YASNAL 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Yasnal10mg orodispersible tablets EFG

Donepezil hydrochloride

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Yasnal and what is it used for
2. What you need to know before taking Yasnal
3. How to take Yasnal
4. Possible side effects

5 Storage of Yasnal

1. Contents of the pack and further information

1. What is Yasnal and what is it 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 for the symptomatic treatment of mild or moderately severe Alzheimer's disease. The symptoms include increased memory loss, confusion, and behavioral changes. As a result, people with Alzheimer's disease have increasing difficulty performing their normal 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 ingredients 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 called torsades de pointes, or if a family member 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;

Talk to your doctor if you are pregnant or think you may be pregnant.

Children and adolescents

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

Other medicines and Yasnal

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

Also, inform your doctor or pharmacist in the future about any medicines you may take if you continue to be treated with Yasnal. This is because these medicines may weaken or enhance the effect of Yasnal.

In particular, it is important to 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, such as galantamine.
• analgesics or treatments for arthritis, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or diclofenac sodium.
• anticholinergic medicines, such as tolterodine.
• anticonvulsants, such as phenytoin, carbamazepine.
• medicines for heart diseases, such as quinidine, beta-blockers (propranolol and atenolol).
• muscle relaxants, such as diazepam, succinylcholine.
• general anesthesia.
• over-the-counter medicines, such as herbal remedies.

If you are going to undergo surgery that requires general anesthesia, you must inform your doctor and anesthesiologist that you are taking Yasnal. The reason is that this medicine may affect the amount of anesthesia needed.

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

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

Taking Yasnal with food, drinks, and alcohol

Food does not affect the effect of Yasnal.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask 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 use machines, so you should not perform 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 symptoms, you should not drive or use machines.

• Yasnal contains:Aspartame (E951)

This medicine contains 0.75 mg of aspartame in each tablet.

Aspartame is a source of phenylalanine, which may be harmful in people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

• Glucose (dextrose) and sucrose

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

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

3. How to take Yasnal

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Amount of Yasnal to take

Initially, the recommended dose is 5 mg each night before bedtime.

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

After a month, your doctor may prescribe 10 mg each night before bedtime.

The dose of the tablet you will take may change depending on the length of time 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 your medicine.

Do not change the dose yourself without your doctor's advice.

How to take your medicine

Yasnal orodispersible tablets are fragile. They should not be pressed through the aluminum 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 follows:

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

Within a few seconds, the tablet will start to disintegrate in the mouth and can be swallowed with or without water. The mouth should be empty before placing the tablet on the 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 emergency department of the nearest hospital immediately if you take more medicine than you should. Bring this package leaflet and your tablets with you.

Symptoms of overdose may include nausea (feeling sick) and vomiting, drooling, sweating, slow heart rate, low blood pressure (dizziness or fainting when standing up), breathing problems, loss of consciousness, and convulsions (seizures).

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone 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 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 a week, call your doctor before taking any more tablets.

If you stop taking Yasnal

Do not stop taking the tablets unless your doctor tells you to. 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 to take Yasnal

Your doctor or pharmacist will advise you how long to 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported by people taking Yasnal.

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

Serious side effects

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

• liver damage, for example, hepatitis. The symptoms of hepatitis are nausea, vomiting, loss of appetite, feeling unwell, fever, itching, yellowing of the skin and eyes, and dark-colored urine (may affect up to 1 in 1,000 people);
• gastric or duodenal ulcers. The symptoms of ulcers are stomach pain, feeling sick between the navel and the ribs (indigestion) (may affect up to 1 in 100 people);
• bleeding in the stomach or intestine. This can cause black stools (like tar) or visible blood from the rectum (may affect up to 1 in 100 people);
• seizures or convulsions (may affect up to 1 in 100 people).
• fever with muscle stiffness, sweating, or decreased level of consciousness (a disorder called "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people).
• muscle weakness, sensitivity, or pain, especially if you also feel unwell, have a fever, or have dark-colored urine. These can be caused by an abnormal muscle breakdown that can be potentially fatal and cause 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) called "prolongation of the QT interval"
• fast and irregular heartbeat, fainting that can be symptoms of a potentially fatal disorder known as torsades de pointes

Other side effects:

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

• diarrhea
• headache.

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

• muscle cramp
• fatigue
• difficulty sleeping (insomnia)
• common cold
• hallucinations (seeing or hearing things that do not really exist)
• abnormal dreams, including nightmares;
• agitation
• aggressive behavior
• 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):

• slow heart rate
• excessive salivation

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

• stiffness, tremor, or uncontrolled movement, especially of the face and tongue, but also of the limbs (extrapyramidal symptoms)

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

• increased libido
• 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 package leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: www.notificaram.es. By reporting side 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 that appears on the packaging after EXP. The expiry date is the last day of the month indicated.

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

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

6. Contents of the pack and further information

Composition ofYasnal:

• The active substance is donepezil hydrochloride. Each orodispersible tablet contains 10.43 mg of donepezil hydrochloride monohydrate, equivalent to 10 mg of donepezil hydrochloride.
• The other ingredients are mannitol (E421), microcrystalline cellulose, low-substituted hydroxypropylcellulose, banana flavor (maltodextrin, dextrose, sucrose, gum arabic), aspartame (E951), calcium silicate, and magnesium stearate.

Appearance of Yasnal and contents of the pack

White and round orodispersible tablets with a beveled edge.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

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

Date of the last revision of this package leaflet:December 2022

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