Consumer medicine information

Blooms the Chemist Olmesartan 20 mg Tablets

Olmesartan medoxomil

BRAND INFORMATION

Brand name

Blooms the Chemist Olmesartan

Active ingredient

Olmesartan medoxomil

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Blooms the Chemist Olmesartan 20 mg Tablets.

1. Why am I using Blooms The Chemist Olmesartan?


Blooms The Chemist Olmesartan contains the active ingredient olmesartan medoxomil. Blooms The Chemist Olmesartan is used to treat high blood pressure which is sometimes called hypertension. For more information, see Section 1. Why am I using Blooms The Chemist Olmesartan? in the full CMI.

2. What should I know before I use Blooms The Chemist Olmesartan?


Do not use if you have ever had an allergic reaction to olmesartan medoxomil 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 Blooms The Chemist Olmesartan? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with Blooms The Chemist Olmesartan 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 Blooms The Chemist Olmesartan?

  • Your doctor or pharmacist will tell you which Blooms The Chemist Olmesartan tablet you will need to take each day. This depends on your condition and whether or not you are taking any other medicines. More instructions can be found in Section 4. How do I use Blooms The Chemist Olmesartan? in the full CMI.

5. What should I know while using Blooms The Chemist Olmesartan?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Blooms The Chemist Olmesartan.
  • Make sure you drink enough water during exercise and hot weather when you are taking Blooms The Chemist Olmesartan, especially if you sweat a lot.
  • Tell your doctor immediately if you experience excess vomiting and/or diarrhoea while taking Blooms The Chemist Olmesartan. You may lose too much water and salt and your blood pressure may drop too much.
  • Tell your doctor immediately if you feel light-headed or dizzy after taking your first dose of Blooms The Chemist Olmesartan, or when your dose is increased.
Things you should not do
  • Do not stop taking Blooms The Chemist Olmesartan, or lower the dosage, without checking with your doctor.
  • Do not stop using this medicine suddenly (if relevant). Do not give Blooms The Chemist Olmesartan to anyone else, even if they have the same condition as you.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how Blooms The Chemist Olmesartan affects you.
  • As with other medicines in this class, Blooms The Chemist Olmesartan may cause dizziness, light-headedness or tiredness in some people.
Drinking alcohol
  • Tell your doctor if you drink alcohol.
  • If you drink alcohol, dizziness or light-headedness may be worse.
Looking after your medicine
  • Store tablets below 25°C.

For more information, see Section 5. What should I know while using Blooms The Chemist Olmesartan? in the full CMI.

6. Are there any side effects?


Common side effects: feeling light-headed, dizzy or faint; cough; headache; feeling sick (nausea) or vomiting; diarrhoea.
Serious side effects: skin rash or itchiness; painful joints; fast heart beat; shortness of breath or tightness in the chest.
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.

BRAND INFORMATION

Brand name

Blooms the Chemist Olmesartan

Active ingredient

Olmesartan medoxomil

Schedule

S4

 

1 Name of Medicine

Olmesartan medoxomil.

2 Qualitative and Quantitative Composition

Blooms the Chemist Olmesartan contains the active ingredient olmesartan medoxomil.
Blooms the Chemist Olmesartan is available for oral use as film-coated tablets containing 20 mg, or 40 mg olmesartan medoxomil.
List of excipients with known effect. Sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

20 mg tablet. Yellow film coated, round, biconvex tablets debossed with 323 on one side and L on the other side.
40 mg tablet. Yellow film coated, oval shape, biconvex tablets debossed with L324 on one side and plain on the other side.

4 Clinical Particulars

4.9 Overdose

Only limited information is available regarding overdosage in humans. The most likely effect of overdosage is hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurs. In the event of overdosage, the patient should be carefully monitored and treatment should be symptomatic and supportive.
No information is available regarding the dialysability of olmesartan.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. 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. 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.
Carcinogenicity. 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.

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.
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.
CAS number. 144689-63-4.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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