Diflex gel 50 mg/g, 170 g, Fiterman

Indications:
Inflammatory diseases and traumas of tendons, ligaments, muscles and joints. Postoperative and posttraumatic edema.

Composition:
One gram of gel contains diclofenac sodium 50 mg and excipients: hydroxyethylcellulose, L-menthol, propylene glycol, ethyl alcohol 96%, diethylene glycol monoethyl ether, methyl p-hydroxybenzoate, n-propyl p-hydroxybenzoate, polysorbate 80, purified water.

Method of administration:
The medicine is only administered to adults.
Diflex is administered externally, in a thin layer, in 2-3 doses per day, to the affected area.
To achieve skin absorption of the gel, a light and prolonged massage is performed on the painful and/or inflamed area.
After each use, hands are washed.

Contraindications:
- hypersensitivity to diclofenac, other non-steroidal anti-inflammatory drugs or any of the excipients
the product;
- skin lesions, such as: eczema, infected lesions, burns, wounds;
- third trimester of pregnancy.

Precautions:

• The medicine should not be applied to mucous membranes, especially the eyes.
• The appearance of a skin rash after applying Diflex requires immediate discontinuation of treatment.
• The drug is administered only to adults, due to the lack of safety studies in children.
• In case of prolonged use, it is recommended that people applying the gel wear gloves.

Pregnancy, lactation and fertility:
In humans, no teratogenic effect of diclofenac has been reported, but further epidemiological studies are needed to confirm the absence of risk from the use of Diflex during pregnancy. Consequently, the drug is administered in the first 2 trimesters of pregnancy only if absolutely necessary, after assessing the maternal benefit/potential fetal risk ratio; from the third trimester onwards, its use is contraindicated, due to the risk of fetal cardiopulmonary toxicity (pulmonary hypertension, with premature closure of the ductus arteriosus) and renal (renal function disorders up to renal failure and oligoamnios) or the risk of prolonged bleeding time at the end of pregnancy.
In the case of other routes of administration, NSAIDs are excreted in breast milk. By extrapolation and as a precautionary measure, it is recommended to avoid the use of Diflex in breastfeeding women.

Driving and using machines:
The medicine does not affect the ability to drive or use machines.

Presentation:
170g

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.