Documents

8 pages
203 views

diclofenac dermapharmn 3 gel1.pdf

Please download to get full document.

View again

of 8
All materials on our website are shared by users. If you have any questions about copyright issues, please report us to resolve them. We are always happy to assist you.
Share
Description
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diclofenac Dermapharm 3% gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of gel contains 30 mg diclofenac sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gel Clear, transparent, colourless to yellowish 4 CLINICAL PARTICULARS 4.1 Therapeutic indications For the cutaneous treatment of actinic keratoses (AKs) with a sev
Transcript
  SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diclofenac Dermapharm 3% gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of gel contains 30 mg diclofenac sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gel Clear, transparent, colourless to yellowish 4 CLINICAL PARTICULARS 4.1 Therapeutic indications For the cutaneous treatment of actinic keratoses (AKs) with a severity grade of 1 or 2 (according to Olsen), preferably on the face or scalp. 4.2 Posology and method of administration Posology Adults: Diclofenac Dermapharm gel should be applied to the affected skin areas twice daily and smoothed into the skin gently. The amount used depends on the size of the area to be treated. Usually 0.5 g of gel (about the size of a pea) is applied to a 5x5 cm lesion site. The usual duration of treatment is 60 to 90 days. Maximum effect has been observed with treatment durations at the upper end of this time range. Complete healing of the lesion(s) or optimal therapeutic effect may not be seen for up to 30 days after completion of therapy. A maximum dose of 8 g daily should not be exceeded. Nothing is known about the long-term effect. Elderly people: The normal dosage can be used. Paediatric population: Dosage recommendations and indications for the use of Diclofenac Dermapharm gel in the paediatric population have not been established.  Method of administration Cutaneous use 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Because of the potential for cross-reactions, the gel should not be used in patients who have experienced hypersensitivity reactions such as symptoms as asthma, allergic rhinitis or urticaria to 2-acetoxybenzoic acid (acetylsalicylic acid) or any other non-steroidal anti-inflammatory medicinal products (NSAIDs). The use of Diclofenac Dermapharm gel is contraindicated in the third trimester of pregnancy (see section 4.6). 4.4 Special warnings and precautions for use Due to the low systemic absorption of Diclofenac Dermapharm gel, the likelihood of systemic adverse reactions following the external use of Diclofenac Dermapharm gel is small compared to the frequency of adverse reactions with oral diclofenac. However, the possibility of systemic adverse events from application of topical diclofenac cannot be excluded if the preparation is used on large areas of skin and over a prolonged period of time (see medicinal product information for systemic formulations of diclofenac). This medicinal product should be used with caution in patients with a history of active gastrointestinal ulceration and/or bleeding, or reduced heart, liver or kidney function because there have been isolated reports of systemic adverse reactions (such as kidney disorders) associated with externally used anti-inflammatory medicinal products. Non-steroidal anti-inflammatory medicinal products are known to have anti-platelet activity. Therefore, although the likelihood of systemic adverse reactions is small, caution should be used in patients with intracranial haemorrhage and bleeding diathesis. Exposure to direct sunlight and solarium use should be avoided during treatment. If hypersensitivity reactions of the skin occur, treatment must be stopped. Topical diclofenac should be applied only to intact skin, and not to skin wounds, open injuries, infected skin areas or exfoliative dermatitis. The gel must not come into contact with the eyes or mucous membranes and should not be ingested. Discontinue the treatment if a (generalised) skin rash develops after applying the medicinal product. Topical diclofenac can be used with non-occlusive bandages but should not be used with an airtight occlusive dressing. 4.5 Interaction with other medicinal products and other forms of interaction Since systemic absorption of diclofenac from a topical formulation is very low, such interactions are very unlikely.  4.6 Fertility, pregnancy and lactation Pregnancy: The systemic concentration of diclofenac is lower after topical application compared to oral formulations. With reference to experience from treatment with non-steroidal anti-inflammatory medicinal products (NSAIDs) with systemic uptake, the following is recommended:  Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo-foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with the dose and duration of therapy. ã Animal studies have shown reproductive toxicity. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimesters of pregnancy, diclofenac should not be given unless clearly necessary. If diclofenac is used by a woman attempting to conceive or during the first or second trimester of pregnancy, the dose should be kept as low (<30% of the body surface) and duration of treatment as short as possible (not longer than 3 weeks). During the second and third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to the following risks: ã renal dysfunction in the foetus. From the 12th week: oligohydramnios (usually reversible after the end of treatment) or anamnios (particularly with prolonged exposure). After birth: renal insufficiency may persist (particularly with late or prolonged exposure); ã cardiopulmonary toxicity in the foetus (pulmonary hypertension with premature closure of the ductus arteriosus). This risk exists from the beginning of the 6th month and increases if administration is close to the end of pregnancy. At the end (during the third trimester) of pregnancy, all prostaglandin synthesis inhibitors may expose the mother and the neonate to the following risks: ã possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses; ã inhibition of uterine contractions resulting in delayed or prolonged labour; ã increased risk of oedema formation in the mother. Consequently, diclofenac is contraindicated during the third trimester of pregnancy (see section 4.3). Breast-feeding: Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at the recommended therapeutic dosage of Diclofenac Dermapharm gel no effects on the suckling child are anticipated. Because of a lack of controlled studies in lactating women, the medicinal product should only be used during lactation under advice from a healthcare professional. Under these circumstances, Diclofenac Dermapharm gel 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 section 4.4). 4.7 Effects on ability to drive and use machines Cutaneous use of topical diclofenac has no influence on the ability to drive and use machines. 4.8 Undesirable effects Common adverse reactions: The most frequently reported adverse reactions are local skin reactions such as contact dermatitis, erythema and rash or application site reactions such as inflammation, skin irritation, pain and blistering. In clinical studies to date there has appeared to be no age-related increase or age-specific pattern of reactions. Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common (>1/10) Common ( ≥  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 (cannot be estimated from the available data) Organ system Common ( ≥  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) Eye disorders Conjunctivitis Eye pain, lacrimation disorder Gastrointestinal disorders Abdominal pain, diarrhoea, feeling sick Gastrointestinal haemorrhage General disorders and administration site conditions Application site reactions (including inflammation, skin irritation, pain and tingling or blistering at the treated site)
We Need Your Support
Thank you for visiting our website and your interest in our free products and services. We are nonprofit website to share and download documents. To the running of this website, we need your help to support us.

Thanks to everyone for your continued support.

No, Thanks
SAVE OUR EARTH

We need your sign to support Project to invent "SMART AND CONTROLLABLE REFLECTIVE BALLOONS" to cover the Sun and Save Our Earth.

More details...

Sign Now!

We are very appreciated for your Prompt Action!

x