Memantine glenmark
PolandTable of Contents
Package leaflet: Information for the user
Memantine Glenmark, 10 mg, film-coated tablets
Memantine Glenmark, 20 mg, film-coated tablets
Memantini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
- Keep this leaflet. 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 someone else, even if their symptoms are the same.
- If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist.
Leaflet contents
- What Memantine Glenmark is and what it is used for
- What you need to know before taking Memantine Glenmark
- How to take Memantine Glenmark
- Possible side effects
- How to store Memantine Glenmark
- Contents of the pack and other information
1. What Memantine Glenmark is and what it is used for
Memantine Glenmark belongs to a group of medicines used to treat 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 transmitting nerve signals important for learning and memory processes. Memantine Glenmark belongs to a group of medicines known as NMDA receptor antagonists. By acting on NMDA receptors, Memantine Glenmark improves the transmission of nerve impulses and memory.
- Memantine Glenmark is used in the treatment of patients with moderate to severe Alzheimer's disease.
2. Important information before using Memantine Glenmark
When not to use Memantine Glenmark:
- if the patient is allergic to memantine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
If the patient is unsure whether this applies, they should discuss it with their doctor or pharmacist before starting treatment with Memantine Glenmark.
Warnings and precautions
Before starting treatment with Memantine Glenmark, discuss this with your doctor or pharmacist:
- if the patient has a history of seizures;
- if the patient has recently had a myocardial infarction (heart attack), or has congestive heart failure, or uncontrolled hypertension (high blood pressure).
In the above situations, treatment with Memantine Glenmark should be carried out under strict supervision of the attending physician, who will regularly assess the effects of ongoing therapy.
If the patient has impaired kidney function (kidney problems), the treating physician should closely monitor kidney function during treatment with Memantine Glenmark and, if necessary, adjust the dosage accordingly.
If the patient has renal tubular acidosis [RTA, excessive concentration of acidic compounds in the blood caused by kidney failure (significant kidney dysfunction)] or severe urinary tract infection (structures through which urine passes), dosage adjustment of Memantine Glenmark by the physician may be required.
Concomitant use of Memantine Glenmark with the following drugs should be avoided:
- amantadine (a medicine used in the treatment of Parkinson's disease), ketamine (a medicine usually used as an anaesthetic), dextromethorphan (a medicine usually used to treat cough), and other drugs belonging to the NMDA antagonists group.
Children and adolescents
Memantine Glenmark is not recommended for use in children and adolescents under 18 years of age.
Memantine Glenmark 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 they plan to use.
In particular, treatment with Memantine Glenmark may affect the action of, and may necessitate dosage adjustment by the physician, of the following medicines:
- amantadine, ketamine, dextromethorphan
- dantrolene, baclofen
- cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
- hydrochlorothiazide (or any combination drug containing hydrochlorothiazide)
- anticholinergic medicines (medicines usually used to treat movement disorders or intestinal spasms)
- anticonvulsant medicines (medicines used to prevent and treat seizures)
- barbiturates (medicines mainly used as sedatives)
- dopaminergic agonists (medicines such as L-dopa, bromocriptine)
- neuroleptics (medicines used to treat psychiatric disorders)
- oral anticoagulants
If the patient is admitted to hospital, they should inform the doctor about the use of Memantine Glenmark.
Memantine Glenmark with food and drink
The patient should inform their treating physician if they have recently significantly changed their diet (e.g. from a normal diet to a strict vegetarian diet) or plan to do so.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
The use of Memantine Glenmark is not recommended in pregnant women.
Women taking Memantine Glenmark should not breastfeed.
Driving and using machines
The doctor should inform the patient whether the severity of their condition allows them to safely drive vehicles or operate machinery.
Memantine Glenmark may additionally affect reaction speed, making driving or operating machinery inadvisable.
3. How to take Memantine Glenmark
This medicine should always be taken as directed by the physician. If in doubt, consult a
doctor or pharmacist.
Dosage
The recommended dose of Memantine Glenmark for adult and elderly patients is
20 mg once daily. To reduce the risk of adverse effects, the dose should be increased
gradually according to the following regimen:
| half a tablet 10 mg |
| one tablet 10 mg |
| one and a half tablets 10 mg |
| two tablets 10 mg once daily or one tablet 20 mg |
The usual dosage starts with half a tablet once daily (1 x 5 mg) during the first week of treatment. In the second week, the dose is increased to one tablet once daily (1 x 10 mg), and to one and a half tablets once daily in the third week of treatment.
From the fourth week onwards, the usual dose is two 10 mg tablets once daily (1 x 20 mg) or one 20 mg tablet once daily (1 x 20 mg).
When increasing the dose, the availability of different tablet strengths should be taken into account.
Dosage in patients with renal impairment
In patients with impaired kidney function, the treating physician will determine the appropriate dose depending on the severity of kidney disease. In such cases, the treating physician will monitor kidney function at regular intervals.
Method of administration
Memantine Glenmark should be administered orally, once daily. To ensure effective treatment, the medicine should be taken regularly every day at the same time. Tablets should be swallowed with water. Memantine Glenmark can be taken with or without food.
The 10 mg and 20 mg tablets may be divided into equal doses.
Duration of treatment
Memantine Glenmark should be taken for as long as the treatment remains beneficial for the patient. The treating physician should regularly assess the course of treatment.
Use of a higher than recommended dose of Memantine Glenmark
- Generally, taking a higher than recommended dose of Memantine Glenmark does not usually pose a health risk. However, intensified symptoms described in section 4, "Possible side effects," may occur.
- In case of significant overdose with Memantine Glenmark, contact the treating physician or another doctor, as medical care may be necessary.
Missed dose of Memantine Glenmark
- If a patient forgets to take a dose of Memantine Glenmark, the next dose should be taken 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 medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences adverse reactions such as seizures or suicidal thoughts,
they should immediately discuss this with their doctor or pharmacist.
The adverse reactions usually observed are mild to moderate in severity.
Common adverse reactions (in less than 1 in 10 patients):
- headache, somnolence, constipation, increased liver enzyme activity, dizziness, balance disorders, dyspnea, high blood pressure, and hypersensitivity to the medicine
Uncommon adverse reactions (in less than 1 in 100 patients):
- fatigue, fungal infections, disorientation, hallucinations, vomiting, abnormal gait, heart failure, and formation of blood clots in veins (thrombophlebitis/venous thromboembolism)
Very rare adverse reactions (in less than 1 in 10,000 patients):
- seizures
Frequency not known (cannot be estimated from available data):
- pancreatitis, hepatitis, and psychotic reactions
Alzheimer's disease is associated with depression, suicidal thoughts, and suicide. Such events have been reported in patients treated with memantine.
Reporting of adverse reactions
If any adverse reactions occur, including any 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 at 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 provide more information on the safety of this medicine.
5. How to store Memantine Glenmark
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box after: Expiry (EXP) or on the blister after the abbreviation EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.
6. Contents of the pack and other information
What Memantine Glenmark contains
The active substance is memantine hydrochloride.
Each Memantine Glenmark 10 mg film-coated tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.
Each Memantine Glenmark 20 mg film-coated tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.
The other ingredients are:
Memantine Glenmark, 10 mg:
Silicified microcrystalline cellulose
Microcrystalline cellulose 98 %
Colloidal anhydrous silica 2 %
Sodium croscarmellose
Talc
Magnesium stearate
Coating Opadry White (03B28796)
containing:
Hypromellose 6cP
Titanium dioxide (E171)
Polyethylene glycol 400
Memantine Glenmark, 20 mg:
Silicified microcrystalline cellulose
Microcrystalline cellulose 98 %
Colloidal anhydrous silica 2 %
Sodium croscarmellose
Talc
Magnesium stearate
Coating Opadry 03B84713 Pink
containing:
Hypromellose 6cP
Titanium dioxide (E171)
Polyethylene glycol 400
Iron oxide red (E172)
What Memantine Glenmark looks like and contents of the pack
Memantine Glenmark 10 mg are white or almost white, oval film-coated tablets measuring approximately 11 mm x 6 mm, with the number "10" engraved on one side and a score line on the other.
The tablet can be divided into equal doses.
Memantine Glenmark 20 mg are pinkish-brown, oval film-coated tablets measuring approximately 14 mm x 7 mm, with the number "20" engraved on one side and a score line on the other.
The tablet can be divided into equal doses.
Memantine Glenmark 10 mg and Memantine Glenmark 20 mg are packed in blisters of 28, 56 or 120 film-coated tablets per cardboard box. One blister contains 14 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic
For further information about this medicinal product and its trade names in the countries of the European Economic Area, please contact the local representative of the Marketing Authorisation Holder:
Glenmark Pharmaceuticals Sp. z o.o.
Osmańska 14
02-823 Warsaw
Poland