Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**Recommended Dose** For oral administration and short-term use only. Adults, the elderly and children over 12 years: The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days. Take 1 caplet with water, up to three times a day as required. Leave at least 4 hours between doses. Do not take more than 3 caplets in any 24 hour period. **Route of administration** Oral
ORAL
Medical Information
**Indications** Nurofen Express is indicated for the relief of pain such as headache, migraine pain, dental pain, period pain, rheumatic pain, muscular pain and backache. It also relieves fever such as fever associated with cold & flu.
**Contraindications** Hypersensitivity to ibuprofen or any of the excipients in the product. Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs. Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding of perforation, related to previous NSAIDs therapy. Severe heart failure, renal failure or hepatic failure (see Special warnings and precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Last trimester of pregnancy (see Pregnancy and lactation – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). In patients who have recently undergone coronary artery bypass graft (CABG) surgery and revascularization procedures.
M01AE01
ibuprofen
Manufacturer Information
RECKITT BENCKISER (SINGAPORE) PTE LTD
Reckitt Benckiser Healthcare International Limited
Active Ingredients
Documents
Package Inserts
Nurofen Express Caplet 684mg_PI.pdf
Approved: October 18, 2021