INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
MED-LEMON HOT MEDICATION WITH VITAMIN C

SCHEDULING STATUS:
Not scheduled.

PROPRIETARY NAME:
(and dosage form)        (Powder)

MED-LEMON HOT MEDICATION WITH VITAMIN C

COMPOSITION:
Each sachet contains:
        Aspirin        800 mg
        Caffeine        50 mg
        Ascorbic Acid        45 mg
        Menthol        2,6 mg

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

PHARMACOLOGICAL ACTION:
Med-Lemon Hot Medication With Vitamin C has analgesic and antipyretic properties.

INDICATIONS:
Med-Lemon Hot Medication With Vitamin C is recommended for the symptomatic treatment of aches, pains, fever and headache associated with the common cold and influenza.

CONTRA-INDICATIONS:
Sensitivity to the ingredients. Should not be taken by patients taking anti-coagulants, by patients suffering from gastro-intestinal (affecting the stomach and intestines) ulcers, haemophilia, severe kidney damage or by patients who are allergic to aspirin. Safety in pregnancy and lactation has not been established.

WARNINGS:
DO NOT USE CONTINUOUSLY FOR MORE THAN 10 DAYS WITHOUT CONSULTING A DOCTOR. Excessive and prolonged use of this medicine may be dangerous. 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: One sachet morning and night. A dose at midday may be taken if desired.
Empty contents of sachet into a tumbler. Half fill with very hot water. Stir. Add cold water if necessary, but drink as hot as possible.

Not to be given to children under the age of 16 except on medical advice.
Do not exceed 3 doses every 24 hours.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Aspirin: Dizziness, irritation of the gastric mucosa and resultant dyspepsia (heartburn), haematemesis (vomiting of blood) and melaena (blood in stools) may occur in some cases. Some persons, especially asthmatics, exhibit notable sensitivity to aspirin which may provoke various hypersensitivity (abnormal or allergic) reactions which may include skin eruptions paroxysmal bronchospasm and dyspnoea (difficulty in breathing). It should be administered with caution to patients with impaired renal (kidney) function, dyspepsia (heartburn), anaemia (decreased number of red blood cells) and when the patient is dehydrated. 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 (affecting the stomach and intestines) haemorrhage, peptic ulceration and renal (kidney) papillary necrosis (death of tissues)

Caffeine: Includes nausea (queasiness), palpitations, diuresis (increased urine secretion), headache, insomnia, increased gastric (stomach) secretions and may cause gastric ulceration.

Menthol: May give rise to sensitivity (allergic) reactions.

SPECIAL PRECAUTIONS:
This product must be used with caution by patients where a tendency to hyperacidity (heartburn) exists or where there is a history of peptic (stomach or duodenum) ulceration.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Aspirin: These include dizziness, deafness, tinnitus (ringing in the ears), sweating, nausea, vomiting, headache, mental confusion, hyperventilation, fever, restlessness, respiratory alkalosis, metabolic acidosis, ketosis (elevated concentration of ketones in body fluids) and depression of the central nervous system, which may lead to coma, cardiovascular collapse and respiratory failure.

In children serious signs of overdosage may develop rapidly. Drowsiness and metabolic acidosis occur commonly. Hypoglycaemia may be severe.

Caffeine: Large doses may cause restlessness, excitement, anxiety neuroses, muscle tremor, tinnitus (ringing in the ears), scintillating scotoma (visual spot disturbances), tachycardia (increased rate of heart beat) and extrasystoles (abnormal heartbeats).

Vitamin C: Large doses may cause diarrhoea.

In cases of overdosage, consult a doctor immediately.
Treatment: Symptomatic and supportive.

IDENTIFICATION:
An off-white powder.

PRESENTATION:
8 sachets per carton and single dose sachets.

STORAGE INSTRUCTIONS:
Store in a cool (below 25°C) dry place.
Keep out of reach of children.

REGISTRATION NUMBER:
27/5.8/0241.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Group Laboratories S.A. (Pty) Ltd.
21 Wrench Road,
Isando, 1600.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
March 1993

809-1902-01        Rosside 28452
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