DONEPEZIL ALTER 5 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Donepezil Alter 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack and other information:

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

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

Donepezil Alter contains the active substance donepezil hydrochloride

Donepezil hydrochloride 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 speed of breakdown of this substance.

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

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

Do not takeDonepezil Alterif:

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

Warnings and precautions

Tell your doctor before you start taking Donepezil Alter if you have or have had:

• a history of stomach or duodenal ulcers
• 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 a family member has "prolongation of the QT interval"
• low levels of magnesium or potassium in the blood
• seizures
• asthma or chronic pulmonary disease
• difficulty urinating or mild kidney disease.

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

Other medicines and Donepezil Alter:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially if you are taking any of the following 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 treating Alzheimer's disease, such as galantamine

- painkillers or treatments for arthritis, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or diclofenac sodium.

- quinidine and beta-blockers for treating irregular heartbeats, such as propranolol and atenolol

- phenytoin and carbamazepine (for treating epilepsy)

- cholinergic agonists and medicines with anticholinergic activity (acting on the central nervous system) such as tolterodine

- succinylcholine, diazepam, and other neuromuscular blockers (for producing muscle relaxation)

- general anesthesia

If you are going to have surgery with general anesthesia, you should tell your doctor that you are taking Donepezil Alter, as this may affect the amount of anesthetic needed.

Donepezil Alter can be used in patients with mild to moderate kidney or liver disease. Tell your doctor before starting treatment if you have kidney or liver problems. Patients with severe liver disease should not take Donepezil Alter.

Taking Donepezil Alter with food, drinks, and alcohol:

This medicine should be taken with a little water.

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

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, 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 Alter if you are pregnant.

You should not take Donepezil Alter if you are breastfeeding.

Driving and using machines:

Your illness may affect your ability to drive or use machines, and you should not do these activities unless your doctor tells you it is safe to do so. Donepezil Alter may cause tiredness, 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.

This medicine 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.

3. How to take Donepezil Alter

Follow exactly the administration instructions of donepezil given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Donepezil is administered orally.

Treatment with donepezil starts with one 5 mg tablet, taken once a day with a little water, at night immediately before bedtime. After one month of treatment, your doctor may tell you to increase the dose to 10 mg, once a day, 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 donepezil in the morning.

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

Use in children

Donepezil is not recommended for use in children.

If you take more Donepezil Alter than you should:

If you have taken more donepezil than you should, talk to your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, stating the medicine and the amount used.

Symptoms of overdose may include nausea, vomiting, salivation, sweating, decreased heart rate, low blood pressure, breathing problems, loss of consciousness, and seizures.

If you forget to take Donepezil Alter

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

If you stop taking Donepezil Alter

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

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

4. Possible side effects

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

The following side effects have been reported by people taking Donepezil Alter.

Tell your doctor if you get any of these side effects while taking Donepezil Alter.

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, 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).
• Fits (seizures) or convulsions (affecting between 1 and 10 in 1,000 people).
• Fever with muscle stiffness, sweating, decreased consciousness (which can be symptoms of a condition called "Neuroleptic Malignant Syndrome") (affecting less than 1 in 10,000 patients)

• Weakness, sensitivity, or muscle pain, especially if you also feel unwell, have a fever, or have dark-colored urine. This can be due to abnormal muscle destruction, which 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
• Discomfort
• Headache

Common: may affect between 1 and 10 in 100 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 between 1 and 10 in 1,000 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 (creatine kinase) in the blood

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

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

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

• Increased libido, hypersexuality
• Pisa syndrome (a condition involving involuntary muscle contraction with abnormal flexion of the body and head to one side)
• 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 known as torsades de pointes

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 through the Spanish Pharmacovigilance System for Human Use Medicines, Website: www.notificaRAM.es.

5. Storing Donepezil Alter

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

This medicine does not require any special storage conditions.

Do not use donepezil after the expiry date 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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Further information

Composition of Donepezil Alter 5 mg tablets

• The active substance is donepezil. Each tablet contains 5 mg of donepezil hydrochloride.
• The other ingredients are: Core:lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycolate, colloidal silicon dioxide, and magnesium stearate. Coating:Opadry White.

Appearance and packaging

Donepezil Alter 5 mg are film-coated tablets, round, biconvex, and white.

They come in packs of 28 or 56 tablets.

Other presentations:

Donepezil Alter 10 mg film-coated tablets: packs of 28 or 56 tablets.

Marketing authorization holder and manufacturer

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036, Madrid,

Spain

or

Laboratorios Alter, S.A.

C/ Zeus, 6

Polígono Industrial R2

28880, Meco (Madrid)

Spain

Date of last revision of this leaflet:

December 2023

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