Consumer medicine information

Irbesartan HCTZ-WGR 300 mg/25 mg Tablets

Irbesartan + Hydrochlorothiazide

BRAND INFORMATION

Brand name

Irbesartan HCTZ-WGR

Active ingredient

Irbesartan + Hydrochlorothiazide

Schedule

S4

1. Why am I taking IRBESARTAN HCTZ-WGR?


IRBESARTAN HCTZ-WGR contains the active ingredients irbesartan and hydrochlorothiazide. IRBESARTAN HCTZ-WGR is used to treat high blood pressure. For more information, see Section 1. Why am I taking IRBESARTAN HCTZ-WGR? in the full CMI.

2. What should I know before I take IRBESARTAN HCTZ-WGR?


Do not take if you have ever had an allergic reaction to IRBESARTAN HCTZ-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 IRBESARTAN HCTZ-WGR? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with IRBESARTAN HCTZ-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 IRBESARTAN HCTZ-WGR?

  • Your doctor will tell you how many tablets to take each day. The usual dose is one tablet per day.
  • Swallow the tablet whole with a glass of water and take IRBESARTAN HCTZ-WGR at about the same time each day.

More instructions can be found in Section 4. How do I take IRBESARTAN HCTZ-WGR? in the full CMI.

5. What should I know while taking IRBESARTAN HCTZ-WGR?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are taking IRBESARTAN HCTZ-WGR.
  • If you become pregnant while taking IRBESARTAN HCTZ-WGR tell your doctor immediately.
  • Before being started on any new medicine, tell your doctor and pharmacist you are taking IRBESARTAN HCTZ-WGR.
  • If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking IRBESARTAN HCTZ-WGR.
  • Make sure you drink enough water during exercise and hot weather when you are taking IRBESARTAN HCTZ-WGR.
  • If you have excessive vomiting and/or diarrhoea while taking IRBESARTAN HCTZ-WGR, tell your doctor.
  • If you feel light-headed or dizzy after your dose is increased, tell your doctor immediately.
  • Tell your doctor if you experience increased skin sensitivity.
Things you should not do
  • Do not stop taking IRBESARTAN HCTZ-WGR or lower the dosage, without checking with your doctor.
Driving or using machines
  • Be careful driving or operating machinery until you know how IRBESARTAN HCTZ-WGR affects you. IRBESARTAN HCTZ-WGR may cause dizziness or light-headedness in some people. If this occurs do not drive.
Drinking alcohol
  • If you drink alcohol, dizziness or light-headedness may be worse.
Looking after your medicine
  • Keep IRBESARTAN HCTZ-WGR tablets in a cool dry place where the temperature stays below 25°C.
  • Keep your tablets in the packaging until it is time to take them.

For more information, see Section 5. What should I know while taking IRBESARTAN HCTZ-WGR? in the full CMI.

6. Are there any side effects?


Common side effects: headache, dizziness or light-headedness (vertigo), unusual tiredness, weakness or fatigue. Shortness of breath when exercising or looking pale. Pain in the stomach or gut. Nausea and/or vomiting, sexual problems, low blood glucose levels. Refer to the full CMI for the full list, including what to do if you have any side effects, see Section 6. Are there any side effects?

BRAND INFORMATION

Brand name

Irbesartan HCTZ-WGR

Active ingredient

Irbesartan + Hydrochlorothiazide

Schedule

S4

1 Name of Medicine

Irbesartan and hydrochlorothiazide.

2 Qualitative and Quantitative Composition

Each film-coated tablet contains irbesartan and hydrochlorothiazide as the active ingredients.
Irbesartan HCTZ-WGR 150/12.5. Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Irbesartan HCTZ-WGR 300/12.5. Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Irbesartan HCTZ-WGR 300/25. Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
Excipients with known effects. Contains sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Tablet.
Irbesartan HCTZ-WGR 150/12.5. Each film-coated tablet is peach coloured, oval shaped, biconvex, debossed with "L183" on one side and plain on the other side.
Irbesartan HCTZ-WGR 300/12.5. Each film-coated tablet is peach coloured, oval shaped, biconvex, debossed with "L184" on one side and plain on the other side.
Irbesartan HCTZ-WGR 300/25. Each film-coated tablet is pinkish coloured, oval shaped, biconvex, debossed with "L185" on one side and plain on the other side.

4 Clinical Particulars

4.9 Overdose

Experience in adults exposed to irbesartan doses of up to 900 mg/day for 8 weeks revealed no toxicity. No specific information is available on the treatment of over-dosage with irbesartan/hydrochlorothiazide. The patient should be closely monitored, and the treatment should be symptomatic and supportive, including fluid and electrolyte replacement. Irbesartan is not removed from the body by haemodialysis.
The most common signs and symptoms observed in adults exposed to hydrochlorothiazide are those caused by electrolyte depletion (hypokalaemia, hypochloraemia, hyponatraemia) and dehydration resulting from excessive diuresis. If a cardiac glycoside (e.g. digoxin) or other antiarrhythmic drugs (e.g. sotalol) has also been administered, hypokalaemia may accentuate cardiac arrhythmias. The degree to which hydrochlorothiazide is removed by haemodialysis has not been established.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Irbesartan and the irbesartan/hydrochlorothiazide combination were not genotoxic in a series of assays for gene-mutagenic activity in bacterial and mammalian cells, and for clastogenic effects in vitro and in vivo. Hydrochlorothiazide alone was not genotoxic in a gene-mutation assay in bacterial cells, or in tests for clastogenic activity in vitro and in vivo. However, positive results were obtained in a mammalian cell assay for gene mutation (mouse lymphoma cell assay) and in two other tests (sister chromatid exchange assay in Chinese hamster ovary cells and nondisjunction assay in Aspergillus nidulans).
Carcinogenicity. The carcinogenic potential of irbesartan and hydrochlorothiazide in combination has not been evaluated in animal studies. However, the carcinogenic potential of irbesartan was assessed in two 104 week studies in mice and rats. No carcinogenic potential was observed in either species at doses of up to 500 mg/kg/day (male rats) and 1000 mg/kg/day (mice and female rats). The AUC based exposure levels were 3 - 6 fold higher in mice, 3 fold higher in male rats and 25 fold higher in female rats than that of humans at the maximum recommended clinical dose of 300 mg/day. With hydrochlorothiazide two year feeding studies in mice and rats uncovered no evidence of carcinogenic potential 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. The studies, however, uncovered equivocal evidence for hepatocarcinogenicity in male mice treated with hydrochlorothiazide at approximately 600 mg/kg/day.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Irbesartan HCTZ-WGR (irbesartan/hydrochlorothiazide) is an oral antihypertensive agent combining a non-peptide angiotensin II receptor (AT1 subtype) antagonist, irbesartan, and a thiazide diuretic, hydrochlorothiazide.
Irbesartan is described chemically as 2-butyl-3-[(2'-(1H-tetrazol-5-yl) biphenyl-4-yl) methyl]-1,3 diazaspiro [4,4] non-1-en-4-one. Its empirical formula is C25H28N6O and molecular weight is 428.5.
Hydrochlorothiazide is described chemically as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and molecular weight is 297.7.
Chemical structure. Irbesartan and hydrochlorothiazide has the following structural formula:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSIRBESA.gif https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSHYDROC.gif Irbesartan is a white or almost white crystalline powder. It is practically insoluble in water, sparingly soluble in methanol, slightly soluble in ethanol (96%) and in methylene chloride.
Hydrochlorothiazide is a white or almost white crystalline powder. It is very slightly soluble in water, soluble in acetone, sparingly soluble in ethanol (96%). It dissolves in dilute solutions of alkali hydroxides.
CAS number. Irbesartan. 138402-11-6.
Hydrochlorothiazide. 58-93-5.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes

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