POLMATINE 10 mg. 28 tablets
How does Polmatine
Polmatine belongs to a group of medicines known as anti-dementia drugs.
Memory loss in Alzheimer's disease is due to disturbances in the signal transmission in the brain. The brain contains so. Called. N-methyl-D-aspartate (NMDA) receptors involved in transmitting nerve signals important in learning and memory. Polmatin belongs to a group of medicines called antagonists of NMDA-receptors. Polmatin acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
What is Polmatine
Polmatin be used to treat patients with moderate to severe Alzheimer's disease.
2. What you need to know before taking Polmatine
Do not take Polmatine:
if you are allergic to memantine or any of the other ingredients (listed in Section 6).
Warnings and Precautions
Talk to your doctor before taking Polmatine:
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 from an uncontrolled hypertension (high blood pressure).
In these situations the treatment should be carefully supervised, and the clinical benefit of Polmatin be regularly reassessed by your doctor.
If you have renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.
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
Polmatin not recommended for children and adolescents under 18 years of age.
Other medicines and Polmatine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, Polmatine may alter the effects of these drugs and may need your doctor to adjust their dose:
amantadine, ketamine, dextramethorphan;
cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine;
hydrochlorothiazide (or any combination with hydrochlorothiazide);
anticholinergic agents (substances that are commonly used to treat movement disorders or intestinal cramps);
anticonvulsants (substances 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 Polmatin.
Polmatin 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, 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 taking Polmatin should not breastfeed.
Driving and using machines
The doctor will tell you whether your illness allows safe to drive and use machines. Furthermore Polmatin may change your reactivity, making driving or operating machinery.
Polmatin contains lactose
If you are told by your doctor that you have intolerance to some sugars, contact him before taking the medicinal product. Your doctor will advise you.
3. How to take Polmatine
Always take this medicine exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
Polmatin 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 (5 mg)
a 10 mg tablet
one and a half tablet of 10 mg (15 mg)
two 10 mg tablets OR one 20 mg tablet once a day
At the beginning of treatment you will start using the 5 mg once daily. This dose will be increased weekly by 5 mg until the recommended (maintenance) dose. The recommended maintenance dose is 20 mg once a day, which is reached at the beginning of the fourth week.
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.
Polmatin 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
Taking Polmatine continues until benefit from it. Your doctor should assess your treatment on a regular basis.
If you take more dose Polmatine
In general, taking too much Polmatine should not harm you. You may experience increased symptoms as described in section 4. "Possible side effects".
If you take Polmatin at a dose much higher than prescribed, contact your doctor or get medical advice, as you may need medical help.
If you forget to take Polmatine
If you find that you forgot to take your dose Polmatin, wait and take your 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 observed side effects are mild to moderate.
Common (affects 1 to 10 of 100);
headache, drowsiness, constipation, elevated liver enzymes, dizziness, balance disorder, shortness of breath, high blood pressure and drug hypersensitivity.
Uncommon (affects 1 to 10 of 1,000 treated):
fatigue, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis / thromboembolism).
Very rare (affects less than 1 in 10,000 treated):
Not known (frequency can not be estimated from the available data):
inflammation of the pancreas and psychotic reactions.
Alzheimer's disease is associated with depression, suicidal thoughts and suicide attempts. These events have been reported in patients treated with Polmatin.
If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
5. How to store Polmatine
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Keep the blisters in the outer carton to protect from light.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of that month.
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
The active substance is memantinov hydrochloride.
Each tablet contains 10 mg or 20 mg memantinov hydrochloride, equivalent to 8,31 mg, respectively, and 16,62 mg memantine.
Other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose, crospovidone type B, silica colloidal anhydrous, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E171), red iron oxide (E172) (only for the tablets of 20 mg), macrogol 400.
Polmatine looks like and contents of the pack
Polmatine 10 mg film-coated tablets are oval, oblong, biconvex, 9,5 x 4,5 mm, white to off-white; after separating the color of the tablet core is a white to off-white. The tablets can be divided into equal doses.