Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CELECOXIB
MYLAN HEALTHCARE SDN. BHD.
CELECOXIB
1 X 10s Capsules; 3 X 10s Capsules; 10 x 10s Capsules
PFIZER PHARMACEUTICALS LLC
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ CEBREX ® Celecoxib (200 mg Capsule) PLD TITLE : CEBREX PLD DATE : 20 June 2023 COUNTRY : Malaysia REFERENCE DOCUMENT : Malaysia LPD dated 14 December 2021 REASON FOR CHANGE : TW 3000086 Update PRH details from Pfizer Parke Davis to Mylan Healthcare _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ CEBREX ® Celecoxib (200 mg Capsule) 1 WHAT IS IN THIS LEAFLET 1. What Cebrex is used for 2. How Cebrex works 3. Before you use Cebrex 4. How to use Cebrex 5. While you are using it 6. Side effects 7. Storage and Disposal of Cebrex 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT CEBREX IS USED FOR Cebrex is used for • Menstrual cramps or period pains. • Relief symptoms of joint pain, tenderness, swelling and stiffness in rheumatoid arthritis and osteoarthritis. • Relief of signs and symptoms of ankylosing spondylitis (a chronic inflammatory rheumatic disorder that primarily affects, but is not limited to, the spine). • The management of low back pain (100 mg and 200 mg only). HOW CEBREX WORKS Cebrex belongs to a group of medicinal products called nonsteroidal anti- inflammatory drugs (NSAID), and specifically a sub-group known as (COX-2) inhibitors. Your body makes prostaglandins that may cause pain and inflammation. In conditions such as rheumatoid arthritis and osteoarthritis your body makes more of these. Cebrex acts by reducing the production of prostaglandins, thereby reducing the pain and inflammation. BEFORE YOU TAKE CEBREX - _When you must not use it _ _ _ Tell your doctor if any of the following are true for you as patients with these conditions should not take Cebrex. _ _ • If you are allergic (hypersensitive) to celecoxib or any of the other ingredients of Cebrex • If you have had an allergic reaction to a group of medicines called “sulfonamides” (e.g. Some antibiotics used to treat infections) • If as a result of taking acetylsalicylic acid or any other anti-inflammatory and pain-relieving Lue koko asiakirja
1 CEBREX ® 200 MG CAPSULE 1. NAME OF THE MEDICINAL PRODUCT CEBREX 200 mg Capsule 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 200 mg capsule contains 200 mg celecoxib. 3. PHARMACEUTICAL FORM Hard capsules for oral use. 200 mg Capsules: Opaque white to off-white, hard gelatin capsule (containing white to off white granulation) with identifying markings, 200 mg marked with gold ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the management of acute pain in adults and for the treatment of primary dysmenorrhoea. Relief of the acute and chronic pain and inflammation of rheumatoid arthritis and osteoarthritis. Relief of signs and symptoms of ankylosing spondylitis. For the management of low back pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Celecoxib capsules can be taken with or without food. Given the association between cardiovascular (CV) risk and exposure to COX-2 inhibitors, doctors are advised to use the lowest effective dose for the shortest possible duration of treatment. ADULTS _SYMPTOMATIC TREATMENT OF OSTEOARTHRITIS (OA):_ The recommended dose of celecoxib is 200 mg administered as a single dose or as 100 mg twice per day. _SYMPTOMATIC TREATMENT OF RHEUMATOID ARTHRITIS (RA)_: The recommended dose of celecoxib is 100 mg or 200 mg twice per day. _ANKYLOSING SPONDYLITIS (AS)_: The recommended dose of celecoxib is 200 mg administered as a single dose or 100 mg twice per day. Some patients may benefit from a total daily dose of 400 mg. _MANAGEMENT OF ACUTE PAIN_: The recommended dose of celecoxib is 400 mg, initially, followed by an additional 200 mg dose, if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily, as needed. _TREATMENT OF PRIMARY DYSMENORRHEA_: The recommended dose of celecoxib is 400 mg, initially, followed by an additional 200 mg dose, if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily, as needed. _LOW BACK PAIN (LBP)_: Usual dosage for adults is 100 mg of celecoxib orally twice daily, morning and even Lue koko asiakirja