Memolek

Package leaflet: Information for the patient

Memolek, 10 mg, coated tablets
Memantini hydrochloridum

Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

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

Leaflet contents:

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

Memolek contains the active substance memantine hydrochloride. Memolek belongs to a group of medicines used in the treatment of dementia.
Memory loss in Alzheimer's disease is caused by 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, which are involved in the transmission of nerve signals important for learning and memory processes.
Memolek belongs to a group of medicines known as NMDA receptor antagonists. By acting on NMDA receptors, Memolek improves the transmission of nerve impulses and memory.
Memolek is used in the treatment of patients with moderate to severe Alzheimer's disease.

2. Important information before taking Memolek

When not to take Memolek

• if the patient is 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 the following with your doctor or pharmacist:

• if the patient has previously experienced epileptic seizures;
• if the patient has recently suffered a myocardial infarction (heart attack) or suffers from congestive heart failure or uncontrolled hypertension (high blood pressure).

In the above situations, treatment with Memolek should be carried out under strict supervision of the attending physician, who should regularly assess the effects of the ongoing therapy.
When administering memantine to patients with renal impairment (kidney problems), the attending physician should closely monitor kidney function and, if necessary, adjust the dosage accordingly.
If the patient has been diagnosed with renal tubular acidosis (RTA, excessive levels of acidic substances in the blood caused by kidney dysfunction (impaired kidney function)) or severe urinary tract infections (infections of the structures through which urine flows), the attending physician may need to modify the dosage of the medicine.
Concomitant use of the following medicines should be avoided: amantadine (used in Parkinson's disease), ketamine (used for anesthesia), dextromethorphan (used to treat cough), as well as other medicines belonging to the group of NMDA antagonists.
Children and adolescents
Memolek is not recommended for children and adolescents under 18 years of age.
Memolek and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, taking Memolek may alter the effects of, and may necessitate dosage adjustments by the attending physician for the following medicines:

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

If hospitalization is required, inform the doctor that the patient is taking Memolek.
Memolek with food and drink
Inform the attending physician if the patient has recently made or plans to make significant changes in dietary habits (e.g. switching from a normal diet to a strict vegetarian diet). In such cases, the attending physician may need to modify the dosage of the medicine.
Pregnancy and breastfeeding
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
Administration of memantine to pregnant women is not recommended.
Breastfeeding
Women taking Memolek should not breastfeed.
Driving and operating machinery
The doctor should inform the patient whether the disease allows him or her to safely drive vehicles and operate machinery.
Memolek may additionally affect reaction speed, thus making driving vehicles or operating machinery inappropriate.
Memolek contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking Memolek.

3. How to take Memolek

This medicine should always be taken according to the doctor's instructions. In case of doubt, consult
your doctor or pharmacist.
The recommended dose of Memolek for adults and elderly patients is 20 mg once daily.
To reduce the risk of adverse effects, the dosage of the medicine should be increased gradually, according to the following scheme.

Obtaining doses of 5 mg and 15 mg is not possible by using Memolek tablets; if these doses are required, other medicines available on the market containing 5 mg or 15 mg of memantine hydrochloride should be used.
Treatment is usually initiated with one 5 mg tablet once daily during the first week of treatment. In the second week, the dose is increased to one 10 mg tablet once daily, and in the third week to one 15 mg tablet once daily. From the fourth week onwards, the usual dose is 2 tablets of 10 mg once daily (20 mg once daily).
The recommended maintenance dose is 20 mg once daily, which is typically reached at the beginning of the 4th week of treatment.
Dosage in patients with renal impairment
In patients with impaired renal function, the appropriate dosage of the medicinal product should be determined by the treating physician. In such cases, regular monitoring of renal function at specified intervals, in accordance with the treating physician's recommendations, is necessary.
Method of administration
Memolek should be administered orally, once daily. For effective treatment, the medicine should be taken regularly every day at the same time. Tablets should be swallowed with water.
The medicine may be taken with food or independently of meals.
Duration of treatment
Treatment should be continued as long as it provides beneficial effects. The treating physician should regularly evaluate the course of therapy.
Overdose of Memolek
Generally, taking an excessive dose of Memolek does not pose a serious health risk. In such cases, the symptoms described in section 4, "Possible side effects," may be intensified. In the event of a significant overdose of Memolek, contact the treating physician or another doctor, as appropriate management measures may be necessary.
Missed dose of Memolek
If a patient forgets to take the medicine, they should take the next dose of Memolek 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 medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Generally observed adverse effects are mild to moderate in intensity.
Common (may affect less than 1 in 10 people):

• Headache, somnolence, constipation, increased liver enzyme concentrations, 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 (thrombosis/embolism).

Very rare (may affect less than 1 in 10,000 people):

• Seizures.

Frequency not known (frequency cannot be estimated from 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 adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Memolek

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following EXP.
The expiry date refers to the last day of the stated month.
No special precautions regarding storage of the medicine are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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.
• Other ingredients are: tablet core: microcrystalline cellulose 102, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate; tablet coating: hypromellose (6 cP), macrogol 3350, titanium dioxide (E171), lactose monohydrate, triacetin, quinoline yellow lake (E104), indigo carmine lake (E132).

What Memolek looks like and contents of the pack
Memolek 10 mg coated tablets are green, oval-shaped, biconvex tablets with the number "10" engraved on one side.
Blister packs made of OPA/Aluminium/PVC-Aluminium, 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
Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.
ul. Ostrzykowizna 14A
05-170 Zakroczym
Tel.: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106