Diclomel Max Strength 2% w/w gel

Diclomel Max Strength 2% w/w gel contains the active substance diclofenac. It belongs to a group of medicines called non-steroid anti-inflammatory drugs (NSAID’s). Diclomel Max Strength gel is indicated for the short-term local symptomatic treatment of mild to moderate pain in acute strains, sprains or contusions following blunt trauma. Suitable for adults and adolescents 14 years and over.

1 g of gel contains diclofenac as 23.2 mg diclofenac diethylamine corresponding to 20 mg of diclofenac sodium

Directions for Use:

The gel is applied to the affected parts of the body thinly and gently rubbed into the skin. It should not be rubbed in with pressure. Afterwards, the hands should be wiped on a paper towel and then washed, unless they are the area to be treated. The paper towel should be disposed of in the residual waste. Before applying a bandage, the gel should be left dry for a few minutes on the skin. Patients should also
wait until the gel has dried on the skin before showering or bathing.

Special warnings and precautions for use:
The possibility of systemic undesirable effects from application of topical diclofenac cannot be excluded if the preparation is used on large areas of skin and over a prolonged period. The gel should therefore be used with caution by patients with
reduced renal function, reduced heart function or reduced liver function as well as patients with active peptic ulcers in the stomach or duodenum.

Diclomel Max Strength must only be applied to intact, not diseased or injured skin. Eyes and oral mucous membranes must not come into contact with the medicinal product and it must not be taken orally. Topical diclofenac may be used with a non-occlusive bandages but not with an airtight occlusive dressing (see section 5.2).

If symptoms worsen or that do not improve after 3-5 days, a doctor should be consulted.

Patients suffering from asthma, hay fever, swelling of nasal mucous membranes (so called nasal polyps) or chronic obstructive pulmonary disease, chronic respiratory infections (particularly associated with hay fever-like symptoms), and patients with
hypersensitivity to painkillers and anti‑rheumatic medicinal products of all kinds are rather at risk to asthma attacks (so called analgesic intolerance/analgesic asthma), to local skin or mucous membrane swelling (so-called Quincke oedema) or to urticaria
than other patients when treated with Diclomel Max Strength. In these patients, Diclomel Max Strength may only be used under certain precautions (emergency preparedness) and direct medical supervision. The same applies for patients who are also allergic to other substances e.g. with skin reactions, itching or urticaria.

If a skin rash occurs during the treatment with Diclomel Max Strength, the treatment should be stopped.

Direct sunlight or artificial sun should be avoided during treatment and two weeks after treatment to avoid the risk of photosensitivity.

Preventive measures should be taken so that children do not contact the skin areas to which the gel has been applied.

List of excipients:
Propylene glycol (E1520)
Oleyl alcohol
Isopropyl alcohol
Butylhydroxytoluene (E321)
Diethylamine
Paraffin light liquid
Macrogol cetostearyl ether
Carbomer 980
Cocoyl caprylocaprate
Perfume cream (contains eugenol and citral)
Purified water

 Keep all medicines out the sight and reach of children.

Always consult the Patient Information Leaflet before using this medicine.