Iasnal Q-tab

Package Leaflet: Information for the Patient

Yasnal Q-Tab, 5 mg, Orally Disintegrating Tablets

Yasnal Q-Tab, 10 mg, Orally 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 pack 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 works by slowing down the breakdown of a substance (acetylcholine) involved in memory function, increasing its concentration in the brain.
Yasnal Q-Tab is used to treat the symptoms of dementia in patients with mild or moderate Alzheimer's disease. Symptoms include worsening memory loss, confusion, and behavioral changes. As a result, patients with Alzheimer's disease may find it increasingly difficult to perform everyday activities.
Yasnal Q-Tab is intended for use in adult patients only.

2. Important information before taking Yasnal Q-Tab

When not to take Yasnal Q-Tab:

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

Warnings and precautions

Before taking Yasnal Q-Tab, the patient should inform their 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 heart rate, heart failure, myocardial infarction),
• heart rhythm disorder 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.

The patient should also inform their doctor if they are pregnant or think they may be pregnant.

Children and adolescents

Yasnal Q-Tab is not intended for use in children and adolescents (under 18 years of age).

Yasnal Q-Tab and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take, including those available without a prescription.
This includes medications that the patient may occasionally take in the future during treatment with Yasnal Q-Tab, as these medications may weaken or enhance the effect of Yasnal Q-Tab.
It is especially important to inform the 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 the patient is scheduled for surgery requiring general anesthesia, they should inform their 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. The patient should inform their doctor if they have kidney or liver disease.
Patient with severe liver disease should not take Yasnal Q-Tab.
The patient should provide their doctor or pharmacist with the name of their caregiver. The caregiver will help the patient take 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.
The patient should not consume alcohol while taking Yasnal Q-Tab, as alcohol may alter the effect of the medication.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.
The patient should not breastfeed while taking Yasnal Q-Tab.

Driving and using machines

Alzheimer's disease may impair the ability to drive or operate machinery, so the patient should not perform these activities unless their doctor considers it safe.
The medication may also cause fatigue, dizziness, and muscle cramps. If the patient experiences any of these symptoms, they should 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 excretion.
• -Glucose (dextrose) and sucroseIf the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medication.

3. How to take Yasnal Q-Tab

This medication should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their 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, the 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 adjusted based on the duration of treatment and the doctor's recommendations. The maximum recommended dose is 10 mg, taken once daily in the evening.
The patient should always follow the doctor's or pharmacist's instructions regarding the method and time of taking the medication.
The patient should not change the dose without consulting their doctor.

How to take the medication

Yasnal Q-Tab orally disintegrating tablets are fragile. The tablets should not be pressed out of the blister pack, as this may damage them. The tablets should not be touched with wet hands, as they may disintegrate. To remove a tablet from the packaging, the patient should 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 marked edge of the foil and completely remove it.
• 3. Shake the tablet onto their hand.
• 4. Place the tablet on the tongue immediately after removing it from the packaging.

After 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).

Overdose of Yasnal Q-Tab

In case of overdose, the patient should immediately contact their doctor or the nearest emergency department. They should bring this leaflet and all remaining tablets with them.
Symptoms of overdose may include nausea, vomiting, salivation, sweating, slow heart rate, low blood pressure (feeling of "emptiness" in the head or dizziness when standing up), breathing problems, loss of consciousness, and seizures or convulsions.

Missed dose of Yasnal Q-Tab

If the patient misses a dose, they should take the next dose at the usual time. They should not take a double dose to make up for the missed tablet.
If the patient stops taking this medication for more than 1 week, they should consult their doctor before restarting Yasnal Q-Tab.

Stopping treatment with Yasnal Q-Tab

The patient should not stop taking the medication unless their doctor recommends it. If the patient stops taking Yasnal Q-Tab, its therapeutic effect will gradually decrease.
If the patient has any further doubts about taking this medication, they should consult their doctor or pharmacist.

How long to take Yasnal Q-Tab

The doctor or pharmacist will recommend how long to continue taking the medication. The patient should regularly visit their doctor to monitor their treatment and assess their 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 the patient experiences any of the following side effects, they should contact their doctor.

Severe side effects:

If the patient experiences any of the following severe side effects, they should immediately inform their doctor. Prompt treatment may be necessary:

• 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 abdominal 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 may 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 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).

Frequency not known:

• changes in heart function visible on an ECG 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

Common 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
• gastrointestinal 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 heart rate
• 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)

Frequency not known:

• 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 the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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

The medication should be stored 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.
Store in the original packaging to protect from moisture.
No special precautions for storage temperature are required.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Yasnal Q-Tab contains

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

What Yasnal Q-Tab looks like and contents of the pack

5 mg: white, round, orally disintegrating tablets with beveled edges, approximately 5.5 mm in diameter.
10 mg: white, round, orally disintegrating tablets with beveled edges, approximately 7 mm in diameter.
Packaging: 28, 30, 56, 60, 98, or 100 orally 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, please 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