Yasnal q-tab

Package leaflet: Information for the patient

Yasnal Q-Tab, 5 mg, orodispersible tablets
Yasnal Q-Tab, 10 mg, orodispersible tablets
donepezili hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Yasnal Q-Tab is and what it is used for
2. What you need to know before taking Yasnal Q-Tab
3. How to take Yasnal Q-Tab
4. Possible side effects
5. How to store Yasnal Q-Tab
6. Contents of the pack and other information

1. What Yasnal Q-Tab is and what it is used for

Yasnal Q-Tab contains the active substance donepezil hydrochloride. Yasnal Q-Tab (donepezil
hydrochloride) belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil
increases the concentration of a substance (acetylcholine) involved in memory function in the brain
by slowing down its breakdown.
Yasnal Q-Tab is used to treat the symptoms of dementia in people diagnosed with mild to
moderate Alzheimer's disease. Symptoms include worsening memory loss, confusion, and
changes in behaviour. As a result, patients with Alzheimer's disease increasingly struggle with
performing everyday tasks.
Yasnal Q-Tab is intended for use in adult patients only.

2. Important information before using Yasnal Q-Tab

When not to use Yasnal Q-Tab:

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

Warnings and precautions
Before taking Yasnal Q-Tab, inform your doctor or pharmacist if you currently have or have had any of the following conditions:

• peptic ulcer disease (stomach or duodenal ulcer),
• seizures or convulsions,
• heart disorders (such as irregular or very slow heartbeat, heart failure, myocardial infarction),
• a heart condition known as "prolonged QT interval" or previously diagnosed certain rhythm disorders called torsade de pointes, or a history of "prolonged QT interval",
• low blood levels of magnesium or potassium,
• asthma or other chronic lung diseases,
• liver disorders or hepatitis,
• difficulty in passing urine or mild kidney impairment.

You should also inform your doctor if you are pregnant or suspect you may be pregnant.
Children and adolescents
Yasnal Q-Tab is not indicated for use in children and adolescents (under 18 years of age).
Yasnal Q-Tab and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including over-the-counter medicines.
This also includes medicines that you may occasionally use in the future during treatment with Yasnal Q-Tab, as these medicines may weaken or intensify the effect of Yasnal Q-Tab.
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 for bacterial infections, e.g. clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin,
• antifungal medicines, e.g. ketoconazole,
• 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 sodium diclofenac,
• anticholinergic medicines, e.g. tolterodine,
• anticonvulsant medicines, e.g. phenytoin, carbamazepine,
• medicines used for heart conditions, e.g. quinidine, beta-blockers (propranolol and atenolol),
• muscle relaxants, e.g. diazepam, suxamethonium chloride,
• medicines used for general anaesthesia,
• over-the-counter medicines, e.g. herbal remedies.

If surgery requiring general anaesthesia is planned, inform your doctor and anaesthetist that you are taking Yasnal Q-Tab. The medicine may affect the amount of anaesthetic required.
Yasnal Q-Tab can be used in patients with kidney impairment and mild to moderate liver impairment. Inform your doctor if you have kidney or liver disease.
Patients with severe liver impairment should not take Yasnal Q-Tab.
The patient should provide their caregiver's name and surname to the doctor or pharmacist. The caregiver will assist in taking the medicine as directed by the doctor.
Yasnal Q-Tab with food, drink and alcohol
Food does not affect the action of Yasnal Q-Tab.
Do not consume alcohol while taking Yasnal Q-Tab, as alcohol may alter the medicine's effects.
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.
Breastfeeding is not recommended during treatment with Yasnal Q-Tab.
Driving and using machines
Alzheimer's disease may impair the ability to drive or operate machinery. Therefore, do not perform these activities unless your doctor considers them safe.
The medicine may also cause fatigue, dizziness, and muscle cramps. If any of these symptoms occur, do not drive or operate machinery.
Yasnal Q-Tab contains:

• Aspartame (E 951) Yasnal Q-Tab 5 mg contains 0.75 mg of aspartame per tablet. Yasnal Q-Tab 10 mg contains 1.5 mg of aspartame per tablet. Aspartame is a source of phenylalanine. It may be harmful for patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.
• Glucose (dextrose) and sucrose If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.

3. How to take Yasnal Q-Tab

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
Recommended dose of Yasnal Q-Tab
The recommended starting dose is 5 mg taken once daily in the evening, before going to bed.
After one month, your doctor may recommend increasing the dose to 10 mg taken once daily in the evening, before going to bed.
If the patient experiences unusual dreams, nightmares, or difficulty falling asleep (see section 4),
your doctor may recommend taking Yasnal Q-Tab in the morning.
The dose of this medicine may be adjusted depending on the duration of treatment and your doctor's instructions. The maximum recommended dose is 10 mg, taken once daily in the evening.
Always follow your doctor’s or pharmacist’s instructions regarding how and when to take the medicine.
Do not change the dose without consulting your doctor.
How to take the medicine
Yasnal Q-Tab orally disintegrating tablets are fragile. Do not push the tablets out of the foil blister, as this may damage them. Do not touch the tablets with wet hands, as the tablet may disintegrate. To remove a tablet from the packaging, follow these steps:

1. Hold the edge of the blister and carefully separate one blister square by tearing at the perforation.
2. Pull the marked edge of the foil and completely peel it back.
3. Tip the tablet onto your hand.
4. Place the tablet on your tongue immediately after removing it from the packaging.

Within a few seconds, the tablet will disintegrate in the mouth and can be swallowed with or without water. The mouth should be empty before placing the tablet on the tongue.
Use in children and adolescents
Yasnal Q-Tab is not recommended for use in children and adolescents (under 18 years of age).
Taking more than the recommended dose of Yasnal Q-Tab
If you take more than the recommended dose, contact your doctor or the nearest emergency department immediately. Bring this leaflet and any remaining tablets with you.
Symptoms of overdose may include nausea, vomiting, salivation, sweating, slow heart rate,
low blood pressure (feeling of "emptiness in the head" or dizziness upon standing),
breathing difficulties, loss of consciousness, seizures, or convulsions.
Missed dose of Yasnal Q-Tab
If you miss a dose, take the next dose at your usual time. Do not take a double dose to make up for a missed tablet.
If the break in treatment lasts longer than 1 week, contact your doctor before restarting Yasnal Q-Tab.
Stopping treatment with Yasnal Q-Tab
Do not stop taking this medicine unless your doctor advises you to do so. If you stop taking Yasnal Q-Tab, its therapeutic effect will gradually decrease.
If you have any further questions about how to use this medicine, consult your doctor or pharmacist.
How long to take Yasnal Q-Tab
Your doctor or pharmacist will advise you on how long to continue taking this medicine. You should visit your doctor regularly to monitor your treatment and assess your symptoms.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been reported in patients taking Yasnal Q-Tab.
If any of the following adverse reactions occur while taking Yasnal Q-Tab, contact your doctor.
Serious adverse reactions:
If a patient experiences any of the serious adverse reactions described below, the doctor must be informed immediately. Immediate treatment may be necessary:

• Liver damage, e.g. hepatitis. Symptoms of hepatitis include: nausea or vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), dark-coloured urine (these adverse reactions occur in 1 to 10 patients per 10,000);
• Gastric or duodenal ulcers. Symptoms of peptic ulcers include abdominal pain, discomfort in the abdominal cavity (similar to indigestion) (these adverse reactions occur in 1 to 10 patients per 1,000);
• Bleeding in the stomach or intestines. This may cause black, tarry stools or visible blood from the rectum (these adverse reactions occur in 1 to 10 patients per 1,000);
• Seizures or convulsions (these adverse reactions occur in 1 to 10 patients per 1,000);
• Fever with muscle rigidity, sweating, or reduced level of consciousness (a condition known as neuroleptic malignant syndrome) (occurs in less than 1 in 10,000 patients);
• Muscle weakness, tenderness or pain, especially when occurring together with malaise, high fever, or darkly coloured urine. This may be due to abnormal muscle breakdown, which can be life-threatening and lead to kidney dysfunction (a condition called rhabdomyolysis) (occurs in less than 1 in 10,000 patients).

Frequency unknown:

• Changes in heart function visible on ECG, known as "QT interval prolongation"
• Rapid, irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called torsade de pointes.

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

• Diarrhoea
• Headache

Common adverse reactions (may occur in up to 1 in 10 patients):

• Muscle cramps
• Fatigue
• Difficulty sleeping (insomnia)
• Common cold
• Hallucinations (seeing or hearing things that are not real)
• Unusual dreams and nightmares
• Restlessness
• Aggressive behaviour
• Fainting
• Dizziness
• Gastrointestinal discomfort
• Rash
• Urinary incontinence
• Pain
• Accidents (patients may be more prone to falls and accidental injuries)

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• Slow heart rate
• Excessive salivation

Rare adverse reactions (may occur in up to 1 in 1,000 patients):

• Muscle stiffness, tremor, or uncontrolled movements, particularly of the face and tongue, but also limbs (extrapyramidal symptoms)

Unknown frequency (cannot be estimated from available data):

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Yasnal Q-Tab

Keep the medicine out of the 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.
Store in the original packaging to protect from moisture.
No special precautions regarding storage temperature are required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Yasnal Q-Tab contains

• The active substance is donepezil hydrochloride. Yasnal Q-Tab, 5 mg: each orodispersible tablet contains 5.22 mg of donepezil hydrochloride monohydrate, equivalent to 5 mg of donepezil hydrochloride corresponding to 4.56 mg of donepezil. Yasnal Q-Tab, 10 mg: each orodispersible tablet contains 10.43 mg of donepezil hydrochloride monohydrate, equivalent to 10 mg of donepezil hydrochloride corresponding to 9.12 mg of donepezil.
• The other ingredients are: mannitol (E 421), microcrystalline cellulose, low-substituted hydroxypropyl cellulose, banana flavour (maltodextrin, dextrose, sucrose, arabic gum, aspartame (E 951), calcium silicate and magnesium stearate.

What Yasnal Q-Tab looks like and contents of the pack
5 mg: white, round orodispersible tablets with bevelled edges, approximately 5.5 mm in diameter.
10 mg: white, round orodispersible tablets with bevelled edges, approximately 7 mm in diameter.
Pack sizes: 28, 30, 56, 60, 98 or 100 orodispersible tablets in blisters, packed in a cardboard box.

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

For more detailed information on the product names available in other European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Tel. 22 57 37 500