Aspirin/ Caffeine/ Ascorbic Acid/ Menthol

Registered South African indications:

• Symptomatic treatment of aches, pains and fever associated with the common cold and influenza

Contraindications

• Hypersensitivity to aspirin, other salicylates, caffeine, ascorbic acid or any of the excipients
• A history of hypersensitivity reactions in response to aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) such as asthma, bronchospasm, rhinitis, urticaria, nasal polyps
• A history of haemophilia, hypothrombinaemia or other clotting disorders
• Pregnancy
• Lactation
• Severe renal failure
• Severe hepatic failure
• A history of gout
• Coadministration with anticoagulants
• History of gastrointestinal perforation, ulceration or bleeding (PUBs) related to previous NSAIDs
• Active or a history of recurrent ulcer/ haemorrhage/ perforations
• Patients allergic to aspirin
• Patients with heart failure

Cautions

• Mild to moderate renal impairment
• Mild to moderate hepatic impairment
• Elderly
• Patients where a tendency to hyperacidity exists
• Continuous use for more than 10 days without consulting a doctor
• Excessive and prolonged use
• Risk of Reye’s syndrome in children and teenagers with chickenpox and influenza
• History of gastrointestinal disease (e.g. ulcerative colitis, Crohn’s disease, hiatus hernia, gastro-oesophageal reflux disease, angiodysplasia)
• Those at risk of hypersensitivity reactions, including skin eruptions, angioedema, rhinitis, and bronchospasm
• Hypertension
• History of hypertension and/or heart failure
• Dyspepsia
• Anaemia
• Dehydration
• Prolonged use of high doses
• Juvenile arthritis
• Other connective tissue disorders
• Repeated administration of large doses
• Excessive intake of caffeine while taking the medication
• Prolonged high intake of caffeine
• May have minor/moderate influence on the ability to drive and use machines

Forms avail. in SA and covered in this monograph: pdr

Dosages below include:

• South African registered indications and dosages

South African registered indications and dosages

Symptomatic treatment of aches, pains and fever associated with the common cold and influenza

Aspirin/ Caffeine/ Ascorbic Acid/ Menthol
800/50/45/9.5 (mg)
800/50/10/2.6 (mg)
800/50/45/2.6 (mg)

• Oral (pdr): 1 sachet, 8-12hrly; Max: 3 sachets/24hrs

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Empty contents of sachet into half a tumbler of hot water (add cold water if necessary); Stir and drink as hot as possible

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Use the lowest effective dose for the shortest possible duration of treatment

Not established for use in children below 16 years

Pregnancy

• Contraindicated
• Safety in pregnancy has not been established and should therefore not be taken during pregnancy
• The use of aspirin during pregnancy has been associated with persistent pulmonary hypertension in the newborn

Breastfeeding

• Contraindicated
• Safety in lactation has not been established and should therefore not be taken during lactation

Renal Impairment

• Mild to moderate: Caution; no dose adjustment recommended
• Severe: Contraindicated

Hepatic Impairment

• Mild to moderate: Caution; no dose adjustment recommended
• Severe: Contraindicated

Elderly

• Caution; no dose adjustment recommended 
  Use with particular caution in elderly patients who are more prone to adverse events

Porphyria Information

• Probably not porphyrinogenic (PNP) (Caffeine)

Drugs in Sport

• Permitted - No warnings

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Aspirin
Central Nervous System Disorders

• Intracranial haemorrhage
• Headache
• Vertigo

Cardiovascular Disorders

• Hypertension
• Cardiac failure
• Hemorrhagic vasculitis

Respiratory Disorders

• Rhinitis
• Dyspnoea
• Bronchospasm
• Asthma attacks

Gastrointestinal Disorders

• Dyspepsia
• Severe gastrointestinal haemorrhage
• Nausea
• Vomiting
• Gastric or duodenal ulcers and perforation
• Diarrhoea

Hepatobiliary Disorders

• Hepatic insufficiency

Genitourinary Disorders

• Menorrhagia
• Impaired renal function
• Salt and water retention

Endocrine and Metabolic Disorders

• Hyperuricemia

Skin and Subcutaneous Tissue Disorders

• Urticaria
• Steven-Johnsons syndrome
• Lyells syndrome
• Purpura
• Erythema nodosum
• Erythema multiforme

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
• Angio-oedema
• Allergic oedema
• Anaphylactic reactions
• Thrombocytopenia
• Granulocytosis
• Aplastic anaemia
• Epistaxis
• Gingival bleeding
• Iron deficiency anaemia

Sensory Disorders

• Reduced hearing ability
• Tinnitus

Caffeine
Central Nervous System Disorders

• Agitation
• Delirium
• Dizziness
• Hallucination
• Headache
• Insomnia
• Irritability
• Psychosis
• Restlessness

Cardiovascular Disorders

• Angina
• Chest pain
• Flushing
• Palpitations
• Sinus tachycardia
• Supraventricular tachycardia
• Vasodilation
• Ventricular arrhythmia

Gastrointestinal Disorders

• Oesophageal motility disorder
• Gastritis

Genitourinary Disorders

• Diuresis

Musculoskeletal Disorders

• Fasciculations

Skin and Subcutaneous Tissue Disorders

• Urticaria

Sensory Disorders

• Increased intraocular pressure
• Miosis

Ascorbic Acid
Central Nervous System Disorders

• Dizziness
• Fatigue
• Headache

Cardiovascular Disorders

• Flushing

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting
• Flank pain
• Heartburn

Endocrine and Metabolic Disorders

• Hyperoxaluria

• Nonsteroidal anti-inflammatory drugs (NSAIDs)
• Corticosteroids
• Anticoagulants
• Warfarin
• Anti-platelet agents
• Selective serotonin reuptake inhibitors (SSRIs)
• Ibuprofen
• Alcohol
• Angiotensin-converting enzyme inhibitors (ACE inhibitors)
• Antacids
• Anticonvulsants
• Phenytoin
• Valproate
• Beta blockers
• Carbonic anhydrase inhibitors
• Acetazolamide
• Diuretics
• Oral hypoglycaemic agents (sulphonylurea type)
• Methotrexate
• Uricosuric agents
• Probenecid
• Sulfinpyrazone
• Sulphonamides
• Barbiturates and other sedatives

None routine

Aspirin
Acetylsalicylic acid inhibits the cyclooxygenase enzyme, thereby preventing production of prostaglandins and thromboxanes.

Caffeine
Caffeine is a nonspecific adenosine receptor antagonist and acts as a central nervous system stimulant.

Ascorbic Acid
Ascorbic acid, a water-soluble vitamin, is essential for formation of collagen and intercellular material, and therefore necessary for the development of cartilage, bone, teeth and for the healing of wounds. It is also essential for the conversion from folic acid to folinic acid, facilitates iron absorption from the gastro-intestinal tract, influences haemoglobin formation and erythrocyte maturation and assists in providing resistance to infections.

Menthol
This ingredient has no pharmacological effect.

Aspirin/ Caffeine/ Ascorbic Acid/ Menthol is available in several formulations. Please note the list below gives examples of products which are available and is not necessarily comprehensive. The listing of a product does not constitute endorsement of the product by EMGuidance; likewise, failure to list a product does not imply that EMGuidance disapproves of the product. This information is put together on the basis of the National Government's Medicines Price Registry at the time of publication

COMBINATION PREPARATIONS

Aspirin/ Caffeine/ Ascorbic Acid/ Menthol

Powder 800mg/50mg/45mg/2.6mg

• Med-lemon hot medication original (GSK) originator

Powder 800mg/50mg/10mg/2.6mg

• Med-lemon hot medication cherry menthol with vitamin C (GSK) originator

Powder 800mg/50mg/45mg/9.5mg

• Med-lemon hot medication lemon menthol with vitamin C (GSK) originator