Phenerine 50 mg Sugar-coated tablet

    Phenerine 50 mg Sugar-coated tablet

    S4
    PDF Leaflet Revision Date: 08 December 1978


    Clinical Summary

    Quick overview from the medicine insert

    Indication

    Treatment of Parkinsonism.

    Dosage (summary)

    1-2 tablets twice to four times daily.

    Special Populations

    • Diabetes mellitus
    • Galactose intolerance

    Key Drug Interactions

    • Anticholinergic agents
    • Amantadine
    • Antihistamines
    • Butyrophenones
    • Phenothiazines
    • Tricyclic antidepressants

    Contraindications

    • Prostatic enlargement
    • Paralytic ileus
    • Pyloric stenosis
    • Closed-angle glaucoma

    Common side effects

    • Dry mouth
    • Thirst
    • Dilated pupils
    • Flushing
    • Bradycardia
    • Constipation

    Counselling Points

    • May cause dryness of mouth
    • Monitor for tachycardia
    • Avoid abrupt withdrawal

    Serious warnings

    • Gradual dosage increase required
    • Monitor for severe mental disturbances
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    Clinical Particulars

    Section 4 of the official insert — extracted exactly as issued, no alterations

    4.1 Therapeutic indications

    Parkinsonism.

    4.2 Posology and method of administration

    One tablet twice a day to two tablets four times a day.

    4.3 Contraindications

    Prostatic enlargement, paralytic ileus, pyloric stenosis, closed-angle glaucoma and patients with a narrow angle between the iris and the cornea. Should be used with caution in conditions characterised by tachycardia, such as thyrotoxicosis, cardiac insufficiency or failure, and in cardiac surgery.

    4.4 Special warnings and precautions for use

    In the treatment of Parkinsonism, increases in dosage, and transfer to other forms of treatment should be gradual and anticholinergic medicines should not be withdrawn abruptly. If higher doses provoke severe mental disturbances, the medicine should be discontinued, but minor reactions may be controlled by reducing the dosage until tolerance has developed.

    PHENERINE contains lactose monohydrate and sucrose which may have an effect on the glycaemic control of patients with diabetes mellitus. Patients with the rare hereditary conditions of galactose intolerance e.g. galactosaemia, Lapp lactase deficiency, glucose-galactose malabsorption, sucrase-isomaltase insufficiency or fructose intolerance should not take PHENERINE.

    4.5 Interactions with other medicines

    The effects of anticholinergic medicines may be enhanced by the concomitant administration of other medicines with anticholinergic properties, such as amantadine, some antihistaminics, butyrophenones and phenothiazines, and tricyclic anti-depressants.

    4.6 Fertility, pregnancy and lactation

    Not known.

    4.7 Effects on ability to drive and use machines

    Not specified.

    4.8 Undesirable effects

    Dryness of the mouth with difficulty in swallowing, thirst, dilatation of the pupils with loss of accommodation and photophobia, increased intra-ocular pressure, flushing and dryness of the skin, bradycardia followed by tachycardia, with palpitations and arrhythmias, a desire to urinate with the inability to do so, as well as reduction in the tone and motility of the gastrointestinal tract leading to constipation. Occasionally vomiting, giddiness and staggering may occur. Retrosternal pain may occur due to increased gastric reflux.

    4.9 Overdose

    Symptoms: Tachycardia, rapid or stertorous respiration, hyperpyrexia, restlessness, confusion and excitement, and hallucinations passing into delirium. Depression of the central nervous system, with hypertension or circulatory failure and respiratory depression.

    Treatment: Treatment of acute poisoning is to empty the stomach. A saline purgative should be given to promote peristalsis. Excitement may be controlled by small doses of a short-acting barbiturate. Supportive therapy may require oxygen and assisted respiration, icebags or alcohol sponges for hyperpyrexia, especially in children, bladder catheterisation, and the administration of fluids.

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