Properties
What is it?
What is Octisept gel and what is it used for? Active ingredients: Octenidine dihydrochloride and Phenoxyethanol. 1 g gel contains 1 mg of octenidine dihydrochloride (an antiseptic and disinfectant) and 10 mg of phenoxyethanol (a bactericidal agent). Other ingredients are: Ethanol 96%, Glycerol 85%, Poloxamer 407 (contains Butylhydroxytoluene (E321)) and Purified water. It is used for the repeated, time-limited, maintenance antiseptic treatment of skin, small and superficial wounds in patients of all age groups. Do not use Octisept gel: · If you are allergic to octenidine dihydrochloride, phenoxyethanol or any of the other ingredients of this medicine. · This medicine must not be used for irrigation of the abdominal cavity (e.g. during surgery [intraoperative]), bladder or tympanic membrane. Warnings and precautions: Talk to your doctor, pharmacist or nurse before using Octisept gel. - Do not use the medicinal product in larger quantities than necessary, do not swallow it and do not let it enter the bloodstream, e.g. through accidental injection. - To avoid possible tissue damage, care must be taken when using this medicine to ensure that the product is not applied under pressure or injected into the tissue. - In the case of cavity wounds (larger, deeper wounds with loss of subcutaneous tissue), the outflow of wound fluid must be ensured (e.g. by drainage or special wound treatment techniques /so-called skin flap/). - Do not use Octisept gel in the eye. In case of contact with eyes, rinse immediately with plenty of water. Children and adolescents: - Use with caution in newborns, especially premature babies. Octisept gel can cause serious skin damage. Remove excess product and ensure that the gel does not remain on the skin for longer than necessary (including dripped material in direct contact with the patient). - In children under 6 years of age, the use of Octisept gel should be limited to a few days. - Due to local use, Octisept gel is used uniformly in adults, children and adolescents. Other medicines and Octisept gel: Tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription. - Do not use this medicine together with skin disinfectants based on povidone-iodine for the treatment of skin areas, as this can lead to strong brown or violet discoloration of the skin. - Do not use Octisept gel together with anionic surfactants (e.g. soaps, detergents or cleaning agents), as this leads to a limitation or loss of the antimicrobial effectiveness of this medicine. Pregnancy: Octisept gel cannot be used during pregnancy. Breastfeeding: It is unlikely that this medicine will pass into breast milk. Octisept gel cannot be used in the breast area during breastfeeding. Driving and using machines: Has no or negligible influence on the ability to drive and use machines. Contains: - Alcohol (ethanol) and Butylhydroxytoluene, Butylhydroxytoluene may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes. - 95.2 mg of alcohol (ethanol) per 1 g. It may cause a burning sensation on damaged skin. How to use: Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist. - This medicine should be applied to the skin (it is intended for skin only). Apply Octisept gel in a thin layer to the area of skin to be treated until it is completely covered. - Wait at least 1 or 2 minutes before taking any further measures, such as applying a wound dressing. This time is necessary for the product to achieve its desired effect. - Octisept gel should be used a maximum of three times a day. - Do not use this medicine for more than 2 weeks without consulting a doctor. If you use more Octisept gel than you should: For a locally applied medicine, overdose is unlikely. However, if you are concerned, consult your doctor or pharmacist for advice. If you accidentally swallow Octisept gel: You should seek medical advice immediately. If you have any further questions about the use of this medicine, ask your doctor or pharmacist. Possible side effects: Rare: In rare cases, burning, redness, itching and a feeling of warmth may occur at the application site. Very rare: Local skin irritation (allergic contact reactions) may occur, such as temporary redness of the treated skin. If Octisept gel gets into the mouth, it causes a temporary bitter taste. Additional side effects in children and adolescents: - In premature babies, the use of this medicine may cause temporary skin rash (erythematous reaction). - The frequency, type and severity of side effects in children and adolescents are expected to be the same as in adults. Storage: - Keep this medicine out of the sight and reach of children. - Do not use this medicine after the expiry date which is stated on the tube and the carton after "EXP". The expiry date refers to the last day of that month. - This medicine does not require any special storage conditions. - After first opening: Store at a temperature not exceeding 25°C. - Shelf life after first opening: 1 year. - Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment. Marketing authorisation holder: EGIS Pharmaceuticals PLC 1106 Budapest, Keresztúri út 30-38. Hungary