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 Package 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 Them, Even if Their Symptoms are the Same.
• If the Patient Experiences Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell the Doctor or Pharmacist. See Section 4.

Table of Contents of the Package 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 Package 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 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 Starting Yasnal, Discuss with Your Doctor or Pharmacist if Any of the Following Situations Apply or Have Applied to the Patient:

• Stomach or Duodenal Ulcer;
• Seizures;
• Heart Diseases (Such as Irregular or Very Slow Heart Rate, Heart Failure, Myocardial Infarction, Sick Sinus Syndrome, or Atrioventricular Conduction Disorders (Atrioventricular Block, Bundle Branch Block));
• A Heart Conduction Disorder Called "Prolonged QT Interval" or a History of Certain Heart Rhythm Disorders Called Torsades de Pointes or a Family History of "Prolonged QT Interval";
• Low Magnesium or Potassium Levels in the Blood;
• Asthma or Other Chronic Lung Diseases;
• Liver Diseases or Hepatitis;
• Urinary Tract Diseases (With Difficulty Urinating);

The Patient Should Also Inform the Doctor if She is Pregnant or Thinks She 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 the Doctor or Pharmacist About All Medications the Patient is Currently Taking or Has Recently Taken, as Well as Any Medications the Patient Plans to Take.
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 or Itraconazole;
• 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;
• Anticholinergic Medications, Such as Tolterodine;
• Antiepileptic Medications, Such as Phenytoin, Carbamazepine;
• Medications Used to Treat Heart Diseases, Such as Quinidine, Beta-Adrenergic Blockers (Propranolol and Atenolol);
• Muscle Relaxants, Such as Tetrazepam, Diazepam, Succinylcholine;
• Medications Used for General Anesthesia;
• Over-the-Counter Medications, Such as Herbal Remedies.

A Patient Who is to Undergo Surgery Requiring General Anesthesia Should Inform the Doctor that They 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. The Doctor Should be Informed About Kidney or Liver Diseases. Patients with Severe Liver Impairment Should Not Take Yasnal.
The Patient Should Provide the Doctor or Pharmacist with the Name and Address of the Caregiver. The Caregiver Will Help with Taking the Medication as Prescribed by the Doctor.

Taking Yasnal with Food, Drink, and Alcohol

Food Does Not Affect the Action of Yasnal.
During Treatment with Yasnal, Do Not Consume Alcohol, as it May Change the Effect of the Medication.

Pregnancy, Breastfeeding, and Fertility

If the Patient is Pregnant or Breastfeeding, Thinks She May be Pregnant, or Plans to Have a Child, She Should Consult a Doctor or Pharmacist Before Taking this Medication.
Taking Yasnal During Pregnancy is Contraindicated. Women Taking Yasnal Should Not Breastfeed.

Driving and Operating Machinery

Alzheimer's Disease May Impair the Ability to Drive and Operate Machinery, So Do Not Perform These Activities Until the Doctor Has Assessed that it is Safe for the Patient to Do So.
Additionally, Yasnal May Cause Fatigue, Dizziness, and Muscle Cramps. If Any of These Side Effects Occur, Do Not Drive or Operate Machinery.

Yasnal Contains Lactose

If the Patient Has Been Diagnosed with an Intolerance to Some Sugars, the Patient Should Consult a Doctor Before Taking Yasnal.

3. How to Take Yasnal

This Medication Should Always be Taken as Directed by the Doctor. If in Doubt, Consult the Doctor or Pharmacist.

Recommended Dose of Yasnal

The Recommended Initial Dose is 5 mg, Taken Before Bedtime.
If the Patient Experiences Vivid Dreams, Nightmares, or Difficulty Falling Asleep (See Section 4), the Doctor May Recommend 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 Change Depending on the Duration of Treatment and the Doctor's Recommendations.
The Maximum Recommended Daily Dose is 10 mg. Do Not Change the Dose Without Consulting the Doctor.

How to Take the Medication

Take the Tablet with a Glass of Water, in the Evening Before Going to Bed. If the Patient Experiences Vivid 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 Kidney and 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 is a Lack of Data on the Use of Yasnal in Patients with Severe Liver Impairment.

Taking More Than the Recommended Dose of Yasnal

If More Than the Recommended Dose of Yasnal is Taken, Immediately Inform the Doctor or Go to the Nearest Hospital. Bring this Package Leaflet and the Medication Packaging with You.
Symptoms of Overdose May Include: Severe Nausea, Vomiting, Salivation, Excessive Sweating, Bradycardia (Slow Heart Rate), Hypotension (Low Blood Pressure), Respiratory Depression, Collapse, and Seizures. Progressive Muscle Weakness May Also Occur, Which Can Lead to Death in the Event of Respiratory Muscle Weakness. Depending on the Symptoms, the Doctor Will Provide Appropriate Treatment.

Missing a Dose of Yasnal

In Such a Case, Take the Next Dose at the Scheduled Time.
Do Not Take a Double Dose to Make Up for the Missed Dose.
If Yasnal is Not Taken for More Than a Week, Consult the Doctor Before Taking the Medication Again.

Stopping Yasnal Treatment

Do Not Stop Taking the Medication Unless the Doctor Recommends it. After Stopping the Medication, the Benefits of Treatment Will Gradually Decrease.
If You Have Any Further Questions About Taking this Medication, Ask Your Doctor or Pharmacist.

How Long to Take Yasnal

The Doctor or Pharmacist Will Recommend How Long to Continue Taking the Medication. Regularly Visit the 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 Any of the Following Side Effects Occur While Taking Yasnal, Contact a Doctor.

Yasnal.

Severe Side Effects:
If the Patient Experiences Any of the Following Severe Side Effects, Immediately Inform the Doctor. Immediate Medical Attention May be Required.

• Liver Dysfunction, Including Hepatitis. Symptoms of Hepatitis are: Nausea or Vomiting, Loss of Appetite, General Malaise, 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 Peptic Ulcers are Abdominal 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 Malaise, High Fever, or Dark Urine. This May be Due to 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 Called "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)
• Vivid Dreams and Nightmares
• Agitation
• Aggressive Behavior
• Fainting
• Dizziness
• Gastrointestinal Disorders, 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)
• Slightly Increased Muscle Enzyme Levels 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, Slowed Movement, Restlessness, Involuntary Muscle Contractions and Involuntary Movements, Especially of the Face and Tongue, but Also of the Hands and Feet)
• Atrioventricular Block, Bundle Branch Block (Heart Conduction Disorders)

Unknown (Frequency Cannot be Estimated from the Available Data):

• Increased Libido, Hypersexuality
• Torticollis (a Condition Characterized by Involuntary Muscle Contraction with Abnormal Posture of the Head and Body)

Reporting Side Effects
If Any Side Effects Occur, Including Those Not Listed in this Package Leaflet, Inform the Doctor or Pharmacist. 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 to Gather More Information on the Safety of the Medication.

5. How to Store Yasnal

Store the Medication in a Place Out of Sight and Reach of Children.
Do Not Use this Medication After the Expiration Date Stated on the Packaging. The Expiration Date is the Last Day of the Specified Month.
There are No Special Storage Precautions.
Do Not Dispose of Medications 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 Contains

• The Active Substance is Donepezil Hydrochloride. Each Film-Coated Tablet Contains 5 mg or 10 mg of Donepezil Hydrochloride.
• 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 What the Package Contains

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 Blister Packs, 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
02-235 Warsaw
Poland
Phone: +48 22 573 75 00

Date of the Last Update of the Package Leaflet: