Yasnal 5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Yasnal 5 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 other people even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Yasnal is and what it is used for

Yasnal contains the active substance donepezil hydrochloride. Yasnal (donepezil hydrochloride) 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.

Yasnal is used to treat the symptoms of dementia in people who have been diagnosed with mild to moderately severe Alzheimer's disease. The symptoms include increasing memory loss, confusion, and changes in behaviour. As a result, people with Alzheimer's disease have increasing difficulty performing their usual daily activities.

Yasnal is only used in adult patients.

2. What you need to know before taking Yasnal

Do not take Yasnal:

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Yasnal if you have or have had:

• Gastric 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 known as torsade de pointes, or if anyone in your family has "prolongation of the QT interval";
• Low levels of magnesium or potassium in the blood;
• Asthma or any lung disease;
• Liver problems or hepatitis;
• Difficulty urinating or mild kidney disease.

Also consult your doctor if you are pregnant or think you might be pregnant.

Children and adolescents

The use of Yasnal is not recommended in children and adolescents (under 18 years of age).

Other medicines and Yasnal

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Also inform them in the future about any medicines you may take while continuing treatment with Yasnal. This is because these medicines may weaken or intensify the effect of Yasnal.

In particular, it is important that you inform your doctor if you are taking any of the following medicines:

• Medicines for heart rhythm problems (e.g., amiodarone, sotalol);
• Medicines for depression (e.g., citalopram, escitalopram, amitriptyline);
• Medicines for psychosis (e.g., pimozide, sertindole, ziprasidone);
• Medicines for bacterial infections (such as clarithromycin, erythromycin, levofloxacin, moxifloxacin);
• Antifungal medicines, e.g., ketoconazole;
• Other medicines for treating Alzheimer's disease, for example galantamine;
• Painkillers or treatments for arthritis, 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;
• Medicines for heart diseases, for example: quinidine, beta-blockers (propranolol and atenolol);
• Muscle relaxants, for example: diazepam, succinylcholine;
• General anesthesia;
• Medicines obtained without a prescription, such as herbal remedies.

If you are scheduled for surgery requiring general anesthesia, you must inform your doctor and anesthesiologist that you are taking Yasnal. This is because this medicine may affect the amount of anesthesia required.

Yasnal can be used in patients with renal disease or with mild or moderate hepatic disease. Inform your doctor if you have renal or hepatic disease. Patients with severe hepatic disease should not take Yasnal.

Inform your doctor or pharmacist of the name of your caregiver. This person will help you take the medication as prescribed.

Taking Yasnal with food, drinks, and alcohol

Food does not affect the action of Yasnal.

Do not drink alcohol during treatment with Yasnal, as it may reduce its effectiveness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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

Alzheimer's disease may affect your ability to drive or operate machinery, so you should not perform these activities unless your doctor tells you it is safe to do so.

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

• Yasnal contains: Aspartame (E951)

This medicine contains 0.75 mg of aspartame per 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 properly eliminate it.

• Glucose (dextrose) and sucrose

This medicine contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Yasnal

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

Amount of Yasnal you should take

Initially, the recommended dose is 5 mg each night before going to bed.

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

After one month, your doctor may prescribe 10 mg each night before going to bed.

The dose of the tablet you take may change depending on how long you have been taking the medicine and on your doctor's advice. The maximum recommended dose is 10 mg each night.

Always follow your doctor’s or pharmacist’s advice on how and when to take your medicine.

Do not change the dose yourself without consulting your doctor.

How to take your medicine

Yasnal orodispersible tablets are fragile. Do not push the tablet through the aluminium foil of the blister pack, as this may damage the tablet. Do not handle the tablets with wet hands, as they may disintegrate. Remove a tablet from the blister pack as detailed below:

1. Hold the blister by the edges and separate one of the cells from the rest of the blister by gently tearing along the perforated line surrounding the cell.
2. Pull the edge of the foil until it is completely separated.
3. Let the tablet drop into your hand.
4. Place the tablet on your tongue as soon as it has been removed from its packaging.

Within a few seconds, the tablet will begin to disintegrate in the mouth and can be swallowed with or without water. Your mouth should be empty before placing the tablet on your tongue.

Use in children and adolescents

Yasnal is not recommended for use in children and adolescents (under 18 years of age).

If you take more Yasnal than you should

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

Symptoms of overdose may include nausea (feeling unwell) and vomiting (sickness), drooling, sweating, decreased heart rate, low blood pressure (dizziness or lightheadedness upon standing), breathing difficulties, loss of consciousness, and seizures (fits).

In case of overdose or accidental ingestion, contact your doctor or pharmacist or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Yasnal

If you forget to take your medicine, take the next dose at your 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, call your doctor before taking any further tablets.

If you stop taking Yasnal

Do not stop taking the tablets unless instructed to do so by your doctor. If you stop taking Yasnal, the benefits of treatment will gradually be lost.

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

How long you should take Yasnal

Your doctor or pharmacist will advise you on how long you should continue taking the tablets.

You will need to see 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 will experience them.

The following adverse effects have been reported in people taking Yasnal.

Tell your doctor if you experience any of these effects while taking Yasnal.

Serious adverse effects

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

• Liver damage, for example, hepatitis. Symptoms of hepatitis include nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), and dark-coloured urine (may affect up to 1 in 1,000 people);
• Gastric or duodenal ulcers. Symptoms of ulcers include stomach pain and discomfort between the navel and the ribs (indigestion) (may affect up to 1 in 100 people);
• Bleeding in the stomach or intestine. This may cause black, tar-like stools or visible rectal bleeding (may affect up to 1 in 100 people);
• Seizures or fits (may affect up to 1 in 100 people);
• Fever with muscle rigidity, sweating, or decreased level of consciousness (a disorder known as "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people);
• Muscle weakness, sensitivity, or pain, especially if accompanied by feeling unwell, fever, or dark urine. These may be caused by abnormal muscle breakdown, which can be potentially life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 people).

Frequency not known:

• Changes in heart activity that can 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

Other adverse effects:

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

• Diarrhoea
• Headache

Common (may affect up to 1 in 10 people):

• Muscle cramps
• Fatigue
• Difficulty sleeping (insomnia)
• Common cold
• Hallucinations (seeing or hearing things that are not really there)
• Abnormal dreams, including nightmares
• Restlessness
• Aggressive behaviour
• Fainting
• Dizziness
• Abdominal discomfort
• Rash
• Urinary incontinence
• Pain
• Accidents (patients may be more prone to falls or accidental injuries)

Uncommon (may affect up to 1 in 100 people):

• Slowed heart rate
• Increased salivation

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

• Stiffness, tremor, or uncontrolled movements, particularly of the face and tongue, but also of the limbs (extrapyramidal symptoms)

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

• Increased libido
• 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 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 Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Yasnal

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 packaging after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect it from moisture. This medicine does not require any special storage temperature.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Yasnal

• The active substance is donepezil hydrochloride. Each orodispersible tablet contains 5.22 mg of donepezil hydrochloride monohydrate, equivalent to 5 mg of donepezil hydrochloride.
• The other components are mannitol (E421), microcrystalline cellulose, low-substituted hydroxypropyl cellulose, banana flavour (maltodextrin, dextrose, sucrose, gum arabic), aspartame (E951), calcium silicate and magnesium stearate.

Appearance of the medicine and contents of the pack

White, round orodispersible tablets with bevelled edges.

The tablets are available in packs of 10, 28, 30, 50, 56, 60, 84, 90, 98 and 100 orodispersible tablets in blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

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

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