Applicant: Hetero Drugs South Africa (Pty) Ltd.  
Product Name: AMLODIPINE HETERO 5 AND AMLODIPINE HETERO 10  
Dosage form and strength: Each tablet contains amlodipine besylate equivalent to 5 mg active amlodipine  
base.  
PACKAGE INSERT FOR AMLODIPINE HETERO 5 AND AMLODIPINE HETERO 10  
SCHEDULING STATUS  
S3  
PROPRIETARY NAME AND DOSAGE FORM  
AMLODIPINE HETERO 5 Tablets  
AMLODIPINE HETERO 10 Tablets  
COMPOSITION  
AMLODIPINE HETERO 5  
Each tablet contains amlodipine besylate equivalent to 5 mg active amlodipine base.  
AMLODIPINE HETERO 10  
Each tablet contains amlodipine besylate equivalent to 10 mg active amlodipine base.  
AMLODIPINE HETERO tablets also contain the following inactive ingredients: microcrystalline  
cellulose, anhydrous colloidal silica, magnesium stearate  
Tablets do not contain lactose, sucrose or mannitol.  
PHARMACOLOGICAL CLASSIFICATION  
A 7.1 Vasodilators, hypotensive medicines  
PHARMACOLOGICAL ACTION  
Pharmacodynamic properties  
Amlodipine is a dihydropyridine calcium channel blocker.  
It inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle without  
affecting serum calcium concentrations. Direct relaxation of vascular smooth muscle forms the basis  
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Initial: K.B  
28.08.2024  
Applicant: Hetero Drugs South Africa (Pty) Ltd.  
Product Name: AMLODIPINE HETERO 5 AND AMLODIPINE HETERO 10  
Dosage form and strength: Each tablet contains amlodipine besylate equivalent to 5 mg active amlodipine  
base.  
of the antihypertensive action.  
In angina pectoris, amlodipine acts as a peripheral arteriolar vasodilator resulting in a reduction in  
total peripheral resistance (afterload). Myocardial energy and oxygen requirements are reduced.  
Amlodipine exerts its activity by binding to the dihydropyridine binding sites. It exerts minimal action  
on cardiac conduction, contraction and heart rate.  
PHARMACOKINETIC PROPERTIES:  
Complete absorption of amlodipine is slow following oral administration with peak plasma levels being  
attained after 6 to 12 hours  
Amlodipine has a bioavailability between 60 % and 64 % and a plasma eliminated half-life of 35 to 50  
hours, allowing for once-daily oral dosing.  
Steady state plasma concentrations are achieved after 7 to 8 days of consecutive dosing  
The volume of distribution is about 20 l/kg  
Metabolism is via the liver and is extensive with less than 10 % of amlodipine appearing unchanged in  
the urine.  
Metabolites are inactive and primarily (up to 60 %) excreted via the kidney.  
Special populations:  
Use in the Elderly:  
Elderly patients may have higher plasma concentrations of amlodipine than those in the  
younger patients. The time to reach peak plasma concentrations of amlodipine is similar in  
elderly and younger subjects. Amlodipine clearance is decreased with resulting increases in  
AUC (approximately 40 - 60 %) and elimination half-life in elderly and hepatically insufficient  
patients. A similar increase in AUC was observed in patients with moderate to severe heart  
failure. Elderly patients should start on a lower dose.  
Use in Renal Failure:  
Amlodipine is extensively metabolised to inactive metabolites with 10 % excreted unchanged  
in the urine. Changes in amlodipine plasma concentrations are not correlated with mild renal  
impairment. AMLODIPINE HETERO may be used in such patients at normal doses. In patients  
Page 2 of 8  
Initial: K.B  
28.08.2024  
Applicant: Hetero Drugs South Africa (Pty) Ltd.  
Product Name: AMLODIPINE HETERO 5 AND AMLODIPINE HETERO 10  
Dosage form and strength: Each tablet contains amlodipine besylate equivalent to 5 mg active amlodipine  
base.  
with severe renal impairment, amlodipine dosages may need to be reduced.  
Amlodipine is not dialysable.  
Use in Patients with Impaired Hepatic Function:  
Amlodipine half-life is prolonged in patients with impaired liver function. AMLODIPINE  
HETERO should therefore be administered at lower (5 mg) initial dose in these patients.  
INDICATIONS  
AMLODIPINE HETERO is indicated for the:  
•
•
Treatment of angina pectoris  
Treatment of mild to moderate hypertension, alone or in combination with other antihypertensive  
medicine.  
CONTRA-INDICATIONS  
Hypersensitivity to amlodipine or any dihydropyridine or for any of the ingredients in AMLODIPINE  
HETERO.  
WARNINGS and SPECIAL PRECAUTIONS:  
AMLODIPINE HETERO should be used with caution in the elderly and patients with severe renal and  
liver impairment (see Pharmacokinetic Properties – Special populations) These patients should start  
with a lower dose.  
The safety and efficacy of amlodipine (such as in AMLODIPINE HETERO) have not been established  
in a hypertensive crisis.  
Patients with heart failure should be treated with caution since an increased incidence of pulmonary  
oedema has been reported. AMLODIPINE HETERO have a negative inotropic effect.  
The use of AMLODIPINE HETERO, should be used with caution in patients with congestive heart  
failure, severe hypotension, shock and high grade aortic stenosis.  
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Applicant: Hetero Drugs South Africa (Pty) Ltd.  
Product Name: AMLODIPINE HETERO 5 AND AMLODIPINE HETERO 10  
Dosage form and strength: Each tablet contains amlodipine besylate equivalent to 5 mg active amlodipine  
base.  
Porphyria:  
Safety has not been established.  
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:  
AMLODIPINE HETERO can have minor or moderate influence on the ability to drive and use  
machines. If patients taking AMLODIPINE HETERO suffer from dizziness, headache, fatigue or  
nausea the ability to react may be impaired. Caution is recommended especially at the start of  
treatment.  
INTERACTIONS  
AMLODIPINE HETERO may be administered with thiazide diuretics, beta blockers, angiotensin-  
converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerine, non-steroidal anti-  
inflammatory drugs, antibiotics and oral hypoglycaemic medicines.  
Concurrent administration of sublingual nitroglycerin, long acting nitrates, beta-blockers or other  
antianginal medicines with amlodipine may produce additive antihypertensive and antianginal effects.  
Sublingual nitroglycerin may be used as needed to abort acute angina attacks during amlodipine  
therapy. Nitrate medication may be used during amlodipine therapy for angina prophylaxis.  
Effects of other medicinal products on AMLODIPINE HETERO:  
CYP3A4 inhibitors:  
Concomitant use of AMLODIPINE HETERO with CYP3A4 inhibitors (protease inhibitors, azole  
antifungals, macrolides like erythromycin or clarithromycin, verapamil or diltiazem) may increase  
amlodipine exposure and dosage adjustments may be required, especially in elderly.  
CYP3A4 inducers:  
The concomitant use of CYP3A4 inducers (e.g., rifampicin, Hypericum perforatum or St John's-wort)  
may result in lower plasma concentration of AMLODIPINE HETERO, and the combination should  
therefore be used with caution.  
Administration of AMLODIPINE HETERO with grapefruit or grapefruit juice is not recommended as  
bioavailability may be increased in some patients resulting in increased blood pressure lowering  
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Initial: K.B  
28.08.2024  
Applicant: Hetero Drugs South Africa (Pty) Ltd.  
Product Name: AMLODIPINE HETERO 5 AND AMLODIPINE HETERO 10  
Dosage form and strength: Each tablet contains amlodipine besylate equivalent to 5 mg active amlodipine  
base.  
effects.  
PREGNANCY AND LACTATION  
Safety on the use of amlodipine in pregnancy and lactation has not been established.  
DOSAGE AND DIRECTIONS FOR USE  
Hypertension and Angina Pectoris:  
Adults:  
An initial dose of 5 mg AMLODIPINE HETERO once daily is recommended which may be increased  
to a maximum dose of 10 mg once a day after 10-14 days of therapy if there is no improvement.  
No dose reduction is required when adding AMLODIPINE HETERO to thiazide diuretics, beta-  
blockers, or angiotensin-converting enzyme inhibitors.  
Children:  
Safety and effectiveness of amlodipine in children has not been established.  
SIDE EFFECTS  
Blood and lymphatic system disorders:  
Less frequent: Leukopenia, thrombocytopenia  
Immune system disorders  
Less frequent: Allergic reaction, erythema multi forme, angioedema  
Endocrine disorders  
Less frequent: Hyperglycaemia  
Psychiatric disorders  
Less frequent: Mood changes, depression  
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Initial: K.B  
28.08.2024  
Applicant: Hetero Drugs South Africa (Pty) Ltd.  
Product Name: AMLODIPINE HETERO 5 AND AMLODIPINE HETERO 10  
Dosage form and strength: Each tablet contains amlodipine besylate equivalent to 5 mg active amlodipine  
base.  
Nervous system disorders  
Frequent: Headache, dizziness  
Less frequent: Dysgeusia, peripheral neuropathy, paraesthesia, hypoaesthesia  
Eye disorders  
Less frequent: Visual disturbances  
Cardiac disorders  
Frequent: Palpitations, oedema,  
Less frequent: Myocardial infraction, dysrhythmia (including ventricular tachycardia and atrial  
fibrillation), and chest pain.  
Vascular disorders  
Less frequent: Hypotension (including orthostatic hypotension) syncope, flushing, vasculitis  
Respiratory, thoracic and mediastinal disorders  
Less frequent: Dyspnoea, rhinitis  
Gastrointestinal disorders  
Frequent: Nausea, vomiting, abdominal pain  
Less frequent: Dry mouth, dyspepsia, altered bowel habits, gingival hyperplasia and pancreatitis  
Hepatobiliary disorders  
Less frequent: Hepatitis, jaundice, hepatic enzyme elevation  
Skin and subcutaneous tissue disorders  
Less frequent: Alopecia, pruritus, rash  
Musculoskeletal and connective tissue disorders  
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Initial: K.B  
28.08.2024  
Applicant: Hetero Drugs South Africa (Pty) Ltd.  
Product Name: AMLODIPINE HETERO 5 AND AMLODIPINE HETERO 10  
Dosage form and strength: Each tablet contains amlodipine besylate equivalent to 5 mg active amlodipine  
base.  
Less frequent: Arthralgia, asthenia, muscle cramps, myalgia, back pain, gingival hyperplasia  
Reproductive system and breast disorders  
Less frequent: Impotence, gynaecomastia  
Renal and urinary disorders  
Less frequent: Increased urinary frequency  
General disorders and administration site conditions  
Less frequent: Asthenia, malaise, gingival hyperplasia, weight increase / decrease  
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT  
Symptoms:  
Over dosage could result in excessive peripheral vasodilation, resulting in marked and probably  
prolonged systemic hypotension.  
Treatment:  
Clinically significant hypotension due to AMLODIPINE HETERO over dosage requires active  
cardiovascular support. Gastric lavage may be of benefit.  
Intravenous calcium gluconate may be of benefit in reversing the effects of calcium channel blockade.  
As a result of amlodipine being highly plasma protein-bound, dialysis is unlikely to be of benefit.  
TREATMENT IS SYMPTOMATIC AND SUPPORTIVE.  
IDENTIFICATION  
AMLODIPINE HETERO 5  
White to off white, round shaped, biconvex tablets debossed with ‘J’ on one side and ‘20’ on the other  
side.  
AMLODIPINE HETERO 10  
White to off white, round shaped, biconvex tablets debossed with ‘J’ on one side and ‘21’ on the other  
Page 7 of 8  
Initial: K.B  
28.08.2024  
Applicant: Hetero Drugs South Africa (Pty) Ltd.  
Product Name: AMLODIPINE HETERO 5 AND AMLODIPINE HETERO 10  
Dosage form and strength: Each tablet contains amlodipine besylate equivalent to 5 mg active amlodipine  
base.  
side.  
PRESENTATION  
AMLODIPINE HETERO Tablets are available in blister packs of Alu/cold from foil or Alu/PVC//PVdC  
containing 10 tablets, packed into cartons of 30 and 100 tablets.  
STORAGE INSTRUCTIONS  
Store at or below 25 °C. Protect from light.  
Do not remove the blister cards from the outer carton until required for use.  
KEEP OUT OF THE REACH OF CHILDREN.  
REGISTRATION NUMBER  
AMLODIPINE HETERO 5: 48/7.1/0584  
AMLODIPINE HETERO 10: 48/7.1/0585  
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION  
Hetero Drugs South Africa (Pty) Ltd  
Waterfall Corporate Campus  
Building No. 2, First floor  
74 Waterfall Drive  
Midrand, 2066.  
Telephone: 012 644 1220.  
DATE OF PUBLICATION OF THE PACKAGE INSERT  
18 February 2016  
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