Yasnal 5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Yasnal 5 mg film-coated tablets EFG

donepezil hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult 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 could 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.

Leaflet Contents

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

   1. Storage of Yasnal

5. Contents of the pack and other information

1. What Yasnal is and what it is used for

Yasnal (donepezil hydrochloride) contains the active substance donepezil hydrochloride. Yasnal (donepezil hydrochloride) belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil increases levels in the brain of a substance related to memory (acetylcholine) by slowing down its breakdown.

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

Yasnal is for use in adults only.

2. What you need to know before taking Yasnal

Do not take Yasnal

• 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 or pharmacist before starting Yasnal if you have or have had:

• stomach or duodenal ulcer,
• seizures or convulsions,
• any heart disease (such as irregular or very slow heartbeat, heart failure, myocardial infarction);
• a heart condition known as "QT interval prolongation" or a history of certain abnormal heart rhythms called Torsade 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 disease or hepatitis;
• difficulty urinating or mild kidney disease.

You should 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

Tell 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. This also includes medicines you might take in the future while continuing to take Yasnal. This is because these medicines could increase or decrease the effect of Yasnal.

It is especially 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, fluoxetine;
• medicines for psychosis, e.g., pimozide, sertindole, ziprasidone;
• medicines for bacterial infections, e.g., clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin;
• antifungal medicines, e.g., ketoconazole;
• other medicines for treating Alzheimer's disease, e.g., galantamine or rivastigmine;
• painkillers or arthritis treatments, e.g., aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac;
• anticholinergic medicines, e.g., tolterodine;
• anticonvulsants, e.g., phenytoin and carbamazepine;
• medicines for heart conditions, e.g., quinidine, beta-blockers (propranolol, atenolol);
• muscle relaxants, e.g., diazepam, succinylcholine;
• general anesthetics;
• over-the-counter medicines, e.g., some 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 may be used in patients with renal impairment or mild to moderate hepatic impairment. Inform your doctor if you have kidney or liver disease. Yasnal must not be used in patients with severe liver disease.

Inform your doctor or pharmacist of your caregiver's name. 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.

Yasnal should not be taken with alcohol, as alcohol may alter its effect.

Pregnancy, breast-feeding, and fertility

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

If you are breast-feeding, you should not take this medicine.

Driving and using machines

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

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

Yasnal contains lactose

If your doctor has informed 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 use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Amount of Yasnal you should take

The recommended starting dose is 5 mg (one white tablet) each night.

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

After one month of treatment, your doctor may increase your dose to one 10 mg tablet (one yellow tablet) each night.

Your dose may vary depending on how long you have been taking this 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 regarding how much and when to take your medicine. Do not change this dose without consulting your doctor.

How to take your medicine

Swallow your Yasnal tablet with a glass of water before going to bed.

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 any remaining tablets with you.

Symptoms of overdose may include nausea (feeling unwell) and vomiting, drooling, sweating, slow heartbeat, low blood pressure (mild headache or dizziness when standing up), difficulty breathing, fainting, and seizures.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 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 the missed dose.

If you forget to take your medicine for more than one week, contact your doctor before taking any further 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 decrease.

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

How long should you 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 with Yasnal.

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

Serious adverse effects:

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

• Liver damage, e.g. hepatitis. Symptoms of hepatitis include feeling or being unwell, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, dark urine (may affect up to 1 in 1,000 people).
• Stomach or duodenal ulcer. Symptoms of ulcer include stomach pain and discomfort (indigestion) between the breastbone and the navel (may affect up to 1 in 100 people).
• Bleeding from the stomach or intestine. This may cause black stools or visible rectal bleeding (may affect up to 1 in 100 people).
• Seizures (fits) (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, tenderness, or pain, particularly if occurring together with feeling unwell, high temperature, or dark urine. This may be caused by abnormal muscle breakdown which can be potentially life-threatening or 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 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

Other adverse effects

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

• Diarrhea
• Nausea
• Headache

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

• Muscle cramps
• Fatigue
• Difficulty sleeping (insomnia)
• Common cold
• Loss of appetite
• Hallucinations (seeing or hearing things that are not real)
• Unusual dreams including nightmares
• Restlessness
• Aggressive behaviour
• Dizziness
• Fainting
• Abdominal discomfort
• Rash
• Itching
• Urinary incontinence
• Pain
• Accidents (patients may be more prone to falls or accidents)

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

• Slowed heart rate
• Excessive salivation

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

• Tremor, stiffness or uncontrolled movements, particularly of the face and tongue, but also of other extremities

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

• Increased libido, hypersexuality
• Pisa syndrome (a condition involving involuntary muscle contractions with abnormal bending of the body and head to one side)

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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 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.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Yasnal

• The active substance is donepezil hydrochloride.

Each film-coated tablet contains 5 mg of donepezil hydrochloride (as monohydrate), equivalent to 4.56 mg of donepezil.

• The other components are: lactose monohydrate, microcrystalline cellulose, maize starch, hydroxypropylcellulose, and magnesium stearate in the tablet core; titanium dioxide (E171), hypromellose 5 cp and macrogol 400 in the film coating.

See section 2 “Yasnal contains lactose”.

Nature of the product and contents of the pack

The 5 mg film-coated tablets are white or almost white, round, biconvex, with an approximate diameter of 7 mm.

Yasnal 5 mg is available in packs containing:

• 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 or 100 film-coated tablets.
• 250 film-coated tablets in a plastic bottle with a tamper-evident screw cap.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

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

Manufacturer:

KRKA, d.d., novo mesto, Smarjeska cesta 6 - Novo mesto - 8501 - Slovenia

OR

TAD Pharma GmbH, Heinz Lohmann strasse, 5 - Groden Cuxhaven - D-27472 - Germany

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

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

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

Date of the last revision of this leaflet: December 2022

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)