Aricept Flas 10 mg orodispersible tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Aricept Flas 10 mg orodispersible tablets

Donepezil hydrochloride

Read all of 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 pass it on 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 effects not listed in this leaflet.

Contents of this leaflet:

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

1. What Aricept Flas is and what it is used for

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

It is used to treat the symptoms of mild to moderately severe Alzheimer's disease. Symptoms include increasing memory loss, confusion, and changes in behaviour.

2. What you need to know before taking Aricept Flas

Do not take Aricept Flas:

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

Warnings and precautions

Talk to your doctor before starting Aricept Flas if you have or have had:

• a history of stomach or duodenal ulcer
• heart disease (such as irregular or very slow heartbeats, heart failure, myocardial infarction)
• a heart condition known as "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
• seizures
• asthma or chronic lung disease
• difficulty in passing urine or mild kidney disease

You should avoid taking Aricept Flas together with other acetylcholinesterase inhibitors and other cholinergic agonists or antagonists.

Taking Aricept Flas with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, especially if you are taking any of the following:

• medicines for heart rhythm problems, for example amiodarone or sotalol
• medicines for depression, for example citalopram, escitalopram, amitriptiline, 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 treating Alzheimer's disease, for example galantamine
• painkillers or treatments for arthritis such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or sodium diclofenac
• quinidine and beta-blocking medicines for treating irregular heartbeats, such as propranolol and atenolol
• phenytoin and carbamazepine (for treating epilepsy)
• cholinergic agonists and medicines with anticholinergic activity (acting on the central nervous system) such as tolterodine
• succinylcholine, diazepam and other neuromuscular blockers (to produce muscle relaxation)
• general anaesthesia

If you are undergoing surgery under general anaesthesia, you must inform your doctor that you are taking Aricept Flas, as this may affect the amount of anaesthetic required.

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

Taking Aricept Flas with food, drinks and alcohol

Place the tablet on the tongue and allow it to dissolve. Swallow with or without water.

Aricept Flas must not be taken with alcohol, as alcohol may alter the effect of this medicine.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not take Aricept Flas if you are breast-feeding your child.

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 has advised you that it is safe to do so. Aricept Flas may cause fatigue, dizziness, somnolence, and muscle cramps, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you should not drive or operate machinery.

3. How to take Aricept Flas

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Aricept Flas is administered orally. The tablet should be placed on the tongue and allowed to dissolve before swallowing it, with or without water.

Treatment with Aricept Flas is initiated with one 5 mg tablet taken once daily at night, immediately before going to bed. After one month of treatment, your doctor may instruct you to increase the dose to 10 mg once daily at night. The maximum recommended dose is 10 mg per day.

If you experience abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend that you take Aricept Flas in the morning.

If you have mild or moderate hepatic impairment (liver disease) or renal impairment (kidney disease), you may take Aricept Flas. Inform your doctor before starting treatment if you have liver or kidney problems. Patients with severe hepatic impairment (liver disease) must not take Aricept Flas.

Use in children

The use of Aricept Flas is not recommended in children.

If you take more Aricept Flas than you should

If you have taken more Aricept Flas than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount taken.

Symptoms of overdose may include nausea (feeling sick), vomiting (being sick), salivation, sweating, slowed heart rate, low blood pressure (dizziness or lightheadedness upon standing), breathing difficulties, loss of consciousness, and seizures.

If you forget to take Aricept Flas

Do not take a double dose to make up for forgotten doses.

If you stop taking Aricept Flas

Do not stop treatment with Aricept Flas unless instructed by your doctor. If you stop taking Aricept Flas, the benefits of treatment will gradually disappear.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

The following adverse effects have been reported by people taking Aricept.

Contact your doctor if you experience any of these effects during treatment with Aricept.

Serious adverse effects:

You must inform your doctor immediately if you notice any of the following serious adverse effects, as you may require urgent medical treatment.

• Liver damage, for example, hepatitis. Symptoms of hepatitis include nausea or vomiting (feeling sick or being sick), loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), and dark-coloured urine (occurs in 1 to 10 out of 10,000 people).
• Stomach or duodenal ulcers. Symptoms of ulcers include stomach pain and discomfort (indigestion) between the navel and the sternum (occurs in 1 to 10 out of 1,000 people).
• Bleeding in the stomach or intestine. This may cause black, tarry stools or visible rectal bleeding (occurs in 1 to 10 out of 1,000 people).
• Dizziness (syncope) or seizures (occurs in 1 to 10 out of 1,000 people).
• Fever with muscle rigidity, reduced sweating, and decreased level of consciousness (may be symptoms of a condition known as "Neuroleptic Malignant Syndrome") (occurs in less than 1 out of 10,000 patients).
• Weakness, tenderness, or muscle 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).

The estimated frequency of occurrence of adverse effects is as follows:

Very common: may affect more than 1 in 10 patients

• Diarrhoea
• Malaise
• Headache

Common: may affect between 1 and 10 in 100 patients

• Cold
• Loss of appetite
• Hallucinations
• Agitation
• Aggressive behaviour
• Abnormal dreams and nightmares
• Fainting
• Dizziness
• Difficulty sleeping
• Vomiting
• Abdominal discomfort
• Urinary incontinence
• Rash
• Itching
• Muscle cramps
• Fatigue
• Pain
• Accidents (patients may be more prone to falls and accidental injuries)

Uncommon: may affect between 1 and 10 in 1,000 patients

• Seizures
• Slowing of the heart rate (bradycardia)
• Gastrointestinal haemorrhage, stomach and duodenal ulcers (a part of the intestine)
• Increase in a type of enzyme (muscle creatine kinase) in the blood

Rare: may affect between 1 and 10 in 10,000 patients

• Extrapyramidal symptoms (such as tremor or stiffness of the hands or legs)
• Cardiac conduction disorders
• Impaired liver function, including hepatitis

Frequency not known (cannot be estimated from available data)

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products, Website: www.notificaRAM.es.

5. Storage of Aricept Flas

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use Aricept Flas after the expiry date stated on the carton. 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 unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aricept Flas 10 mg orodispersible tablets

• The active substance is donepezil hydrochloride. Each tablet contains 10 mg of donepezil hydrochloride.
• The other components are: mannitol, anhydrous colloidal silica, carrageenan k, polyvinyl alcohol, and yellow iron oxide (E172).

Appearance of the product and contents of the pack

• Aricept Flas 10 mg is presented as orodispersible tablets, i.e., tablets that dissolve in the mouth. The tablets are round, yellow in colour, and marked with “10” on one side and “ARICEPT” on the other.

Aricept Flas 10 mg orodispersible tablets are available in a single-dose blister pack made of PVC/PVdC/PE/PVdC/PVC with an aluminium backing foil, containing 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Eisai GmbH

Edmund-Rumpler-Straße 3

60549 Frankfurt am Main

Germany

Manufacturer:

Fareva Amboise

Zone Industrielle

29 route des Industries

37530 Pocé-sur-Cisse

France

or

Eisai GmbH

Edmund-Rumpler-Straße 3

60549 Frankfurt am Main

Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Eisai Farmacéutica, S.A.

Parque Empresarial Cristalia

Calle Via de los Poblados 3, Edif. 7/8

4th floor

28033 Madrid

Tel: + (34) 91 455 94 55

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

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