INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo FENOX NASAL SPRAY : Spray
SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form)

FENOX NASAL SPRAY : Spray

COMPOSITION
Each 15 mL contains:
  Phenylephrine HCl B.P 0,075 g
  Cetrimide B.P. (Preservative) 0,025% m/v
  Methyl hydroxybenzoate BP (Preservative) 0,07% m/v
PHARMACOLOGICAL CLASSIFICATION
A/16.1/Nasal decongestants

PHARMACOLOGICAL ACTION
Phenylephrine hydrochloride is a sympathomimetic agent with mainly direct effects on adrenergic receptors. It reduces blood flow to the skin.

INDICATIONS
For the relief of nasal congestion in coryza, sinusitis, and hayfever.

CONTRA-INDICATIONS
Sensitivity to any of the ingredients.
Should not be used in the presence of high blood pressure, thyrotoxicosis or patients with cardiovascular disease. Contra-indicated in patients receiving treatment with mono-amine oxidase inhibitors. Not indicated for use in children under 6 years of age.

DOSAGE AND DIRECTIONS FOR USE
For adults and children over 12 years : 2 sprays in each nostril
For children from 6 to 12 years : 1 spray in each nostril
Blow nose. Tilt head back and spray into each nostril. Sniff up well. Use morning and night and every four hours if necessary.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Do not use for a period longer than 5 days.
May cause rebound congestion and rhinorrhoea if used excessively or for prolonged periods. May also cause irritation and discomfort at the site of application.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Apart from the side-effects mentioned above, if swallowed may cause bradycardia or other cardiac irregularities, hypertension, and irregular respiration. Treatment is symptomatic and supportive.

IDENTIFICATION
A clear mobile liquid, colourless and odourless.

PRESENTATION
15 mL white spray bottle

STORAGE INSTRUCTIONS
Store below 25 °C out of direct sunlight.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER
Z/16.1/254

NAME AND BUSINESS ADDRESS OF THE APPLICANT
THE BOOTS COMPANY (SOUTH AFRICA) (PTY) LTD.
Electron Avenue
Isando 1600

DATE OF PUBLICATION OF THIS PACKAGE INSERT
25 February 1993

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