Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CELECOXIB
SYNERRV SDN BHD
CELECOXIB
3 x 10 Capsules; 10 x 10 Capsules
Macleods Pharmaceuticals Limited
_Consumer Medication Information Leaflet (RiMUP) _ CELEBIB 100/200 CELECOXIB CAPSULES 100 MG / 200 MG Page 1 of 3 WHAT IS IN THIS LEAFLET? 1) What Celebib 100 / 200 is used for 2) How Celebib 100 / 200 works 3) Before you use Celebib 100 / 200 4) How to use Celebib 100 / 200 5) While you are using Celebib 100 / 200 6) Side effects 7) Storage and Disposal of Celebib 100 / 200 8) Product Description 9) Manufacturer 10) Product Registration Holder 1. WHAT CELEBIB 100 / 200 IS USED FOR: Celebib 100 / 200 is used in acute pain in adults and for the treatment of primary dysmenorrhoea. Relief of acute and chronic pain and inflammation of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. 2. HOW CELEBIB 100 / 200 WORKS: Celecoxib 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. Celecoxib acts by reducing the production of prostaglandins, thereby reducing the pain and inflammation. You should expect your medicine to start working within hours of taking the first dose, but you may not experience a full effect for several days. 3. BEFORE YOU USE CELEBIB 100 / 200 : - _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 Celecoxib: • if you are allergic to celecoxib or any of the other ingredients of this medicine • if you have had an allergic reaction to a group of medicines called “sulphonamides” (e.g. some antibiotics used to treat infections) • if you currently have an ulcer in your stomach or intestines, or bleeding in your stomach or intestines • if as a result of taking acetylsalicylic acid or any other anti-inflammatory and pain-relieving medicine (NSAID) you have had asthma, nose polyps, severe nose congestion, or an allergic reaction such as an itch Baca dokumen lengkap
HEPATIC IMPAIRMENT: No dosage adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A). Introduce celecoxib at half the recommended dose in arthritis or pain patients with moderate hepatic impairment (Child-Pugh Class B). SYMPTOMATIC TREATMENT OF RHEUMATOID ARTHRITIS (RA): The recommended dose of celecoxib is 100 mg or 200 mg twice per day. CYP2C9 POOR METABOLIZERS: Patients who are known, or suspected to be CYP2C9 poor metabolizers based on genotyping or previous history/experience with other CYP2C9 substrates should be administered celecoxib with caution as the risk of dose-dependent adverse effects is increased. Consider reducing the dose to half the lowest recommended dose. 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. Adults 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. 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. RENAL IMPAIRMENT: No dosage adjustment is necessary in patients with mild or moderate renal impairment. There is no clinical experience in patients with severe renal impairment (see Special Warnings and Special Precautions for Use – Renal Effects). CHILDREN: Celecoxib is not indicated for use in children. Patients with severe hepatic impairment (Child-Pugh Class C) have not been studied (see Special Warnings and Special Precautions for Use - Hepatic Effects). LOW BACK PAIN (LBP): Usual dosage for adults is 100 mg of celecoxib orally twice daily, morning and evening after meal, or 200 mg once daily (100 mg and 200 mg only). SYMPTOMATIC TREATMENT OF OSTEOARTHRITIS (OA): Baca dokumen lengkap