NEODIPIN 5 mg. 30 tablets

WHAT NEODIPIN BES-T AND WHAT IT IS USED
Tablets Neodipin BES-T of 5 and 10 mg in blister PVC / aluminum foil, packaged in a carton containing patient information leaflet. The package is of 30 tablets.
Neodipin BES-T is indicated as first-line treatment of hypertension and may be used alone to control blood pressure in most 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 vessels.

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 of the other ingredients of this medicine.
Warnings and Precautions
Use in patients with heart failure:
During clinical trials in heart failure patients with non-ischemic origin amlodipine was associated with increased reports of pulmonary edema despite no significant difference in the deterioration of heart failure compared to placebo (tablet without the active substance).

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: The concomitant use 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, did not significantly alter the pharmacokinetics of amlodipine.

Sildenafil: When amlodipine and sildenafil are used in combination, each of them has its own hypotensive effect.

Effect of amlodipine on other drugs
Atorvastatin: Co-administration of multiple doses of 10 mg of amlodipine and 80 mg of atorvastatin showed no significant change in the steady state pharmacokinetic parameters of atorvastatin.

Digoxin: Concomitant administration of amlodipine with digoxin did not change serum digoxin or its 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 alter prothrombin time response to warfarin.

Cyclosporin: Pharmacokinetic studies with cyclosporin have demonstrated that amlodipine does not significantly alter the pharmacokinetics of ciclosporin.

Interactions drug / lab tests: None 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, the application of amlodipine during pregnancy is recommended only when there is no safer alternative and when the disease itself carries greater risk for the 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 indicates that therapy it does not make patients driving or operating machinery.

3. HOW TO TAKE NEODIPIN BES-T
Always take Neodipin BES-T, exactly as your doctor has told you. If you're not sure, ask your doctor or pharmacist.

In adults: In hypertension and angina the usual starting dose is 5 mg amlodipine once daily and this dose may be increased to up to 10 mg depending on the individual response of the patient.
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 Elderly: Amlodipine, used at similar doses in young and elderly patients, is equally well tolerated.

Use in patients with hepatic insufficiency: See Warnings above.

Use in patients with renal insufficiency: Changes in plasma concentrations of amlodipine are not related to the level of renal insufficiency and therefore it is recommended normal 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 occur 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 evolution of the underlying disease: myocardial infarction, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation) and chest pain.

5. HOW TO STORE NEODIPIN BES-T
Keep at temperatures below 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 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
What 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).

How does Neodipin BES-T and contents of the pack
White, round, flat tablets marked "AP" on one side and scored on the other side.
Tablets for oral administration in blister PVC / aluminum foil, packaged in a carton containing patient information leaflet. The package is of 30 tablets.