Donepezil Normon 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Donepezil Normon 5 mg film-coated 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 you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Donepezil belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil increases the levels in the brain of a substance involved in memory (acetylcholine) by slowing down its breakdown.

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

2. What you need to know before 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).
• if you are pregnant, think you may be pregnant, or are breastfeeding.

Warnings and precautions

Talk to 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 "QT interval prolongation" or a history of certain abnormal heart rhythms known as torsade de pointes, or if anyone in your family has "QT interval prolongation";
• 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 donepezil together with other acetylcholinesterase inhibitors and other cholinergic agonists or antagonists.

Taking Donepezil Normon with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, especially if you are taking any of the following:

• Other medicines to treat Alzheimer's disease, for example galantamine
• Painkillers or treatments for arthritis such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac
• Ketoconazole and itraconazole (to treat fungal infections)
• Quinidine and beta-blockers used to treat irregular heartbeats such as propranolol and atenolol
• Antibiotics to treat bacterial infections such as erythromycin, rifampicin
• Antidepressants such as fluoxetine
• Phenytoin and carbamazepine (to treat 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 anesthetics
• Medicines for heart rhythm disorders (e.g., amiodarone, sotalol, and quinidine)
• Medicines for depression (e.g., citalopram, escitalopram, amitriptyline), medicines for psychosis (e.g., pimozide, sertindole, ziprasidone), medicines for bacterial infections (such as clarithromycin, erythromycin, levofloxacin, moxifloxacin)

If you are undergoing surgery with general anesthesia, you must inform your doctor and anesthesiologist that you are taking donepezil, as this may affect the amount of anesthetic required.

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

Taking Donepezil Normon with food, drinks, and alcohol

Donepezil Normon should be taken with a glass of water.

Alcohol should not be consumed 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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 medical condition may affect your ability to drive or operate machinery, and you should not engage in these activities unless your doctor tells you it is safe to do so. Donepezil may cause fatigue, dizziness, drowsiness, 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.

Donepezil Normon contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult with him or her before taking this medicine.

3. How to take Donepezil Normon

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

Donepezil is administered orally.

Treatment with donepezil starts with one 5 mg tablet taken once daily with a glass of water, 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 per 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 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 donepezil.

Use in children

The use of donepezil in children is not recommended.

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: 91 562 04 20, indicating the medication and the amount taken.

Symptoms of overdose may include feeling or being sick, salivation, sweating, slowed heart rate, low blood pressure (dizziness or lightheadedness upon standing), breathing difficulties, loss of consciousness, and seizures (fits) 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 treatment with donepezil unless your doctor tells you to. 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 can cause adverse effects, although not everyone experiences 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.

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 feeling sick or unwell, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), and dark-colored urine (occurs in 1 to 10 out of 10,000 people).
• Stomach or duodenal ulcers. Symptoms of ulcers include stomach pain and discomfort (dyspepsia) between the navel and the breastbone (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).
• Seizures (fits) or convulsions (occurs in 1 to 10 out of 1,000 people).
• Fever with muscle rigidity, sweating, or decreased level of consciousness (a disorder known as "Neuroleptic Malignant Syndrome") (occurs in fewer than 1 out of 10,000 people).
• Muscle weakness, tenderness, or pain, particularly if accompanied by feeling unwell, fever, or dark-colored 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

• 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 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 in the hands or legs)
• Cardiac conduction disturbances
• Impaired liver function, including hepatitis

Frequency not known: cannot be estimated from available data

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

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 Medicines: https://www.notificaram.es. By reporting adverse 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.

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.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Donepezilo Normon

The active substance is donepezil hydrochloride. Each tablet contains 5 mg of donepezil hydrochloride, equivalent to 4.56 mg of donepezil. The other components are: Tablet core: Lactose monohydrate, corn starch, hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate. Film coating: Hypromellose (E464), titanium dioxide (E171), propylene glycol, talc.

Appearance of the product and contents of the container

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

Available pack sizes: 14, 28, 42, 56, 84, 98, 112 tablets.

Only some of the package sizes may be marketed.

Marketing Authorization 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: October 2022

Detailed and up-to-date 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 about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging.

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