BALSEM VITA WIT (Solution); BALSEM VITA GEEL (Solution); BALSEM VITA ROOI (Solution)

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

BALSEM VITA WIT (Solution)
BALSEM VITA GEEL (Solution)
BALSEM VITA ROOI (Solution)

SCHEDULING STATUS:
Not scheduled.

PROPRIETARY NAME
(and dosage form):

BALSEM VITA WIT (Solution)
BALSEM VITA GEEL (Solution)
BALSEM VITA ROOI (Solution)

COMPOSITION:
Balsem Vita WIT
Each 5 mL contains: Cassia Oil 0,020 mL; Spike Lavender Oil 0,1164 mL; Clove Oil 0,020 mL; Nutmeg Oil 0,020 mL; Thyme Oil 0,006 mL; Ethanol (100%) 86,70% v/v.

Balsem Vita GEEL
Each 5 mL contains: Spike Lavender Oil 0,0518 mL; Rosemary Oil 0,0031 mL; Clove Oil 0,0249 mL; Cassia Oil 0,0269 mL; Nutmeg Oil 0,0269 mL; Lemon Oil 0,0249 mL; Thyme Oil 0,0165 mL; Ethanol (100%) 86,40% v/v.
Contains Tartrazine

Balsem Vita ROOI
Each 5 mL contains: Spike Lavender Oil 0,01506 mL; Clove Oil 0,0234 mL; Cassia Oil 0,0259 mL; Nutmeg Oil 0,0259 mL; Lemon Oil 0,0234 mL; Rosemary Oil 0,0026 mL; Thyme Oil 0,0156 mL; Ethanol (100%) 87,39% v/v

PHARMACOLOGICAL CLASSIFICATION:
A 11.2 Gastro-intestinal antispasmodics and cholinolytics (anti-cholinergics)

PHARMACOLOGICAL ACTION:
The volatile principles in these preparations have a carminative action and are believed to exert some antispasmodic action on the gastro-intestinal tract.

INDICATIONS:
Gastric discomfort, flatulent colic and to counteract the griping action of purgatives.

CONTRA-INDICATIONS:
Hepatic and renal insufficiency.

WARNING:
(Balsem Vita Geel)
This product contains FD and C Yellow No 5 (Tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of Tartrazine sensitivity in the general population is currently thought to be low, it is frequently seen in patients who also have aspirin sensitivity.

DOSAGE AND DIRECTIONS FOR USE:
Adults: 1,5 –2 mL (20 - 30 drops) in water four to five times a day, preferably after meals.
Children: 0,5 mL (10 drops) in sweetened water four to five times daily, preferably after meals.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
None when used as directed

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Excessive doses are irritant to the gastro-intestinal tract and may cause nausea, vomiting and diarrhoea. There may be occasional irritation of the urinary tract and aggravation of pre-existing inflammatory conditions. The central nervous system may either be depressed leading to stupor and respiratory failure, or stimulated, leading to excitement and convulsions.
In acute poisoning the stomach should be emptied by aspiration and lavage. A saline purgative may be given such as sodium sulphate (30 g in 250 mL water) unless catharsis is already present.
Demulcent drinks may be given. Large volumes of fluid should be given provided renal function is adequate.

IDENTIFICATION:

Balsem Vita WIT	A clear colourless solution with a strong aromatic odour.
Balsem Vita GEEL:	A clear pale yellow solution with a strong aromatic odour.
Balsem Vita ROOI:	A clear red solution with a strong aromatic odour.

PRESENTATION:
Bottles of 20 mL.

STORAGE INSTRUCTIONS:
Store below 25°C in airtight containers
KEEP OUT OF REACH OF CHILDREN

APPLICATION NUMBERS:

Balsem Vita WIT:	E1517 (Act/Wet 101/1965)
Balsem Vita GEEL:	E1471 (Act/Wet 101/1965)
Balsem Vita ROOI:	E1503 (Act/Wet 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
Lennon Limited
7 Fairclough Road
Port Elizabeth 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

4.4.1985

K4808