INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
KARVOL DECONGESTANT CAPSULES : Inhalation Capsules

SCHEDULING STATUS
Not scheduled.

PROPRIETARY NAME
(and dosage form)

KARVOL DECONGESTANT CAPSULES : Inhalation Capsules

COMPOSITION
Natural coloured soft gelatin capsules containing:

	Menthol BP	35,55 mg
	Chlorbutol BP	2,25 mg
	Thymol BP	3,15 mg
	Total Pine Oil	112,05 mg
	Terpineol BP	66,60 mg
	Cinnamon Oil	12,15 mg

PHARMACOLOGICAL CLASSIFICATION
A/10.2.1/Medicines acting on respiratory system. Inhalants.

PHARMACOLOGICAL ACTION
The aromatic vapours of the active agents have a decongestant action on the upper respiratory tract, giving symptomatic relief in nasal congestion, coryza and bronchitis.

INDICATIONS
For symptomatic relief in nasal congestion, coryza (head colds) and bronchitis.

CONTRA-INDICATIONS
Not recommended for children under 3 months of age

Warning:
There have been reports of apnoea and instant collapse in infants following the local application of menthol to their nostrils.

DOSAGE AND DIRECTIONS FOR USE
(A drawing of instructions is inserted at this point)

Adults & Older Children
Snip off the tip of one or two capsules. Squeeze the contents into 500 mL hot water or onto a tissue and inhale the vapour. At night the inhalant can be effectively used on the bedding or in a humidifier. Consult your doctor if symptoms persist.

Young Children and Babies Older than 3 months:
Dab the contents of a CAPSULE onto a handkerchief tied down securely in the vicinity, but out of reach of the child. Karvol may be used in a humidifier.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Hypersensitivity reactions to the individual ingredients could occur.

Precautions:
NOT to be taken internally. Avoid contact with eyes.
NOT to be applied directly to the nostrils.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
An overdose by inhaling is treated by taking the patient into fresh air. Accidental intake by mouth may cause diarrhoea, stomach pain, nausea, vomiting and sweating.

Treatment: Empty stomach by aspiration and lavage (sucking out and washing). When large quantities are swallowed, hypotension (low blood pressure), dyspnoea (shortness of breath) and respiratory failure may occur. The respiration (breathing) should be assisted until spontaneous breathing is fully restored.

IDENTIFICATION
A light brown, gelatin, flask-shaped capsule containing a faintly yellow oil with a characteristic odour.

PRESENTATION
Cartons containing 10 or 20 blister packed capsules.

STORAGE INSTRUCTIONS
Store below 25 °C in a dry place.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBER
G.777

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
April 1983
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