Indication
This medicine is indicated in adults (over 15 years of age) for the symptomatic treatment of pain of tendino-ligamentary origin, and post-traumatic pain: sprains and contusions. This medicine is indicated in adults for the treatment of painful flare-ups of osteoarthritis of the knee, after initial medical advice.
How to take this medicine
1. Cut the envelope containing FLECTORTISSUGELEP (box of 2, 5, 10 or 14 medicated plasters) where indicated. 2. Remove one FLECTORTISSUGELEP and carefully close the envelope with the slide. 3. Remove the clear plastic sheet that protects the adhesive surface of FLECTORTISSUGELEP. 4. Apply the adhesive surface of FLECTORTISSUGELEP to the joint or painful area. FLECTORTISSUGELEP may be held in place by an elastic mesh, if the area to be treated requires it. In all cases, follow the recommendations of your doctor or pharmacist.
Dosage
FLECTORTISSUGELEP is used in local application at the following dose: - Treatment of painful flare-ups of osteoarthritis of the knee: 7 days, to be continued, if necessary, but not exceeding a maximum of 14 days of treatment. - Treatment of pain of tendino-ligamentary origin: 7 days. If pain persists after 7 days, consult your doctor, who will decide whether to continue the treatment. - Treatment of sprains and bruises: 3 days up to a maximum of 7 days if necessary. If there is no improvement after 3 days of treatment, consult your doctor. If there is no improvement during the recommended treatment period, a doctor should be consulted.
Composition
The active substance is: Diclofenac sodium (1% m/m) ...................................................................................................... 140 mg
In the form of diclofenac epolamine For one medicated plaster of 10 cm x 14 cm.
The other components are: Carrier: Non-woven polyester carrier. Adhesive layer (active gel): Gelatin, povidone K90, liquid sorbitol (non-crystallisable), heavy kaolin, titanium dioxide (E 171), propylene glycol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), disodium edetate (E 385), tartaric acid, aluminium aminoacetate, sodium carmellose, sodium polyacrylate, 1,3-butylene glycol, polysorbate 80, DALIN PH fragrance (propylene glycol, benzyl salicylate, phenyl ethyl alcohol, alpha amylcinnamic aldehyde, hydroxycitronellal, phenyl ethyl acetate, cinnamyl acetate, benzyl acetate, terpineol, cinnamic alcohol, cyclamenaldehyde), purified water.
Packaging
This medicine is presented as a medicated plaster. The plasters are packaged in a sealed envelope containing 10 plasters.
Precautions and special warnings
This medicine is for adults only (over 15 years of age). Do not apply to mucous membranes or the eyes. Do not use under an occlusive bandage. If a rash appears after application, treatment must be stopped immediately. To avoid any risk of skin reaction when exposed to sunlight (photosensitisation), it is preferable to avoid direct exposure to the sun or in a UV cabin during treatment. Never apply more than the recommended dose (see Dosage). Respect the frequency and duration of treatment indicated in this leaflet or recommended by your doctor. To be used with caution under medical supervision: - in case of heart, kidney or liver disease, - in case of a history of ulcer or digestive bleeding, - in case of inflammatory bowel disease. - in subjects with a history of asthma, allergic disease or allergy to aspirin or other NSAIDs, the administration of this drug may cause respiratory discomfort or an asthma attack. By extrapolation with other routes of administration.
Contraindications
Never use FLECTORTISSUGELEP 1% medicated plaster - if you are allergic to Diclofenac, aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the other components of this product (see What does FLECTORTISSUGELEP 1% medicated plaster contain?) - If you have any type of skin damage, such as oozing lesions, eczema, infected lesions, burns or wounds. - In case of an evolving digestive ulcer. - From the 6th month of pregnancy. In case of doubt, it is essential to ask your doctor or pharmacist for advice.
Interactions with other medicines
FLECTORTISSUGELEP contains an anti-inflammatory drug: Diclofenac. You should not take other medicines, either systemic or for application to the skin, containing Diclofenac or other non-steroidal anti-inflammatory drugs at the same time as this medicine. Read the package insert of any other medicine you are taking carefully to make sure it does not contain Diclofenac and/or non-steroidal anti-inflammatory drugs.
Pregnancy and breastfeeding
Pregnancy During the first and second trimesters of pregnancy, this medicine should only be used on the advice of your doctor and only for short periods. Prolonged use of this medicine is strongly discouraged. From the beginning of the 6th month of pregnancy, you must NOT take this medicine under any circumstances, as its effects on your child may have serious consequences, particularly in terms of cardio-pulmonary and renal health, even if you take it only once. If you have taken this medicine when you are more than five months pregnant, talk to your obstetrician-gynaecologist so that appropriate monitoring can be offered. Ask your doctor or pharmacist for advice before taking any medicine. There are no experimental data on the excretion of Diclofenac epolamine into human or animal milk, therefore, the use of FLECTORTISSUGELEP should be avoided when breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.
Possible side effects
Like all medicines, FLECTORTISSUGELEP 1% medicated plaster is likely to have side effects, although not everyone is susceptible. If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist. - Skin reactions are sometimes reported: itching, redness of the skin, rash, eczema, skin inflammation. - Allergic reactions or skin reactions after exposure to the sun and UV light have been observed in exceptional cases. In all these cases, treatment must be stopped immediately and your doctor must be informed. - Other general effects of non-steroidal anti-inflammatory drugs may also occur, depending on the condition of the treated area and the duration of treatment.
Instructions in case of overdose
You should inform your doctor or pharmacist.
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