Package leaflet: Information for the user

Donectil, 5 mg, film-coated tablets
Donectil, 10 mg, film-coated tablets
Donepezili hydrochloridum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.

Contents of the leaflet:

What Donectil is and what it is used for
What you need to know before taking Donectil
How to take Donectil
Possible side effects
How to store Donectil
Contents of the pack and other information

1. What Donectil is and what it is used for

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

2. Important information before using Donectil

When not to use Donectil

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

Warnings and precautions
Before starting treatment with Donectil, discuss with a doctor or pharmacist if:

the patient has ever had stomach or duodenal ulcers
the patient has ever experienced epileptic or convulsive seizures
the patient has or has had heart conditions (such as irregular or very slow heartbeat, heart failure, myocardial infarction)
the patient has or has had a heart condition called "prolonged QT interval" or has previously experienced certain heart rhythm disorders known as torsade de pointes, or has a family history of "prolonged QT interval"
the patient has or has had low blood levels of magnesium or potassium
the patient has bronchial asthma (difficulty breathing) or another chronic lung disease
the patient has ever had hepatitis or other liver diseases
the patient has difficulty urinating or has mild kidney disease

Donectil may be used in patients with mild to moderate kidney or liver disease. The doctor should be informed about any kidney or liver disease before starting treatment. Patients with severe liver disease should not take Donectil.

Donectil and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

Always inform the doctor or pharmacist if any of the following medicines are taken together with Donectil:

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

If a surgical procedure requiring general anaesthesia (general anaesthetic) is planned, the patient should inform the doctor and anaesthetist about taking Donectil. This medicine may affect the amount of anaesthetic required.

Donectil with food, drink and alcohol
Donectil should be taken with liquid (a glass of water). Food does not affect the action of the medicine. Alcohol intake should be limited during treatment with donepezil, as alcohol may reduce the blood concentration of donepezil.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Donectil should not be used during breastfeeding.

Driving and operating machinery
Patients should not drive, as Alzheimer's disease may impair the ability to do so, nor operate mechanical equipment. These activities should not be undertaken until a doctor decides it is safe.
Do not use any devices or operate machinery, as the medicine may cause fatigue, dizziness, and muscle cramps. If these symptoms occur, driving and operating mechanical equipment must be avoided.

Donectil contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.

3. How to use Donectil

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult
your doctor or pharmacist.
The recommended dose is 5 mg once daily, taken in the evening before bedtime. After one month,
the doctor may recommend increasing the dose to 10 mg once daily, taken 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 the patient experiences
unusual dreams, nightmares, or difficulty sleeping (see section 4), the doctor may advise taking
Donectil in the morning instead.
The dose of the medicine may change depending on the duration of treatment and the doctor's
recommendations. Always follow your doctor's or pharmacist's instructions regarding how to take
the medicine. Do not change the dose without consulting your doctor. Your doctor or pharmacist
will advise you on the appropriate duration of treatment. Periodic consultations with your doctor
are necessary to assess the effectiveness of treatment and the course of the disease.
Taking more Donectil than recommended
Do not take more than one tablet per day. If an overdose occurs, symptoms such as nausea,
vomiting, excessive salivation, sweating, slowed heart rate, low blood pressure (dizziness upon
standing), breathing difficulties, collapse, and seizures may occur. In case of overdose, seek
immediate medical advice from your doctor or go to the nearest hospital.
Always bring the medicine in its original packaging so the doctor knows which medicine has been
taken.
If you miss a dose of Donectil
If you miss a dose, take one tablet the next day at your usual time. If you have not taken the medicine
for more than one week, contact your doctor before restarting treatment. Do not take a double
dose to make up for a missed dose.
Stopping Donectil treatment
Do not stop taking this medicine unless your doctor advises you to do so.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Patients taking Donectil have reported the following adverse reactions:
Serious adverse reactions:
Inform your doctor immediately if the patient experiences any of the following serious adverse reactions. Immediate medical attention may be required.
Uncommon: may affect up to 1 in 100 people
Gastric and duodenal ulcers. Symptoms of ulcers include: abdominal pain and discomfort (dyspepsia) felt between the navel and the breastbone.
Gastrointestinal bleeding. This may cause black, tarry stools or visible rectal bleeding.
Seizures or convulsions.
Rare: may affect up to 1 in 1,000 people
Liver damage, for example, hepatitis. Symptoms of hepatitis include: nausea or vomiting, malaise, loss of appetite, fever, itching, yellowing of the skin and eyes (jaundice), and dark urine.
Very rare: may affect up to 1 in 10,000 people
Fever with muscle rigidity, sweating, and reduced level of consciousness (a complication known as neuroleptic malignant syndrome).
Muscle weakness, tenderness, or pain, especially when 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 known as rhabdomyolysis).
Frequency not known:

Changes in heart function visible on ECG known as "QT interval prolongation"
Rapid, irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called torsade de pointes.

You should report these symptoms to your doctor during treatment with Donectil.
Other adverse reactions:
Very common: may affect more than 1 in 10 people

diarrhoea
nausea
headache

Common: may affect up to 1 in 10 people

cold symptoms • injuries (patients may be more prone to falls and accidental injuries)
loss of appetite • vomiting
abdominal discomfort • hallucinations (seeing or hearing things that are not really there)
unusual dreams, including nightmares • rash
restlessness • itching
aggressive behaviour • muscle cramps
fainting • urinary incontinence
dizziness • fatigue
insomnia (difficulty falling asleep) • pain

Uncommon: may affect up to 1 in 100 people

slow heart rate
slight increase in serum creatine kinase concentration

Rare: may affect up to 1 in 1,000 people

sinoatrial block, atrioventricular block
muscle stiffness or uncontrolled movements, particularly of the face and tongue, but also of the limbs

Frequency not known:

increased libido, hypersexuality
the "Pisa syndrome" (involuntary muscle contractions causing abnormal twisting of the body and head to one side)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Donectil

Do not store above 30°C.
Keep the medicine out of 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine Donectil contains
The active substance is donepezil hydrochloride.
5 mg tablet: one tablet contains 5 mg of donepezil hydrochloride, equivalent to 4.56 mg of free base donepezil.
10 mg tablet: one tablet contains 10 mg of donepezil hydrochloride, equivalent to 9.12 mg of free base donepezil.
Other ingredients are:
Tablet core:
Lactose monohydrate, corn starch, hydroxypropylcellulose, 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 packaging
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 break line on one side.
Donectil is packed in PVC/PE/PVDC/Aluminium 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 Authorisation 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.
ul. Przemysłowa 2
35-959 Rzeszów
Poland