Cobix Capsules (Generic Celecoxib Capsules)

1. Cobix Capsules (Generic Celecoxib Capsules) © The Swiss Pharmacy

2. Cobix Capsules (Generic Celecoxib Capsules) Cobix (Generic Celecoxib Capsules) is used for the management of the signs and symptoms of Osteoarthritis (OA), for the management of the signs and symptoms of Rheumatoid Arthritis (RA), for the management of the signs and symptoms of Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older , for the management of the signs and symptoms of Ankylosing Spondylitis (AS), for the management of acute pain in adults and for the management of primary dysmenorrhea. © The Swiss Pharmacy

3. Cobix Capsules (Generic Celecoxib Capsules) Cobix Capsules (Generic Celecoxib Capsules) are manufactured by Cipla Limited, India in the strengths of 100 mg and 200 mg. © The Swiss Pharmacy

4. Cobix Capsules (Generic Celecoxib Capsules) Chemical Structure © The Swiss Pharmacy

5. Cobix Capsules (Generic Celecoxib Capsules) The active pharmaceutical ingredient contained in Cobix capsules is Celecoxib. Each hard gelatin Cobix capsule contains 100 mg or 200 mg of Celecoxib. © The Swiss Pharmacy

6. Cobix Capsules (Generic Celecoxib Capsules) Uses of Cobix 100 mg and 200 mg Capsules: Cobix (Generic Celecoxib Capsules) is is a nonsteroidal anti- inflammatory drug (NSAID) used in adults for the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, juvenile rheumatoid arthritis and ankylosing spondylitis. However, this medicine does not cure arthritis and will help you only as long as you continue to take it. Celecoxib is also used to treat ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine. This medicine may also be used to treat acute pain and menstrual cramps. Celecoxib is also used to treat acute migraine headaches with or without aura. However, this medicine is not used to prevent migraines. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html © The Swiss Pharmacy

7. Cobix Capsules (Generic Celecoxib Capsules) Uses of Cobix 100 mg and 200 mg Capsules: 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html © The Swiss Pharmacy

8. Cobix Capsules (Generic Celecoxib Capsules) Recommended Adult Dosage Use the lowest effective Cobix Capsules Cobix Capsules (Generic Celecoxib Capsules) dosage for shortest duration consistent with individual patient treatment goals. The dosage for the various indications is given below: Osteoarthritis (OA): Osteoarthritis (OA): 200 mg once daily or 100 mg twice daily. Rheumatoid Arthritis (RA): 100 mg to 200 mg twice daily. Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older: Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older: 50 mg twice daily in patients 10-25 kg. 100 mg twice daily in patients more than 25 kg. Ankylosing Spondylitis (AS): Ankylosing Spondylitis (AS): 200 mg once daily single dose or 100 mg twice daily. If no effect is observed after 6 weeks, a trial of 400 mg (single or divided doses) may be of benefit. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html © The Swiss Pharmacy

9. Cobix Capsules (Generic Celecoxib Capsules) Recommended Adult Dosage Acute Pain (AP) and Primary Dysmenorrhea (PD): Acute Pain (AP) and Primary Dysmenorrhea (PD): 400 mg initially, followed by 200 mg dose if needed on first day. On subsequent days, 200 mg twice daily as needed. Hepatic Impairment: Hepatic Impairment: Reduce daily dose by 50% in patients with moderate hepatic impairment (Child-Pugh Class B).Consider a dose reduction by 50% (or alternative management for JRA) in patients who are known or suspected to be CYP2C9 poor metabolizers. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html © The Swiss Pharmacy

10. Cobix Capsules (Generic Celecoxib Capsules) Contraindications ➔Cobix Capsules are contraindicated in patients with a known hypersensitivity to Celecoxib, Sulfonamides or any component of the tablet. ➔Cobix capsules must not be used in patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. ➔Use of Cobix capsules during the perioperative period in the setting of coronary artery bypass graft (CABG) surgery is contraindicated. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html © The Swiss Pharmacy

11. Cobix Capsules (Generic Celecoxib Capsules) Storage Instructions Cobix Capsules (Generic Celecoxib Capsules) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html © The Swiss Pharmacy

12. Cobix Capsules (Generic Celecoxib Capsules) Warnings Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure. Heart Failure and Edema: Avoid use of Celecoxib in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html © The Swiss Pharmacy

13. Cobix Capsules (Generic Celecoxib Capsules) Warnings Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of Celecoxib in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function. Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs. Exacerbation of Asthma Related to Aspirin Sensitivity: Celecoxib is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity). Serious Skin Reactions: Discontinue Celecoxib at first appearance of skin rash or other signs of hypersensitivity. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html © The Swiss Pharmacy

14. Cobix Capsules (Generic Celecoxib Capsules) Warnings Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically. Fetal Toxicity: Limit use of NSAIDs, including Celecoxib, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios /fetal renal dysfunction and premature closure of the fetal ductus arteriosus. Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html © The Swiss Pharmacy

15. Cobix Capsules (Generic Celecoxib Capsules) Driving And Using Machines You should be aware of how you react to Celecoxib (Cobix capsules) before you drive or operate machinery. If you feel dizzy or drowsy after taking Celecoxib, do not drive or operate machinery until these effects wear off. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html © The Swiss Pharmacy

16. Cobix Capsules (Generic Celecoxib Capsules) Possible Side Effects The Most common Side Effects of Celecoxib capsules (Cobix capsules) during arthritis trials with an incidence rate of 2% and greater and more than placebo are: abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, rash. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html © The Swiss Pharmacy

17. Cobix Capsules (Generic Celecoxib Capsules) Cobix Capsules Overdosage Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare. No overdoses of Celecoxib capsules (Cobix capsules) were reported during clinical trials. Doses up to 2400 mg/day for up to 10 days in 12 patients did not result in serious toxicity. No information is available regarding the removal of Celecoxib by hemodialysis, but based on its high degree of plasma protein binding (greater than 97%) dialysis is unlikely to be useful in overdose. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html © The Swiss Pharmacy

18. Cobix Capsules (Generic Celecoxib Capsules) Treatment of Cobix Capsules Overdosage Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html © The Swiss Pharmacy

19. Cobix Capsules (Generic Celecoxib Capsules) Cobix Capsules During Pregnancy Celecoxib (Cobix capsules) is classified by the US FDA as Pregnancy Category C prior to 30 weeks gestation and Pregnancy Category D starting at 30 weeks gestation. Celecoxib must not be used by women who are pregnant or can become pregnant (i.e. women of child bearing potential who are not using adequate contraception) during ongoing treatment. If you become pregnant during treatment with Celecoxib you should discontinue the treatment and contact your doctor for alternative treatment. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html © The Swiss Pharmacy

20. Cobix Capsules (Generic Celecoxib Capsules) Cobix Capsules During Pregnancy Use of NSAIDs, including Celecoxib (Cobix capsules), can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of Celecoxib capsules use between about 20 and 30 weeks of gestation and avoid Cobix use at about 30 weeks of gestation and later in pregnancy. Use of NSAIDs, including Celecoxib (Cobix capsules), at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html © The Swiss Pharmacy

21. Cobix Capsules (Generic Celecoxib Capsules) Cobix Capsules Cobix Capsules (Generic Celecoxib Capsules) are manufactured by Cipla Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9901_Cobix-Capsules.html © The Swiss Pharmacy