RINOFED PLUS SYRUP 120ML

Indications

Approved Uses

Symptomatic relief of common cold/flu and allergic rhinitis symptoms including nasal congestion, rhinorrhea (runny nose), sneezing, and associated headache/fever/pain.

Dosage & Administration

Dose Adjustment Notes

Use caution in hepatic impairment and avoid exceeding total daily paracetamol limits; avoid or use with specialist advice in severe hepatic impairment. Use caution in renal impairment (especially severe) due to pseudoephedrine accumulation; consider longer dosing intervals. Use caution in older adults due to anticholinergic/sedation and cardiovascular effects.

Side Effects

Common Side Effects

Drowsiness/sedation, dizziness, dry mouth, blurred vision; nausea; nervousness/restlessness/insomnia; palpitations/tachycardia; urinary retention (especially in men with prostatic enlargement).

Side Effect Frequency

Common (≥1% to <10%): drowsiness/sedation, dizziness, dry mouth, nausea, headache. Uncommon (<1%): blurred vision, constipation, urinary retention/hesitancy, palpitations/tachycardia, increased blood pressure, rash/hypersensitivity. Rare: serious allergic reactions; hepatotoxicity is primarily associated with paracetamol overdose rather than usual therapeutic use.

Safety & Warnings

Contraindications

Hypersensitivity to paracetamol, pseudoephedrine, triprolidine or excipients; concomitant use of MAOIs or within 14 days of stopping; severe hypertension or severe coronary artery disease; narrow-angle glaucoma; urinary retention/prostatic hypertrophy; severe hepatic impairment

Warnings & Precautions

Do not exceed recommended dose; avoid other paracetamol-containing products; avoid use with/within 14 days of MAOIs; caution in hypertension, ischemic heart disease/arrhythmias, diabetes, hyperthyroidism, glaucoma, prostatic hypertrophy/urinary retention, hepatic or renal impairment; may cause drowsiness-avoid driving/alcohol/CNS depressants; stop and seek care if rash, jaundice, palpitations, severe headache, or breathing/swelling occurs

Age Restriction

Not recommended for children under 6 years.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

MAOIs (contraindicated-hypertensive crisis with pseudoephedrine); other sympathomimetics/decongestants (additive CV/CNS stimulation); tricyclic antidepressants (enhanced pressor effects); antihypertensives (reduced effect, especially adrenergic neuron blockers); beta-blockers (may increase BP/HR response); CNS depressants including alcohol (additive sedation with triprolidine); warfarin (paracetamol at repeated/high doses may increase INR)

Interaction Severity

MAJOR/Contraindicated: MAO inhibitors (and within 14 days) due to risk of hypertensive crisis with pseudoephedrine. MODERATE: other CNS depressants/alcohol (additive sedation with triprolidine); tricyclic antidepressants/other sympathomimetics (enhanced pressor/CNS effects); antihypertensives (reduced effect/raised BP). MONITOR: warfarin with repeated/high-dose paracetamol (↑INR).

Food Interaction

No restriction

Alcohol Interaction

Avoid

Special Populations

Breastfeeding

Caution

Kidney Impairment

Caution in renal impairment; if significant renal impairment (e.g., CrCl <30 mL/min), extend dosing interval and limit total daily paracetamol; avoid or use only with close supervision in severe renal failure

Liver Impairment

Severe hepatic impairment: avoid/contraindicated; mild-moderate hepatic impairment or chronic alcohol use: use with caution and reduce total daily paracetamol exposure (lower dose/longer interval; do not exceed 2-3 g/day paracetamol equivalent)

Storage & Patient Advice

Stopping the Medicine

Safe to stop anytime; this product is intended for short-term symptomatic use only

Overdose

Paracetamol overdose may be initially mild (nausea/vomiting) with delayed severe hepatotoxicity at 24-72 h-urgent ED evaluation and prompt N-acetylcysteine per protocols; pseudoephedrine overdose can cause hypertension, tachycardia, agitation, seizures; triprolidine overdose can cause marked sedation or paradoxical excitation and anticholinergic toxicity-supportive care; seek immediate medical attention for any suspected overdose

Patient Counseling

Do not exceed the recommended dose or combine with other paracetamol-containing products (liver toxicity risk). May cause drowsiness/blurred vision-avoid driving/operating machinery; avoid alcohol and other sedatives. Pseudoephedrine may raise BP/heart rate-seek advice if you have hypertension, heart disease, hyperthyroidism, diabetes, glaucoma, or prostate enlargement/urinary retention. Stop and seek care if symptoms persist >7 days, worsen, or fever is high/prolonged. Shake well and measure doses accurately; keep out of reach of children.

Monitoring Requirements

No routine monitoring required for short-term OTC use. Monitor blood pressure in hypertensive patients. Monitor liver function with prolonged use or in patients with hepatic disease.

Pharmacology

Mechanism of Action

Paracetamol: central analgesic/antipyretic via inhibition of prostaglandin synthesis in the CNS. Pseudoephedrine: sympathomimetic (primarily alpha-adrenergic) causing vasoconstriction of nasal mucosa to reduce congestion. Triprolidine: first-generation H1 receptor antagonist reducing histamine-mediated symptoms (sneezing, rhinorrhea, itching).

Onset of Action

Typically within 30-60 minutes for noticeable symptom relief (paracetamol and pseudoephedrine often ~30 minutes; triprolidine may be within ~1 hour).

Duration of Effect

Approximately 4-6 hours per dose for overall symptom relief.

Half-Life

Paracetamol: ~2 hours (typical range ~1.5-3 hours in healthy adults). Pseudoephedrine: ~5-8 hours (urine pH-dependent). Triprolidine: ~3-5 hours (often reported around ~3-4 hours).

Bioavailability

Paracetamol: oral bioavailability is variable (approximately 60-90% due to first-pass metabolism). Pseudoephedrine: high oral bioavailability (often ~90% or higher) with predominant renal elimination. Triprolidine: well absorbed; precise bioavailability is not consistently established in standard references.

Metabolism

Paracetamol: extensive hepatic metabolism via glucuronidation and sulfation with a minor CYP-mediated (e.g., CYP2E1) pathway. Pseudoephedrine: minimal hepatic metabolism; most is excreted unchanged in urine. Triprolidine: hepatic metabolism (extensive) with metabolites excreted renally.

Product Information

Composition per Dose

Each 5ml: Paracetamol 125mg + Pseudoephedrine Hydrochloride 25mg + Triprolidine 1.25mg

Generic Availability

Yes

OTC Alternatives

Single-symptom options: paracetamol alone for fever/pain; non-sedating antihistamines (cetirizine/loratadine) for allergic symptoms; topical nasal decongestants (e.g., xylometazoline/oxymetazoline) short-term for congestion; saline nasal spray/irrigation.

Symptom Target

Multi-symptom

Sedating

Yes

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 31-07-2026