Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
ibuprofen, Quantity: 400 mg
Reckitt Benckiser Pty Ltd
Ibuprofen
Tablet, sugar coated
Excipient Ingredients: titanium dioxide; sodium citrate dihydrate; purified talc; Acacia; colloidal anhydrous silica; sucrose; stearic acid; macrogol 6000; croscarmellose sodium; sodium lauryl sulfate; carmellose sodium; propylene glycol; butan-1-ol; isopropyl alcohol; iron oxide red; strong ammonia solution; simethicone; ethanol; Shellac; sulfuric acid
Oral
10, 12, 8, 2, 4, 20, 36, 30, 48, 24, 50, 40
(S2) Pharmacy Medicine, (S3) Pharmacist Only Medicine
The temporary relief of pain (and discomfort) associated with headache, migraine headache, tension headache, sinus pain, toothache, dental procedures, backache, muscular aches and pains, period pain, sore throat, tennis elbow, arthritis, rheumatic pain and the aches and pains associated with colds and flu. Reduces fever.
Visual Identification: white to off-white, biconvex, sugar coated tablet printed with an identifying logo in red on one face.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2007-07-11
Nurofen Double Strength 1 NUROFEN DOUBLE STRENGTH ACTIVE INGREDIENT(S): ibuprofen 400mg CONSUMER MEDICINE INFORMATION (CMI) This leaflet provides important information about using Nurofen Double Strength. YOU SHOULD ALSO SPEAK TO YOUR DOCTOR OR PHARMACIST IF YOU WOULD LIKE FURTHER INFORMATION OR IF YOU HAVE ANY CONCERNS OR QUESTIONS ABOUT USING NUROFEN DOUBLE STRENGTH. WHERE TO FIND INFORMATION IN THIS LEAFLET: 1. Why am I using Nurofen Double Strength? 2. What should I know before I use Nurofen Double Strength? 3. What if I am taking other medicines? 4. How do I use Nurofen Double Strength? 5. What should I know while using Nurofen Double Strength? 6. Are there any side effects? 7. Product details 1. WHY AM I USING NUROFEN DOUBLE STRENGTH? NUROFEN DOUBLE STRENGTH CONTAINS THE ACTIVE INGREDIENT IBUPROFEN. Nurofen Double Strength is a Pharmacy Medicine (pack size of 12 or less) and Pharmacist Only. NUROFEN DOUBLE STRENGTH IS USED FOR THE TEMPORARY RELIEF OF PAIN AND/OR INFLAMMATION ASSOCIATED WITH HEADACHE, MIGRAINE HEADACHE, TENSION HEADACHE, SINUS PAIN, TOOTHACHE, DENTAL PROCEDURES, BACKACHE, MUSCULAR ACHES AND PAINS, PERIOD PAIN, SORE THROAT, TENNIS ELBOW, ARTHRITIS, RHEUMATIC PAIN AND THE ACHES AND PAINS ASSOCIATED WITH COLDS AND FLU. IT ALSO REDUCES FEVER. 2. WHAT SHOULD I KNOW BEFORE I USE NUROFEN DOUBLE STRENGTH? WARNINGS DO NOT USE NUROFEN DOUBLE STRENGTH IF: • you are allergic to ibuprofen or any of the ingredients listed at the end of this leaflet. • Some of the symptoms of an allergic reaction may include: - shortness of breath - wheezing or difficulty breathing - swelling of the face, lips, tongue, or other parts of the body - rash, itching or hives on the skin • Always check the ingredients to make sure you can use this medicine • You are in the third trimester of pregnancy. • For children under 12 years of age • you have the following conditions: - liver or kidney disease - renal impairment - heart problems - asthma - a stomach or duodenal ulcer or if you have had either of these conditio Прочитать полный документ
Nurofen Double Strength Tablets PI December 2021 1 AUSTRALIAN PRODUCT INFORMATION – NUROFEN ® DOUBLE STRENGTH TABLETS (IBUPROFEN) 1 NAME OF THE MEDICINE Ibuprofen 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains ibuprofen 400mg. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Nurofen DOUBLE STRENGTH tablets: white to off-white biconvex sugar-coated tablets with « Nurofen 400 » printed in red on one face. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Nurofen Double Strength is indicated for the temporary relief of pain and/or inflammation associated with headache, migraine headache, tension headache, sinus pain, toothache, dental procedures, backache, muscular aches and pains, period pain, sore throat, tennis elbow, arthritis, rheumatic pain and the aches and pains associated with colds and flu. Reduces fever. 4.2 D OSE AND METHOD OF ADMINISTRATION The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). • Dosage: _Adults and Children 12 years & over:_ One tablet to be taken with or without food. If necessary, repeat every 4-6 hours Pregnancy: see Section 4.3 Contraindications and Section 4.6 Fertility, pregnancy and lactation. Not recommended for children under 12. • Maximum tolerated daily dose: Maximum 3 tablets in 24 hours. Nurofen Double Strength should not be used for more than 3 days a time, except on medical advice, in which case the patient should be reviewed regularly with regards to efficacy, risk factors and ongoing need for treatment. • Monitoring advice If symptoms persist, please consult your healthcare professional. 4.3 C ONTRAINDICATIONS Nurofen Double Strength is contraindicated for use in patients with: Nurofen Double Strength Tablets PI December 2021 2 • known hypersensitivity or idiosyncratic reaction to ibuprofen (or any of the other ingredients in the product) • known hypersensitivity to aspirin and other NSAIDs • asthma that is aspirin or NSAID sensitiv Прочитать полный документ