Donepezil Flas Stada 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Donepezilo Flas Stada 5 mg orodispersible tablets EFG

Donepezilo Flas Stada 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 you should not give it to others, even if they have the same symptoms as you, because 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. See section 4.

Contents of the leaflet

1. What Donepezilo Flas Stada is and what it is used for
2. What you need to know before taking Donepezilo Flas Stada
3. How to take Donepezilo Flas Stada
4. Possible side effects
5. How to store Donepezilo Flas Stada
6. Contents of the pack and other 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 levels in the brain of a substance involved in memory (acetylcholine), by slowing down the breakdown of this substance.

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

Donepezil is for use in adult patients only.

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

Do NOT take Donepezilo Flas Stada:

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Donepezilo Flas Stada, especially if you have or have had:

• • stomach or duodenal ulcers
• a spasm (attack) or seizure
• heart disease (such as irregular or very slow heartbeat, heart failure, myocardial infarction)
• a heart condition called “QT interval prolongation” or a history of certain abnormal heart rhythms known as Torsades de Pointes, or if anyone in your family has “QT interval prolongation”
• low levels of magnesium or potassium in the blood
• asthma or another chronic 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

Donepezil is not indicated for use in children and adolescents (young people over 18 years of age).

Other medicines and Donepezilo Flas Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This also includes medicines not prescribed by your doctor but which you have purchased from a pharmacy. It also applies to medicines you may take in the future while continuing to take donepezil. This is because these medicines could weaken or strengthen the effects of donepezil.

It is particularly important to inform 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 sodium diclofenac

• anticholinergic medicines, e.g., tolterodine

• anticonvulsants (medicines used to prevent various types of seizures), e.g., phenytoin, carbamazepine

• medicines for heart conditions, e.g., quinidine, beta-blockers (propranolol and atenolol)

• muscle relaxants, e.g., diazepam, succinylcholine

• general anaesthesia

• over-the-counter medicines, e.g., herbal remedies

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

Donepezil 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 donepezil.

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

Donepezilo Flas Stada with food, drinks and alcohol

Food does not influence the effect of this medicine. Donepezil should not be taken with alcohol, as alcohol may alter 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 impair 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.

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

Donepezilo Flas Stada contains aspartame, lactose and sodium

Aspartame

Donepezilo Flas Stada 5 mg

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

Donepezilo Flas Stada 10 mg

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

Aspartame contains a source of phenylalanine which 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 informed you that you have an intolerance to certain sugars, consult with him 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 Donepezilo Flas Stada

How much donepezil should you take?

Always follow exactly your doctor’s or pharmacist’s instructions for taking this medicine. Consult your doctor or pharmacist if you have any doubts.

Usually, you will start by taking 5 mg once daily at bedtime. After one month, your doctor may instruct you to take 10 mg every night before going to bed.

If you experience 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 on your doctor’s recommendation.

The maximum recommended dose is 10 mg once daily at bedtime.

Always follow your doctor’s or pharmacist’s advice 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 use in children and adolescents (under 18 years of age).

If you take more Donepezilo 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 may include nausea or vomiting, excessive salivation, sweating, slow heart rate, low blood pressure (dizziness or lightheadedness when standing), breathing difficulties, loss of consciousness, and seizures or convulsions.

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

If you forget to take Donepezilo Flas Stada

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

If you have forgotten to take your medicine for more than one week, consult your doctor before taking any further doses.

If you stop taking Donepezilo Flas Stada

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

If you have any further questions about 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 taking your tablets. You will need to visit your doctor from time to time to review your treatment and assess your symptoms.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported by patients taking donepezil.

Inform your doctor if you experience any of these effects during treatment with donepezil.

Serious adverse effects:

You should inform your doctor immediately if you notice any of the serious adverse effects listed below. You may require urgent medical treatment.

• Liver disorders, e.g., hepatitis. Symptoms of hepatitis include nausea (feeling sick or being sick), vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), and dark-coloured urine (rare: may affect up to 1 in 1,000 people).
• Stomach or duodenal ulcers. Symptoms of ulcers include stomach pain and discomfort (indigestion) between the navel and the sternum (uncommon: may affect up to 1 in 100 people).
• Bleeding in the stomach or intestines. This may cause your stools to appear tarry or visible blood from the rectum (uncommon: may affect up to 1 in 100 people).
• Spasms (attacks) or seizures (uncommon: may affect up to 1 in 100 people).
• Fever with muscle rigidity, sweating, or decreased level of consciousness (a condition known as Neuroleptic Malignant Syndrome) (very rare: may affect up to 1 in 10,000 people).
• Muscle weakness, sensitivity, or pain, particularly if you also feel unwell, have a fever, or have dark-coloured urine. This may be due to abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 people).
• Fast and irregular heartbeat, fainting, which may be symptoms of a potentially life-threatening disorder known as Torsade de Pointes (frequency cannot be estimated from available data).

Other adverse effects

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

• Diarrhoea
• Nausea (feeling sick)
• Headaches

Common (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 behaviour
• Fainting
• Dizziness
• Vomiting (feeling sick)
• Feeling of stomach discomfort
• Rash
• Itching
• Urgent desire 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
• Increased salivation

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

• Stiffness, agitation, or uncontrollable movements, especially of the face and tongue, but also of the limbs

Not known (frequency cannot be estimated from available data)

• Changes in heart activity that may be seen on an electrocardiogram (ECG), known as "prolongation of the QT interval".
• Increased libido, hypersexuality
• Pisa syndrome (a condition involving involuntary muscle contractions with abnormal sideways bending of the body and head).

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Donepezil Flas Stada

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

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Store in the original packaging to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point in your pharmacy. 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 Donepezilo Flas Stada

• The active substance in Donepezilo Flas Stada is donepezil hydrochloride.

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

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

• The other components are:

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

Appearance of the product and contents of the container

Donepezilo Flas Stada 5 mg are white to almost white, round, flat tablets with bevelled edges, marked with the number '5' on one side and smooth on the other.

Donepezilo Flas Stada 10 mg are white to almost white, round, flat tablets with bevelled edges, marked with the number '10' on one side and smooth on the other.

Packaging:

Blister packs of 7, 10 or 14 tablets.

Pack sizes:

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

Only certain 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 medicinal product 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 orodispersible tablets EFG

Date of the most recent review of this leaflet: December 2022

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