Cognem 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cognem 10 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, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you think any of the side effects you experience are serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not mentioned in this leaflet. See section 4.

Leaflet contents

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

1. What Cognem is and what it is used for

Cognem contains the active substance donepezil hydrochloride. Donepezil belongs to a group of medicines called acetylcholinesterase inhibitors.

Donepezil 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 to treat the symptoms of dementia in people with mild to moderately severe Alzheimer's disease. Symptoms include progressive memory loss, confusion, and changes in behaviour. As a result, patients with Alzheimer's disease find it increasingly difficult to carry out their normal daily activities.

Donepezil should only be used in adult patients.

2. What you need to know before taking Cognem

Do not take Cognem

• if you are allergic (hypersensitive) to donepezil hydrochloride or to piperidine derivatives or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist or nurse before starting to take Cognem. Talk to them if you have or have had:

• stomach or duodenal ulcers
• seizures (fits)
• 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 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
• asthma or any other chronic lung disease
• liver problems or hepatitis
• difficulty in passing urine or mild renal impairment

Also inform your doctor if you are pregnant or think you might be pregnant.

Children and adolescents

The use of Cognem is not recommended in children and adolescents (under 18 years of age).

Other medicines and Cognem

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines your doctor has not prescribed but that you have purchased on your own at a pharmacy. It also applies to medicines you may take in the future while continuing to take Cognem. This is because other medicines may weaken or strengthen the effects of Cognem.

• In particular, it is important to inform your doctor if you are taking any of the following types of medicines: medicines for heart rhythm problems, for example, amiodarone or sotalol

• medicines for depression, for example, citalopram, escitalopram, amitriptyline, 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 Alzheimer's disease, e.g. galantamine

• painkillers or medicines for the treatment of arthritis, e.g. aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, or sodium diclofenac

• anticholinergic medicines, e.g. tolterodine

• anticonvulsants, e.g. phenytoin, carbamazepine

• heart medicines, e.g. quinidine, beta-blockers (propranolol and atenolol)

• muscle relaxants, e.g. diazepam, succinylcholine

• general anaesthetics

• medicines obtained without a prescription, e.g. herbal remedies

If you are undergoing surgery requiring general anaesthesia, you must inform your doctor and anaesthetist that you are being treated with Cognem. Because donepezil may affect the amount of anaesthetic required.

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

Inform your doctor or pharmacist of your caregiver's name. Your caregiver will help you take your medicine as prescribed.

Taking Cognem with food, drinks and alcohol

Food does not affect the action of Cognem.

Do not drink alcohol while taking Cognem, as alcohol may alter its effect.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not take Cognem during pregnancy unless clearly necessary.

You must not take Cognem while breast-feeding.

Driving and using machines

Your illness 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 tiredness, dizziness and muscle cramps. If you experience these effects, you should not drive or operate machinery.

Cognem contains lactose

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

3. How to take Cognem

How much Cognem you should take

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

Initially, the recommended dose is 5 mg (one white tablet) each night before going to bed. After the first month, your doctor may instruct you to take 10 mg (one yellow tablet) each night before going to bed.

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

Your dose may be adjusted depending on the duration of your treatment or as advised by your doctor. The maximum recommended dose is 10 mg each night.

Always follow your doctor's or pharmacist's instructions on how and when to take your medicine. Do not change the dose yourself without consulting your doctor.

How to take your medicine

Swallow Cognem with a glass of water before going to bed at night.

Use in children and adolescents

The use of donepezil is not recommended in children and adolescents (under 18 years of age).

Duration of Cognem treatment

Your doctor or pharmacist will tell you how long to take the treatment. It is necessary for your doctor to see you to assess the progress of the treatment.

If you take more Cognem than you should

Do not take more than one tablet per day. Contact your doctor or the nearest hospital emergency department immediately if you take more medicine than you should. Always take the remaining tablets and this leaflet with you to the hospital so that doctors know what you have taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

Symptoms of overdose may include nausea (feeling sick), vomiting (being sick), salivation, sweating, slow heart rate, low blood pressure (feeling dizzy or dizziness upon standing), breathing difficulties, loss of consciousness, and seizures (fits).

If you forget to take Cognem

If you forget to take a tablet, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you have forgotten to take your medicine for more than one week, call your doctor before taking any further medication.

If you stop treatment with Cognem

Do not stop taking Cognem without consulting your doctor. If treatment with donepezil is interrupted, the beneficial effects 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 may cause adverse effects, although not everybody gets them.

The following adverse effects have been reported in people taking Cognem.

Contact your doctor if you experience any of these adverse effects during treatment with Cognem:

Serious adverse effects:

Inform your doctor immediately if you experience any of the following serious adverse effects listed below. You may require urgent medical treatment.

• Stomach or duodenal ulcers. Symptoms of ulcers include stomach pain and discomfort (indigestion) between the navel and the sternum (may affect up to 1 in 100 people).
• Bleeding in the stomach or intestine. This may cause dark stools or visible blood from the rectum (may affect up to 1 in 100 people).
• Seizures or fits (may affect up to 1 in 100 people).
• Liver damage, for example, hepatitis. Symptoms of hepatitis include nausea (feeling sick) or vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and dark-colored urine (may affect up to 1 in 1,000 people).
• Inform your doctor immediately if you notice fever, muscle stiffness, sweating, or decreased level of consciousness (a disorder known as "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people).
• Muscle weakness, tenderness, or pain, especially if you also feel unwell, have fever, or have dark-colored urine. This could be due to abnormal muscle breakdown, which may be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 people).
• Rapid or irregular heartbeat and fainting, which could be symptoms of a potentially life-threatening condition known as Torsade de Pointes (frequency cannot be estimated from available data).

Other possible adverse effects

Very common side effects (may affect more than 1 in 10 people):

• diarrhea
• feeling or being unwell
• headache

Frequent adverse effects (may affect up to 1 in 10 patients):

• muscle cramps
• fatigue
• difficulty sleeping (insomnia)
• common cold
• loss of appetite
• hallucinations (seeing or hearing things that are not real)
• abnormal dreams including nightmares
• agitation
• aggressive behavior
• fainting
• dizziness
• stomach pain
• rash
• itching
• involuntary urination
• pain
• accidents (patients may be more prone to falls and accidental injuries)

Uncommon (may affect up to 1 in 100 patients):

• slow heartbeats
• hypersalivation

Rare adverse effects (may affect up to 1 in 1,000 patients):

• stiffness, tremors, or uncontrollable movements, especially of the face and tongue, as well as of the limbs

Frequency not known:

• changes in heart activity, which may be seen on an electrocardiogram (ECG) called "prolongation of the QT interval"
• .
• increased libido, hypersexuality
• Pisa syndrome (a condition involving involuntary muscle contractions with abnormal lateral bending of the body and head).

Reporting of Adverse Reactions

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

5. Storage of Cognem

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to 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 unused medicines and their containers at the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cognem

The active substance is donepezil hydrochloride.

Each 10 mg film-coated tablet contains donepezil hydrochloride monohydrate, equivalent to 10 mg of donepezil hydrochloride.

The other components are:

Core:

Monohydrate lactose, corn starch, microcrystalline cellulose, low-substituted hydroxypropylcellulose, magnesium stearate.

Coating:

Hypromellose (E464), macrogol 400, talc (E553b), titanium dioxide (E171), yellow iron oxide (E172).

Appearance of the product and contents of the pack

Cognem is available in 5 mg and 10 mg tablet strengths. The tablets are described below.

10 mg: yellow, film-coated, round, biconvex tablets, approximately 8.73 mm in diameter, marked with "10" on one side and smooth on the other.

Cognem 10 mg is available in the following pack sizes:

PVC/Alu blisters in cardboard cartons:

28, 56, 98, 119, 120 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.

C/ de las Rosas de Aravaca, 31 - 2nd floor

28023 Madrid

Spain

Manufacturer

Laboratori FUNDACIO DAU

C/De la letra C, 12-14, Polígono Industrial de la Zona Franca

Barcelona 08040

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of latest review of this leaflet: April 2023

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