Cognomem

Package leaflet: Information for the patient

Cognomem, 10 mg, film-coated tablets
Cognomem, 20 mg, film-coated tablets
Memantini hydrochloridum
Please read carefully all the information in this leaflet before taking this medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms appear identical.
• If the patient experiences any adverse effects, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Cognomem is and what it is 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 Cognomem is and what it is used for

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

2. Important information before taking Cognomem

When not to take Cognomem

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

Warnings and precautions
Before starting treatment with Cognomem, discuss this with a doctor or pharmacist:

• if the patient has had seizures in the past;
• if the patient recently suffered a myocardial infarction (heart attack), has congestive heart failure, or uncontrolled hypertension (high blood pressure).

In the above situations, treatment should be conducted under strict medical supervision, with the doctor regularly assessing the clinical effects of Cognomem therapy.
Inform the treating physician if the patient has been diagnosed with renal tubular acidosis [excessive concentration of acidic substances in the blood caused by kidney dysfunction (impaired kidney function)] or severe urinary tract infections (structures through which urine flows). In such cases, dose adjustment of the medicine by the treating physician may be necessary.
When administering memantine to patients with impaired renal function (kidney problems), the treating physician should closely monitor kidney function and, if necessary, appropriately adjust the memantine dosage.
Concomitant use of the following drugs should be avoided: amantadine (used in the treatment of Parkinson's disease), ketamine (usually used as an anaesthetic), dextromethorphan (usually used to treat cough), and other drugs belonging to the NMDA antagonist group.

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

Cognomem and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines the patient plans to take.
In particular, treatment with Cognomem may alter the effects of, and may require dose adjustment by the treating physician for the following medicines:

• amantadine, ketamine, dextromethorphan;
• dantrolene, baclofen;
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine;
• hydrochlorothiazide (and all combination products containing hydrochlorothiazide);
• anticholinergic drugs (substances usually used to treat movement disorders or intestinal spasms);
• anticonvulsants (substances used to prevent or stop seizures);
• barbiturates (substances mainly used as sedatives);
• dopaminergic agonists (such as: L-dopa, bromocriptine);
• neuroleptics (substances used to treat psychiatric disorders);
• oral anticoagulants.

If hospitalised, inform the doctor that the patient is taking Cognomem.

Cognomem with food, drink and alcohol
Inform the treating physician if the patient has recently made or plans to make significant changes in diet (e.g. switching from a normal diet to a strict vegetarian diet). In such cases, dose adjustment of the medicine by the treating physician may be necessary.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Use of Cognomem during pregnancy is not recommended.

Breastfeeding
Women taking this medicine should not breastfeed.

Driving and operating machinery
The doctor should inform the patient whether their condition allows them to safely drive vehicles or operate machinery. Cognomem may additionally affect reaction speed, making driving or operating machinery inadvisable.

Cognomem contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.

3. How to take Cognomem

This medicine should always be taken as advised by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Dosage
The recommended dose of Cognomem for adults and elderly patients is 20 mg once daily.
To reduce the risk of adverse effects, this dose should be reached gradually according to the following regimen:

The usual starting dose is half a 10 mg tablet once daily (1 x 5 mg) for the first week.
In the second week, the dose is increased to one 10 mg tablet once daily (1 x 10 mg). In the third
week of treatment, the dose is increased to one and a half 10 mg tablets once daily (1 x 15 mg). From
the 4th week onwards, the usual dose is two 10 mg tablets or one 20 mg tablet once daily (1 x 20 mg).

Dosage in patients with renal impairment
In patients with impaired kidney function, the appropriate dosage of the medicinal product should be determined by the attending physician based on the patient's health status. In such cases, regular monitoring of kidney function at specified intervals, according to the attending physician's recommendations, is necessary.

Method of administration
Cognomem should be taken orally, once daily. For effective treatment, the medicinal product should be taken regularly, every day at the same time. The tablets should be swallowed with a small amount of water. The tablets may be taken with food or independently of meals.

Duration of treatment
Treatment should be continued as long as beneficial effects are observed. The attending physician should regularly assess the course of treatment.

Overdose of Cognomem

• Generally, taking an excessive dose of Cognomem does not pose a health risk to the patient. In such a case, the adverse reactions described in section 4, "Possible side effects," may be intensified.
• In case of significant overdose of Cognomem, contact the attending physician or another doctor, as appropriate medical management may become necessary.

Missed dose of Cognomem

• If a patient forgets to take Cognomem, they should take the next dose at the usual time.
• A double dose should not be taken to make up for the missed dose.

If there are any further doubts regarding the use of this medicinal product, consult a physician or pharmacist.

4. Possible side effects

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

• headache, drowsiness, constipation, increased liver enzyme activity 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 (blood clots with or without embolism).

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

• seizures.

Not known (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 of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected].
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Cognomem

No special storage instructions are required for this medicinal product.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices 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:

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

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

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

Importer
S.C. Zentiva S.A., Bdul Theodor Pallady no. 50, sector 3, Bucharest, 032266, Romania

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

For further information about the medicinal product and its names in the European Economic Area countries, please contact:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. (22) 375 92 00