Donepezil sanexcel

Package leaflet: Information for the user

Donepezil SaneXcel, 5 mg, film-coated tablets
Donepezil SaneXcel, 10 mg, film-coated tablets
Donepezili hydrochloridum
Please read 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Donepezil SaneXcel is and what it is used for
2. What you need to know before taking Donepezil SaneXcel
3. How to take Donepezil SaneXcel
4. Possible side effects
5. How to store Donepezil SaneXcel
6. Contents of the pack and other information

1. What Donepezil SaneXcel is and what it is used for

Donepezil SaneXcel (donepezil hydrochloride) belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil increases the concentration in the brain of a substance (acetylcholine) involved in memory function by slowing down the breakdown of acetylcholine.
It is used for the symptomatic treatment of dementia in patients diagnosed with mild to moderate Alzheimer's disease. The symptoms of the disease include increasing memory loss, confusion, and changes in behaviour. As a result, patients with Alzheimer's disease have increasing difficulty performing daily activities.
This medicine is intended for use in adult patients only.

2. Important information before taking Donepezil SaneXcel

When not to take Donepezil SaneXcel

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

Warnings and precautions
Before starting treatment with Donepezil SaneXcel, discuss this with your doctor or
pharmacist.
Tell your doctor or pharmacist if the patient has or has had:

• stomach or duodenal ulcers
• seizures or convulsions
• heart diseases (such as irregular or very slow heartbeat, heart failure, myocardial infarction)
• heart conditions known as "prolonged QT interval" or a history of certain heart rhythm disorders called torsade de pointes, or if someone in the patient's family has "prolonged QT interval"
• low levels of magnesium or potassium in the blood
• asthma or other chronic lung diseases
• liver dysfunction or hepatitis
• difficulty in passing urine or mild kidney disease.

You should also inform the doctor if the patient is pregnant or suspects she may be pregnant.
Children and adolescents
Donepezil SaneXcel is not recommended for use in children and adolescents under 18 years of age.
Donepezil SaneXcel and other medicines
Tell your 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. This includes medicines not prescribed by a doctor but purchased over-the-counter at a pharmacy. It also includes medicines that may be taken in the future while continuing treatment with Donepezil SaneXcel.
These medicines may weaken or enhance the effect of Donepezil SaneXcel.
It is especially important to inform the doctor if the patient is taking any of the following types of medicines:

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

A patient scheduled for surgery requiring general anaesthesia should inform the doctor that they are taking Donepezil SaneXcel. This medicine may affect the amount of anaesthetic agent required.
Inform your doctor if the patient has kidney or liver disease. Patients with severe hepatic impairment should not take Donepezil SaneXcel. Donepezil SaneXcel may be used in patients with kidney disease and mild to moderate hepatic impairment.
Provide the patient’s caregiver’s name and surname to the doctor or pharmacist. The caregiver will assist the patient in taking the medicine according to the doctor’s instructions.
Donepezil SaneXcel with food, drink and alcohol
Food does not affect the action of Donepezil SaneXcel.
Do not take Donepezil SaneXcel with alcohol, as alcohol may alter its effects.
Pregnancy and breastfeeding
Do not use Donepezil SaneXcel during breastfeeding.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Donepezil SaneXcel should not be used in pregnant women unless absolutely necessary.
Driving and operating machinery
Alzheimer's disease may impair the ability to drive vehicles or operate machinery. The patient should not perform these activities unless the doctor confirms it is safe. In addition, donepezil may cause fatigue, dizziness, and muscle cramps. If any of these effects occur, the patient must not drive or operate machinery.
Donepezil SaneXcel contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to take Donepezil SaneXcel

This medicine should always be taken as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.
What dose of Donepezil SaneXcel should be taken?
Treatment usually starts with a dose of 5 mg (one white tablet) taken once daily in the evening.
After one month, the doctor may recommend increasing the dose to 10 mg (one yellow tablet),
taken once daily in the evening.
The Donepezil SaneXcel tablet should be swallowed with a drink or water in the evening before going to bed.
If the patient experiences unusual dreams, nightmares, or difficulty falling asleep (see section 4),
the doctor may recommend taking Donepezil SaneXcel in the morning instead.
The dose may change depending on the duration of treatment and the doctor's instructions.
The maximum recommended dose is 10 mg per day.
Always follow the doctor’s or pharmacist’s instructions regarding how and when to take the medicine.
Do not change the dose on your own without consulting your doctor.
How long should Donepezil SaneXcel be taken?
The doctor or pharmacist will advise the patient on how long to continue taking the tablets.
The patient should periodically consult the doctor to assess the effectiveness of treatment and disease symptoms.
Stopping the use of Donepezil SaneXcel
Do not stop taking the tablets unless instructed by the doctor. If treatment with Donepezil SaneXcel is discontinued,
the benefits of treatment will gradually diminish.
Taking more Donepezil SaneXcel than prescribed
Do not take more than one tablet per day. If a higher dose than recommended is taken, contact the doctor immediately.
If unable to contact a doctor, go to the nearest emergency department. Always bring the tablets and packaging to the hospital
so the doctor knows which medicine has been taken.
Symptoms of overdose include nausea, excessive salivation, sweating, slowed 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 Donepezil SaneXcel
If a dose is missed, take one tablet the next day at the usual time. Do not take a double dose to make up for the missed tablet.
If treatment has been missed for more than one week, contact the doctor before resuming the medicine.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
The following adverse reactions have been reported in people taking donepezil.
If any of the following adverse reactions occur while taking Donepezil SaneXcel, contact your doctor.

Serious adverse reactions:
Inform your doctor immediately if any of the serious adverse reactions listed below occur. Immediate medical help may be required.

• Muscle weakness, tenderness or pain, especially if accompanied by feeling unwell, high temperature or dark-coloured urine. These symptoms may be due to abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis).
• Liver damage, e.g. hepatitis. Symptoms of hepatitis include nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), and dark urine (may occur in up to 1 in 10,000 users).
• Stomach or duodenal ulcers. Symptoms of ulcers include stomach pain and discomfort (dyspepsia) felt between the navel and the breastbone (may occur in up to 1 in 1,000 users).
• Bleeding from the stomach or intestines. This may cause black, tarry stools or visible blood from the rectum (may occur in up to 1 in 1,000 users).
• Seizures or convulsions (may occur in up to 1 in 1,000 users).
• Fever with muscle stiffness, sweating, or reduced level of consciousness (a disorder known as "neuroleptic malignant syndrome") (may occur in less than 1 in 10,000 users).

Very common adverse reactions (may affect more than 1 in 10 users):

• Diarrhoea
• Nausea and vomiting
• Headache

Common adverse reactions (may affect up to 1 in 100 users):

• Muscle cramps
• Fatigue
• Difficulty sleeping (insomnia)
• Common cold
• Loss of appetite
• Hallucinations (seeing or hearing things that are not real)
• Unusual dreams, including nightmares
• Restlessness
• Aggressive behaviour
• Fainting
• Dizziness
• Stomach discomfort
• Skin rash
• Itching
• Urinary incontinence
• Pain
• Accidents (patients may be more prone to falls and accidental injuries)

Uncommon adverse reactions (may affect up to 1 in 1,000 users):

• Slow heartbeat
• Excessive salivation

Rare adverse reactions (may affect up to 1 in 1,000 users):

• Stiffness, tremor or involuntary movements, particularly of the face and tongue, but also of the limbs

Frequency not known (frequency cannot be estimated from available data):

• Changes in heart function seen on electrocardiogram (ECG), known as "prolongation of QT interval"
• Fast, irregular heartbeat, fainting, which may be symptoms of a life-threatening condition known as torsade de pointes
• Increased libido, hypersexuality
• Pisa syndrome (characterised by involuntary muscle contractions causing abnormal twisting of the body and head to one side)

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 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 this medicine.

5. How to store the medicine Donepezil SaneXcel

Keep the medicine out of sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the cardboard packaging and blister
after: EXP. 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 required. This will help protect the environment.

6. Contents of the pack and other information

What Donepezil SaneXcel contains
The active substance is donepezil hydrochloride.
Donepezil SaneXcel is available in two strengths: the 5 mg tablet contains 5 mg of donepezil hydrochloride, and the 10 mg tablet contains 10 mg of donepezil hydrochloride.
The other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose, maize starch, hydroxypropylcellulose, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E 171), talc, macrogol 400, and yellow iron oxide (E 172) (only for the 10 mg strength).

What Donepezil SaneXcel looks like and contents of the pack
Donepezil SaneXcel 5 mg tablets are white, round, biconvex, film-coated tablets with a diameter of 7.0 mm ± 0.2 mm.
Donepezil SaneXcel 10 mg tablets are yellow, round, biconvex, film-coated tablets with a diameter of 9.0 mm ± 0.2 mm.
Donepezil SaneXcel film-coated tablets are available in blisters containing 28 film-coated tablets, packed in a cardboard box.

Marketing Authorisation Holder:
J.J. Bishop Health a.s.
Rybná 682/14, Staré Město
110 00 Prague 1
Czech Republic
e-mail: [email protected]

Manufacturer:
Atlantic Pharma – Produções Farmacêuticas S.A.
Rua de Tapada Grande 2, Abrunheira
2710-228 Sintra
Portugal

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Donepezil SaneXcel
Czech Republic: Donepezil SaneXcel
Slovakia: Donepezil SaneXcel 5 mg
Donepezil SaneXcel 10 mg
Bulgaria: Донепезил Санексел 5 mg филмирани таблетки
Donepezil SaneXcel 5 mg film-coated tablets
Донепезил Санексел 10 mg филмирани таблетки
Donepezil SaneXcel 10 mg film-coated tablets
Hungary: Donepezil SaneXcel 5 mg filmtabletta
Donepezil SaneXcel 10 mg filmtabletta
Romania: Donepezil SaneXcel 5mg, 10 mg comprimate filmate
Portugal: Donepezilo J.J. Bishop