Consumer medicine information

1. Why am I taking OLMESARTAN AMLODIPINE-WGR?

OLMESARTAN AMLODIPINE-WGR contains the active ingredients olmesartan medoxomil and amlodipine (as besilate). OLMESARTAN AMLODIPINE-WGR is used to treat high blood pressure.
For more information, see Section 1. Why am I taking OLMESARTAN AMLODIPINE-WGR? in the full CMI.

2. What should I know before I take OLMESARTAN AMLODIPINE-WGR?

Do not take if you have ever had an allergic reaction to OLMESARTAN AMLODIPINE-WGR or any of the ingredients listed at the end of the CMI.
Talk to your doctor 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 take OLMESARTAN AMLODIPINE-WGR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with OLMESARTAN AMLODIPINE-WGR 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 take OLMESARTAN AMLODIPINE-WGR?

• Follow all directions given to you by your doctor or pharmacist carefully. Your doctor will tell you which OLMESARTAN AMLODIPINE-WGR tablet you will need to take each day.

• Swallow OLMESARTAN AMLODIPINE-WGR tablet whole with a full glass of water.

• Take your OLMESARTAN AMLODIPINE-WGR tablet at the same time each day.

5. What should I know while taking OLMESARTAN AMLODIPINE-WGR?

6. Are there any side effects?

There are a number of side effects associated with OLMESARTAN AMLODIPINE-WGR. It is important to be aware of them so that you can identify any symptoms if they occur. 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

Olmesartan medoxomil and amlodipine besilate.

2 Qualitative and Quantitative Composition

Olmesartan Amlodipine-WGR 20/5 tablets contain 20 mg olmesartan medoxomil and 5 mg amlodipine (as besilate).
Olmesartan Amlodipine-WGR 20/10 tablets contain 20 mg olmesartan medoxomil and 10 mg amlodipine (as besilate).
Olmesartan Amlodipine-WGR 40/5 tablets contain 40 mg olmesartan medoxomil and 5 mg amlodipine (as besilate).
Olmesartan Amlodipine-WGR 40/10 tablets contain 40 mg olmesartan medoxomil and 10 mg amlodipine (as besilate).
The tablets contain no excipients with a known effect. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Olmesartan Amlodipine-WGR 20/5. White, round, biconvex, film-coated tablets debossed with "L75" on one side and plain on other side.
Olmesartan Amlodipine-WGR 20/10. Greyish-orange, round, biconvex, film-coated tablets debossed with "L76" on one side and plain on other side.
Olmesartan Amlodipine-WGR 40/5. Light yellow, round, biconvex, film-coated tablets debossed with "L77" on one side and plain on other side.
Olmesartan Amlodipine-WGR 40/10. Red (brownish red), round, biconvex, film-coated tablets debossed with "L78" on one side and plain on other side.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).
Symptoms. There is no experience of overdose with Olmesartan medoxomil/Amlodipine besilate. The most likely effects of olmesartan medoxomil overdosage are hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurred. Amlodipine overdosage can be expected to lead to excessive peripheral vasodilatation with marked hypotension and possibly a reflex tachycardia. Marked and potentially prolonged systemic hypotension up to and including shock with fatal outcome has been reported. 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 (see Section 5 Pharmacological Properties).
Therapy. If intake is recent, gastric lavage or induction of emesis may be considered. In healthy subjects, the administration of activated charcoal immediately or up to 2 hours after ingestion of amlodipine has been shown to reduce substantially the absorption of amlodipine.
Clinically significant hypotension due to an overdose of Olmesartan medoxomil/Amlodipine besilate requires active support of the cardiovascular system, including close monitoring of heart and lung function, elevation of the extremities, and attention to circulating fluid volume and urine output. A vasoconstrictor may be helpful in restoring vascular tone and blood pressure, provided that there is no contraindication to its use. Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.
Since amlodipine is highly protein-bound, dialysis is not likely to be of benefit. The dialysability of olmesartan is unknown.
Haemodialysis has not been shown to be helpful.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No genotoxicity studies have been conducted with the olmesartan medoxomil/amlodipine combination.
Both olmesartan medoxomil and olmesartan tested negative in the in vitro Syrian hamster embryo cell transformation assay and showed no evidence of genetic toxicity in the Ames (bacterial mutagenicity) test. However, both were shown to induce chromosomal aberrations in cultured cells in vitro (Chinese hamster lung) and tested positive for thymidine kinase mutations in the in vitro mouse lymphoma assay. Olmesartan medoxomil tested negative in vivo for mutations in intestinal and kidney cells from the transgenic mouse strain MutaMouse and for clastogenicity in mouse bone marrow (micronucleus test) at oral doses of up to 2000 mg/kg (olmesartan not tested).
Amlodipine did not induce gene mutation in bacteria and mouse lymphoma cells; nor did it induce chromosome aberrations in human lymphocytes or Chinese hamster V79 fibroblast (in vitro) and in mouse bone marrow cells (in vivo).
Carcinogenicity. There are no carcinogenicity studies with the olmesartan medoxomil/amlodipine combination.
Olmesartan was not carcinogenic when administered by dietary administration to rats for up to 2 years. The highest dose tested (2000 mg/kg/day) was, on a mg/m² basis, about 480 times the maximum recommended human dose (MRHD) of 40 mg/day. Two carcinogenicity studies conducted in mice, a 6-month gavage study in the p53 knockout mouse and a 6-month dietary administration study in the Hras2 transgenic mouse, at doses of up to 1000 mg/kg/day (about 120 times the MRHD), revealed no evidence of a carcinogenic effect of olmesartan.
Rats and mice treated with amlodipine maleate in the diet for up to two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 mg amlodipine/kg/day, showed no evidence of a carcinogenic effect of the drug. For the mouse, the highest dose was, on mg/m² basis, similar to the maximum recommended human dose [MRHD] of 10 mg amlodipine/day. For the rat, the highest dose was, on a mg/m² basis, about two and a half times the MRHD (calculations based on a 60 kg patient).

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder. It is practically insoluble in water and sparingly soluble in methanol.
Olmesartan medoxomil is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1- methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. The empirical formula is C₂₉H₃₀N₆O₆ and its molecular weight is 558.59.
Amlodipine besilate is a white crystalline powder, slightly soluble in water and sparingly soluble in ethanol.
Amlodipine besilate is a racemic mixture and is chemically described as 3-ethyl-5methyl-2- (2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzene sulphonate. The empirical formula is C₂₀H₂₅ClN₂O₅.C₆H₆O₃S and its molecular weight is 567.1.
Chemical structure. Olmesartan medoxomil.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSOLMMED.gif Amlodipine besilate.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSAMBESI.gif CAS number. Olmesartan medoxomil: 144689-63-4.
Amlodipine besilate: 111470-99-6.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

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