Iasnal

Package Leaflet: Information for the Patient

Yasnal, 5 mg, Film-Coated Tablets

Yasnal, 10 mg, Film-Coated Tablets

Donepezil Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication 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, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Yasnal and What is it Used For
• 2. Important Information Before Taking Yasnal
• 3. How to Take Yasnal
• 4. Possible Side Effects
• 5. How to Store Yasnal
• 6. Contents of the Pack and Other Information

1. What is Yasnal and What is it Used For

Yasnal contains the active substance donepezil hydrochloride, which belongs to a group of medications called acetylcholinesterase inhibitors.
Donepezil, by slowing down the breakdown of acetylcholine, an important substance for memory function, increases its concentration in the brain.
Yasnal is used for the symptomatic treatment of mild to moderate Alzheimer's disease. These symptoms may include increasing memory loss, disorientation, and changes in behavior.
Yasnal can be used by adult patients.

2. Important Information Before Taking Yasnal

When Not to Take Yasnal

• if you are allergic to donepezil hydrochloride, piperidine derivatives, or any of the other ingredients of this medication (listed in section 6).

Warnings and Precautions

Before starting to take Yasnal, you should discuss with your doctor or pharmacist if any of the following situations apply or have applied to you:

• stomach or duodenal ulcer;
• seizures;
• heart diseases (such as irregular or very slow heart rate, heart failure, heart attack, sick sinus syndrome, or atrioventricular conduction disorders (sinoatrial block, atrioventricular block));
• you have a heart condition called "prolonged QT interval" or have been diagnosed with a certain type of irregular heartbeat called torsades de pointesor have a family history of "prolonged QT interval";
• you have low levels of magnesium or potassium in the blood;
• asthma or other chronic lung diseases;
• liver diseases or hepatitis;
• urinary tract diseases (with difficulty urinating);

You should also inform your doctor if you are pregnant or think you may be pregnant.

Children and Adolescents

Yasnal is not indicated for use in children and adolescents (under 18 years of age).

Yasnal and Other Medications

Tell your doctor or pharmacist about all medications you are taking, have recently taken, or plan to take.
It is especially important to inform your doctor about taking any of the following medications:

• medications used to treat irregular heart rhythms, such as amiodarone, sotalol;
• medications used to treat depression, such as citalopram, escitalopram, amitriptyline, fluoxetine;
• antipsychotic medications, such as pimozide, sertindole, ziprasidone;
• medications used to treat bacterial infections, such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin;
• antifungal medications, such as ketoconazole or itraconazole;
• other medications used in Alzheimer's disease, such as galantamine,
• pain relievers or medications used for arthritis, such as acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or diclofenac,
• anticholinergic medications, such as tolterodine,
• antiepileptic medications, such as phenytoin, carbamazepine,
• medications used for heart diseases, such as quinidine, beta-blockers (propranolol and atenolol),
• muscle relaxants, such as tetrazepam, diazepam, succinylcholine,
• medications used for general anesthesia,
• over-the-counter medications, such as herbal remedies.

If you are going to have surgery that requires general anesthesia, tell your doctor that you are taking Yasnal. Yasnal may affect the amount of anesthetic needed.
Yasnal can be used in patients with kidney diseases and mild to moderate liver impairment. You should inform your doctor about kidney or liver diseases. Patients with severe liver impairment should not take Yasnal.
You should give your doctor or pharmacist the name of your caregiver. The caregiver will help you take the medication according to the doctor's instructions.

Taking Yasnal with Food, Drink, and Alcohol

Food does not affect the action of Yasnal.
Do not drink alcohol while taking Yasnal, as alcohol may change the effect of the medication.

Pregnancy, Breast-Feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medication.
Using Yasnal during pregnancy is contraindicated. Women taking Yasnal should not breast-feed.

Driving and Using Machines

Alzheimer's disease may impair your ability to drive or operate machines, so you should not perform these activities until your doctor has assessed that it is safe for you to do so.
Additionally, Yasnal may cause drowsiness, dizziness, and muscle cramps. If you experience any of these effects, do not drive or operate machines.

Yasnal Contains Lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking Yasnal.

3. How to Take Yasnal

Always take this medication exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Recommended Dose of Yasnal

The recommended initial dose is 5 mg, taken before bedtime.
If you experience unusual dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend taking Yasnal in the morning.
After one month, your doctor may increase the dose of Yasnal to 10 mg, taken before bedtime.
The dose of Yasnal used may change depending on the duration of treatment and your doctor's recommendations.
The maximum recommended daily dose is 10 mg. Do not change the dose without consulting your doctor.

How to Take the Medication

Swallow the tablet with water, in the evening before going to bed. If you experience unusual dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend taking Yasnal in the morning.

Use in Children and Adolescents

Yasnal is not recommended for use in children and adolescents under 18 years of age.

Use in Patients with Kidney or Liver Impairment

Patients with kidney impairment may use a similar dosing schedule as patients with normal kidney function.
In patients with mild to moderate liver impairment, dose increases should be made according to individual patient tolerance. There are no data on the use of Yasnal in patients with severe liver impairment.

Overdose of Yasnal

If you have taken more than the recommended dose of Yasnal, contact your doctor or go to the nearest hospital immediately. Bring this leaflet and the packaging of the medication with you.
Symptoms of overdose may include: severe nausea, vomiting, salivation, excessive sweating, bradycardia (slow heart rate), hypotension (low blood pressure), respiratory depression, and seizures. Progressive muscle weakness may also occur, which can lead to death in the event of respiratory muscle weakness. Depending on the symptoms, your doctor will provide appropriate treatment.

Missing a Dose of Yasnal

In this case, take the next dose at the scheduled time.
Do not take a double dose to make up for a missed dose.
If you have missed taking Yasnal for more than a week, consult your doctor before taking the medication again.

Stopping Yasnal Treatment

Do not stop taking Yasnal unless your doctor tells you to. After stopping the treatment, the benefits of the treatment will gradually disappear.
If you have any further questions about taking this medication, ask your doctor or pharmacist.

How Long to Take Yasnal

Your doctor or pharmacist will tell you how long to continue taking the medication. You should regularly visit your doctor to monitor the treatment and assess the symptoms.

4. Possible Side Effects

Like all medications, Yasnal can cause side effects, although not everybody gets them.
The following side effects have been reported in patients taking Yasnal.

If You Experience Any of the Following Side Effects, Contact Your Doctor.

Yasnal.

Severe side effects:
If you experience any of the following severe side effects, tell your doctor immediately. You may need urgent medical attention.

• liver dysfunction, including hepatitis. Symptoms of hepatitis are: nausea or vomiting, loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin and eyes, dark urine (frequency: rare, may occur in less than 1 in 1000 patients);
• stomach or duodenal ulcers. Symptoms of stomach ulcers are: stomach pain, discomfort in the upper abdomen (frequency: uncommon, may occur in less than 1 in 100 patients);
• gastrointestinal bleeding. May cause black stools or visible blood in the stool (frequency: uncommon);
• seizures or convulsions (frequency: uncommon, may occur in less than 1 in 100 patients);
• fever with muscle stiffness, sweating, or decreased consciousness (a condition called neuroleptic malignant syndrome) (frequency: very rare, may occur in less than 1 in 10,000 patients);
• weakness, tenderness, or muscle pain, especially if occurring together with feeling unwell, high fever, or dark urine. This may be caused by abnormal muscle breakdown, which can be life-threatening and lead to kidney dysfunction (a condition called rhabdomyolysis) (frequency: very rare).
• changes in heart function visible on the ECG as "prolonged QT interval" (frequency not known: cannot be estimated from the available data)
• rapid, irregular heartbeat, fainting, which may be symptoms of a condition called torsades de pointes, which can be life-threatening (frequency not known: cannot be estimated from the available data).

Other side effects include:
Very common side effects (may occur in more than 1 in 10 patients):

• diarrhea
• nausea
• headache

Common side effects (may occur in less than 1 in 10 patients):

• muscle cramps
• fatigue
• sleep disturbances (insomnia)
• cold
• loss of appetite
• hallucinations (delusions)
• unusual dreams and nightmares
• agitation
• aggressive behavior
• fainting
• dizziness
• gastrointestinal disturbances, vomiting
• rash
• itching
• urinary incontinence
• pain
• accidents (patients may be more prone to falls and accidental injuries)

Uncommon side effects (may occur in less than 1 in 100 patients):

• bradycardia (slow heart rate)
• mild increase in creatine kinase activity in the blood
• increased salivation

Rare side effects (may occur in less than 1 in 1000 patients):

• extrapyramidal symptoms (movement disorders due to nervous system disorders, such as: muscle stiffness, reduced facial expressions, slow movement, restlessness, involuntary muscle contractions and involuntary movements, especially of the face and tongue, but also of the hands and feet)
• sinoatrial block, atrioventricular block (heart function disorders)

Unknown frequency (cannot be estimated from the available data):

• increased libido, hypersexuality
• Tower of Pisa syndrome (characterized by involuntary muscle contraction with abnormal bending of the body and head to one side)

Reporting Side Effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Yasnal

Keep the medication out of sight and reach of children.
Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Yasnal Contains

• The active substance is donepezil hydrochloride. Each film-coated tablet contains 5 mg or 10 mg of donepezil hydrochloride.
• The other ingredients are: 5 mg, film-coated tablets: tablet core: hydroxypropyl cellulose, lactose monohydrate, microcrystalline cellulose, corn starch, magnesium stearate; tablet coating: Opadry Y-1-7000 (titanium dioxide, hypromellose, macrogol). 10 mg, film-coated tablets: tablet core: hydroxypropyl cellulose, lactose monohydrate, microcrystalline cellulose, corn starch, magnesium stearate; tablet coating: Opadry 02B22462 Yellow (titanium dioxide, hypromellose, macrogol, yellow iron oxide). See section 2 "Yasnal contains lactose".

What Yasnal Looks Like and Contents of the Pack

5 mg: white or almost white, round, biconvex film-coated tablets
10 mg: yellow-brown, round, biconvex film-coated tablets
Packaging:28 or 84 film-coated tablets in blisters, in a cardboard box

Marketing Authorization Holder and Manufacturer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information, contact the local representative of the marketing authorization holder:
Krka Polska Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Poland
phone: +48 22 573 75 00

Date of Last Revision of the Leaflet: