Yasnal 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Yasnal 10 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. 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 effects, talk to your doctor or pharmacist, even if they are adverse effects 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 adverse effects

   1. How to store 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 involved in memory (acetylcholine), by slowing down the breakdown of this substance.

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 disease 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

Consult your doctor or pharmacist before taking Yasnal if you have or have had:

• stomach or duodenal ulcer,
• seizures or convulsions,
• any heart disease (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 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. The reason is that these medicines could increase or decrease the effect of Yasnal.

It is especially 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, 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 anaesthetics,
• over-the-counter medicines, e.g., some herbal remedies.

If you are scheduled for surgery requiring general anaesthesia, you must inform your doctor and anaesthetist that you are taking Yasnal. The reason is that this medicine may affect the amount of anaesthesia required.

Yasnal can be used in patients with renal disease or mild to moderate hepatic impairment. 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

Food does not affect the effect of Yasnal.

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

If you are breastfeeding, you should not take this medicine.

Driving and use of machines

Alzheimer's disease can impair your ability to drive or operate machinery, and you should not engage in 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 instructions regarding how much and when to take your medication. 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

The use of Yasnal is not recommended 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 do so. 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 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 with Yasnal.

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

Serious adverse effects:

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

• Liver damage, e.g. hepatitis. Symptoms of hepatitis include feeling or being sick, 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 sternum and the navel (may affect up to 1 in 100 people).
• Bleeding from the stomach or intestine. This may cause black stools or visible blood from the rectum (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 known as “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
• Feeling sick (nausea)
• Headaches

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

• Muscle cramps
• Tiredness
• Difficulty sleeping (insomnia)
• Common cold
• Loss of appetite
• Hallucinations (seeing or hearing things that are not really there)
• 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):

• Slowing of the heartbeat
• Increased 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 limbs

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

• Increased libido, hypersexuality
• Pisa syndrome (a condition involving involuntary muscle contraction with abnormal flexion 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 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 stated on the packaging after “EXP”. The expiry date is the last day of the month indicated.

This medicine requires no special storage precautions.

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

6. Contents of the pack and other information

Composition of Yasnal

• The active substance is donepezil hydrochloride.

Each film-coated tablet contains 10 mg of donepezil hydrochloride (as monohydrate), equivalent to 9.12 mg of donepezil.

• The other components are: lactose monohydrate, microcrystalline cellulose, corn starch, hydroxypropylcellulose, and magnesium stearate in the tablet core; and titanium dioxide (E171), hypromellose 5 cp, macrogol 400, and yellow iron oxide (E172) in the film coating.

See section 2 "Yasnal contains lactose".

Appearance of the product and contents of the pack

The 10 mg film-coated tablets are yellowish-brown, round, biconvex, with a diameter of approximately 9 mm.

Yasnal 10 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-proof screw cap.

Only certain pack sizes may be marketed.

Marketing Authorization Holder:

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

Manufacturer:

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

Or

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

You can request further information about this medicinal product from the local representative of the Marketing Authorization Holder:

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

This medicinal product is authorized in the European Economic Area member states and in the United Kingdom (Northern Ireland) under the following names:

Date of last review of this leaflet: December 2022

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