Donepezil Normon 5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Donepezilo Normon 5 mg orodispersible tablets EFG

Donepezil hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Donepezilo Normon 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 at which this substance breaks down.

It is used to treat the symptoms of mild to moderately severe Alzheimer's disease. Symptoms include increasing memory loss, confusion, and behavioural changes.

2. +Taking Donepezil Normon

Do not take Donepezil Normon

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

Warnings and precautions

Consult your doctor before starting to take Donepezil Normon if you have or have had:

• A history of stomach or duodenal ulcer.

• 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 known as torsade de pointes, or if anyone 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 Donepezil Normon together with other acetylcholinesterase inhibitors and other cholinergic agonists or antagonists.

Taking Donepezil Normon with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, especially if you are taking any of the following:

• Medicines for heart rhythm disorders, for example amiodarone or sotalol.
• Medicines for depression, such as citalopram, escitalopram, amitriptiline, fluoxetine.
• Medicines for psychosis, e.g. pimozide, sertindole, or ziprasidone.
• Medicines for bacterial infections, for example, 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 sodium diclofenac.
• Quinidine, and beta-blockers used to treat 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 (used to produce muscle relaxation).
• General anesthesia.

If you undergo surgery under general anesthesia, you must inform your doctor that you are taking Donepezil Normon, as this may affect the amount of anesthetic required.

Donepezil Normon may be used in patients with mild to moderate renal or hepatic impairment. Inform your doctor if you have any kidney or liver disease. Patients with severe hepatic impairment should not take Donepezil Normon.

Taking Donepezil Normon with food, drinks, and alcohol

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

Do not take Donepezil Normon with alcohol, as alcohol may alter the effect of this medicine.

Pregnancy, breastfeeding, and fertility

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

Do not take Donepezil Normon if you are breastfeeding.

Driving and using machines

Your illness may affect your ability to drive or operate machinery, and you should not perform these activities unless your doctor confirms it is safe to do so. Donepezil Normon may cause fatigue, dizziness, somnolence, and muscle cramps, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you should not drive or operate machinery.

Important information about some of the ingredients of Donepezil Normon

Lactose:

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Aspartame:

This medicine contains 5 mg of aspartame per orodispersible tablet.

Aspartame is a source of phenylalanine, which may be harmful if you have 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; this is essentially "sodium-free".

3. How to take Donepezil Normon

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Treatment with donepezil starts with one 5 mg tablet taken once daily at night, immediately before going to bed. After one month of treatment, your doctor may instruct you to increase the dose to 10 mg once daily at night. 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 this medicine in the morning.

If you have mild or moderate hepatic impairment (liver disease) or renal impairment (kidney disease), you may still take donepezil. Inform your doctor before starting treatment if you have liver or kidney problems. Patients with severe hepatic impairment (liver disease) must not take this medicine.

Use in children

Donepezil is not recommended for use in children.

If you take more Donepezil Normon than you should

If you have taken more donepezil than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

Symptoms of overdose may include nausea (feeling sick), vomiting (being sick), salivation, sweating, slowed heart rate, low blood pressure (dizziness or lightheadedness upon standing), breathing difficulties, loss of consciousness, and seizures.

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 with this medicine unless instructed by your doctor. If you stop taking donepezil, the benefits of treatment will gradually disappear.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

The following adverse effects have been reported in people taking Donepezil.

Contact your doctor if you experience any of these effects during treatment with Donepezil Normon.

Serious adverse effects:

You must inform your doctor immediately if you notice any of the following serious adverse effects, as you may require urgent medical treatment.

• Liver damage, for example, hepatitis. Symptoms of hepatitis include nausea or vomiting (feeling sick or being sick), loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), and dark urine (occurs in 1 to 10 out of 10,000 people).
• Stomach or duodenal ulcers. Symptoms of ulcers include stomach pain and discomfort (indigestion) between the navel and the sternum (occurs in 1 to 10 out of 1,000 people).
• Bleeding in the stomach or intestines. This may cause black, tarry stools or visible rectal bleeding (occurs in 1 to 10 out of 1,000 people).
• Dizziness (attacks) or seizures (occurs in 1 to 10 out of 1,000 people).
• Fever with muscle rigidity, reduced sweating, and decreased level of consciousness (may be symptoms of a condition known as "Neuroleptic Malignant Syndrome") (occurs in fewer than 1 out of 10,000 patients).
• Muscle weakness, tenderness, or pain, particularly if accompanied by feeling unwell, fever, or dark urine. This may be due to abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis).

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

Very common: may affect more than 1 in 10 patients

• Diarrhea
• Nausea
• Headache

Common: may affect between 1 and 10 in 100 patients

• Cold
• Loss of appetite
• Hallucinations
• Agitation
• Aggressive behaviour
• 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
• Slowing of the heart rate (bradycardia)
• Gastrointestinal bleeding, stomach and duodenal ulcers (a part of the intestine)
• Increase in a type of enzyme (muscle creatine kinase) 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)
• Cardiac conduction disturbances
• Liver function abnormalities, including hepatitis

Frequency not known (cannot be estimated from available data)

• Increased libido, hypersexuality
• Pisa syndrome (a condition involving involuntary muscle contractions with abnormal bending of the body and head to one side)
• Changes in heart activity that may be seen on an electrocardiogram (ECG), known as "QT interval prolongation"
• Fast and irregular heartbeat, fainting, which may be symptoms of a potentially life-threatening disorder known as torsade de pointes

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: Website: www.notificaRAM.es.

5. Storage of Donepezil Normon

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Additional information

Composition of Donepezil Normon

• The active substance is donepezil hydrochloride. Each tablet contains 5 mg of donepezil hydrochloride.
• The other components are: potassium polacrilin, microcrystalline cellulose, monohydrate lactose, anhydrous monosodium citrate, aspartame (E-951), sodium croscarmellose, colloidal anhydrous silica, magnesium stearate, hydrochloric acid and purified water.

Appearance of the product and contents of the pack

Donepezil Normon is presented as orodispersible tablets, i.e. tablets that dissolve in the mouth. The orodispersible tablets of Donepezil Normon 5 mg are flat, round, bevelled-edge tablets, white or almost white in colour, marked with '5' on one side and plain on the other.

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent review of this leaflet: November 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75006/P_75006.html.