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 may harm them, even if they show symptoms 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.

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

1. What Coxolin is and what it is used for

  • Cooling contains the active substance etoricoxib and 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 ).
  • Cooling reduces pain and swelling ( inflammation ) in joints and muscles in people 16 years and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.
  • Cooling 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 Coxolin 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

2. What you need to know before you use Coxolin

Do not use Coxolin

  • 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 Coxolin 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 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 may mask 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.

Etoricoxib 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 drugs and Coxolin

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 etoricoxib treatment:

  • 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)
  • 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 at the same time as acetylsalicylic acid.
    • acetylsalicylic acid for the prevention of myocardial infarction or stroke: etoricoxib can be taken concomitantly with 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 ): you should not take higher doses of acetylsalicylic acid or other anti-inflammatory drugs while taking etoricoxib.

Cooling with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

Pregnancy

Etoricoxib 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 this medicine and talk to your doctor if you become pregnant. Talk to your doctor if you are unsure or need more advice.

A mining

It is unknown whether etoricoxib is excreted in human milk. If you are breast-feeding or planning to breast-feed, talk to your doctor before using this medicine. If you are taking this medicine, do not breast-feed.

Fertility

Etoricoxib is not recommended for women trying to conceive.

Driving and using machines

Dizziness and drowsiness have been reported in some people taking etoricoxib.

Do not drive or use any tools or machines 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.

Cooling contains Lactose

Cooling 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 use Coxolin

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 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.

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.

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

Coxolin tablets should be swallowed. Take the tablets once a day. Cooling can be taken with or without food.

Use for children and adolescents

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

If you use more Coxolin 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 immediately for risk assessment and advice.

If you forget to use Coxolin

It is important that you take etoricoxib 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 Coxolin and contact a 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.

Other side effects that may occur during treatment with etoricoxib:

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 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 ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

www.lakemedelsverket.se

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,  By reporting side effects, you can help increase drug safety information.

5. How to store Coxolin

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.

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.
  • Other ingredients are:Core: microcrystalline cellulose (E460), magnesium stearate (E572), croscarmellose sodium (E468), calcium hydrogen phosphate (E341)Film coating: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518)

What the medicine looks like and the contents of the pack

Etoricoxib film-coated tablets are available in 4 strengths.

30 mg white round biconvex film-coated tablets (approx. 6 mm) marked “E9OX” on one side and “30” on the other side.

60 mg white round biconvex film-coated tablets (approx. 8 mm) marked “E9OX” on one side and “60” on the other side.

90 mg white round biconvex film-coated tablets (approx. 9 mm) marked “E9OX” on one side and “90” on the other side.

120 mg white round biconvex film-coated tablets (approx. 10 mm) marked “E9OX” on one side and “120” on the other side.

Packs of 2, 5, 7, 10, 14, 20, 28, 30, 49, 50, 84, 98 or 100 tablets in blisters.

Multipack containing 98 (2 packs of 49) tablets in blisters.

Packs of 5×1, 50×1 or 100×1 tablets in single-dose blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

2care4 Generics ApS

Stenhuggervej 12-14

DK-6710 Esbjerg V

Denmark

Manufacturer

Synthon Hispania, SL

Castello 1, Poligono Las Salinas, Sant Boi de Llobregat

08830 Barcelona

Spain

Synthon, sro

Brnenska 32 / cp. 597

678 01 Blansko

Czech Republic

Muhammad Nadeem

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