Cenex

Cenex

celecoxib

Manufacturer:

Nexpharm

Distributor:

Star Medical Supplies
Full Prescribing Info
Contents
Celecoxib.
Description
Excipients/Inactive Ingredients: D-Mannitol, Sodium Lauryl Sulfate, Hydroxypropylcellulose, Crospovidone, Magnesium Stearate, Gelatin, Titanium Dioxide, Purified water, Shellac 51% IN SD-35A Alcohol, Iron oxide yellow, N-Butyl Alcohol and Isopropyl Alcohol.
Indications/Uses
Cenex is indicated in adults for the symptomatic relief in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
Dosage/Direction for Use
Cenex should be used at the lowest effective dose for shortest possible time.
The recommended dose is: Osteoarthritis: One 200mg capsule once a day increased by the doctor to max. 400mg if needed.
Rheumatoid Arthritis: Increased by the doctor to max. 400mg if needed.
Ankylosing spondylitis: One 200mg capsule once a day increased by the doctor to max. 400mg if needed.
Kidney or liver problem: Make sure the doctor knows if the patient has liver or kidney problems as the patient may need a lower dose.
The elderly, especially those with a weight less than 50kg: If the patient is over 65 years of age and especially if the patient weighs less than 50kg, the doctor may want to monitor the patient more closely, the patient should not take more than 400mg per day.
Use in children: Cenex is for adults only, it is not for use in children.
If the patient forgets to take Cenex: If the patient forgets to take a capsule, the patient should take it as soon as he/she remembers. Do not take a double dose to make up for a forgotten dose.
If the patient stops to take Cenex: Suddenly stopping treatment with Cenex may lead to symptoms getting worse. Do not stop taking Cenex unless the doctor tells to. The doctor may tell the patient to reduce the dose over a few days before stopping completely.
Overdosage
If the patient takes too many capsules, the doctor, pharmacist or hospital must be contacted and the patient must take the medicine with him/her.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in Description.
Known hypersensitivity to sulphonamides.
Active peptic ulceration or gastrointestinal bleeding.
Have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic type reactions after taking acetylsalicylic acid or other NSAIDs including COX-2 inhibitors.
In pregnancy and in women of childbearing potential unless using an effective method of contraception.
Breast-feeding.
Severe hepatic dysfunction.
Patients with estimated creatinine clearance < 30ml/min.
Inflammatory bowel disease.
Congestive heart failure NYHA II-IV.
Established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
In patient with severe heart failure.
For the treatment of peri-operative pain in the setting of coronary artery bypass graft surgery.
Warnings
In rare cases, Cenex has been associated with serious liver injury.
Fatalities associated with the administration of sulfonamides, although rare, have occurred due to severe reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.
Special Precautions
Before the patient takes Cenex, the doctor must be told if the patient has: Previously had an ulcer or bleeding in his/her stomach or intestines (The patient must not take Cenex if he/she currently has an ulcer or bleeding in the stomach or intestine).
Medicine to reduce blood clotting.
Taking acetylsalicylic acid.
Medicine called corticosteroids.
Using Cenex at the same time as other non-acetylsalicylic NSAID such as ibuprofen or diclofenac. The use of these medicines together should be avoided.
Heart, liver or kidneys dysfunction.
Smoking, has diabetes, raised blood pressure or raised cholesterol.
Fluid retention.
Dehydration, for instance due to sickness, diarrhea or the use of diuretics.
A serious allergic reaction or a serious skin reaction to any medicines.
Illness due to infection or think the patient has an infection, as Cenex may mask a fever or other signs of infection and inflammation.
Age over 65 years the doctor will want to monitor the patient regularly.
The consumption of alcohol and NSAID may increase the risk of gastrointestinal problem.
Cardiovascular Risk: NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
Gastrointestinal Risk: NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
Renal Effects: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretic and ACE inhibitors, and the elderly.
Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
Advanced Renal Disease: No information is available from controlled clinical studies regarding the use of "Cenex" in patients with advanced renal disease. Therefore, treatment with "Cenex" is not recommended in these patients with advanced renal disease. If therapy must be initiated, close monitoring of the patient's renal function is advisable.
Driving and using machines: The patient should be aware of how he/she reacts to Cenex before driving or operating machinery. If the patient feels dizzy or drowsy after taking Cenex, he/she must not drive or operate machinery until these effects wear off.
Use In Pregnancy & Lactation
If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby the doctor or pharmacist must be asked for advice before taking this medicine.
Pregnancy: Cenex must not be used by women who are pregnant or can become pregnant during ongoing treatment. If happen, the doctor must be asked for alternative treatment.
Breast-feeding: Cenex must not be used during breast-feeding.
Fertility: NSAID, including Cenex may make it more difficult to become pregnant. The patient should tell the doctor if she is planning to become pregnant or if she has problems becoming pregnant.
Side Effects
Like all medicines, Cenex may cause side effects.
STOP taking Cenex and contact the doctor immediately if the patient develops any of these symptoms: An allergic reaction such as skin rash, swelling of the face, wheezing or difficult breathing.
Heart problems such as pain in the chest.
Severe stomach pain or any sign of bleeding in the stomach or intestines, such as passing black or bloodstained stools or vomiting blood.
A skin reaction such as rash, blistering or peeling of the skin.
Liver failure.
If the patient develops any of the side effects described, or if the patient has any other unusual symptoms or feelings not listed, the doctor or pharmacist must be contacted as soon as possible.
Drug Interactions
Before the patient starts to take Cenex the doctor or pharmacist must be told about any other medication that the patient is taking or plans to take, including herbal medicines and natural products.
In particular the patient must tell the doctor if he/she is taking, have recently taken or might take: Dextromethorphan; ACE inhibitors, angiotensin II antagonists, beta blockers and diuretics; Fluconazole and rifampicin; Warfarin or other warfarin like medicines; Lithium; Other medicines to treat depression, sleep disorders, high blood pressure or an irregular heartbeat; Neuroleptics; Methotrexate; Carbamazepine; Barbiturates; Ciclosporin and tacrolimus.
Cenex can be taken with low dose acetylsalicylic acid (75mg or less daily). The doctor must be asked for advice before taking both medicines together.
Storage
Store below 25°C.
ATC Classification
M01AH01 - celecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Presentation/Packing
Cap 200 mg x 10 x 10's.
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