Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
CAPSULE, LIQUID FILLED
**Recommended Dosage****Adults and children over 12 years** For oral use and short-term use only. Capsules should not be chewed. Single dose: 1–2 liquid capsule of 200mg respectively. 1 liquid capsule of 400mg. If necessary, take additional doses of 1 or 2 capsules (200mg ibuprofen) or 1 capsule (400mg ibuprofen) but do not exceed a total dose of 1200mg ibuprofen in any 24-hour period. The dosing interval should not be below 4 hours for the 200mg dose and not below 6 hours for the 400mg dose. If this product is required for more than 3 days, or if the symptoms worsen, the patient is advised to consult a doctor. It is recommended that patients with sensitive stomachs take Nurofen Express Liquid Capsules with food. If taken shortly after eating, the onset of action of Nurofen Express Liquid Capsules may be delayed. If this happens, do not take more Nurofen Express Liquid Capsules than recommended or until the correct re-dosing interval has passed.
ORAL
Medical Information
**Indications** Nurofen Express Liquid Capsules are indicated for the relief of pain such as headache, dental pain, period pain, rheumatic pain, muscular pain and backache. Nurofen Express Liquid Capsules also relieve fever such as fever associated with cold & flu.
**Contraindications** - Hypersensitivity to ibuprofen, ponceau 4R (E124) or to any of the excipients - In patients with a history of hypersensitivity reactions (e.g. bronchospasm, asthma, rhinitis, angioedema or urticaria) associated with the intake of acetylsalicylic acid (ASA) or other non-steroidal anti-inflammatory drugs (NSAIDs) - Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) - History of gastrointestinal bleeding or perforation related to previous NSAIDs therapy - Patients with severe hepatic failure, severe renal failure, coronary heart disease or severe heart failure (see also section Warnings and Precautions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) - In patients with cerebrovascular or other active bleeding - In patients with bleeding diathesis or coagulation disorders - In patients with unclarified blood-formation disturbances - In patients with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake) - In patients who have recently undergone coronary artery bypass graft (CABG) surgery and re-vascularization procedures - The last trimester of pregnancy (see section Pregnancy and Lactation – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) - Adolescents weighing less than 40 kg or children under 12 years of age
M01AE01
ibuprofen
Manufacturer Information
RECKITT BENCKISER (SINGAPORE) PTE LTD
Patheon Softgels B.V
Reckitt Benckiser Healthcare International Limited (Primary and Secondary Packager)
Active Ingredients
Documents
Package Inserts
Nurofen Express Liquid Capsule 400mg PI.pdf
Approved: October 18, 2021