Consumer medicine information

1. Why am I using Olmesartan/HCT Sandoz?

Olmesartan/HCT Sandoz contains the active ingredient olmesartan medoxomil and hydrochlorothiazide. Olmesartan/HCT Sandoz is used to treat high blood pressure.
For more information, see Section 1. Why am I using Olmesartan/HCT Sandoz? in the full CMI.

2. What should I know before I use Olmesartan/HCT Sandoz?

Do not use if you have ever had an allergic reaction to olmesartan, sulfonamide derived medicines (e.g. thiazide diuretics), 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 use Olmesartan/HCT Sandoz? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Olmesartan/HCT Sandoz 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 Olmesartan/HCT Sandoz?

• Follow all directions given to you by your doctor or pharmacist carefully. Your doctor will tell you which Olmesartan/HCT Sandoz tablet you will need to take each day.

• Take Olmesartan/HCT Sandoz at the same time each day.

• Swallow Olmesartan/HCT Sandoz tablets whole with a full glass of water.

5. What should I know while using Olmesartan/HCT Sandoz?

6. Are there any side effects?

Common side effects may include dizziness, feeling light-headed, cough, headache, feeling nauseous or vomiting, diarrhoea, tiredness, 'flu-like' symptoms, sore throat and difficulty swallowing, back pain, swelling of the face or body, blurred vision, jaundice, skin rash, depression and urinary infection. Serious side effects may include swelling of the face, lips tongue or throat which causes difficulty swallowing or breathing, muscle or joint pain, fast heartbeat and chest pain.
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/hydrochlorothiazide.

2 Qualitative and Quantitative Composition

Each Olmesartan/HCT Sandoz 20/12.5 mg film coated tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
Each Olmesartan/HCT Sandoz 20/25 mg film coated tablet contains 20 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
Each Olmesartan/HCT Sandoz 40/12.5 mg film coated tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
Each Olmesartan/HCT Sandoz 40/25 mg film coated tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
Excipients with known effect. Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Olmesartan/HCT Sandoz 20/12.5 film coated tablets - yellow film coated, round, biconvex tablets debossed with '346' on one side and 'L' on other side.
Olmesartan/HCT Sandoz 20/25 film coated tablets - yellow film coated, oval shape, biconvex tablets debossed with 'L400' on one side and plain on other side.
Olmesartan/HCT Sandoz 40/12.5 film coated tablets - yellow film coated, oval shape, biconvex tablets debossed with 'L347' on one side and plain on other side.
Olmesartan/HCT Sandoz 40/25 film coated tablets - yellow film coated, oval shape, biconvex tablets debossed with 'L348' on one side and plain on other side.

4 Clinical Particulars

4.9 Overdose

No specific information is available on the effects or treatment of Olmesartan/HCT Sandoz overdosage. The patient should be closely monitored, and the treatment should be symptomatic and supportive. Management depends upon the time since ingestion and the severity of the symptoms. Activated charcoal may be useful in the treatment of overdosage. Serum electrolytes and creatinine should be monitored frequently. If hypotension occurs, the patient should be placed in a supine position, with salt and volume replacements given quickly.
The most likely manifestations of olmesartan medoxomil overdosage are expected to be hypotension and tachycardia; bradycardia might also occur. Overdosage with HCT is associated with electrolyte depletion (hypokalaemia, hypochloraemia) and dehydration resulting from excessive diuresis. The most common signs and symptoms of overdosage are nausea and somnolence. Hypokalaemia may result in muscle spasm and/or accentuate cardiac arrhythmias associated with the concomitant use of digitalis glycosides or certain anti-arrhythmic drugs.
No information is available regarding the dialysability of olmesartan or HCT.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Olmesartan medoxomil. 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 the intestine and kidney of a mutagenic susceptible mouse (MutaMouse) and for clastogenicity in mouse bone marrow (micronucleus test) at oral doses of up to 2,000 mg/kg/day. Olmesartan not tested in this mouse model. On balance, the weight-of-evidence indicates that olmesartan medoxomil does not pose a genotoxic risk at clinically relevant doses.
HCT. HCT was negative in several different assays of gene mutation and chromosomal aberration. However, positive test results were obtained in the in vitro CHO sister chromatid exchange (clastogenicity) assay and the mouse lymphoma (mutagenicity) assay at HCT concentrations of 43-1,200 microgram/mL.
Olmesartan medoxomil and HCT. Olmesartan medoxomil/HCT in a ratio of 20:12.5 was negative in the bacterial reverse mutation test up to the maximum recommended plate concentration for the standard assays. As expected, positive clastogenicity responses were observed with either drug or the combination (40:12.5, 20:12.5, 10:12.5) in Chinese hamster lung cells but no synergistic clastogenicity was observed. However, the combination (20:12.5) was negative in the in vivo mouse micronucleus test at oral doses (1,935/1,209 mg/kg) that were likely to achieve high relative systemic exposure (> 33-700-fold based on AUC) to both components.
Carcinogenicity. The carcinogenic potential of olmesartan medoxomil and HCT in combination has not been investigated.
Olmesartan medoxomil was not carcinogenic when administered by dietary administration to rats for up to 2 years. The highest dose tested (2,000 mg/kg/day) corresponded to a relative systemic exposure to olmesartan that was about 30 times that anticipated at the maximum recommended human dose (MRHD) of 40 mg/day (based on AUC). 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 1,000 mg/kg/day (about 11 times anticipated clinical exposure to olmesartan at the MRHD, based on AUC in Hras2), revealed no evidence of a carcinogenic effect of olmesartan medoxomil.
Two-year feeding studies in mice and rats showed no evidence of carcinogenic potential for HCT in female mice at doses up to approximately 600 mg/kg/day, or in male and female rats at doses up to approximately 100 mg/kg/day. There was equivocal evidence for hepatocarcinogenicity in male mice treated with HCT at approximately 600 mg/kg/day.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Olmesartan medoxomil. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder. It is practically insoluble in water and sparingly soluble in methanol.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSOLMMED.gif Chemical name: 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.
Molecular formula: C₂₉H₃₀N₆O₆.
Molecular weight: 558.59.
HCT. Hydrochlorothiazide (HCT) is a white, or almost white, crystalline powder. HCT is very slightly soluble in water, soluble in acetone, sparingly soluble in alcohol. It dissolves in dilute solutions of alkali hydroxides.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSHYDROC.gif Chemical name: 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.
Molecular formula: C₇H₈ClN₃O₄S₂.
Molecular weight: 297.7.
CAS number. Olmesartan medoxomil. 144689-63-4.
HCT. 58-93-5.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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