Nifedipin. 10 mg. 50 tablets
Nifedipin. 10 mg. 50 tablets
Composition of a coated tablet : Active substance : Nifedipine 10 mg
Excipients: lactose monohydrate, microcrystalline cellulose , corn starch , gelatin, magnesium stearate, talc , opaglos NA 7150 , subcoat opaluks AS 22808 , sucrose, opaglos 6000.
PHARMACEUTICAL FORM AND Pharmacotherapeutic group
Nifedipin in the form of coated tablets is a product from the group of calcium antagonists with vasodilatory effects on kravonostite vessels. Made a comparative study of nifedipine ( Sopharma ) with the original preparation Korinfar (AWD GmbH) showed no difference in activity between the two products .
In which cases can be applied Nifedipin ?
• For the treatment of coronary artery disease (Crohn's heart vessels )
- Chronic stable angina
- Vasospastic angina ( angina of Prinzmetal)
• For the treatment of hypertension ( essential hypertension after clinical assessment )
In which cases should not apply ?
Hypersensitivity to any component of Nifedipine , cardiogenic shock, severe stenosis of the aortic valve of the heart, unstable angina , myocardial infarction within the first 4 weeks.
PRECAUTIONS FOR USE
When Nifedipin should be used with caution ? Careful monitoring of blood pressure at the start of treatment with nifedipine and finding the required dose. Particular care is required for patients taking drugs that lower blood pressure.
Upon application of the product may have mild to moderate peripheral edema due to sadorazshryavashtoto action. These swellings appear first on the lower limbs and usually respond to diuretics (medicines for dehydration ) .
This product contains the excipient wheat starch , which can be dangerous for people with celiac disease ( intolerance to gluten protein ingredient contained in wheat grains ) .
There are no adequate and well-controlled studies in pregnant women. Nifedipine can be used during pregnancy only if the potential benefit justifies the potential : risk . No adverse effects on the mother and fetus during prolonged use of nifedipine before and during pregnancy.
Nifedipin is excreted in human milk, therefore , you should decide to discontinue nursing or to break the drug , taking into account the importance of the drug to the mother.
Upon initiation and adjustment of the nifedipine dose , patients should not perform potentially hazardous activities or drive vehicles as a decrease in blood pressure can lead to accidents.
What other drugs affect the action of nifedipin ?
All drugs that cause lowering of blood pressure may enhance the effect of nifedipine .
When coadministered with digoxin , nifedipine may increase its effect .
Nifedipine can reduce the effect of coumarin anticoagulants ( anti-clotting drugs ) .
Cimetidine and to a lesser extent, enhance the action of the ranitidine Nifedipine .
Nifedipine is possible to reduce the effect of quinidine .
Karpamazepin , phenobarbital, phenytoin and rifampin may reduce the effect of nifedipine .
Indomethacin , and possibly other non-steroidal antiinflammatory drugs may antagonize the effect of nifedipine .
The joint use of lithium and Nifedipine can lead to neurotoxicity in the form of nausea , vomiting , diarrhea , ataxia , tremor, tinnitus .
Nifedipine may increase the blood levels and the effects of cyclosporin .
The use of grapefruit juice * suppress degradation of Nifedipine as a result of which the concentrations in the blood are increased, and this can lead to a sharp decrease in blood pressure .
Itraconazole can affect the metabolism of nifedipine and to enhance its effect.
You should inform your doctor in case of any concomitant medicinal products in order to avoid any possible interaction between them.
METHOD AND DOSAGE
Coated tablets are normally taken after food without chewing, with some liquid.
Treatment starts c 10 mg ( 1 coated tablet) Nifedipine 2-3 times daily. In most cases the increase of the dose should be in 7-10 day period , so that the physician to evaluate the response of each dose to monitor the blood pressure before going to the higher doses .
Guide dosing in various displays of the product are :
1. With coronary disease :
- In case of chronic stable angina is administered 3 times 10-20 mg (1-2 coated tablets ) per day ;
- In - vasospastic angina is administered 3 times daily 10-20 mg : If you need a higher dose , it should be increased gradually , first 4 times 20 mg, then up to 6 times 20 mg.
2 . When high blood pressure is being applied 3 times in 10-20 mg daily.
What side effects may occur in the application of Nifedipin ?
Side effects are common but usually not serious and rarely require discontinuation of treatment. Most are expected consequence of sadorazshiryavashite effects of nifedipine .
The most common adverse reactions approximately 10 % were peripheral edema , dizziness, vertigo , nausea, headache, flushing , weakness , about 5% - transient hypotension (low blood pressure), about 2% less - palpitations , diarrhea, sleep disorder , muscle cramps , itching, allergic rashes , fever, sexual disorders , anxiety , tremor , blurred vision , balance disorder , about 0.5% - syncope ( sudden drop in blood pressure with fainting ), and below 0.5% - thrombocytopenia (reduced platelet count ) , anemia , leukopenia , (reducing the total number of leukocytes ) , edema of the gums, depression , transient blindness , joint inflammation .
- Some of these side effects are dose-dependent . Transient hypotension which is usually mild to moderate rarely requires discontinuation of treatment , the introduction of a rarely Nafedipin can lead to amplification of anginal pain .
Reversible increases in serum urea and creatinine have been reported in individual patients with pre-existing chronic renal failure, although nifedipine safely used in patients with impaired renal function.
For all adverse reactions, including not listed in this leaflet, the patient should immediately tell their doctor.
Overdosage with Nifedipine most often occur dizziness , nausea , headache and low blood pressure .
In case of overdose you should immediately contact your doctor or the nearest emergency unit .
In original packaging in a dry and dark place at a temperature below 25 ° C.
Keep out of reach of children!
Two years from date of manufacture.
Do not use after the expiry date !
The medicinal product is packaged in 10 wrapped : tablets in blister packs solid red PVC / aluminum foil. Five blister placed in a cardboard box with a package leaflet .