Do Not Use Diclofenac 2% Gel Teva If Any Of The Following Apply To You
- Hypersensitivity to the active substance or to any of the excipients listed (see ingredients above)
- History of hypersensitivity reactions, such as asthma, bronchospasmus, urticaria, acute rhinitis in response to acetylsalicylic acid or non-steroidal anti-inflammatory drugs (NSAIDs)
- Use on open injuries, inflammations or infections of the skin as well as on eczema or mucous membranes
- During the the last trimester of pregnancy (see more information below)
- If you are aged under 14 years old
Pregnancy & Breastfeeding
- During the first and second trimester of pregnancy, diclofenac should not be used unless clearly necessary. We recommedn consuklting your doctor prior to using Diclofenac 2% Gel during first or second trimester of pregnancy.
- Diclofenac Gel should not be used at all during third trimester of pregnancy
Breastfeeding and Diclofenac Gel
- Diclofenac passes into breast milk in small amounts. However, at therapeutic doses of Diclofenac Sodium Teva 2% w/w Gel no effects on the breast-fed child are anticipated.
- Because of a lack of controlled studies in breast-feeding women, the medicinal product should only be used during breast-feeding under advice from a healthcare professional. Under this circumstance, Diclofenac Sodium Teva 2% w/w Gel should not be applied on the breasts of breast-feeding mothers, nor elsewhere on large areas of skin or for a prolonged period of time
Possibe Side Effects
- Common: Dermatitis (including contact dermatitis), skin rash, erythema, eczema, pruritus
- Very rare: Gastrointestinal complaints, asthma, hypersensitivity (including urticaria), angioedema,rash pustular.
Special Warnings Before 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 (see product information on systemic forms of diclofenac)
- Diclofenac Sodium Teva 2% w/w Gel 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
- 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 edema) or to urticaria than other patients when treated with Diclofenac Sodium Teva 2% w/w Gel
- In these patients, Diclofenac Sodium Teva 2% w/w Gel 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 Diclofenac Sodium Teva 2% w/w Gel, the treatment should be stopped
- During treatment photosensitivity can occur with the appearance of skin reactions after exposition to sunlight. Preventive measures should be taken so that children do not contact the skin areas to which the gel has been applied
- Diclofenac Sodium Teva 2% w/w Gel contains butylhydroxytoluene which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
- This medicinal product contains fragrance with benzyl alcohol (0.15 mg/g), citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene and linalool which may cause allergic reactions.
- In addition, benzyl alcohol may cause mild local irritation.
KEEP ALL MEDICINES OUT OF THE EACH OF CHILDREN.