Arcoxia - Etoricoxib uses, dose and side effects - zeepedia.com (2025)

• Muhammad Nadeem
• December 21, 2020
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30 mg, 60 mg, 90 mg and 120 mgfilm-coated tablets
etoricoxib

1. What Arcoxia is and what it is used for

What is Arcoxia:

• Arcoxia contains the active substance etoricoxib.Arcoxia belongs to a group of medicines called selectivecyclooxygenase-2(COX-2) inhibitors.These in turn belong to a group of drugs called non-steroidal anti-inflammatory drugs (NSAIDs).

What is Arcoxia used for?

• Arcoxia reduces pain and swelling (inflammation) in joints and muscles in people 16 years and older withosteoarthritis,rheumatoid arthritis,ankylosing spondylitis,andgout.
• Arcoxia is also used for short-term treatment of moderate pain after dental surgery in people 16 years and older.

What isosteoarthritis?

Osteoarthritisis a joint disease.It is caused by a gradual breakdown ofcartilagethat dampens the contact of the bone ends with each other.This causes swelling (inflammation), pain, tenderness, stiffness, and reduced mobility.

What isrheumatoid arthritis?

Rheumatoid arthritisis a long-terminflammatorydisease of the joints.It causes pain, stiffness, swelling, and a decrease in mobility in the affected joints.It can also causeinflammationin other parts of the body.

What isgout?

Goutis a joint disease that involves sudden, recurrent attacks of very painfulinflammationandrednessof the joints.It is caused by the storage of mineral crystals in the joint.

What isankylosing spondylitis?

Ankylosing spondylitisis aninflammatorydisease of the spine and major joints.

What you need to know before you take Arcoxia

Do not take Arcoxia

• if you are allergic to etoricoxib or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to non-steroidal anti-inflammatory drugs (NSAIDs), includingacetylsalicylic acidandCOX-2inhibitors (see Possibleside effects, section 4)
• if you have an activestomach ulceror bleeding in your stomach or intestines
• if you have severe liver disease
• if you have severe kidney disease
• if you are or think you may be pregnant, or if you are breast-feeding (see Pregnancy, breast-feeding andfertility)
• if you are under 16 years of age
• if you haveinflammatorybowel diseases such asCrohn’s disease,ulcerative colitis, orcolitis.
• if you have highblood pressurethat has not been controlled with treatment (if you are not sure if yourblood pressureis under control, ask your doctor or nurse).
• if your doctor has diagnosed you with heart problems includingheart failure(moderate or severe), angina (chest pain)
• if you have had a heart attack, undergone bypasssurgery,peripheralarterial disease (poor circulation in the legs or feet caused by blockage or narrowing of blood vessels)
• if you have had any kind ofstroke(including mini-stroke,transientischemic attack, so-calledTIA).Etoricoxib may slightly increase the risk of heart attack andstroke, which is why it should not be used by people who have previously had heart problems orstrokes.

If you think any of these apply to you, do not take the tablets until you have consulted your doctor.

Warnings and cautions

Talk to your doctor or pharmacist before taking Arcoxia:

• if you have or have had bleeding in the stomach orstomach ulcers
• if you are dehydrated, for example after a long period of vomiting and diarrhea
• if you have swelling due to fluid retention
• if you have previously hadheart failureor any other heart disease
• if you have a history of highblood pressure.Arcoxia can increaseblood pressure in some people, especially at highdoses.Your doctor may want to check yourblood pressure from timeto time
• if you have a history of liver or kidney disease
• if you are being treated for aninfection.Arcoxia can mask a fever, which is a sign ofinfection
• if you havediabetes, high cholesterol, or if you smoke, which may increase your risk of heart disease.
• if you are planning to become pregnant
• if you are over 65 years old

If you arenot sureif any of the above applies to you,talk to your doctorto see if this medicine is right for youbefore taking Arcoxia.

Arcoxia works just as well in older and younger adult patients.If you are over 65, your doctor may want to monitor your treatment.No dose adjustment is necessary for patients over 65 years of age.

Children and young people

Do not give this medicine to children and adolescents under 16 years of age.

Other medicines and Arcoxia

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Your doctor should be especially aware if you are already being treated with any of the following medicines and may need to check the effect of the medication when starting treatment with Arcoxia:

• blood thinners (anticoagulants), such aswarfarin
• rifampicin (antibiotic)
• methotrexate (a drug for disorders of the immune system and often used inrheumatoid arthritis)
• ciclosporin or tacrolimus (so-called immunosuppressive drugs)
• lithium (antidepressant)
• drugs for highblood pressureandheart failure, so-calledACE inhibitors, such asenalapriland ramipril, andangiotensin-II receptorinhibitors, suchaslosartan valsartan
• diuretics(diuretics)
• digoxin(medicine forheart failureand irregular heartbeat)
• minoxidil (medicine for highblood pressure)
• salbutamoltablets ororalsolution (anasthmamedicine)
• birth control pills(the combination may increase the risk ofside effects)
• hormone therapy for menopausal symptoms (the combination may increase the risk ofside effects)
• acetylsalicylic acid.The risk of stomach bleeding is greater if you use Arcoxia at the same time asacetylsalicylic acid.
  • acetylsalicylic acidfor the prevention of myocardial infarction or stroke:
    Arcoxia can be taken at the same time asacetylsalicylic acidin lowdoses.If you are usinglow-doseacetylsalicylic acidto prevent heart attack orstroke, do not stop without talking to your doctor first.
  • Acetylsalicylic acidand other non-steroidal anti-inflammatory drugs (NSAIDs):
    Do not use higherdosesofacetylsalicylic acidor other anti-inflammatory drugs while you are taking Arcoxia.

Arcoxia with food and drink

The effect can be achieved faster if Arcoxia is taken without food.

Pregnancy, breastfeeding, and fertility

Pregnancy

Arcoxia should not be used during pregnancy.If you are pregnant, think you may be pregnant, or are planning to have a baby, do not take the tablets.Stop taking the tablets and consult your doctor if you become pregnant.Talk to your doctor if you are unsure or need more advice.

Breast-feeding

It is unknown if Arcoxia passes into breast milk.If you are breast-feeding or planning to breast-feed, talk to your doctor before taking Arcoxia.If you are taking Arcoxia, do not breast-feed.

Fertility

Arcoxia is not recommended for women trying to conceive

Driving and using machines

Dizziness and drowsiness have been reported in some people who have used Arcoxia.Do not drive or use machines or tools if you feel dizzy or drowsy.You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance.One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / orside effects.Descriptions of these effects andside effectscan be found in other sections.Read all the information in this leaflet for guidance.If you are not sure, talk to your doctor or pharmacist.

Arcoxia contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Arcoxia

Always take this medicine exactly as your doctor has told you.Ask your doctor or pharmacist if you are unsure.

Do not take more than therecommendeddosefor your illness.Your doctor may occasionally want to discuss your treatment.It is important that you use the lowest possibledosefor pain relief and you should not use Arcoxia for longer than necessary as the risk of heart attack andstrokemay increase with long-term treatment, especially at highdoses.

There are different strengths available of this drug and depending on your illness, your doctor will prescribe the strength that is right for you.

The recommendeddoseis:

Arthritis

The recommendeddoseis 30 mg once daily.If necessary, thedosecan be increased to a maximum of 60 mg once daily.

Rheumatoid arthritis

The recommendeddoseis 60 mg once daily.If necessary, thedosecan be increased to a maximum of 90 mg once daily.

Ankylosing spondylitis

The recommendeddoseis 60 mg once daily.If necessary, thedosecan be increased to a maximum of 90 mg once daily.

Acute pain conditions

Etoricoxib should only be used during the acute period of pain.

Gout

The recommendeddoseis 120 mg once daily which should only be used during the acute period of pain and aches, limited to a maximum of 8 days of treatment.

Pain after dental surgery

The recommendeddoseis 90 mg once daily, limited to a maximum of 3 days of treatment.

People with liver problems

• If you have mild liver disease, you should not take more than 60 mg daily.
• If you havemoderateliver disease, you should not take more than30 mg daily.

Use for children and adolescents

Children and adolescents under 16 years of age should not take Arcoxia.

Older

No dose adjustment is necessary for elderly patients.As with other medicines, caution should be exercised in elderly patients.

How to take this medicine

Take Arcoxia tablets by mouth.Take the tablets once a day.Arcoxia can be taken with or without food.

If you forget to take Arcoxia

It is important that you take yourdoseaccording toyourdoctor’s prescription.If you forget to take adose, return to the usual schedule the next day.Do not take a doubledoseto make up for a forgotten tablet.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can causeside effects,although not everybody gets them.

Stop taking Arcoxia and contact your doctor immediately if you get any of the following symptoms (see What you need to know before you take Arcoxia section 2):

• shortness of breath, chest pain or swelling of the feet, or if they worsen

Yellowish skin or yellowish whites of the eyes (jaundice) – these are signs of liver problems

• severe or persistent abdominal pain or if you have black stools

•allergic reactionincluding skin reactions such as sores or blisters, or swelling of the face, lips, tongue, or throat which may cause difficulty breathing.

The frequency of possibleside effectslisted below is defined as follows.

Very common (affects more than 1 user in 10)

Common (affects 1 to 10 users in 100)

Uncommon (affects 1 to 10 users in 1,000)

Rare (affects 1 to 10 users in 10,000)

Very rare (affects less than 1 user in 10,000)

The followingside effectsmay occur during treatment with Arcoxia:

Very common:

• stomach ache

Usual:

• dry gingivitis (inflammationand pain after tooth extraction)
• swelling of legs and/or feet due to fluid retention (edema)
• dizziness, headache
• palpitations (fast or irregular heartbeat), irregular heartbeat (arrhythmia)
• highblood pressure
• wheezing or shortness of breath (bronchospasm)
• constipation, flatulence (high intestinal gas),gastritis(inflammation of the stomach), heartburn, diarrhea, indigestion (dyspepsia) / upset stomach, nausea, vomiting,inflammationof the esophagus, sores in the mouth
• altered liver blood levels
• bruises
• weakness and fatigue,flu-like symptoms

Uncommon:

• gastroenteritis(inflammationof the gastrointestinal tract involving both the stomach and small intestine/stomach flu), upper respiratory tract infection, urinary tract infection
• change in laboratory values ​​(decreased number ofred blood cells, decreased number ofwhite blood cells, decreased number ofplatelets)
• hypersensitivity (anallergic reactionincluding hives which may be so serious that immediate medical attention is required)
• increased or decreased appetite, weight gain
• anxiety, depression, impaired mental acuity, seeing, feeling, or hearing things that do not exist (hallucinations)
• taste changes, difficulty sleeping, numbness or tingling, drowsiness
• blurred vision, irritation, andrednessof the eyes
• ringing in the ears, dizziness (feeling of rotation when still)
• Abnormal heart rhythm (atrial fibrillation), rapid heartbeat,heart failure, a feeling of tightness, pressure or heaviness over the chest (angina pectoris), heart attack
• hemorrhage,stroke, mini-stroke(transientischemic attack), severe increase inblood pressure,inflammationof the blood vessels
• cough, shortness of breath, nosebleeds
• gases in the stomach or intestines, altered bowel habits,dry mouth,stomach ulcers,gastricinflammation that can become severe and can lead to bleeding, irritable bowel syndrome,inflammationof the pancreas
• swelling of the face, rash or itchy skin, reddening of the skin
• muscle cramps / twitching, muscle pain / stiffness
• elevated potassium levels in the blood, altered blood or urine levels in the kidneys, severe renal impairment
• chest pain

Rare:

• angioedema(severeallergic reactionwith swelling of the face, lips, tongue, and/or throat which may cause breathing or swallowing difficulties which may be so severe that immediate medical attention is required) / anaphylactic/anaphylactoid reactions includingshock(a severeallergic reactionrequiring immediate medical attention )
• confusion, restlessness
• liver problem (hepatitis)
• decreased sodium content in the blood
• liver failure, yellowish skin and/or yellowish whites of the eyes (jaundice)
• severe skin reactions

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse.This includes any possible side effects not listed in this leaflet.You can also report side effects directly to the Medical Products Agency,www.lakemedelsverket.se.By reporting side effects, you can help increase drug safety information.

5. How to store Arcoxia

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton.The expiration date is the last day of the specified month.

Jar: Close the jar tightly.Moisture sensitive.

Blister: Store in the original package.Moisture sensitive.

Medicines should not be disposed of via wastewater or household waste.Ask your pharmacist how to dispose of medicines no longer required.These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

• The active substance is etoricoxib.Each film-coated tablet contains 30, 60, 90 or 120 mg etoricoxib.

• Other ingredients are Core: calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate, microcrystalline cellulose. Film coating: carnauba wax,lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin.The 30, 60, and 120 mg tablets also contain yellow iron oxide (E172, dye) and indigo carmine (E132, dye).

What the medicine looks like and the contents of the pack

Arcoxia tablets are available in 4 strengths.

30 mg: blue-green, apple-shaped biconvex tablets marked “ACX 30” on one side and “101” on the other side.

60 mg: dark green, apple-shaped, biconvex tablets marked “ARCOXIA 60” on one side and “200” on the other side.

90 mg: white, apple-shaped, biconvex tablets marked “ARCOXIA 90” on one side and “202” on the other side.

120 mg: light green, apple-shaped, biconvex tablets marked “ARCOXIA 120” on one side and “204” on the other side.

Pack sizes:

30 mg: Blister packs containing 2, 7, 14, 20, 28, 49, 98 film-coated tablets, multiple packs containing 98 (2 packs of 49) film-coated tablets.

60 mg: Blister packs containing 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98, 100 film-coated tablets, multiple packs containing 98 (2 packs of 49) film-coated tablets.Jars containing 30 or 90 film-coated tablets and containers with desiccant.The desiccant (one or two containers) in the jar used to keep the tablets dry should not be swallowed.

90 and 120 mg: Blister packs containing 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 100 film-coated tablets, multiple packs containing 98 (2 packs of 49) film-coated tablets.Jars containing 30 or 90 film-coated tablets and containers with desiccant.The desiccant (one or two containers) in the jar used to keep the tablets dry should not be swallowed.

60, 90 and 120 mg: Aluminum / aluminum blisters (single dose) in packs of 5, 50 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Local representative

This medicinal product is authorized under the European Economic Area under the names:

Belgium, Cyprus, Denmark, Estonia, Finland, France, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, United Kingdom, Czech Republic, Germany, Hungary, Austria:

ARCOXIA