Patient Information Leaflet

Yasnal 5 mg bucodispersable tablets EFG

Donepezil hydrochloride

Read 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 give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Yasnal and what is it used for

2.What you need to know before you start taking Yasnal

3.How to take Yasnal

4.Possible side effects

5.Storage of Yasnal

6.Contents of the pack and additional information

Yasnal contains the active substance hydrochloride of donepezil. Yasnal (hydrochloride of donepezil) belongs to a group of medications 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 treatment of symptoms of dementia in those who have been diagnosed with mild or moderately severe Alzheimer's disease.The symptoms include an increase in memory loss, confusion, and changes in behavior. As a result, Alzheimer's patients increasingly have difficulty carrying out their normal daily activities.

Yasnal is only used in adult patients.

Do not take Yasnal:

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

Warnings and precautions

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

• Stomach 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 torsade 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 any lung disease;
• Liver problems or hepatitis;
• Difficulty urinating or mild kidney disease;

Also, consult 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 medications and Yasnal

Inform your doctor or pharmacist if you are taking, have taken recently or may take any other medication, including those purchased without a prescription.

Also, inform your doctor or pharmacist in the future of any medications you may take while continuing to take Yasnal. This is because these medications may weaken or intensify the effect of Yasnal.

Particularly, inform your doctor if you are taking any of the following medications:

• Medications for heart rhythm problems (e.g., amiodarone, sotalol);
• Medications for depression (e.g., citalopram, escitalopram, amitriptyline);
• Medications for psychosis (e.g., pimozide, sertindole, ziprasidone);
• Medications for bacterial infections (e.g., clarithromycin, erythromycin, levofloxacin, moxifloxacin);
• Antifungal medications, for example: ketoconazole;
• Other medications for treating Alzheimer's disease, for example: galantamine.
• Pain relievers or treatments for arthritis, for example: aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium;
• Anticholinergic medications, for example: tolterodine;
• Anticonvulsants, for example: phenytoin, carbamazepine;
• Medications for heart disease, for example: quinidine, beta-blockers (propranolol and atenolol);
• Muscle relaxants, for example: diazepam, succinylcholine;
• General anesthesia;
• Over-the-counter medications, such as herbal remedies.

If you are to undergo a surgical procedure that requires general anesthesia, you must inform your doctor and anesthesiologist that you are taking Yasnal. This is because this medication may affect the amount of anesthesia needed.

Yasnal can be used in patients with kidney disease or mild to moderate liver disease. Inform your doctor if you have kidney or liver disease. Patients with severe liver 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

Foods do not affect the effect 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, or think you may be pregnant, ask your doctor or pharmacist before using this medication.

If you are breastfeeding, do not take this medication.

Driving and using machines

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

Additionally, this medication may cause fatigue, dizziness, and muscle cramps. If you experience any of these symptoms, do not drive or use machines.

• Yasnal contains:Aspartame (E951)

This medication contains 0.75 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly..

• Glucose (dextrose) and sucrose

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

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

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

Amount of Yasnal you should take

The initial recommended dose is 5 mg each night before going to bed.

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 going to bed.

The dose of the tablet you will take may change depending on the amount of time you have been taking the medication 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 medication.

Do not alter the dose yourself without consulting your doctor.

How to take your medication

The Yasnal buccal dispersible tablets are fragile. Do not press them through the aluminum foil of the blister, as this could damage the tablet. Do not handle the tablets with wet hands, as they may disintegrate. Remove a tablet from the blister as follows:

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 that delimits the cell.
2. Pull the edge of the foil until it is completely separated.
3. Let the tablet fall onto your hand.
4. Deposit the tablet on your tongue as soon as you have removed it from its packaging.

In a few seconds, the tablet will begin to disintegrate in the mouth and can be swallowed with or without water. The mouth must be empty before depositing the tablet on the tongue.

Use in children and adolescents

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

If you take more Yasnal than you should

Contact your doctor or the emergency department of the nearest hospital immediately if you take more medication than you should. Carry this leaflet and your tablets with you at all times.

The symptoms of overdose may include nausea (feeling unwell) and vomiting (sickness), drooling, sweating, decreased heart rate, low blood pressure (dizziness or dizziness when standing up), breathing difficulties, loss of consciousness, and seizures (attacks).

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 medication and the amount ingested.

If you forget to take Yasnal

If you forget to take your medication, take the next dose at your usual time.Do not take a double dose to compensate for the missed doses.

If you forget to take your medication for more than a week, call your doctor before taking any more tablets.

If you interrupt treatment with Yasnal

Do not stop taking the tablets unless your doctor has told you to. If you stop taking Yasnal, the benefits of treatment will be lost gradually.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

How long should you take Yasnal

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

You will need to see your doctor from time to time to review your treatment and evaluate your symptoms.

Like all medicines, this medicine can cause side effects, although not everyone will experience 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.

Severe side effects

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

• Liver damage, for example, hepatitis. The symptoms of hepatitis are nausea, vomiting, loss of appetite, general feeling of discomfort, fever, itching, yellowing of the skin and eyes, and dark-colored urine (may affect up to 1 in 1,000 people);
• Stomach ulcers or duodenal ulcers. The symptoms of ulcers are stomach pain, feeling of discomfort between the navel and ribs (indigestion) (may affect up to 1 in 100 people);
• Bleeding in the stomach or intestines. This can cause black, tar-like stools or visible blood from the rectum (may affect up to 1 in 100 people);
• Convulsions or seizures (may affect up to 1 in 100 people).
• Fever with muscle stiffness, sweating, or decreased level of consciousness (a condition called "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people).
• Muscle weakness, sensitivity, or pain, and especially if you feel unwell, have a fever, or dark-colored urine. They may be caused by an abnormal muscle rupture that can be potentially fatal and cause kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 people).

Unknown frequency

• Changes in heart activity that can be seen on an electrocardiogram (ECG) called "prolongation of the QT interval"
• Fast and irregular heartbeat, fainting, which may be symptoms of a potentially fatal condition known as torsade 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
• Tiredness
• Difficulty sleeping (insomnia)
• Common cold
• Hallucinations (seeing or hearing things that do not exist)
• Abnormal dreams, including nightmares;
• Restlessness
• Aggressive behavior
• Fainting
• Dizziness
• Abdominal discomfort
• Rash
• Urinary incontinence
• Pain
• Accidents (patients may be more prone to falls or accidental injuries).

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

• Decreased heart rate
• Excessive salivation

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

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

Unknown frequency (cannot be estimated from 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Yasnal

• The active ingredient is hydrochloride of donepezil. Each buccal dispersible tablet contains 5.22 mg of monohydrate hydrochloride of donepezil, equivalent to 5 mg of hydrochloride of donepezil.
• The other components are mannitol (E421), microcrystalline cellulose, hydroxypropylmethylcellulose, banana flavoring (maltodextrin, dextrose, sucrose, gum arabic), aspartame (E951), calcium silicate, and magnesium stearate.

Appearance of the product and contents of the packaging

White and round buccal dispersible tablets with a beveled edge.

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

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible manufacturer

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

For more information about this medication, please contact the local representative of the marketing authorization holder:

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

This medication is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Last review date of this leaflet: January 2022

For detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)