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AMLODIPINE AUROBINDO 5 MG TABLETS

Information leaflet

                                                   Irish Medicines Board




                                  Summary of Product Characteristics
 1 NAME OF THE MEDICINAL PRODUCT

 Amlodipine Aurobindo 5 mg tablets

 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each tablet contains Amlodipine besilate equivalent to 5 mg of amlodipine.

 For a full list of excipients, see section 6.1.

 3 PHARMACEUTICAL FORM

 Tablet

 White or almost white, flat, bevelled edges, barrel-shaped tablet debossed with "C" on one side and "58" on the other
 side.

 4 CLINICAL PARTICULARS

 4.1 Therapeutic Indications

 Hypertension
 Chronic stable angina pectoris.
 Vasospastic (Prinzmetal’s) angina

 4.2 Posology and method of administration

 Posology

 Adults
 For both hypertension and angina the usual initial dose is 5 mg Amlodipin Aurobindo once daily which may be
 increased to a maximum dose of 10 mg depending on the individual patient's response.

 In hypertensive patients, Amlodipin Aurobindo has been used in combination with a thiazide diuretic, alpha blocker,
 beta blocker, or an angiotensin converting enzyme inhibitor. For angina, Amlodipin Aurobindo may be used as
 monotherapy or in combination with other antianginal medicinal products in patients with angina that is refractory to
 nitrates and/or to adequate doses of beta blockers.
 No dose adjustment of Amlodipin Aurobindo is required upon concomitant administration of thiazide diuretics, beta
 blockers, and angiotensin-converting enzyme inhibitors.

 Special populations
 Elderly
 Amlodipin Aurobindo used at similar doses in elderly or younger patients is equally well tolerated. Normal dosage
 regimens are recommended in the elderly, but increase of the dosage should take place with care (see sections 4.4 and
 5.2).

 Hepatic impairment
 Dosage recommendations have not been established in patients with mild to moderate hepatic impairment; therefore
 dose selection should be cautious and should start at the lower end of the dosing range (see sections 4.4 and 5.2). The
 pharmacokinetics of amlodipine have not been studied in severe hepatic impairment. Amlodipine should be initiated at
 the lowest dose and titrated slowly in patients with severe hepatic impairment.




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Date Printed 25/01/2012                               CRN 2108093                                         page number: 1
                                                    Irish Medicines Board




 Renal impairment
 Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment, therefore the normal
 dosage is recommended. Amlodipine is not dialysable.

 Paediatric population
 Children and adolescents with hypertension from 6 years to 17 years of age
 The recommended antihypertensive oral dose in paediatric patients ages 6-17 years is 2.5 mg once daily as a starting
 dose, up-titrated to 5 mg once daily if blood pressure goal is not achieved after 4 weeks. Doses in excess of 5 mg daily
 have not been studied in paediatric patients (see sections 5.1 and 5.2).

 Doses of amlodipine 2.5 mg are not possible with this medicinal product.

 Children under 6 years old
 No data are available.

 Method of administration
 Tablet for oral administration.
 Hard capsule for oral administration.

 4.3 Contraindications

 Amlodipine is contraindicated in patients with:
 - hypersensitivity to dihydropyridine derivatives, amlodipine or any of the excipients
 - severe hypotension
 - shock (including cardiogenic shock)
 - obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis)
 - haemodynamically unstable heart failure after acute myocardial infarction

 4.4 Special warnings and precautions for use

 The safety and efficacy of amlodipine in hypertensive crisis has not been established.

 Patients with cardiac failure:
 Patients with heart failure should be treated with caution. In a long-term, placebo controlled study in patients with
 severe heart failure (NYHA class III and IV) the reported incidence of pulmonary oedema was higher in the
 amlodipine treated group than in the placebo group (see section 5.1). Calcium channel blockers, including amlodipine,
 should be used with caution in patients with congestive heart failure, as they may increase the risk of future
 cardiovascular events and mortality.

 Use in patients with impaired hepatic function:
 The half life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dosage
 recommendations have not been established. Amlodipine should therefore be initiated at the lower end of the dosing
 range and caution should be used, both on initial treatment and when increasing the dose. Slow dose titration and
 careful monitoring may be required in patients with severe hepatic impairment..

 Use in elderly patients
 In the elderly increase of the dosage should take place with care (see sections 4.2 and 5.2).

 Use in renal failure
 Amlodipine may be used in such patients at normal doses. Changes in amlodipine plasma concentrations are not
 correlated with degree of renal impairment. Amlodipine is not dialyzable




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Date Printed 25/01/2012                               CRN 2108093                                         page number: 2
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