30 mg, 60 mg, 90 mg, 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: 
1. What Etoricoxib Sandoz is and what it is used for 
2. What you need to know before you take Etoricoxib Sandoz 
3. How to take Etoricoxib Sandoz 
4. Possible side effects 
5. How to store Etoricoxib Sandoz 
6. Contents of the packaging and other information 

1. What Etoricoxib Sandoz is and what it is used for

What is Etoricoxib Sandoz?

  • Etoricoxib Sandoz contains the active substance etoricoxib. Etoricoxib Sandoz belongs to a group of medicines called selective cyclooxygenase ‑2 (COX ‑ 2). Inhibitors. These in turn belong to a group of medicines called non-steroidal anti-inflammatory drugs ( NSAIDs ).

What is Etoricoxib Sandoz used for?

  • Etoricoxib Sandoz reduces pain and swelling ( inflammation ) in joints and muscles in people 16 years and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.
  • Etoricoxib Sandoz 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 ankylosing spondylitis?

Ankylosing spondylitis is an inflammatory disease of the spine and major joints.

What is gout?

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

Etoricoxib contained in Etoricoxib Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Etoricoxib Sandoz

Do not take Etoricoxib Sandoz

  • 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 section 4 “Possible side effects”)
  • 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 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), or if you have had a heart attack, or have undergone bypass surgery
  • if you have had the 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, or 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 this medicine until you have consulted your doctor.

Warnings and cautions

Talk to your doctor or pharmacist before taking Etoricoxib Sandoz

  • if you have or have had to bleed 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. Etoricoxib Sandoz may 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. Etoricoxib Sandoz may mask a fever, which is a sign of infection.
  • if you have diabetes, high cholesterol, or if 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 suitable for you before taking Etoricoxib Sandoz.

Etoricoxib Sandoz 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 Etoricoxib Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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 Etoricoxib Sandoz:

  • 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 used eg after organ transplantation)
  • lithium (medicine for certain types of depression)
  • medicines for high blood pressure and heart failure, so-called ACE inhibitors, such as enalapril and ramipril, and angiotensin ‑II receptor inhibitor, losartan, and 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 )
  • on 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 Etoricoxib Sandoz at the same time as acetylsalicylic acid- aspirin to prevent heart attack or stroke: 
    Etoricoxib Sandoz may be taken with aspirin in low dose s. If you are using low-dose acetylsalicylic acid to prevent heart attack or stroke, do not stop without talking to your doctor first.- aspirin and other nonsteroidal anti-inflammatory drugs ( NSAIDs ): 
    You should not use a higher dose s of aspirin or other anti-inflammatory drugs while taking etoricoxib Sandoz.

Pregnancy, breastfeeding, and fertility

Pregnancy

Etoricoxib Sandoz 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 this medicine. 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 whether Etoricoxib Sandoz passes into breast milk. If you are breast-feeding or planning to breast-feed, talk to your doctor before taking Etoricoxib Sandoz. If you are taking Etoricoxib Sandoz, do not breast-feed.

Fertility

Etoricoxib Sandoz may make it harder to get pregnant. Etoricoxib Sandoz is not recommended for women trying to conceive. 
You should tell your doctor if you are planning to become pregnant or if you are having difficulty getting pregnant.

Driving and using machines

Dizziness and drowsiness have been reported in some people who have used Etoricoxib Sandoz. 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 sharpened attention. 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.

Etoricoxib Sandoz 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.

How to take Etoricoxib Sandoz

Always take this medicine exactly as your doctor or pharmacist 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. You must use the lowest possible dose for pain relief and you should not use Etoricoxib Sandoz 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 Sandoz should only be used during the acute period of pain.

  • Goethe 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 recommended dose is 90 mg once daily, limited to a maximum of 3 days of treatment.

Older

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

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.

Method of administration

Take Etoricoxib Sandoz by mouth once daily. Etoricoxib Sandoz can be taken with or without food.

The effect of Etoricoxib Sandoz may be faster if taken without food.

If you take more Etoricoxib Sandoz then you should

You should never take more tablets than your doctor recommends. 
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Etoricoxib Sandoz

You must 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 Etoricoxib Sandoz and contact your doctor immediately if you get any of the following symptoms:

  • shortness of breath, chest pain, or swelling of the feet, or if these worsen
  • yellowish skin or yellowish whites of the eyes (jaundice) – these are signs of liver problems
  • severe or persistent abdominal pain or if you get 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 following side effects may occur during treatment with Etoricoxib Sandoz:

Very common (may affect more than 1 user in 10):

  • stomach ache.

Common (may affect up to 1 in 10 people):

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

Uncommon (may affect up to 1 in 100 people):

  • inflammation of the gastrointestinal tract involving both the stomach and small intestine / gastric flu ( gastroenteritis )
  • upper respiratory tract infection
  • urinary tract infection
  • decreased number of red blood cells which can make the skin pale and cause weakness or shortness of breath
  • decreased white blood cell count
  • decreased platelet count which increases the risk of bleeding or bruising 
  • 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, the feeling of tightness, pressure, or heaviness over the chest ( angina pectoris ), heart attack
  • hemorrhage, stroke, mini-stroke ( transient ischemic attack [TIA]), severe increase in blood pressure, inflammation of blood vessels, often with a rash
  • cough, shortness of breath, nosebleeds
  • gas in the stomach or intestines, altered intestinal habits, dry mouth, ulcers in the stomach or small intestine, inflammation of the stomach that can become serious and can lead to bleeding, irritated bowel, 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 which can cause abnormal heart rhythm, altered blood or urine levels regarding the kidneys, severe kidney effects
  • chest pain.

Rare (may affect up to 1 in 1,000 people):

  • a severe allergic reaction with swelling of the face, lips, tongue, and/or throat which may cause breathing or swallowing difficulties ( angioedema ) requires immediate medical attention
  • confusion, restlessness
  • inflammation of the liver ( hepatitis ), liver failure, yellowish skin and/or yellowish whites of the eyes (jaundice)
  • decreased sodium content in the blood which can cause fatigue and confusion, muscle twitching, seizures, and coma
  • severe skin reactions.

5. How to store Etoricoxib Sandoz

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 after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

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 calcium hydrogen phosphate (anhydrous), microcrystalline cellulose, povidone K29-32, magnesium stearate, croscarmellose sodium, hypromellose, lactose monohydrate, titanium dioxide (E171), triacetin. The 30, 60, and 120 mg tablets also contain indigo carmine (E132) and yellow iron oxide (E172).

What the medicine looks like and the contents of the pack

Etoricoxib Sandoz tablets are available in 4 strengths.

30 mg: blue-green, round, biconvex, film-coated tablets.

60 mg: dark green, round, biconvex, film-coated tablets.

90 mg: white, round, biconvex, film-coated tablets.

120 mg: light green, round, biconvex, film-coated tablets.

Pack sizes:

Packs containing 5, 7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100 film-coated tablets in blister packs or in cans with screw caps containing desiccant (silica gel). The desiccant in the jar used to keep the tablets dry should not be swallowed.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

or

Pharmacare Premium Ltd., HHF 003, Hal Far Industrial Estate, Birzebbugia BBG 3000, Malta

Muhammad Nadeem

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