Memigmin 10 mg. 28 tablets

1. What Memigmin is and what it is used for
How Memigmin works:
Memigmin contains the active ingredient memantine hydrochloride. It belongs to a group of medicines known as anti-dementia medicines.
Memigmin is used to treat patients with moderate to severe Alzheimer's disease.
The memory loss in Alzheimer's disease is caused by disturbances in the way messages are sent in the brain. The brain contains so-called N-methyl-O-aspartate (NMDA) receptors, which are involved in the transmission of nerve signals that are important for learning and memory. Memigmin belongs to a group of medicines called NMDA receptor antagonists.
Memigmin acts on these NMDA receptors, improving the transmission of nerve signals and memory.
What Memigmin is used for:
Memigmin is used to treat patients with moderate to severe Alzheimer's disease.
2. What you need to know before you take Memigmin
Do not take Memigmin:
if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions:
Talk to your doctor or pharmacist before taking Memigmin

if you have had epileptic seizures;
if you have recently had a myocardial infarction (heart attack) or if you suffer from congestive heart failure or uncontrolled hypertension (high blood pressure).
In these cases, the treatment should be carefully monitored and the clinical benefit of Memigmin should be regularly assessed by your doctor.

If you have renal impairment (kidney problems), your doctor should carefully monitor your kidney function and, if necessary, adjust the doses of memantine accordingly.

The concomitant use of the medicinal products amantadine (for the treatment of Parkinson's disease), ketamine (a substance commonly used as an anaesthetic), dextramethorphan (commonly used to treat cough) and other NMDA antagonists should be avoided.

Children and adolescents:
Memigmin is not recommended for children and adolescents under 18 years of age.

Other medicines and Memigmin:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, Memigmin may alter the effects of the following medicines and your doctor may need to adjust their dose:

amantadine, ketamine, dextramethorphan;

dantrolene, baclofen;

cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine;

hydrochlorothiazide (or combination with hydrochlorothiazide);

anticholinergics (substances usually used to treat movement disorders or intestinal spasms);
anticonvulsants (substances used to prevent or relieve seizures);
barbiturates (substances usually used to induce sleep);
dopaminergic agonists (substances such as L-dopa, bromocriptine);
neuroleptics (substances used to treat mental disorders);
oral anticoagulants.
If you are admitted to hospital, tell the doctor that you are taking Memigmin.

Memantine with food and drink:
Tell your doctor if you have recently changed or are planning to change your diet drastically (for example from a normal diet to a strict vegetarian diet) or if you suffer from renal tubular acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (improper functioning of the kidneys)) or severe infections of the urinary tract (urinary tract), as the dose of the medicine may need to be adjusted.
Pregnancy and breast-feeding:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
Memantine is not recommended for use in pregnant women.
Women taking Memantine should not breast-feed.
Driving and using machines:
Your doctor will tell you whether your condition allows you to drive or use machines safely. Furthermore, Memigmin may alter your ability to react, which poses a risk when driving or operating machinery.
Memigmin contains lactose.
This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact him/her before taking this medicine.

3. How to take Memigmin
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Dosage:
The recommended dose of Memigmin for adults and elderly patients is 20 mg once a day.

To reduce the risk of side effects, this dose is gradually reached according to the following daily treatment schedule:

Week 1 half a 10 mg tablet (1 x 5 mg) once a day
Week 2 one 10 mg tablet (1 x 10 mg) once a day
Week 3 one and a half 10 mg tablets (1 x 15 mg) once a day
Week 4 and then two 10 mg tablets (1 x 20 mg) once a day
The recommended starting dose is half a tablet once a day (1 x 5 mg) during the first week. This is increased to one tablet daily (1 x 10 mg) during the second week and on the 1st and 2nd
half a tablet daily during the third week. From the fourth week onwards, the recommended dose is 2 tablets daily (1 x 20 mg).

Dosage in patients with impaired renal function:
If you have impaired renal function, your doctor will decide what dose is appropriate for your condition. In this case, your doctor should monitor your renal function at regular intervals.
Method of administration:
Memigmin should be taken orally once a day. To benefit from the medicine, you should take it regularly, at the same time each day. The tablets should be swallowed with some water. The tablets can be taken with or without food.
Duration of treatment:
Take Memigmin as long as it is effective for you. Your doctor should regularly reassess your treatment.

If you take more Memigmin than you should:
Usually taking too much Memigmin should not harm you. Some of the symptoms mentioned in section 4 "Possible side effects" may be intensified.
If you take Memigmin in a dose many times higher than prescribed, contact your doctor or seek medical advice, as you may need medical attention.
If you forget to take Memigmin:
If you find that you have forgotten to take your dose of Memigmin, wait and take the next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on 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.

Usually, the side effects observed are mild to moderate.

Common (may affect up to 1 in 10 people):
headache, drowsiness, constipation, increased liver function tests, dizziness, balance disorder, shortness of breath, high blood pressure and hypersensitivity to drugs.
Uncommon (may affect up to 1 in 100 people):
tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and blood clots in the veins (thrombosis/thromboembolism).
Very rare (may affect up to 1 in 10,000 people):
convulsions.
Not known (frequency cannot be estimated from the available data):
inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions.
Alzheimer's disease is associated with depression, thoughts and suicide attempts. These events have been reported in patients treated with Memigmin.

If any of the side effects gets serious or you notice any other side effects not listed in this leaflet, tell your doctor or pharmacist.
5. How to store Memigmin
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Memigmin contains:
The active ingredient is: memantine hydrochloride. Each film-coated tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.
The other ingredients are: microcrystalline cellulose, lactose monohydrate, povidone K 30, talc, silicon dioxide, colloidal anhydrous, magnesium stearate - in the tablet core; and hypromellose (E464), titanium dioxide (E 171) and macrogol 400 (E 1521) - in the tablet shell.
What Memigmin looks like and contents of the pack:
Memigmin film-coated tablets are white to off-white, oblong, biconvex, with a score line on both sides. The tablet can be divided into equal doses.
Memigmin film-coated tablets are available in PVC/-PE/-PVDC//Al blister packs containing 7, 14, 28, 30, 42, 49, 50, 56, 70, 84, 98, 100 or 112 film-coated tablets.
Not all packaging types can be released for sale.

 

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