Diclofenac
Overview
Gel, 10 mg/g
COMPOSITION
Each gram of gel contains the active substance diclofenac sodium 10 mg.
Excipients: Transcutol P, Labrasol, benzyl alcohol, Carbopol 980, Metolose 60SH-4000, Ethomeen C 25, purified water.
WHAT IT IS USED FOR
A topical non-steroidal anti-inflammatory drug (NSAID) with local analgesic and anti-inflammatory action, for:
relief of pain and inflammation in injuries to tendons, ligaments, muscles and joints (dislocations, sprains, bruises, back pain after sports activity);
localised forms of soft-tissue rheumatism: tendinitis, bursitis, shoulder-hand syndrome, periarthritis;
localised mild-to-moderate forms of degenerative rheumatism: peripheral osteoarthritis of the fingers or knees.
HOW IT WORKS
Diclofenac inhibits the synthesis of prostaglandins responsible for pain and inflammation, acting locally at the affected site. Blood concentrations after topical application are approximately 100 times lower than after oral administration of the same amount.
HOW TO USE
Apply to the skin (external use) 3–4 times a day on the affected area, massaging gently until fully absorbed. The recommended amount per application is 2–4 g (a ball of gel about 2–2.5 cm in diameter). Wash your hands after applying (unless the hands are being treated).
Maximum duration of treatment:
injuries and soft-tissue rheumatism: no more than 14 days;
joint pain from arthritis: up to 21 days.
If symptoms do not improve after 7 days of self-treatment, consult a doctor. For use in adults and adolescents aged 14 years and over. Not for use in children under 14 years.
WHEN IT SHOULD NOT BE USED
hypersensitivity to diclofenac sodium or to any of the excipients;
a history of asthma attacks, urticaria or acute rhinitis triggered by acetylsalicylic acid or other NSAIDs;
the third trimester of pregnancy;
children and adolescents under 14 years.
Important to know
Apply only to intact, healthy skin, free of wounds or open lesions; do not apply to mucous membranes (especially the eyes) and do not swallow the gel. Avoid excessive sun exposure on the treated area (risk of photosensitivity). Do not use occlusive dressings; non-occlusive bandages are permitted.
Do not use at the same time as other medicines containing diclofenac, and avoid combining with oral NSAIDs (increases the risk of side effects). In the first and second trimesters of pregnancy, use only if strictly necessary, at the lowest dose and for the shortest time; during breast-feeding, do not apply to the breasts. If a skin rash appears after application, stop treatment. Read the package leaflet carefully before use.
Possible side effects
Common: skin rash, eczema, redness, itching, dermatitis (including contact dermatitis).
Rare: bullous dermatitis. Very rare: photosensitivity reactions, pruritic pustules, hypersensitivity reactions (urticaria, angioedema), bronchospasm.
With increased skin absorption (large amount, large area, damaged skin, occlusive dressing), systemic NSAID effects (gastrointestinal, hepatic, renal) may occur.
If side effects occur, stop using the product and consult a doctor or pharmacist.
STORAGE
Store below 25 °C. Do not freeze. Keep out of the reach of children. Shelf life: 36 months.
PACK SIZE
40 g of gel in an aluminium tube; 1 tube together with the package leaflet in a carton pack.
QUESTIONS AND CONTACTS
For questions about the medicine, please consult your doctor or pharmacist. Manufacturer: FARMAPRIM SRL, 5 Crinilor str., Porumbeni village, Criuleni district, Republic of Moldova, MD-4829. Pharmacovigilance: safety@farmaprim.md.