Consumer medicine information

1. Why am I taking DICLOFENAC-WGR?

DICLOFENAC-WGR contains the active ingredient diclofenac sodium. DICLOFENAC-WGR is taken to treat pain and reduce inflammation (swelling and redness) that may occur in different types of arthritis including rheumatoid arthritis and osteoarthritis, other painful conditions where swelling is a problem such as back pain, rheumatism, muscle strains, sprains and tendonitis (e.g. tennis elbow), menstrual cramps (period pain). For more information, see Section 1. Why am I taking DICLOFENAC-WGR? in the full CMI.

2. What should I know before I take DICLOFENAC-WGR?

Do not take DICLOFENAC-WGR if you have ever had an allergic reaction to diclofenac sodium or any of the ingredients listed at the end of this leaflet. Do not take if you have had a stomach or intestinal ulcer, bleeding from the stomach or bowel (symptoms of which may include blood in your stools or black stools), severe kidney or liver problems, severe heart failure, heart bypass surgery.
Do not take DICLOFENAC-WGR during the first 6 months of pregnancy, except on doctor's advice. Do not take DICLOFENAC-WGR during the last three months of pregnancy. Use of this medicine during the last 3 months of pregnancy may affect your baby and may delay labour and birth. Use of non-aspirin NSAIDs can increase the risk of miscarriage, particularly when taken close to the time of conception. Tell your doctor if you are breastfeeding or wish to breastfeed. Like most NSAID medicines, DICLOFENAC-WGR is not recommended for use during breastfeeding because DICLOFENAC-WGR passes into breast milk and may affect your baby.
For more information, see Section 2. What should I know before I take DICLOFENAC-WGR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with DICLOFENAC-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 DICLOFENAC-WGR?

• DICLOFENAC-WGR tablets are usually taken in 2 or 3 doses during the day.

• Swallow the tablets whole with a full glass of water or other liquid. Do not chew them.

5. What should I know while taking DICLOFENAC-WGR?

6. Are there any side effects?

There are a number of side effects associated with DICLOFENAC-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

Diclofenac sodium.

2 Qualitative and Quantitative Composition

Diclofenac-WGR tablets are enteric coated and contain either 25 mg or 50 mg of diclofenac sodium.
Excipient with known effect. Contains sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

25 mg tablets. Pale yellow, round, enteric coated tablets plain on both sides.
50 mg tablets. Pale brown, round, enteric coated tablets plain on both sides.

4 Clinical Particulars

4.9 Overdose

Management of acute poisoning with NSAIDs, including diclofenac, consists essentially of supportive measures and symptomatic treatment. There is no typical clinical picture resulting from an overdosage of diclofenac. Overdosage can cause symptoms such as vomiting, gastrointestinal haemorrhage, diarrhoea, dizziness, tinnitus or convulsions. In the event of significant poisoning, acute renal failure and liver damage are possible.
Activated charcoal may reduce absorption of the medicine if given within one or two hours after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via nasogastric tube, once the airway is protected.
Supportive and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder, and respiratory depression. Haematological and biochemical parameters, and the presence or absence of blood in the stools, should be monitored.
Specific therapies such as forced diuresis, dialysis, or haemoperfusion are probably of no help in eliminating NSAIDs, including diclofenac, because of their high protein-binding rate and extensive metabolism.
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. Diclofenac showed no mutagenic effects in the studies conducted.
Carcinogenicity. Dietary administration of diclofenac to mice and rats at doses up to 0.5 mg/kg/day revealed no carcinogenic activity. However, the plasma concentration of diclofenac at this dose level was 20 to 100 times lower than that in humans. Administration of higher doses to rats and mice resulted in increased mortality due to gastrointestinal ulceration. Diclofenac showed no carcinogenic effects in the studies conducted.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

The active ingredient of Diclofenac-WGR tablets is diclofenac sodium, a phenylacetic acid derivative, structurally similar to both the phenylalkanoic acid and the anthranilic acid series of compounds. Diclofenac sodium is an odourless, yellowish-white, crystalline powder sparingly soluble in water.
Chemical name: sodium-2-[(2,6-dichlorophenyl)-amino] phenyl]-acetate.
CAS number. 15307-79-5.
Molecular weight: 318.1.
Molecular formula: C₁₄H₁₀Cl₂NNaO₂.
Chemical structure.
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7 Medicine Schedule (Poisons Standard)

S4 Prescription only medicine.

Summary Table of Changes

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