APO-DOPERIL 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Package Leaflet Contents:
2. What Apo-Doperil is and what it is used for
3. Important information before taking Apo-Doperil
   1. When not to take Apo-Doperil:
   2. Warnings and precautions
   3. Children and adolescents
   4. Apo-Doperil and other medicines
   5. Taking Apo-Doperil with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Apo-Doperil contains lactose
4. How to take Apo-Doperil
   1. How to take the medicine
   2. Dosage
   3. Taking Apo-Doperil in children and adolescents
   4. How long to take Apo-Doperil
   5. Taking more Apo-Doperil than prescribed
   6. Missing a dose of Apo-Doperil
   7. Stopping treatment with Apo-Doperil
5. Possible side effects
   1. Tell your doctor if you experience any of the following side effects.
   2. Severe side effects:
   3. Other side effects
   4. Reporting side effects
6. How to store Apo-Doperil
7. Contents of the pack and other information
   1. What Apo-Doperil contains
   2. What Apo-Doperil looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Apotex Europe B.V.
   5. Apotex Nederland B.V.
   6. Special Product's line S.p.A.
   7. Date of last revision of the package leaflet: 09.2020

Package Leaflet: Information for the Patient

Apo-Doperil, 5 mg, film-coated tablets
Apo-Doperil, 10 mg, film-coated tablets
Donepezil hydrochloride

Read the package leaflet carefully before taking the medicine, 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 medicine 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, please inform your doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 1. What Apo-Doperil is and what it is used for
• 2. Important information before taking Apo-Doperil
• 3. How to take Apo-Doperil
• 4. Possible side effects
• 5. How to store Apo-Doperil
• 6. Contents of the pack and other information

1. What Apo-Doperil is and what it is used for

Apo-Doperil belongs to a group of medicines called acetylcholinesterase inhibitors.
Donepezil (the active substance of the medicine) increases the concentration in the brain of a substance (acetylcholine) involved in the process of remembering, as a result of slowing down its breakdown.
The medicine is used to treat the symptoms of dementia in people diagnosed with mild to moderate Alzheimer's disease. These symptoms include increasing memory loss, disorientation, and changes in behavior. Their consequence is increasing difficulty in performing everyday activities by patients with Alzheimer's disease.
Apo-Doperil is intended for use only in adult patients.

2. Important information before taking Apo-Doperil

When not to take Apo-Doperil:

if you are allergic to donepezil hydrochloride, piperidine derivatives, or any of the other ingredients of this medicine (listed in section 6).
Do not take this medicine if any of the above situations apply to you. If in doubt, tell your doctor or pharmacist before taking Apo-Doperil.

Warnings and precautions

Before starting to take Apo-Doperil, discuss it with your doctor or pharmacist if you have or have had in the past:
stomach or duodenal ulcers
seizures or convulsions
heart disease (irregular or very slow heart rate)
asthma or other chronic lung disease
liver disorders or hepatitis
difficulty urinating or mild kidney disease.
You should also tell your doctor if you are pregnant or think you may be pregnant.

Children and adolescents

Apo-Doperil film-coated tablets should not be used in children and adolescents under 18 years of age.

Apo-Doperil and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take. This includes medicines not prescribed by a doctor that you have bought yourself from a pharmacy. This is important because some medicines may weaken or strengthen the effect of Apo-Doperil.
It is especially important to tell your doctor if you are taking any of the following types of medicines:
other medicines used in Alzheimer's disease, such as galantamine
painkillers or medicines used to treat arthritis, such as acetylsalicylic acid (aspirin), non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac
cholinolytic medicines, such as tolterodine
antibiotics, such as erythromycin, rifampicin
antifungal medicines, such as ketoconazole
antidepressants, such as fluoxetine
antiepileptic medicines, such as phenytoin, carbamazepine
medicines used in heart diseases, such as quinidine, beta-blockers (propranolol and atenolol)
muscle relaxants, such as diazepam, succinylcholine
general anesthetics
over-the-counter medicines, such as herbal medicines.
If you are going to have surgery that requires general anesthesia, you should inform the surgeon and anesthesiologist that you are taking Apo-Doperil. The medicine may interfere with the effect of the anesthetic.
Apo-Doperil can be used in patients with kidney or mild to moderate liver disease. You should tell your doctor if you have kidney or liver disease. Do not take Apo-Doperil if you have severe liver disease.
You should give your doctor or pharmacist the name of your caregiver. The caregiver will help you take the medicine according to the doctor's instructions.

Taking Apo-Doperil with food, drink, and alcohol

Food does not affect the action of Apo-Doperil.
Apo-Doperil should not be taken with alcohol, as it may change the effect of the medicine.

Pregnancy, breastfeeding, and fertility

Apo-Doperil should not be taken during breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Alzheimer's disease may impair your ability to drive or operate machinery, so you should not perform these activities unless your doctor tells you it is safe to do so.
Additionally, taking the medicine may cause drowsiness, dizziness, and muscle cramps. If you experience any of these effects, you should not drive or operate machinery.

Apo-Doperil contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Apo-Doperil

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

How to take the medicine

Take the medicine in the evening before going to bed.
Swallow the tablets whole with water.

Dosage

Treatment usually starts with a dose of 5 mg (one white tablet) taken once daily in the evening. After one month, your doctor may increase the dose to 10 mg (one yellow tablet) taken once daily in the evening.
Take one Apo-Doperil tablet with water in the evening before bedtime.
The strength of the tablet you take may be different depending on the duration of treatment and the dose prescribed by your doctor. The maximum recommended dose is 10 mg once daily in the evening.
Always follow the instructions of your doctor or pharmacist regarding the method and time of taking the medicine. Do not change the dose yourself without consulting your doctor.

Taking Apo-Doperil in children and adolescents

Apo-Doperil should not be used in children and adolescents under 18 years of age.

How long to take Apo-Doperil

Your doctor or pharmacist will tell you how long to take the medicine. You should have regular check-ups with your doctor to monitor your treatment and examine your symptoms.

Taking more Apo-Doperil than prescribed

DO NOT take more than one tablet per day. If you have taken more Apo-Doperil than prescribed, contact your doctor immediately. If this is not possible, go to the hospital immediately. Always take the tablets and the package of the medicine with you to the hospital, so the doctor knows what medicine has been taken.
Symptoms of overdose include nausea and vomiting, salivation, sweating, slow heart rate, low blood pressure (feeling of emptiness in the head or dizziness when standing up), difficulty breathing, loss of consciousness, and seizures or convulsions.

Missing a dose of Apo-Doperil

If you forget to take a dose, take one tablet the next day at the usual time. Do not take a double dose to make up for the missed tablet.
If you forget to take the medicine for more than a week, contact your doctor before resuming treatment.

Stopping treatment with Apo-Doperil

Do not stop taking the tablets unless your doctor tells you to do so. After stopping treatment with Apo-Doperil, the benefits of treatment will gradually disappear.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Apo-Doperil can cause side effects, although not everybody gets them.
The following side effects have been reported in patients taking this medicine.

Tell your doctor if you experience any of the following side effects.

Severe side effects:

Tell your doctor immediately if you experience any of the following severe side effects. You may need urgent medical attention.
liver damage, such as hepatitis. Symptoms of hepatitis are nausea (vomiting) or vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, dark urine (may occur less frequently than in 1 in 1000 people).
stomach or duodenal ulcers. Symptoms of ulcers are stomach pain and discomfort (indigestion) felt between the navel and the chest (may occur less frequently than in 1 in 100 people).
bleeding from the stomach or intestines. It may cause black stools or visible blood from the anus (may occur less frequently than in 1 in 100 people).
seizures or convulsions (may occur less frequently than in 1 in 100 people).
fever, muscle stiffness, sweating, or decreased level of consciousness (a condition known as neuroleptic malignant syndrome) (may occur less frequently than in 1 in 10,000 people).
muscle weakness, tenderness, or pain, especially in combination with malaise, high fever, or dark urine. This may be caused by the breakdown of muscle cells, which can be life-threatening and lead to kidney problems (a condition known as rhabdomyolysis) (may occur less frequently than in 1 in 10,000 people).

Other side effects

Very common side effects(may occur more frequently than in 1 in 10 people):
diarrhea
headache.
Common side effects(may occur less frequently than in 1 in 10 people):
muscle cramps
fatigue
difficulty sleeping (insomnia)
common cold
hallucinations (seeing or hearing things that do not exist)
abnormal dreams, including nightmares
agitation
aggressive behavior
fainting
dizziness
discomfort in the stomach
skin rash
incontinence (loss of bladder control)
pain
accidents (patients may be more prone to falls and accidental injuries).
Uncommon side effects(may occur less frequently than in 1 in 100 people):
slow heart rate
mild increase in serum activity of a certain muscle enzyme (creatine kinase)
excessive salivation.
Rare side effects(may occur less frequently than in 1 in 1000 people):
stiffness of the body, tremors, or uncontrolled movements of the body, especially the face and tongue, but also limbs
disorders of the electrical conduction system of the heart (sinoatrial block, atrioventricular block).

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your 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, Al. Jerozolimskie 181C, PL-02 222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Apo-Doperil

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month. The batch number is stated after the prefix "Lot".
There are no special precautions for storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Apo-Doperil contains

• The active substance of the medicine is donepezil hydrochloride. Each Apo-Doperil 5 mg tablet contains 5 mg of donepezil hydrochloride, equivalent to 4.56 mg of donepezil. Each Apo-Doperil 10 mg tablet contains 10 mg of donepezil hydrochloride, equivalent to 9.12 mg of donepezil.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, magnesium stearate, hypromellose (E464), talc (E553b), macrogol 8000, and titanium dioxide (E171). The 10 mg tablet also contains yellow iron oxide (E172).

What Apo-Doperil looks like and contents of the pack

Apo-Doperil 5 mg: white or almost white, round, biconvex, film-coated tablets with "APO" on one side and "DO" above "5" on the other.
Apo-Doperil 10 mg: light yellow or yellow, round, biconvex, film-coated tablets with "APO" on one side and "DO" above "10" on the other.
Apo-Doperil 5 mg is available in blisters of 28 film-coated tablets.
Apo-Doperil 10 mg is available in blisters of 28 and 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Apotex Europe B.V.

Archimedesweg 2
2333 CN Leiden
Netherlands
Manufacturer:

Apotex Nederland B.V.

Archimedesweg 2
2333 CN Leiden
Netherlands

Special Product's line S.p.A.

Via Fratta Rotonda Vado Largo 1-03012
Anagni (FR)
Italy

Date of last revision of the package leaflet: 09.2020