Country: Israel
Language: English
Source: Ministry of Health
DICLOFENAC SODIUM
CTS LTD
M02AA15
PATCHES
DICLOFENAC SODIUM 140 MG
TOPICAL
Not required
IBSA INSTITUTE BIOCHIMIQUE SA, SWITZERLAND
DICLOFENAC
DICLOFENAC
Dicloplast is indicated for topical treatment of rheumatic diseases, pain and non-infectious inflammation.
2013-12-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed without a doctor’s prescription DICLOPLAST ® PATCH Each patch contains: 180 mg Diclofenac Epolamine )equivalent to 140 mg Diclofenac Sodium( For a list of the inactive and allergenic ingredients in the preparation - see Section 6 “Further information” and Section 2 “Important information about some of the ingredients of the medicine”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. Use the preparation according to the instructions in the section on dosage in this leaflet. If you need further information, consult with the pharmacist. Refer to the doctor if signs of the disease )symptoms( worsen or do not improve after 7 days. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is indicated for topical treatment of rheumatic diseases, pain and non-infectious inflammation. THERAPEUTIC GROUP: Non-steroidal anti-inflammatory drugs )NSAIDs(. 2. BEFORE USING THE MEDICINE: DO NOT USE THE MEDICINE IF: • You are hypersensitive )allergic( to the active ingredient Diclofenac or to any of the other ingredients contained in the medicine, to aspirin and salicylates, or to other NSAID preparations. • You have breathing problems, asthma, skin rash or a runny nose after taking acetylsalicylic acid )aspirin( or other NSAIDs. • You have entered or are beyond your sixth month of pregnancy. • You have an active stomach ulcer )peptic ulcer(. • You have damaged skin, including discharge, infections, eczema, burns or wounds. • You are a child or adolescent below the age of 16 years. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE TREATMENT WITH DICLOPLAST, TELL THE DOCTOR IF: • You have heart disease. • You have kidney disease. • You have liver disease. • You have had stomach ulcers in the past. • You have an inflammatory bowel dise Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT DICLOPLAST 140mg medicated topical patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 140 cm 2 (10 cm x 14 cm) of medicated patch contains a total of 180 mg of diclofenac epolamine corresponding to 140 mg of diclofenac sodium (1% w/w). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Medicated patch White to pale yellow paste spread as a uniform layer onto unwoven support. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DICLOPLAST IS INDICATED FOR TOPICAL TREATMENT OF RHEUMATIC DISEASES, PAIN AND ON-INFECTIOUS INFLAMMATION. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cutaneous use only _Posology _ Adults and adolescents 16 years and older 1 application morning and evening (for up to 12 hours) _Duration of administration _ Dicloplast is to 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. _Elderly _ This medication should be used with caution in elderly patients who are more prone to adverse events. See also Section 4.4. _Children and adolescents below the age of 16 years _ There are insufficient data on efficacy and safety available for children and adolescents below 16 years of age (see also contraindication section 4.3). In children aged 16 years and over, if this product is required for more than 7 days for pain relief or if the symptoms worsen, the patient/parents of the adolescents is/are advised to consult a doctor. _Patients with hepatic or renal insufficiency _ For the use of Dicloplast in patients with hepatic or renal insufficiency see section 4.4. _Method of administration _ Cut the envelope containing the medicated patch as indicated. Remove one medicated patch, remove the plastic film used to protect the adhesive surface and apply it to painful joint or region. If necessary, it can be held in place with an elastic net. Carefully reseal the envelop Read the complete document