Sudomyl is a white biconvex circular tablet with a diameter of about 8.5mm. Each tablet contains 60mg of Pseudoephedrine Hydrochloride. Tablets cannot be halved.
Sudomyl is indicated for the effective relief of runny nose; sinus and nasal congestion; and sinus pain due to congestion. Sudomyl reduces the swelling and secretions in the nose and sinuses, allowing the patient to breathe more easily. Itrelieves the pressure behind the nose and eyes, which is the cause of sinus pain and headache.
Adults and children over 12 years
: One tablet if necessary, up to 3 times daily at intervals of not less than 4 hours, with a maximum of 3 tablets in 24 hours.
Children under 12 years: Must not be used in children under 12 years of age. Elderly: There is no need for dosage reduction in the elderly. Do not exceed the recommended dose. Do not halve the tablet. If symptoms do not improve within seven days, consult your doctor.
Sudomyl is contraindicated for use in children under 12 years of age. Pseudoephedrine is contraindicated for use in patients: with known hypersensitivity or idiosyncratic reaction to pseudoephedrine (or any of the other ingredients in the product); with severe hypertension or coronary artery disease; taking monoamine oxidase inhibitors (MAOIs) or who have taken MAOIs within the previous 14 days. Refer to 'INTERACTIONS' for additional information.
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Pseudoephedrine should be used with caution in patients with: hypertension hyperthyroidism diabetes mellitus coronary heart disease ischaemic heart disease glaucoma prostatic hypertrophy severe hepatic or renal dysfunction Caution should be taken when used in conjunction with Cough & Cold Medicines. Refer to 'INTERACTIONS' for additional information.
Category B2: Pseudoephedrine has been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals are inadequate or may be lacking, but available data shows no evidence of an increased occurrence of foetal damage. Pseudoephedrine should be used in pregnancy only if the potential benefits to the patient are weighed against the possible risk to the foetus.
Pseudoephedrine is secreted in breast milk in small amounts. It has been estimated that 0.5% to 0.7% of a single dose of pseudoephedrine ingested by the mother will be excreted in the breast milk over 24 hours. Therefore it is not recommended for breastfeeding mothers unless the potential benefits to the patient are weighed against the possible risk to the infant.
Likely to produce minor or moderate adverse effects on the ability to drive or use machinery.
Adverse effects include: cardiovascular stimulation - elevated blood pressure, tachycardia or arrhythmias central nervous system (CNS) stimulation - restlessness, insomnia, anxiety, tremors and (rarely) hallucinations skin rashes and urinary retention Children and the elderly are more likely to experience adverse effects than other age groups.
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The following interactions with pseudoephedrine have been noted: Antidepressant medication eg tricyclic antidepressants and monoamine oxidase inhibitors (MAOIs) - may cause a serious increase in blood pressure or hypertensive crisis other sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psychostimulants - may cause an increase in blood pressure and additive effects methyldopa and b-blockers - may cause an increase in blood pressure urinary acidifiers enhance elimination of pseudoephedrine urinary alkalinisers decrease elimination of pseudoephedrine
In all cases of suspected overdose, immediately call the National Poison Centre in New Zealand on 0800 POISON or 0800 764 766 (24 hours a day). Symptoms associated with pseudoephedrine overdose may include: restlessness excitement nervousness nausea vomiting abdominal pain ataxia hallucinations convulsions tachycardia In the event of overdose, discontinue medication and seek medical help immediately.
Pseudoephedrine hydrochloride is a nasal and bronchial decongestant.
Pseudoephedrine is readily absorbed from the gastrointestinal tract. It is largely excreted unchanged in the urine together with small amounts of its hepatic metabolite. It has a half-life of about 5-8 hours; elimination is enhanced and half-life reduced accordingly in acid urine. Small amounts are distributed into breast milk.
Pseudoephedrine has direct- and indirect- sympathomimetic activity and is an effective decongestant in the upper respiratory tract. It is a stereoisomer of ephedrine and has a similar action, but has been found to have less pressor activity and fewer central nervous system (CNS) effects.
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Sympathomimetic agents are used as nasal decongestants to provide symptomatic relief. They act by causing vasoconstriction resulting in redistribution of local blood flow to reduce oedema of the nasal mucosa, thus improving ventilation, drainage and nasal stuffiness.
In addition to pseudoephedrine hydrochloride, Sudomyl contains magnesium stearate, maize starch and lactose.
Store below 25degC. Shelf-life is 36 months. Protect from light and moisture. Keep out of reach of children.
100 tablets in a glass bottle. 500 tablets in a glass bottle (Not marketed). 30 tablets in blister packs (Not marketed).
Class B2 Controlled Drug
PSM Healthcare Ltd trading as API Consumer Brands PO Box 76 401 Manukau City Auckland 2241 Phone No. (09) 2797 979
17th January 2012
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