DONEPEZILO 10 mg Orally Disintegrating Tablets

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

Do not take Donepezil Flas TecniGen

• if you are allergic (hypersensitive) to donepezil hydrochloride, piperidine derivatives, or any of the other ingredients of Donepezil Flas TecniGen orodispersible tablets (listed in section 6).

Warnings and precautions

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

Tell your doctor if you have or have had:

• Stomach or duodenal ulcers.
• Seizures or convulsions.
• Heart problems (such as irregular or very slow heartbeats, 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 long-term lung disease.
• Liver problems or hepatitis.
• Difficulty urinating or mild kidney disease.

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

Children and adolescents

Donepezil Flas TecniGen is not recommended for use in pediatric populations (under 18 years of age).

Using Donepezil Flas TecniGen with other medicines

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medicines.

It is especially important that you tell your doctor if you are using or have used any of the following 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

ketoconazole, an antifungal medicine

• other medicines for Alzheimer's disease, such as galantamine
• analgesics or treatments for arthritis, 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 anesthetics
• over-the-counter medicines, such as herbal remedies

If you are going to have an operation that requires general anesthesia, you must tell your doctor and anesthetist that you are taking Donepezil Flas. This is because your medicine may affect the amount of anesthetic needed.

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

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

Taking Donepezil Flas TecniGen with food, drinks, and alcohol

Food does not affect the effect of donepezil hydrochloride. Donepezil hydrochloride 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

If you are breastfeeding, you should not take this medicine.

Driving and using machines

Your illness may affect your ability to drive or use machines, and you should not carry out these activities unless your doctor tells you it is safe to do so.

Donepezil Flas may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose. If you experience these effects, you should not drive or use machines.

Donepezil Flas TecniGen contains sodium

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

3. How to take Donepezil Flas TecniGen

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

You and your caregiver should take into account the instructions given by your doctor.

Donepezil Flas TecniGen 10 mg orodispersible tablets are administered orally.

Treatment with Donepezil Flas starts with a 5 mg tablet, taken once a day at night before bedtime. The tablet should be placed on the tongue and allowed to dissolve before swallowing, with or without water, as the patient prefers.

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

Do not change the dose without consulting your doctor.

How long should you take Donepezil Flas TecniGen tablets?

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

You will need to visit your doctor regularly to review your treatment and assess your symptoms.

If you take more Donepezil Flas TecniGen 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 medicine and the amount taken.

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

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

• nausea
• vomiting
• salivation
• sweating
• slow heart rate
• low blood pressure
• respiratory depression
• loss of consciousness, seizures, or convulsions

If you forget to take Donepezil Flas TecniGen tablets

Do not take a double dose to make up for the forgotten dose. Take your usual dose the next day at the usual time.

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

If you stop taking Donepezil Flas TecniGen tablets

When treatment with Donepezil Flas is stopped, the beneficial effects of the treatment disappear gradually. Do not stop treatment with Donepezil Flas without first talking to your doctor.

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

4. Possible side effects

Like all medicines, Donepezil Flas can cause side effects, although not everybody gets them.

Serious side effects:

If you notice any of the following serious side effects, tell your doctor immediately. 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 in color. This can be due to abnormal muscle destruction, which can be life-threatening and cause kidney problems (a disease called rhabdomyolysis).
• liver disorders, such as hepatitis. The symptoms of hepatitis are nausea, vomiting, loss of appetite, general malaise, fever, itching, yellow skin and eyes, and dark urine (may 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 sternum (may affect up to 1 in 100 patients).
• gastrointestinal bleeding. The symptoms are black, tarry stools or blood in the rectum (may affect up to 1 in 100 patients).
• seizures or convulsions (may affect up to 1 in 100 patients).
• fever, muscle stiffness, sweating, or decreased level of consciousness (may be a condition called "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 patients).

Other side effects:

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

• headache
• diarrhea
• nausea

Common (may 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 upset
• skin rash
• itching
• uncontrolled urination
• pain
• accidents (patients may be more prone to falls and accidental injuries)

Uncommon (may affect up to 1 in 100 patients)

• seizures
• slow heart rate
• gastrointestinal bleeding, stomach, and duodenal ulcers
• small increase in serum creatine kinase muscle levels

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

• rigidity, tremors, or uncontrolled movements, especially of the face and tongue, but also of the limbs
• changes in heart conduction
• liver function changes, including hepatitis

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

• 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 condition called torsades 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 not listed in this leaflet.

5. Storage of Donepezil Flas TecniGen

Keep out of the sight and reach of children.

This medicine does not require special storage conditions.

Do not use Donepezil Flas after the expiration date stated on the packaging after the abbreviation EXP. The expiration date is the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Donepezil Flas TecniGen 10 mg

• The active substance is donepezil hydrochloride. Each orodispersible tablet contains 10 mg of donepezil hydrochloride (equivalent to 9.12 mg of donepezil).
• The other ingredients (excipients) are: mannitol (E-421), crospovidone, sucralose, sodium chloride, magnesium stearate, and yellow iron oxide (E-172).

Appearance of the product and packaging contents

Round, yellow, flat tablets with beveled edges, marked with "CL 32" on one side and smooth on the other side.

Other presentations

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

TECNIMEDE ESPAÑA IND. FCA., S.A.

Avda. de Bruselas, nº 13. 3ºD

28108 - Alcobendas (Madrid)

Spain

Manufacturer

Medinfar Manufacturing, S.A.

Parque Industrial Armando Martins Tavares

Rua Outeiro Da Armada, nº 5.

Condeixa-a-Nova, 3150-194.

Portugal

This leaflet was last revised in September 2022

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/.