THE RANGE
MED-LEMON HOT MEDICATION - LEMON MENTHOL WITH VITAMIN C
Scheduling status: S0
PROPRIETARY NAME (and dosage form):
MED-LEMON HOT MEDICATION - LEMON MENTHOL WITH VITAMIN C (Powder)
PHARMACOLOGICAL CLASSIFICATION:
A 5.8 Preparations for the common cold, including nasal decongestants and antihistaminics.
PHARMACOLOGICAL ACTION:
MED-LEMON HOT MEDICATION - LEMON MENTHOL WITH VITAMIN C has analgesic and antipyretic properties.
INDICATIONS:
MED-LEMON HOT MEDICATION - LEMON MENTHOL WITH VITAMIN C is recommended for the symptomatic treatment of pain and fever associated with the common cold and influenza.
CONTRA-INDICATIONS:
Hypersensitivity to the ingredients.
CONTAINS ASPIRIN
Each sachet contains:
Aspirin 800 mg
Caffeine 50 mg
Ascorbic Acid 45 mg
Menthol 9,5 mg
Sucrose 4329,7 mg
Should not be taken by patients taking anticoagulants, by patients with a history of gastrointestinal bleeding or perforation (PUBs) related to previous NSAIDs, by patients with liver damage, with active or a history of recurrent ulcer/haemorrhage/perforations, gout, haemophilia, severe kidney damage, by patients who are allergic to aspirin, by patients with heart failure. or children under 12 years of age.
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.
- Caution is required in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with aspirin therapy.
- Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation (PUBs) which may be fatal.
- The risk of gastrointestinal bleeding or perforation (PUBs) is higher with increasing doses of MED-LEMON HOT MEDICATION - LEMON MENTHOL WITH VITAMIN C, in patients with a history of ulcers, and the elderly.
- When gastrointestinal bleeding or ulceration occurs in patients receiving MED-LEMON HOT MEDICATION - LEMON MENTHOL WITH VITAMIN C, treatment with MED-LEMON HOT MEDICATION - LEMON MENTHOL WITH VITAMIN C should be stopped
- MED-LEMON HOT MEDICATION - LEMON MENTHOL WITH VITAMIN C should be given with caution to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohn’s disease, hiatus hernia, gastro-oesophageal reflux disease, angiodysplasia) as the condition may be exacerbated.
- Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported. MED-LEMON HOT MEDICATION - LEMON MENTHOL WITH VITAMIN C should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
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.
INTERACTIONS:
NSAIDs: Use of two or more NSAIDs concomitantly could result in an increase in side effects.
Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (PUBs).
Anticoagulants: MED-LEMON HOT MEDICATION - LEMON MENTHOL WITH VITAMIN C may enhance the effects of anticoagulants such as warfarin.
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.
DOSAGE AND DIRECTIONS FOR USE:
Use the lowest effective dose for the shortest possible duration of treatment.
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 years except on medical advice.
Do not exceed 3 doses every 24 hours.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Aspirin:
Cardiovascular: Oedema, hypertension, cardiac failure.
Gastrointestinal: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease, gastritis. Slight blood loss may occur in about 70% of patients. Slight blood loss is not usually significant but may, in a few patients, cause iron-deficiency anaemia during long term therapy.
Skin reactions: Bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.
Some persons especially those with asthma, chronic urticaria, or chronic rhinitis, exhibit notable sensitivity to aspirin which may provoke various reactions including urticaria and other skin eruptions, angioedema, rhinitis and severe even fatal paroxysmal bronchospasm and dyspnoea.
Aspirin increases the bleeding time, decreases platelet adhesiveness, and in large doses, may cause hypoprothrombinaemia. Aspirin may cause hepatotoxicity, particularly in patients with juvenile arthritis or other connective tissue disorders. In children the use of aspirin has been implicated in some cases of Reye's syndrome. 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 anticoagulants, oral antidiabetic preparations, methotrexate, phenytoin and valproic acid. Aspirin diminishes the effects of antigout 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.
Mild chronic salicylate intoxication, or salicylism, usually occurs only after repeated administration of large doses. Symptoms include dizziness, tinnitus, deafness, sweating, nausea and vomiting, headache, and mental confusion, and may be controlled by reducing the dosage.
Caffeine:
Gastrointestinal irritation and bleeding, stimulation of the central nervous system, nausea, vomiting, abdominal pain, diarrhoea, insomnia, headache, anxiety, restlessness, dizziness and palpitations. Prolonged high intake of caffeine may lead to tolerance of some of the pharmacological actions and physical signs of withdrawal if intake is discontinued abruptly.
Menthol:
May give rise to hypersensitivity reactions.
Special Precautions:
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 (ascorbic acid):
Large doses may cause diarrhoea and other gastrointestinal disturbances.
In cases of overdosage, consult a doctor immediately.
Treatment:
Symptomatic and supportive.
IDENTIFICATION:
Light green powder with strong sweet odour with lemon and menthol background. Cloudy green solution with a strong lemon/menthol odour when reconstituted.
PRESENTATION:
8 sachets per carton and 72 sachets per dispenser.
STORAGE INSTRUCTIONS:
Store in a cool (below 25 °C) dry place.
Keep out of reach of children.
REGISTRATION NUMBER:
29/5.8/0427
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
GlaxoSmithKline South Africa (Pty) Ltd
39 Hawkins Avenue
Epping Industria 1
7420
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
February 1995
