NUROFEN 400/MG TAB 12/TAB

Indications

Approved Uses

OTC short-term symptomatic relief of mild to moderate pain (e.g., headache, dental pain, backache, muscular pain, dysmenorrhea) and reduction of fever, including pain/fever associated with cold/flu symptoms.

Dosage & Administration

Dosing by Condition

Pain/Fever/Dysmenorrhea (OTC): 400 mg every 6-8 hours as needed (some references allow every 4-6 hours); maximum 1200 mg/day without medical advice.
Inflammatory conditions (medical supervision): 1200-3200 mg/day in 3-4 divided doses (e.g., 400-800 mg 3-4 times daily), per clinician direction.

Initial Dose

400mg

Maintenance Dose

400mg every 4-6 hours as needed

Maximum Dose

1200mg per day (OTC use); 3200mg per day (prescription/supervised use)

Children's Dosage

Children 6 months to 12 years: 5-10mg/kg every 6-8 hours, max 40mg/kg/day (use appropriate pediatric formulation). This 400mg tablet is not suitable for children under 12 years

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration. In elderly or patients with renal/hepatic impairment, use with caution and consider lower dose/shorter duration; avoid use in severe renal failure and in severe hepatic impairment unless directed by a clinician.

How to Take

Swallow the coated tablet whole with a full glass of water; do not crush or chew. Preferably take with or after food (or milk) to reduce gastrointestinal irritation.

Side Effects

Common Side Effects

Indigestion, heartburn, nausea, vomiting, abdominal pain, diarrhea, constipation, headache, dizziness, rash.

Side Effect Frequency

Common (1-10%): gastrointestinal adverse effects such as dyspepsia/indigestion, nausea, abdominal pain/epigastric pain, diarrhea; Uncommon (0.1-1%): vomiting, flatulence, constipation, gastritis; Rare/very rare: GI ulceration/bleeding/perforation and serious hypersensitivity reactions.

Safety & Warnings

Contraindications

Active or history of peptic ulcer disease, active GI bleeding, severe heart failure, severe renal impairment, severe hepatic impairment, known hypersensitivity to ibuprofen or any NSAID, aspirin-exacerbated respiratory disease (AERD), third trimester of pregnancy, history of NSAID-induced asthma or urticaria

Warnings & Precautions

Increased risk of serious cardiovascular thrombotic events with prolonged use; use with caution in patients with cardiovascular disease or risk factors. Increased risk of GI bleeding, ulceration, and perforation - use with caution in patients with history of GI disease. May cause fluid retention and worsen hypertension or heart failure. Avoid in patients with renal impairment; monitor renal function with prolonged use. May mask signs of infection. Use with caution in patients with asthma. Avoid in third trimester of pregnancy. Use lowest effective dose for shortest duration.

Age Restriction

Not recommended under 12 years for this 400mg tablet formulation

Drug Interactions

Drug Interactions

Anticoagulants (warfarin - increased bleeding risk), antiplatelet agents/aspirin (increased GI bleeding risk), other NSAIDs (additive toxicity), ACE inhibitors/ARBs (reduced antihypertensive effect, increased renal impairment risk), diuretics (reduced efficacy, increased nephrotoxicity), lithium (increased lithium levels), methotrexate (increased methotrexate toxicity), SSRIs (increased GI bleeding risk), corticosteroids (increased GI ulceration risk), ciclosporin (increased nephrotoxicity)

Interaction Severity

"MAJOR: ["Anticoagulants (e.g., warfarin) and other antithrombotics/antiplatelets (increased bleeding risk)
Other NSAIDs (including high-dose aspirin) (additive GI/renal toxicity and bleeding risk)
High-dose methotrexate (reduced clearance → toxicity)"], "MODERATE: ["ACE inhibitors/ARBs and diuretics (reduced antihypertensive/diuretic effect; increased AKI risk-\"triple whammy\")
Lithium (increased lithium levels/toxicity)
SSRIs/SNRIs and systemic corticosteroids (increased GI bleeding risk)
Cyclosporine/tacrolimus (increased nephrotoxicity)"], "MINOR: ["Antacids (may slightly affect absorption rate)"]

Food Interaction

Take with or after food (or milk) to reduce stomach upset; food may delay onset slightly but does not meaningfully reduce overall effect.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Caution

Children

Children 6 months to 12 years: 5-10mg/kg every 6-8 hours, max 40mg/kg/day (use appropriate pediatric formulation). This 400mg tablet is not suitable for children under 12 years

Elderly

Use lowest effective dose for shortest duration. Increased risk of GI bleeding, renal impairment, and cardiovascular events. Monitor renal function and blood pressure regularly.

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if near next scheduled dose. Do not double the dose.

Stopping the Medicine

Safe to stop anytime if used for short-term pain or fever. Consult a doctor if used for chronic conditions.

Overdose

Symptoms: nausea, vomiting, epigastric pain, drowsiness, headache, tinnitus; severe cases may include metabolic acidosis, renal failure, GI bleeding, seizures, coma. Management: gastric lavage if within 1 hour of ingestion, activated charcoal, supportive care, monitor renal function and electrolytes. Seek immediate medical attention.

Patient Counseling

Take with/after food or milk; swallow whole with water. Do not exceed 1200 mg/day OTC (for this 400 mg strength: max 3 tablets/24 h) unless advised by a clinician. Use the shortest duration-seek advice if symptoms persist (commonly: >3 days for fever or >5-10 days for pain depending on local labeling). Avoid combining with other NSAIDs; consult a clinician if on anticoagulants/antiplatelets, have prior ulcer/bleeding, kidney disease, uncontrolled hypertension/heart disease, or asthma sensitive to NSAIDs. Limit alcohol. Stop and seek urgent care for black stools/vomiting blood, severe abdominal pain, chest pain/shortness of breath, facial swelling/wheezing, or severe rash. Avoid in the 3rd trimester of pregnancy.

Monitoring Requirements

No routine labs are required for short-term OTC use in otherwise healthy patients. If prolonged/high-dose use or in at-risk patients: monitor blood pressure, renal function (SCr/eGFR), CBC (for anemia/bleeding), and consider liver enzymes; monitor for GI bleeding symptoms.

Pharmacology

Mechanism of Action

Non-selective inhibitor of cyclooxygenase enzymes (COX-1 and COX-2), reducing synthesis of prostaglandins and thromboxanes, thereby decreasing inflammation, pain, and fever

Onset of Action

20-30 minutes

Duration of Effect

4-6 hours.

Bioavailability

Approximately 80-100% (commonly cited ~80-90%) oral bioavailability; rapidly absorbed with peak levels typically within 1-2 hours (food may delay).

Product Information

Available Dosage Forms

For this product: oral coated tablet (400 mg) in blister pack of 12 tablets.

Composition per Dose

Each coated tablet: 400mg ibuprofen

OTC Alternatives

Paracetamol (acetaminophen) and other ibuprofen products (e.g., 200 mg tablets/capsules) are common OTC alternatives; naproxen may be OTC in some jurisdictions; aspirin is an adult-only alternative but is generally avoided for routine analgesia due to GI/bleeding risk.

Pain Type

General/Muscular/Joint

Nsaid

Yes

Opioid

No

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