DONEPEZIL NORMON 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Donepezil Normon 5 mg Film-Coated Tablets EFG

Donepezil, Hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Package Leaflet Contents

1. What is Donepezil Normon and what is it used for
2. What you need to know before taking Donepezil Normon
3. How to take Donepezil Normon
4. Possible side effects
5. Storage of Donepezil Normon
6. Package Contents and Additional Information

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

Donepezil belongs to a group of medications called acetylcholinesterase inhibitors. Donepezil increases the levels in the brain of a substance related to memory (acetylcholine) by reducing the breakdown of this substance.

It is used to treat the symptoms 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 taking Donepezil Normon

Do not take Donepezil Normon

• if you are allergic to donepezil hydrochloride, piperidine derivatives, or any of the other ingredients of this medication (listed in section 6).
• if you are pregnant, think you may be pregnant, or are breastfeeding.

Warnings and Precautions

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

• stomach or duodenal ulcers;
• a heart condition (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";
• seizures;
• asthma or chronic pulmonary disease;
• difficulty urinating or mild kidney disease;
• low magnesium or potassium levels in the blood.

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

Taking Donepezil Normon with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, especially if you are taking any of the following medications:

• Other medications for treating Alzheimer's disease, such as galantamine
• Pain relievers or treatments for arthritis, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or diclofenac sodium
• Ketoconazole and itraconazole (for treating fungal infections)
• Quinidine and beta-blockers for treating irregular heartbeats, such as propranolol and atenolol
• Antibiotics for treating bacterial infections, such as erythromycin and rifampicin
• Antidepressants, such as fluoxetine
• Phenytoin and carbamazepine (for treating epilepsy)
• Cholinergic agonists and medications with anticholinergic activity (with action on the central nervous system) such as tolterodine
• Succinylcholine, diazepam, and other neuromuscular blockers (for producing muscle relaxation)
• General anesthetics
• Medications for heart rhythm problems (e.g., amiodarone, sotalol, and quinidine)
• Medications for depression (e.g., citalopram, escitalopram, amitriptyline), medications for psychosis (e.g., pimozide, sertindole, ziprasidone), medications for bacterial infections (such as clarithromycin, erythromycin, levofloxacin, moxifloxacin)

In the event of surgical intervention with general anesthesia, you should inform your doctor and anesthesiologist that you are taking donepezil, as this may affect the amount of anesthetic needed.

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

Taking Donepezil Normon with food, drinks, and alcohol

Donepezil Normon should be taken with a little water.

You should not drink alcohol during treatment with donepezil, as alcohol may reduce its effectiveness.

Pregnancy, Breastfeeding, and Fertility

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

Do not take donepezil if you are pregnant or think you may be pregnant.

Do not take donepezil if you are breastfeeding.

Driving and Using Machines

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

Donepezil Normon contains lactose

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

3. How to take Donepezil Normon

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Donepezil is administered orally.

Treatment with donepezil starts with a 5 mg tablet, taken once a day with a little water, at night, immediately before bedtime.

After a month of treatment, your doctor may instruct you to increase the dose to 10 mg, once a day, at night. The maximum recommended dose is 10 mg per day.

If you have abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend taking Donepezil Normon in the morning.

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

Use in Children

The use of donepezil is not recommended in children.

If you take more Donepezil Normon than you should

If you have taken more donepezil than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

The symptoms of overdose may include feeling or being sick, drooling, sweating, decreased heart rate, low blood pressure (dizziness or fainting when standing up), breathing problems, loss of consciousness, and seizures or convulsions.

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 taking donepezil unless your doctor tells you to. If you stop taking donepezil, the benefits of treatment will gradually disappear.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

The following side effects have been reported by people taking donepezil. Contact your doctor if you have any of these side effects during treatment with donepezil.

Serious side effects:

You should inform 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 feeling or being sick, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and dark urine (affecting 1 to 10 in 10,000).
• Ulcers in the stomach or duodenum. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the sternum (affecting 1 to 10 in 1,000).
• Bleeding in the stomach or intestine. This can cause you to have black, tarry stools or visible blood from the rectum (affecting 1 to 10 in 1,000).
• Seizures or convulsions (affecting 1 to 10 in 1,000).
• Fever with muscle stiffness, sweating, or decreased level of consciousness (a condition called "Neuroleptic Malignant Syndrome"). (affecting less than 1 in 10,000).
• Weakness, sensitivity, or muscle pain, particularly if you also feel unwell, have a fever, or have dark urine. This may 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 patients

• Diarrhea
• Nausea
• Headache

Common: may affect 1 to 10 in 100 patients

• Common cold
• Loss of appetite
• Hallucinations
• Agitation
• Aggressive behavior
• Abnormal dreams, including 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 1 to 10 in 1,000 patients

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

Rare: may affect 1 to 10 in 10,000 patients

• Extrapyramidal symptoms (such as tremor or rigidity of the hands or feet)
• Changes in cardiac conduction
• Changes in liver function, including hepatitis

Frequency not known: cannot be estimated from available data

• Changes in cardiac 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 called "Torsades de Pointes"
• Increased libido, hypersexuality

• Pisa syndrome (a condition involving involuntary muscle contraction with abnormal flexion of the body and head to one side)

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Donepezil Normon

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

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If you have any questions, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Donepezil Normon

The active ingredient is donepezil hydrochloride. Each tablet contains 5 mg of donepezil hydrochloride, equivalent to 4.56 mg of donepezil. The other ingredients are: Core of the tablet:Lactose monohydrate, cornstarch, hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate. Coating:Hypromellose (E464), titanium dioxide (E171), propylene glycol, talc.

Appearance of the product and package contents

White, round, film-coated tablets with a diameter of approximately 7.5 mm.

The formats are as follows: 14, 28, 42, 56, 84, 98, 112 tablets.

It is possible that only some of the package sizes are marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the last revision of this package leaflet:October 2022

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

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone.

You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75011/P_75011.html