THE RANGE
MED-LEMON HOT MEDICATION WITH VITAMIN C (Powder)
Scheduling status: S0
PHARMACOLOGICAL CLASSIFICATION:
A 5.8 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.
CONTAINS ASPIRIN
Each sachet contains:
Aspirin 800 mg
Caffeine 50 mg
Ascorbic Acid 45 mg
Menthol 2,6 mg
Sucrose 4254,63 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 active or a history of recurrent ulcer/haemorrhage/perforations, haemophilia, severe kidney damage, by patients who are allergic to aspirin or by patients with heart failure.
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 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 WITH VITAMIN C, treatment with MED-LEMON HOT MEDICATION WITH VITAMIN C should be stopped.
- MED-LEMON HOT MEDICATION 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 WITH VITAMIN C should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
- 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 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 WITH VITAMIN C, treatment with MED-LEMON HOT MEDICATION WITH VITAMIN C should be stopped.
- MED-LEMON HOT MEDICATION 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 WITH VITAMIN C should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
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 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 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:
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.
Skin reactions: Bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.
Dizziness 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 anticoagulants and oral antidiabetic preparations and sulphonamides. 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. Prolonged use of high doses may lead to anaemia (decreased number of red blood cells), blood dyscrasias (serious blood disorders), gastrointestinal (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 heartbeat) 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, 18 sachets per carton and 72 sachets per dispenser pack.
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:
GlaxoSmithKline South Africa (Pty) Limited
39 Hawkins Avenue
Epping Industry 1
Cape Town
7460
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
March 1993
- 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 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 WITH VITAMIN C, treatment with MED-LEMON HOT MEDICATION WITH VITAMIN C should be stopped.
- MED-LEMON HOT MEDICATION 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 WITH VITAMIN C should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
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 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 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:
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.
Skin reactions: Bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.
Dizziness 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 anticoagulants and oral antidiabetic preparations and sulphonamides. 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. Prolonged use of high doses may lead to anaemia (decreased number of red blood cells), blood dyscrasias (serious blood disorders), gastrointestinal (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 heartbeat) 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, 18 sachets per carton and 72 sachets per dispenser pack.
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:
GlaxoSmithKline South Africa (Pty) Limited
39 Hawkins Avenue
Epping Industry 1
Cape Town
7460
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
March 1993
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 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 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:
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.
Skin reactions: Bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.
Dizziness 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 anticoagulants and oral antidiabetic preparations and sulphonamides. 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. Prolonged use of high doses may lead to anaemia (decreased number of red blood cells), blood dyscrasias (serious blood disorders), gastrointestinal (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 heartbeat) 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, 18 sachets per carton and 72 sachets per dispenser pack.
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:
GlaxoSmithKline South Africa (Pty) Limited
39 Hawkins Avenue
Epping Industry 1
Cape Town
7460
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
March 1993
