Consumer medicine information

1. Why am I using Amlodipine GH?

Amlodipine GH contains the active ingredient amlodipine besilate. Amlodipine GH is used to lower high blood pressure (hypertension) and treat angina pectoris. For more information, see Section 1. Why am I using Amlodipine GH? in the full CMI.

2. What should I know before I use Amlodipine GH?

Do not use if you have ever had an allergic reaction to amlodipine besilate or any of the ingredients listed at the end of the CMI. Talk to your doctor or pharmacist if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use Amlodipine GH? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Amlodipine GH and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Amlodipine GH?

• The usual dose of Amlodipine GH is one 5 mg tablet each day, although a 2.5 mg dose may be prescribed in some cases. Your doctor may increase this to one 10 mg tablet each day.

• Your doctor may prescribe another dose of Amlodipine GH depending on your condition and how you respond to this medicine.

• Swallow the tablet whole with a full glass of water. Amlodipine GH 5 mg tablets can be divided in half along the scoreline if your doctor has prescribed a 2.5 mg dose.

5. What should I know while using Amlodipine GH?

6. Are there any side effects?

Common side effects: headache, dizziness, flushing, tiredness, drowsiness or sleepiness, stomach pain or nausea. Serious side effects: changes in heart beat (fast or slow), swelling of the ankles, feet, face of hands, tingling or numbness of the hands or feet, muscle cramps or aches, changes in mood, feeling anxious or nervous.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Amlodipine besilate.

2 Qualitative and Quantitative Composition

Each tablet contains 5 mg or 10 mg amlodipine (as besilate).
List of excipients with known effects. Mannitol.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Amlodipine GH 5 mg tablets: White to off-white, octagonal shaped, uncoated tablets, debossed with "AM 5" on one side and scoreline on the other side.
Amlodipine GH 10 mg tablets: White to off-white, octagonal shaped uncoated tablets, debossed with "AM 10" on one side and plain on the other side.

4 Clinical Particulars

4.9 Overdose

Signs and symptoms. Non-cardiogenic pulmonary oedema has rarely been reported as a consequence of amlodipine overdose that may manifest with a delayed onset (24-48 hours post-ingestion) and require ventilatory support. Early resuscitative measures (including fluid overload) to maintain perfusion and cardiac output may be precipitating factors.
Available data suggest that overdose might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. Dysrhythmias may occur following overdose with any calcium antagonists. Hypotension and bradycardia are usually seen within 1 to 5 hours following overdose. Hypotension can persist for longer than 24 hours despite treatment. Cardiac rhythm disturbances have been noted to persist for up to 7 days. Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome have been reported.
Reports of intentional overdose include a patient who ingested 250 mg and was asymptomatic and was not hospitalised; another patient (ingested 120 mg) was hospitalised, underwent gastric lavage and remained normotensive; a third patient (ingested 105 mg) was hospitalised and had hypotension (90/50 mmHg) which normalised following plasma expansion. Death resulted from a mixed overdose of amlodipine 140 mg and 10 mefenamic acid capsules in a 15 year old girl, and from a mixed overdose of amlodipine 70 mg and an unknown quantity of oxazepam in a 63 year old woman. A case of accidental drug overdose has been documented in a 19 month old male who ingested 30 mg amlodipine (about 2 mg/kg). During the emergency room presentation, vital signs were stable with no evidence of hypotension, but a heart rate of 180 bpm.
Recommended treatment. If massive overdose should occur, active cardiac and respiratory monitoring should be instituted. Frequent blood pressure measurements are essential. Should hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated. If hypotension remains unresponsive to these conservative measures, administration of vasopressors (such as phenylephrine), should be considered with attention to circulating volume and urine output. Intravenous calcium may help to reverse the effects of calcium entry blockade.
Administration of activated charcoal to healthy volunteers immediately or up to 2 hours after ingestion of amlodipine 10 mg has been shown to significantly decrease amlodipine absorption. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via nasogastric tube once the airway is protected. Ipecac emesis is not recommended since haemodynamic instability and central nervous system (CNS) depression may rapidly develop. Since amlodipine is highly protein bound, dialysis is not likely to be of benefit.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. The carcinogenic potential of amlodipine has not been fully elucidated. Amlodipine did not induce any tumours when tested in rats at oral doses up to 2.5 mg/kg. This dose gave rise to plasma levels that are similar to those achieved clinically.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Amlodipine besilate is a dihydropyridine derivative. Amlodipine besilate is a white crystalline powder and is slightly soluble in water and sparingly soluble in ethanol.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSAMLBSI.gif Chemical Name: 3-ethyl 5-methyl-(4RS)-2-(2-(aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate.
Molecular Formula: C₂₀H₂₅ClN₂O₅.C₆H₆O₃S.
Molecular Weight: 567.1 (free base 408.9).
CAS number. 111470-99-6.

7 Medicine Schedule (Poisons Standard)

(S4) Prescription only medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/AMLOGHST.gif