Memantine grindeks
Poland
Table of Contents
Package leaflet: Information for the user
Memantine Grindeks, 10 mg, film-coated tablets
Memantini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
- Keep this leaflet, as you may need to read it again.
- If you have any further 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 other people, even if their symptoms are the same.
- If the patient experiences any adverse reactions, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
Contents of the leaflet
- What Memantine Grindeks is and what it is used for
- Important information before taking Memantine Grindeks
- How to take Memantine Grindeks
- Possible side effects
- How to store Memantine Grindeks
- Contents of the package and other information
1. What Memantine Grindeks is and what it is used for
Memantine Grindeks contains the active substance memantine hydrochloride (referred to hereinafter as memantine). It belongs to a group of medicines known as anti-dementia drugs. It helps to reduce the symptoms of dementia in Alzheimer's disease.
How Memantine Grindeks works
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. Memantine belongs to a group of medicines known as NMDA receptor antagonists. It acts on NMDA receptors, improving nerve signal transmission and memory.
What Memantine Grindeks is and what it is used for
Memantine Grindeks is used in the treatment of patients with moderate to severe Alzheimer's disease.
2. Important information before using Memantine Grindeks
When not to use Memantine Grindeks
- 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 Memantine Grindeks, discuss with your doctor:
- if the patient has had seizures in the past;
- if the patient has recently had a heart attack or suffers from congestive heart failure, or has uncontrolled hypertension (high blood pressure).
In the above situations, treatment with memantine should be carried out under strict medical supervision, and the doctor should regularly assess the effectiveness of the ongoing therapy.
When administering memantine to patients with impaired renal function, the treating physician should closely monitor kidney function and, if necessary, appropriately adjust the dosage of the medicine.
Children and adolescents
Memantine Grindeks is not recommended for use in children and adolescents under 18 years of age.
Memantine Grindeks and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines the patient plans to take.
Do not take Memantine Grindeks together with the following medicines:
- amantadine (a medicine used to treat Parkinson's disease);
- ketamine (mainly used as an anaesthetic);
- dextromethorphan (mainly used to treat cough);
- other NMDA antagonists.
Memantine Grindeks may affect the action of, and may require dose adjustments by the treating physician for the following medicines:
- dantrolene, baclofen;
- cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine;
- hydrochlorothiazide (and all combination medicines containing hydrochlorothiazide);
- anticholinergic agents (medicines usually used to treat movement disorders or intestinal spasms);
- anticonvulsants (substances used to prevent and stop seizures);
- barbiturates (substances mainly used as sedatives);
- dopaminergic agonists (such as L-dopa, bromocriptine);
- antipsychotic medicines (used to treat psychiatric disorders);
- oral anticoagulants (used to prevent blood clotting).
If hospitalization occurs, inform the doctor that the patient is taking Memantine Grindeks.
Memantine Grindeks with food and drink
Inform your treating doctor 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), or if the patient has renal tubular acidosis (RTA), or severe urinary tract infections, as dose adjustment of the medicine may be necessary.
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 her doctor or pharmacist before using this medicine. Memantine should not be used during pregnancy.
Women taking Memantine Grindeks should not breastfeed.
Driving and operating machinery
The doctor should advise the patient whether the disease allows him or her to drive safely and operate machinery. Memantine Grindeks may additionally affect reaction speed, making driving or operating machinery inappropriate.
Memantine Grindeks contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.
3. How to use Memantine Grindeks
The medicine should always be used as directed by the physician. If in doubt, consult
your doctor or pharmacist.
Dosage for adults and elderly patients (aged 65 and over)
The recommended dose is 20 mg once daily. To reduce the risk of adverse effects, the dose should be increased gradually according to the following scheme:
| half a tablet 10 mg |
| one tablet 10 mg |
| one and a half tablets 10 mg |
| two tablets 10 mg |
The usual dose starts with half a tablet once daily. This dose is increased to one tablet daily in the second week, and to one and a half tablets once daily in the third week. From the fourth week onwards, the usual dose is two tablets once daily.
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
The tablets 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 water. This medicinal product may be taken with or without food. The tablet may be divided into equal doses.
Duration of treatment
Treatment with Memantine Grindeks should be continued for as long as it produces beneficial effects. The treating physician should regularly assess the course of treatment.
Overdose of Memantine Grindeks
Generally, taking an excessive dose of Memantine Grindeks does not pose a health risk. In such a case, the symptoms described in section 4 may be intensified.
In the event of a significant overdose of Memantine Grindeks, medical advice should be sought from a physician or healthcare provider, as appropriate management may be required.
Missed dose of Memantine Grindeks
If a patient forgets to take a dose of Memantine Grindeks, 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 questions regarding the use of this medicinal product, consult your physician 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 severity.
Common (occur in no more than 1 in 10 patients):
- Hypersensitivity to the medicine
- Drowsiness
- Dizziness
- Balance disorders
- High blood pressure
- Shallow breathing
- Constipation
- Increased liver enzyme activity results
- Headache
Uncommon (occur in no more than 1 in 100 patients):
- Fungal infections
- Confusion
- Hallucinations
- Abnormal gait
- Heart failure
- Venous thromboembolism (venous thrombosis/embolism)
- Vomiting
- Fatigue
Very rare (occur in less than 1 in 10,000 patients):
- Seizures
Frequency not known (cannot be estimated from the available data):
- Psychotic reactions
- Pancreatitis
- Hepatitis
Alzheimer's disease is associated with depression, suicidal thoughts, and suicide. Such cases have been reported in patients treated with memantine.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows the collection of further information on the safety of the medicine.
5. How to store Memantine Grindeks
Keep this medicine out of sight and reach of children.
No special precautions for storage of the medicine are required.
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 specified month.
Medicines must 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 Memantine Grindeks contains
- The active substance is memantine hydrochloride. Each coated tablet contains 10 mg of memantine hydrochloride.
- Other components of the medicine:
Tablet core: Lactose monohydrate, microcrystalline cellulose, talc, colloidal anhydrous silica, magnesium stearate.
Tablet coating: Opadry II White 33G28707 (hypromellose (E 464), titanium dioxide (E 171), lactose monohydrate, macrogol 3000, triacetin), carnauba wax.
What Memantine Grindeks looks like and contents of the pack
White or almost white, oblong, biconvex coated tablets with rounded ends, slightly concave in the middle, with a score line on both sides. Tablet size: approximately 12.7 mm in length, 3.7 mm in height.
PVC/PVDC/Aluminium blisters containing 7 or 10 coated tablets in a cardboard box.
Pack sizes: 28, 30, 56 or 60 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
AS GRINDEKS
Krustpils iela 53
Rīga, LV-1057
Latvia
This medicinal product is authorised in the European Economic Area countries under the following names:
Estonia Memantine Grindeks
Austria Memantin Grindeks 10 mg Filmtabletten
Croatia Memantine Grindeks 10 mg filmom obložena tableta
Czech Republic Memantine Grindeks
France MEMANTINE GRINDEKS 10 mg, comprimé pelliculé sécable
Greece Memantine Grindeks 10 mg, επικαλυμμένα με λεπτό υμένιο δισκία
Hungary Memantine Grindeks 10 mg filmtabletta
Ireland Memantine Grindeks 10 mg film-coated tablets
Italy Memantina Grindeks
Latvia Memantine Grindeks 10 mg apvalkotās tabletes
Lithuania Memantine Grindeks 10 mg plėvele dengtos tabletės
Poland Memantine Grindeks
Portugal Memantină Grindeks 10mg comprimidos revestidos por película
Romania Memantină Grindeks 10mg comprimate filmate
Slovakia Memantine Grindeks 10 mg filmom obalené tablety
07/2023