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  • Siran 200
    / Megapharm


    Active Ingredient

    Status in Israel
    OTC

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Effervescent Tablets

    20 X 200 mg

    full basket chart 87158 19855

    Related information


    Dosage

    If not prescribed otherwise, the following dosage is recommended for Siran 200 mg effervescent tablets:
    Adults and juveniles aged 14 and above: 1 effervescent tablet 2 – 3 times a day (corresponding to 400 -600 mg acetylcysteine per day).
    Children and juveniles from 6 – 14 years of age: 1 effervescent tablet twice a day (corresponding to 400 mg acetylcysteine per day).
    Children from 2 – 5 years of age: ½ effervescent tablet 2 – 3 times a day (corresponding to 200 – 300 mg acetylcysteine per day).
    Nature and overall duration of the application: Do not take Siran 200 mg effervescent tablets without medical advice for longer than 4 – 5 days.
    Siran 200 mg effervescent tablets are taken dissolved in a glass of water after meals.


    Indications

    Mucolytic in respiratory tract disorders where reduction of sputum viscosity is required.


    Contra-Indications

    Siran 200 mg effervescent tablets may not be administered in the event of hypersensitivity against acetylcysteine or one of the other ingredients.
    Siran 200 mg effervescent tablets may not be used for children under the age of 2 due to the high content of the active substance.


    Special Precautions

    Very rarely, the occurrence of severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome has been reported in close connection with the application of acetylcysteine.
    If new changes to the skin and the mucous membranes occur, medical advice should be obtained without delay and the application of acetylcysteine should be stopped.
    Caution is advised in case of patients with histamine intolerance. Treatment of these patients over a longer period of time should be avoided because Siran 600mg effervescent tablets exert an influence on histamine metabolism and might cause symptoms of intolerance (e.g. headaches, rhinorrhea, pruritus).
    Take care in use with patients suffering from Asthma bronchiale and patients with an ulcer anamnesis.
    One effervescent tablet contains 6.37 mmol (146.5 mg) sodium. This is to be taken into account for persons on a sodium-controlled (low-sodium/low-salt) diet.
    Contains aspartame as a source of phenylalanine and may be damaging for patients with phenylketonuria.


    Side Effects

    See prescribing information for full details.


    Drug interactions

    In combined application of Siran 200 mg effervescent tablets with antitussives (cough-relieving agents), a dangerous secretion congestion can result due to the limited coughing reflex, which means that the indication for this combination treatment should be made particularly carefully.
    Reports on a deactivation of antibiotics (tetracycline, amino glycoside, penicillin) by acetylcysteine have been exclusively concerned with in-vitro tests up to now, in which the substances concerned were mixed directly.
    Nevertheless, for safety reasons, oral applications of antibiotics should be separate and with an interval of at least two hours. This does not apply to Cefixim and Loracarbef.


    Pregnancy and Lactation

    No sufficient clinical data are available for acetylcysteine concerning exposed pregnant women. Experimental studies on animals give no indication of direct or indirect damaging effects on pregnancy, embryonic/foetal development, birth or post-natal development. No information on excretion into the mother’s milk is available. It should only be applied in pregnancy and lactation after a strict risk/benefit consideration.


    Overdose

    With oral forms of administration of acetylcysteine, no case of a toxic overdose has yet been observed. Volunteers were treated for 3 months with a dose of 11.6 g acetylcysteine/day without severe side-effects being observed. Oral doses of up to 500 mg acetylcysteine/day were tolerated without intoxication phenomena.
    a) Symptoms of intoxication: Overdoses may lead to gastrointestinal symptoms such as nausea, vomiting and diarrhoea. With babies, there is the risk of hypersecretion.
    b) Therapy measures for intoxications: If need be, symptomatically. From intravenous acetylcysteine treatment of paracetamol intoxication, experience with maximum daily doses of up to 30 g acetylcysteine is available for humans.
    The i.v. application of extremely high acetylcysteine concentrations might cause „anaphylactoid“ responses, especially when rapidly applied. One case of epileptic seizures and cerebral oedema with fatal outcome after a massive i.v. overdose has been reported.


    Manufacturer
    Temmler Pharma
    Licence holder
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