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COMPOSITION
Per gram of emulsion gel: Diclofenac (D.C.I.) diethylammonium 11,6 mg. (equivalent to 10 mg. of diclofenac sodium) and excipients: diethylamine, acrylic acid polymer, polyoxyethylene cetyl ether, caprylic/capric acid fatty alcohol ester, isopropyl alcohol, liquid paraffin, perfume creme, propylene glycol and water.
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INDICATIONS
Diclofenac is a non-steroidal anti-inflammatory drug, which also has analgesic properties. It is indicated in a number of conditions characterized by pain and inflammation, such as arthrosis, acute musculoskeletal disorders or post-traumatic disorders, including tendonitis, tenosynovitis, periarthritis, sprains, distension and lumbago pain.
POSOLOGY
This product is for external use only. Do not use with occlusive bandages. Voltarén Emulgel is rubbed in gently until there is none left on the skin. Depending on the size of the affected site to be treated, 2 to 4 grams of Voltarén Emulgel (approximately 5 to 10 cm.) should be applied over the affected area 3 or 4 times a day. It can be used in children of more than 6 years of age.
CONTRAINDICATIONS
It must not be taken by patients who have ever experienced hypersensitivity to Voltarén Emulgel or to diclofenac in any of its presentations. There is a possibility of cross-hypersensitivity with acetylsalicylic acid and other non-steroidal anti-inflammatory drugs.
It should not be administered to patients who experience rhinitis, asthma, angio-oedema or urticaria after taking acetylsalicylic acid and other non-steroidal anti-inflammatory drugs.
It must not be used in patients that are allergic to isopropanol or propylene glycol.
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PRECAUTIONS
- Use during pregnancy: topical diclofenac is not recommended during pregnancy or lactation because the safety of its administration in these situations has not been established.
- Use in children: Voltarén Emulgel is not recommended for use in children of less than 6 years of age as dosage recommendations and indications for use in this group of patients have not been established.
If the use of topical diclofenac causes local irritation, discontinue treatment and institute appropriate therapy. Do not apply to eyes or mucous membranes, or open wounds, or any other area where the skin is abnormal.
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SIDE EFFECTS
The side effects reported were mild or moderate local irritation, reddening, skin rash, itching and similar local reactions, where the gel was applied.
Photosensitivity has been reported on isolated occasions.
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OVERDOSE
Since topical diclofenac is a medication for external use only, it is unlikely to cause symptoms of overdose.
In the case of an overdose or accidental ingestion, consult your local poison centre (Servicio de Información Toxicológica (Telephone 91 562 04 20)).
PRESENTATION
Available in tubes of 60 gr.
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