Paracetamol/ Caffeine/ Ephedrine/ Chlorphenamine

Registered South African indications:

• Symptomatic relief of colds and influenza

Registered South African contraindications

• Hypersensitivity to the active ingredient or to any of the excipients in this combination product
• Severe liver function impairment
• Severe kidney function impairment
• Cardiovascular disease
• Kidney disease
• Hypertension
• Hyperthyroidism
• Hyperexcitability
• Phaeochromocytoma
• Closed-angle glaucoma
• Prostatism
• Bladder dysfunction
• Patients being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment
• Epilepsy and all convulsive states
• During an attack of asthma

South African recommendations

• Pregnancy
• Breastfeeding
• Mild to moderate renal impairment
• Mild to moderate hepatic impairment

Elderly

• Elderly patients are most susceptible to the antimuscarinic effects of chlorpheniramine; sedation and hypotension

Excess doses

• Dosages in excess of those recommended may cause liver damage. Patient should not use continuously for more than 10 days without consulting a doctor
• If no relief is obtained with the recommended dosage, advise patient to consult a doctor

Drowsiness and impaired concentration

• This combination medicine may lead to drowsiness and impaired concentration, which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant agents

May affect the ability to drive and use machines

• Patients should be warned not to drive a motor vehicle, operate dangerous machinery or climb dangerous heights, as impaired decision making could lead to accidents

Caffeine

• Caution to patients with a history of peptic ulceration or hyperacidity

Caffeine intake

• Prolonged high intake of caffeine may lead to tolerance to some of the pharmacological actions and physical signs of withdrawal if intake is discontinued abruptly

Ephedrine

Caution to patients with:

• Organic heart disease
• Cardiac decompensation
• Angina of effort

Anaesthesia use

• Avoid during anaesthesia with cyclopropane, halothane or other halogenated anaesthetics

Patients with angina pectoris

• Anginal pain may be precipitated in patients with angina pectoris

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

South African registered indications and dosages

Symptomatic relief of colds and influenza
- Nasal congestion, and minor aches and pains

Paracetamol/ Caffeine/ Ephedrine/ Chlorphenamine
200/20/6/2 (mg)

• Oral (tab): 2 tab, 4hrly

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

South African registered indications and dosages

Symptomatic relief of colds and influenza
- Nasal congestion, and minor aches and pains

Paracetamol/ Caffeine/ Ephedrine/ Chlorphenamine
200/20/6/2 (mg)

• Younger than 8 years: Not recommended
• Between 8-12 years: 1 tab, 4hrly
• Older than 12 years: See adult dosage

Pregnancy

South African recommendations

• Caution
• Safety in pregnancy has not been established

Breastfeeding

South African recommendations

• Caution
• Safety in lactation has not been established

Fertility

South African recommendations

• No information available

South African recommendations

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

South African recommendations

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

Endocrine and Metabolic Disorders

• Pancreatitis

Skin and Subcutaneous Tissue Disorders

• Skin rashes

Immune, Blood and Lymphatic System Disorders

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

Caffeine

• Adverse effects of caffeine commonly affect the gastrointestinal tract and central nervous system

Ephedrine

Central Nervous System Disorders

• Fear
• Anxiety
• Restlessness
• Insomnia
• Tremor
• Confusion
• Irritability
• Psychotic states
• Headache (common)

Respiratory Disorders

• Dyspnoea

Gastrointestinal Disorders

• Reduced appetite
• Nausea and vomiting

Genitourinary Disorders

• Difficulty in micturition
• Urinary retention

Endocrine and Metabolic Disorders

• Altered metabolism including disturbances of glucose metabolism, sweating, and hypersalivation

Others

• Weakness

Chlorphenamine

Central Nervous System Disorders

• Sedation, varying from slight drowsiness to deep sleep
• Inability to concentrate
• Lassitude
• Inco-ordination
• Paradoxical CNS stimulation may occur especially in children
• Insomnia
• Nervousness
• Euphoria
• Irritability
• Tremors
• Nightmares (rarely)
• Hallucinations
• Convulsions
• Extrapyramidal symptoms
• CNS stimulation (high doses)

Cardiovascular Disorders

• Transient bradycardia followed by tachycardia with palpitations and arrhythmias (high doses)

Respiratory Disorders

• Thickened respiratory secretions
• Tightness of the chest

Gastrointestinal Disorders

• Reduction in tone and motility of the gastrointestinal tract resulting in constipation and increased gastric reflux
• Dry mouth
• Nausea and vomiting
• Diarrhoea
• Epigastric pain

Genitourinary Disorders

• Urinary difficulty and retention

Sensory Disorders

• Blurred vision

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

Paracetamol/ Caffeine/ Ephedrine/ Chlorphenamine

• Cardiac glycosides
• Quinidine
• Tricyclic antidepressants

Ephedrine

• Cyclopropane
• Halothane or other halogenated anaesthetics

Chlorphenamine

• Central nervous system depressants
• Alcohol
• Barbiturates
• Hypnotics
• Opioid analgesics
• Anxiolytic sedatives
• Neuroleptics
• Monoamine oxidase inhibitors 
• Antimuscarinic medicines
• Atropine
• Tricyclic antidepressants

None routine. Specific cases may require

• Hepatic function
• Renal function

Paracetamol/ caffeine/ ephedrine/ chlorphenamine has analgesic, antipyretic, sympathomimetic and antihistaminic properties.

COMBINATION PREPARATIONS

Paracetamol/ Caffeine/ Ephedrine/ Chlorpheniramine

Tablet 200mg/20mg/6mg/2mg

• Colcleer (Adcock)
• Flusin (Pharmacare)
• Sinucon (Ascendis)
• Sinuend (Alliance Pharma) originator