Donesin

Package Leaflet: Information for the Patient

Donesyn, 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 Any Not Mentioned in this Package Leaflet, Tell the Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 1. What is Donesyn and What is it Used for
• 2. Important Information Before Taking Donesyn
• 3. How to Take Donesyn
• 4. Possible Side Effects
• 5. How to Store Donesyn
• 6. Package Contents and Other Information

1. What is Donesyn and What is it Used for

Donesyn Contains the Active Substance Donepezil Hydrochloride, Which Belongs to a Group of Medications Called Acetylcholinesterase Inhibitors.
Donesyn is Indicated for the Symptomatic Treatment of Mild to Moderate Alzheimer's Disease. Donesyn Can be Used in Adult Patients.

2. Important Information Before Taking Donesyn

When Not to Take Donesyn

• If the Patient is Allergic to Donepezil or to Piperidine Derivatives, or to Any of the Other Ingredients of this Medication (Listed in Section 6).

Warnings and Precautions

Before Starting Donesyn, Discuss with the Doctor or Pharmacist if Any of the Following Applies to the Patient:
If the Patient Has or Has Ever Had Heart Problems (Especially Sick Sinus Syndrome or Similar Conditions Such as Irregular or Very Slow Heartbeat, Heart Failure, Myocardial Infarction). Donepezil May Slow Down the Heart Rate;
There is a Conduction Disorder in the Heart Called "Prolonged QT Interval" or There Have Been Certain Heart Rhythm Disorders Called Torsades de Pointes or There Have Been Previous Instances of "QT Interval Prolongation".
There is a Low Level of Magnesium or Potassium in the Blood.
If the Patient Has Ever Had Stomach or Duodenal Ulcers or is Taking a Certain Type of Pain Relief Medication (Non-Steroidal Anti-Inflammatory Drugs - NSAIDs). The Doctor Should Monitor the Symptoms;
If the Patient Has Difficulty Urinating. The Doctor Should Monitor the Symptoms;
If the Patient Has Ever Had Seizures. Donepezil May Cause a New Seizure.
The Doctor Should Monitor the Symptoms;
If the Patient Has Asthma or Other Chronic Lung Disease. Symptoms May Worsen;
If the Doctor Has Informed the Patient of Intolerance to Certain Sugars, Such as Lactose.
Donesyn Can be Used in Patients with Kidney or Mild to Moderate Liver Disease. However, the Doctor Should be Informed of Kidney or Liver Disease. Patients with Severe Liver Disease Should Not Take Donesyn.

Children and Adolescents

Donesyn is Not Indicated for Use in Children and Adolescents (Below 18 Years of Age).

Donesyn 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.
Inform the Doctor if the Patient is Taking the Following Medications:

• Anesthetics. If the Patient is Scheduled for Surgery Requiring General Anesthesia, Inform the Doctor and Anesthesiologist About Taking Donesyn. This is Because the Medication May Affect the Amount of Anesthetic Needed.
• Medications Used to Control Heart Rhythm (Quinidine), Antifungal Medications (Ketoconazole and Itraconazole), Certain Antibiotics (Erythromycin), and Medications Used to Treat Depression, Such as Fluoxetine. These Medications May Enhance the Effect of Donesyn.
• Medications Used to Treat Tuberculosis (Rifampicin), Medications Used to Treat Epilepsy (Phenytoin and Carbamazepine). These Medications May Weaken the Effect of Donesyn.
• Medications Used for Short-Term Muscle Relaxation in Anesthesia and Intensive Care (Succinylcholine), Other Muscle Relaxants, Medications that Stimulate a Certain Area of the Nervous System (Cholinergic Agonists), and Certain Medications that Lower Blood Pressure (Beta-Blockers). The Effect of Both Medications is Enhanced.
• Medications that Inhibit a Certain Area of the Nervous System (Anticholinergic Medications).
• Pain Relief Medications or Anti-Arthritis Medications, Such as Acetylsalicylic Acid, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Such as Ibuprofen or Diclofenac.
• Other Medications for Alzheimer's Disease, Such as Galantamine.
• Over-the-Counter Medications, Such as Herbal Remedies.
• Medications Used to Treat Heart Rhythm Disorders (Such as Amiodarone, Sotalol, and Quinidine).
• Medications Used to Treat Depression (Such as Citalopram, Escitalopram, Amitriptyline), Medications Used to Treat Psychosis (Such as Pimozide, Sertindol, Ziprasidone), Medications Used to Treat Bacterial Infections (Such as Clarithromycin, Erythromycin, Levofloxacin, Moxifloxacin).

Taking Donesyn with Food, Drink, and Alcohol

Food Does Not Affect the Action of the Medication.
Do Not Consume Alcohol While Taking Donesyn, as Alcohol May Change the Effect of the Medication.

Pregnancy, Breastfeeding, and Fertility

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

Driving and Using Machines

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

Donesyn Contains Lactose

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

Donesyn Contains Sodium

The Medication Contains Less Than 1 mmol (23 mg) of Sodium per Tablet, Which Means the Medication is Considered "Sodium-Free".

3. How to Take Donesyn

Always Take this Medication Exactly as the Doctor Has Advised. If You are Not Sure, Ask the Doctor or Pharmacist.
The Patient Should Inform the Doctor or Pharmacist of the Name of Their Caregiver. The Caregiver Will Help the Patient Take the Prescribed Medication.
The Dose of Donesyn May Vary Depending on the Duration of Treatment and the Doctor's Recommendations.
The Recommended Initial Dose is One 5 mg Donepezil Hydrochloride Tablet Taken in the Evening.
After One Month, the Doctor May Increase the Dose to One 10 mg Donesyn Tablet (10 mg Donepezil Hydrochloride) Taken in the Evening.
The Maximum Recommended Daily Dose is 10 mg.
In Cases Where the Dose Cannot be Achieved with this Strength, Other Strengths of this Medication are Available.
In Patients with Impaired Renal Function, No Dose Adjustment is Necessary.
In Patients with Mild and Moderate Liver Impairment, Dose Titration Should be Performed According to Individual Patient Tolerance. In Cases of Severe Liver Impairment, Donesyn Should Not be Taken (See Section 2, Before Taking Donesyn). In Cases of Unexplained Liver Disease, the Doctor May Decide to Completely Discontinue Treatment with Donesyn.
The Donesyn Tablet(s) Should be Taken Orally, with Water, in the Evening, Before Bedtime.
If the Patient Experiences Unusual Dreams, Nightmares, or Difficulty Falling Asleep (See Section 4), the Doctor May Recommend Taking Donesyn in the Morning.
The Doctor Will Inform How Long to Take Donesyn. Regular Contact with the Doctor Should be Maintained to Verify the Treatment and Assess the Symptoms.

Taking More Than the Recommended Dose of Donesyn

Symptoms of Overdose May Include: Severe Nausea, Vomiting, Salivation, Excessive Sweating, Bradycardia (Slow Heart Rate), Hypotension, Respiratory Depression. Muscle Weakness (Collapse) and Involuntary Muscle Contractions (Seizures) May Also Occur, as Well as Increasing Muscle Weakness, Which Can be Life-Threatening.
If a Larger Dose of Donesyn is Taken Than Recommended, the Doctor Should be Informed Immediately or the Patient Should Go to the Nearest Hospital. The Package Leaflet and Medication Packaging Should be Taken Along.

Missing a Dose of Donesyn

Do Not Take a Double Dose to Make Up for a Missed Dose.
Take the Next Dose at the Usual Time.
If Donesyn Has Been Missed for More Than One Week, Consult the Doctor Before Taking the Medication Again.

Stopping Donesyn Treatment

Do Not Stop Taking the Medication, Even if the Patient Feels Well, Unless the Doctor Recommends it.
If There are Any Further Questions About the Use of this Medication, Ask the Doctor or Pharmacist.

4. Possible Side Effects

Like All Medications, Donesyn Can Cause Side Effects, Although Not Everybody Gets Them.
Severe Side Effects:
If Any of the Following Severe Side Effects Occur, Seek Medical Attention Immediately, as Prompt Medical Attention May be Necessary.

• Liver Dysfunction, Including Hepatitis. Symptoms of Hepatitis are Nausea or Vomiting, Loss of Appetite, General Feeling of Being Unwell, Fever, Itching, Yellowing of the Skin and Eyes, Dark Urine (May Affect Up to 1 in 1,000 People)
• Stomach or Duodenal Ulcers. Symptoms of Ulcers are Stomach Pain and Discomfort in the Upper Abdomen (Indigestion) (May Affect Up to 1 in 100 People)
• Bleeding from the Stomach or Intestine. May Cause Black, Tarry Stools or Blood in the Stool (May Affect Up to 1 in 100 People)
• Seizures or Convulsions (May Affect Up to 1 in 100 People)
• Fever with Muscle Stiffness, Sweating, or Decreased Consciousness (a Condition Called Neuroleptic Malignant Syndrome) (May Affect Up to 1 in 10,000 People)
• Weakness, Tenderness, or Pain in the Muscles, Especially if Accompanied by Feeling Unwell, High Temperature, or Dark Urine. These Symptoms May be Caused by Abnormal Breakdown of Muscle Cells, Which Can be Life-Threatening and Lead to Kidney Dysfunction (a Condition Called Rhabdomyolysis) (May Affect Up to 1 in 10,000 People)

Very Common(May Affect More Than 1 in 10 People):

• Diarrhea
• Nausea
• Headache

Common(May Affect Up to 1 in 10 People):

• Cold
• Loss of Appetite (Anorexia)
• Hallucinations
• Agitation
• Aggressive Behavior
• Unusual Dreams, Including Nightmares
• Fainting
• Dizziness
• Sleep Disturbances (Insomnia)
• Vomiting
• Stomach Upset
• Rash
• Fatigue
• Sleep Disturbances (Insomnia)
• Itching
• Muscle Cramps
• Urinary Incontinence
• Accidents (Patients May be More Prone to Falls and Accidental Injuries)
• Pain

Uncommon(May Affect Up to 1 in 100 People):

• Bradycardia (Slow Heart Rate)
• Slightly Increased Muscle Enzyme Levels in the Blood

Rare(May Affect Up to 1 in 1,000 People):

• Involuntary Body and Face Movements (Extrapyramidal Symptoms)
• Certain Heart Conduction Disorders Leading to Heart Rhythm Disturbances (Sinoatrial Block, Atrioventricular Block)

Frequency Not Known(Frequency Cannot be Estimated from the Available Data):

• Changes in Heart Function Visible on the ECG Called "Prolonged QT Interval"
• Fast, Irregular Heartbeat, Fainting, Which Can be Symptoms of a Life-Threatening Condition Called Torsades de Pointes
• Increased Libido, Hypersexuality
• A Condition Called "Pisa Syndrome" (Characterized by Involuntary Muscle Contraction with Abnormal Twisting of the Body and Head to One Side).

Reporting Side Effects
If Any Side Effects Occur, Including Any Not Mentioned in the Package Leaflet, Tell the Doctor or Pharmacist. Side Effects Can be Reported Directly to the Department of Medicinal Product Monitoring, 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 or Their Representative.

5. How to Store Donesyn

Keep the Medication Out of Sight and Reach of Children.
Do Not Use the Medication After the Expiration Date Stated on the Carton and Blister Pack After: EXP.
The Expiration Date Refers to the Last Day of the Specified Month.
Store in a Temperature Below 30°C.
Medications Should Not be Disposed of via Wastewater or Household Waste. Ask the Pharmacist How to Dispose of Medications That are No Longer Needed. This Will Help Protect the Environment.

6. Package Contents and Other Information

What Donesyn Contains

The Active Substance is Donepezil Hydrochloride.
Each 10 mg Donesyn Film-Coated Tablet Contains 10.44 mg of Donepezil Hydrochloride Monohydrate, Equivalent to 10 mg of Donepezil Hydrochloride, Which is Equivalent to 9.12 mg of Donepezil.
The Other Ingredients of the Tablet Core are: Lactose Monohydrate, Microcrystalline Cellulose (E460), Sodium Carboxymethylcellulose (Type A), Hydroxypropylcellulose (E463), Magnesium Stearate (E470b).
The Ingredients of the Tablet Coating are: Hypromellose (E464), Lactose Monohydrate, Macrogol 4000, Titanium Dioxide (E171), and Yellow Iron Oxide (E172).

What Donesyn Looks Like and What the Package Contains

Donesyn 10 mg Film-Coated Tablets are Yellow, Round, and Biconvex Tablets with a Notch and the Engraving D9EI on One Side and the Number 10 on the Other Side.
The Film-Coated Tablets are Available in Blisters of 7, 28, 30, 50, 56, 60, 84, 98, 100, 120 Film-Coated Tablets and in Divisible Blisters for Single Doses of 50 Film-Coated Tablets (Exclusively for Hospital Use).
Not All Pack Sizes May be Marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
Vipharm S.A.
A. and F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
Poland

Manufacturers:

Synthon BV
Microweg 22
6545 CM, Nijmegen
Netherlands
Synthon Hispania S.L.
Castelló 1, Polígono Las Salinas
08830 San Boi de Llobregat
Spain

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Germany
Donesyn 10 mg Filmtabletten
Bulgaria
Donesyn 10 mg Филмирана таблетка
Czech Republic
Donpethon 10 mg, Potahovaná Tableta
Estonia
Donesyn 10 mg
Greece
Donepezil Synthon Hispania 10 mg
Finland
Donesyn 10 mg Tabletti
Hungary
Donesyn 10 mg Filmtabletta
Ireland
Donesyn 10 mg Film-Coated Tablets
Iceland
Donesyn 10 mg Filmuhúðaðar Töflur
Lithuania
Donesyn 10 mg Plėvele Dengtos Tabletės
Latvia
Donesyn 10 mg Apvalkotās Tabletes
Norway
Donesyn 10 mg Tablett
Poland
Donesyn
Portugal
Dosylien 10 mg Comprimidos Revestidos por Película
Romania
Donesyn 10 mg
Slovenia
Donesyn 10 mg Filmsko Obložene Tablete
Slovakia
Donesyn 10 mg
Date of Package Leaflet Approval:01.11.2022