Paracetamol/ Phenylephrine/ Chlorphenamine

Registered South African indications:

• Symptomatic relief of sinusitis, rhinitis and allergic conditions of the upper respiratory tract, hay fever and influenza

Paracetamol/ phenylephrine/ chlorphenamine 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 active ingredient or to any of the excipients of this combination product
• Severe renal impairment
• Pregnancy
• Lactation
• Heart disease
• Epilepsy
• Hypertension
• Hyperthyroidism
• Diabetes
• Phaeochromocytoma
• Closed angle glaucoma
• Concomitant use of other sympathomimetic decongestants
• Patients taking tricyclic antidepressants or beta blocking medicines
• Patients on monoamine oxidase inhibitors or within 10 days of stopping such treatment
• Not recommended for use in children younger than 6 years
• Patients suffering from hepatitis or alcoholism, or recovering from any form of liver disease, should not take medicines containing paracetamol, such as this combination product

South African recommendations

• Mild to moderate renal impairment

Severe liver damage

• Avoid excessive dosages

Children and elderly

• More susceptible to neurological and paradoxical effects; avoid in elderly with confusion

Interaction

• Do not use with other paracetamol-containing medicines
• Concurrent use with sedatives may increase sedative effects
• Avoid alcohol; may intensify effects

Specific patient cautions

• Exercise caution in patients with
  • Pyloroduodenal obstruction
  • Prostatic hypertrophy
  • Emphysema
  • Bronchitis
  • Bronchiectasis
  • Asthma
  • Chronic lung diseases
  • Porphyria
  • Paradoxical hyperexcitability
  • Nervousness
  • Insomnia
  • Metabolic deficiencies affecting glutathione
  • Occlusive vascular disease e.g Raynaud's phenomenon

Drowsiness and impaired concentration

• Paracetamol/phenylephrine/chlorphenamine may cause these effects, worsened by alcohol or CNS depressants

Lactose monohydrate

• Not suitable for patients with certain hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption

Colour additives

• Sunset Yellow (E 110) and Ponceau 4R (E 124) may cause allergic reactions

Driving and machinery use

• Do not drive or operate heavy machinery; product may cause drowsiness, dizziness, and impaired concentration, heightened by alcohol or CNS depressants

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

South African registered indications and dosages

Symptomatic relief of sinusitis, rhinitis and allergic conditions of the upper respiratory tract, hay fever and influenza

Paracetamol/ Phenylephrine/ Chlorphenamine
300/5/2 (mg)

• Oral (cap): 2 cap, 3 times a day

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Continuous use beyond 10 days is not recommended without consulting a doctor

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

South African registered indications and dosages

Symptomatic relief of sinusitis, rhinitis and allergic conditions of the upper respiratory tract, hay fever and influenza

Paracetamol/ Phenylephrine/ Chlorphenamine
300/5/2 (mg)

• Younger than 6 years: Contraindicated
• Between 6-12 years: 1 cap, 3 times a day
• Older than 12 years: See adult dosage

---

Continuous use beyond 10 days is not recommended without consulting a doctor

Pregnancy 

South African recommendations

• Contraindicated
• Pregnant women should not use paracetamol/ phenylephrine/ chlorphenamine

Breastfeeding

South African recommendations

• Contraindicated
• Lactating women should not use paracetamol/ phenylephrine/ chlorphenamine

Fertility

South African recommendations

• No information available

South African recommendations

• Mild to moderate: Caution; no information available
• Severe: Contraindicated

South African recommendations

• Contraindicated
  Patients suffering from hepatitis or alcoholism, or recovering from any form of liver disease, should not take medicines containing paracetamol, such as paracetamol/ phenylephrine/ chlorphenamine

• Caution; no dose adjustment recommended
  Elderly patients are more likely to experience neurological anticholinergic effects and paradoxical excitation (e.g. increased energy, restlessness and nervousness), therefore the use of paracetamol/ phenylephrine/ chlorphenamine should be avoided in elderly patients with confusion

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

Paracetamol

Blood and Lymphatic System Disorders

Frequency unknown

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

Immune System Disorders

Frequency unknown

• Allergic reactions
• Anaphylaxis
• Cutaneous hypersensitivity reactions
• Angioedema

Hepatobiliary Disorders

Frequency unknown

• Pancreatitis
• Hepatitis
• Hepatic dysfunction

Skin and Subcutaneous Tissue Disorders

Frequency unknown

• Dermatitis
• Skin rashes (usually erythematous or urticarial, sometimes more serious and accompanied by fever and mucosal lesions)

Renal and Urinary Disorders

Frequency unknown

• Renal colic
• Renal failure
• Sterile pyuria

Respiratory, Thoracic and Mediastinal Disorders

Frequency unknown

• Bronchospasm

Phenylephrine Hydrochloride

Blood and Lymphatic System Disorders

Frequency unknown

• Cerebral haemorrhage

Metabolism and Nutrition Disorders

Frequency unknown

• Appetite may be reduced
• Altered metabolism including blood sugar levels

Psychiatric Disorders

Frequent

• Nervousness

Frequency unknown

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

Nervous System Disorders

Frequent

• Headache
• Dizziness
• Insomnia

Frequency unknown

• Tremor

Cardiac Disorders

Frequent

• Hypertension

Frequency unknown

• Palpitations
• Tachycardia
• Reflex bradycardia
• Anginal pain in angina pectoris
• Cardiac arrest

Respiratory, Thoracic and Mediastinal Disorders

Frequency unknown

• Dyspnoea
• Pulmonary oedema

Gastrointestinal Disorders

Frequent

• Nausea
• Vomiting
• Diarrhoea

Skin and Subcutaneous Tissue Disorders

Frequency unknown

• Flushing
• Rash

Renal and Urinary Disorders

Frequency unknown

• Difficulty in micturition
• Urinary retention
• Dysuria

General Disorders and Administration Site Conditions

Frequency unknown

• Weakness

Immune System Disorders

Frequency unknown

• Hypersensitivity
• Allergic dermatitis
• Urticaria

Eye Disorders

Frequency unknown

• Mydriasis
• Acute angle closure glaucoma (most likely to occur in those with closed angle glaucoma)

Chlorphenamine Maleate

Blood and Lymphatic System Disorders

Frequency unknown

• Haemolytic anaemia
• Blood dyscrasias
  • Agranulocytosis
  • Leucopenia
  • Thrombocytopenia

Immune System Disorders

Frequency unknown

• Allergy
• Anaphylaxis
• Angioedema

Psychiatric Disorders

Frequency unknown

• Confusion
• Hallucinations
• Nervousness
• Excitation
• Irritability
• Nightmares
• Depression

Nervous System Disorders

Frequency unknown

• Sedation
• Drowsiness
• Insomnia
• Incoordination
• Dizziness
• Tremors
• Convulsions
• Headache
• Cerebral stimulation (particularly in children)
• Somnolence
• Disturbance in attention

Eye Disorders

Frequency unknown

• Blurred vision

Ear and Labyrinth Disorders

Frequency unknown

• Tinnitus

Cardiac Disorders

Frequency unknown

• Tachycardia
• Palpitations, dysrhythmias

Vascular Disorders

Frequency unknown

• Hypotension

Respiratory, Thoracic and Mediastinal Disorders

Frequency unknown

• Thickening of mucus

Gastrointestinal Disorders

Frequency unknown

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

Skin and Subcutaneous Tissue Disorders

Frequency unknown

• Allergic dermatitis
• Skin rash
• Photosensitivity
• Flushing
• Exfoliative dermatitis
• Urticaria

Musculoskeletal and Connective Tissue Disorders

Frequency unknown

• Extrapyramidal effects with muscle spasm and dystonia, ataxia
• Muscle twitching
• Muscle weakness

Renal and Urinary Disorders

Frequency unknown

• Urinary retention or frequency
• Dysuria

General Disorders and Administration Site Conditions

Frequency unknown

• Fatigue
• Medicine-induced fever
• Dryness of the nose
• Chest tightness

Metabolism and Nutritional Disorders

Frequency unknown

• Anorexia

Hepatobiliary Disorders

Frequency unknown

• Hepatitis
• Including jaundice

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

Paracetamol/ Phenylephrine/ Chlorphenamine

• Medicines causing extrapyramidal reactions
• Medicines with anticholinergic effects
• Atropine
• Tricyclic antidepressants
• Maprotiline
• Reserpine
• Guanethidine
• Monoamine oxidase inhibitors
• All sedatives (including alcohol)
• Hypnotics
• Anxiolytics

Paracetamol

• Enzyme-inducing medicines
• Alcohol
• Metoclopramide
• Domperidone
• Colestyramine
• Warfarin
• Other coumarins

Phenylephrine

• Monoamine oxidase inhibitors
• Moclobemide
• Sympathomimetic amines
• Beta blockers
• Antihypertensives
• Debrisoquine
• Guanethidine
• Reserpine
• Methyldopa
• Tricyclic antidepressants
• Amitriptyline
• Digoxin
• Cardiac glycosides
• Ergot alkaloids
• Ergotamine
• Methysergide

Chlorphenamine

• Phenytoin

Other interactions

• Skin test results suppression

None routine

Paracetamol
Paracetamol is an analgesic and antipyretic.

Phenylephrine
Phenylephrine hydrochloride is a sympathomimetic decongestant.

Chlorpheniramine
Chlorphenamine maleate is a potent antihistamine (H1-antagonist). Antihistamines diminish or abolish the actions of histamine in the body by competitive reversible blockade of histamine H1- receptor sites on tissues. Chlorphenamine also has anticholinergic activity. Antihistamines act to prevent the release of histamine, prostaglandins and leukotrienes and have been shown to prevent the migration of inflammatory mediators. The actions of chlorphenamine include inhibition of histamine on smooth muscle, capillary permeability and hence reduction of oedema and wheal in hypersensitivity reactions such as allergy and anaphylaxis.

COMBINATION PREPARATIONS

Paracetamol/ Phenylephrine/ Chlorpheniramine

Capsule 300mg/5mg/2mg

• Famucaps (Brunel) originator