Each tablet contains 5 mg amlodipine (as amlodipine mesilate monohydrate).

Tablet The tablets are white to off-white, round biconvex and embossed with “5” on one side.

Essential hypertension.

Chronic stable and vasospastic angina pectoris.

In adults

For treatment of both hypertension and angina pectoris the usual initial dose is 5 mg once daily. If the desired therapeutic effect cannot be achieved within 2-4 weeks this dose may be increased to a maximum dose of 10 mg daily (as single dose) depending on the individual patient's response.

Children with hypertension from 6 years to 17 years of age.

The recommended antihypertensive oral dose in pediatric 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 pediatric patients. The effect of amlodipine on blood pressure in patients less than 6 years of age is not known.

The 2.5 mg dose cannot be obtained with Amlodipine tablets 5 mg as these tablets are not manufactured to break into two equal halves

In the elderly

Normal dosage regimens are recommended in the elderly, however, increase of the dosage should take place with care. 

In patients with renal impairment

Amlodipine is not dialysable. In these patients amlodipine can be used in the normal dosage

In patients with hepatic impairment

A dosage regimen for patients with hepatic impairment has not been established , therefore amlodipine should be administered with caution.

The tablets should be taken with a glass of water independently from meals.

Amlodipine is contra-indicated in patients with:

• severe hypotension

• shock, including cardiogenic shock

• hypersensitivity to dihydropyridine derivatives, amlodipine or any of the excipients

• heart failure after acute myocardial infarction (during the first 28 days)

• obstruction of the outflow-tract of the left ventricle (e.g. high grade aortic stenosis)

• unstable angina pectoris

Amlodipine should be administered with caution to patients with low cardiac reserve. There are no data to support the use of amlodipine alone, during or within one month of myocardial infarction. The safety and efficacy of amlodipine in hypertensive crisis has not been established.

Patients with cardiac failure

Patients with cardiac failure should be treated with caution In a long-term study including patients suffering from severe heart failure (NYHA grade III and IV) the reported incidence of pulmonary oedema was higher in the amlodipine treated group than in the placebo group, but this was not indicating an aggravation of the heart failure.

Use in patients with impaired hepatic function

Amlodipine's half-life is prolonged in patients with impaired liver function; dosage recommendations have not been established. Amlodipine should therefore be administered with caution in these patients.

Use in elderly patients

In the elderly, increase of the dosage should take place with care.

Use in children (under 18 years of age)

Amlodipine should not be given to children due to insufficient clinical experience.

Effects of other medicinal products on amlodipine

CYP3A4 inhibitors: A study of elderly patients has shown that diltiazem inhibits metabolism of amlodipine, probably via CYP3A4, since plasma concentration increases by approx. 50% and the effect of amlodipine is increased. It cannot be excluded that stronger inhibitors of CYP3A4 (i.e. ketoconazole, itraconazole, ritonavir) increase the plasma concentration of amlodipine to a greater extent than diltiazem. Caution should be exercised in combination of amlodipine and CYP3A4 inhibitors.

CYP3A4 inducers: There is no information available on the effect of CYP3A4 inducers (i.e. rifampicin, St. John's wort) on amlodipine. Co-administration may lead to reduced plasma concentration of amlodipine. Caution should be exercised in combination of amlodipine and CYP3A4 inducers.

In clinical interaction studies grapefruit juice, cimetidine, aluminium/magnesium (antacid) and sildenafil did not affect the pharmacokinetics of amlodipine.

Effects of amlodipine on other medicinal products

Amlodipine may potentiate the effect of other antihypertensive agents, such as beta-adrenoceptor blocking agents, ACE-inhibitors, alpha-1-blockers and diuretics. In patients with an increased risk (for example after myocardial infarction) the combination of a calcium channel blocker with a beta-adrenoceptor blocking agent may lead to heart failure, to hypotension and to a (new) myocardial infarction.

In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin, warfarin or ciclosporin.

There is no effect of amlodipine on laboratory parameters.

Actavis UK Ltd

POM-Prescription Only Medicine

22 September 2010