Package Leaflet: Information for the User

SUN 10 mg Film-Coated Tablets, Donepezil Hydrochloride

Donepezil Hydrochloride

Contents of the Package Leaflet

1. What Donepezil SUN is and what it is used for
2. What you need to know before you start 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

Donepezilo belongs to a group of medicines called cholinesterase inhibitors. Donepezilo hydrochloride increases the levels in the brain of a substance related to memory (acetylcholine), by decreasing the rate of breakdown of this substance.

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

Remember:Inform your doctor about your caregivers.

Do not take Donepezilo SUN:

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

Warnings and precautions::

Donepezil treatment should only be initiated and monitored by a doctor with experience in diagnosing and treating Alzheimer's disease.

Consult your doctor before starting to take Donepezilo 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 torsade 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 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 children.

Other medications and Donepezilo SUN:

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication, including those purchased without a prescription.

Especially, it is essential to inform your doctor if you are taking any of the following types of medications:1:

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

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

Donepezilo SUN with food, drinks, and alcohol:

This medication should be taken with a little water.

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

Pregnancy, lactation, and fertility:

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

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 operating machinery:

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

Donepezilo SUN contains lactose:

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Donepezilo SUN contains sodium:

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

Follow exactly the administration instructions for Donepezilo SUN as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

The treatment with donepezilo starts with a 5 mg tablet, taken once a day, at night, immediately before going to bed. After a month of treatment, your doctor may recommend an increase in the dose to 10 mg, once a day and at night. 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 Donepezilo SUN in the morning.

If you have mild or moderate liver disease (a disease that affects the liver) or kidney disease (a disease that affects the kidney), you can take Donepezilo SUN. Inform your doctor before starting treatment if you have liver or kidney problems. Patients with severe liver disease should not take Donepezilo SUN.

Use in children

Donepezilo SUN is not recommended for use in children.

If you take more Donepezilo SUN than you should

If you have taken more Donepezilo SUN than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

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

If you forget to take Donepezilo SUN

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

If you interrupt treatment with Donepezilo SUN

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Donepezilo SUN may cause side effects, although not everyone will experience them.

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

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

Severe side effects:

You should inform your doctor immediately if you notice any of the following severe 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 discomfort, fever, itching, yellowing of the skin and eyes, and dark-colored urine (affects between 1 and 10 out of 10,000).

- Ulcers in the stomach or duodenum. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the breastbone (affects between 1 and 10 out of 1,000).

- Bleeding in the stomach or intestines. This can cause you to have black, tar-like stools or visible blood from the rectum (affects between 1 and 10 out of 1,000).

- Dizziness (attacks) or convulsions (affects between 1 and 10 out of 1,000).

- Fever with muscle stiffness, sweating, decreased level of consciousness (may be symptoms of a condition called "Neuroleptic Malignant Syndrome") (affects fewer than 1 out of 10,000 patients).

- Weakness, sensitivity, or muscle pain, particularly if you are also feeling unwell, have a fever, or your urine is dark-colored. This can be due to abnormal muscle destruction that can be fatal and cause kidney problems (a condition called rhabdomyolysis).

The estimated frequency of side effects is as follows:

Very common:may affect more than 1 in 10 patients

• Diarrhea
• Discomfort
• Headache

Common: may affect between 1 and 10 in 100 patients

• Common 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 between 1 and 10 in 1,000 patients

• Convulsions
• Decreased heart rate (bradycardia)
• Gastrointestinal bleeding, ulcers in the stomach and duodenum (a part of the intestine)
• Increased levels of a type of enzyme (creatine kinase muscle) 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)
• Alterations in heart conduction
• Liver function alterations, including hepatitis

Frequency unknown

• Changes in heart activity that can be seen on an electrocardiogram (ECG) called "prolongation of the QT interval".
• Fast and irregular heartbeat, fainting that may be symptoms of a potentially fatal condition called torsade 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special conditions for conservation.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Donepezilo SUN

• The active ingredient is donepezilo hydrochloride. Each tablet contains 10.526 mg of donepezilo hydrochloride, equivalent to 10 mg of donepezilo.
• The other components (excipients) are: lactose monohydrate, cornstarch, 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 packaging

Donepezilo SUN tablets are circular, yellow in color, and marked with “RC” and “26” on either side of the groove on one face and with a groove on the other face.

Donepezilo SUNis available in blisters. Each package contains 28 tablets.

Holder of the marketing authorization and Responsible for the manufacture

Holder of the marketing authorization

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, Netherlands

Responsible for the manufacture

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 medication by contacting the local representative of the holder of the marketing authorization:Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona. Spain

Tel.: +34 93 342 78 90

Date of the last review of this leaflet:September 2022

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/