Donepezil CINFA 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

donepezil cinfa 5 mg 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 must 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.

Leaflet contents

1. What donepezil cinfa is and what it is used for.

2. What you need to know before taking donepezil cinfa.

3. How to take donepezil cinfa.

4. Possible side effects.

5. Storage of donepezil cinfa.

6. Contents of the pack and other information.

1. What donepezilo cinfa is and what it is used for

Donepezilo cinfa 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 is broken down.

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

2. What you need to know before taking donepezil cinfa

Do not take donepezil cinfa

• 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 might be pregnant, or are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting donepezil cinfa 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
• seizures
• asthma or chronic lung disease
• difficulty urinating or mild kidney disease.

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

Children and adolescents

Donepezil is not recommended for use in children.

Taking donepezil cinfa with other medicines

Tell 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 medicines:

• medicines for heart rhythm problems, for example amiodarone or sotalol
• medicines for depression, for example 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, for example galantamine
• painkillers or treatments for arthritis such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac
• anticholinergic medicines, e.g. tolterodine
• anticonvulsants, e.g., phenytoin, carbamazepine
• medication for heart disease, for example quinidine, beta-blockers (propranolol and atenolol)
• muscle relaxants, e.g., diazepam, succinylcholine
• general anaesthetic
• medicines obtained without prescription, for example, herbal remedies

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

Donepezil 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.

Taking donepezil cinfa with food, drinks and alcohol

This medicine should be taken with a glass of water.

Donepezil should not be taken 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 if you are pregnant or think you might be pregnant.

Do not take donepezil 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 has advised you that it is safe to do so. Donepezil 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.

donepezil cinfa contains lactose

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

3. How to take donepezil cinfa

Follow exactly the instructions given by your doctor or pharmacist 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 (2 tablets) once daily at night. The maximum recommended dose is 10 mg (2 tablets) per day.

If you experience abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend that you take donepezil in the morning.

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

Use in children

The use of donepezil in children is not recommended.

If you take more donepezil cinfa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the package leaflet and medicine container to the healthcare professional.

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 cinfa

Do not take a double dose to make up for forgotten doses.

If you stop taking donepezil cinfa

Do not stop treatment with donepezil 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 can cause adverse effects, although not everyone experiences them.

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

Serious adverse effects

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

• Liver damage, for example, hepatitis. Symptoms of hepatitis include feeling unwell, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), and dark-colored urine (very rare adverse effects (may affect up to 1 in 10,000 patients)).
• Stomach or duodenal ulcers. Symptoms of ulcers include stomach pain and discomfort (dyspepsia) between the navel and the sternum (rare adverse effects (may affect up to 1 in 1,000 patients)).
• Bleeding in the stomach or intestine. This may cause black, tarry stools or visible rectal bleeding (rare adverse effects (may affect up to 1 in 1,000 patients)).
• Dizziness (fainting) or seizures (rare adverse effects (may affect up to 1 in 1,000 patients)).
• Fever with muscle rigidity, sweating, and decreased level of consciousness (these may be symptoms of a condition called "Neuroleptic Malignant Syndrome") (very rare adverse effects (may affect up to 1 in 10,000 patients)).
• Muscle weakness, sensitivity, or pain, particularly if you also feel unwell, have 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 known as 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 up to 1 in 10 patients)

• Cold (nasopharyngitis)
• Loss of appetite
• Hallucinations
• Agitation
• Aggressive behavior
• 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 up to 1 in 100 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 up to 1 in 1,000 patients)

• Extrapyramidal symptoms (such as tremor or rigidity of the hands or legs)
• Cardiac conduction disorders
• Liver function abnormalities, 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 and 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 leading to abnormal sideways bending of the body and head)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of donepezil cinfa

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 refers to the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly discard containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of donepezil cinfa

• 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: monohydrate lactose, corn starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate.

Appearance of the product and contents of the pack

White, cylindrical, biconvex tablets marked with the code “DL”.

Each pack contains 28 or 50 tablets (hospital pack).

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - 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 for Medicines and Health Products (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 package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/73153/P_73153.html

QR code to: https://cima.aemps.es/cima/dochtml/p/73153/P_73153.html