BRUFEN 600/MG FC TAB 30/FC TAB

Indications

Approved Uses

Relief of signs and symptoms of rheumatoid arthritis and osteoarthritis; relief of mild to moderate pain; treatment of primary dysmenorrhea; reduction of fever.

Dosage & Administration

Dosing by Condition

Rheumatoid arthritis/Osteoarthritis: 1200-3200 mg/day orally in 3-4 divided doses (max 3200 mg/day). Mild-moderate pain: 200-400 mg every 4-6 hours as needed; prescription regimens may use 400-600 mg every 6-8 hours; typical max 2400 mg/day unless specifically directed. Primary dysmenorrhea: 400 mg initially then 400 mg every 4-6 hours as needed. Fever (adults): 200-400 mg every 4-6 hours as needed (do not exceed labeled maximum; higher totals only under prescriber direction).

Initial Dose

400mg-600mg

Maintenance Dose

400mg-600mg every 6-8 hours

Children's Dosage

Children 6 months to 12 years: 5-10mg/kg every 6-8 hours (max 40mg/kg/day). The 600mg tablet is not appropriate for young children; use appropriate pediatric formulation

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; in older adults use caution and consider lower starting doses; avoid use in severe renal impairment and use caution/consider dose reduction in renal or hepatic impairment; titrate to response and tolerability.

Side Effects

Common Side Effects

Dyspepsia/indigestion (including heartburn), nausea (± vomiting), abdominal pain, diarrhea or constipation, flatulence, headache, dizziness.

Side Effect Frequency

Common (1-10%): dyspepsia, nausea, abdominal pain, diarrhea; headache. Uncommon (0.1-1%): rash, dizziness, gastritis, vomiting. Rare/very rare (<0.1%): GI ulceration/bleeding/perforation; severe cutaneous adverse reactions (e.g., SJS/TEN); renal impairment/failure; hypersensitivity reactions.

Safety & Warnings

Contraindications

Hypersensitivity to ibuprofen/other NSAIDs; history of NSAID/aspirin-induced asthma, urticaria or other allergic-type reactions (AERD); active GI bleeding or active peptic ulcer; peri-operative pain in the setting of CABG surgery; third trimester of pregnancy. Avoid/contraindicated in severe renal failure and severe hepatic impairment and in severe heart failure per standard NSAID labeling/clinical guidance.

Warnings & Precautions

Use the lowest effective dose for the shortest duration; increased risk of CV thrombotic events and worsening hypertension/heart failure/edema; increased risk of serious GI bleeding/ulcer/perforation (higher in elderly, prior ulcer/GI bleed, concomitant anticoagulants/antiplatelets/SSRIs/corticosteroids); renal toxicity risk (CKD, dehydration, diuretics/ACEi/ARB); hepatic injury (monitor if prolonged use); bronchospasm in asthma/AERD; may mask fever/infection; avoid in third trimester pregnancy and use caution earlier in pregnancy.

Drug Interactions

Drug Interactions

Clinically significant interactions include: anticoagulants (e.g., warfarin) and antiplatelets (including aspirin) ↑ bleeding; other NSAIDs ↑ GI/renal toxicity; ACE inhibitors/ARBs and diuretics ↑ AKI risk and may blunt antihypertensive/diuretic effect; lithium ↑ levels; methotrexate ↑ toxicity; corticosteroids and SSRIs/SNRIs ↑ GI bleeding; cyclosporine/tacrolimus ↑ nephrotoxicity; digoxin ↑ levels; ibuprofen may interfere with low-dose aspirin’s antiplatelet effect if taken concomitantly.

Food Interaction

Take with food

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Contraindicated

Children

Children 6 months to 12 years: 5-10mg/kg every 6-8 hours (max 40mg/kg/day). The 600mg tablet is not appropriate for young children; use appropriate pediatric formulation

Storage & Patient Advice

Patient Counseling

Take with food or milk and a full glass of water; use the lowest effective dose for the shortest time and do not combine with other NSAIDs; avoid alcohol/excess alcohol due to GI bleeding risk; seek urgent care for black/tarry stools, vomiting blood, severe abdominal pain, chest pain, shortness of breath, sudden weakness/slurred speech, or facial/leg swelling; tell your clinician if you have ulcer history, kidney disease, heart disease/heart failure, hypertension, are on anticoagulants/antiplatelets/SSRIs, or are pregnant-avoid in the 3rd trimester; this 600 mg strength is prescription-only and should not be shared.

Monitoring Requirements

Long-term or high-dose use: monitor blood pressure, renal function (SCr/eGFR), liver function tests, and CBC; monitor for GI bleeding/ulcer symptoms and for edema/heart failure or thrombotic events in at-risk patients.

Pharmacology

Mechanism of Action

Reversibly and nonselectively inhibits COX‑1 and COX‑2, decreasing prostaglandin synthesis, which reduces inflammation, pain, and fever.

Onset of Action

30-60 minutes.

Bioavailability

Approximately 80% (often cited range ~80-100% depending on formulation).

Product Information

Available Dosage Forms

For this SFDA-registered product: oral film‑coated tablet (600 mg). For ibuprofen generally: tablets/caplets (including film‑coated), capsules, oral suspension, oral drops (pediatric), chewable tablets (some markets), topical gel, and IV ibuprofen (where available).

Composition per Dose

Each film-coated tablet: 600mg ibuprofen

OTC Alternatives

Paracetamol (acetaminophen) and lower-strength OTC ibuprofen (e.g., 200 mg) where available; naproxen is an OTC alternative in some countries but availability varies by jurisdiction.

Pain Type

General/Muscular/Joint

Nsaid

Yes

Opioid

No

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.