Package Leaflet: Information for the User

Donepezilo Normon 5 mg Film-Coated Tablets EFG

Donepezilo, 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.

Donepezilo belongs to a group of medicines called cholinesterase inhibitors. Donepezilo increases the levels in the brain of a substance related to memory (acetylcholine), by reducing the rate of breakdown of this substance.

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

Do not take Donepezilo Normon

• if you are allergic to hydrochloride of donepezilo, to piperidina derivatives or to any of the other components 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 Donepezilo Normon if you have or have had:

• stomach or duodenum 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 torsade de pointes or if someone in your family has "prolongation of the QT interval";
• seizures;
• asthma or chronic lung disease;
• difficulty urinating or mild kidney disease;
• low levels of magnesium or potassium in the blood.

You should avoid taking donepezilo with other acetylcholinesterase inhibitors and other cholinergic agonists or antagonists.

Donepezilo Normon intake with other medications

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

• Other medications for treating Alzheimer's disease, for example galantamine
• Pain relievers or arthritis treatments such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium
• Ketoconazole and itraconazole (to treat fungal infections)
• Quinidine and beta-blockers for treating irregular heartbeats such as propranolol and atenolol
• Antibiotics for treating bacterial infections such as erythromycin, rifampicin
• Antidepressants such as fluoxetine
• Phenytoin and carbamazepine (to treat epilepsy)
• Cholinergic agonists and medications with anticholinergic activity (acting at the central nervous system) such as tolterodine
• Succinylcholine, diazepam and other neuromuscular blockers (to produce 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, sertindol, ziprasidone), medications for bacterial infections (such as clarithromycin, erythromycin, levofloxacin, moxifloxacin)

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

Donepezilo may be used in patients with renal or mild to moderate liver disease. Inform your doctor if you have kidney or liver disease. Patients with severe liver disease should not take donepezilo.

Donepezilo Normon intake with food, drinks and alcohol

Donepezilo Normon should be taken with a little water.

You should not take alcohol during treatment with donepezilo as alcohol may reduce its effectiveness.

Pregnancy, breastfeeding and fertility

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

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

Do not take donepezilo 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 do so unless your doctor tells you it is safe to do so. Donepezilo may cause fatigue, dizziness, drowsiness and muscle cramps mainly at the start of treatment or when increasing the dose. If you experience these effects, you should not drive or operate machinery

Donepezilo Normon contains lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Donepezilo is administered orally.

Treatment with donepezilo starts with a 5 mg tablet, taken once a day with a little water, at night immediately before going to bed.

After a month of treatment, your doctor may recommend an increase in the dose to 10 mg, taken once a day and 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 that you take 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 kidneys), you can take donepezilo. Inform your doctor before starting treatment if you have liver or kidney problems. Patients with severe liver disease should not take donepezilo.

Use in children

Donepezilo is not recommended for use in children.

If you take more Donepezilo Normon than you should

If you have taken more donepezilo 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.

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

If you forgot to take Donepezilo Normon

Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Donepezilo Normon

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

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

Like all medicines, this medicinecan cause side effects, although not everyone will experience them.

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

Severe side effects:

You should inform your doctor immediately if you notice any of the following severe side effects mentioned, 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 discomfort, fever, itching, yellowing of the skin and eyes, and dark-colored urine (affecting between 1 and 10 out of 10,000 people).

• Ulcers in the stomach or duodenum. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the breastbone (affecting between 1 and 10 out of 1,000 people).

• Bleeding in the stomach or intestine. This can cause you to have black, tar-like stools or visible blood from the rectum (affecting between 1 and 10 out of 1,000 people).

• Seizures (attacks) or convulsions (affecting between 1 and 10 out of 1,000 people).

• Fever with muscle stiffness, sweating, or decreased level of consciousness (a condition called "Neuroleptic Malignant Syndrome"). (Affects fewer than 1 out of 10,000 people).

• Weakness, sensitivity, or muscle pain, particularly if you also feel unwell, have a fever, or have dark-colored urine. This can be due to abnormal muscle destruction that can be fatal and cause kidney problems (a disease called rhabdomyolysis).

The estimated frequency of side effects is as follows:

Common: may affect more than 1 in 10 patients

• Diarrhea
• Discomfort
• Headache

Frequent: may affect between 1 and 10 out of 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 between 1 and 10 out of 1,000 patients

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

Rare: may affect between 1 and 10 out of 10,000 patients

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

Frequency unknown: cannot be estimated from available data

• Changes in heart activity that can be seen on an electrocardiogram (ECG) called "prolongation of the QT interval"
• Fast and irregular heartbeat, fainting that may be symptoms of a potentially fatal condition called torsade de pointes
• Increased libido, hypersexuality

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

Reporting side effects

If you experience any type of side effects, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears 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 drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointof 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 equivalent to 4.56 mg of donepezilo. The other components are: Nucleus 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 contents of the packaging

Coated tablets white, round, with a diameter of approximately 7.5 mm.

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

Only some of the packaging sizes may be commercially available.

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 leaflet: October 2022

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