Paracetamol/ Ascorbic Acid/ Pseudoephedrine/ Chlorphenamine

Registered South African indications:

• Symptomatic relief of colds and flu

Paracetamol/ ascorbic acid/ pseudoephedrine/ chlorphenamine effervescent tablets contain paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or poison centre must be contacted immediately

Registered South African contraindications

• Hypersensitivity to the active ingredients or any of the excipients in this combination product
• Coronary disease and cardiovascular disease such as ischaemic heart disease, dysrhythmia, or tachycardia
• Children under the age of 12 years old
• Patients sensitive to one antihistamine may be sensitive to others
• Patients receiving monoamine oxidase inhibitor treatment, or within 14 days of stopping such treatment
• Severe liver function impairment
• Patients undergoing anaesthesia with halothane or other halogenated anaesthetics as they may induce ventricular fibrillation
• Pregnancy
• Lactation

South African recommendations

• Renal impairment
• Mild to moderate hepatic impairment
• Elderly

Contains aspartame

• Aspartame should be avoided or its intake restricted in patients with phenylketonuria

Effects on ability to drive and use machines

• May lead to drowsiness and impaired concentration that may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be advised, particularly at the initiation of therapy, against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration could lead to accidents

Chlorphenamine maleate

Caution in patients with:

• Prostatic hypertrophy
• Narrow-angle glaucoma
• Emphysema or chronic bronchitis
• Porphyria
• Pyloroduodenal obstruction
• Epilepsy
• Severe cardiovascular disorders

Drowsiness and impaired concentration

• This combination medicine may lead to drowsiness and impaired concentration that may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants. May enhance the sedative effects of CNS depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives and antipsychotics

Taking charge of vehicles or machinery

• Patients should be advised, particularly at the initiation of therapy, against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration could lead to accidents

Children and the elderly

• Paradoxical hyperexcitability, nervousness and insomnia may occur in children and in the elderly
• Elderly patients are especially susceptible to dizziness, sedation, confusion, hypotension and anticholinergic effects such as dry mouth and urinary retention

Skin test results

• Chlorphenamine may suppress positive skin test results and should be stopped several days before the test

Pseudoephedrine hydrochloride

Caution in patients with:

• Hypertension
• Hyperthyroidism
• Diabetes mellitus
• Closed-angle glaucoma
• Prostatic hypertrophy
• Phaeochromocytoma
• Occlusive vascular disease including arteriosclerosis, aneurysms

Tachyphylaxis

• After 5-7 days tachyphylaxis may occur and the product loses effect. If symptoms do not improve, or are accompanied by a fever, consult a doctor. Exceeding the recommended dosage may result in nervousness, dizziness, sleeplessness, tremulousness or cardiac dysrhythmia. This may also occur in sensitive individuals at small doses

Anginal patients

• Anginal pains may be precipitated in patients with angina pectoris

Paracetamol

Persistent fever and pain

• The combination effervescent tablets should be stopped if fever persists or pain worsens

Excess doses

• Dosages in excess of those recommended may cause severe liver damage

Hepatitis and alcoholism

• Patients suffering from hepatitis or alcoholism, or recovering from any form of liver disease, should not take paracetamol

Renal disease

• Use with caution in renal disease

Ascorbic Acid

G6PD deficiency

• Large doses of vitamin C have resulted in haemolysis in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency

Renal and urinary disorders

• Associated with the formation of renal calcium oxalate calculi. Ascorbic acid should be given with care to patients with hyperoxaluria

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

South African registered indications and dosages

Symptomatic relief of colds and flu
- Minor aches and pains
- Sinus and nasal congestion

Paracetamol/ Ascorbic acid/ Pseudoephedrine/ Chlorphenamine
500/330/50/4 (mg)

• Oral (eft): 1 tab, 6hrly as needed

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Effervescent tablet should be placed in a glass of warm water and allowed to dissolve. Contents should be consumed immediately once the whole tablet has dissolved

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Patients should be advised to consult a doctor if no relief is obtained from the recommended dosage. Paracetamol/ ascorbic acid/ pseudoephedrine/ chlorphenamine should not be used for more than 7 days without consulting a doctor

Paed. forms avail. in SA and covered in this monograph: eft

South African registered indications and dosages

Symptomatic relief of colds and flu
- Minor aches and pains
- Sinus and nasal congestion

Paracetamol/ Ascorbic acid/ Pseudoephedrine/ Chlorphenamine
500/330/50/4 (mg)

• Younger than 12 years: Contraindicated
• Older than 12 years: See adult dosage

Pregnancy

South African recommendations

• Contraindicated
• Safety in pregnancy has not been established

Breastfeeding

South African recommendations

• Contraindicated
• Safety in lactation has not been established

Fertility

South African recommendations

• No information available

South African recommendations

• Caution; no dose adjustment recommended

South African recommendations

• Mild to moderate: Caution; not recommended
  Patients suffering from hepatitis or alcoholism, or recovering from any form of liver disease, should not take paracetamol
• Severe: Contraindicated

South African recommendations

• Caution; no dose adjustment recommended

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

Paracetamol

Blood and the Lymphatic System Disorders

• Agranulocytosis (Less frequent)
• Thrombocytopenia (Less frequent)
• Neutropenia (Less frequent)
• Pancytopenia (Less frequent)
• Leukopenia (Less frequent)
• Anaemia (Less frequent)

Hepatobiliary Disorders

• Hepatitis (Less frequent)
• Pancreatitis (Frequency unknown)

Skin and Subcutaneous Tissue Disorders

• Skin rashes and allergic reactions (Less frequent)
• Erythematous or urticarial rash (Less frequent)
• More serious rash accompanied by fever and mucosal lesions (Less frequent)
• Dermatitis (Frequency unknown)

Renal and Urinary Disorders

• Renal colic (Frequency unknown)
• Renal failure (Frequency unknown)
• Sterile pyuria (Frequency unknown)

Ascorbic Acid

Blood and the Lymphatic System Disorders

• Haemolysis in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency (Frequency unknown)

Gastrointestinal Disorders

• Diarrhoea and other gastrointestinal disturbances from large doses (Less frequent)

Renal and Urinary Disorders

• Formation of renal calcium oxalate calculi; care advised in patients with hyperoxaluria. Tolerance may develop with prolonged use of large doses (Frequency unknown)

Pseudoephedrine hydrochloride

Metabolism and Nutrition Disorders

• Altered metabolism, including disturbances of glucose metabolism (Frequency unknown)

Psychiatric Disorders

• Anxiety (Frequent)
• Restlessness (Frequent)
• Insomnia (Frequent)
• Tremor (Less frequent)
• Weakness (Less frequent)
• Psychotic states (Less frequent)
• Fear (Frequency unknown)
• Confusion (Frequency unknown)
• Irritability (Frequency unknown)

Nervous System Disorders

• Headache (Less frequent)

Cardiac Disorders

• Hypotension with dizziness and fainting, and flushing (Less frequent)
• Tachycardia and cardiac dysrhythmias (Less frequent)
• Palpitations (Less frequent)
• Cardiac arrest (Less frequent)
• Reflex bradycardia (Less frequent)
• Vasoconstriction with resultant hypertension (Frequency unknown)
• Cerebral haemorrhage (Frequency unknown)
• Pulmonary oedema (Frequency unknown)

Respiratory, Thoracic and Mediastinal Disorders

• Dyspnoea (Less frequent)

Gastrointestinal Disorders

• Nausea and vomiting (Less frequent)
• Appetite may be reduced (Frequency unknown)

Skin and Subcutaneous Tissue Disorders

• Sweating (Less frequent)
• Hypersalivation (Frequency unknown)

Renal and Urinary Disorders

• Difficulty in micturition (Less frequent)
• Urinary retention (Less frequent)

Chlorphenamine maleate

Blood and Lymphatic System Disorders

• Blood dyscrasias (Less frequent)
• Agranulocytosis (Less frequent)
• Leukopenia (Less frequent)
• Haemolytic anaemia (Less frequent)
• Thrombocytopenia (Less frequent)

Psychiatric Disorders

• Depression (Frequency unknown)

Nervous System Disorders

• Sedation (Less frequent)
• Drowsiness (Less frequent)
• Dizziness (Less frequent)
• Fatigue (Less frequent)
• Tremors (Less frequent)
• Incoordination (Less frequent)
• Confusion (Frequency unknown)
• Hallucinations (Frequency unknown)
• Convulsions (Frequency unknown)
• Headache (Frequency unknown)
• Tinnitus (Frequency unknown)
• Lassitude (Frequency unknown)
• Nervousness (Frequency unknown)
• Insomnia (Frequency unknown)
• Paraesthesias (Frequency unknown)
• Ataxia (Frequency unknown)
• Blurred vision (Frequency unknown)

Cardiac Disorders

• Palpitation (Less frequent)
• Dysrhythmias (Less frequent)
• Tachycardia (Less frequent)
• Hypertension (Frequency unknown)
• Hypotension (Frequency unknown)
• Headache (Frequency unknown)
• Tightness of the chest (Frequency unknown)
• Tingling (Frequency unknown)
• Heaviness (Frequency unknown)
• Weakness of the hands (Frequency unknown)

Respiratory, Thoracic, and Mediastinal Disorders

• Thickening of mucous (Less frequent)
• Dryness of the respiratory passages (Frequency unknown)

Gastrointestinal Disorders

• Loss of appetite (Less frequent)
• Reduction in tone and motility of the gastrointestinal tract resulting in constipation (Less frequent)
• Nausea and vomiting (Frequency unknown)
• Epigastric pain (Frequency unknown)
• Gastric reflux (Frequency unknown)
• Diarrhoea (Frequency unknown)
• Dryness of the mouth and throat (Frequency unknown)

Skin and Subcutaneous Tissue Disorders

• May cause rashes and hypersensitivity reactions including bronchospasm, angioedema, and anaphylaxis (Less frequent)
• Photosensitivity and skin rash (Frequency unknown)
• Allergic dermatitis (Frequency unknown)
• Drug fever (Frequency unknown)
• Hair loss (Frequency unknown)
• Sweating (Frequency unknown)

Musculoskeletal Disorders

• Extrapyramidal effects with muscle spasms and dystonia (Frequency unknown)
• Myalgia (Frequency unknown)

Renal and Urinary Disorders

• Urinary retention  (Less frequent)
• Dysuria (Less frequent)
• Urinary frequency (Frequency unknown)

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

Paracetamol/ ascorbic acid/ pseudoephedrine/ chlorphenamine

• Monoamine oxidase inhibitors
• Other central nervous system depressants
• Sedatives
• Tranquillizers
• Alcohol

Paracetamol

• Hepatotoxic medicines
• Isoniazid
• Medicines that induce liver microsomal enzymes
• Metoclopramide
• Probenecid
• Colestyramine

Ascorbic Acid

• Desferrioxamine
• Hormonal contraceptives
• Fluphenazine
• Warfarin

Pseudoephedrine

• Antihypertensive agents
• Monoamine oxidase inhibitors
• Halothane or other halogenated anaesthetics
• Alpha blockers
• Beta blockers
• Cardiac glycosides
• Quinidine
• Tricyclic antidepressants
• Guanethidine
• Reserpine
• Alpha-methyldopa
• Digoxin
• Aluminium hydroxide

Chlorphenamine maleate

• Phenytoin
• Belladonna
• All sedatives
• Alcohol
• Medications tending to cause extrapyramidal reactions
• Anticholinergic agents
• Tricyclic antidepressants
• Maprotiline
• Monoamine oxidase inhibitors

None routine

Paracetamol
Paracetamol has analgesic and antipyretic effects.

Ascorbic Acid
A vitamin supplement.

Pseudoephedrine hydrochloride
Pseudoephedrine is a sympathomimetic vasoconstrictor with properties that can produce tachycardia, increased blood pressure, and CNS stimulation.

Chlorphenamine maleate
Chlorphenamine maleate is a reversible H1 receptor antagonist which inhibits the interaction of histamine with H1 receptors. H1 antagonists inhibit most of the effects of histamine on smooth muscles, especially the constriction of respiratory smooth muscle. H1 antagonists suppress histamine-evoked salivary lacrimal and other exocrine secretions.

COMBINATION PREPARATIONS

Paracetamol/ Ascorbic acid/ Pseudoephrine/ Chlorpheniramine

Tablet effervescent 500mg/330mg/50mg/4mg

• Flusin S (Pharmacare)
• Flutex effervescent (Pharmacare)