País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
IBUPROFEN
MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.
IBUPROFEN
60 ml
MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 PRUFEN ORAL SUSPENSION 100MG/5ML Ibuprofen (100mg/5ml) WHAT IS IN THIS LEAFLET: 1. What Prufen Oral Suspension is used for 2. How Prufen Oral Suspension works 3. Before you use Prufen Oral Suspension 4. How to use Prufen Oral Suspension 5. While you are using it 6. Side effects 7. Storage and Disposal of Prufen Oral Suspension 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT PRUFEN ORAL SUSPENSION IS USED FOR Ibuprofen is the active ingredient of Prufen Oral Suspension. It is indicated for the relief of fever and pain the children older than 6 months and control of symptoms associated with juvenile arthritis (inflammation of the synovium in children aged 16 or younger) and dysmenorrhoea (painful menstruation). HOW PRUFEN ORAL SUSPENSION WORKS Ibuprofen is a non-steroidal anti- inflammatory agent that possesses analgesic (relieve pain), antipyretic (reduce fever) and anti- inflammatory activities. The mode of action, like that of other NSAIDs may be related to prostaglandin synthetase inhibition (prevent production of prostaglandin). BEFORE YOU USE PRUFEN ORAL SUSPENSION - _When you must not use it _ If you are allergic (hypersensitive) to ibuprofen and other ingredients of the oral suspension. If you are sensitive to aspirin or other NSAID drugs i.e if you develop bronchospasm (constriction of the airway), angioedema (swelling of your skin), nasal polyps or urticaria (itching or hives) with those drugs or with a history of bronchial asthma. If you have stomach and intestinal bleeding or in the presence of peptic ulceration. If you are pregnant or a nursing mother - _Before you start to use it_ You must tell your doctor if: You have allergies to any medicine which you have taken previously to treat your current condition. You are pregnant, trying to become pregnant or breast- feeding. You have bleeding disorders. You have kidney, heart or liver problem. You have or have had ulcer Llegiu el document complet
7119-06 PRUFEN ORAL SUSPENSION 100MG/5ML NAME AND STRENGTH OF ACTIVE INGREDIENT(S): Each 5ml of suspension contains: IBUPROFEN …………………………………………………100mg PRODUCT DESCRIPTION: An orange coloured suspension with tutti frutti flavour and sweet sour taste. PHARMACODYNAMICS : Ibuprofen is a non-steroidal anti-inflammatory agent that possesses analgesic, antipyretic and anti-inflammatory activities. Its mode of action, like that of other NSAIDs, is not completely understood, but may be related to prostaglandin synthetase inhibition. PHARMACOKINETICS: Ibuprofen is absorbed from the gastro-intestinal tract and peak plasma concentrations occur about 1 to 2 hours after ingestion. Ibuprofen is extensively bound to plasma proteins and has a half-life of about 2 hours. It is rapidly excreted in the urine mainly as metabolites and their conjugates. About 1% is excreted in urine as unchanged ibuprofen and about 14% as conjugated ibuprofen. INDICATION: It is indicated for the relief of fever and pain in children older than 6 months, control of symptoms associated with juvenile arthritis and dysmenorrhoea. RECOMMENDED DOSAGE: To be taken orally. It may be given with food or milk to reduce gastro-intestinal disturbances. _SHAKE WELL PRIOR TO ADMINISTRATION. _ Fever : Children 6 months to 12 years old : 5 –10 mg/kg body weight up to maximum of daily dose 40 mg/kg daily for temperature below or above 39 C, respectively. This can be achieved as follows : 6 months – 2 years : 2.5 ml, three to four times a day 3 – 7 years : 5 ml, three to four times a day 8 –12 years : 10 ml, three to four times a day ROUTE OF ADMINISTRATION: Oral CONTRAINDICATIONS: 1. Known hypersensitivity to ibuprofen. 2. Sensitivity to aspirin or other NSAID drugs i.e. in patients who develop bronchospasm, angioedema, nasal polyps or urticaria with those drugs or with a history of bronchial asthma. 3. Ibuprofen should not be used in active gastro-intestinal bleeding or in the presence of peptic ulceration. 4. Use in p Llegiu el document complet