Etoricoxib Mylan

Package leaflet: Information for the patient

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

Etoricoxib
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Etoricoxib Mylan is and what it is used for
2. What you need to know before taking Etoricoxib Mylan
3. How to take Etoricoxib Mylan
4. Possible side effects
5. How to store Etoricoxib Mylan
6. Contents of the pack and other information

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

Etoricoxib Mylan belongs to a group of medicines known as selective COX-2 inhibitors.
These belong to a family of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

• Etoricoxib Mylan helps reduce pain and swelling (inflammation) in the joints and muscles of people aged 16 years and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.
• Etoricoxib Mylan is also used for the short-term treatment of moderate pain following dental surgery in people aged 16 years and older.

What is osteoarthritis?
Osteoarthritis is a joint disease. It is caused by the progressive deterioration of the cartilage that covers the ends of bones. This leads to 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 progressive loss of movement in the affected joints. It may also cause inflammation in other parts of the body.
What is gout?
Gout is a disease characterized by sudden and recurrent attacks of very painful inflammation and redness of the joints. It is caused by the deposition of mineral crystals in the joints.
What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease of the spine and large joints.

2. What you need to know before taking Etoricoxib Mylan

Do not take Etoricoxib Mylan:

• if you are allergic to etoricoxib or to any of the other ingredients of Etoricoxib Mylan (listed in section 6)
• if you are allergic to non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid (aspirin) and COX-2 inhibitors (see section 4)
• if you have experienced breathlessness, chest tightness or wheezing, runny or blocked nose with facial pain, nasal swelling causing blockage (nasal polyps), or an allergic reaction with an itchy rash known as urticaria, or swelling of the face, lips, mouth, tongue, or throat causing difficulty in swallowing or breathing, following the intake of salicylic acid or other NSAIDs
• if you have a stomach ulcer or gastrointestinal bleeding
• if you have severe liver or kidney problems
• if you are pregnant or suspect you may be pregnant, or if you are breastfeeding (see 'Pregnancy, breastfeeding and fertility')
• if you are under 16 years of age
• if you have an inflammatory bowel disease such as Crohn's disease, ulcerative colitis, or colitis
• if you have uncontrolled high blood pressure persistently above 140/90 mmHg (check with your doctor or nurse if you are unsure whether your blood pressure is adequately controlled)
• if your doctor has diagnosed you with heart problems such as heart failure (moderate or severe), angina (chest pain), or if you have had a heart attack, coronary artery bypass surgery, peripheral arterial disease (reduced circulation to legs and feet due to narrowed or blocked blood vessels), or any type of stroke (including mini-stroke, transient ischemic attack or TIA). Etoricoxib may slightly increase the risk of heart attack and stroke; therefore, it should not be used in people who have already had heart problems or stroke.

If you think any of these conditions apply to you, do not take these tablets
before consulting your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Etoricoxib Mylan if:

• You have a history of gastrointestinal bleeding or ulcers.
• You are taking acetylsalicylic acid (even at low doses for cardiovascular protection) or
  other NSAIDs
• You are dehydrated, for example due to prolonged vomiting or diarrhoea.
• You have swelling due to fluid retention.
• You have a history of high blood pressure. In some people, etoricoxib, especially at higher doses, may increase blood pressure and your doctor will periodically monitor your blood pressure.
• You have any other heart, liver, or kidney problems.
• You are being treated for an infection. Etoricoxib may mask or hide fever, which is a sign of infection.
• You are taking medicines to reduce blood clotting (e.g., warfarin)
• You are a woman trying to become pregnant.
• You are elderly (over 65 years of age).
• You have diabetes, high cholesterol, or are a smoker. These conditions may increase the risk of heart disease.

If you have any doubts about any of the conditions mentioned above, discuss them with your doctor
before taking Etoricoxib Mylan to confirm whether this medicine is suitable for you.
During treatment
During the first month of treatment, there is an increased risk of serious skin reactions.
Stop taking Etoricoxib Mylan if you develop a skin rash, mouth lesions (mucosal or gum damage), or any other symptoms of an allergic reaction (see section 4 “Possible side effects”).
If signs of liver problems occur, such as yellowing of the skin or whites of the eyes, dark urine, pale stools, or a general feeling of being unwell, stop taking Etoricoxib Mylan and contact your doctor immediately.
Children and adolescents
Do not give this medicine to children or adolescents under 16 years of age.
Other medicines and Etoricoxib Mylan
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 need to monitor whether these medicines remain effective after you start taking Etoricoxib Mylan:

• blood-thinning medicines (anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a medicine used to suppress the immune system, often used in the treatment of rheumatoid arthritis)
• cyclosporine or tacrolimus (medicines used to suppress the immune system)
• lithium (a medicine used to treat certain types of depression)
• medicines used to control high blood pressure and heart failure called ACE inhibitors and angiotensin receptor blockers, such as enalapril and ramipril, and losartan and valsartan
• diuretics
• digoxin (a medicine used to treat heart failure and irregular heartbeat)
• minoxidil (a medicine used to treat high blood pressure)
• oral salbutamol tablets or oral solution (a medicine used to treat asthma)
• oral contraceptives (the combination may increase the risk of side effects)
• hormone replacement therapy (the combination may increase the risk of side effects)
• acetylsalicylic acid (aspirin) or other NSAIDs; the risk of stomach ulcers is higher if you take etoricoxib with these medicines.
• etoricoxib may be taken with low-dose aspirin used for prevention of heart attacks or strokes. If you are taking low-dose aspirin for prevention of heart attacks or strokes, do not stop taking aspirin without consulting your doctor.
• you should not take high-dose aspirin or other anti-inflammatory medicines while taking etoricoxib.

Etoricoxib Mylan with food
Etoricoxib may act more quickly when taken on an empty stomach. This should be considered when rapid relief from pain or inflammation is needed.
Pregnancy, breastfeeding and fertility
Etoricoxib tablets should not be taken during pregnancy. If you are pregnant, suspect you may be pregnant, or think you could become pregnant, do not take the tablets. If you become pregnant, stop taking the tablets and consult your doctor. Ask your doctor or pharmacist for advice before taking this medicine.
It is not known whether etoricoxib is excreted in human milk. If you are breastfeeding or plan to breastfeed, contact your doctor before taking Etoricoxib Mylan. If you are taking Etoricoxib Mylan, you should not breastfeed.
Etoricoxib is not recommended for women attempting to become pregnant.
Driving and using machines
Some patients taking etoricoxib have reported dizziness, vertigo (a spinning sensation while stationary), and drowsiness. Do not drive if you feel dizzy or drowsy.
Do not drive or operate tools or machinery if you experience these side effects.
Etoricoxib Mylan contains lactose
If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Etoricoxib Mylan

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Do not take more than the recommended dose for the treatment of your condition. Your doctor will periodically evaluate your treatment. It is important to use the lowest effective dose that controls your pain and to take Etoricoxib Mylan only for as long as necessary. This is because the risk of heart attack and stroke may increase with prolonged treatment, especially at higher doses.
Take Etoricoxib Mylan tablets once daily by mouth. This medicine can be taken with or without food.
Etoricoxib may act more quickly when taken without food. This should be considered when rapid relief from pain or inflammation is needed.

The recommended dose is:
Osteoarthritis
The recommended dose is 30 mg once daily, which may be increased if necessary up to a maximum dose of 60 mg (equivalent to two 30 mg tablets or one 60 mg tablet) once daily.

Rheumatoid arthritis
The recommended dose is 60 mg (equivalent to two 30 mg tablets) once daily, which may be increased if necessary up to a maximum of 90 mg once daily.

Ankylosing spondylitis
The recommended dose is 60 mg (equivalent to two 30 mg tablets once daily), which may be increased if necessary up to a maximum of 90 mg once daily.

Acute pain conditions
Etoricoxib should be used only for the duration of the acute pain.

Gout
The recommended dose is 120 mg (equivalent to four 30 mg tablets or two 60 mg tablets or one 120 mg tablet) once daily (maximum daily dose), which should be used only for the duration of acute pain, limited to a maximum of 8 days of treatment.

Dental surgery pain
The recommended dose is 90 mg (equivalent to three 30 mg tablets or one 90 mg tablet) once daily (maximum daily dose), limited to a maximum of 3 days of treatment. Talk to your doctor if you still have pain after taking etoricoxib.

Patients with liver problems

• If you have mild liver disease, you should not take more than 60 mg (equivalent to two 30 mg tablets or one 60 mg tablet) per day.
• If you have moderate liver disease, you should not take more than 30 mg per day.

Use in children and adolescents
Do not give this medicine to children and adolescents under 16 years of age.

If you take more Etoricoxib Mylan than you should
Never take more tablets than recommended by your doctor. You may experience problems with your stomach or intestines, heart, or kidneys. If you take too many Etoricoxib Mylan tablets, contact a doctor immediately or go to the nearest hospital emergency department, taking the pack with you.

If you forget to take Etoricoxib Mylan
It is important to follow the prescribed dose of Etoricoxib Mylan. If you miss a dose, simply take your next dose at the usual time. Do not take a double dose to make up for the missed tablet.

If you have any questions about 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 everyone gets them.
If you experience any of the following symptoms, you must stop taking Etoricoxib Mylan
and immediately contact your doctor or go to the nearest hospital emergency department
(see also section 2 “What you should know before taking Etoricoxib Mylan”):

• an allergic reaction such as skin rash, hives, itching, or swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty breathing or swallowing
• shortness of breath, severe chest pain, severe headache with increasing confusion or blurred vision, swelling of the ankles. These may be signs of dangerously high blood pressure
• yellowing of the skin or eyes, dark urine, fatigue, fever, nausea, weakness, drowsiness, and stomach pain. These are symptoms of serious liver problems
• severe or persistent stomach pain, black or bloody stools, vomiting (which may contain blood), bloated stomach, loss of appetite, or nausea. These may be signs of serious stomach, intestinal, or pancreatic problems
• a serious skin condition with blistering and bleeding of the lips, eyes, mouth, and nose (Stevens-Johnson syndrome), or a severe reaction starting with red, painful areas followed by large blisters and leading to peeling of skin layers.
• This may be accompanied by fever and chills, muscle pain, and a general feeling of being unwell (toxic epidermal necrolysis)
• an increased number of infections, which may present as fever, severe chills, sore throat, or mouth ulcers. These symptoms may indicate a reduced number of white blood cells
• abnormally fast or dangerously rapid heartbeat
• sudden collapse, dizziness, weakness in arms or legs, headache, dizziness or confusion, visual disturbances, difficulty swallowing, slurred or incoherent speech. These may be symptoms of stroke or mini-stroke (transient ischemic attack) caused by a blood clot or bleeding blocking blood flow to part of the brain
• a feeling of pressure or heaviness in the chest, with pain and breathlessness during physical exertion. These may be signs of angina
• sudden chest pain that may spread to the neck or arm, with breathlessness and sweating. These may be signs of a heart attack or other heart problems
• reduced heart function, which may cause fatigue, weakness, and/or fluid retention with swelling in the legs and ankles, difficulty breathing, including frothy cough or watery sputum
• reduced or no urine production, cloudy or bloody urine, pain during urination, or lower back pain. These may be signs of serious kidney problems.

Other possible side effects include:
Very common (may affect more than 1 in 10 people):

• stomach pain

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

• alveolitis (inflammation and pain after tooth extraction)
• swelling of the legs and/or feet due to fluid retention (edema)
• dizziness, headache
• fast or irregular heartbeat (palpitations), irregular heart rhythm (arrhythmia)
• increased blood pressure (hypertension)
• constipation, flatulence (excess gas), gastritis (inflammation of the inner stomach lining), heartburn, diarrhoea, difficulty digesting (dyspepsia)/stomach discomfort, nausea, vomiting, inflammation of the oesophagus
• changes in certain blood tests related to liver function
• bruising
• weakness and fatigue, flu-like illness

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

• chest or throat infection
• discomfort or pain with burning sensation when urinating. This may be a sign of urinary tract infection
• fatigue, shortness of breath, cold hands and feet, pale skin. These may be signs of low red blood cell count
• unexplained appearance of bruises or more frequent or prolonged bleeding than normal. These may be signs of low platelet count
• increased or decreased appetite, weight gain
• anxiety, depression, reduced mental sharpness, seeing, perceiving, or hearing things that are not there (hallucinations)
• altered taste, difficulty sleeping, tingling or numbness in hands or feet, reduced skin sensitivity, drowsiness
• blurred vision, eye irritation and redness
• ringing in the ears, vertigo (sensation of dizziness while stationary)
• abnormalities in the heart's electrical activity
• hot flushes, inflammation of blood vessels
• cough, nosebleeds
• changes in bowel habits, dry mouth, irritable bowel syndrome
• muscle cramps/spasms, muscle pain/stiffness
• elevated potassium levels in the blood, changes in certain blood or urine tests related to kidney function

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

• confusion, restlessness
• low sodium levels in the blood

Reporting of side effects
If you experience any side effect, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet. Side effects can also be reported directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Etoricoxib Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the wording EXP. The expiry date refers to the last day of the month indicated.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Etoricoxib Mylan contains
The active substance is etoricoxib. Each film-coated tablet contains 30, 60,
90 or 120 mg of etoricoxib.
The other components are:
Tablet core:
anhydrous dibasic calcium phosphate, microcrystalline cellulose, croscarmellose sodium, anhydrous colloidal silica, magnesium stearate.
Tablet coating:
30 mg: hypromellose, monohydrate lactose, titanium dioxide (E171), triacetin, carnauba wax,
Brilliant Blue FCF (E133), black iron oxide (E172), yellow iron oxide (E172)
60 mg: hypromellose, monohydrate lactose, titanium dioxide (E171), triacetin, yellow iron oxide
(E172), indigotine (E132), carnauba wax
90 mg: hypromellose, monohydrate lactose, titanium dioxide (E171), triacetin, carnauba wax
120 mg: hypromellose, monohydrate lactose, titanium dioxide (E171), triacetin, yellow iron oxide
(E172), indigotine (E132), carnauba wax.

What Etoricoxib Mylan looks like and contents of the pack
30 mg tablets: blue-green, film-coated, round tablets, with “E” engraved on one side and “30” on the other side.
60 mg tablets: green, film-coated, round, biconvex, bevelled-edge tablets, with “E” engraved on one side and “60” on the other side.
90 mg tablets: white, film-coated, round tablets, with “E” engraved on one side and “90” on the other side.
120 mg tablets: light green, film-coated, round tablets, with “E” engraved on one side and “120” on the other side.

Pack contents:
30 mg
Blister pack containing 7, 28 tablets.
60 mg
Blister pack containing 20 tablets.
90 mg
Blister pack containing 5, 20 tablets.
120 mg
Blister pack containing 5 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Manufacturers
Mylan Hungary Kft, Mylan utca 1, Komarom, H-2900 Hungary.
Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
McDermott Laboratories Limited trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland

This medicinal product is authorized in other EEA Member States under the following names:
Italy Etoricoxib Mylan 30mg, 60 mg, 90 mg, 120 mg film-coated tablets
Netherlands Etoricoxib 30 mg, 60 mg, 90 mg, 120 mg filmomhulde tabletten