Donepezil Flas Tecnigen 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Donepezil Flas TecniGen 10 mg orodispersible 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, since 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.

Leaflet contents

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

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

Donepezilo Flas TecniGen belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil increases the levels of a substance (acetylcholine) in the brain involved in memory function, by reducing the breakdown of acetylcholine.

Donepezilo Flas TecniGen is used to treat the symptoms of dementia in people diagnosed with mild to moderately severe Alzheimer's disease. Symptoms include memory loss, confusion, and changes in behaviour. As a result, people with Alzheimer's disease find it increasingly difficult to carry out their usual daily activities.

Donepezil hydrochloride is for use in adult patients only.

2. What you need to know before taking Donepezilo Flas TecniGen

Do not take Donepezilo Flas TecniGen

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

Warnings and precautions

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

Inform your doctor if you have or have had:

• Stomach or duodenal ulcers.
• Seizures or convulsions.
• Heart conditions (such as irregular or very slow heartbeats, heart failure, myocardial infarction).
• A heart condition known as «QT interval prolongation» or a history of certain abnormal heart rhythms called torsade de pointes, or if anyone in your family has «QT interval prolongation».
• Low levels of magnesium or potassium in the blood.
• Asthma or another 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 might be pregnant.

Children and adolescents

The use of Donepezilo Flas TecniGen is not recommended in the paediatric population (under 18 years of age).

Taking Donepezilo Flas TecniGen with other medicines

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

It is especially important that you inform your doctor if you are taking or have taken 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, 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, for example, tolterodine
• anticonvulsants, for example, phenytoin, carbamazepine
• medication for heart disease, for example quinidine, beta-blockers (propranolol and atenolol)
• muscle relaxants, for example, diazepam, succinylcholine
• general anaesthetic
• medicines obtained without a prescription, for example, herbal remedies

If you are undergoing surgery requiring general anaesthesia, you must inform your doctor and anaesthetist that you are taking Donepezilo Flas. This is because your medicine may affect the amount of anaesthetic required.

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

Inform your doctor or pharmacist of your caregiver's name. Your caregiver will help you take your medicine as prescribed.

Taking Donepezilo Flas TecniGen with food, drinks and alcohol

Food does not affect the action of donepezil hydrochloride. Donepezil hydrochloride should not be taken with alcohol, as alcohol may affect 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.

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

Driving and using machines

Your illness may affect your ability to drive or operate machinery, and you should not engage in these activities unless your doctor advises that it is safe to do so.

Donepezilo Flas may cause dizziness and drowsiness, mainly at the beginning of treatment or when the dose is increased. If you experience these effects, you should 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”.

3. How to take Donepezil Flas TecniGen

Follow exactly the administration instructions given by your doctor. If in doubt, consult your doctor or pharmacist again.

You and your caregiver should carefully follow your doctor's instructions.

Donepezil Flas TecniGen 10 mg orodispersible tablets are administered orally.

Treatment with Donepezil Flas is initiated with one 5 mg tablet taken once daily at bedtime. The tablet must be placed on the tongue and allowed to disintegrate before swallowing, with or without water, according to the patient's preference.

After one month of treatment, your doctor may instruct you to increase the dose to 10 mg once daily at 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 orodispersible tablets?

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

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

If you take more Donepezil Flas TecniGen orodispersible tablets than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medication and amount taken.

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

Signs of an overdose requiring urgent medical attention include:

• nausea
• vomiting
• salivation
• sweating
• slow heartbeat
• low blood pressure
• respiratory depression
• loss of consciousness, attacks, or seizures

If you forget to take Donepezil Flas TecniGen orodispersible tablets

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

If you have missed taking your medication for more than one week, contact your doctor before resuming treatment.

If you stop taking Donepezil Flas TecniGen orodispersible tablets

When treatment with Donepezil Flas is discontinued, the beneficial effects of treatment gradually disappear. Do not stop treatment with Donepezil Flas without first discussing it with your doctor.

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

4. Possible adverse effects

Like all medicines, Donepezil Flas may produce adverse effects, although not everyone experiences them.

Serious adverse effects:

If you notice any of the following serious adverse effects listed below, inform your doctor immediately. 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-coloured. This may be due to abnormal muscle breakdown which can be life-threatening and may lead to kidney problems (a condition called rhabdomyolysis).
• Liver disorders, for example hepatitis. Symptoms of hepatitis include nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and dark urine (may affect up to 1 in 1,000 patients).
• Stomach and duodenal ulcers. Symptoms of ulcers include stomach pain and discomfort (indigestion) between the navel and the breastbone (may affect up to 1 in 100 patients).
• Gastrointestinal bleeding. Symptoms include passing black, tar-like stools or rectal bleeding (may affect up to 1 in 100 patients).
• Stroke or seizures (may affect up to 1 in 100 patients).
• Fever, muscle rigidity, sweating, or decreased level of consciousness (may indicate a disorder known as "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 patients).

Other adverse effects:

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

• Headache
• Diarrhoea
• 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 behaviour
• Fainting
• Dizziness
• Stomach discomfort
• Skin rash
• Itching
• Involuntary passing of urine
• Pain
• Accidents (patients may be more prone to falls and accidental injuries)

Uncommon (may affect up to 1 in 100 patients)

• Seizures
• Slow heartbeat
• Gastrointestinal bleeding, gastric and duodenal ulcers
• Slight increase in serum concentration of creatine kinase (muscle)

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

• Stiffness, tremors, or uncontrollable movements, especially of the face and tongue, but also of the limbs
• disturbances in cardiac conduction
• liver function abnormalities, including hepatitis

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

• Changes in heart activity that may be seen on an electrocardiogram (ECG), known as "prolongation of the QT interval"
• Fast and irregular heartbeat, fainting, which may be symptoms of a potentially life-threatening disorder known as torsade de pointes
• Increased libido, hypersexuality
• Pisa syndrome (a condition involving involuntary muscle contractions with abnormal sideways bending of the body and head)

5. Storage of Donepezil Flas TecniGen

Keep out of sight and reach of children.

This medicine does not require any special storage conditions.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. 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 components (excipients) are: mannitol (E-421), crospovidone, sucralose, sodium chloride, magnesium stearate and yellow iron oxide (E-172).

Description of the product and contents of the pack

Round, yellow, flat tablets with bevelled edges, marked “CL 32” on one side and smooth on the other.

Other presentations

The tablets are packaged in blisters in cartons containing 28 tablets, 56 tablets or 120 tablets (hospital pack).

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

The last revision of this leaflet was in September 2022

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