DONEPEZIL SUN 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Donepezil SUN 5 mg film-coated tablets EFG

Donepezil Hydrochloride

Read all of this leaflet carefully before you start 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 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. See section 4.

Contents of the pack and other information

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

1. What is Donepezil SUN and what is it 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 of breakdown of this substance.

It is used to relieve the symptoms of Alzheimer's disease of mild to moderate severity. The symptoms include increasing memory loss, confusion, and changes in behavior.

2. What you need to know before you take Donepezil SUN

Remember:You should tell your doctor who your caregivers are.

Do not take Donepezil SUN:

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

Warnings and precautions:

Treatment with donepezil should only be started and supervised by a doctor with experience in the diagnosis and treatment of Alzheimer's disease.

• Tell your doctor before you start taking Donepezil SUN if you have or have had:
• • history of stomach or duodenal ulcers.
  • seizures.
  • heart disease (such as irregular or very slow heartbeats, heart failure, myocardial infarction).
  • a heart condition called "prolongation of the QT interval" or a history of certain abnormal heart rhythms called torsades de pointes or if someone in your family has "prolongation of the QT interval".
  • low levels of magnesium or potassium in the blood.
  • asthma or chronic pulmonary disease.
  • difficulty urinating or mild kidney disease.

You should avoid taking Donepezil SUN with other acetylcholinesterase inhibitors and other agonists or antagonists of the cholinergic system.

Children:

Donepezil is not recommended for use in children.

Other medicines and Donepezil SUN:

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

In particular, it is important to tell your doctor if you are taking any of the following types of medicines:

• medicines for heart rhythm problems, such as amiodarone or sotalol
• medicines for depression, such as citalopram, escitalopram, amitriptyline, fluoxetine
• medicines for psychosis, such as pimozide, sertindole, or ziprasidone
• medicines for bacterial infections, such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungal medicines, such as ketoconazole
• other medicines for Alzheimer's disease, such as galantamine
• analgesics or treatments for arthritis, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or diclofenac sodium
• anticholinergic medicines, such as tolterodine
• anticonvulsants, such as phenytoin, carbamazepine
• medicines for heart disease, such as quinidine, beta-blockers (propranolol and atenolol)
• muscle relaxants, such as diazepam, succinylcholine
• general anesthetics
• over-the-counter medicines, such as herbal remedies

In case of surgery with general anesthesia, you should inform your doctor that you are taking Donepezil SUN, as this may affect the amount of anesthetic needed. Donepezil SUN can be used in patients with mild to moderate kidney or liver disease. Tell your doctor if you have any kidney or liver disease. Patients with severe liver disease should not take Donepezil SUN.

Taking Donepezil SUN with food, drinks, and alcohol

This medicine should be taken with a little water.

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

Pregnancy, breast-feeding, and fertility:

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.

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

Do not take Donepezil SUN if you are breast-feeding.

Driving and using machines:

Alzheimer's disease may affect your ability to drive or use machines, and you should not perform these activities unless your doctor tells you it is safe to do so. Donepezil SUN may cause fatigue, dizziness, somnolence, and muscle cramps, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or use machines.

Donepezil SUN contains lactose:

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Donepezil SUN contains sodium:

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

3. How to take Donepezil SUN

Follow exactly the administration instructions of Donepezil SUN given by your doctor. If you are in doubt, consult your doctor or pharmacist again.

Donepezil SUN is administered orally. The tablets should be swallowed with the help of a little water.

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

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

If you have mild or moderate liver or kidney disease, you can take Donepezil SUN. Tell your doctor before starting treatment if you have liver or kidney problems. Patients with severe liver disease should not take Donepezil SUN.

Use in children

Donepezil SUN is not recommended for use in children.

If you take more Donepezil SUN than you should

If you have taken more Donepezil SUN than you should, contact your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

Symptoms of overdose may include nausea (feeling sick), vomiting (being sick), drooling, sweating, decreased heart rate, low blood pressure (dizziness or fainting when standing up), breathing problems, loss of consciousness, and seizures.

If you forget to take Donepezil SUN

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

If you stop taking Donepezil SUN

Do not stop taking Donepezil SUN unless your doctor tells you to do so. If you stop taking Donepezil SUN, the benefits of treatment will gradually disappear.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Donepezil SUN can cause side effects, although not everybody gets them.

The following side effects have been reported by people taking donepezil.

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

Serious side effects:

You should tell your doctor immediately if you notice any of the following serious side effects, as you may need urgent medical treatment.

• Liver damage, for example, hepatitis. The symptoms of hepatitis are nausea or vomiting (feeling or being sick), loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and dark-colored urine (affecting between 1 and 10 in 10,000 people).
• Ulcers in the stomach or duodenum. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the sternum (affecting between 1 and 10 in 1,000 people).
• Bleeding in the stomach or intestine. This can cause you to have black, tarry stools or visible blood from the rectum (affecting between 1 and 10 in 1,000 people).
• Dizziness (fits) or seizures (affecting between 1 and 10 in 1,000 people).
• Fever with muscle stiffness, sweating, decreased level of consciousness (can be symptoms of a condition called "Neuroleptic Malignant Syndrome") (affecting less than 1 in 10,000 patients).
• Weakness, sensitivity, or muscle pain, particularly if you also feel unwell, have a fever, or have dark-colored urine. This can be due to an abnormal breakdown of muscle that can be life-threatening and cause kidney problems (a condition called rhabdomyolysis).

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

Very common: may affect more than 1 in 10 people

• Diarrhea
• Nausea
• Headache

Common: may affect up to 1 in 10 people

• Cold
• Loss of appetite
• Hallucinations
• Agitation
• Aggressive behavior
• 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 up to 1 in 100 people

• Seizures
• Decreased heart rate (bradycardia)
• Gastrointestinal bleeding, ulcers in the stomach and duodenum (a part of the intestine)
• Increased levels of a type of enzyme (creatinine kinase) in the blood

Rare: may affect up to 1 in 10,000 people

• Extrapyramidal symptoms (such as tremor or rigidity of the hands or feet)
• Conduction disorders
• Liver function disorders, including hepatitis

Frequency not known

• Changes in heart activity that can be seen on an electrocardiogram (ECG) called "prolongation of the QT interval".
• Rapid and irregular heartbeat, fainting that can be symptoms of a potentially life-threatening condition called torsades de pointes.
• Increased libido, hypersexuality.
• Pisa syndrome (a condition that involves involuntary muscle contraction with abnormal flexion of the body and head to one side).

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 via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Donepezil SUN 5 mg film-coated 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 which is stated on the carton. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. 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 5.26 mg of donepezil hydrochloride, equivalent to 5 mg of donepezil.
• The other ingredients (excipients) are: lactose monohydrate, 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 and packaging of the product

Donepezil SUN tablets are circular, yellow, and marked with "RC25" on one side.

Donepezil SUN is available in blister packs. Each pack contains 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp,

Netherlands

or

Terapia S.A.

Str. Fabricii nr. 124,

Cluj, Napoca,

Romania

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Sun Pharma Laboratories, S.L.

Rambla de Catalunya 53-55

08007 Barcelona, Spain

Phone: +34 93 342 78 90

Date of last revision of this leaflet:September 2022

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