Paracetamol/ Ascorbic Acid/ Chlorphenamine

Registered South African indications:

• Symptomatic relief of runny nose, sneezing, sore throat, headache and generalised aching due to colds and flu

Paracetamol/ ascorbic acid/ chlorphenamine contains paracetamol which may be fatal in overdosage. 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 ingredient or any of the excipients in this combination product
• Severe liver function impairment
• Coronary disease and cardiovascular disease such as ischaemic heart disease, dysrhythmia, or tachycardia
• Epilepsy
• Children under the age of 12 years
• Prior sensitivity to any antihistamine
• Patients receiving monoamine oxidase inhibitor treatment, or within 14 days of stopping such treatment
• 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

May impair ability to drive and operate machinery

• 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

Paracetamol

Excess doses

• Dosages in excess of those recommended may cause severe liver damage. Consult a medical practitioner if pain or fever persists or gets worse at the recommended dosage, if new symptoms occur or if redness and swelling is present, as these could be signs of a more serious condition
• Do not use this combination product continuously for more than 7 days without consulting your doctor

Liver disease

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

Renal disease

• Use with caution in renal disease

Contains the sugar alcohol, sorbitol

• Patients with rare hereditary problems of fructose intolerance should not take this medicine

Chlorphenamine maleate

Caution in patients with:

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

Children and 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

Drowsiness and impaired concentration

• 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

Skin test results

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

Sensitivity

• Patients sensitive to another antihistamine may be sensitive to this combination product

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

South African registered indications and dosages

Symptomatic relief of runny nose, sneezing, sore throat, headache and generalised aching due to colds and flu 

Paracetamol/ Ascorbic Acid/ Chlorphenamine
500/250/2 (mg)

• Oral (eft): 1 tab, 8hrly if needed; Treatment duration: Not more than 7 days without further consultation

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Dissolve one tablet in a glass of water and drink immediately once the whole tablet has dissolved

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Patient should seek medical advice if no relief is obtained from the recommended dosage

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Recommended doses should not be exceeded

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Missed dose: Patients should take a dose as soon as possible and then continue with the normal dose. Patients should not take a double dose to compensate for the missed dose

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

South African registered indications and dosages

Symptomatic relief of runny nose, sneezing, sore throat, headache and generalised aching due to colds and flu 

Paracetamol/ Ascorbic Acid/ Chlorphenamine
500/250/2 (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 during 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; no dose adjustment recommended
  Patients suffering from hepatitis or alcoholism, or recovering from any form of liver disease, should not take excessive quantities of paracetamol/ ascorbic acid/ chlorphenamine, as dosages in excess of those recommended may cause severe liver damage
• Severe: Contraindicated

South African recommendations

• Caution; no dose adjustment recommended
  Elderly patients are especially susceptible to dizziness, sedation, confusion, hypotension and anticholinergic effects such as dry mouth and urinary retention

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

Paracetamol

Blood and Lymphatic System Disorders

Less frequent

• Agranulocytosis
• Thrombocytopenia
• Leucopenia
• Pancytopenia
• Neutropenia
• Anaemia

Hepato-Biliary Disorders

Less frequent

• Hepatitis

Frequency unknown

• Pancreatitis

Skin and Subcutaneous Tissue Disorders

Less frequent

• Allergic dermatitis

Frequency unknown

• Dermatitis

Renal and Urinary Disorders

Less frequent

• Renal colic
• Renal failure
• Sterile pyuria

General Disorders and Administrative Site Conditions

Frequency unknown

• Dermatitis
• Skin rashes and other allergic reactions
• Rash types (erythematous or urticarial), which can be serious and accompanied by fever and mucosal lesions

Ascorbic Acid

Blood and Lymphatic System Disorders

Frequency unknown

• Haemolysis in patients with glucose-6-phosphate dehydrogenase deficiency due to large doses of ascorbic acid

Gastrointestinal Disorders

Less frequent

• Diarrhoea and other gastrointestinal disturbances from large doses

Renal and Urinary Disorders

Frequency unknown

• Hyperoxaluria and formation of renal calcium oxalate calculi from large doses
• Need for caution in patients with hyperoxaluria
• Tolerance development with prolonged use of large doses

Chlorphenamine maleate

Blood and Lymphatic System Disorders

Less frequent

• Blood dyscrasias
• Agranulocytosis
• Leukopenia
• Haemolytic anaemia
• Thrombocytopenia

Immune System Disorders

Less frequent

• Anaphylaxis (including tightness of the chest)
• Hypersensitivity reactions (including bronchospasm, angioedema)

Psychiatric Disorders

Frequency unknown

• Depression

Nervous System Disorders

Frequent

• Drowsiness

Less frequent

• Central nervous system reactions
  • Sedation
  • Seizures
  • Dizziness
  • Increased sweating
  • Abnormal coordination
  • Tremor
  • Lassitude
  • Euphoria
  • Nervousness
  • Insomnia
  • Headache

Frequency unknown

• Confusion
• Hallucinations
• Paraesthesias
• Ataxia

Eye Disorders

Less frequent

• Blurred vision
• Diplopia

Ear and Labyrinth Disorders

Less frequent

• Tinnitus

Cardiac Disorders

Less frequent

• Hypotension
• Palpitations
• Dysrhythmia
• Tachycardia

Frequency unknown

• Hypertension
• Tightness of the chest
• Tingling
• Heaviness and weakness of the hands

Respiratory, Thoracic, and Mediastinal Disorders

Less frequent

• Thickening of mucous

Frequency unknown

• Dryness of the respiratory passages

Gastrointestinal Disorders

Frequent

• Dryness of mouth, nose, or throat
• Gastrointestinal upset
• Loss of appetite
• Constipation
• Diarrhoea
• Nausea
• Vomiting

Frequency unknown

• Epigastric pain
• Gastric reflux

Hepato-Biliary Disorders

Less frequent

• Cholestasis
• Hepatitis
• Other hepatic function abnormalities

Skin and Subcutaneous Tissue Disorders

Less frequent

• Exfoliative dermatitis
• Rashes

Frequency unknown

• Photosensitivity and skin rash
• Allergic dermatitis
• Drug fever
• Hair loss
• Sweating

Musculoskeletal, Connective Tissue and Bone Disorders

Frequency unknown

• Extrapyramidal effects (including muscle spasms and dystonia)
• Myalgia

Renal and Urinary Disorders

Less frequent

• Difficult or painful urination (dysuria)

Frequency unknown

• Urinary frequency

General Disorders and Administrative Site Conditions

Less frequent

• Oedema
• Fatigue

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

Paracetamol/ Ascorbic Acid/ Chlorphenamine

• Central nervous system depressants
• Sedatives
• Tranquillizers

Paracetamol

• Hepatotoxic agents
• Enzyme inducing agents
• Metoclopramide
• Cholestyramine
• Salicylates
• Probenecid

Ascorbic acid

• Desferrioxamine
• Oral contraceptives
• Fluphenazine
• Warfarin

Chlorpheniramine

• Monoamine oxidase inhibitors
• Central nervous system depressants
• Barbiturates
• Hypnotics
• Opioid analgesics
• Anxiolytic sedatives
• Antipsychotics
• Belladonna
• Tricyclic antidepressants
• Maprotiline
• Guanethidine
• Reserpine
• Methyldopa
• Atropine

Other interactions

• Alcohol

None routine

Paracetamol/chlorphenamine maleate/ascorbic acid effervescent tablets have analgesic, antipyretic and antihistaminic properties.

Paracetamol
Paracetamol has analgesic and antipyretic effects.

Ascorbic acid
A vitamin supplement.

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/ Chlorpheniramine

Tablet effervescent 500mg/250mg/2mg

• Efferflu-C Cold & Flu (Pharma Dynamics)
• Paragrip C (Pharma Dynamics)