Paracetamol/ Ascorbic Acid/ Phenylephrine

Registered South African indications:

• Relief of mild to moderate pain, fever, nasal sinus and eustachian tube mucal congestion associated with colds and influenza

In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or poison control centre must be contacted immediately.

Registered South African contraindications

• Hypersensitivity to active ingredient or to any of the excipients in this combination product
• Severe liver function impairment
• Patients receiving monoamine oxidase inhibitor treatment, or within 14 days of its termination
• Pregnancy
• Lactation
• Do not use in children under the age of 12 years

South African recommendations

• Renal impairment
• Mild to moderate hepatic impairment
• Elderly

Continuous use

• Do not use continuously for more than 10 days without doctor consultation

Excess doses

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

Caution in the following patient groups:

• Hyperthyroidism
• Cardiovascular disease such as ischaemic heart disease, arrhythmia or tachycardia
• Occlusive vascular disorders, including arteriosclerosis, hypertension or aneurysms
• Diabetes mellitus
• Closed-angle glaucoma
• Prostatic enlargement

Coadministration with other medicines

• This combination product should not be used without proper assessment in patients presently taking monoamine oxidase inhibitors or other medicines for depression, psychiatric or emotional conditions or hypertension
• Caution in patients undergoing anaesthesia with cyclopropane, halothane or other halogenated anaesthetics as they may induce ventricular fibrillation
• An increased risk of arrhythmias may occur if given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants

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

South African registered indications and dosages

Relief of mild to moderate pain, fever, nasal sinus and eustachian tube mucal congestion associated with colds and influenza

Paracetamol/ Ascorbic Acid/ Phenylephrine
650/250/10 (mg)

• Oral (eft): 1 tab, 3-4 times dly dissolved in a glass of water

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

South African registered indications and dosages

Relief of mild to moderate pain, fever, nasal sinus and eustachian tube mucal congestion associated with colds and influenza

Paracetamol/ Ascorbic acid/ Phenylephrine
650/250/10 (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
  Patients suffering from kidney disease should take paracetamol-containing preparations under medical supervision

South African recommendations

• Mild to moderate: Caution; no dose adjustment recommended
  Patients suffering from liver disease should take paracetamol-containing preparations under medical supervision
• Severe: Contraindicated

South African recommendations

• Caution; no information available

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

Paracetamol

Immune, Blood and Lymphatic System Disorders

Frequency not specified

• Haematological reactions
• Thrombocytopenia
• Leucopenia
• Pancytopenia
• Neutropenia
• Agranulocytosis

Gastrointestinal Disorders

Less frequent

• Pancreatitis

Skin and Subcutaneous Tissue Disorders

Less frequent

Skin rashes and other allergic reactions
- The rash is typically erythematous or urticarial
- In some cases, the rash can be more serious and accompanied by fever and mucosal lesions

Phenylephrine

Central Nervous System Disorders

Common

• Headache

Frequency not specified

• Fear
• Anxiety
• Restlessness
• Tremor
• Insomnia
• Confusion
• Irritability
• Weakness
• Psychotic states
• Reduced appetite

Cardiovascular System Disorders

Frequency not specified

• Vasoconstriction leading to hypertension
• Possible cerebral haemorrhage
• Pulmonary oedema
• Reflex bradycardia
• Stimulation of β1-adrenergic receptors may cause:
  • Tachycardia
  • Cardiac arrhythmias
  • Anginal pain
  • Palpitations
  • Cardiac arrest
• Hypotension with symptoms like dizziness, fainting, and flushing
• Anginal pain may be exacerbated in patients with pre-existing angina pectoris

Gastrointestinal Disorders

Frequency not specified

• Nausea and vomiting

• Hypersalivation

Respiratory Disorders

Frequency not specified

• Dyspnoea

Genitourinary Disorders

Frequency not specified

• Difficulty in micturition
• Urinary retention

Endocrine and Metabolic Disorders

Frequency not specified

• Altered metabolism, including disturbances in glucose metabolism

Skin and Subcutaneous Tissue Disorders

Frequency not specified

• Sweating

Others

Frequency not specified

• Weakness

Paracetamol/ Ascorbic Acid/ Phenylephrine

• Monoamine oxidase inhibitors
• Antihypertensive therapy
• Alpha-blocking agents
• Beta-blocking agents
• Guanethidine
• Reserpine
• Tricyclic antidepressants
• Cardiac glycosides
• Digoxin
• Quinidine
• Alpha-methyldopa
• Anaesthesia with cyclopropane
• Halothane or other halogenated anaesthetics

Phenylephrine

• Aluminium hydroxide

None routine. Specific cases may require

• Hepatic function
• Renal function

Paracetamol/ ascorbic acid/ phenylephrine has analgesic, antipyretic and decongestant actions.

COMBINATION PREPARATIONS

Paracetamol/ Ascorbic acid/ Phenylephrine

Tablet effervescent 650mg/250mg/10mg

• Corenza Para-C (Adcock)