DONEPEZIL STADA 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Donepezil Flas Stada 5 mg orodispersible tablets EFG

Donepezil Flas Stada 10 mg orodispersible 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 thepackage leaflet

1. What is Donepezil Flas Stada and what is it used for
2. What you need to know before you take Donepezil Flas Stada
3. How to take Donepezil Flas Stada
4. Possible side effects
5. Storing Donepezil Flas Stada
6. Package contents and further information

1. What is Donepezil Flas Stada and what is it used for

Donepezil Flas Stada (donepezil hydrochloride) belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil increases the levels in the brain of a substance related to memory (acetylcholine), by reducing the speed of breakdown of this substance.

It is used to treat the symptoms of dementia in people diagnosed with mild to moderately severe Alzheimer's disease. The symptoms include increasing memory loss, confusion, and changes in behavior. As a result, patients with Alzheimer's disease find it increasingly difficult to carry out their daily activities.

Donepezil is only for use in adult patients.

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

Do not take Donepezil Flas Stada:

• if you are allergic to donepezil hydrochloride, to medicines similar to donepezil (known as piperidine derivatives), or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Donepezil Flas Stada, especially if you have or have had:

• • stomach or duodenal ulcers
• a seizure (fit) or convulsion
• a heart condition (such as irregular or very slow heart beats, heart failure, heart attack)
• 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 chronic lung disease
• liver or hepatitis problems
• difficulty urinating or mild kidney disease

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

Children and adolescents

Donepezil is not indicated for use in children and adolescents (under 18 years).

Other medicines and Donepezil Flas Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that your doctor has not prescribed for you but that you have bought yourself. It also applies to medicines that you might take in the future while you are still taking donepezil. This is because these medicines could weaken or strengthen the effects of donepezil.

It is especially important to tell your doctor if you are taking any of the following types of 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, ziprasidone
• medicines for bacterial infections, for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungal medicines, e.g., ketoconazole

• other medicines for Alzheimer's disease, e.g., galantamine
• painkillers or treatment for arthritis, e.g., acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium
• anticholinergic medicines, e.g., tolterodine
• anticonvulsants (medicines used to prevent the occurrence of various types of seizures), e.g., phenytoin, carbamazepine
• medicines for heart diseases, e.g., quinidine, beta-blockers(propranolol and atenolol)
• muscle relaxants, e.g., diazepam, succinylcholine
• general anesthesia
• those purchased without a medical prescription, e.g., herbal remedies

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

Donepezil may 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.

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

Donepezil Flas Stada with food, drinks, and alcohol

Food does not affect the effect of this medicine.Donepezil should not be taken with alcohol, as alcohol may change its effects.

Pregnancy and breastfeeding

Donepezil should not be used during breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this medicine.

Driving and using machines

Alzheimer's disease 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.

Additionally, this medicine may cause fatigue, dizziness, and muscle cramps. If you experience any of these effects, you should not drive or operate machinery.

Donepezil Flas Stada contains aspartame, lactose, and sodium

Aspartame

Donepezil Flas Stada 5 mg

This medicine contains 5 mg of aspartame in each 5 mg orodispersible tablet.

Donepezil Flas Stada 10 mg

This medicine contains 10 mg of aspartame in each 10 mg orodispersible tablet.

Aspartame contains a source of phenylalanine that may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

Lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Sodium

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

3. How to take Donepezil Flas Stada

How much donepezil should you take?

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Normally, you will start by taking 5 mg each night before bedtime. After one month, your doctor may tell you to take 10 mg every night before bedtime.

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 of the tablets you take may change depending on how long you have been taking the medicine and what your doctor recommends.

The maximum recommended dose is 10 mg each night.

Always follow the advice of your doctor or pharmacist on how and when to take the medicine.

Do not change the dose on your own without consulting your doctor.

How to take donepezil?

The tablet should be placed on the tongue and allowed to dissolve before swallowing, with or without water according to your preference.

Use in children and adolescents

This medicine is not recommended for children and adolescents (under 18 years).

If you take more Donepezil Flas Stada than you should

Contact your doctor or the nearest hospital emergency department immediately if you take more medicine than you should. Bring this leaflet and any remaining tablets with you.

Symptoms of overdose are, among others, feeling unwell or vomiting, drooling, sweating, slow heartbeat, low blood pressure (dizziness or fainting when standing up), breathing problems, loss of consciousness, and seizures or fits.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 5620420, indicating the medicine and the amount ingested.

If you forget to take Donepezil Flas Stada

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

If you forget to take your medicine for more than one week, consult your doctor before taking any more medicine.

If you stop taking Donepezil Flas Stada

Do not stop taking the tablets unless your doctor tells you to do so. If you stop treatment with donepezil, the benefits of your treatment may gradually disappear.

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

How long should you take donepezil?

Your doctor or pharmacist will advise you on how long you should continue to take your tablets. You will need to visit your doctor from time to time to review your treatment and assess your symptoms.

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 by patients taking donepezil.

Tell your doctor if you have any of these effects during treatment with donepezil.

Serious side effects:

You must tell your doctor immediately if you notice any of the following serious side effects mentioned. You may need urgent medical treatment.

• liver disorders, e.g., hepatitis. The symptoms of hepatitis are nausea (feeling sick), vomiting, loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin and eyes, and dark-colored urine (rare: may affect up to 1 in 1,000 people).
• stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the breastbone (uncommon: may affect up to 1 in 100 people).
• bleeding in the stomach or intestines. This can cause your stools to be black or tarry or for visible blood to appear in the rectum (uncommon: may affect up to 1 in 100 people).
• seizures (fits) or convulsions (uncommon: may affect up to 1 in 100 people).
• fever with muscle stiffness, sweating, or decreased level of consciousness (a condition called Neuroleptic Malignant Syndrome) (very rare: may affect up to 1 in 10,000 people).
• weakness, sensitivity, or pain in the muscles, especially if you also feel unwell, have a fever, or have dark-colored urine. This can be due to an abnormal breakdown of muscle that can lead to kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 people).
• rapid and irregular heartbeat, fainting that can be symptoms of a potentially life-threatening condition known as Torsade de Pointes (frequency cannot be estimated from the available data).

Other side effects

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

• diarrhea
• nausea (feeling sick)
• headache

Common (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 really do not exist)
• unusual dreams including nightmares
• agitation
• aggressive behavior
• fainting
• dizziness
• vomiting (feeling sick)
• feeling of discomfort in the stomach
• rash
• itching
• uncontrollable urge to urinate
• pain
• accidents (patients may be more prone to falls and accidental injuries)

Uncommon (may affect up to 1 in 100 people)

• slow heartbeat
• excessive salivation

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

• stiffness, agitation, or uncontrolled movements, especially of the face and tongue, but also of the limbs

Not known (frequency 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”.
• 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Donepezil Flas Stada

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

Do not use this medicine after the expiry date which is stated on the carton, after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and further information

Composition of Donepezil Flas Stada

• The active substance of Donepezil Flas Stada is donepezil hydrochloride.

Each Donepezil Flas Stada 5 mg tablet contains 5 mg of donepezil hydrochloride.

Each Donepezil Flas Stada 10 mg tablet contains 10 mg of donepezil hydrochloride.

• The other ingredients are:

potassium polacrylate, microcrystalline cellulose, lactose monohydrate (spray-dried), anhydrous monosodium citrate, aspartame (E951), sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and package contents

Donepezil Flas Stada 5 mg are white to almost white, round, flat tablets with beveled edges, marked with '5' on one face and smooth on the other face.

Donepezil Flas Stada 10 mg are white to almost white, round, flat tablets with beveled edges, marked with '10' on one face and smooth on the other face.

Packaging:

Blisters of 7, 10, or 14 tablets.

Package sizes:

10, 14, 28, 30, 56, 98, 126, 154, and 196 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Genepharm S.A

18th Km Marathonos Avenue,

153 51 Pallini Attikis

Greece

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Donepezilhydrochlorid AL 5/10 mg Schmelztabletten

Spain: Donepezilo Flas STADA 5/10 mg comprimidos bucodispersables EFG

Date of the last revision of thisleaflet:December 2022

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