Package Insert: Information for the User

Donepezilo SUN 5 mg Film-Coated Tablets EFG

Donepezil Hydrochloride

Read this entire package insert carefully before starting to take this medicine, as it contains important information for you

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of this package insert

1. What Donepezilo SUN is and for what it is used
2. What you need to know before starting to take Donepezilo SUN
3. How to take Donepezilo SUN
4. Possible adverse effects
5. Storage of Donepezilo SUN
6. Contents of the package 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 reducing 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 piperidine derivatives (donepezil is a piperidine 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 experienced in the diagnosis and treatment of Alzheimer's disease.

• Consult your doctor before starting to take Donepezilo SUN if you have or have had:
• • stomach or duodenal ulcers.
  • convulsions.
  • 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.

Do not take Donepezilo SUN with other acetylcholinesterase inhibitors and other cholinergic agonists or antagonists.

Children:

Donepezil is not recommended for use in 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 obtained 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.
• analgesics or arthritis treatment, for example aspirin, non-steroidal 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.

In the event of surgical intervention with general anesthesia, inform your doctor that you are taking Donepezilo SUN as this may affect the amount of anesthetic needed. Donepezilo SUN may 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 intend 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 your child.

Driving and operating machinery:

Alzheimer's disease may affect your ability to drive or operate machinery, and you should not engage in these activities unless your doctor indicates it is safe to do so. Donepezilo SUN may cause fatigue, dizziness, drowsiness and muscle cramps, mainly at the start 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 indicated 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; this is essentially "sodium-free".

Follow exactly the administration instructions for Donepezilo SUN as indicated 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.

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.

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 forgot to take Donepezilo SUN

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

If you interrupt the treatment with Donepezilo SUN

Do not stop taking 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 seizures (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 also feel unwell, have a fever, or your urine is dark. This may be due to abnormal muscle destruction that can be fatal and cause kidney problems (a disease 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

• 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 (creatine kinase muscle) in the blood

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

• Extrapyramidal symptoms (such as tremors 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 contractions 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 Pharmacovigilance of Medicines 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 storage conditions.

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 hydrochloride of donepezilo. Each tablet contains 5.26 mg of hydrochloride of donepezilo, equivalent to 5 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 iron oxide yellow (E-172).

Appearance of the product and content of the container

Donepezilo SUN tablets are circular, yellow in color, and marked with “RC25” on one side.

Donepezilo SUN is available in blisters. Each container contains 28 tablets.

Holder of the marketing authorization and Responsible for the manufacturing

Holder of the marketing authorization

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, Netherlands

Responsible for the manufacturing

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

Last review date of this leaflet:September 2022

The detailed information of this medication is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS) http://www.aemps.gob.es