PATIENT INFORMATION LEAFLET

Donepezilo NORMON 5 mg buccal tablets EFG

Donepezil hydrochloride

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.Before taking Donepezilo NORMON

3.How to take Donepezilo NORMON

4.Possible side effects

5Storage of Donepezilo NORMON

6.Additional information

Donepezilo 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.

Do not takeDonepezilo NORMON

- If you are allergic to hydrochloride of donepezilo, to piperidina derivatives or to any of the other components of this medication (included in section 6).

• If you are pregnant or breastfeeding.

Be especially careful with Donepezilo NORMON

• Before starting treatment with Donepezilo NORMON, you must inform your doctor if you have or have a history of stomach ulcers, heart disease, seizures, asthma, chronic lung disease or difficulty urinating.
• In case of surgical intervention with general anesthesia, you must inform your doctor that you are taking Donepezilo NORMON.
• Donepezilo NORMON is not recommended for use in children.
• You should avoid taking Donepezilo 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 torsade de pointes or if someone in your family has "prolongation of the QT interval".
• If you have low levels of magnesium or potassium in your blood.

Other medications and Donepezilo NORMON

Inform your doctor or pharmacist if you are using, have used recently or may have to use any other medication, including those purchased without a prescription and especially if you are taking any of the following medications:

• 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 to treat Alzheimer's disease, for example galantamine.
• analgesics or treatments for arthritis such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium.
• anticholinergic medications, for example Tolterodina.
• anticonvulsants, for example, phenytoin, carbamazepine.
• medications for heart disease, for example quinidine, beta blockers (propranolol and atenolol).
• muscle relaxants, for example, diazepam, succinylcholine.
• general anesthetic.
• over-the-counter medications, for example, herbal remedies.

The consumption of Donepezilo NORMON with alcohol may reduce the absorption of this medication.

Donepezilo 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, consult your doctor or pharmacist before using this medication.

Do not take Donepezilo NORMON if you are pregnant.

Do not take Donepezilo NORMON if you are breastfeeding your child.

Driving and operating machinery

Your condition 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 NORMON may cause dizziness and drowsiness, mainly at the beginning of treatment or when increasing the dose. If you experience these effects, do not drive or operate machinery.

Important information about some of the components of Donepezilo NORMON

Lactose:

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Aspartame:

This medication contains 5 mg of aspartame in each buccal tablet.

Aspartame is a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Sodium:

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

Follow exactly the administration instructions for this medication as indicated by your doctor.Consult your doctor or pharmacist again if you are unsure.

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

The treatment with Donepezilo NORMON 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 experience abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend taking Donepezilo NORMON 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 follow a similar dosing schedule as indicated above.

If you take more Donepezilo NORMON than you should

If you have taken more Donepezilo NORMON 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.

If you forgot to take Donepezilo NORMON

Do not take a double dose to compensate for the missed dose.

If you interrupt the treatment with Donepezilo NORMON

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

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

Like all medications,this medicationmay cause side effects, although not everyone will experience them.

Severe side effects:

Consult your doctor immediately if you experience these severe side effects. You may need urgent medical treatment.

• Weakness, sensitivity, or muscle pain, particularly if you also feel unwell, have a fever, or your urine is dark in color. This can be due to abnormal muscle destruction that can be fatal and cause kidney problems (a condition known as rhabdomyolysis).

The estimated frequency of these side effects is as follows:

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

• Diarrhea
• Nausea
• Headache

The common side effects that may affect more than 1 person in 100 but less than 1 in 10 are:

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

The less common side effects that may affect more than 1 person in 1,000 but less than 1 in 100 are:

• Seizures
• Decreased heart rate
• 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

The rare side effects that may affect less than 1 person in 1,000 are:

• Extrapyramidal symptoms (such as tremors or stiffness of the hands or legs)
• Alterations in heart conduction
• Liver function impairment, including hepatitis

The side effects with unknown frequency that cannot be estimated from available data are:

• Changes in heart activity that can be observed on an electrocardiogram (ECG) called "prolongation of the QT interval"
• Fast and irregular heartbeat, fainting that may be symptoms of a potentially fatal condition known as 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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sightand reachof children.

This medication does not require special storage conditions.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. 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 pointat 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 NORMON

• The active ingredient is hydrochloride of donepezilo. Each tablet contains 5 mg of hydrochloride of donepezilo.
• The other components are:potassium polacrilin, microcrystalline cellulose, lactose monohydrate, anhydrous sodium citrate, aspartame, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, hydrochloric acid, purified water.

Appearance of the product and contents of the package

Donepezilo NORMON is presented in buccal dispersible tablets, that is, they dissolve in the mouth. The buccal dispersible tablets of Donepezilo NORMON 5 mg are flat, round, with beveled edges and white or off-white in color, engraved with ‘5’ on one face and flat on the other.

Donepezilo NORMON 5 mgis available in PVC/PCTFE (Aclar)/Aluminum blister packs with7, 14, 28, 30, 50, 56, 60, 98 and 120 buccal dispersible tablets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Date of the last review of this prospectus:October 2022

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