Donectil

Package Leaflet: Information for the User

Donectil, 5 mg, Film-Coated Tablets

Donectil, 10 mg, Film-Coated Tablets

Donepezil Hydrochloride

Read All of This Leaflet Carefully Before You Start Taking This Medicine Because It Contains Important Information for You.

• You should 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the Pack and Other Information

• 1. What is Donectil and What is it Used For
• 2. Before You Take 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 to moderate dementia in Alzheimer's disease. It is intended for use in adult patients only.

2. Before You Take 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, you should 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 problems (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 ever had a condition called torsades de pointes or have a family history of "prolonged QT interval".
• you have or have had low levels of magnesium or potassium in the blood
• you have asthma or other chronic lung disease
• you have ever had liver problems, including hepatitis
• 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. You should inform your doctor if you have kidney or liver disease before starting treatment. Patients with severe liver disease should not take Donectil.

Donectil with Other Medicines

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

• other medicines for Alzheimer's disease, such as galantamine
• medicines for irregular heartbeats, such as amiodarone, sotalol
• medicines for depression, such as citalopram, escitalopram, amitriptyline, fluoxetine
• medicines for psychosis, such as pimozide, sertindole, ziprasidone
• medicines for bacterial infections, such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungal medicines, such as ketoconazole
• pain relievers or anti-inflammatory medicines, 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 for heart conditions, such as quinidine, beta-blockers (propranolol and atenolol)
• medicines for general anesthesia
• over-the-counter medicines, such as herbal remedies.

If you are going to have an operation that requires general anesthesia, you should tell your doctor and anesthesiologist that you are 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. Food does not affect the action of the medicine.
While taking donepezil, you should limit your alcohol intake, as alcohol may reduce the levels of donepezil in your blood.

Pregnancy and Breast-Feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Donectil should not be used during breast-feeding.

Driving and Using Machines

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

Donectil Contains Lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to Take Donectil

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is 5 mg once daily, taken in the evening before bedtime. After one month, your doctor may increase 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 you experience unusual dreams, nightmares, or difficulty sleeping (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. You will need to have regular check-ups with your doctor to assess the effectiveness of the treatment and the progression of the disease.

If You Take More Donectil Than You Should

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

If You Forget to Take 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.

If You Stop Taking Donectil

Do not stop taking the medicine unless your doctor tells you to.
If you have any questions about taking this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

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

Serious Side Effects:

You should immediately inform your doctor if you notice any of the following serious 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 you also feel unwell, have a high fever, or have 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 seen on an ECG called "prolonged QT interval"
• Rapid, irregular heartbeat, fainting, which can be symptoms of a life-threatening condition called torsades de pointes.

You should inform your doctor if you experience any of these symptoms 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)
• unusual dreams, including nightmares
• rash
• agitation
• itching
• aggressive behavior
• muscle cramps
• fainting
• incontinence
• dizziness
• fatigue
• insomnia (difficulty sleeping)
• 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 "torticollis" (involuntary muscle contraction leading to abnormal twisting of the head and neck)

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects 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
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Donectil

Do not store above 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Other Information

What 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 donepezil base.
10 mg tablet: one tablet contains 10 mg of donepezil hydrochloride, equivalent to 9.12 mg of free donepezil base.
The other ingredients are:
Tablet 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, film-coated tablets, approximately 7.5 mm in diameter.
10 mg tablets: white, round, film-coated tablets, approximately 9.3 mm in diameter, with a score line on one side.
Donectil is packaged in PVC/PE/PVDC/Aluminum blisters. Each blister contains 14 film-coated tablets.
Pack sizes:
5 mg: 14, 28, 42, 56, 84, 98, 112 film-coated tablets.
10 mg: 14, 28, 42, 56, 84, 98, 112 film-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