Dicloplast

/ CTS

Adults and adolescents 16 years and older:
1 application morning and evening (for up to 12 hours). Maximal daily dose is 2 plasters. Only one painful area can be treated at a time.
This medicinal product should be used for as short as possible. The duration of the treatment should not exceed 14 days.
If there is no improvement, during the recommended duration of treatment or symptoms worsen, a doctor should be consulted.
Please refer to the license holder for further details.

Dicloplast is indicated for topical treatment of rheumatic diseases, pain and non-infectious inflammation.

* Hypersensitivity to diclofenac, acetylsalicylic acid or other non-steroidal anti- inflammatory drugs (NSAIDs) or any excipients of the finished medicinal product.
* Patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDS)
* damaged skin, whatever the lesion involved: exudative dermatitis, eczema, infected lesion, burn or wound.
* from the beginning of the 6th month of pregnancy (see 4.6 Pregnancy and lactation).
* Patients with active peptic ulceration.
* Children and adolescents aged less than 16 years.

The medicated patch should be applied only to intact, non-diseased skin, and not to skin wounds or open injuries, and should not be worn when bathing or showering.
– The medicated patch should not come into contact with or be applied to the mucosae or the eyes.
– Not for use with occlusive dressing.
– Discontinue the treatment immediately if a skin rash develops after applying the medicated patch.
– Do not administer concurrently, by either the topical or the systemic route, any medicinal product containing diclofenac or other NSAIDs.
– The possibility of systemic adverse events from application of topical diclofenac cannot be excluded if the preparation is used over a prolonged period. Although systemic effects should be low, the patch should be used with caution in patients with renal, cardiac or hepatic impairment, history of peptic ulceration or inflammatory bowel disease or bleeding diathesis. Non-steroidal anti-inflammatory drugs should be used with particular caution in elderly patients who are more prone to adverse events.
– Patients should be warned against exposure to direct and solarium sunlight in order to reduce the risk of photosensitivity.
– Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergenic disease or allergy to acetylsalicylic acid or other NSAID. The medicated patch should be used with caution in patients with or without chronic asthma in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or other non
-steroidal anti-inflammatory agents. In order to minimise the occurrence of undesirable effects it is recommended to use the lowest effective dose for the shortest duration necessary to control symptoms, without exceeding the approved maximum 14 days.

Common: Rash, eczema, erythema, dermatitis (including allergic and contact dermatitis), pruritus, application site reactions.
See prescribing information for full details.

Since systemic absorption of diclofenac during labelled use of the medicated patches is very low, the risk of developing clinically relevant drug-drug interactions is negligible.

Pregnancy: Use of NSAIDs can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of this product between about 20 and 30 weeks of gestation, and avoid use at about 30 weeks of gestation and later in pregnancy.Premature Closure of Fetal Ductus Arteriosus: Use of NSAIDs, including Dicloplast, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus.
Oligohydramnios/Neonatal Renal Impairment: Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment.
Lactation: Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of diclofenac medicated patch no effects on the suckling child are anticipated.
Because of a lack of controlled studies in lactating women, the product should only be used during lactation under advice from a healthcare professional. Under this circumstance, Dicloplast should not be applied on the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period of time.
See prescribing information for full details.       

There is no experience with overdose of diclofenac medicated patch. Should systemic side effects occur due to incorrect use or accidental overdose (e.g. in children) of this product, the general measures recommended for intoxication with non-steroidal anti-inflammatory drugs should be taken.