DONEPEZIL NORMON 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Donepezil Normon 5 mg orodispersible 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 Normon and what is it used for
2. Before taking Donepezil Normon
3. How to take Donepezil Normon
4. Possible side effects

5 Storage of Donepezil Normon

1. Further information

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

Donepezil Normon is a specific and reversible inhibitor of acetylcholinesterase, the predominant cholinesterase in the brain.

It is used for the symptomatic treatment of mild to moderately severe Alzheimer's disease.

2. Before taking Donepezil Normon

Do not takeDonepezil Normon

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

Special warnings and precautions

• Before starting treatment with Donepezil Normon, your doctor should know if you have or have had stomach ulcers, heart disease, seizures, asthma, chronic pulmonary disease, or difficulty urinating.
• In case of surgery with general anesthesia, you should inform your doctor that you are taking Donepezil Normon.
• The use of Donepezil Normon is not recommended in children.
• You should avoid taking Donepezil Normon with other acetylcholinesterase inhibitors and other agonists or antagonists of the cholinergic system.
• If you have vascular dementia (loss of brain function due to a series of small strokes).
• If you have or have had a heart condition (such as irregular or very slow heartbeats, heart failure, myocardial infarction).
• If you have or have had 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".
• If you have low levels of magnesium or potassium in your blood.

Other medicines and Donepezil Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, 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.
• 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 conditions, such as quinidine, beta-blockers (propranolol and atenolol).
• muscle relaxants, such as diazepam, succinylcholine.
• general anesthetics.
• medicines obtained without a prescription, such as herbal remedies.

Taking Donepezil Normon with alcohol may reduce the absorption of this medicine.

Taking Donepezil Normon with food and drinks

Place the tablet on the tongue and let it dissolve. Swallow with or without water.

Pregnancy and breastfeeding

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 Normon if you are pregnant.

Do not take Donepezil Normon if you are breastfeeding.

Driving and using machines

Your illness may affect your ability to drive or use machines, and you should not carry out these activities unless your doctor tells you it is safe to do so. Donepezil Normon may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or use machines.

Important information about some of the ingredients of Donepezil Normon

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.

Aspartame:

This medicine contains 5 mg of aspartame in each orodispersible tablet.

Aspartame is a source of phenylalanine that may be harmful in people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

Sodium:

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

3. How to take Donepezil Normon

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

Donepezil Normon is administered orally. The tablet should be placed on the tongue and allowed to dissolve before swallowing with or without water.

Treatment with Donepezil Normon 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 experience abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend that you take Donepezil Normon in the morning.

If you have mild or moderate hepatic insufficiency (a disease that affects the liver) or renal insufficiency (a disease that affects the kidneys), you may follow a similar dosage regimen as indicated above.

If you take more Donepezil Normon than you should

If you have taken more Donepezil Normon 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.

If you forget to take Donepezil Normon

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

If you stop taking Donepezil Normon

Do not stop treatment without consulting your doctor first, even if you feel well.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:

See a doctor immediately if you experience these serious side effects. You may need urgent medical treatment.

• Weakness, sensitivity, or muscle pain, especially if you feel unwell, have a fever, or your urine is dark in color. This may be due to abnormal muscle destruction that can be life-threatening and cause kidney problems (a condition called rhabdomyolysis).

The estimated frequency of occurrence is as follows:

The most common side effects that may affect at least 1 in 10 people are:

• Diarrhea
• Nausea
• Headache

Common side effects that may affect up to 1 in 100 people but more than 1 in 10 are:

• Cold
• Loss of appetite
• Hallucinations, agitation, aggressive behavior
• Fainting, dizziness, difficulty sleeping
• Vomiting, abdominal discomfort
• Urinary incontinence
• Rash, itching
• Muscle cramps
• Fatigue, pain
• Accidents

Uncommon side effects that may affect up to 1 in 1,000 people but more than 1 in 100 are:

• Seizures
• Decreased heart rate
• Gastrointestinal bleeding, stomach and duodenal ulcers
• Increased levels of a type of enzyme (creatine kinase) in the blood

Rare side effects that may affect less than 1 in 1,000 people are:

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

Side effects with unknown frequency that cannot be estimated from the available data are:

• 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 disorder known as 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 Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Donepezil Normon

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 after EXP. The expiry date refers to the last day of the month shown.

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 Normon

• The active substance is donepezil hydrochloride. Each tablet contains 5 mg of donepezil hydrochloride.
• The other ingredients are: potassium polacrylate, microcrystalline cellulose, lactose monohydrate, anhydrous monosodium citrate, aspartame, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, hydrochloric acid, purified water.

Appearance and packaging

Donepezil Normon is presented in orodispersible tablets, which dissolve in the mouth. The orodispersible tablets of Donepezil Normon 5 mg are flat, round, with beveled edges, and white or almost white in color, engraved with '5' on one face and flat on the other.

Donepezil Normon 5 mg is available in PVC/PCTFE (Aclar)/Aluminum blister packs of 7, 14, 28, 30, 50, 56, 60, 98, and 120 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of last revision of this leaflet:October 2022

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75006/P_75006.html