Etoricoxib Teva

Etoricoxib.

Each film-coated tablet contains 60 mg, 90 mg, or 120 mg of etoricoxib.
Excipients/Inactive Ingredients: Core: Calcium hydrogen phosphate (anhydrous), Crospovidone (type A), Cellulose microcrystalline, Povidone K25, Magnesium stearate.
Tablet coating: Hypromellose, Hydroxypropylcellulose, Talc, Triglyceride medium chain, Titanium dioxide (E171), Indigo carmine Al-lake (E132) (60 & 120 mg), Brilliant blue Al-lake (E133) (60 & 120 mg), Iron oxide yellow (E172) (60 & 120 mg), Iron oxide black (E172) (60 & 120 mg).

Etoricoxib Teva Tablet contains the active substance etoricoxib. Etoricoxib Teva Tablet is one of a group of medicines called selective COX-2 inhibitors. These belong to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

Etoricoxib Teva Tablet helps to reduce the pain and swelling (inflammation) in the joints and muscles of people 16 years of age and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout.
Etoricoxib Teva Tablet is also used for the short term treatment of moderate pain after dental surgery in people 16 years of age and older.
What is osteoarthritis?: Osteoarthritis is a disease of the joints. It results from the gradual breakdown of cartilage that cushions the ends of the bones. This causes swelling (inflammation), pain, tenderness, stiffness and disability.
What is rheumatoid arthritis?: Rheumatoid arthritis is a long term inflammatory disease of the joints. It causes pain, stiffness, swelling, and increasing loss of movement in the joints it affects. It may also cause inflammation in other areas of the body.
What is gout?: Gout is a disease of sudden, recurring attacks of very painful inflammation and redness in the joints. It is caused by deposits of mineral crystals in the joint.
What is ankylosing spondylitis?: Ankylosing spondylitis is an inflammatory disease of the spine and large joints.

Etoricoxib Teva Tablets should be used at the lowest effective dose for the shortest possible time.
There are different strengths available for this medicinal product and depending on the disease the doctor will prescribe the tablet strength that is appropriate.
The recommended dose is: Osteoarthritis: The recommended dose is 30 mg* once a day, increased to a maximum of 60 mg once a day if needed.
Rheumatoid arthritis: The recommended dose is 60 mg once a day, increased to a maximum of 90 mg once a day if needed.
Ankylosing spondylitis: The recommended dose is 60 mg once a day, increased to a maximum of 90 mg once a day if needed.
Acute pain conditions: Etoricoxib should be used only for the acute painful period.
Gout: The recommended dose is 120 mg once a day which should only be used for the acute painful period, limited to a maximum of 8 days treatment.
Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days treatment.
*Dosage of 30 mg should be provided by other preparation.
People with liver problems: If patient has mild liver disease, he/she should not take more than 60 mg a day.
If patient has moderate liver disease, he/she should not take more than 30 mg* a day.
Do not take more than the recommended dose for the condition. The doctor will want to discuss the treatment from time to time. It is important that the patient uses the lowest dose that controls the pain and he/she should not take Etoricoxib Teva Tablet for longer than necessary. This is because the risk of heart attacks and strokes might increase after prolonged treatment, especially with high doses.
*Dosage of 30 mg should be provided by other preparation.
Use in children and adolescents: Etoricoxib Teva Tablet should not be taken by children or adolescents under 16 years of age.
Elderly: No dose adjustment is necessary for elderly patients. As with other medicines, caution should be exercised in elderly patients.
Method of administration: Etoricoxib Teva Tablet is for oral use.
Take tablets once a day. Etoricoxib Teva Tablet can be taken with or without food.
If patient forgets to take Etoricoxib Teva Tablet: It is important to take Etoricoxib Teva Tablet as prescribed. If a dose is missed, just resume the usual schedule the following day.
Do not take a double dose to make up for the forgotten tablet. If the patient has any further questions on the use of this medicine, ask the doctor or pharmacist.

Never take more tablets than the recommended amount. If patient takes too many Etoricoxib Teva Tablet tablets, he/she should seek medical attention immediately.

Etoricoxib Teva Tablet is contraindicated: in patients with severe heart failure and for the treatment of peri-operative pain in the setting of coronary artery bypass graft surgery.
Do not take Etoricoxib Teva Tablet: if allergic to etoricoxib or any of the other ingredients of this medicine (listed in Description).
If allergic to non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid (aspirin) and COX-2 inhibitors (see Side Effects).
If patient has a current stomach ulcer or bleeding in the stomach or intestines.
If patient has serious liver disease.
If patient has serious kidney disease.
If patient is or could be pregnant or is breast-feeding (see Use in Pregnancy & Lactation).
If patient is under 16 years of age.
If patient has inflammatory bowel disease, such as Crohn's Disease, Ulcerative Colitis, or Colitis.
If patient has high blood pressure that has not been controlled by treatment (check with the doctor or nurse if not sure whether the blood pressure is adequately controlled).
If the doctor has diagnosed heart problems including heart failure (moderate or severe types), angina (chest pain).
If patient has had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrow or blocked arteries).
If patient has had any kind of stroke (including mini-stroke, transient ischaemic attack or TIA). Etoricoxib may slightly increase the risk of heart attack and stroke and this is why it should not be used in those who have already had heart problems or stroke.
If the patient thinks any of these are relevant, do not take the tablets until the doctor has been consulted.

Talk to the doctor or pharmacist before taking Etoricoxib Teva Tablet if: The patient has a history of stomach bleeding or ulcers: 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 occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
The patient is dehydrated, for example by a prolonged bout of vomiting or diarrhoea.
The patient has swelling due to fluid retention.
The patient has a history of heart failure, or any other form of heart disease: 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.
The patient has a history of high blood pressure. Etoricoxib Teva Tablet can increase blood pressure in some people, especially in high doses, and the doctor will want to check the blood pressure from time to time.
The patient has any history of liver or kidney disease: 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 a 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 diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
No information is available from controlled clinical studies regarding the use of Etoricoxib Teva Tablet in patients with advanced renal disease. Therefore, treatment with Etoricoxib Teva Tablet 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.
In rare cases, etoricoxib tablet has been associated with serious liver injury.
The patient is being treated for an infection. Etoricoxib Teva Tablet can mask or hide a fever, which is a sign of infection.
The patient has diabetes, high cholesterol, or is a smoker. These can increase the risk of heart disease.
The patient is a woman trying to become pregnant.
The patient is over 65 years of age.
If not sure if any of the previously mentioned apply, talk to the doctor before taking Etoricoxib Teva Tablet to see if this medicine is suitable.
Etoricoxib Teva Tablet works equally well in elderly and younger adult patients. If patient is over 65 years of age, the doctor will want to appropriately keep a check on the patient. No dose adjustment is necessary for patients over 65 years of age.
Driving and using machines: Dizziness and sleepiness have been reported in some patients taking Etoricoxib Teva Tablet.
Do not drive if the patient experiences dizziness or sleepiness.
Do not use any tools or machines if the patient experiences dizziness or sleepiness.
Use in children: Do not give this medicine to children and adolescents under 16 years of age.

Pregnancy: Etoricoxib Teva Tablet must not be taken during pregnancy. If patient is pregnant or thinks she could be pregnant, or if planning to become pregnant, do not take the tablets. If patient becomes pregnant, stop taking the tablets and consult the doctor. Consult the doctor if unsure or need more advice.
Breast-feeding: It is not known if etoricoxib is excreted in human milk. If patient is breast-feeding, or planning to breast-feed, consult the doctor before taking Etoricoxib Teva Tablet. If patient is using Etoricoxib Teva Tablet, she must not breast-feed.
Fertility: Etoricoxib Teva Tablet is not recommended in women attempting to become pregnant.
Extra information for healthcare professionals: Special Populations: Pregnant Women: Etoricoxib Teva Tablet are contraindicated for use during the third trimester of pregnancy because of risks of premature closure of the ductus arteriosus and the potential to prolong parturition. Caution is recommended in prescribing Etoricoxib Teva Tablet during the first and second trimesters of pregnancy, particularly from the middle to end of the second trimester of pregnancy (onset at approximately 20 weeks) due to possible fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment or failure.
Etoricoxib Teva Tablet should not be used during the first two trimesters of pregnancy unless the expected benefits to the mother outweigh the risks to the fetus.
Published studies and post-marketing reports describe maternal Non-Steroidal Anti-Inflammatory Drug (NSAID) use at approximately 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment or failure. NSAIDs were shown to cause significant reduction in fetal urine production prior to reduction of amniotic fluid volume. There have also been a limited number of case reports of maternal NSAID use and neonatal renal dysfunction and renal impairment without oligohydramnios, some of which were irreversible, even after treatment discontinuation.
These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation.
Complications of prolonged oligohydramnios may for example, include limb contractures and delayed lung maturation. In some post-marketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
If after careful consideration of the benefit-risk, NSAID treatment is considered necessary to be administered anywhere from the middle (onset at approximately 20 weeks) to the end of the second trimester of pregnancy, the use should be limited to the lowest effective dose and shortest duration possible. It is also recommended that ultrasound monitoring of amniotic fluid be considered if Etoricoxib Teva Tablet treatment extends beyond 48 hours and that NSAIDs treatment be discontinued if oligohydramnios occurs, followed by appropriate medical follow-up.
Contraindications: The third trimester of pregnancy, because of risks of premature closure of the ductus arteriosus, and prolonged parturition.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If patient develops any of these signs, stop Etoricoxib Teva Tablet and patient should talk to the doctor immediately (see Contraindications and Precautions): shortness of breath, chest pains, or ankle swelling appear or if they get worse; yellowing of the skin and eyes (jaundice) - these are signs of liver problems; severe or continual stomach pain or the stools become black; an allergic reaction- which can include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue, or throat which may cause difficulty in breathing.
The following side effects can occur during treatment with Etoricoxib Teva Tablet: Very common (may affect more than 1 in 10 people): stomach pain.
Common (may affect up to 1 to 10 people): dry socket (inflammation and pain after a tooth extraction); swelling of the legs and/or feet due to fluid retention (oedema); dizziness, headache; palpitations (fast or irregular heartbeat), irregular heart rhythm (arrhythmia); increased blood pressure; wheezing or shortness of breath (bronchospasms); constipation, wind (excessive gas), gastritis (inflammation of the lining of the stomach), heartburn, diarrhoea, indigestion (dyspepsia)/stomach discomfort, nausea, being sick (vomiting), inflammation of the oesophagus, mouth ulcers; changes in blood tests related to liver; bruising; weakness and fatigue, flu-like illness.
Uncommon (may affect up to 1 to 100 people): gastroenteritis (inflammation of the gastrointestinal tract that involves both the stomach and small intestine/stomach flu), upper respiratory infection, urinary tract infection; changes in laboratory values (decreased number of red blood cells, decreased number of white blood cells, platelets decreased); hypersensitivity (an allergic reaction including hives which may be serious enough to require immediate medical attention); appetite increases or decreases, weight gain; anxiety, depression, decreases in mental sharpness; seeing, feeling or hearing things that are not there (hallucinations); taste alteration, inability to sleep, numbness or tingling, sleepiness; blurred vision, eye irritation and redness; ringing in the ears, vertigo (sensation of spinning while remaining still); abnormal heart rhythm (atrial fibrillation), fast heart rate, heart failure, feeling of tightness, pressure or heaviness in the chest (angina pectoris), heart attack; flushing, stroke, mini-stroke (transient ischaemic attack), severe increase in blood pressure; inflammation of the blood vessels; cough, breathlessness, nose bleed; stomach or bowel bloating, changes in bowel habits, dry mouth, stomach ulcer, inflammation of the stomach lining that can become serious and may lead to bleeding, irritable bowel syndrome, inflammation of the pancreas; swelling of the face, skin rash or itchy skin, redness of the skin; muscle cramp/spasm, muscle pain/stiffness; high levels of potassium in the blood, changes in blood or urine tests relating to kidney, serious kidney problems; chest pain.
Rare (may affect up to 1 in 1, 000 people): angioedema (an allergic reaction with swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing, which may be serious enough to require immediate medical attention)/anaphylactic/anaphylactoid reactions including shock (a serious allergic reaction that requires immediate medical attention); confusion, restlessness; liver problems (hepatitis); low blood levels of sodium; liver failure, yellowing of the skin and/or eyes (jaundice); severe skin reactions.
Reporting of side effects: If patient gets any side effects, talk to the doctor, pharmacist, or nurse. This includes any possible side effects not listed. By reporting side effects patient can help provide more information on the safety of this medicine.

Tell the doctor or pharmacist if patient is taking, has recently taken or might take any other medicines, including medicines obtained without a prescription.
In particular if patient is taking any of the following medicines, the doctor may want to monitor the patient to check that the medicines are working properly, once Etoricoxib Teva Tablet has started to be taken: Medicines that thin the blood (anticoagulants), such as warfarin; rifampicin (an antibiotic); methotrexate (a medicine used for suppressing the immune system, and often used in rheumatoid arthritis); ciclosporin or tacrolimus (medicines used for suppressing the immune system); lithium (a medicine used to treat some types of depression); medicines used to help control high blood pressure and heart failure called ACE inhibitors and angiotensin receptor blockers, examples include enalapril and ramipril, and losartan and valsartan; diuretics (water tablets); digoxin (a medicine for heart failure and irregular heart rhythm); minoxidil (a medicine used to treat high blood pressure); salbutamol tablets or oral solution (a medicine for asthma); birth control pills (the combination may increase the risk of side effects); hormone replacement therapy (the combination may increase the risk of side effects); acetylsalicylic acid (aspirin), the risk of stomach ulcers is greater if the patient takes Etoricoxib Teva Tablet with acetylsalicylic acid.
Acetylsalicylic acid for prevention of heart attacks or stroke: Etoricoxib Teva Tablet can be taken with low-dose acetylsalicylic acid. If patient is currently taking low-dose acetylsalicylic acid to prevent heart attacks or stroke, he/she should stop taking acetylsalicylic acid until consultation with the doctor.
Acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs): Do not take high dose acetylsalicylic acid or other anti-inflammatory medicines while taking Etoricoxib Teva Tablet.

Store in the original package in order to protect from light.
Do not use this medicine if visible signs of deterioration are noticed. Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer in use. These measures will help to protect the environment.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AH05 - etoricoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.

P₁S₁S₃