SUNFLU Tablet Ref.[50590] Active ingredients: Caffeine Chlorphenamine Paracetamol Phenylephrine

Source: Health Sciences Authority (SG)  Revision Year: 2021  Publisher: Sunward Pharmaceutical Pte.Ltd., 11, Wan Lee Road, Singapore, 627943

4.3. Contraindications

It is contraindicated in patients who are hypersensitive to any of the ingredients.

Due to the component phenylephrine, it is contraindicated in patients with ventricular tachycardia or severe hypertension.

Due to the component chlorpheniramine maleate, it is contraindicated in patients on monoamine oxidase inhibitor therapy and also in lower respiratory tract infections.

4.4. Special warnings and precautions for use

Alcoholic beverages and driving a motor vehicle or operating heavy machinery should be avoided while taking this product. May cause drowsiness or excitability, especially in children. Persons with asthma, glaucoma, high blood pressure, diabetes, heart or thyroid disease, difficulty in urination due to enlarged prostate gland or taking an antidepressant drug, should use only as directed by a physician. The recommended doses should not be exceeded because at higher doses nervousness, dizziness, or sleeplessness may occur.

This product is not recommended to be used during pregnancy and breastfeeding unless advised by a healthcare professional.

This product should not be given to children under 6 years of age.

Rarely, paracetamol may cause serious skin reactions such as acute generalised exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reaction and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity

4.8. Undesirable effects

Adverse reactions to phenylephrine hydrochloride include:

Headache, reflex bradycardia, excitability, restlessness and rarely arryhthmias.

Adverse reactions to chlorpheniramine maleate include:

General: urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat.

Cardiovascular system: hypotension, headache, palpitations, tachycardia, extrasystoles.

Hematologic system: hemolytic anaemia, thrombocytopenia, agranulocytosis.

Nervous system: sedation, dizziness, disturbed co-ordination, fatigue, confusion, restlessness, excitation, nervousness. tremor, irritability, insomnia, euphoria, paresthesias, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions.

Gastrointestinal system: epigastric distress, anorexia, nausea, vomiting, diarrhoea, constipation.

Genitourinary system: urinary frequency, difficult urination, urinary retention, menses.

Respiratory system: thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.

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