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    Active Ingredient

    Status in Israel
    OTC

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Tablets

    10 X 25 mg

    not in the basket chart 69513 20582

    Related information


    Dosage

    Adults and children over 12 years old: 1/2-1 tablet half an hour before bedtime.

    TONIGHT tablets should not be used for more than ten days consecutively.
    Children: Not intended for children under 12 years of age.


    Indications

    Relief of temporary sleep disturbance.


    Contra-Indications

    Hypersensitivity to doxylamine, other antihistamines in the ethanolamine class, or any of the excipients.
    Doxylamine should not to be given to premature or newborn infants due to their heightened susceptibility to antimuscarinic effects


    Special Precautions

    Concurrent use with alcohol should be avoided and medications which suppress the CNS as the effects of both may be enhanced.
    Risk/benefit approach should be adopted for patients with glaucoma. Increased ocular pressure could precipitate an attack of angle closure glaucoma. Use in caution in patients with asthma,
    bladder neck obstruction, urinary retention, chronic bronchitis, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy and epilepsy.


    Side Effects

    Drowsiness, dizziness, lassitude, disturbed coordination, headache, psychomotor impairment and muscular weakness. Antimuscarinic effects include dry mouth, nose and throat and thickened respiratory tract secretions.


    Drug interactions

    Doxylamine has additive antimuscarinic effects with atropine-like drugs, tricyclic antidepressants and MAOIs. Concurrent use with other drugs and substances which suppress the CNS should be
    avoided. These include alcohol, sedatives (such as benzodiazepines and barbiturates), tranquillizers (e.g. antipsychotics) and opioid analgesics. Use with ototoxic medications, e.g.
    aminoglycoside antibiotics, may mask the symptoms of ototoxicity such as tinnitus, dizziness or
    vertigo.


    Pregnancy and Lactation

    Pregnancy: Medical or pharmacist advice is required before use in pregnancy. Non pharmacological interventions for insomnia should be considered as first line therapy.
    Lactation: Medical or pharmacist advice is required before use in breast-feeding. Doxylamine may be excreted into breast milk in small amounts and cause unusual excitement or irritability in infants. Anticholinergic effects may inhibit lactation.


    Overdose

    Severe drowsiness, severe dryness of the mouth, nose and throat, flushing or redness in the face, shortness of breath, tachycardia, CNS stimulation, hallucinations, seizures, insomnia,
    hypotension, delirium, convulsions and fixed and dilated pupils. Coma progressing to respiratory failure and cardiovascular collapse may occur.
    Cardiorespiratory collapse and death may occur several days after onset of toxic symptoms.
    Children are at higher risk for cardiorespiratory arrest. Rhabdomyolysis and subsequent acute renal failure may also occur in certain individuals (adults).


    Important notes

    Drowsiness and hang-over affects may affect ability to drive or operate machinery the day following use.


    Manufacturer
    CTS Chemical Industries Ltd
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