Sinutab Cold/Sinutab Cold Plus

Sinutab Cold/Sinutab Cold Plus

Manufacturer:

Probiotec Pharma

Distributor:

JNTL Consumer Health
Concise Prescribing Info
Contents
Per Sinutab Cold Paracetamol 500 mg, phenylephrine HCl 5 mg. Per Sinutab Cold Plus Paracetamol 500 mg, phenylephrine HCl 5 mg, chlorpheniramine maleate 2 mg
Indications/Uses
Temporary relief of nasal & sinus congestion, sinus pressure, sinus pain, headache, minor aches & pains due to common cold, flu, hay fever (allergic rhinitis), sinusitis & other upper resp allergies. Promotes nasal &/or sinus drainage. Fever reduction. Sinutab Cold Plus Runny nose, sneezing, itching of the nose/throat, itchy, watery eyes.
Dosage/Direction for Use
Adult & childn ≥12 yr 1-2 tab every 6 hr as needed. Do not exceed 8 tab w/in 24-hr period.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Phenylephrine: Not to be used in patients taking MAOIs or for 2 wk after stopping MAOI.
Special Precautions
Taking more than the recommended dose of paracetamol may cause liver damage. Chronic alcohol users. Patients w/ hepatic disease. Very rare report of serious skin reactions eg, generalized exanthematous pustulosis (AGEP), SJS, & TEN. Discontinue use at 1st appearance of skin rash or any other sign of hypersensitivity; if symptoms persist or worsen, or new symptoms occur. Do not use w/ any other product containing paracetamol. No adequate & well-controlled studies in pregnant or breastfeeding women. Phenylephrine: Not to be taken by patients w/ heart disease, high BP, thyroid disease, diabetes, difficulty in urination &/or prostate enlargement. Not to be used during pregnancy or lactation unless potential benefit of treatment to mother outweighs the possible risks to developing fetus or breastfeeding infant. Sinutab Cold Plus Patients w/ resp condition eg, emphysema, chronic bronchitis, bronchial asthma, or where cough is accompanied by excessive secretions or glaucoma. May cause drowsiness. Caution when driving a motor vehicle or operating machinery. Chlorpheniramine: Avoid alcoholic beverages prior to taking w/ CNS depressants including alcohol, sedatives, & tranquilizers.
Adverse Reactions
Phenylephrine: Nausea, nasal dryness & headache. Chlorpheniramine: Dizziness, somnolence, dry mouth, dyspepsia, pharyngitis & jittery feeling.
Drug Interactions
Phenylephrine: MAOIs may potentiate pressor effect of phenylephrine. Paracetamol: Possible potentiating the anticoagulant effect of warfarin & other coumarin derivatives. Report of high anion gap metabolic acidosis in concomitant use w/ flucloxacillin. Chlorpheniramine: Enhanced sedative effects of CNS depressants including alcohol, sedatives & tranquilizers.
MIMS Class
Cough & Cold Preparations
ATC Classification
R01BA53 - phenylephrine, combinations ; Belongs to the class of systemic sympathomimetic preparations used as nasal decongestants.
Presentation/Packing
Form
Sinutab Cold FC tab
Packing/Price
200's
Form
Sinutab Cold Plus FC tab
Packing/Price
200's