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.

In this leaflet: 
1. What Etoricoxib Krka is and what it is used for 
2. What you need to know before you use Etoricoxib Krka 
3. How to use Etoricoxib Krka 
4. Possible side effects 
5. How to store Etoricoxib Krka 
6. Contents of the pack and other information 

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

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

What is Etoricoxib Krka used for?

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

Etoricoxib contained in Etoricoxib Krka may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 use Etoricoxib Krka

Do not use Etoricoxib Krka

  • 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 ‑ passport 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 Etoricoxib Krka if:

  • You have had to bleed in the stomach or stomach ulcers
  • You are dehydrated, for example after a long period of vomiting and diarrhea
  • You have swelling due to fluid retention
  • You have previously had heart failure or any other heart disease
  • You have had high blood pressure in the past. Etoricoxib Krka may increase blood pressure in some people, especially at high doses. Your doctor may want to check your blood pressure from time to time
  • You have previously had liver or kidney disease
  • You are being treated for an infection. Etoricoxib Krka may mask a fever, which is a sign of infection
  • You have diabetes, high cholesterol, or if smoke, which can increase your risk of heart disease
  • You are planning to get pregnant
  • 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 Krka.

Etoricoxib Krka 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 Krka

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 Krkap:

  • 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)
  • medicines for high blood pressure and heart failure, so-called ACE inhibitors, such as enalapril and
  • ramipril, and angiotensin -II receptor inhibitors, such as losartan and rolling stock 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 take Etoricoxib Krka at the same time as acetylsalicylic acid
  • Acetylsalicylic acid for the prevention of myocardial infarction or stroke: Etoricoxib Krka can be taken at the same time as acetylsalicylic acid in low doses. If you use 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 ): You should not take more dose you of aspirin or other anti-inflammatory drugs while taking etoricoxib Krka.

Etoricoxib Krka with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

Pregnancy

Etoricoxib Krka 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 whether Etoricoxib Krka is excreted in human milk. If you are breast-feeding or planning to breast-feed, talk to your doctor before taking Etoricoxib Krka. If you are taking Etoricoxib Krkaska do not breast-feed.

Fertility

Etoricoxib Krka is not recommended for women trying to conceive.

Driving and using machines

Dizziness and drowsiness have been reported in some people who have used Etoricoxib Krka. 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.

How to use Etoricoxib Krka

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 Etoricoxib Krka for longer than necessary. This is because the risk of heart attack and stroke can 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.

  • 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.

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 Etoricoxib Krka.

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

If you use more Etoricoxib Krka then you should  

You should never take more tablets than your doctor recommends. If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Bring the carton Etoricoxib Krka.

If you forget to use Etoricoxib Krka

You must take Etoricoxib Krka exactly as your doctor has told you. 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 Krka and contact your doctor immediately if you get any of the following symptoms (see What you need to know before taking Etoricoxib Krka section 2) :

  • 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.

Other side effects that may occur during treatment with Etoricoxib Krka:

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

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

  • 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 serious 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

5. How to store Etoricoxib Krka

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 mg, 60 mg, 90 mg or 120 mg etoricoxib.
  • The other ingredients are microcrystalline cellulose, calcium hydrogen phosphate, croscarmellose sodium, sodium stearyl fumarate, anhydrous colloidal silica in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol 3000, talc, yellow iron oxide (E172) (in red (E172) (in red) in the tablets of 90 mg and 120 mg) in the tablet coating.

What the medicine looks like and the contents of the pack

Etoricoxib Krka film-coated tablets are available in 4 strengths.

Etoricoxib Krka 30 mg film-coated tablets are white or almost white, round (diameter: 6 mm), slightly biconvex, film-coated tablets with beveled edges.

Etoricoxib Krka 60 mg film-coated tablets are light brown-yellow, round (diameter: 8 mm), biconvex, film-coated tablets with beveled edges, marked “60” on one side of the tablet.

Etoricoxib Krka 90 mg film-coated tablets are pink, round (diameter: 9 mm), biconvex, film-coated tablets with beveled edges, marked “90” on one side of the tablet.

Etoricoxib Krka 120 mg film-coated tablets are reddish-brown, round (diameter: 10 mm), slightly biconvex, film-coated tablets with beveled edges and a score line on one side of the tablet. The notch is not intended for splitting the tablet.

Etoricoxib Krka 30 mg film-coated tablets

Boxes of 7, 14, 28, 30, 56, 60, 84, 98 or 100 tablets in blisters are available.

Etoricoxib Krka  60 mg film-coated tablets

Boxes of 7, 14, 20, 28, 30, 50, 56, 60, 84, 98 or 100 tablets in blisters are available.

Etoricoxib Krka 90 mg film-coated tablets

Boxes of 5, 7, 14, 20, 28, 30, 50, 56, 60, 84, 98 or 100 tablets in blisters are available.

Etoricoxib Krka 120 mg film-coated tablets

Boxes of 5, 7, 14, 20, 28, 30, 56, 60, 84, 98 or 100 tablets in blisters are available.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany

Muhammad Nadeem

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