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Package leaflet: Information for the user

Etoricoxib 30 mg film-coated tablets Etoricoxib 60 mg film-coated tablets Etoricoxib 90 mg film-coated tablets Etoricoxib 120 mg film-coated tablets

Etoricoxib

Read al l of t his le aflet carefully before you st art taking t his medicine because i t co ntains important information for you.

-    Keep this leaflet. 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Etoricoxib is and what it is used for

2.    What you need to know before you take Etoricoxib

3.    How to take Etoricoxib

4.    Possible side effects

5.    How to store Etoricoxib

6.    Contents of the pack and other information

1. What Etoricoxib is and what it is used for

Etoricoxib is one of a group of medicines called selective COX-2 inhibitors. These belong to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

Etoricoxib helps to reduce the pain and swelling (inflammation) in the joints and muscles of people with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout.

Etoricoxib is also used for the short term treatment of moderate pain after dental surgery.

What is osteoarthritis?

Osteoarthritis is a disease of the joints. It results from the gradual breakdown of cartilage that cushions the ends of the bones. This causes swelling (inflammation), pain, tenderness, stiffness and disability.

What is rheumatoid arthritis?

Rheumatoid arthritis is a long term inflammatory disease of the joints. It causes pain, stiffness, swelling, and increasing loss of movement in the joints it affects. It may also cause inflammation in other areas of the body.

What is gout?

Gout is a disease of sudden, recurring attacks of very painful inflammation and redness in the joints. It is caused by deposits of mineral crystals in the joint.

What is ankylosing spondylitis?

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

2. What you need to know before you take Etoricoxib

Do not take Etoricoxib

• 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 (cyclooxygenase-2) inhibitors (see also section 4, Possible Side Effects).

• if you have a current stomach ulcer or bleeding in your stomach or intestines.

• if you have serious liver disease.

• if you have serious kidney disease.

• if you are or could be pregnant or are breast-feeding (see also section 2, Pregnancy and breastfeeding).

• if you are under 16 years of age.

• if you have inflammatory bowel disease, such as Crohn’s Disease, ulcerative colitis, or colitis.

• if your doctor has diagnosed heart problems including heart failure (moderate or severe types), angina (chest pain) or if you have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrow or blocked arteries), or any kind of stroke (including ministroke, transient ischaemic attack or TIA). Etoricoxib may slightly increase your risk of heart attack and stroke and this is why it should not be used in those who have already had heart problems or stroke.

• if you have high blood pressure that has not been controlled by treatment (check with your doctor if you are not sure whether your blood pressure is adequately controlled).

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Etoricoxib, if:

•    You have a history of stomach bleeding or ulcers.

•    You are dehydrated, for example by a prolonged bout of vomiting or diarrhoea.

•    You have swelling due to fluid retention.

•    You have a history of heart failure or any other form of heart disease.

•    You have a history of high blood pressure. Etoricoxib can increase blood pressure in some people, especially in high doses, and your doctor will want to check your blood pressure from time to time.

•    You have any history of liver or kidney disease.

•    You are being treated for an infection. Etoricoxib can mask or hide a fever, which is a sign of infection.

•    You are a woman trying to become pregnant (see also section 2, Do not take Etoricoxib).

•    You are elderly (i.e., over 65 years of age).

•    You have diabetes, high cholesterol, or are a smoker. These can increase your risk of heart disease.

If you are not sure if any of the above apply to you, talk to your doctor before see if this medicine is suitable for you.

Etoricoxib works equally well in older and younger adult patients. If you are years of age), your doctor will want to appropriately keep a check on you. No necessary for elderly patients.

Children and adolescents

Do not give Etoricoxib to children or adolescents under 16 years of age.

Other medicines and Etoricoxib

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

In particular if you are taking any of the following medicines, your doctor may want to monitor you to check that your medicines are working properly, once you start taking Etoricoxib:

•    medicines that thin your blood (anticoagulants), such as warfarin

•    rifampicin (an antibiotic)

•    methotrexate (a drug used for suppressing the immune system, and often used in rheumatoid arthritis)

•    medicines used to help control high blood pressure and heart failure called ACE inhibitors and angiotensin receptor blockers, examples include enalapril and ramipril, and losartan and valsartan

•    lithium (a medicine used to treat some types of depression)

•    diuretics (water tablets)

•    ciclosporin or tacrolimus (drugs used for suppressing the immune system)

•    digoxin (a medicine for heart failure and irregular heart rhythm)

•    minoxidil (a drug used to treat high blood pressure)

•    salbutamol tablets or oral solution (a medicine for asthma)

•    birth control pills

•    hormone replacement therapy

•    acetylsalicylic acid, because the risk of stomach ulcers is greater if you take Etoricoxib with acetylsalicylic acid. Etoricoxib can be taken with low-dose acetylsalicylic acid. If you are currently taking low-dose acetylsalicylic acid to prevent heart attacks or stroke, you should not stop taking acetylsalicylic acid until you talk to your doctor. Do not take high dose acetylsalicylic acid or other anti-inflammatory medicines while taking Etoricoxib.

Etoricoxib with food and drink

The onset of the effect of Etoricoxib may be faster when taken without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Etoricoxib tablets must not be taken during pregnancy. If you are pregnant or think you could be pregnant, or if you are planning to become pregnant, do not take the tablets. If you become pregnant, stop taking the tablets and consult your doctor. Consult your doctor if you are unsure or need more advice.

Breast-feeding

You must not breast-feed during treatment with Etoricoxib. It is not known if Etoricoxib is excreted in human milk. If you are breast-feeding, or planning to breastfeed, consult your doctor before taking Etoricoxib.

Driving and using machines

Dizziness and sleepiness have been reported in some patients taking Etoricoxib.

Do not drive or use any tools or machines if you experience dizziness or sleepiness.

Etoricoxib contains lactose

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

3. How to take Etoricoxib

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Do not take more than the recommended dose for your condition. Your doctor will want to discuss your treatment from time to time. It is important that you use the lowest dose that controls your pain.

The recommended dose is:

Osteoarthritis

The recommended dose is 30 mg (equivalent to increase to a maximum of 60 mg (equivalent to 2 60 mg film-coated tablet) once a day if needed.

Rheumatoid arthritis

The recommended dose is 90 mg (equivalent to 3 90 mg film-coated tablet) once a day.

Ankylosing spondylitis

The recommended dose is 90 mg (equivalent to 3 90 mg film-coated tablet) once a day.

Acute pain conditions

Etoricoxib should be used only for the acute painful period.

Gout

The recommended dose is 120 mg (equivalent to 4 Etoricoxib 30 mg film-coated tablets, or 2 Etoricoxib 60 mg film-coated tablets, or 1 Etoricoxib 120 mg film-coated tablet) once a day which should only be used for the acute painful period, limited to a maximum of 8 days treatment.

Postoperative dental surgery pain

The recommended dose is 90 mg (equivalent to 3 Etoricoxib 30 mg film-coated tablets or 1 Etoricoxib 90 mg film-coated tablet) once daily, limited to a maximum of 3 days treatment.

Use in children and adolescents

Etoricoxib must not be taken by children or adolescents under 16 years of age.

Elderly

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 a day.

•    If you have moderate liver disease, you should not take more than 30 mg a day.

Duration of administration

You should not take Etoricoxib for longer than necessary. This is because the risk of heart attacks and strokes might increase after prolonged treatment, especially with high doses.

Method of administration

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

If you take more Etoricoxib than you should

You should never take more tablets than the doctor recommends. If you take too many Etoricoxib tablets, you should seek medical attention immediately.

If you forget to take Etoricoxib

It is important to take Etoricoxib as your doctor has prescribed. If you miss a dose, just resume your usual schedule the following day. Do not take a double dose to make up for the forgotten tablet.

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

4. Possible side effects

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

If you d evelop any o f these s igns you s hould s top Etoricoxib and t alk t o you r d octor immediately:

•    shortness of breath, chest pain, or ankle swelling appear or if they get worse,

•    yellowing of the skin and eyes (jaundice) - these are signs of liver problems,

•    severe or continual stomach pain or your stools become black,

•    an allergic reaction- which can include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue, or throat which may cause difficulty in breathing.

The following side effects can occur during treatment with Etoricoxib:

Very Common (may affect more than 1 in 10 people)

•    stomach pain.

Common (may affect up to 1 in 10 people)

•    dry socket (inflammation and pain after a tooth extraction),

•    swelling of the legs and/or feet due to fluid retention (oedema),

•    dizziness, headache,

•    palpitations, (fast or irregular heartbeat), irregular heart rhythm (arrythmia),

•    increased blood pressure,

•    wheezing or shortness of breath (bronchospasms),

•    constipation, wind (excessive gas), gastritis (inflammation of the lining of the stomach), heartburn, diarrhoea, indigestion (dyspepsia)/stomach discomfort, nausea, being sick (vomiting), inflammation of the oesophagus, mouth ulcers,

•    changes in blood tests related to your liver,

•    bruising,

•    weakness and fatigue, flu-like illness.

Uncommon (may affect up to 1 in 100 people)

•    gastroenteritis (inflammation of the gastrointestinal tract that involves both the stomach and small intestine/stomach flu), upper respiratory infection, urinary tract infection,

•    decreased number of red blood cells, decreased number of white blood cells, platelets decreased,

•    hypersensitivity (an allergic reaction including hives which may be serious enough to require immediate medical attention),

•    appetite increases or decreases, weight gain,

•    anxiety, depression, decreases in mental sharpness; seeing, feeling or hearing things that are not there (hallucinations),

•    taste alteration, inability to sleep, sleepiness, numbness or tingling,

•    blurred vision, eye irritation and redness,

•    ringing in the ears, vertigo (sensation of spinning while remaining still),

•    abnormal heart rhythm (atrial fibrillation), fast heart rate, heart failure, feeling of tightness, pressure or heaviness in the chest (angina pectoris), heart attack,

•    flushing, stroke, mini-stroke (transient ischaemic attack), severe increase in blood pressure. inflammation of the blood vessels,

•    cough, breathlessness, nose bleed,

•    stomach or bowel bloating, changes in your bowel habits, dry mouth, stomach ulcer, inflammation of the stomach lining that can become serious and may lead to bleeding, irritable bowel syndrome, inflammation of the pancreas,

•    swelling of the face, skin rash or itchy skin, redness of the skin,

•    muscle cramp/spasm, muscle pain/stiffness,

•    high levels of potassium in your blood, changes in blood or urine tests relating to your kidney, serious kidney problems,

•    chest pain,

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

•    angioedema (an allergic reaction with swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing, which may be serious enough to require immediate medical attention)/anaphylactic/anaphylactoid reactions including shock (a serious allergic reaction that requires immediate medical attention),

•    confusion, restlessness,

•    liver problems (hepatitis),

•    low blood levels of sodium,

•    liver failure, yellowing of the skin and/or eyes (jaundice),

•    severe skin reactions.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Etoricoxib

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 or blister after EXP. The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice that the tablet or coating is damaged.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Etoricoxib contains

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

-    The other ingredients are:

Core:

sodium lauryl sulfate, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium, colloidal anhydrous silica, magnesium stearate (plant based)

Tablet coating:

lactose monohydrate, glycerol triacetate, HPMC 2910/hypromellose, titanium dioxide (E171)

30 mg, 60 mg, 120 mg additionally:

indigo carmine lake (E132), iron (III) oxide hydroxide x H₂O (E172)

What Etoricoxib looks like and contents of the pack

Etoricoxib 30 mg film-coated tablets:

Light green to bluish-green, round, biconvex, film-coated tablets plain on both sides.

Etoricoxib 60 mg film-coated tablets:

Green, round, biconvex, film-coated tablets), debossed “60” on one side and plain on the other side.

Etoricoxib 90 mg film-coated tablets:

White to off-white, round, biconvex, film-coated tablets plain on both sides.

Etoricoxib 30 mg film-coated tablets:

Green, round, biconvex, film-coated tablets, debossed ‘120’ on one side and plain on the other side.

Pack sizes of 28 tablets in OPA/Aluminium/PVC-Aluminium blisters, each containing 7 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

ZYDUS France ZAC des hautes patures 25, rue des peupliers 92752 Nanterre France

Manufacturer

ZYDUS France ZAC des hautes patures 25, rue des peupliers 92752 Nanterre France

This m edicinal pr oduct i s au thorised i n the Member St ates of t he EEA unde r t he following names:

Belgium	Etoricoxib Zydus 30 mg, 60 mg, 90 mg, 120 mg Comprime pellicule
Germany	Etoricoxib Zydus 30 mg, 60 mg, 90 mg, 120 mg Filmtabletten
Greece	Etoricoxib Zydus 30 mg, 60 mg, 90 mg, 120 mg EmKaA,ugg£vo gs 'ksnxo ugevio SiaKo
Spain	Etoricoxib Zydus 30 mg, 60 mg, 90 mg, 120 mg Comprimido recubierto con pelicula
France	Etoricoxib Zydus France 30 mg, 60 mg, 90 mg, 120 mg Comprime pellicule
Hungary	Etoricoxib Zydus 30 mg, 60 mg, 90 mg, 120 mg Filmtabletta
Italy	Etoricoxib Zydus France 30 mg Compressa rivestita con film Etoricoxib Zydus France 60 mg Compressa rivestita con film Etoricoxib Zydus France 90 mg Compressa rivestita con film Etoricoxib Zydus France 120 mg Compressa rivestita con film
The Netherlands	Etoricoxib Zydus 30 mg, 60 mg, 90 mg, 120 mg Filmomhulde tablet
Poland, Portugal	Etoricoxib Zydus
United Kingdom	Etoricoxib 30 mg, 60 mg, 90 mg, 120 mg film-coated tablets

This leaflet was last revised in October 2013.

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