Cognomem

Package Leaflet: Information for the Patient

Cognomem, 10 mg, coated tablets

Cognomem, 20 mg, coated tablets

Memantine hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Cognomem and what is it used for

Cognomem contains memantine hydrochloride as the active substance.
Cognomem is used to treat patients with moderate to severe Alzheimer's disease. Cognomem belongs to a group of medicines called anti-dementia medicines.
Memory loss in Alzheimer's disease is due to disturbances in the transmission of nerve impulses that carry information in the brain. In the brain, there are so-called N-methyl-D-aspartate (NMDA) receptors that are involved in transmitting nerve signals important for the learning and memory process. Cognomem belongs to a group of medicines called NMDA receptor antagonists. Cognomem, by acting on NMDA receptors, improves the transmission of nerve impulses and memory.

2. Important information before taking Cognomem

When not to take Cognomem

• if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take Cognomem, discuss with your doctor or pharmacist:

• if you have ever had seizures;
• if you have recently had a heart attack (myocardial infarction), have congestive heart failure or uncontrolled high blood pressure.

In these situations, treatment should be carried out under close medical supervision, and your doctor should regularly assess the clinical effects of Cognomem therapy.
Inform your doctor if you have been diagnosed with renal tubular acidosis (excessive concentration of acidic substances in the blood due to kidney dysfunction) or severe urinary tract infections. In these cases, it may be necessary to adjust the dose of Cognomem by your doctor.
When administering memantine to patients with kidney problems, your doctor should closely monitor kidney function and, if necessary, adjust the dose of memantine accordingly.
It is recommended to avoid taking medicines such as amantadine (used to treat Parkinson's disease), ketamine (usually used as an anesthetic), dextromethorphan (usually used to treat cough), and other NMDA receptor antagonist medicines.

Children and adolescents

Cognomem is not recommended for children and adolescents under 18 years of age.

Cognomem and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
In particular, taking Cognomem may affect the action of and require dose adjustment by your doctor of the following medicines:

• amantadine, ketamine, dextromethorphan;
• dantrolene, baclofen;
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine;
• hydrochlorothiazide (and all combination medicines containing hydrochlorothiazide);
• anticholinergic medicines (substances used to treat movement disorders or intestinal cramps);
• antiepileptic medicines (substances used to prevent and stop seizures);
• barbiturates (substances used mainly as sleeping pills);
• dopaminergic agonists (substances such as L-dopa, bromocriptine);
• neuroleptics (substances used to treat mental disorders);
• oral anticoagulants.

If you are hospitalized, inform your doctor that you are taking Cognomem.

Cognomem with food, drink, and alcohol

Inform your doctor if you have recently changed or plan to change your diet (e.g., switch from a normal diet to a strict vegetarian diet). In these cases, it may be necessary to adjust the dose of Cognomem by your doctor.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Cognomem is not recommended during pregnancy.

Breastfeeding

Women taking this medicine should not breastfeed.

Driving and using machines

Your doctor should inform you whether your illness allows you to drive and use machines safely. Cognomem may also affect your reaction speed, making it inadvisable to drive or operate machinery.

Cognomem contains lactose

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

3. How to take Cognomem

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

Dosage

The recommended dose of Cognomem for adults and elderly patients is 20 mg per day.
To reduce the risk of side effects, this dose is achieved gradually, according to the following scheme:
Usually, the initial dose is half a 10 mg tablet once a day (1 x 5 mg) for the first week.
In the second week, the dose is increased to one 10 mg tablet once a day (1 x 10 mg). In the third week of treatment, the dose is increased to one and a half 10 mg tablets once a day (1 x 15 mg). From the 4th week onwards, usually two 10 mg tablets or one 20 mg tablet are given once a day (1 x 20 mg).
Dosing in patients with renal impairment
The dose of Cognomem is determined by the doctor based on the patient's health condition. In such cases, it is necessary to constantly monitor kidney function at specified time intervals, according to the doctor's instructions.

Method of administration

Cognomem should be taken orally, once a day. To ensure the treatment is effective, the medicine should be taken regularly, every day at the same time. The tablets should be swallowed with a small amount of water. The tablets can be taken with or without food.

Duration of treatment

Treatment should be continued as long as it is beneficial.
Your doctor should regularly assess the course of treatment.

Taking more than the recommended dose of Cognomem

• Generally, taking too much Cognomem does not pose a risk to the patient's health. In such cases, the enhanced symptoms described in section 4 "Possible side effects" may occur.

• In case of significant overdose of Cognomem, contact your doctor or another doctor, as medical intervention may be necessary.

Missing a dose of Cognomem

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

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cognomem can cause side effects, although not everybody gets them.
Generally, the observed side effects are mild to moderate.
Common (may affect up to 1 in 10 people):

• headache, drowsiness, constipation, increased activity of liver enzymes shown in laboratory tests, dizziness, balance disorders, shallow breathing, high blood pressure, and hypersensitivity to the medicine.

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

• fatigue, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure, and venous thrombosis/thromboembolism.

Rare (may affect up to 1 in 10,000 people):

• seizures.

Unknown (frequency cannot be estimated from the available data):

• pancreatitis, hepatitis, and psychotic reactions.

Alzheimer's disease is associated with depression, suicidal thoughts, and suicide. Such cases have been reported in patients treated with Cognomem.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cognomem

There are no special precautions for storage.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. 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

What Cognomem contains

The active substance is memantine hydrochloride.
The other ingredients are:

• Core: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, talc, magnesium stearate.
• Coating: Opadry White 03b28796: hypromellose (E 464), titanium dioxide (E 171), macrogol 400 (E 1521).

What Cognomem looks like and contents of the pack

Cognomem, 10 mg, coated tablets: divisible coated tablets of 10 mg.
White or almost white, elongated coated tablets with a length of about 11.1±0.2 mm and a width of about 5.1±0.2 mm, with a dividing line on both sides.
Cognomem, 20 mg, coated tablets: divisible coated tablets of 20 mg.
White or almost white, elongated coated tablets with a length of about 13.3±0.2 mm and a width of about 7.2±0.2 mm, with a "SNAP TAB" dividing line on one side and a dividing line on the other side.
The tablet can be divided into equal doses.
Cognomem, 10 mg, coated tablets: PVC/aluminum blisters containing 14, 28, 30, 56, 60 coated tablets.
Cognomem, 20 mg, coated tablets: PVC/aluminum blisters containing 14, 28, 30, 56, 60 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

Importer

S.C. Zentiva S.A., B-dul Theodor Pallady nr. 50, sector 3, Bucharest, 032266, Romania

Manufacturer/Importer

Zentiva k.s., U Kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

For more information about this medicine and its names in the Member States of the European Economic Area, please contact:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. (22) 375 92 00

Date of last revision of the leaflet: