Yasnal

Package leaflet: Information for the patient

Yasnal, 5 mg, film-coated tablets
Yasnal, 10 mg, film-coated tablets
Donepezili hydrochloridum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Yasnal is and what it is 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 Yasnal is and what it is used for

Yasnal contains donepezil hydrochloride as the active substance, which belongs to a group of medicines called acetylcholinesterase inhibitors.
Donepezil increases the concentration of acetylcholine in the brain by slowing down the breakdown of this substance, which plays an important role in memory function.
Yasnal is used for the symptomatic treatment of mild to moderate Alzheimer's dementia. These symptoms may include progressive memory loss, disorientation, and changes in behaviour.
Yasnal may be used in adult patients.

2. Important information before using Yasnal

When not to use Yasnal

• if the patient is allergic to donepezil hydrochloride, derivatives of piperidine, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Yasnal, discuss with your doctor or pharmacist if any of the following situations apply or have applied in the past:

• peptic ulcer disease of the stomach or duodenum;
• seizures;
• heart diseases (such as irregular or very slow heartbeat, heart failure, myocardial infarction, sick sinus syndrome, or supraventricular conduction disorders (sinus-atrial block, atrioventricular block));
• presence of a heart condition called "prolonged QT interval", or previously diagnosed certain rhythm disorders called torsade de pointes tachycardia, or a family history of "prolonged QT interval";
• low blood levels of magnesium or potassium;
• asthma or other chronic lung diseases;
• liver disorders or hepatitis;
• urinary tract or genital system disorders (with difficulty in passing urine).

You should also inform 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).
Yasnal and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
It is particularly important to inform your doctor if you are taking any of the following medicines:

• medicines used to treat heart rhythm disorders, e.g. amiodarone, sotalol;
• medicines used to treat depression, e.g. citalopram, escitalopram, amitriptyline, fluoxetine;
• antipsychotic medicines, e.g. pimozide, sertindole, ziprasidone;
• medicines used to treat bacterial infections, e.g. clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin;
• antifungal medicines, e.g. ketoconazole or itraconazole;
• other medicines used in Alzheimer's disease, e.g. galantamine;
• painkillers or medicines used for joint inflammation, e.g. acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen or diclofenac;
• anticholinergic medicines, e.g. tolterodine;
• antiepileptic medicines, e.g. phenytoin, carbamazepine;
• medicines used for heart conditions, e.g. quinidine, beta-blockers (propranolol and atenolol);
• muscle relaxants, e.g. tetrazepam, diazepam, suxamethonium;
• medicines used for general anaesthesia;
• over-the-counter medicines, e.g. herbal remedies.

If a patient is scheduled for surgery requiring general anaesthesia, they should inform the doctor that they are taking Yasnal. Yasnal may affect the amount of anaesthetic agent required.
Yasnal can be used in patients with kidney disorders and mild to moderate liver impairment. Inform your doctor about any kidney or liver problems. Yasnal should not be used in patients with severe liver impairment.
The patient should provide the doctor or pharmacist with the name and surname of their caregiver. The caregiver will assist in taking the medicine as directed by the doctor.
Taking Yasnal with food, drink and alcohol
Food does not affect the action of Yasnal.
Do not consume alcohol while taking Yasnal, as alcohol may alter the effect of the medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Use of Yasnal during pregnancy is contraindicated. Women taking Yasnal should not breastfeed.
Driving and operating machinery
Dementia in Alzheimer's disease may impair the ability to drive vehicles and operate machinery. Therefore, these activities should not be performed until your doctor assesses that it is safe for you to do so.
Additionally, Yasnal may cause fatigue, dizziness, and muscle cramps. If any of these effects occur, do not drive or operate machinery.
Yasnal contains lactose
If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking Yasnal.

3. How to use Yasnal

This medicine should always be used exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist.

Recommended dose of Yasnal
The recommended initial dose is 5 mg, taken before bedtime.
If the patient experiences unusual dreams, nightmares, or difficulty falling asleep (see section 4), the doctor may advise taking Yasnal in the morning.
After one month, the doctor may increase the dose to 10 mg, taken before bedtime.
The dose of Yasnal may vary depending on the duration of treatment and the recommendations of the treating physician.
The maximum recommended daily dose is 10 mg. Do not change the dose without consulting your doctor.

How to take the medicine
The tablet should be taken with water in the evening before going to bed. If the patient experiences unusual dreams, nightmares, or difficulty falling asleep (see section 4), the 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 renal or hepatic impairment
Patients with impaired kidney function may follow a similar dosing regimen as patients with normal kidney function.
In patients with mild to moderate liver impairment, dose escalation should be based on individual patient tolerance. There is no data available on the use of Yasnal in patients with severe liver impairment.

Taking more Yasnal than recommended
If you take more Yasnal than recommended, contact your doctor immediately or go to the nearest hospital. Bring this leaflet and the medicine’s packaging with you.
Symptoms of overdose may include: severe nausea, vomiting, salivation, excessive sweating, bradycardia (slowed heart rate), hypotension (low blood pressure), respiratory depression, collapse, and seizures. Progressive muscle weakness may also occur, which could lead to death if respiratory muscles are affected. The doctor will provide appropriate treatment depending on the symptoms observed.

If you miss a dose of Yasnal
Take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
If you have missed taking Yasnal for longer than one week, consult your treating physician before resuming treatment.

Stopping the use of Yasnal
Do not stop taking Yasnal unless your doctor advises you to do so. After stopping the medicine, the benefits of treatment will gradually diminish over time.

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

How long to use Yasnal
Your doctor or pharmacist will advise you on how long to continue taking the medicine. You should visit your doctor regularly to monitor treatment and assess symptoms.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been reported in patients taking Yasnal.
If any of the following adverse reactions occur while taking Yasnal, contact your doctor.
Severe adverse reactions:
If any of the severe adverse reactions described below occur in a patient,
tell your doctor immediately. Immediate medical help may be required.

• Liver function disorders, including hepatitis. Symptoms of hepatitis include: nausea or vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, dark-coloured urine (frequency: rare, may occur in less than 1 in 1,000 patients);
• Gastric or duodenal ulcers. Symptoms of peptic ulcers include abdominal pain, discomfort in the upper abdomen (frequency: uncommon, may occur in less than 1 in 100 patients);
• Bleeding from the stomach or intestines. This may cause black, tarry stools or visible blood from the rectum (frequency: uncommon);
• Seizures or convulsions (frequency: uncommon, may occur in less than 1 in 100 patients);
• Fever with muscle stiffness, sweating, or decreased level of consciousness (a disorder known as neuroleptic malignant syndrome) (frequency: very rare, may occur in less than 1 in 10,000 patients);
• Weakness, tenderness, or muscle pain, especially when occurring together with malaise, high fever, or dark urine. This may be due to abnormal muscle breakdown, which may be life-threatening and lead to kidney dysfunction (a condition known as rhabdomyolysis) (frequency: very rare);
• Changes in heart function seen on ECG, known as "QT interval prolongation" (frequency unknown: cannot be estimated from available data);
• Fast, irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called torsade de pointes (frequency unknown: cannot be estimated from available data).

Other adverse reactions include:
Very common adverse reactions (may occur in more than 1 in 10 patients):

• Diarrhoea
• Nausea
• Headache

Common adverse reactions (may occur in less than 1 in 10 patients):

• Muscle spasms
• Fatigue
• Sleep problems (insomnia)
• Cold symptoms
• Loss of appetite
• Hallucinations
• Unusual dreams and nightmares
• Restlessness
• Aggressive behaviour
• Fainting
• Dizziness
• Gastrointestinal disturbances, vomiting
• Rash
• Itching
• Urinary incontinence
• Pain
• Accidents (patients may be more prone to falls and accidental injuries)

Uncommon adverse reactions (may occur in less than 1 in 100 patients):

• Bradycardia (slowing of the heart rate)
• Slight increase in blood creatine kinase muscle activity
• Increased salivation

Rare adverse reactions (may occur in less than 1 in 1,000 patients):

• Extrapyramidal symptoms (movement disorders of the nervous system such as: muscle rigidity, reduced facial expression, bradykinesia, motor 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 conduction disorders)

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

• Increased libido, hypersexuality
• Tower of Pisa sign (involuntary muscle contraction causing abnormal bending of the body and head to one side)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Reactions of Medicinal Products
of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Yasnal

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Yasnal contains

• The active substance is donepezil hydrochloride. Each coated tablet contains 5 mg or 10 mg of donepezil hydrochloride.
• The other ingredients are:
  5 mg coated tablets: tablet core: hydroxypropylcellulose, monohydrate lactose, microcrystalline cellulose, corn starch, magnesium stearate; tablet coating: Opadry Y-1-7000 (titanium dioxide, hypromellose, polyethylene glycol).
  10 mg coated tablets: tablet core: hydroxypropylcellulose, monohydrate lactose, microcrystalline cellulose, corn starch, magnesium stearate; tablet coating: Opadry 02B22462 Yellow (titanium dioxide, hypromellose, polyethylene glycol, 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 coated tablets
10 mg: yellow-brown, round, biconvex coated tablets
Packaging: 28 or 84 coated tablets in blisters, in a cardboard box
Marketing authorisation holder and manufacturer:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For further information, please contact the local representative of the marketing authorisation holder:
Krka Polska Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
Poland
tel.: + 48 22 573 75 00