Donectil Odt

Package Leaflet: Information for the User

Donectil ODT, 10 mg, Orodispersible 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 You Only. Do Not Pass it on to Others. It May Harm Them, Even if Their Symptoms are the Same as Yours.
• If You Experience Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

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

1. What is Donectil ODT and What is it Used for

Donectil ODT Contains the Active Substance Donepezil Hydrochloride, Which Belongs to a Group of Medicines Called Acetylcholinesterase Inhibitors.
It is Used to Treat the Symptoms of Dementia (Disorders of Rational Behavior) in Patients with Mild to Moderate Alzheimer's Disease. It is Intended for Use in Adult Patients Only.

2. Important Information Before Taking Donectil ODT

When Not to Take Donectil ODT

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

Warnings and Precautions

Before Starting Treatment with Donectil ODT, Discuss with Your Doctor or Pharmacist if You Have Ever Had:
Stomach or Duodenal Ulcers
Seizures or Convulsions
Heart Conditions (Such as Irregular or Very Slow Heart Rate, Heart Failure, Myocardial Infarction),
A Condition Called "Prolonged QT Interval" or Have Had Certain Heart Rhythm Disorders Called Torsades de Pointes,
Low Magnesium or Potassium Levels in the Blood;
Asthma or Other Chronic Lung Disease
Liver Inflammation or Other Liver Diseases
Difficulty Urinating or Have Been Diagnosed with Mild Kidney Disease.
Donectil ODT Can be Used in Patients with Kidney or Liver Disease of Mild to Moderate Severity. Inform Your Doctor of Any Kidney or Liver Disease Before Starting Treatment. Patients with Severe Liver Disease Should Not Take Donectil ODT.

Donectil ODT and Other Medications

Tell Your Doctor or Pharmacist About All Medications You are Currently Taking, Have Recently Taken, or Plan to Take, Including Those Available Without a Prescription.
Always Inform Your Doctor or Pharmacist if You are Taking Any of the Following Medications with Donectil ODT:

• Other Medications for Alzheimer's Disease, Such as Galantamine
• Medications Used to Treat Heart Rhythm Disorders, Such as Amiodarone, Sotalol;
• Medications Used to Treat Depression, Such as Citalopram, Escitalopram, Amitriptyline, Fluoxetine,
• Medications Used to Treat Psychosis, Such as Pimozide, Sertindole, Ziprasidone,
• Medications Used to Treat Bacterial Infections, Such as Clarithromycin, Erythromycin, Levofloxacin, Moxifloxacin, Rifampicin
• Antifungal Medications, Such as Ketoconazole
• Pain or Anti-Inflammatory Medications, Such as Acetylsalicylic Acid, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Such as Ibuprofen or Sodium Diclofenac
• Anticholinergic Medications, Such as Tolterodine
• Muscle Relaxants, Such as Diazepam, Succinylcholine
• Anticonvulsant Medications, Such as Phenytoin, Carbamazepine
• Medications Used to Treat Heart Conditions, Such as Quinidine, Beta-Blockers (Propranolol and Atenolol)
• Medications Used for General Anesthesia
• Over-the-Counter Medications, Such as Herbal Remedies.

If You are Scheduled for Surgery Requiring General Anesthesia, Inform Your Doctor and Anesthesiologist that You are Taking Donectil ODT, as it May Affect the Amount of Anesthetic Needed.

Donectil ODT with Food, Drink, and Alcohol

Take Donectil ODT After the Tablet Has Dissolved on the Tongue, Swallowing it with a Glass of Water.
Food Does Not Affect the Action of the Medication. During Treatment with Donectil ODT, Limit Alcohol Consumption, as Alcohol May Decrease Donepezil Levels in the Blood.

Pregnancy and Breastfeeding

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 Take Donectil ODT During Breastfeeding.

Driving and Operating Machinery

Do Not Drive, as Alzheimer's Disease May Impair Your Ability to Drive, or Operate Machinery. Do Not Engage in These Activities Until Your Doctor Decides it is Safe.
Do Not Use Any Devices or Operate Machinery, as the Medication May Cause Drowsiness, Dizziness, and Muscle Cramps. If You Experience These Symptoms, Do Not Drive or Operate Machinery.

Donectil ODT Contains Lactose and Aspartame

Donectil ODT Contains Lactose. If You Have Been Diagnosed with Intolerance to Some Sugars, Consult Your Doctor Before Taking this Medication.
Donectil ODT Contains Aspartame (E 951), a Source of Phenylalanine. It May be Harmful to Patients with Phenylketonuria.

3. How to Take Donectil ODT

Always Take this Medication Exactly as Your Doctor Has Told You. If You are Not Sure, Ask Your Doctor or Pharmacist.
The Recommended Dose is 5 mg Once Daily, in the Evening Before Bedtime. After One Month, Your Doctor May Increase the Dose to 10 mg Once Daily, in the Evening Before Bedtime. The Maximum Recommended Daily Dose is 10 mg.
Take Donectil ODT Orally, in the Evening Before Bedtime. If You Experience Unusual Dreams, Nightmares, or Difficulty Falling Asleep (See Section 4), Your Doctor May Advise You to Take Donectil ODT in the Morning.
Place the Tablet on the Tongue and Wait for it to Dissolve Before Swallowing. You Can Then Drink Water or Not, Depending on Your Personal Preference.
The Dose of the Medication May be Changed Depending on the Duration of Treatment and Your Doctor's Recommendations.
Always Follow the Advice of Your Doctor or Pharmacist on How to Take the Medication. Do Not Change the Dose Without Consulting Your Doctor. Your Doctor or Pharmacist Will Advise You on How Long to Take the Medication. You Will Need to Have Regular Check-Ups with Your Doctor to Assess the Effectiveness of the Treatment and the Symptoms of the Disease.

Taking More Than the Recommended Dose of Donectil ODT

Do Not Take More Than One Tablet per Day. If You Take More Than the Recommended Dose, You May Experience Nausea, Vomiting, Salivation, Sweating, Slow Heart Rate, Low Blood Pressure (Dizziness When Standing Up), Breathing Difficulties, Collapse, and Seizures.
Immediately Contact Your Doctor or Go to the Nearest Hospital.
Always Take the Medication Packaging with You, so Your Doctor Knows Which Medication You Have Taken.

Missing a Dose of Donectil ODT

If You Miss a Dose, Take One Tablet the Next Day at the Usual Time. If You Have Not Taken the Medication for More Than a Week, Consult Your Doctor Before Taking it Again. Do Not Take a Double Dose to Make Up for the Missed Dose.

Stopping Treatment with Donectil ODT

Do Not Stop Taking the Medication Unless Your Doctor Advises You to Do So.
If You Have Any Questions About Taking the Medication, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medications, Donectil ODT Can Cause Side Effects, Although Not Everybody Gets Them.
Patients Taking Donectil ODT Have Reported the Following Side Effects:

Severe Side Effects:

Immediately Inform Your Doctor if You Notice Any of the Following Severe Side Effects, as You May Need Urgent Medical Attention.
Uncommon:May Affect Up to 1 in 100 People
Stomach and Duodenal Ulcers. Symptoms of Ulcers are: Stomach Pain and Discomfort (Indigestion) Felt Between the Navel and the Breastbone.
Bleeding from the Stomach or Intestines. This Can Cause Black, Tarry Stools or Visible Bleeding from the Anus.
Seizures or Convulsions.
Rare:May Affect Up to 1 in 1,000 People
Liver Damage, Such as Hepatitis. Symptoms of Hepatitis are: Nausea or Vomiting, Feeling Unwell, Loss of Appetite, Fever, Itching, Yellowing of the Skin and Eyes, Dark Urine.
Very Rare:May Affect Up to 1 in 10,000 People
Fever with Muscle Stiffness, Sweating, and Decreased Consciousness (a Condition Called Malignant Neuroleptic Syndrome).
Muscle Weakness, Tenderness, or Pain, Especially if it Occurs with Feeling Unwell, High Fever, or Dark Urine. This Can be Caused by Abnormal Muscle Breakdown, Which Can be Life-Threatening and Lead to Kidney Problems (a Condition Called Rhabdomyolysis).

Frequency Not Known:

Changes in Heart Function Visible on an ECG Called "Prolonged QT Interval"
Fast, Irregular Heartbeat, Fainting, Which Can be Symptoms of a Condition Called Torsades de Pointes, Which Can be Life-Threatening.
Report Any of These Symptoms to Your Doctor if You Experience Them While Taking Donectil ODT.

Other Side Effects:

Very Common:May Affect More Than 1 in 10 People

• Diarrhea
• Nausea
• Headache

Common:May Affect Up to 1 in 10 People

• Cold
• Injuries (Patients May be More Prone to Falls and Accidental Injuries)
• Loss of Appetite
• Vomiting
• Hallucinations (Seeing or Hearing Things That Do Not Exist)
• Abdominal Discomfort
• Unusual Dreams, Including Nightmares
• Rash
• Agitation
• Itching
• Aggressive Behavior
• Muscle Cramps
• Fainting
• Urinary Incontinence
• Dizziness
• Fatigue
• Insomnia (Difficulty Falling Asleep)
• Pain

Uncommon:May Affect Up to 1 in 100 People

• Slow Heart Rate
• Slightly Elevated Creatine Kinase Levels in the Blood

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

• Sinoatrial Block, Atrioventricular Block
• Muscle Stiffness or Uncontrolled Movements, Especially of the Face and Tongue, but Also of the Limbs

Frequency Not Known:

• Increased Libido, Hypersexuality
• Tower of Pisa Syndrome (Involuntary Muscle Contraction with Abnormal Twisting of the Body and Head to One Side)

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist, or Nurse. 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, Tel.: 22 49-21-301, Fax: 22 49-21-309, Email:
ndl@urpl.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 this Medication.

5. How to Store Donectil ODT

Keep the Medication 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.
There are No Special Precautions for the Storage of the Medicinal Product.
Do Not Throw Away 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. Package Contents and Other Information

What Donectil ODT Contains

The Active Substance of Donectil ODT is Donepezil Hydrochloride.
Each Tablet Contains 10 mg of Donepezil Hydrochloride.
Other Ingredients of the Medication are:
Potassium Polacrilin, Microcrystalline Cellulose, Lactose Monohydrate, Anhydrous Sodium Citrate, Aspartame (E 951), Croscarmellose Sodium, Colloidal Anhydrous Silica, Magnesium Stearate, Hydrochloric Acid to Adjust pH.

What Donectil ODT Looks Like and Contents of the Package

Round, Flat Tablets with Beveled Edges, White to Cream-Colored, with the Engraving "10" on One Side and Smooth on the Other, Containing 10 mg of Donepezil Hydrochloride.
Packaging:
PVC/Aclar/Aluminum and Aluminum/Aluminum Blisters Containing 7, 10, or 14 Tablets in a Cardboard Box.
Package Sizes:
30, 60 Orodispersible Tablets.
Not All Pack Sizes May be Marketed.

Marketing Authorization Holder

PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c
170 00 Prague 7
Czech Republic

Manufacturer

Genepharm S.A.
18 km Marathonos Avenue
153 51 Pallini Attikis
Greece
Bausch Health Poland sp. z o.o.
Przemysłowa 2
35-959 Rzeszów
Bausch Health Poland sp. z o.o.
Kosztowska 21
41-409 Mysłowice
Date of Last Revision of the Package Leaflet:October 2022