COGNEM 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Cognem 10 mg Film-Coated Tablets EFG

Donepezil Hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Cognem and what is it 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 speed of breakdown of this substance.

It is used to treat the symptoms of dementia in people with mild to moderately severe Alzheimer's disease. The symptoms include progressive loss of memory, confusion, and changes in behavior. As a result, people 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 you take Cognem

Do not takeCognem

• if you are allergic (hypersensitive) to Donepezil Hydrochloride or to piperidine derivatives or to any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions

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

• stomach or duodenal ulcers
• seizures (fits)
• a heart condition (such as irregular or very slow heart beats, heart failure, heart attack)
• a heart condition called "prolongation of the QT interval" or a history of certain abnormal heart rhythms called Torsade de Pointes or if a family member has "prolongation of the QT interval"
• low levels of magnesium or potassium in the blood
• asthma or other chronic lung disease
• liver problems or hepatitis
• difficulty urinating or mild kidney failure

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

Children and Adolescents

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

Other Medicines and Cognem

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that your doctor has not prescribed but that you have bought yourself in a pharmacy. It also applies to medicines that you might take in the future while you are still taking Cognem. This is because other medicines may weaken or strengthen the effects of Cognem.

• In particular, it is important that you tell your doctor if you are taking any of the following types of medicines: medicines for heart rhythm problems, such as amiodarone or sotalol
• medicines for depression, such as citalopram, escitalopram, amitriptyline, fluoxetine
• medicines for psychosis, such as pimozide, sertindole, or ziprasidone
• medicines for bacterial infections, such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungal medicines, such as ketoconazole

• other medicines for Alzheimer's disease, such as galantamine
• analgesics or for the treatment of arthritis, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, or diclofenac sodium
• anticholinergic medicines, such as tolterodine
• anticonvulsants, such as phenytoin, carbamazepine
• medicines for the heart, such as quinidine, beta-blockers (propranolol and atenolol)
• muscle relaxants, such as diazepam, succinylcholine
• general anesthetics
• medicines obtained without a prescription, such as herbal remedies

If you are going to have an operation that requires general anesthesia, you must inform your doctor and anesthetist that you are taking Cognem. This is because donepezil may affect the amounts of anesthesia needed.

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

Tell your doctor or pharmacist the name of your caregiver. Your caregiver will help you take your medicine as prescribed.

Taking Cognem with Food, Drinks, and Alcohol

Food does not affect the effect of Cognem.

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

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Cognem during pregnancy unless clearly necessary.

Do not take Cognem if you are breast-feeding.

Driving and Using Machines

Your illness may affect your ability to drive or use machines, and you should not carry out 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, do not drive or use machines.

Cognem Contains Lactose

If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to Take Cognem

How Much Cognem to Take

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist or nurse. If you are unsure, consult your doctor or 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 tell you to take 10 mg (one yellow tablet) each night before going to bed.

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

The dose you take may change depending on the duration of your treatment or what your doctor recommends. The maximum recommended dose is 10 mg each night.

Always follow the instructions of your doctor or pharmacist 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

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

Duration of Treatment with Cognem

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. Immediately call your doctor or the emergency department of the nearest hospital if you take more medicine than you should. Always bring the remaining tablets and this leaflet to the hospital with you so that the 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, telephone: 91 562 04 20, indicating the medicine and the amount taken.

Symptoms of overdose may include nausea (feeling sick) and vomiting (being sick), drooling, sweating, slow heart rate, low blood pressure (feeling dizzy or faint when standing up), breathing problems, 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 forgotten dose.

If you forget to take your medicine for more than one week, call your doctor before taking another medicine.

If You Stop Taking Cognem

Do not stop taking Cognem without consulting your doctor. If you stop taking donepezil, the benefits will gradually disappear.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

People taking Cognem have reported the following side effects.

Tell your doctor if you have any of these side effects while taking Cognem:

Serious Side Effects:

Tell your doctor immediately if you notice any of the following serious side effects. You may need urgent medical treatment.

• Stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the breastbone (may affect up to 1 in 100 people).
• Bleeding in the stomach or intestine. This can cause the appearance of dark stools or visible blood in the rectum (may affect up to 1 in 100 people).
• Seizures or fits (may affect up to 1 in 100 people).
• Liver damage, such as hepatitis. The symptoms of hepatitis are nausea (feeling sick) or vomiting (feeling like vomiting), loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and dark urine (may affect up to 1 in 1,000 people).
• Tell your doctor immediately if you notice that you have fever, muscle stiffness, sweating, or a decrease in the level of consciousness (a disorder known as "Neuroleptic Malignant Syndrome"), (may affect up to 1 in 10,000 people).
• Weakness, sensitivity, or muscle pain, especially 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 disease called rhabdomyolysis) (may affect up to 1 in 10,000 people).
• Fast and irregular heartbeats and fainting, which could be symptoms of a potentially life-threatening condition called Torsade de Pointes (frequency cannot be estimated from the available data).

Other Possible Side Effects

Very Common Side Effects (may affect more than 1 in 10 patients):

• Diarrhea
• Feeling or being sick
• Headache

Common Side Effects (may affect up to 1 in 10 patients):

• Muscle cramps
• Tiredness
• 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
• Uncontrolled urination
• Pain
• Accidents (patients may be more prone to falls and accidental injuries)

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

• Slow heart rate
• Increased salivation

Rare Side Effects (may affect up to 1 in 1,000 patients):

• Stiffness, tremors, or uncontrolled movements, especially of the face and tongue, and also of the limbs

Frequency Not Known:

• Changes in heart activity, which can be seen on an electrocardiogram (ECG) called "prolongation of the QT interval"
• .
• Increased libido, hypersexuality
• Pisa syndrome (a condition that involves involuntary muscle contraction with abnormal flexion of the body and head to one side).

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via their website: www.notificaram.es. By reporting side effects, 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 which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.
• This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

Composition of Cognem

The active substance is Donepezil Hydrochloride.

Each film-coated tablet of 10 mg contains Donepezil Hydrochloride monohydrate, equivalent to 10 mg of Donepezil Hydrochloride.

The other ingredients are:

Core:

Lactose monohydrate, 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 film-coated tablets. The tablets are described below.

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

Cognem 10 mg is available in the following pack sizes:

PVC/Alu blister in a cardboard box:

28, 56, 98, 119, 120 tablets.

Not all 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 - 2ª planta

28023 Madrid

Spain

Manufacturer

Laboratori FUNDACIO DAU

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

Barcelona 08040

Spain

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

Date of Last Revision of this Leaflet:April 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es