Memolek

Package Leaflet: Information for the Patient

Memolek, 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 package 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 package leaflet, please inform your doctor or pharmacist. 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 disturbances in the transmission of nerve impulses in the brain. In the brain, there are so-called N-methyl-D-aspartate (NMDA) receptors that are involved in the transmission of nerve signals important for learning and memory processes.
Memolek belongs to a group of medicines called NMDA receptor antagonists. Memolek, by acting on NMDA receptors, improves the transmission of nerve impulses 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 starting treatment with Memolek, discuss with your doctor or pharmacist:

• if you have had seizures in the past;
• if you have recently had a heart attack (myocardial infarction) or suffer from congestive heart failure or uncontrolled high blood pressure.

In these situations, treatment with Memolek should be carried out under close medical supervision, and the doctor should regularly assess the effects of the treatment.
When administering memantine to patients with renal impairment (kidney problems), the doctor should closely monitor kidney function and, if necessary, adjust the dosage of the medicine.
If the patient has been diagnosed with renal tubular acidosis (RTA, excessive concentration of acidic substances in the blood due to kidney dysfunction) or severe urinary tract infections (structures through which urine flows), the doctor may need to modify the dosage of the medicine.
Concomitant use of such medicines as amantadine (used in Parkinson's disease), ketamine (used for anesthesia), dextromethorphan (used to treat cough), and other NMDA receptor antagonists should be avoided.

Children and adolescents

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

Memolek and other medicines

Tell your doctor or pharmacist about all 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 drugs (substances used to prevent and interrupt seizures);
• barbiturates (substances used mainly as sedatives);
• dopaminergic agonists (substances such as L-dopa, bromocriptine);
• neuroleptics (substances used to treat mental disorders);
• oral anticoagulants.

In the event of hospitalization, inform your doctor that you are taking Memolek.

Memolek with food and drink

Inform your doctor if you have recently changed or plan to change your diet (e.g., switching from a normal diet to a strict vegetarian diet). In such cases, the doctor may need to adjust the dosage of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Memantine is not recommended during pregnancy.
Breastfeeding
Women taking Memolek should not breastfeed.

Driving and using machines

Your doctor should inform you whether your condition 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 diagnosed with an intolerance to some sugars, consult your doctor before taking Memolek.

3. How to take Memolek

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Memolek for adults and the elderly is 20 mg once a day.
To reduce the risk of side effects, the dosage 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 these doses are necessary, other available medicines containing 5 mg or 15 mg of memantine hydrochloride should be used.
Treatment usually starts with one 5 mg tablet per day for the first week of treatment. In the second week, the dose is increased to one 10 mg tablet per day, in the third week to one 15 mg tablet per day. From the fourth week, one 20 mg tablet per day is usually given.
The recommended maintenance dose is 20 mg once a day, which is achieved at the beginning of the 4th week of treatment.

Dosage in patients with renal impairment

In patients with impaired kidney function, the doctor will determine the appropriate dosage of the medicine.
In such cases, regular monitoring of kidney function is necessary, at intervals determined by the doctor.

Method of administration

Memolek should be taken orally, once a day. To ensure the treatment is effective, the medicine should be taken regularly, at the same time every day. 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 assess 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 symptoms described in section 4 "Possible side effects" may occur.

In the event of significant overdose of Memolek, contact your doctor or another doctor, as appropriate action may be necessary.

Missing a dose of Memolek

If you forget to take a dose, take the next dose of Memolek at the usual time.
Do not take a double dose to make up for the 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, this medicine can cause side effects, although not everybody gets them.
Generally, the observed side effects are mild to moderate.
Common (may affect less than 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 less than 1 in 100 people):

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

Rare (may affect less than 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 get serious, or if you notice any side effects not listed in this package leaflet, please tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Medicines Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. 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 stated on the packaging after EXP.
The expiry date refers to the last day of the 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. This 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 20 mg of memantine hydrochloride, equivalent to 16.62 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 20 mg coated tablets are green, oval, biconvex, with the number "20" engraved on one side of the tablet.
OPA/Aluminium/PVC-Aluminium blisters, placed in a cardboard box.
The pack contains 14, 28, 30, 56, 60, 90, 112, or 120 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: