Paracetamol/ Caffeine/ Phenylephrine

Registered South African indications: 

• Symptomatic relief of sinus and nasal congestion, pain and fever 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 the active ingredient or any of the excipients in this combination product
• Severe liver function impairment
• Coronary disease
• Hypertension
• Cardiovascular disease
• Hyperthyroidism
• Epilepsy
• Patients being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment
• Pregnancy
• Phaeochromocytoma; avoid use of this combination product during cyclopropane, halothane anaesthesia, or any other halogenated anaesthetic

South African recommendations

• Breastfeeding
• Renal impairment
• Mild to moderate hepatic impairment
• Elderly

Excess doses

• Dosages in excess of those recommended may cause liver damage. If no relief is obtained from recommended dosage or continuously used for more than 10 days, the patient should be advised to consult a doctor

Renal or hepatic disease

• Patients suffering from liver or kidney disease should take paracetamol or caffeine under medical supervision

Continuous use

• Patients should not use continuously for more than 10 days without consulting a doctor

Paracetamol

Skin rashes

• Risk of skin rashes, allergic reaction with possible neutropenia, pancytopenia, leucopenia

Caffeine

Care in specific diseases

• Caution in patients with peptic ulceration, hyperthyroidism, hypertension, cardiac arrhythmias, or other cardiovascular diseases
• Use cautiously in alcoholics, patients with cor pulmonale, elderly, patients with acute febrile conditions, hypoxia, acute pulmonary oedema, lung diseases, or impaired respiratory function

Phenylephrine

Care in specific diseases

• Caution in hyperthyroidism, cardiovascular diseases (ischemic heart disease, arrhythmia, tachycardia, occlusive vascular disorders, arteriosclerosis, hypertension, aneurysms), diabetes mellitus, closed angle glaucoma
• Use carefully in elderly and debilitated patients
• May interfere with antihypertensive agents; avoid with cardiac glycosides, quinidine, tricyclic antidepressants

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

South African registered indications and dosages

Symptomatic relief of sinus and nasal congestion, pain and fever associated with colds and influenza

Paracetamol/ Caffeine/ Phenylephrine
300/25/5 (mg) 

• Oral (cap): 1-2 cap, 3 times dly; Max: 4 doses/24hrs (Should not exceed 8 capsules in any 24hr period)

---

Do not exceed the recommended dose

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

South African registered indications and dosages

Symptomatic relief of sinus and nasal congestion, pain and fever associated with colds and influenza

Paracetamol/ Caffeine/ Phenylephrine
300/25/5 (mg) 

• Younger than 12 years: Not established for use
• Older than 12 years: Oral (cap): 1 cap, 3 times dly

---

Do not exceed the recommended dose

Pregnancy

South African recommendations

• Contraindicated
• Safety in pregnancy has not been established

Breastfeeding

South African recommendations

• Caution; no information available

Fertility

South African recommendations

• No information available

South African recommendations

• Caution; no dose adjustment recommended
  Patients suffering from kidney disease should take paracetamol or caffeine under medical supervision

South African recommendations

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

South African recommendations

• Caution; no dose adjustment recommended
  Use carefully in elderly and debilitated patients

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

Paracetamol

Skin and Subcutaneous Tissue Disorders

Frequency unknown

• Skin rashes (usually erythematous or urticarial)
• Allergic reactions (sometimes serious and accompanied by fever and mucosal lesions)

Blood and Lymphatic System Disorders

Frequency unknown

• Neutropenia
• Pancytopenia
• Leucopenia

Caffeine

Gastrointestinal Disorders

Frequency unknown

• Gastrointestinal irritation
• Nausea and vomiting
• Abdominal pain
• Gastrointestinal bleeding

Nervous System Disorders

Frequency unknown

• Insomnia
• Headache
• Anxiety
• Restlessness
• Vertigo
• Central nervous system stimulation

Cardiac Disorders

Frequency unknown

• Hypotension
• Palpitations

Phenylephrine

Nervous System Disorders

Common

• Headache

Frequency unknown

• Dizziness
• Fainting
• Tremor

Gastrointestinal Disorders

Frequency unknown

• Nausea and vomiting

Metabolism and Nutrition Disorders

• Reduced appetite
• Disturbances of glucose metabolism

Cardiac Disorders

Frequency unknown

• Tachycardia
• Cardiac arrhythmias
• Anginal pain
• Palpitations
• Cardiac arrest
• Reflex bradycardia

Vascular Disorders

Frequency unknown

• Vasoconstriction (may result in hypertension, cerebral haemorrhage, pulmonary oedema)
• Flushing

Psychiatric Disorders

Frequency unknown

• Agitation
• Anxiety
• Confusion
• Fear
• Insomnia
• Irritability
• Psychotic states
• Restlessness

Eye Disorders

Frequency unknown

• Miosis

Renal and Urinary Disorders

Frequency unknown

• Difficulty in micturition
• Urinary retention

Respiratory, Thoracic and Mediastinal Disorders

Frequency unknown

• Dyspnoea
• Dry mouth

General Disorders and Administration Site Conditions

Frequency unknown

• Sweating
• Weakness

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

• Monoamine oxidase inhibitors
• Cyclopropane
• Halothane anaesthesia, or any other halogenated anaesthetic
• Antihypertensive agents
• Cardiac glycosides
• Quinidine
• Tricyclic antidepressant agents

None routine. Specific cases may require

• Hepatic function
• Renal function

Paracetamol/ caffeine/ phenylephrine has an analgesic, antipyretic and a nasal decongestant action.

COMBINATION PREPARATIONS

Paracetamol/ Caffeine/ Phenylephrine

Capsule 300mg/25mg/5mg

• Adco-Sinal NS (Adcock)