Medicinal Products

DICLOFENAC RATIOPHARM COUNCIL 1%

Generic drug of the therapeutic class: Rheumatology
Active ingredients: Diclofenac
laboratory: Ratiopharm

Medicated plaster
Box of 1 Sachet of 5
All forms

Indication

Short-term local treatment for mild painful trauma: strains, sprains or bruises, eg trauma resulting from sports.

Dosage DICLOFENAC RATIOPHARM COUNCIL 1% Medicated plaster Box of 1 Pack of 5

Dosage

In adults, apply a patch on the painful area twice a day (morning and evening). The maximum total daily dose that can be used is two plasters, even if there is more than one injured area to be treated. Only treat one painful area at a time.

Application mode

For cutaneous application.

Never cut the plaster.

If necessary, the plaster can be held in place by an elastic net.

Do not use the plaster under an occlusive dressing.

Duration of use

Use DICLOFENAC RATIOPHARM CONSEIL for as short a time as possible.

The duration of use should not exceed 7 days. The therapeutic interest of a longer use is not demonstrated.

Elderly patients and patients with renal insufficiency or liver failure

No specific dosage recommendations (see Warnings and Precautions ) section.

Children and adolescents

Due to the lack of a specific study on its effectiveness and safety of use, the use of DICLOFENAC RATIOPHARM CONSEIL is not recommended in children and adolescents under 15 years.

Against indications

DICLOFENAC RATIOPHARM CONSEIL should not be used in the following situations:

Hypersensitivity to the active substance or to any of the excipients of the medicinal product (eg propylene glycol, butylhydroxytoluene),

· Hypersensitivity to any other analgesic and anti-inflammatory drug [nonsteroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid],

· A history of asthma, urticaria or acute rhinitis attack caused by acetylsalicylic acid or other NSAIDs,

· Evolving gastrointestinal ulcer,

· Open wounds, burns, skin infections or eczema,

· During the last trimester of pregnancy.

Adverse effects Diclofenac Ratiopharm Conseil

By convention, the frequencies of adverse events were classified according to their incidence using the following classification:

Very common (≥1 / 10)

Frequent (≥1 / 100 to <1/10)

Uncommon (≥1 / 1, 000 to <1/100)

Rare (≥1 / 10, 000 to <1 / 1, 000)

Very rare (<1 / 10, 000)

Not known (can not be estimated from the available data).

Common side effects: Local skin reactions such as redness of the skin, burning sensation, pruritus, erythema, rash sometimes accompanied by pustules or papules.

Uncommon side effects: hypersensitivity reactions or local allergic reactions (contact dermatitis).

In patients using topical preparations containing topical NSAIDs, isolated cases of generalized rash and hypersensitivity reactions such as angioedema, anaphylactic reactions and photosensitization have been reported.

The systemic absorption of diclofenac after topical application is very low compared to the plasma levels of active principle observed after the use of oral forms. The likelihood of systemic adverse events (such as gastrointestinal or renal disorders, bronchospasm) is very low compared to the frequency of such effects associated with oral diclofenac. However, when diclofenac is applied to an extended skin surface and for a prolonged period of time, the possibility of systemic adverse effects can not be ruled out.

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