Paracetamol/ Phenylephrine/ Mepyramine

Registered South African indications:

• Relief the symptoms associated with sinus congestion, colds and flu, including pain and fever

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 any of the excipients in this combination product
• Severe liver impairment
• Patients receiving monoamine oxidase inhibitor treatment, or within 14 days of its termination
• Pregnancy
• Lactation
• Patients who are sensitive to other antihistamines due to the possibility of cross-sensitivity
• Patients suffering from severe hyperthyroidism, since the phenylephrine hydrochloride in this combination product may induce tachycardia or reflex bradycardia

South African recommendations

Renal impairment

• Use with caution in renal disease

Mild to moderate hepatic impairment

• Patients who suffer from hepatitis or alcoholism, or who are recovering from liver disease, should not take paracetamol and therefore also this combination product. To avoid accidental overdosage, store in a safe place, out of reach of children

Excess doses

• Paracetamol administration in excess of the recommended dosage may cause severe liver damage

Persistent pain and fever

• Patient should consult a doctor if pain or fever persists or gets worse, if new symptoms occur or if redness or swelling is present, as these could be signs of a serious condition

Use limits

• Patient should not use this product continuously without consulting a doctor, for pain for not more than 10 days and for fever for not more than 3 days

Event of overdosage or suspected overdosage

• In the event of overdosage or suspected overdosage, prompt medical attention is critical for adults and children, even if there are no obvious signs or symptoms. The nearest doctor, hospital or poisons control centre must be contacted immediately. A doctor should be consulted if no relief is obtained from the recommended dosage

Drowsiness and impaired concentration

• This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressants, e.g., sedatives and tranquillisers

Ability to drive and use machines

• Caution should be used when driving a motor vehicle or operating machinery or performing potentially dangerous tasks, where loss of concentration may lead to accidents. Paracetamol/ phenylephrine/ mepyramine tablets may cause drowsiness. Patients should be advised not to drive or operate machines in the event of feeling sleepy or tired

Caution should be used when the following medical conditions exist:

• Prostatic hypertrophy
• Narrow angle glaucoma
• Emphysema
• Chronic bronchitis
• Porphyria
• Severe ischaemic heart disease

Effects in children and the elderly

• Paradoxical hyperexcitability, nervousness and insomnia may occur in children and the elderly taking antihistamines. Elderly patients are especially susceptible to dizziness, sedation, confusion, hypotension, and to anticholinergic effects, such as dry mouth and urinary retention

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

South African registered indications and dosages

Relief the symptoms associated with sinus congestion, colds and flu, including pain and fever

Paracetamol/ Phenylephrine/ Mepyramine
400/5/5 (mg)

• Oral (tab): Usual dose: 2 tab, 6hrly while symptoms persist; Max: 8 tab/24hrs

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

South African registered indications and dosages

Relief the symptoms associated with sinus congestion, colds and flu, including pain and fever

Paracetamol/ Phenylephrine/ Mepyramine
400/5/5 (mg)

• Younger than 9 years: No information available
• Between 9-12 years: Oral (tab): Usual dose: 1 tab, 6hrly while symptoms persist; Treatment duration: No longer than 5 days; Max: 4 tab/24hrs
• Older than 12 years: See adult dosage

Pregnancy 

South African recommendations

• Contraindicated
  Safety in pregnancy has not been established

Breastfeeding

South African recommendations

• Contraindicated

Fertility

South African recommendations

• No information available

South African recommendations

• Caution; no dose adjustment recommended
  Use with caution in renal disease

South African recommendations

• Mild to moderate: Caution; not recommended
  Patients who suffer from hepatitis or alcoholism, or who are recovering from liver disease, should not take paracetamol and therefore also not this combination product
• Severe: Contraindicated

South African recommendations

• Caution; no dose adjustment recommended
  Elderly patients are especially susceptible to dizziness, sedation, confusion, hypotension, and to anticholinergic effects, such as dry mouth and urinary retention

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

Paracetamol

Blood and Lymphatic System Disorders

Less frequent

• Agranulocytosis
• Anaemia
• Thrombocytopenia

Frequency unknown

• Leucopenia
• Pancytopenia
• Neutropenia

Immune System Disorders

Less frequent

• Allergic dermatitis

Frequency unknown

• Pancreatitis
• Skin rashes
  - The rash is usually erythematous or urticarial, but sometimes more serious and accompanied by fever and mucosal lesions
• Other allergic reactions

Hepatobiliary System Disorders

Less frequent

• Hepatitis

Skin and Subcutaneous Tissue Disorders

Less frequent

• Dermatitis

Renal and Urinary System Disorders

Less frequent

• Renal colic
• Renal failure
• Sterile pyuria

Phenylephrine

Metabolism and Nutrition Disorders

Frequency unknown

• Altered metabolism
• Disturbances of glucose metabolism
• Sweating

Neuropsychiatric System Disorders

Common

• Headache

Frequency unknown

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

Ear and labyrinth disorders

Frequency unknown

• Tinnitus

Cardiovascular System Disorders

Frequency unknown

• Vasoconstriction with resultant hypertension
• Cerebral haemorrhage
• Pulmonary oedema
• Reflex bradycardia
• Tachycardia
• Cardiac arrhythmias
• Anginal pain
• Palpitations
• Cardiac arrest
• Hypotension with dizziness and fainting
• Flushing

Respiratory System Disorders

Frequency unknown

• Dyspnoea

Gastrointestinal System Disorders

Frequency unknown

• Appetite may be reduced
• Nausea and vomiting
• Hypersalivation

Renal and Urinary System Disorders

Frequency unknown

• Difficulty in micturition
• Urinary retention

Mepyramine

Blood and Lymphatic System Disorders

Frequency unknown

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

Neuropsychiatric System Disorders

Frequency unknown

• Sedation
• Drowsiness
• Nervousness
• Fatigue
• Dizziness
• Tremors
• Incoordination
• Insomnia
• Confusion
• Hallucinations
• Convulsions
• Headache
• Extrapyramidal effects, muscle spasms, dystonia
• Anticholinergic effects
• Ataxia
• Flushing
• Blurred vision
• Dryness of the mouth and nose
• Thickening of mucus
• Urinary retention or frequency
• Dysuria
• Reduced gastrointestinal tract tone and motility leading to constipation
• Increased gastric reflux

Cardiovascular System Disorders

Frequency unknown

• Hypotension
• Tachycardia

Gastrointestinal System Disorders

Frequency unknown

• Nausea and vomiting
• Diarrhoea
• Epigastric pain 

Skin and Subcutaneous Tissue Disorders

Frequency unknown

• Photosensitivity
• Skin rash
• Allergic dermatitis

General Disorders

Frequency unknown

• Drug fever

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

Paracetamol/ Phenylephrine/ Mepyramine

• Central nervous system depressants
• Sedatives
• Tranquillisers

Phenylephrine hydrochloride

• Antihypertensive agents
• Alpha-blocking agents
• Beta-blocking agents
• Guanethidine
• Reserpine
• Tricyclic antidepressants
• Digoxin
• Alpha-methyldopa

Mepyramine maleate

• Sedatives
• Monoamine oxidase inhibitors
• Anticholinergic agents
• Medications tending to cause extrapyramidal reactions
• Tricyclic antidepressants
• Maprotiline

Other interactions

• Alcohol
• Skin test results (See additional prescribing points)

None routine 

Skin test results

• Antihistamines, and therefore paracetamol/ phenylephrine/ mepyramine tablets, may suppress positive skin test results and should be stopped several days before the test

Paracetamol
Paracetamol has analgesic and antipyretic properties and acts predominantly by the inhibition of prostaglandin synthesis.

Phenylephrine
Phenylephrine hydrochloride mainly acts by directly affecting adrenergic receptors. It has predominantly alpha-adrenergic activity and does significantly stimulate the central nervous system at usual doses. Its pressor activity is weaker than that of ephedrine.

Mepyramine
Mepyramine is a histamine H1-receptor antagonist with antimuscarinic and central sedative properties.

COMBINATION PREPARATIONS

Paracetamol/ Phenylephedrine/ Mepyramine

Tablet 400mg/5mg/5mg

• Sinu-Flu (Cipla) originator