Donepezil Sun 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Donepezil SUN 10 mg film-coated tablets EFG.

Donepezil hydrochloride

Contents of this leaflet

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

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

Donepezil belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil hydrochloride increases the levels in the brain of a substance related to memory (acetylcholine), by reducing the rate at which this substance breaks down.

It is used to relieve the symptoms of mild to moderately severe Alzheimer's disease. These symptoms include increasing memory loss, confusion, and behavioural changes.

2. What you need to know before taking Donepezilo SUN

Remember: You must inform your doctor who your caregivers are.

Do not take Donepezilo SUN:

• If you are allergic (hypersensitive) to donepezil hydrochloride, to piperidine derivatives (donepezil is a piperidine derivative), or to any of the other components of this medicine (listed in section 6).
• If you are pregnant, think you may be pregnant, or are breastfeeding.

Warnings and precautions:

Treatment with donepezil should only be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's disease.

Talk to your doctor before starting Donepezilo SUN if you have or have had:

• A history of stomach or duodenal ulcer.
• Seizures.
• Heart disease (such as irregular or very slow heartbeats, heart failure, myocardial infarction).
• A heart condition known as "QT interval prolongation" or a history of certain abnormal heart rhythms called torsade de pointes, or if anyone in your family has "QT interval prolongation".
• Low levels of magnesium or potassium in the blood.
• Asthma or chronic lung disease.
• Difficulty urinating or mild kidney disease.

You should avoid taking Donepezilo SUN with other acetylcholinesterase inhibitors and other cholinergic agonists or antagonists.

Children:

Donepezil is not recommended for use in children.

Other medicines and Donepezilo SUN:

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

In particular, it is important that you inform your doctor if you are taking any of the following types of medicines^1:

• Medicines for heart rhythm problems, e.g., amiodarone or sotalol
• Medicines for depression, e.g., citalopram, escitalopram, amitriptyline, fluoxetine
• Medicines for psychosis, e.g., pimozide, sertindole, or ziprasidone
• Medicines for bacterial infections, e.g., clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• Antifungal medicines, such as ketoconazole
• Other medicines for Alzheimer's disease, e.g., galantamine
• Painkillers or arthritis treatment, e.g., aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac
• Anticholinergic medicines, e.g., tolterodine
• Anticonvulsants, e.g., phenytoin, carbamazepine
• Medications for heart disease, e.g., quinidine, beta-blockers (propranolol and atenolol)
• Muscle relaxants, e.g., diazepam, succinylcholine
• General anesthetics
• Over-the-counter medicines, e.g., herbal remedies

If you are undergoing surgery with general anesthesia, you must inform your doctor that you are taking Donepezilo SUN, as this may affect the amount of anesthetic required. Donepezilo SUN can be used in patients with mild to moderate renal or hepatic impairment. Inform your doctor if you have any kidney or liver disease. Patients with severe hepatic impairment should not take Donepezilo SUN.

Taking Donepezilo SUN with food, drinks, and alcohol:

This medicine should be taken with a glass of water.

Donepezilo SUN should not be taken with alcohol, as alcohol may alter the effect of this medicine.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take Donepezilo SUN if you are pregnant or think you may be pregnant.

Do not take Donepezilo SUN if you are breastfeeding.

Driving and using machines:

Alzheimer's disease may impair your ability to drive or operate machinery, and you should not engage in such activities unless your doctor tells you it is safe to do so. Donepezilo SUN may cause fatigue, dizziness, somnolence, and muscle cramps, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you should not drive or operate machinery.

Donepezilo SUN contains lactose:

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Donepezilo SUN contains sodium:

This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; essentially "sodium-free".

3. How to take Donepezilo SUN

Follow exactly the dosing instructions for Donepezilo SUN given by your doctor. If in doubt, consult your doctor or pharmacist again.

Donepezilo SUN is administered orally. The tablets should be swallowed with a little water.

Treatment with donepezil starts with one 5 mg tablet taken once daily at night, immediately before going to bed. After one month of treatment, your doctor may instruct you to increase the dose to 10 mg once daily at night. The maximum recommended dose is 10 mg/day.

If you experience abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend that you take Donepezilo SUN in the morning.

If you have mild or moderate hepatic impairment (liver disease) or renal impairment (kidney disease), you may take Donepezilo SUN. Inform your doctor before starting treatment if you have liver or kidney problems. Patients with severe hepatic impairment (liver disease) must not take Donepezilo.

Use in children

Use of Donepezilo SUN is not recommended in children.

If you take more Donepezilo SUN than you should

If you have taken more Donepezilo SUN than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, stating the medicine and amount taken.

Symptoms of overdose may include nausea (feeling sick), vomiting (being sick), salivation, sweating, slowed heart rate, low blood pressure (dizziness or lightheadedness upon standing), breathing difficulties, loss of consciousness, and seizures.

If you forget to take Donepezilo SUN

Do not take a double dose to make up for missed doses.

If you stop taking Donepezilo SUN

Do not stop treatment with Donepezilo SUN unless instructed by your doctor. If you stop taking Donepezilo SUN, the benefits of treatment will gradually disappear.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Donepezil SUN may cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported in people taking donepezil.

Contact your doctor if you experience any of these effects during treatment with Donepezil SUN.

Serious adverse effects:

You must inform your doctor immediately if you notice any of the following serious adverse effects listed below, as you may require urgent medical treatment.

• Liver damage, for example, hepatitis. Symptoms of hepatitis include nausea or vomiting (feeling sick or being sick), loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), and dark urine (occurs in 1 to 10 out of 10,000 people).
• Stomach or duodenal ulcers. Symptoms of ulcers include stomach pain and discomfort (indigestion) between the navel and the breastbone (occurs in 1 to 10 out of 1,000 people).
• Bleeding in the stomach or intestine. This may cause black, tarry stools or visible rectal bleeding (occurs in 1 to 10 out of 1,000 people).
• Dizziness (syncope) or seizures (occurs in 1 to 10 out of 1,000 people).
• Fever with muscle rigidity, sweating, and decreased level of consciousness (may be symptoms of a condition called "Neuroleptic Malignant Syndrome") (occurs in fewer than 1 out of 10,000 patients).
• Muscle weakness, tenderness, or pain, particularly if accompanied by feeling unwell, fever, or dark urine. This may be due to abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition known as rhabdomyolysis).

The estimated frequency of occurrence of adverse effects is as follows:

Very common: may affect more than 1 in 10 patients

• Diarrhea
• Nausea
• Headache

Common: may affect between 1 and 10 in 100 patients

• Cold (nasopharyngitis)
• Loss of appetite
• Hallucinations
• Agitation
• Aggressive behaviour
• Abnormal dreams and nightmares
• Fainting
• Dizziness
• Difficulty sleeping
• Vomiting
• Abdominal discomfort
• Urinary incontinence
• Rash
• Itching
• Muscle cramps
• Fatigue
• Pain
• Accidents (patients may be more prone to falls and accidental injuries)

Uncommon: may affect between 1 and 10 in 1,000 patients

• Seizures
• Slowing of the heart rate (bradycardia)
• Gastrointestinal bleeding, stomach and duodenal ulcers (a part of the intestine)
• Increase in a type of enzyme (muscle creatine kinase) in the blood

Rare: may affect between 1 and 10 in 10,000 patients

• Extrapyramidal symptoms (such as tremor or stiffness of the hands or legs)
• Cardiac conduction disturbances
• Liver function abnormalities, including hepatitis

Frequency not known

• Changes in heart activity that may be seen on an electrocardiogram (ECG), known as "QT interval prolongation".
• Fast and irregular heartbeat, fainting, which may be symptoms of a potentially life-threatening disorder known as torsade de pointes.
• Increased libido, hypersexuality.
• Pisa syndrome (a condition involving involuntary muscle contractions with abnormal sideways bending of the body and head).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Donepezil SUN 10 mg tablets

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Donepezil SUN

• The active substance is donepezil hydrochloride. Each tablet contains 10.526 mg of donepezil hydrochloride, equivalent to 10 mg of donepezil.
• The other components (excipients) are: monohydrate lactose, corn starch, hydroxypropylcellulose (E-463), microcrystalline cellulose (E-460i), sodium starch glycolate (from potato) and magnesium stearate (E-572). The film coating contains: hypromellose, titanium dioxide (E171), macrogol, talc (E-553b) and yellow iron oxide (E-172).

Appearance of the product and contents of the pack

Donepezil SUN tablets are circular, yellow in colour, and marked with “RC” and “26” on either side of the breakline on one side, and have a breakline on the other side.

Donepezil SUN is available in blisters. Each pack contains 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, The Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp,

The Netherlands

or

Terapia S.A.

Str. Fabricii nr. 124,

Cluj, Napoca,

Romania

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder: Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona, Spain

Tel.: +34 93 342 78 90

Date of the most recent revision of this leaflet: September 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/