Consumer medicine information

1. Why am I using FUROSEMIDE-WGR?

FUROSEMIDE-WGR contains the active ingredient, which belongs to a group of medicines called diuretics. Diuretics are used to help the kidneys remove excess fluid from the body.
For more information, see Section 1. Why am I using this medicine? in the full CMI.

2. What should I know before I use FUROSEMIDE-WGR?

Do not use if you have ever had an allergic reaction to FUROSEMIDE-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 use this medicine? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with FUROSEMIDE-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 use FUROSEMIDE-WGR?

The dose of FUROSEMIDE-WGR may be different for each person and their medical condition. Your doctor will decide the right dose for you. FUROSEMIDE-WGR is available as either a 20mg or 40mg tablet.
More instructions can be found in Section 4. How do I use this medicine? in the full CMI.

5. What should I know while using FUROSEMIDE-WGR?

6. Are there any side effects?

Tell your doctor as soon as possible if you do not feel well while you are taking This medicine.
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. You can help by reporting any side affects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.

1 Name of Medicine

Furosemide.

2 Qualitative and Quantitative Composition

Each tablet contains 20 mg or 40 mg furosemide, as the active ingredient.
Excipients with known effect. Sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Furosemide-WGR 20 mg. White to off-white, round tablets, debossed with 'F2' on one side and plain on the other side.
Furosemide-WGR 40 mg. White to off-white, round tablets, debossed with 'F4' on one side and break line on the other side.

4 Clinical Particulars

4.9 Overdose

Symptoms. The clinical picture in acute or chronic overdose depends primarily on the extent and consequences of electrolyte and fluid loss e.g. dehydration, blood volume reduction, hypotension, electrolyte imbalance, cardiac arrhythmias (including A-V block and ventricular fibrillation), hypokalaemia and hypochloraemic alkalosis, and extensions of its diuretic action. Symptoms of these disturbances include severe hypotension (progressing to shock), acute renal failure, thrombosis, delirious states, flaccid paralysis, apathy and confusion.
The acute toxicity of furosemide has been determined in mice, rats and dogs. In all three, the oral LD₅₀ exceeded 1,000 mg/kg body weight, while the intravenous LD₅₀ ranged from 300-680 mg/kg. The acute intragastric toxicity in neonatal rats is 7-10x that of adult rats. The concentration of furosemide in biological fluids associated with toxicity or death is not known.
Treatment. No specific antidote to furosemide is known. If ingestion has only just taken place, attempts may be made to limit further systemic absorption of the active ingredient by measures such as activated charcoal.
Treatment of overdosage is supportive and consists of replacement of excessive fluid and electrolyte losses. Serum electrolytes, carbon dioxide level and blood pressure should be determined frequently. Adequate drainage must be assured in patients with urinary bladder outlet obstruction (such as prostatic hypertrophy). Haemodialysis does not accelerate furosemide elimination.
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. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Furosemide is an anthranilic acid derivative. It is a white to off-white odourless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSFUROSE.gif Chemical name: 4-chloro-2-(furan-2-ylmethylamino)-5-sulfamoylbenzoic acid.
Molecular formula: C₁₂H₁₁ClN₂O₅S.
Molecular weight: 330.744.
CAS number. 54-31-9.

7 Medicine Schedule (Poisons Standard)

S4: Prescription Only Medicine.

Summary Table of Changes

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