30 mg, 60 mg, 90 mg and 120 mg film-coated tablets 
etoricoxib

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Arcoxia is and what it is used for 
2. What you need to know before you take Arcoxia 
3. How to take Arcoxia 
4. Possible side effects 
5. How to store Arcoxia 
6. Contents of the packaging and other information 

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 selective cyclooxygenase -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 with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.
  • Arcoxia is also used for short-term treatment of moderate pain after dental surgery in people 16 years and older.

What is osteoarthritis?

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

What is rheumatoid arthritis?

Rheumatoid arthritis is a long-term inflammatory disease of the joints. It causes pain, stiffness, swelling, and a decrease in mobility in the affected joints. It can also cause inflammation in other parts of the body.

What is gout?

Gout is a joint disease that involves sudden, recurrent attacks of very painful inflammation and redness of the joints. It is caused by the storage of mineral crystals in the joint.

What is ankylosing spondylitis?

Ankylosing spondylitis is an inflammatory disease 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 ), including acetylsalicylic acid and COX-2 inhibitors (see Possible side effects, section 4)
  • if you have an active stomach ulcer or 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 and fertility )
  • if you are under 16 years of age
  • if you have inflammatory bowel diseases such as Crohn’s disease, ulcerative colitis, or colitis.
  • if you have high blood pressure that has not been controlled with treatment (if you are not sure if your blood pressure is under control, ask your doctor or nurse).
  • if your doctor has diagnosed you with heart problems including heart failure(moderate or severe), angina (chest pain)
  • if you have had a heart attack, undergone bypass surgery, peripheral arterial disease (poor circulation in the legs or feet caused by blockage or narrowing of blood vessels)
  • if you have had any kind of stroke (including mini-stroke, transient ischemic attack, so-called TIA ). Etoricoxib may slightly increase the risk of heart attack and stroke, which is why it should not be used by people who have previously had heart problems or strokes.

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 or stomach 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 had heart failure or any other heart disease
  • if you have a history of high blood pressure. Arcoxia can increase blood pressure in some people, especially at high doses. Your doctor may want to check your blood pressure from time to time
  • if you have a history of liver or kidney disease
  • if you are being treated for an infection. Arcoxia can mask a fever, which is a sign of infection
  • if you have diabetes, 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 are not sure if any of the above applies to you, talk to your doctor to see if this medicine is right for you before 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 as warfarin
  • rifampicin ( antibiotic )
  • methotrexate (a drug for disorders of the immune system and often used in rheumatoid arthritis )
  • ciclosporin or tacrolimus (so-called immunosuppressive drugs)
  • lithium (antidepressant)
  • drugs for high blood pressure and heart failure, so-called ACE inhibitors, such as enalapril and ramipril, and angiotensin -II receptor inhibitors, such as losartan valsartan
  • diuretics ( diuretics )
  • digoxin (medicine for heart failure and irregular heartbeat)
  • minoxidil (medicine for high blood pressure )
  • salbutamol tablets or oral solution (an asthma medicine )
  • birth control pills (the combination may increase the risk of side effects )
  • hormone therapy for menopausal symptoms (the combination may increase the risk of side effects )
  • acetylsalicylic acid. The risk of stomach bleeding is greater if you use Arcoxia at the same time as acetylsalicylic acid.
    • acetylsalicylic acid for the prevention of myocardial infarction or stroke: 
      Arcoxia can be taken at the same time as acetylsalicylic acid in low doses. If you are using low-dose acetylsalicylic acid to prevent heart attack or stroke, do not stop without talking to your doctor first.
    • Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs ( NSAIDs ): 
      Do not use higher doses of acetylsalicylic acid or 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 / or side effects. Descriptions of these effects and side effects can 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 the recommended dose for your illness. Your doctor may occasionally want to discuss your treatment. It is important that you use the lowest possible dose for pain relief and you should not use Arcoxia for longer than necessary as the risk of heart attack and stroke may increase with long-term treatment, especially at high doses.

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 recommended dose is:

Arthritis

The recommended dose is 30 mg once daily. If necessary, the dose can be increased to a maximum of 60 mg once daily.

Rheumatoid arthritis

The recommended dose is 60 mg once daily. If necessary, the dose can be increased to a maximum of 90 mg once daily.

Ankylosing spondylitis

The recommended dose is 60 mg once daily. If necessary, the dose can 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 recommended dose is 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 recommended dose is 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 have moderate liver disease, you should not take more than 30 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 your dose according to your doctor’s prescription. If you forget to take a dose, return to the usual schedule the next day. Do not take a double dose to 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 cause side 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 reaction including skin reactions such as sores or blisters, or swelling of the face, lips, tongue, or throat which may cause difficulty breathing.

The frequency of possible side effects listed 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 following side effects may occur during treatment with Arcoxia:

Very common:

  • stomach ache

Usual:

  • dry gingivitis ( inflammation and 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 )
  • high blood 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, inflammation of the esophagus, sores in the mouth
  • altered liver blood levels
  • bruises
  • weakness and fatigue, flu-like symptoms

Uncommon:

  • gastroenteritis ( inflammation of 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 of red blood cells, decreased number of white blood cells, decreased number of platelets )
  • hypersensitivity (an allergic reaction including 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, and redness of 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 ( transient ischemic attack), severe increase in blood pressure, inflammation of the blood vessels
  • cough, shortness of breath, nosebleeds
  • gases in the stomach or intestines, altered bowel habits, dry mouth, stomach ulcers, gastric inflammation that can become severe and can lead to bleeding, irritable bowel syndrome, inflammation of 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 (severe allergic reaction with 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 including shock (a severe allergic reaction requiring 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

Marketing Authorisation HolderMerck Sharp & Dohme BVPO Box 5812003 PC HaarlemNetherlands ManufacturerMerck Sharp & Dohme BVWaarderweg 392031 BN HaarlemNetherlands

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

Muhammad Nadeem

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