Memolek

Package Leaflet: Information for the Patient

Memolek, 10 mg, Film-Coated Tablets

Memantine Hydrochloride

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

• You should 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

1. What is Memolek and what is it used for

Memolek contains the active substance memantine hydrochloride. Memolek belongs to a group of medicines called anti-dementia medicines.
Memory loss in Alzheimer's disease is due to a disturbance of message signals in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors that are involved in the transmission of nerve signals that are important for learning and memory.
Memolek belongs to a group of medicines known as NMDA receptor antagonists. Memolek acts on NMDA receptors, improving the transmission of nerve signals and memory.
Memolek is used to treat patients with moderate to severe Alzheimer's disease.

2. Important information before taking Memolek

When not to take Memolek

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

Warnings and precautions

Before taking Memolek, you should discuss with your doctor or pharmacist:

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

In these situations, treatment with Memolek should be carried out under close medical supervision, with regular evaluation of the treatment effects.
When memantine is given to patients with kidney problems, the doctor should closely monitor kidney function and, if necessary, adjust the dose of the medicine.
If the patient has been diagnosed with renal tubular acidosis (RTA, excessive levels of acidic substances in the blood due to kidney dysfunction) or severe urinary tract infections, the doctor may need to adjust the dose of the medicine.
You should avoid taking other medicines such as amantadine (used for Parkinson's disease), ketamine (used for anesthesia), dextromethorphan (used for cough treatment), and other NMDA receptor antagonists.

Children and adolescents

Memolek should not be given to children and adolescents under the age of 18.

Memolek with other medicines

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

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

If you are admitted to hospital, tell your doctor that you are taking Memolek.

Memolek with food and drink

Tell 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, the doctor may need to adjust the dose of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Memantine should not be used during pregnancy.
Breastfeeding
Women taking Memolek should not breastfeed.

Driving and using machines

Your doctor should advise you whether your illness allows you to drive or use machines safely.
Memolek may also affect your reaction speed, making it inappropriate to drive or use machines.

Memolek contains lactose

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

3. How to take Memolek

This medicine should always be taken exactly as your doctor has instructed you.
In case of doubt, consult your doctor or pharmacist.
The recommended dose of Memolek for adults and elderly patients is 20 mg once a day.
To reduce the risk of side effects, the dose of the medicine should be increased gradually, according to the following scheme.
It is not possible to achieve doses of 5 mg and 15 mg using Memolek; if necessary, other available medicines containing 5 mg or 15 mg of memantine hydrochloride should be used.
Treatment usually starts with one 5 mg tablet once a day for the first week of treatment. In the second week, the dose is increased to one 10 mg tablet once a day, and in the third week to one 15 mg tablet once a day. From the fourth week, two 10 mg tablets are usually taken once a day (20 mg once a day).
The recommended maintenance dose is 20 mg once a day, which is reached at the beginning of the 4th week of treatment.

Dose in patients with renal impairment

In patients with impaired kidney function, the doctor will determine the appropriate dose of the medicine.
In such cases, regular monitoring of kidney function should be carried out at specified intervals, according to the doctor's instructions.

Method of administration

Memolek should be taken orally, once a day. To make the treatment effective, the medicine should be taken regularly every day at the same time. The tablets should be swallowed with water.
The medicine can be taken with or without food.

Duration of treatment

Treatment should be continued as long as it is effective. The doctor should regularly evaluate the course of treatment.

Taking more than the recommended dose of Memolek

Generally, taking too much Memolek does not pose a risk to health. In such cases, increased side effects may occur, as described in section 4 "Possible side effects".

In case of significant overdose of Memolek, you should contact your doctor or another doctor, as there may be a need to implement appropriate procedures.

Missing a dose of Memolek

If you forget to take a dose, you should take the next dose of Memolek at the usual time.
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Memolek 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, elevated liver enzymes, 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.

Frequency 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 memantine.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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:
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Memolek

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 packaging after EXP.
The expiry date refers to the last day of that month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Memolek contains

• The active substance is memantine hydrochloride. Each tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.
• The other ingredients are: tablet core:microcrystalline cellulose 102, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate; tablet coating:hypromellose (6cP), macrogol 3350, titanium dioxide (E171), lactose monohydrate, triacetin, quinoline yellow (E104) lake, indigo carmine (E132) lake.

What Memolek looks like and contents of the pack

Memolek 10 mg film-coated tablets are green, oval, biconvex, with the number "10" engraved on one side of the tablet.
OPA/Aluminium/PVC-Aluminium blisters in a cardboard box.
The pack contains 14, 28, 30, 56, 60, 90, 112, or 120 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14A
05-170 Zakroczym
Phone: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106

Date of last revision of the package leaflet: