Iasnal Q-tab

Package Leaflet: Information for the Patient

Yasnal Q-Tab, 5 mg, Oral Disintegrating Tablets

Yasnal Q-Tab, 10 mg, Oral Disintegrating 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 a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Yasnal Q-Tab and What is it Used For
• 2. Important Information 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 Package and Other Information

1. What is Yasnal Q-Tab and What is it Used For

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

2. Important Information Before Taking Yasnal Q-Tab

When Not to Take Yasnal Q-Tab:

Warnings and Precautions

Before taking Yasnal Q-Tab, inform your doctor or pharmacist about any current or past medical conditions:

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

Women should also inform their doctor if they are pregnant or think they 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 Medications

Tell your doctor or pharmacist about all medications you are taking, have recently taken, or plan to take, including those available without a prescription.
This includes medications that you may take from time to time in the future while taking Yasnal Q-Tab, as they may weaken or enhance the effect of Yasnal Q-Tab.
It is especially important to inform your doctor about taking any of the following medications:

• medications used to treat heart rhythm disorders, 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,
• other medications used to treat Alzheimer's disease, such as galantamine,
• pain relievers or medications used to treat arthritis, such as acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or diclofenac sodium,
• anticholinergic medications, such as tolterodine,
• anticonvulsant medications, such as phenytoin, carbamazepine,
• medications used to treat heart conditions, such as quinidine, beta blockers (propranolol and atenolol),
• muscle relaxants, such as diazepam, succinylcholine,
• medications used for general anesthesia,
• over-the-counter medications, such as herbal remedies.

If surgery requiring general anesthesia is planned, inform your doctor and anesthesiologist about taking Yasnal Q-Tab. The medication may affect the amount of anesthetic needed.
Yasnal Q-Tab can be used in patients with kidney disease and mild to moderate liver disease. Inform your doctor if you have kidney or liver disease.
Patients with severe liver disease should not take Yasnal Q-Tab.
The patient should provide their caregiver's name to the doctor or pharmacist. The caregiver will help with taking the medication 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 effect of the medication.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication.
Do not breastfeed while taking Yasnal Q-Tab.

Driving and Operating Machinery

Alzheimer's disease may impair the ability to drive or operate machinery, so do not perform these activities unless your doctor considers it safe.
The medication may also cause fatigue, dizziness, and muscle cramps. If you experience any of these symptoms, do not drive or operate machinery.

What 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 to patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to its improper elimination.
• -Glucose (Dextrose) and SucroseIf you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medication.

3. How to Take Yasnal Q-Tab

Always take this medication exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist.

Recommended Dose of Yasnal Q-Tab

The recommended initial dose is 5 mg once daily, taken in the evening, before bedtime.
After one month, your doctor may recommend increasing the dose to 10 mg once daily, taken in the evening, before bedtime.
If the patient experiences unusual dreams, nightmares, or difficulty falling asleep (see section 4), the doctor may recommend taking Yasnal Q-Tab in the morning.
The dose of the medication may be changed depending on the duration of treatment and the doctor's recommendations. The maximum recommended dose is 10 mg, taken once daily in the evening.
Always follow the doctor's or pharmacist's instructions regarding the method and time of taking the medication.
Do not change the dose without consulting your doctor.

How to Take the Medication

Yasnal Q-Tab oral disintegrating tablets are fragile. Do not push the tablets out of the blister pack, as this may damage them. Do not touch the tablets with wet hands, as they may disintegrate. To remove a tablet from the packaging, follow these steps:

• 1. Hold the edge of the blister pack and separate one square of the blister pack by gently tearing it off at the perforation.
• 2. Pull the labeled edge of the foil and completely remove it.
• 3. Shake the tablet onto your hand.
• 4. Place the tablet on your tongue immediately after removing it from the packaging.

After a few seconds, the tablet will disintegrate in your mouth and can be swallowed, with or without water. The mouth should be empty before placing the tablet on your 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

In case of taking more than the recommended dose, immediately contact your doctor or the nearest emergency department. Bring this leaflet and all remaining tablets with you.
Symptoms of overdose may include nausea, vomiting, salivation, sweating, slow heartbeat, low blood pressure (feeling of "emptiness" in the head or dizziness when standing up), breathing problems, loss of consciousness, and seizures or convulsions.

Missing a Dose of Yasnal Q-Tab

If you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for the missed tablet.
If the break in taking this medication lasts more than 1 week, consult your doctor before resuming treatment with Yasnal Q-Tab.

Stopping Treatment with Yasnal Q-Tab

Do not stop taking the medication unless your doctor tells you to. If you stop taking Yasnal Q-Tab, its therapeutic effect will gradually decrease.
If you have any further questions about taking this medication, ask your doctor or pharmacist.

How Long to Take Yasnal Q-Tab

Your doctor or pharmacist will advise you on how long to continue taking the medication. Regularly visit your doctor to monitor your treatment and assess your symptoms.

4. Possible Side Effects

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

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

Severe Side Effects:

If you experience any of the following severe side effects, tell your doctor immediately. You may need to start treatment right away:

• liver damage, such as hepatitis. Symptoms of hepatitis include nausea or vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, dark urine (these side effects occur in 1 to 10 patients per 10,000);
• stomach or duodenal ulcers. Symptoms of stomach ulcers include stomach pain, discomfort in the abdominal cavity (like indigestion) (these side effects occur in 1 to 10 patients per 1,000);
• bleeding in the stomach or intestines. This can cause black stools or visible blood in the stool (these side effects occur in 1 to 10 patients per 1,000);
• seizures or convulsions (these side effects occur in 1 to 10 patients per 1,000);
• fever with muscle stiffness, sweating, or decreased consciousness (a condition called malignant neuroleptic syndrome) (occurs in less than 1 in 10,000 patients);
• muscle weakness, tenderness, or pain, especially if occurring together with malaise, high fever, or dark urine. This may be caused by abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (occurs in less than 1 in 10,000 patients).

Unknown frequency:

• changes in heart function visible on an EKG called "prolonged QT interval"
• rapid, irregular heartbeat, fainting, which can be symptoms of a life-threatening condition called torsades de pointes.

Other Side Effects:

• diarrhea
• headache

Frequent side effects (may occur in up to 1 in 10 patients):

• muscle cramps
• fatigue
• difficulty falling asleep (insomnia)
• common cold
• hallucinations (seeing or hearing things that do not exist)
• unusual dreams and nightmares
• agitation
• aggressive behavior
• fainting
• dizziness
• stomach problems
• rash
• urinary incontinence
• pain
• accidents (patients may be more prone to falls and accidental injuries)

Uncommon side effects (may occur in up to 1 in 100 patients):

• slow heartbeat
• excessive salivation

Rare side effects (may occur in up to 1 in 1,000 patients):

• stiffness, trembling, or uncontrolled movements of the muscles, especially of the face and tongue, but also of the limbs (extrapyramidal symptoms)

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

• increased libido, hypersexuality
• a condition called "tower of Pisa" (involving 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, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medication.

5. How to Store Yasnal Q-Tab

Keep the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Store in the original packaging to protect from moisture.
No special precautions are required for storing the medication at a certain temperature.
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 Package and Other Information

What Yasnal Q-Tab Contains

• -The active substance of the medication is donepezil hydrochloride. Yasnal Q-Tab, 5 mg: each oral disintegrating 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 oral disintegrating 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 hydroxypropylcellulose, banana flavor (maltodextrin, dextrose, sucrose, gum arabic, aspartame (E 951), calcium silicate, and magnesium stearate.

What Yasnal Q-Tab Looks Like and What the Package Contains

5 mg: white, round oral disintegrating tablets with beveled edges, approximately 5.5 mm in diameter.
10 mg: white, round oral disintegrating tablets with beveled edges, approximately 7 mm in diameter.
Packaging: 28, 30, 56, 60, 98, or 100 oral disintegrating tablets in blister packs, in a cardboard box.

Marketing Authorization 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
To obtain more detailed information about the names of medicinal products in other EU member states, contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500

Date of Last Revision of the Leaflet: 15.12.2022