PHENERINE Sugar-coated tablet Ref.[51181] Active ingredients: Orphenadrine

Source: Health Products Regulatory Authority (ZA)  Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191

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in dosage, and transfer to other forms of treatment should be gradual and anticholinergic medicines should not be withdrawn abruptly.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.

Excipients

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. Interaction with other medicinal products and other forms of interaction

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. Pregnancy and lactation

Not known.

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 gastointestinal tract leading to constipation.

Occasionally vomiting, giddiness and staggering may occur. Retrosternal pain may occur due to increased gastric reflux.

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