Memigmin
Poland
Table of Contents
Package leaflet: Information for the patient
Memigmin, 10 mg, film-coated tablets
(Memantini hydrochloridum)
Read the entire leaflet before starting treatment, as it contains important information for the patient
- Keep this leaflet for future reference.
- Consult your doctor or pharmacist if you have any further questions.
- This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
- If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents
- What Memigmin is and what it is used for
- Important information before taking Memigmin
- How to take Memigmin
- Possible side effects
- How to store Memigmin
- Contents of the pack and other information
1. What Memigmin is and what it is used for
How Memigmin works
Memigmin belongs to a group of medicines known as antidementia agents.
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 receptors known as N-methyl-D-aspartate (NMDA) receptors, which are involved in transmitting nerve signals important for learning and memory processes. Memigmin belongs to a group of medicines called NMDA receptor antagonists. By acting on NMDA receptors, Memigmin improves the transmission of nerve impulses and memory function.
What Memigmin is used for
Memigmin is used in the treatment of patients with moderate to severe Alzheimer's disease.
2. Important information before using Memigmin
When not to use Memigmin
- 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 Memigmin, consult a 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 Memigmin should be carried out under strict medical supervision, with the treating physician regularly assessing the effectiveness of the ongoing therapy.
If the patient has impaired kidney function (kidney problems), the treating physician should closely monitor kidney function and, if necessary, adjust the memantine dosage accordingly.
Concomitant use of the following drugs should be avoided: amantadine (used to treat Parkinson's disease), ketamine (a substance usually used as an anaesthetic), dextromethorphan (commonly used to treat cough), and other medicines belonging to the group of NMDA antagonists.
The treating physician should be informed if the patient has recently changed or plans to substantially change their diet (e.g. switching from a normal diet to a strict vegetarian diet), or if the patient has been diagnosed with renal tubular acidosis (RTA, excessive concentration of acidic substances in the blood caused by impaired kidney function) or severe urinary tract infections. In such cases, the treating physician may need to modify the dosage of the medicine.
Children and adolescents
Memigmin is not recommended for use in children and adolescents under 18 years of age.
Other medicines and Memigmin
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to take.
In particular, treatment with Memigmin may alter the effects of, and may necessitate dosage adjustments by the treating physician for the following medicines:
- amantadine, ketamine, dextromethorphan;
- dantrolene, baclofen;
- cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine;
- hydrochlorothiazide (and all combination medicines containing hydrochlorothiazide);
- anticholinergic drugs (substances usually used in the treatment of movement disorders or intestinal spasms);
- anticonvulsants (substances used to prevent and stop epileptic seizures);
- barbiturates (substances mainly used as sedatives or sleeping pills);
- dopaminergic agonists (such as L-dopa, bromocriptine);
- neuroleptics (medicines used in the treatment of psychiatric disorders);
- oral anticoagulants.
If hospitalization occurs, inform the doctor that the patient is taking Memigmin.
Pregnancy and breastfeeding
During pregnancy, while breastfeeding, if pregnancy is suspected, or if planning a pregnancy, consult a doctor before using this medicine. Use of memantine is not recommended in pregnant women.
Women taking Memigmin should not breastfeed.
Driving and operating machinery
The treating physician should advise the patient whether their condition allows them to drive safely and operate machinery. Memigmin may additionally affect reaction speed, thus driving vehicles or operating machinery may be contraindicated.
Memigmin contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking this medicine.
3. How to use the medicine Memigmin
This medicine should always be used as recommended by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Dosage
The recommended dose of Memigmin for adults and elderly patients is 20 mg once daily.
To reduce the risk of adverse effects, the dose of the medicine should be increased gradually according to the following scheme:
| half a 10 mg tablet (1 x 5 mg) once daily |
| one 10 mg tablet (1 x 10 mg) once daily |
| one 10 mg tablet and half a 10 mg tablet (1 x 15 mg) daily |
| two 10 mg tablets (1 x 20 mg) once daily |
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.
In such cases, regular monitoring of kidney function at specified intervals, in accordance with the attending physician's recommendations, is necessary.
Method of administration
Memigmin should be taken orally, once daily. For effective treatment, the medicinal product should be taken regularly every day at the same time. Tablets should be swallowed with water. The tablets may be taken with food or independently of meals.
Duration of treatment
Treatment should be continued as long as it provides positive effects. The attending physician should regularly evaluate the course of treatment.
Use of a higher than recommended dose of Memigmin
- Generally, ingestion of an excessive dose of Memigmin does not pose a health hazard. In such a case, intensified adverse reactions described in section 4, "Possible adverse reactions," may occur.
- In case of significant overdose of Memigmin, contact the attending physician or another doctor, as appropriate medical intervention may become necessary.
Missed dose of Memigmin
- If a patient forgets to take a dose of Memigmin, they should wait and take the next dose at the usual time.
- A double dose should not be taken to make up for the missed dose.
If you have any further doubts concerning the use of this medicinal product, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Generally observed adverse reactions are mild to moderate in intensity.
Common (may occur in 1 out of 10 patients)
- Headache, drowsiness, constipation, increased liver enzyme activity, dizziness, loss of balance, shallow breathing, high blood pressure, and hypersensitivity to the medicine.
Uncommon (may occur in 1 out of 100 patients)
- Feeling of fatigue, fungal infections, confusion, hallucinations, vomiting, unsteady gait, heart failure, and formation of blood clots in veins (thrombosis/venous thromboembolism).
Very rare (may occur in 1 out of 10,000 patients)
- Seizures.
Unknown (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 Memigmin.
If any of the adverse reactions worsen, or if any adverse reactions occur, including those not listed in this leaflet, consult a doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions 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 181C
02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store the medicine Memigmin
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the specified month.
No special storage instructions for this medicinal product.
Medicines must 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 Memigmin contains
The active substance is memantine hydrochloride. Each film-coated tablet contains 10 mg
of memantine hydrochloride, equivalent to 8.31 mg of memantine.
The other components are: tablet core – microcrystalline cellulose, lactose DC consisting of:
Monohydrate lactose, Povidone K 30, colloidal anhydrous silica, talc, magnesium stearate; coating
Opadry White Y-1-7000 – hypromellose 5 cp, titanium dioxide (E171), macrogol 400.
What Memigmin looks like and contents of the pack
Memigmin film-coated tablets are white or almost white, elongated, biconvex
film-coated tablets with a division line on both sides. The tablet can be divided into equal
doses.
Memigmin film-coated tablets are available in PVC/PE/PVDC/Aluminium blisters containing
7, 14, 28, 30, 42, 49, 50, 56, 70, 84, 98, 100 and 112 film-coated tablets.
In Poland, only packs containing 28 and 56 tablets are marketed.
Marketing Authorisation Holder
EGIS Pharmaceuticals PLC
Keresztúri út 30-38
H-1106 Budapest,
Hungary
Manufacturer
EGIS Pharmaceuticals PLC
Bökényföldi út 118-120
H-1165 Budapest
Hungary
HBM Pharma s.r.o.
Sklabinská 30
036 80 Martin
Slovakia
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Bulgaria Memigmin 10 mg film-coated tablets
Czech Republic Memigmin 10 mg potahované tablety
Hungary Memigmin 10 mg filmtabletta
Lithuania Memigmin 10 mg plėvele dengtos tabletės
Latvia Memigmin 10 mg apvalkotās tabletes
Poland Memigmin, 10 mg, film-coated tablets
Romania Memigmin 10 mg comprimate filmate
Slovakia Memigmin 10 mg filmom obalené tablety