It is a film-coated tablet used to relieve mild to moderate pain of inflammatory origin and to reduce fever. It is suitable for short-term use in adults and adolescents from 12 years and older. The medicine belongs to the non-steroidal anti-inflammatory drug (NSAID) group and offers pain-relief, anti-inflammatory and fever-reducing actions.

What it is and what it is used for

Table of Contents

Active ingredient and class: Each film-coated tablet contains ibuprofen 400 mg, an NSAID with anti-inflammatory, pain-relieving and fever-reducing properties.

Indications/uses : Treatment of mild to moderate pain of inflammatory origin and fever, including:

Soft-tissue injuries (sprains and strains)
Headache
Back pain of musculoskeletal origin
Fever
Muscular aches and pains
Menstrual pain
Dental pain
Pain associated with migraine
Earache

How it works

Ibuprofen works through antiprostaglandin properties, which reduces substances in the body (prostaglandins) that contribute to inflammation, pain and fever. In practical terms, lowering these signals can ease sore, swollen tissues and bring down a raised temperature.

Absorption note: After an oral dose on an empty stomach, peak levels occur at about 45 minutes. When taken with food, absorption is slower, and peak levels are lower.

Who should NOT use this medicine

Do not use BRUFEN 400 EXTRA STRENGTH if you:

Have peptic ulceration or a history of GI perforation, ulceration, or bleeding linked to previous NSAID use
Have an active or recurrent ulcer, haemorrhage, or perforation
Are in the third trimester of pregnancy or in labour
Are hypersensitive to ibuprofen, aspirin, or any other NSAID (cross-sensitivity can occur)
Have heart failure
Have renal (kidney) failure

Not for children under 12 years.

Warnings and precautions (Read before use)

Cardiovascular and fluid retention: Use caution if you have a history of hypertension or heart failure; oedema and fluid retention have been reported. BRUFEN 400 EXTRA STRENGTH can precipitate heart failure in compromised patients.
Older adults: The elderly have a higher rate of adverse reactions, especially GI perforation, ulceration and bleeding (PUBs), which may be fatal.
GI risk: The risk of PUBs increases at higher doses, in those with a history of ulcers, and in the elderly. Stop treatment if GI bleeding or ulceration occurs.
Existing GI disease: Use with care in ulcerative colitis, Crohn’s disease, hiatus hernia, gastro-oesophageal reflux disease, or angiodysplasia, as these may be exacerbated.
Serious skin reactions: Rare but severe reactions have been reported, including exfoliative dermatitis, Stevens–Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). Stop at the first sign of skin rash, mucosal lesions, or other hypersensitivity features.
Pregnancy (third trimester): Regular NSAID use may cause premature closure of the foetal ductus arteriosus and possibly persistent pulmonary hypertension of the newborn; labour onset may be delayed and duration increased.
Sugar intolerance: Contains lactose monohydrate. Do not use if you have galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
Asthma and allergic disease: Use carefully in asthma or bronchospasm; hypersensitivity to aspirin/NSAIDs suggests higher risk.
Bleeding disorders and anticoagulants: Use with care in bleeding disorders or if taking warfarin or other anticoagulants.
Liver and kidney: Use cautiously in liver or renal failure. People with congestive heart failure, cirrhosis, diuretic-induced volume depletion, or renal insufficiency may rely on prostaglandins to maintain kidney perfusion and are at greater risk of renal dysfunction on NSAIDs.
Vision changes: Stop ibuprofen if you develop blurred or reduced vision or changes in colour vision.
Collagen disease: Patients with collagen disease may have an increased risk of aseptic meningitis.
Driving and machinery: Dizziness, drowsiness, fatigue, and visual disturbances may occur. If affected, do not drive or operate machinery.

Warning: If you notice black stools, vomiting blood, severe abdominal pain, a widespread rash, blistering skin, sudden breathing difficulty, facial swelling, or a dramatic drop in urine output, stop taking the medicine and seek medical advice urgently.

Pregnancy, planning pregnancy, and breastfeeding

Pregnancy: Do not use in the third trimester or during labour. Regular NSAID use in late pregnancy may lead to premature closure of the foetal ductus arteriosus and possibly persistent pulmonary hypertension of the newborn; labour may be delayed and last longer.
Planning pregnancy: Not specified in the source. Speak to your doctor or pharmacist before use.
Breastfeeding: Not specified in the source. Speak to your doctor or pharmacist before use.

Interactions

Use caution and discuss with a healthcare professional if you take any of the following :

Antihypertensives (including ACE inhibitors), beta-blockers, diuretics: Ibuprofen may reduce their effect; diuretics can increase nephrotoxicity risk.
Other NSAIDs: Using two or more NSAIDs together may increase side effects.
Corticosteroids: Higher risk of GI perforation, ulceration or bleeding (PUBs).
Anticoagulants (e.g., warfarin): Effects may be enhanced.
Antiplatelet medicines and SSRIs: Increased risk of GI bleeding.
Digoxin: May exacerbate cardiac failure, reduce GFR, and increase plasma digoxin levels.
Lithium: Decreased elimination of lithium.
Ciclosporin: Increased risk of nephrotoxicity.
Mifepristone: A theoretical decrease in efficacy due to antiprostaglandin action; limited evidence suggests co-administration on the day of prostaglandin does not reduce efficacy for medical termination.
Quinolone antibiotics: Animal data suggest NSAIDs increase risk of convulsions; combined use may raise seizure risk.
Aminoglycosides: Decreased excretion may occur.
Herbal extracts: Ginkgo biloba may increase bleeding risk.

How to take (Step-by-step)

Check suitability: Ensure you are 12 years or older and none of the contraindications apply (e.g., active ulcer, heart failure, renal failure, third-trimester pregnancy, labour, or known NSAID hypersensitivity).
Dose and timing: The recommended adult dose is 1 tablet (400 mg) every 8 hours.
Daily maximum: Do not exceed 1,200 mg in 24 hours (i.e., three 400 mg tablets).
Duration: Use the lowest effective dose for the shortest possible time needed for symptom relief.
Food and absorption: The medicine is absorbed more slowly after food and reaches peak levels faster when taken on an empty stomach.
Missed dose: Not specified in the source.
Overdose: The most likely symptoms include epigastric (upper tummy) pain and nausea. There is no specific antidote; treatment is supportive. Seek urgent medical assistance if too many tablets are taken.

Dosing table

Age group	Dose per intake	Frequency	Maximum daily dose	Notes
Adults and ≥ 12 years	400 mg (1 tablet)	Every 8 hours	1,200 mg	Use the lowest effective dose for the shortest time
Children < 12 years	–	–	–	Not to be given

Indications covered by the above dosing: mild to moderate pain of inflammatory origin (including sprains, strains, dental pain, back pain of musculoskeletal origin, pain associated with migraine, muscular aches, earache, menstrual pain) and fever.

Possible side effects

Below are effects reported with ibuprofen as listed in the source. Stop the medicine and seek medical advice if serious symptoms appear.

Common frequent

Gastrointestinal (most commonly observed): Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia (indigestion), abdominal pain, melaena (black stools), haematemesis (vomiting blood), ulcerative stomatitis, gastritis; peptic ulcers, perforation or GI bleeding (sometimes fatal); worsening of colitis or Crohn’s disease
Nervous system (frequent): Dizziness, nervousness, tinnitus (ringing in the ears), drowsiness, insomnia
Psychiatric (frequent): Depression

Less common

Gastrointestinal (less frequent): Abdominal discomfort or pain, nausea, vomiting, GI ulcers (sometimes with bleeding)
Renal and urinary (less frequent): Acute renal failure, cystitis, haematuria (blood in urine), interstitial nephritis, nephrotic syndrome
Hepatobiliary (less frequent): Hepatotoxicity, abnormalities in liver function tests
Blood and lymphatic (less frequent): Anaemia, thrombocytopenia (low platelets), neutropenia (low neutrophils), eosinophilia, agranulocytosis
Immune (less frequent): Aseptic meningitis, angio-oedema, anaphylaxis
Hypersensitivity (less frequent): Fever, rashes, exacerbation of asthma, bronchospasm
Eye disorders: Visual impairment, changes in colour perception, toxic amblyopia

Serious — seek urgent help

GI perforation, ulceration or bleeding (can be fatal)
Severe skin reactions (bullous reactions) including Stevens–Johnson syndrome and toxic epidermal necrolysis (frequency unknown)
Cardiovascular: Oedema, hypertension, cardiac failure (frequency unknown)
Severe allergic reactions: Anaphylaxis or angio-oedema
Acute kidney problems: Acute renal failure
Neurological: Aseptic meningitis

What to do: Stop taking the medicine and seek medical advice immediately if you develop any serious symptom such as black stools, vomiting blood, blistering rash, extensive skin peeling, wheeze or sudden breathing difficulty, facial swelling, severe tummy pain, or markedly reduced urine output.

Storage and disposal

Store at or below 25 °C.
Keep out of reach of children.

What the medicine contains

Active ingredient: Ibuprofen 400 mg per film-coated tablet
Excipients: Microcrystalline cellulose, croscamellose sodium, lactose monohydrate, colloidal anhydrous silica, sodium lauryl sulfate, magnesium stearate, hypromellose, titanium dioxide, purified water, industrial methylated spirit, dry colour dispersion (white 06A28611), opaspray white M-1-7111B
Allergen/sugar note: Contains lactose monohydrate

Pack information and appearance

Appearance: White, pillow-shaped, film-coated tablet
Packs: Blister strips of 10 tablets per pack (PVC/Aluminium or PVC/PVDC/Aluminium)
Applicant: Abbott Laboratories S.A. (Pty) Limited

FAQs

1) What conditions can BRUFEN 400 EXTRA STRENGTH treat?
It relieves mild to moderate pain of inflammatory origin (e.g., sprains, strains, back pain of musculoskeletal origin, muscular aches, dental pain, menstrual pain, pain associated with migraine, earache) and fever.

2) How quickly does it work?
After a dose on an empty stomach, peak blood levels are reached in about 45 minutes. Absorption is slower after food.

3) What is the usual adult dose and maximum daily amount?
400 mg every 8 hours, with a maximum of 1,200 mg per day.

4) Can children take it?
No. It is not to be given to children under 12 years.

5) Can I use it in late pregnancy or during labour?
No. Do not use in the third trimester or during labour.

6) I have heart failure or kidney failure. Can I take it?
No. It is contraindicated in heart failure and in renal failure.

7) Does it affect driving or operating machines?
It can cause dizziness, drowsiness, fatigue, and visual disturbances. If affected, do not drive or operate machinery.

8) Can I take it with my blood pressure tablets or water tablets (diuretics)?
It may reduce the effect of antihypertensives (including ACE inhibitors and beta-blockers) and diuretics, and diuretics may increase kidney risk.

9) Can I combine it with other painkillers like aspirin or another NSAID?
Using two or more NSAIDs together may increase side effects; it is not recommended.

10) Does it contain lactose?
Yes. It contains lactose monohydrate and should not be used by people with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

11) I’m on warfarin or an SSRI — is that a problem?
Ibuprofen may enhance the effects of anticoagulants (e.g., warfarin) and, with SSRIs, may increase GI bleeding risk. Discuss with a healthcare professional.

12) What should I do if I notice black stools or vomit blood?
Stop the medicine. These can indicate GI bleeding, which is a serious side effect. Seek medical advice urgently.

Militian Inessa Mesropovna

Education:
Sochi Medical College 2014 – 2017

Work experience:
2017 – to date Sochi Pharmacy – Pharmacist