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

Logo MED-LEMON®HOT MEDICATION-LEMON MENTHOL
SCHEDULING STATUS:
Not scheduled.

PROPRIETARY NAME:
(and dosage form)        (Powder)

MED-LEMON®HOT MEDICATION-LEMON MENTHOL

COMPOSITION:
Each sachet contains:
        Aspirin        800 mg
        Caffeine        50 mg
        Ascorbic Acid        10 mg
        Menthol        9,6 mg

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

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

INDICATIONS:
Med-Lemon Hot Medication is recommended for the symptomatic treatment of pain and fever 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 ulcers, haemophilia, severe kidney damage or by patients who are allergic to aspirin.

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 half full tumbler of hot water. Stir. 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, haematemesis and melaena may occur in some cases. Some persons, especially asthmatics, exhibit notable sensitivity to aspirin which may provoke various hypersensitivity reactions which may include skin eruptions, paroxysmal bronchospasm and dyspnoea. It should be administered with caution to patients with impaired renal function, dyspepsia, anaemia 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, blood dyscrasias, gastro-intestinal haemorrhage, peptic ulceration and renal papillary necrosis.

Caffeine: Includes nausea, palpitations, diuresis, headache, insomnia, increased gastric secretions and may cause gastric ulceration.

Menthol: May give rise to hypersensitivity reactions.

SPECIAL PRECAUTIONS:
1.        The use of this medicine during the first and third trimester of pregnancy is not advised.
2.        This product must be used with caution by patients where a tendency to hyperacidity exists or where there is a history of peptic ulceration.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Aspirin: These include dizziness, tinnitus, sweating, nausea, vomiting, mental confusion, hyperventilation, respiratory alkalosis, metabolic acidosis, ketosis and depression of the central nervous system.
In children serious signs of overdosage may develop rapidly.

Caffeine: Large doses may cause restlessness, excitement, anxiety neuroses, muscle tremor, tinnitus, scintillating scotoma, tachycardia and extrasystoles.

Vitamin C: Large doses may cause diarrhoea and other gastro-intestinal disturbances.

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

IDENTIFICATION:
A light green 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:
Y/5.8/203

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:
May 1991
        Rosside 28451
        809-1904-01

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