Patient Information Leaflet: Yasnal 5 mg Film-Coated Tablets

Hydrochloride of Donepezil

Read this 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, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as 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 Yasnal is and what it is used for

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

3.How to take Yasnal

4.Possible side effects

1. Storage of Yasnal

6.Contents of the pack and additional information

Yasnal (donepezil hydrochloride) contains the active ingredient donepezil hydrochloride. Yasnal (donepezil hydrochloride) belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil increases the levels in the brain of a substance related to memory (acetylcholine), by reducing the rate of breakdown of this substance.

It is used for the treatment of 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 behavior. As a result, patients with Alzheimer's find it increasingly difficult to carry out their normal daily activities.

Yasnal is used only in adults.

Do not take Yasnal

• if you are allergic to donepezil hydrochloride, piperidine derivatives, or 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
• 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 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 other chronic lung disease
• liver disease 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 medications obtained without a prescription. Also, include medications you may take in the future while continuing to take Yasnal. The reason is that these medications may increase or decrease the effect of Yasnal.

Especially, it is essential to 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, fluoxetine
• medications for psychosis, e.g., pimozide, sertindole, ziprasidone

• medications for bacterial infections, e.g., clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin

• antifungal medications, e.g., ketoconazole

• other medications for treating Alzheimer's disease, e.g., galantamine or rivastigmine
• analgesics or arthritis treatments, e.g., aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium
• anticholinergic medications, e.g., tolterodine
• anticonvulsants, e.g., phenytoin and carbamazepine
• medications for heart disease, e.g., quinidine, beta blockers (propranolol, atenolol)
• muscle relaxants, e.g., diazepam, succinylcholine
• general anesthetics
• over-the-counter medications, e.g., some 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. The reason is that 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.

Yasnal with food, drinks, and alcohol

Food does not affect the effect of Yasnal.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

If you are breastfeeding, do not take this medication.

Driving and operating machinery

Alzheimer's disease may affect your ability to drive or operate machinery and should not engage in these activities unless your doctor indicates it is safe to do so.

Additionally, this medication may cause fatigue, drowsiness, and muscle cramps. If you experience any of these effects, do not drive or operate machinery.

Yasnal contains lactose

If your doctor has indicated 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 recommended initial dose is 5 mg (one white tablet) each night.

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

After a 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 the time you have been taking this 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 much and when to take your medication. Do not alter this dose without consulting your doctor.

How to take your medication

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 old).

If you take more Yasnal than you should

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

The symptoms of overdose may include nausea (feeling unwell) and vomiting (illness), drooling, sweating, slow heart rate, decreased blood pressure (mild headache or dizziness when standing up), difficulty breathing, fainting, and convulsions.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forgot 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 dose.

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 tells you to. If you stop taking Yasnal, the benefits of treatment will gradually decrease.

If you have any other questions about the use of this medication, 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 evaluate your symptoms.

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

The following side effects have been reported with Yasnal.

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

Severe side effects:

If you observe any of the severe side effects, inform your doctor immediately. You may need urgent medical treatment.

• Liver damage, for example, hepatitis. The symptoms of hepatitis are feeling or being sick, loss of appetite, general discomfort, fever, itching, yellowing of the skin and eyes, dark urine (may affect up to 1 in 1,000 people).
• Stomach or duodenal ulcer.The symptoms of ulcers are stomach pain and discomfort (indigestion) between the sternum and navel (may affect up to 1 in 100 people).
• Stomach or intestinal bleeding.This may cause black stools or visible blood in the rectum (may affect up to 1 in 100 people).
• Seizures (attacks) (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, and particularly, if you experience any of these symptoms at the same time, if you feel unwell, have a high temperature, or dark urine. This may be caused by an abnormal muscle rupture that may be potentially fatal or lead to kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 people).

Unknown frequency

• Changes in heart activity that can be observed in an electrocardiogram (ECG) called "prolongation of the QT interval"
• Fast and irregular heartbeat, fainting, which may be symptoms of a potentially fatal disorder known as Torsade de Pointes

Other side effects

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

• Diarrhea
• Uncomfortable feeling (nauseas)
• Headaches

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

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

Uncommon side effects(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):

• Trembling, stiffness, or uncontrolled movements, particularly of the face and tongue, but also of other limbs

Unknown frequency (cannot be estimated from available data):

• Increased libido, hypersexuality
• 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 theSpanish 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.

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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.

This medication does not require special storage precautions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection 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 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, cornstarch, hydroxypropylcellulose, magnesium stearate in the core of the tablet and titanium dioxide (E171), hypromellose 5 cp and macrogol 400 in the film coating.

See section 2 “Yasnal contains lactose”.

Appearance of the product and contents of the pack

The film-coated tablets of 5 mg are white or off-white, round, biconvex, approximately 7 mm in diameter.

Yasnal 5mg 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 screw cap tamper-evident.

Please note that only some pack sizes may be marketed.

Marketing Authorisation Holder

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

Responsible for manufacturing:

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

Ó

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

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

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

This medicine is authorised in the member states of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

Last review date of this leaflet:December 2022

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