Paracetamol/ Ascorbic Acid/ Caffeine/ Phenylephrine/ Chlorphenamine

Registered South African indications:

• Relief of symptoms associated with colds and influenza

This combination product contains 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 ingredient or to any of the excipients in this combination product
• Coronary disease
• Hypertension
• Cardiovascular disease
• Hyperthyroidism
• Epilepsy
• Pregnancy
• Persons being treated with monoamine oxidase inhibitors or within 10 days of stopping such treatment
• Prostatic enlargement
• Paralytic ileus or pyloric stenosis
• Closed angle glaucoma or with a narrow angle between the iris and the cornea
• Not recommended for children under the age of 6 years

South African recommendations

• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly

Excess doses

• Dosages in excess of those recommended may cause liver damage. The patient should not use continuously for more than 10 days without consulting 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

Contains lactose monohydrate

• Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine

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

Paracetamol

Excess doses

• Dosages in excess of those recommended may cause severe liver damage. Patients suffering from liver or kidney disease should take paracetamol under medical supervision

Severe cutaneous adverse reactions (SCARs)

• Severe cutaneous adverse reactions (SCARs) such as toxic epidermal necrolysis (TEN), Steven-Johnson syndrome (SJS), acute generalised exanthematous pustulosis (AGEP), eosinophilia and systemic (DRESS)/Drug-induced hypersensitivity syndrome (DIHS) and fixed drug eruptions (FDE) have been reported in patients treated with paracetamol containing medicines. If a patient develops SCAR, treatment with this combination medicine must immediately be discontinued and appropriate treatment instituted

Caffeine

History of peptic ulcers

• Caffeine should be given with care to patients with a history of peptic ulcers

Phenylephrine

Hypersensitive patients

• Administer with caution to hypersensitive patients, particularly those with hyperthyroidism, patients with cardiovascular disease, diabetes mellitus or closed angle glaucoma

Chlorphenamine

Sedation

• Chlorphenamine may produce sedation, persons should not operate machinery, drive cars, climb dangerous heights or perform potentially dangerous tasks where impaired decision making could lead to accidents

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

South African registered indications and dosages

Relief of symptoms associated with colds and influenza
- Such as nasal congestion, sniffing, headache, minor aches and pains

Paracetamol/ Ascorbic acid/ Caffeine/ Phenylephrine/ Chlorphenamine
 300/75/30/5/2 (mg)

• Oral (cap): 2 cap, 3 times dly

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

South African registered indications and dosages

Relief of symptoms associated with colds and influenza
- Such as nasal congestion, sniffing, headache, minor aches and pains

Paracetamol/ Ascorbic acid/ Caffeine/ Phenylephrine/ Chlorphenamine
 300/75/30/5/2 (mg)

• Younger than 6 years: Contraindicated
• Between 6-12 years: Oral (cap): 1 cap, 3 times dly
• Older than 12 years: See adult dosage

Pregnancy

South African recommendations

• Contraindicated

Breastfeeding

South African recommendations

• Caution
• Safety during 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 under medical supervision

South African recommendations

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

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

Blood and the Lymphatic System Disorders

Unknown frequency

• Neutropenia
• Pancytopenia
• Leucopenia

Immune System Disorders

Unknown frequency

• Reversible skin rash

Skin and Subcutaneous Tissue Disorders

Unknown frequency

• Erythematous rash
• Urticarial rash
• Fever and mucosal lesions accompanying rash
• Fixed drug eruptions
• Drug-induced hypersensitivity syndrome

Caffeine

Nervous System Disorders

Unknown frequency

• Headache
• Insomnia

Cardiac Disorders

Unknown frequency

• Palpitations

Gastrointestinal Disorders

Unknown frequency

• Nausea

Phenylephrine

Endocrine Disorders

Unknown frequency

• Hypersalivation

Metabolism and Nutrition Disorders

Unknown frequency

• Altered metabolism including disturbance of glucose metabolism

Psychiatric Disorders

Unknown frequency

• Psychotic states
• Fear
• Anxiety

Nervous System Disorders

Unknown frequency

• Restlessness
• Tremor
• Insomnia
• Confusion
• Irritability
• Cerebral haemorrhage
• Headache

Cardiac Disorders

Unknown frequency

• Vasoconstriction
• Hypertension
• Bradycardia
• Tachycardia
• Cardiac arrhythmias
• Anginal pain
• Palpitations
• Cardiac arrest
• Hypotension with dizziness and fainting

Respiratory, Thoracic and Mediastinal Disorders

Unknown frequency

• Pulmonary oedema
• Dyspnoea

Gastrointestinal Disorders

Unknown frequency

• Nausea and vomiting

Renal and Urinary Disorders

Unknown frequency

• Difficulty in micturition
• Urinary retention

General Disorders and Administrative Site Conditions

Unknown frequency

• Weakness
• Reduced appetite
• Flushing
• Sweating

Chlorphenamine

Metabolism and Nutrition Disorders

Unknown frequency

• Anorexia

Psychiatric Disorders

Unknown frequency

• Elation
• Depression
• Nightmares
• Irritability

Nervous System Disorders

Unknown frequency

• Sedation
• Headache
• Cerebral stimulation particularly in children
• Dizziness
• Nervousness
• Tremors
• Muscle twitching
• Convulsions

Eye Disorders

Unknown frequency

• Blurred vision

Ear and Labyrinth Disorders

Unknown frequency

• Tinnitus

Cardiac Disorders

Unknown frequency

• Tightness of chest and tingling
• Hypotension
• Tachycardia

Gastrointestinal Disorders

Unknown frequency

• Nausea and vomiting
• Diarrhoea
• Constipation
• Colic
• Epigastric pain

Renal and Urinary Disorders

Unknown frequency

• Difficulty in micturition

General Disorders and Administrative Site Conditions

Unknown frequency

• Dryness of mouth
• Heaviness and weakness of hands
• Allergy and anaphylaxis
• Inability to concentrate
• Incoordination
• Lassitude

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

Paracetamol/ Ascorbic Acid/ Caffeine/ Phenylephrine/ Chlorphenamine

• Monoamine oxidase inhibitors

Phenylephrine

• Cyclopropane
• Halothane, or other halogenated anaesthetics
• Antihypertensives
• Cardiac glycosides
• Quinidine
• Tricyclic antidepressants

Chlorphenamine

• CNS depressants
• Barbiturates
• Hypnotics
• Narcotic analgesics
• Sedatives
• Tranquillisers
• Tricyclic antidepressants
• Guanethidine
• Reserpine
• Methyldopa
• Atropine

None routine. Specific cases may require

• Hepatic function
• Renal function

Paracetamol/ Ascorbic Acid/ Caffeine/ Phenylephrine/ Chlorphenamine
Paracetamol/ ascorbic acid/ caffeine/ phenylephrine/ chlorphenamine has analgesic, antipyretic, antihistaminic and decongestant properties.

Paracetamol
Paracetamol has analgesic and antipyretic actions.

Ascorbic Acid
Ascorbic acid is vitamin C.

Phenylephrine hydrochloride
Phenylephrine hydrochloride is a sympathomimetic agent.

Chlorphenamine maleate
Chlorphenamine maleate is an antihistamine.

COMBINATION PREPARATIONS

Paracetamol/ Ascorbic acid/ Caffeine/ Phenylephrine/ Chlorpheniramine

Capsule 300mg/75mg/30mg/5mg/2mg

• Degoran C (Novartis) originator
• Flustat (Ranbaxy)
• Grippon (Adcock)
• Sinustat flu (Litha Pharma) originator