Donectil

Package Leaflet: Information for the User

Donectil, 5 mg, coated tablets

Donectil, 10 mg, coated tablets

Donepezil hydrochloride

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

Table of Contents of the Leaflet:

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

1. What is Donectil and what is it used for

Donectil contains the active substance donepezil hydrochloride, which belongs to a group of medicines called acetylcholinesterase inhibitors.
It is used to treat mild and moderate Alzheimer's disease. It is intended for use in adult patients only.

2. Important information before taking Donectil

When not to take Donectil

• if you are allergic to donepezil hydrochloride, piperidine derivatives, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Donectil, discuss with your doctor or pharmacist if:

• you have ever had stomach or duodenal ulcers
• you have ever had a seizure or convulsion
• you have or have had heart disease (such as irregular or very slow heart rate, heart failure, heart attack)
• you have or have had a condition called "prolonged QT interval" or have had certain heart rhythm disorders called torsades de pointes or have had a "prolonged QT interval" in the past.
• you have or have had low magnesium or potassium levels in the blood
• you have asthma or other chronic lung disease
• you have ever had liver inflammation or other liver diseases
• you have difficulty urinating or have been diagnosed with mild kidney disease.

Donectil may be used in patients with kidney or liver disease of mild to moderate severity. Inform your doctor about kidney or liver disease before starting treatment. Patients with severe liver disease should not take Donectil.

Donectil and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those obtained without a prescription.
Always inform your doctor or pharmacist if you are taking any of the following medicines with Donectil:

• other medicines for Alzheimer's disease, such as galantamine
• medicines used to treat heart rhythm disorders, such as amiodarone, sotalol
• medicines used to treat depression, such as citalopram, escitalopram, amitriptyline, fluoxetine
• medicines used to treat psychosis, such as pimozide, sertindole, ziprasidone
• medicines used to treat bacterial infections, such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungal medicines, such as ketoconazole
• painkillers or medicines used to treat joint inflammation, such as acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or sodium diclofenac
• anticholinergic medicines, such as tolterodine
• muscle relaxants, such as diazepam, succinylcholine
• antiepileptic medicines, such as phenytoin, carbamazepine
• medicines used to treat heart conditions, such as quinidine, beta-blockers (propranolol and atenolol)
• medicines used for general anesthesia
• over-the-counter medicines, such as herbal medicines.

In case of planned surgery requiring general anesthesia, the patient should inform the doctor and anesthesiologist about taking Donectil, as it may affect the amount of anesthetic needed.

Donectil with food, drink, and alcohol

Donectil should be taken with a drink of water (a glass of water). Food does not affect the action of the medicine. During treatment with donepezil, alcohol consumption should be limited, as alcohol may decrease the level of donepezil in the blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Donectil should not be used during breastfeeding.

Driving and using machines

Do not drive vehicles, as Alzheimer's disease may impair your ability to drive, or operate machinery. Do not perform these activities until your doctor decides it is safe.
Do not use any devices or operate machinery, as the medicine may cause drowsiness, dizziness, and muscle cramps. If you experience these symptoms, do not drive vehicles or operate machinery.

Donectil contains lactose.

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Donectil

Take this medicine always as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
The recommended dose is 5 mg once daily, in the evening before bedtime. After one month, your doctor may recommend taking 10 mg once daily, in the evening before bedtime. The maximum recommended daily dose is 10 mg.
Donectil should be taken orally, with water, in the evening before bedtime. If you experience unusual dreams, nightmares, or difficulty falling asleep (see section 4), your doctor may recommend taking Donectil in the morning.
The dose of the medicine may change depending on the duration of treatment and your doctor's recommendations.
Always follow your doctor's or pharmacist's instructions for taking the medicine. Do not change the dose without consulting your doctor. Your doctor or pharmacist will recommend the appropriate duration of treatment. Regular check-ups with your doctor will be necessary to assess the effectiveness of treatment and the symptoms of the disease.

Taking more than the recommended dose of Donectil

Do not take more than one tablet per day. If you take more than the recommended dose of Donectil, you may experience nausea, vomiting, salivation, sweating, slow heart rate, low blood pressure (dizziness when standing up), breathing difficulties, collapse, and seizures. If you take too much of the medicine, contact your doctor immediately or go to the nearest hospital.
Always take the medicine in its packaging, so your doctor knows what medicine you have taken.

Missing a dose of Donectil

If you miss a dose, take one tablet the next day at the usual time. If you do not take the medicine for more than a week, consult your doctor before taking it again. Do not take a double dose to make up for a missed dose.

Stopping treatment with Donectil

Do not stop taking the medicine unless your doctor recommends it.
If you have any doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Donectil can cause side effects, although not everybody gets them.
Patient taking Donectil have reported the following side effects:

Severe side effects:

Inform your doctor immediately if you notice any of the following severe side effects. 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 may 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 neuroleptic malignant syndrome).
Muscle weakness, tenderness, or pain, especially if occurring with feeling unwell, 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).

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 condition called torsades de pointes, which can be life-threatening.

Inform your doctor about any of these symptoms that occur while taking Donectil.

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 in reality)
• unusual dreams, including nightmares
• rash
• agitation
• itching
• aggressive behavior
• muscle cramps
• fainting
• incontinence
• dizziness
• fatigue
• insomnia (difficulty falling asleep)
• pain

Uncommon:may affect up to 1 in 100 people

• slow heart rate
• mild increase in 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
• a condition called "Pisa tower 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 leaflet, inform your doctor or 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: 22 49-21-301
Fax: 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 medicine.

5. How to store Donectil

Do not store above 30°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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 Donectil contains

The active substance of Donectil is donepezil hydrochloride.
5 mg tablet: one tablet contains 5 mg of donepezil hydrochloride, equivalent to 4.56 mg of free donepezil base.
10 mg tablet: one tablet contains 10 mg of donepezil hydrochloride, equivalent to 9.12 mg of free donepezil base.
Other ingredients of the medicine are:
Core:
Lactose monohydrate, corn starch, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate.
Coating:
Opadry White: HPMC 2910/hypromellose 5 cP (E464), titanium dioxide (E171), propylene glycol, talc.

What Donectil looks like and contents of the pack

5 mg tablets: white, round, coated tablets with a diameter of approximately 7.5 mm.
10 mg tablets: white, round, coated tablets with a diameter of approximately 9.3 mm, with a dividing line on one side.
Donectil is packaged in PVC/PE/PVDC/Aluminum blisters. Each blister contains 14 coated tablets.
Pack sizes:
5 mg: 14, 28, 42, 56, 84, 98, 112 coated tablets.
10 mg: 14, 28, 42, 56, 84, 98, 112 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

PharmaPath S.A.
28is Oktovriou 1,
Agia Varvara, 123 51
Greece
Bausch Health Poland sp. z o.o.
Przemysłowa 2
35-959 Rzeszów
Date of last revision of the leaflet:October 2022