NEMDATINE. 10 mg. 28 tablets
NEMDATINE. 10 mg. 28 tablets
What Nemdatine and what it is used
How does Nemdatine
Nemdatine belongs to a group of medicines known as anti-dementia drugs. Memory loss in Alzheimer's disease is due to abnormal transmission of signals in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in the transmission of nerve signals, which are important for learning and memory. Nemdatine refers to a group of medicines called NMDA-receptor antagonists. Nemdatine acts on these NMDA-receptors such as improving the transmission of nerve signals and the memory.
What is it used Nemdatine
Nemdatine used for treatment of patients with moderate to severe Alzheimer's expressed.
2. What you should know before taking Nemdatine
Do not take Nemdatine:
if you are allergic to memantinov 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 Nemdatine:
if you have a history of epileptic seizures;
if you have recently experienced a myocardial infarction (heart attack) or if you have congestive heart failure or hypertension (high blood pressure).
In these situations the treatment should be carefully monitored and the clinical benefit of Nemdatine be reassessed regularly by your doctor.
If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary to adjust the dose of memantine.
The use of medicinal products amantadine (for the treatment of Parkinson's disease), ketamine (a substance which is generally used as an anesthetic), dextromethorphan (generally used for treatment of cough) and other NMDA-antagonists should be avoided.
Children and adolescents
Nemdatine not recommended for use in children and adolescents under 18 years.
Other medicines and Nemdatine
Tell your doctor or pharmacist if you are taking, have recently taken or might take other medicines.
In particular, Nemdatine may alter the effects of these drugs and may be necessary for your doctor to adjust their dose:
amantadine, ketamine, dextromethorphan;
cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine;
hydrochlorothiazide (or any combination with hydrochlorothiazide);
anticholinergic agents (substances that are generally used to treat movement disorders or intestinal cramps);
anticonvulsants (substances to be used for the prevention or treatment of seizures);
barbiturates (substances that are commonly used to induce sleep);
dopaminergic agonists (substances such as L-dopa, bromocriptine);
neuroleptics (substances that are used to treat psychiatric disorders);
If you go into hospital, let your doctor that you are taking Nemdatine.
Nemdatine with food and drink
Tell your doctor if you have recently changed or intend to change your diet (eg from normal diet to 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 (malfunction kidney)) or severe infections of the urinary tract (structure that carries urine), as you may need to adjust the dose of the drug.
Pregnancy and lactation
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
Memantine is not recommended for use in pregnant women.
Women who take Nemdatine, should not breastfeed.
Driving and using machines
Your doctor will tell you whether your illness allows safe to drive or operate machinery. Also, Nemdatine can change your reactivity, making driving or operating machinery.
Nemdatine contains lactose monohydrate
If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.
3. How to take Nemdatine
Always take this medicine exactly as your told your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
Nemdatine recommended dose for adults and elderly patients is 20 mg once daily.
To reduce the risk of side effects, this dose is achieved gradually by the following daily treatment scheme:
Week 1: Half a tablet of 10 mg;
Week 2: One tablet of 10 mg;
Week 3: One and a half tablet of 10 mg;
Week 4: and then two tablets of 10 mg once daily.
The usual starting dose is half a tablet once daily (1 x 5 mg) in the first week. This is increased to one tablet once per day (1 x 10 mg) for the second week and up to one and a half tablet once daily (1 x 15 mg) for the third week. From the fourth week on, the usual dose is 2 tablets once daily (1 x 20 mg).
Dosage in patients with impaired renal function
If you have impaired kidney function, your doctor will decide what dose is appropriate for your condition. The doctor will monitor your kidney function at regular intervals.
Nemdatine should be administered orally once daily. To benefit from your medicine, you should take it regularly every day at the same time of day. The tablets should be swallowed with some water. The tablets can be taken with or without food.
Duration of treatment
Continue to take Nemdatine, while you benefit from it. Your doctor should assess your treatment on a regular basis.
If you take more dose Nemdatine
In general, taking excessive amounts Nemdatine should not harm you. You may experience increased symptoms as described in section 4. "Possible side effects";
If you accept Nemdatine at a dose much higher than prescribed, contact your doctor or seek medical advice, as you may need medical attention.
If you forget to take Nemdatine
If you find that you forgot to take your dose Nemdatine, wait and take your next dose at the usual time;
Do not take a double dose to make up for a missed 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 observed side effects are mild to moderate.
Common (affects 1 to 10 users in 100):
Headache, drowsiness, constipation, elevated liver enzymes, dizziness, balance disorder, asthma, high blood pressure and drug hypersensitivity.
Uncommon (affects 1 to 10 of 1000 users):
Fatigue, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous clots (thrombosis / embolism).
Very rare (affects less than 1 in 10,000 users):
Not known (data can not be estimated frequency):
Inflammation of the pancreas, liver inflammation (hepatitis) and psychotic reactions.
Alzheimer's disease is associated with depression, suicidal thoughts and suicide attempts. These events have been reported in patients treated with memantine.
If you get any side effects, tell your doctor or pharmacist. This includes all listed in this leaflet.
5. How to store Nemdatine
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". Expiry date refers to the last day of that month.
Do not store above 25 ° C.
<[Only HDPE packaging for tablets:]>
Use within 100 days after opening.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What does Nemdatine
The active ingredient is memantinov hydrochloride. Each tablet contains 10 mg of memantinov hydrochloride equivalent to 8,31 mg memantine.
Other ingredients are:
Tablet core: cellulose microcrystalline, crospovidone type A, talc and magnesium stearate.
Tablet coating (Opadry II white 33G28435): hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350 and triacetin.
Nemdatine looks like and contents of pack
Nemdatine 10 mg film-coated tablets (tablets) are white, capsule shaped, biconvex, size 9,8 mm x 4,9 mm, scored and marked "M 10" engraved on the side of the score.
Type of packaging
Blister packs 28, 30, 42, 50, 56, 60, 98 or 112 tablets.
Tablet 100 tablets.
Not all pack sizes may be marketed.