NEODIPIN. 5 mg. 30 tablets
NEODIPIN. 5 mg. 30 tablets
WHAT NEODIPIN BES - T AND WHAT IT IS USED
Tablets Neodipin BES T of 5 and 10 mg in packs of PVC / aluminum foil packaged in a carton containing patient information leaflet . The package is 30 tablets.
Neodipin BES - T is indicated as first- line treatment for hypertension, and may be used alone to control blood pressure in the majority of patients .
Neodipin BES - T is the drug of choice in the treatment of myocardial ischemia due to obstruction of a permanent (stable angina ), and / or vasospasm / vasoconstriction ( Prinzmetal angina or
variant angina ) coronary artery .
2 . WHAT YOU SHOULD KNOW BEFORE YOU TAKE NEODIPIN BES - T
Do not take Neodipin BES -T:
if you are allergic to amlodipine or any other ingredients of this medicine.
Warnings and Precautions
Use in patients with heart failure :
In clinical studies in patients with heart failure nonischaemic origin amlodipine was associated with increased reports of pulmonary edema despite no significant difference in the deterioration of heart failure compared with placebo (a pill with no active ingredient) .
Use in patients with impaired hepatic function:
As with all calcium antagonists, amlodipine half-life is prolonged in patients with impaired liver function and dosage recommendations have not yet been established. For this reason, the product should be administered to these patients with caution.
Other medicines and Neodipin BES - T
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Effect of other drugs on amlodipine
Cimetidine : Co-administration of amlodipine with cimetidine did not alter the pharmacokinetics of amlodipine.
Grapefruit juice: Co-administration of grapefruit juice with a single oral dose of amlodipine 10 mg had no significant effect on the pharmacokinetics of amlodipine.
Aluminum / magnesium ( antacid ): Co-administration of a single dose of amlodipine and antacid containing aluminum / magnesium does not alter the pharmacokinetics of amlodipine.
Sildenafil : When amlodipine and sildenafil were used in combination, each of them has its own hypotensive effect .
Effect of amlodipine on other drugs
Atorvastatin : Co-administration of multiple 10 mg doses of amlodipine and atorvastatin 80 mg showed no significant change in the steady state pharmacokinetic parameters of atorvastatin .
Digoxin: Co-administration of amlodipine with digoxin did not change serum digoxin levels or the renal clearance in healthy volunteers.
Ethanol ( alcohol) : Amlodipine 10 mg after single and repeated administration did not significantly alter the pharmacokinetics of ethanol.
Warfarin: Co-administration of amlodipine with warfarin did not change the time of the prothrombin response to warfarin.
Cyclosporine : Pharmacokinetic studies with cyclosporin have demonstrated that amlodipine does not significantly alter the pharmacokinetics of cyclosporine .
Interactions drug / laboratory tests : Not known.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine .
The safety of amlodipine during pregnancy and lactation has not been established . Therefore amlodipine during pregnancy is recommended only when there is no safer alternative and when the disease itself carries greater risk for mother and fetus.
It is not known whether amlodipine passes into breast milk . It is therefore recommended breastfeeding during treatment with amlodipine.
Driving and using machines
Clinical experience with amlodipine showed that therapy with him does not make the patient's driving or operating machinery .
3 . HOW TO TAKE NEODIPIN BES - T
Always take Neodipin BES -T exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist.
In adults, in the hypertension and angina , the usual starting dose is 5 mg of amlodipine once daily, this dose may be increased to up to 10 mg depending on the patient's response .
Not recommended dosage adjustment of amlodipine when coadministered with thiazide diuretics, beta blockers and angiotensin converting enzyme inhibitors.
Use in children : Not recommended .
Use in the elderly : Amlodipine , used at similar doses in young and elderly patients , is equally well tolerated .
Use in patients with hepatic insufficiency : See section Special warnings above.
Use in patients with renal failure : Changes in amlodipine plasma concentrations are not associated with the level of renal insufficiency and therefore the normal recommended dose. Amlodipine is not dialysable .
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 . POSSIBLE SIDE EFFECTS
Like all medicines, Neodipin BES - T can cause side effects, although not everybody gets them .
If any of the side effects gets serious , or you notice other effects not listed in this leaflet , please tell your doctor or pharmacist.
In rare cases, observed allergic reactions, including itching , rash , angioedema and erythema multiforme .
In very rare cases, hepatitis, jaundice and elevated liver enzymes ( primarily showing cholestasis ) .
As with other calcium channel blockers , the following adverse reactions have been reported rarely and can not be distinguished from the natural progression of the underlying disease : myocardial infarction , arrhythmia (including bradycardia , ventricular tachycardia and atrial fibrillation) and chest pain .
5 . HOW TO STORE NEODIPIN BES - T
Do not store above 25 ° C. Keep away from heat and light.
Keep out of reach of children.
Do not use Neodipin BES - T after the expiry date stated on the label and carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . PACKAGE CONTENTS AND ADDITIONAL INFORMATION
What does Neodipin BES - T
The active ingredient is amlodipine besylate .
The other ingredients are microcrystalline cellulose ( Avicel PH 102 ) , a basic calcium phosphate, magnesium stearate , sodium starch glycolate, colloidal silicon dioxide ( Aerosil 200 ) .
Looks like Neodipin BES - T and contents of the pack
White, round , flat tablets marked "AP" on one side and scored on the other side.
Tablets in blister PVC / Aluminium foil packed in a carton containing patient information leaflet . The package is 30 tablets.