BORSTOL®COLD AND FLU POWDERS WITH VITAMIN C

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

BORSTOL®COLD AND FLU POWDERS WITH VITAMIN C

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME:
(and dosage form)

BORSTOL^®COLD AND FLU POWDERS WITH VITAMIN C

COMPOSITION:
Each powder contains:

	Aspirin	650 mg
	Ascorbic Acid	45 mg

PHARMACOLOGICAL CLASSIFICATION:
A5.8 - Preparations for the common cold including nasal decongestants and anti-histaminics

PHARMACOLOGICAL ACTION:
Borstol Cold and flu Powders with Vitamin C have analgesic (relief of pain), antipyretic (reduces fever) and anti-inflammatory (reduces swelling) properties. It inhibits the biosynthesis of prostaglandins (substances in the body involved in production of inflammation and pain).

INDICATIONS:
For the symptomatic relief of mild to moderate pain and fever associated with colds and flu.

CONTRA-INDICATIONS:
Sensitivity (abnormal or allergic reaction) to the ingredients. Should not be taken by patients taking anti-coagulants, suffering from gastro-intestinal (affecting the stomach and intestines) ulcers, haemophilia (inherited bleeding disorder), severe kidney damage or who are allergic to aspirin, or by asthmatics.

WARNING:
DO NOT USE CONTINUOUSLY FOR MORE THAN 10 DAYS WITHOUT CONSULTING YOUR DOCTOR. EXCESSIVE AND PROLONGED USE OF THIS MEDICINE MAY BE DANGEROUS.

NOT TO BE TAKEN DURING THE FIRST AND THIRD TRIMESTER OF PREGNANCY EXCEPT UNDER THE ADVICE AND SUPERVISION OF A MEDICAL DOCTOR.

ASPIRIN HAS BEEN IMPLICATED IN REYE’S SYNDROME, A RARE BUT SERIOUS ILLNESS IN CHILDREN AND TEENAGERS WITH CHICKENPOX AND INFLUENZA. A DOCTOR SHOULD BE CONSULTED BEFORE ASPIRIN IS USED IN SUCH PATIENTS.

In the event of overdosage and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Control Centre must be contacted immediately.

Do not exceed the recommended daily dose.

DOSAGE AND DIRECTIONS FOR USE:
ADULTS: Take one powder with water every four hours. For the best results, take the powder dry on the tongue followed by a glass of water.

Do not exceed 5 powders in 24 hours.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most common adverse effects are gastro-intestinal disturbances such as nausea and vomiting. Dizziness or irritation of the gastric mucosa and resultant dyspepsia (heartburn), erosion, ulceration, haematemesis (vomiting of blood) and melaena (blood in stools) may occur. It should be administered with caution to patients with impaired renal (kidney) function, dyspepsia, anaemia (decreased number of red blood cells) and when the patient is dehydrated (lack of water/fluid).

Notable sensitivity to Aspirin which may provoke various sensitivity reactions which may include skin eruptions, angioedema, rhinitis, paroxysmal bronchospasm (constriction of air passages) and dyspnoea (difficulty in breathing), may occur, especially in asthmatics. Aspirin increases the bleeding time, decreases platelet adhesiveness and may cause hypoprothrombinaemia. Aspirin may enhance the activity of coumarin anti-coagulants and oral anti-diabetic preparations and sulphonamides. Aspirin diminishes the effects of anti-gout preparations such as probenecid and sulphinpyrazone. Barbiturates and other sedatives may mask the respiratory symptoms of aspirin overdosage and have been reported to enhance its toxicity. Prolonged use of high doses may lead to anaemia (decreased number of red blood cells), blood dyscrasias (serious blood disorder), gastro-intestinal haemorrhage (bleeding), peptic (stomach and duodenum) ulceration and renal papillary necrosis (death of tissue).

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
ASPIRIN: These include dizziness, tinnitus (ringing in the ears), deafness, sweating, nausea, vomiting, mental confusion, hyperventilation (abnormally deep and rapid breathing), respiratory alkalosis, metabolic acidosis, ketosis (elevated level of ketones in body fluids) and depression of the central nervous system.
VITAMIN C: Large doses may cause diarrhoea and other gastro-intestinal (stomach and intestines) disturbances.
In children serious signs of overdosage may develop rapidly. In cases of overdosage, consult your doctor immediately.
Treatment is supportive and symptomatic.

IDENTIFICATION:
White uniform powder with a bitter taste.

PRESENTATION:
10 Powders packed in a carton or as single doses in an envelope.

STORAGE INSTRUCTIONS:
Store in a cool (below 25°C) plate, protected from light. Exposure to air should be minimal. Keep out of reach of children.

REGISTRATION NUMBER:
27/5.8/0504

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Group Laboratories SA (Pty) Limited
21 Wrench Road, Isando, 1600

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
SEPTEMBER 1993

809-7101-01

Rosside 28485