YASNAL 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Yasnal 5 mg Film-Coated Tablets EFG

Donepezil Hydrochloride

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

• Keep this package leaflet, as 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 symptoms 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 you take Yasnal
3. How to take Yasnal
4. Possible side effects
   1. Storage of Yasnal

1. Contents of the pack and further information

1. What is Yasnal and what is it 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 the levels in the brain of a substance related to memory (acetylcholine) by reducing the speed of breakdown of this substance.

It is used for the treatment of the symptoms of dementia in people 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 disease find it increasingly difficult to carry out their normal daily activities.

Yasnal is used only in adults.

2. What you need to know before you take 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 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 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

Talk to your doctor if you are pregnant or think you might 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. This also includes medicines that you might take in the future if you continue to take Yasnal. The reason is that these medicines may increase or decrease the effect of Yasnal.

Especially, it is important to tell 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
• analgesics or treatments for arthritis, e.g., aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium
• anticholinergic medicines, e.g., tolterodine
• anticonvulsants, e.g., phenytoin and carbamazepine
• medicines for treating heart diseases, e.g., quinidine, beta blockers (propranolol, atenolol)
• muscle relaxants, e.g., diazepam, succinylcholine
• general anesthetics
• over-the-counter medicines, e.g., some herbal medicines.

If you are going to have 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. Tell 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.

Yasnal should not be taken with alcohol because alcohol may change 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 Using Machines

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

Additionally, this medicine may cause tiredness, drowsiness, and muscle cramps. If you experience any of these effects, do not drive or use machines.

Yasnal Contains Lactose

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

3. How to Take Yasnal

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

How Much Yasnal Should You 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 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.

The dose you take may vary depending on how long you have been taking this 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 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. Bring this package leaflet and any remaining tablets with you.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

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 the forgotten dose.

If you forget to take your medicine for more than one 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 the treatment will gradually decrease.

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 with Yasnal.

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

Serious Side Effects:

If you notice any of these serious side effects, tell your doctor immediately. You may need urgent medical treatment.

• liver damage, e.g., hepatitis. Symptoms of hepatitis are feeling or being sick, loss of appetite, general feeling of being unwell, 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 an ulcer are stomach pain and discomfort (indigestion) between the breastbone and the navel (may affect up to 1 in 100 people).
• bleeding from the stomach or intestines. This can cause black stools or visible blood in 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 called "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people).
• muscle weakness, tenderness, or pain, and particularly if these occur at the same time, if you feel unwell, have a high temperature, or dark urine. This can be caused by an abnormal muscle breakdown that 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 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 life-threatening disorder known as Torsade de Pointes

Other Side Effects

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

• diarrhea
• nausea
• headache

Common side 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 there)
• unusual dreams, including nightmares
• agitation
• aggressive behavior
• dizziness
• fainting
• abdominal upset
• 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):

• slow heart rate
• excessive salivation

Rare side 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 the 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 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 to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

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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 stated.

This medicine does not require any special storage precautions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. 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 hydrochloride (as monohydrate) of donepezil, equivalent to 4.56 mg of donepezil.

• The other ingredients are: lactose monohydrate, microcrystalline cellulose, maize starch, hydroxypropylcellulose, magnesium stearate in the tablet core, 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 Pack Size

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

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 screw cap and child-resistant closure.

Not all 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, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

or

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

You can request more information about this medicine from 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 Area and in the United Kingdom (Northern Ireland) under the following names:

Date of 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 Healthcare Products (AEMPS) (http://www.aemps.gob.es/)