NEMDATINE 10 mg. 56 tablets
How does Nemdatine
Nemdatine belongs to a group of medicines known as anti-dementia drugs. Memory loss in Alzheimer's disease is due to impaired sending signals to the brain. The brain contains so. Called. N-methyl-D-aspartate (NMDA) receptors, which 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 improving the transmission of nerve signals and the memory.
What is Nemdatine
Nemdatine be used to treat patients with moderate to severe Alzheimer's disease expressed.
2. What you need to 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 are suffering from congestive heart failure or uncontrolled 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 generally used as an anesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists should be avoided.
Children and adolescents
Nemdatine not recommended for use in children and adolescents aged under 18 years.
Other medicines and Nemdatine
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any 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 that are used to prevent or treat 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 substantially (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 may be necessary to adjust the dose of the drug.
Pregnancy and lactation
If you are pregnant or breast-feeding, you think 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 and use machines. Also, Nemdatine may 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 him before taking this medicine.
3. How to take Nemdatine
Always take this medicine exactly as you have been told by your doctor or pharmacist. If you're 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 schedule:
Week 1: Half a tablet of 10 mg;
Week 2: One tablet of 10 mg;
Week 3: One tablet and a half of the 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 daily (1 x 10 mg) in the second week and up to one and a half tablet once daily (1 x 15 mg) in the third week. From the fourth week on, the usual dose is 2 tablets once daily (1 x 20 mg).
In patients with impaired renal function
If you have impaired kidney function, your doctor will determine what dose is appropriate for your condition. In this case, the physician should monitor your kidney function at certain 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
Keep taking 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. It may experience increased symptoms as described in section 4. "Possible side effects";
If you accept Nemdatine at a dose several times higher than prescribed, contact your doctor or get medical advice, as you may need medical help.
If you forget to take Nemdatine
If you find that you forgot to take your dose Nemdatine, wait and take the next dose at the usual time;
Do not take a double dose to make up the 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, sleepiness, constipation, elevated liver enzymes, dizziness, balance disorder, shortness of breath, high blood pressure and drug hypersensitivity.
Uncommon (affects 1 to 10 of 1000 users):
Tiredness, 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 (from the available 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, contact 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". The expiry date refers to the last day of that month.
Do not store above 25 ° C.
Only for HDPE packaging for tablets:
Use up to 100 days after opening.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and further information
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 33G28435 white): 6cP hypromellose, titanium dioxide (E 171), lactose monohydrate, macrogol 3350 and triacetin.
Nemdatine looks like and contents of the 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 and 112 tablets.
Tablet 100 tablets.
Not all pack sizes may be marketed.