Krajina: Malajzia
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CELECOXIB
VIATRIS SDN. BHD.
CELECOXIB
30Capsule Capsules; 10Capsule Capsules; 100Capsule Capsules
PFIZER PHARMACEUTICALS LLC
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ CELEBREX ® CAPSULES Celecoxib (100 mg, 200 mg, 400 mg) 1 WHAT IS IN THIS LEAFLET 1. What Celebrex is used for 2. How Celebrex works 3. Before you use Celebrex 4. How to use Celebrex 5. While you are using it 6. Side effects 7. Storage and Disposal of Celebrex 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT CELEBREX IS USED FOR Celebrex 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 CELEBREX WORKS Celebrex 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. Celebrex acts by reducing the production of prostaglandins, thereby reducing the pain and inflammation. BEFORE YOU USE CELEBREX - _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 Celebrex. If you are allergic (hypersensitive) to celecoxib or any of the other ingredients of Celebrex 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 medicine (NSAID) you have had asthma, , severe nose congestion, or an allergic reaction such as an itchy skin rash, swelling of the face, lips, tongue or throat, breathing difficulties or wheezing If you have been diagnosed with a heart attack, Prečítajte si celý dokument
1 1. NAME OF THE MEDICINAL PRODUCT CELEBREX 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100 mg capsule contains 100 mg celecoxib. Each 200 mg capsule contains 200 mg celecoxib. Each 400 mg capsule contains 400 mg celecoxib. 3. PHARMACEUTICAL FORM Hard capsules for oral use. 100 mg Capsules: Opaque white to off-white, hard gelatin capsule with identifying markings, 100 mg marked with blue ink. 200 mg Capsules: Opaque white to off-white, hard gelatin capsule with identifying markings, 200 mg marked with gold ink. 400 mg Capsules: Hard gelatin capsule (containing white to off white granulation), White opaque body with green ink band containing in white “400”. White opaque cap with green band containing in white “7767”. 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 (100 mg and 200 mg only). 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 dos Prečítajte si celý dokument