulsions.
• Cardiac disease (such as irregular or very slow heartbeats, heart failure, myocardial infarction).
• A cardiac 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 long-term lung disease.
• Liver problems or hepatitis.
• Difficulty urinating or mild kidney disease.

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

Children and adolescents

Donepezilo Flas TecniGen is not recommended for use in pediatric population (under 18 years).

Use of Donepezilo Flas TecniGen with other medicines

Inform your doctor or pharmacist if you are using or have used recently or might have to use any other medicine.

It is especially important to inform your doctor if you are using or have used any of the following medicines:

• Medicines for heart rhythm problems, for example amiodarone or sotalol.
• Medicines for depression, for example citalopram, escitalopram, amitriptyline, fluoxetine.
• Medicines for psychosis, for example 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 diclofenac sodium.
• Anticholinergic medicines, for example, tolterodine.
• Anticonvulsants, for example, phenytoin, carbamazepine.
• Medicines for heart disease, for example quinidine, beta-blockers (propranolol and atenolol).
• Relaxants, for example, diazepam, succinylcholine.
• General anesthetic
• Over-the-counter medicines, for example, herbal remedies.

If you are to undergo a surgery that requires a general anesthetic, you must tell your doctor and the anesthetist that you are taking Donepezilo Flas. This is because your medicine may affect the amount of anesthetic needed.

Donepezilo Flas may be used in patients with renal disease or mild to moderate liver disease. Tell your doctor if you have renal or liver disease. Patients with severe liver disease should not take Donepezilo Flas.

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

Taking Donepezilo Flas TecniGen with food and drinks and alcohol

Foods do not affect the effect of hydrochloride of donepezilo. Hydrochloride of donepezilo should not be taken with alcohol because alcohol may affect 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 medicine.

If you are breastfeeding, do not take this medicine.

Driving and operating machinery

Your condition may affect your ability to drive or operate machinery and you should not do so unless your doctor tells you it is safe to do so.

Donepezilo Flas may cause dizziness and drowsiness, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or operate machinery.

Donepezilo Flas TecniGen contains sodium

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

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

You and your caregiver must take into account the instructions of your doctor.

Donepezilo Flas TecniGen 10 mg buccal tablets are administered orally.

The treatment with Donepezilo Flas starts with a 5 mg tablet, taken once a day at night before going to bed. The tablet must be placed on your tongue and let it disintegrate before swallowing, with water or without water as you prefer.

After a month of treatment, your doctor may indicate an increase in the dose to 10 mg, once a day at night, before going to bed.If you have abnormal dreams, nightmares or difficulty sleeping (see section 4), your doctor may recommend that you take Donepezilo Flas in the morning.The maximum recommended dose is 10 mg/day.

Do not modify the dose without consulting your doctor.

How long should you take Donepezilo Flas TecniGen buccal tablets?

Your doctor or pharmacist will indicate how long you should continue taking your tablets.

You will need to visit your doctor periodically to review your treatment and evaluate your symptoms.

If you take more Donepezilo Flas TecniGen buccal tablets than you should

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 taken.

Bring with you the coated tablets, this leaflet and/or the packaging to show your doctor what you have taken.

The signs of an overdose that require urgent medical care are:

-nausea

-vomiting

-salivation

-sweating

-slow heart rate

-low blood pressure

-respiratory depression

-loss of consciousness, seizures or convulsions

If you forgot to take Donepezilo Flas TecniGen buccal tablets

Do not take a double dose to compensate for the missed dose. Take your usual dose the next day at the usual time.

If you forgot to take your medication for more than a week, call your doctor before taking the dose again.

If you interrupt the treatment with Donepezilo Flas TecniGen buccal tablets

When treatment with Donepezilo Flas is interrupted, the beneficial effects of treatment disappear gradually. Do not interrupt treatment with Donepezilo Flas without first informing your doctor.

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

Like all medications, Donepezilo Flas can produce side effects, although not everyone will experience them.

Severe side effects:

If you notice the following severe side effects mentioned, inform your doctor immediately. You may need urgent medical treatment.

• Muscle weakness, sensitivity, or pain, particularly if you are also feeling unwell, have a fever, or your urine is dark in color. This can be due to abnormal muscle destruction that can be fatal and cause kidney problems (a condition called rhabdomyolysis).
• Liver problems, such as hepatitis. The symptoms of hepatitis are nausea, vomiting, loss of appetite, general discomfort, fever, itching, yellow skin and eyes, and dark-colored urine (which can affect up to 1 in 1,000 patients).
• Stomach and duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the breastbone (which can affect up to 1 in 100 patients).
• Gastrointestinal bleeding. The symptoms are black, tar-like stools or blood in the rectum (which can affect up to 1 in 100 patients).
• Seizures or convulsions (which can affect up to 1 in 100 patients).
• Fever, muscle stiffness, sweating, or decreased level of consciousness (which can present a condition called "Neuroleptic Malignant Syndrome") (which can affect up to 1 in 10,000 patients).

Other side effects:

Very common (can affect more than 1 in 10 patients)

• Headache
• Diarrhea
• Nausea

Common (can affect up to 1 in 10 patients)

• 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
• Rash
• Itching
• Urinary incontinence
• Pain
• Accidents (patients may be more prone to falls and accidental injuries)
  

Uncommon (can affect up to 1 in 100 patients)

• Convulsions
• Slow heart rate
• Gastrointestinal bleeding, stomach and duodenal ulcers
• Small increase in serum creatine kinase
  

Rare (can affect up to 1 in 1,000 patients)

• Rigidity, tremors, or uncontrollable movements, especially of the face and tongue, but also of the limbs
• Alterations in cardiac conduction
• Liver function alteration, including hepatitis

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

• Changes in cardiac activity that can be observed on an electrocardiogram (ECG) called "prolongation of the QT interval"
• Fast and irregular heart rate, fainting that can be a symptom of a potentially fatal condition called torsade de pointes
• Increased libido, hypersexuality
• Pisa syndrome (a condition that involves involuntary muscle contraction with abnormal flexion of the body and head to one side)

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this prospectus.

Keep out of the sight and reach of children.

This medication does not require special conditions for conservation.

Do not use Donepezilo Flas after the expiration date that appears on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Donepezilo Flas TecniGen 10 mg

-The active ingredient is donepezil hydrochloride. Each buccal dispersible tablet contains 10 mg of donepezil hydrochloride (equivalent to 9.12 mg of donepezil).

-The other components (excipients) are: mannitol (E-421), crospovidone, sucralose, sodium chloride, magnesium stearate, and yellow iron oxide (E-172).

Appearance of the product and contents of the packaging

Round tablets, yellow in color, flat with beveled edges, marked with “CL 32” on one face and smooth on the other face..

Other presentations

The tablets are packaged in blisters in boxes of 28 tablets, 56 tablets, or 120 tablets (clinical packaging).

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder

TECNIMEDE ESPAÑA IND. FCA., S.A.

Avda. de Bruselas, nº 13. 3ºD

28108 - Alcobendas (Madrid)

Spain

Responsible for manufacturing

Medinfar Manufacturing, S.A.

Parque Industrial Armando Martins Tavares

Rua Outeiro Da Armada, nº 5.

Condeixa-a-Nova, 3150-194.

Portugal

This prospectus was last revised in September 2022

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/.