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Luai Al Bakour
El Temamy Pharmacy
Akoni Hijyen Teknolojileri Sanayi ve Dış Ticaret LTD. ŞTİ
Britton Chance Center for Biomedical Photonics
Arabian Trade Center - ATC
Medical Facility (32206):
Legality International. (Pvt.) Ltd.
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For the local symptomatic relief of pain and inflammation in: - trauma of the tendons, ligaments, muscles and joints, e.g. due to sprains, strains and bruises - localised forms of soft tissue rheumatism It is recommended that treatment be reviewed after 14 days in these indications. For the treatment of osteoarthritis of superficial joints such as the knee. In the treatment of osteoarthritis, therapy should be reviewed after 4 weeks.
Patients with or without chronic asthma in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory agents (NSAIDs). • Hypersensitivity to the active substance or any of the excipients , • Hypersensitivity to propylene glycol, isopropanol or other components of the gel base.
Systemic absorption of this medicine is low and hence the risk of an interaction is small. There are no known interactions with this medicine but for a list of interactions known with oral diclofenac the data sheet for oral dosage forms should be consulted.
The likelihood of systemic side effects with topical diclofenac is small compared to the frequency of side effects in patients using oral diclofenac. However when this medicine is applied to relatively large areas of skin over a prolonged period of time, as described in the product information on systemic forms the possibility of systemic side effects cannot be excluded. this medicine contains propylene glycol, which may cause mild, localised skin irritation in some people. Precautions Concomitant use of oral NSAID’s should be cautioned as the incidence of untoward effects, particularly systemic side effects, may increase. (See also ’Interactions’) this medicine should not be co-administered with other products containing diclofenac. this medicine should be applied only to intact, non-diseased skin and not to skin wounds or open injuries. It should be not be used with occlusion. It should not be allowed to come into contact with the eyes or mucous membranes, and should never be taken by mouth. Some possibility of gastro-intestinal bleeding in those with a significant history of this condition has been reported in isolated cases. Pregnancy Since no experience has been acquired with this medicine in pregnancy or lactation, it is not recommended for use in these circumstances. During the last trimester of pregnancy the use of prostaglandin synthetase inhibitors may result in premature closure of the ductus arteriosus, or in uterine inertia. Animal data has shown an increased incidence of dystonia and delayed parturition when drug administration is continued into late pregnancy (see section 5.3 Preclinical safety data). Lactation It is not known whether topical diclofenac is excreted in human milk, and this medicine is therefore not recommended during breast-feeding, if there are compelling reasons for using Voltarol Emugel during breast feeding it should not be applied to the breast or to large areas of skin, nor should it be used for a prolonged period.
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Samir Moussa M.D.
Yaser Habrawi , F.R.C.S.Ed
Dr. Talal Sabouni
Dr . Dirar Abboud
Dr. Tahsin Martini
Dr. Hani Najjar
Dr. Faisal Dibsi
Dr. Samer Al-Jneidy