el-GRen-US

 

Name of the medicinal product: BEFIMAT

Content: Each film coated tablet contains 30mg of nimodipine.

Pharmaceutical form: Film coated Tablet

Pharmacotherapeutic group:Calcium channel blockers

Packaging description: Paper box which contains 30 tablets in blisters PVC/PVDC- aluminum foil

BEFIMAT is a cerebral circulation improver.
BEFIMAT film-coated tablets contain nimodipine, a drug of the calcium antagonists class , which is used for the prevention and treatment of ischemic neurological disorders that occur after cerebral vasospasm, a consequence of subarachnoid hemorrhage. Nimodipine has a preferably cerebral vasodilating and anti-ischemic activity. The vasoconstriction, caused by various vasoactive substances (e.g. norepinephrine, serotonin, prostaglandins or histamine) and the blood or blood products, can be prevented or eliminated by the use of nimodipine. Moreover nimodipine has neuro- and psycho-pharmacological activity. According to studies in patients suffering from acute cerebral circulation disorders, nimodipine dilates the blood vessels of the brain and increases cerebral circulation, with intense increase perfusion in the affected brain regions compared with healthy brain. The effect is manifested with particular clarity in the cerebral vasospasm following a subarachnoid hemorrhage. The ischemic neurological damage and mortality occurring after vasospasm is significantly reduced by the use of nimodipine.
BEFIMAT indicated for:
  • Functional disorders of brain that occur during old age
  • Prevention and treatment of ischemic neurological disorders occur after cerebral vasospasm, a consequence of subarachnoid hemorrhage.
Do not take BEFIMAT if:
Previous chronic administration of the antiepileptic drugs phenobarbital, phenytoin or carbamazepine, reduces significantly the bioavailability of the oral nimodipine.
Therefore, no simultaneous administration is recommended, for oral nimodipine and antiepileptics.
In very elderly patients suffering from numerous disease, in patients with very severe renal function (glomerular filtration rate <20ml / min), and in patients with severe cardiovascular failure, the need to a BEFIMAT treatment should be studied carefully and should also be conducted regular monitoring of the patient by appropriate examinations.
Caution is advised in patients with severe hypotension (systolic blood pressure <90mm Hg).

Functional brain disorders, of organic origin, observed in old age:
BEFIMAT should not be used in patients with severe impairment of liver function (eg liver cirrhosis).

Prevention and treatment of ischemic neurological disorders that occur after cerebral vasospasm, as consequence of subarachnoid hemorrhage: The film-coated tablets BEFIMAT should be used with great caution in patients with generalized cerebral edema or increased intracranial pressure.

Take special care with BEFIMAT:
Tell your doctor or pharmacist about any medical problems you have or have had, including some allergy or renal dysfunction. If you have trouble swallowing or other gastrointestinal problems, discuss them with your doctor before taking BEFIMAT.

Taking / using other medicines:
Functional disorders of the brain in old age:
In patients receiving drugs to lower blood pressure, BEFIMAT can intensify the effect of concomitant treatment with drugs that lower blood pressure.
Concomitant use of H2-antagonist cimetidine or the anticonvulsant valproic acid may increase the concentration of nimodipine in plasma. There is insufficient information regarding the simultaneous administration BEFIMAT with neuroleptics or antidepressants.

Prevention and treatment of neurological disorders that occur after cerebral vasospasm, a consequence of subarachnoid hemorrhage:
Concomitant use of H2-antagonist cimetidine or the anticonvulsant valproic acid may increase the concentration of nimodipine plasma. There is insufficient information regarding the simultaneous administration BEFIMAT with neuroleptics or antidepressants.
In patients with high blood pressure treated with antihypertensive drugs, film-coated tablets BEFIMAT may enhance the antihypertensive effect of the drug, which is used simultaneously.
They should not be administered, concomitantly with BEFIMAT, intravenous beta-blockers, as this may cause further reduction in blood pressure.

Taking BEFIMAT with food and drink:
The BEFIMAT can be taken regardless of meals.

Pregnancy and breast-feeding:
In accordance with the general guidelines for the use of drugs, as also as in the case of film-coated tablets BEFIMAT should, for safety reasons, the indication to be put strictly during pregnancy and lactation.

Driving and using machines:
There is insufficient literature data on the effect of nimodipine on ability to drive and use machines.

Important information about some of the ingredients of BEFIMAT:
They are not mentioned.
The dosage should be individualized according to the needs of each patient.
Functional disorders of the brain that occur during old age:
1 tablet 3 times daily (3x30mg nimodipine).
Prevention and treatment of ischemic neurological disorders that occur after cerebral vasospasm, a consequence of subarachnoid hemorrhage:
If your the doctor have not set otherwise, it's recommended for 21 consecutive days, the daily oral dose to be 60mg (two 30mg coated tablets) every 4 hours (6x60mg nimodipine daily).
Therapy should be initiated within 96 hours after the onset of subarachnoid hemorrhage.
BEFIMAT film-coated tablets are generally swallowed whole with liquid, independently of meals. Should be allowed a period of at least four hours between successive doses.

If you take more BEFIMAT than you should:
Evidence of toxicity of nimodipine, aren't found in the literature, when administered in high doses by the oral route. However the symptoms of overdose are expected to relate to the cardiovascular system as peripheral vasodilatation with systemic hypotension. Clinically significant hypotension due to overdose with BEFIMAT may require cardiovascular support. The norepinephrine or dopamine may be useful in maintaining blood pressure at satisfactory levels.

(Poison Centre Telephone (Athens): 210 7793777).

If you forget to take BEFIMAT:
If the medication must be taken continuously and you miss a dose, you should take the missed dose as soon as possible. If, however, it is almost time for your next dose do not take the missed dose, but continue treatment..
Do not double doses.

If you stop taking BEFIMAT:
You should take BEFIMAT for as long as the doctor prescribes you. Do not stop treatment without first talking to your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.
The following side effects may be addressed:
Functional disorders of organic origin brain that occur during old age:
Drop in blood pressure (especially when the initial value is high), headache, flushing, sweating, dizziness, gastrointestinal disturbances, feeling of weakness, peripheral edema, nausea, sensation of heat or burning, increased heart rate (tachycardia). Some patients may develop CNS symptoms, such as insomnia, increased mobility, agitation and aggressiveness. Hyperkinesia, depression and thrombocytopenia may occur rarely.

Prevention and treatment of neurological disorders that occur after cerebral vasospasm, a consequence of subarachnoid hemorrhage:

Marked drop in blood pressure (especially when the initial value is high), headache, flushing, sweating, dizziness, gastrointestinal disorders, nausea, warm feeling or sensation, decrease in heart rate (bradycardia).
Very rarely observed thrombocytopenia and in some cases the dose of 6x60mg daily ileus (intestinal motility disorders due to intestinal paralysis).

If you think your medication caused any side effects please inform your physician or pharmacist or other professional healthcare, or directly to the National Medicines Agency (284 Mesogeion str., Cholargos 15562, www.eof.gr )..
Store out of the reach and sight of children. BEFIMAT should be kept away from sunlight and at ambient temperature (≤25 ° C).
The lifespan of BEFIMAT is 36 months. The expiration date is on the outer and inner packaging. If this date has passed, do not use.
Do not use BEFIMAT if you notice any visible sign of deterioration.
Medicines should not be disposed via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

What BEFIMAT tablets contain:
Each film-coated tablet contains 30mg Nimodipine.

Excipients: Cellulose Microcrystalline, Polyvidone, Crospovidone, Starch Maize, Magnesium Stearate.
Coating: Titanium Dioxide E 717 CI 77891, Hypromellose

What BEFIMAT tablets look like and contents of the pack:
BEFIMAT film-coated tablets are white, round and packed in blisters of PVC / Aluminium. Περιέχονται σε χάρτινο κουτί μαζί με οδηγία χρήσης, (3blistχ10).

Product of STILINGTON Ltd

MAH & Manufacturer:

MAH:
Mediapharm Ltd.
22 Athinas Str & Apollonos Str
153 44 Gerakas, Attica, GREECE
Τel: 210 6015821, Fax: 210 6015822

Manufacturer:
Pharmathen SA
6 Dervenakion Str, 153 44 Pallini, Attica
Τel: 210 6604300
Fax: 210 6666749

This Leaflet was last approved in: 02/2013