Source: Medicines Authority (MT) Revision Year: 2022 Publisher: Ferrer Internacional, S.A., Gran Via Carlos III, 94 Barcelona, 08028, Spain
Short-term treatment of dyspeptic syndrome (anorexia, meteorism, sense of epigastric tension, postprandial headache, heartburn, belching, diarrhoea, constipation) from delayed gastric emptying linked to organic (diabetic gastroparesis, neoplasms, etc.) and/or functional factors (visceral somatisation in anxious-depressive subjects) in patients who have not responded to other therapy.
Symptomatic and short-term treatment of vomiting and nausea induced by antiblastic drugs following failure of first-line therapy.
Short-term and symptomatic treatment of dizziness, tinnitus and hearing loss and nausea associated with Ménière’s disease.
One 25 mg ampoule (i.m. or i.v.) 2 or 3 times per day.
If patients have severe symptoms with nausea and vomiting and oral administration is difficult, initiate treatment with Dislep 25 mg solution for injection/infusion (i.m. or i.v.) 2 or 3 times per day for a few days and, when symptoms become milder, switch to oral administration for 10-15 days. If necessary, repeat the course of therapy orally for another 2 or 3 weeks, after an interruption period of at least 8-10 days. When oral administration is needed, other medicinal products containing levosulpiride in pharmaceutical forms for oral use, should be administered. Treatment of vomiting: an i.m. or i.v. ampoule, possibly repeated 2-3 times per day, until symptoms disappear.
If the drug is used in the treatment of antiblastic agent-induced vomiting (cisplatin, anthracyclines) administer 1-2 ampoules of Dislep 25 mg solution for injection/infusion by slow intravenous route or by infusion 30 minutes before administration of the antiblastic or during administration of the antiblastic and repeat the same dose 30 minutes after the end of chemotherapy.
Dislep 25 mg solution for injection/infusion can be administered intramuscularly or intravenously, directly as a slow intravenous infusion or diluted in usual sodium chloride or glucose serums.
No data are available. Therefore, the use of Dislep in children and adolescents is not recommended.
In the treatment of elderly patients, the posology must be carefully established by the doctor who will have to evaluate a possible reduction of the dosages indicated above.
In internal medicine, extrapyramidal disorders and sleep disturbances have never been observed which, from a theoretical point of view, could occur with very high doses. In this case it is sufficient to interrupt the therapy or reduce the dosage depending on the judgement of the doctor.
Before first opening: 4 years.
After dilution: Chemical and physical in-use stability has been demonstrated for 6 hours at room temperature when diluted with 0,9% sodium chloride solution or 5% glucose solution.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8ºC, unless dilution has taken place in controlled and validated aseptic conditions.
This medicine do not require any special precautions for storage.
Carton containing 6 glass ampoules of 25 mg/2 ml.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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