clinical studies

• Consumer Study
• Efficacy-Metaanalysis
• Bioavailability
• Safety

sport injuries

• Sport injuries

product information

• Facts about Diclofenac
• Summary of product characteristics

references

• References

safety

• Safety information
• Global Tolerability
• Safety

dosing

• Dosing
• Posology and method of administration

contraindication and special warnings

• Effects on ability to drive and use machines
• Pregnancy and lactation
• Contraindications
• Interaction with other medicinal products and other forms of interaction

undesirable effects

• Undesirable effects

indication

• Therapeutic indications

efficasy

• Efficasy of Diclofenac
• Efficasy



Pregnancy and lactation

There are no adequate data from the use of Diclofenac sodium 4% Spray Gel (DicloFlex®) in pregnant and nursing women. Therefore the use is not recommended.

Use in pregnancy:

No evidence of a malformative effect was observed with diclofenac. However, additional epidemiological data is necessary to assess safety. During the last trimester of pregnancy, the use of prostaglandin synthetase inhibitors may result in:

• pulmonary and cardiac toxicity in the foetus (pulmonary hypertension with preterm closing of the ductus arteriosus)
• renal insufficiency in the foetus with oligohydramnios
• and increased possibility of bleeding in the mother and child.

Therefore, during the first six months of pregnancy, Diclofenac sodium 4% Spray Gel (DicloFlex®) should not be used unless clearly necessary and must not be applied to a large area of the skin (i.e. more than 600 square centimetres of the body surface). It must not be used for long-term treatment (> three weeks). Diclofenac sodium 4% Spray Gel (DicloFlex®) is contraindicated (see 4.3) during the last trimester of pregnancy.

Studies in animals have shown reproductive toxicity (see 5.3). The potential risk for humans is unknown.

Use during lactation:

It is not expected that any measurable amount of diclofenac will occur in breast milk following topical application. However, NSAIDs are excreted in human milk. Therefore Diclofenac sodium 4% Spray Gel (DicloFlex®) is not recommended for use in nursing mothers. An application to the breast area of nursing mothers is contraindicated.