Etoricoxib Teva

Package leaflet: Information for the user

ETORICOXIB TEVA 30 mg film-coated tablets, 60 mg film-coated tablets, 90 mg film-coated tablets, 120 mg film-coated tablets

Generic Medicine
Please read all of this leaflet carefully before 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 give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What ETORICOXIB TEVA is and what it is used for

What is ETORICOXIB TEVA?

• ETORICOXIB TEVA contains the active substance etoricoxib. ETORICOXIB TEVA belongs to a group of medicines known as selective COX-2 inhibitors. These medicines are part of a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs).

What is ETORICOXIB TEVA used for?

• ETORICOXIB TEVA helps reduce pain and swelling (inflammation) in the joints and muscles in patients aged 16 years and older who have osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, or gout.
• ETORICOXIB TEVA is also used for the short-term treatment of moderate pain following dental surgery in patients aged 16 years and older.

What is osteoarthritis?
Osteoarthritis is a joint disease. It is caused by the progressive breakdown 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 joint movement. It may also cause inflammation in other parts of the body.
What is gout?
Gout is a disease characterized by sudden and recurring attacks of very painful inflammation and redness in the joints. It is caused by the deposition of mineral crystals in the joints.
What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease affecting the spine and large joints.

2. What you need to know before taking ETORICOXIB TEVA

Do not take ETORICOXIB TEVA:

• if you are allergic to etoricoxib or to 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 (aspirin) and COX-2 inhibitors (see “Possible side effects”, section 4)
• if you currently have a stomach ulcer or active bleeding in the stomach or intestines
• if you suffer from severe liver disease
• if you suffer from severe kidney disease
• if you are pregnant or think you might 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 (consult 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)
• if you have had a heart attack, undergone bypass surgery, or have peripheral arterial disease (reduced circulation in the legs and feet due to narrowed or blocked arteries)
• if you have ever had a stroke (including mini-stroke, transient ischaemic attack or TIA). Etoricoxib may slightly increase the risk of heart attack or stroke; therefore, it must not be used in patients 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 TEVA if:

• You have a history of stomach bleeding or stomach ulcers.
• You are dehydrated, for example due to prolonged 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. In some people, ETORICOXIB TEVA, especially at high doses, may increase blood pressure; therefore, your doctor will periodically monitor your blood pressure.
• You have a history of liver or kidney disease.
• You are being treated for an infection. ETORICOXIB TEVA may mask or hide fever, which is a sign of infection.
• You have diabetes, high cholesterol, or are a smoker. These are conditions that may increase your risk of heart disease.
• You are a woman trying to become pregnant.
• You are over 65 years of age.

If you are unsure whether any of the situations listed above apply to you, consult your doctor before taking ETORICOXIB TEVA to confirm whether this medicine is suitable for you.
ETORICOXIB TEVA has the same efficacy in younger and older patients. If you are over 65 years of age, your doctor will monitor you appropriately. No dose adjustment is necessary for patients over 65 years of age.
Children and adolescents
Do not give this medicine to children and adolescents under 16 years of age.
Other medicines and ETORICOXIB TEVA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
In particular, if you are taking any of the following medicines, your doctor may require monitoring to ensure these medicines are working properly once you start taking ETORICOXIB TEVA:

• medicines used to thin the blood (anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a medicine used to suppress the immune system and 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 that help control high blood pressure and heart failure, called ACE inhibitors and angiotensin receptor blockers, such as enalapril and ramipril, losartan and valsartan
• diuretics (water tablets)
• digoxin (a medicine for treating heart failure and irregular heartbeat)
• minoxidil (a medicine used to treat high blood pressure)
• oral salbutamol tablets or oral solution (a medicine for treating 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): the risk of stomach ulcers is higher if you take ETORICOXIB TEVA with acetylsalicylic acid.
• acetylsalicylic acid for the prevention of heart attacks or strokes: ETORICOXIB TEVA may be taken with low-dose acetylsalicylic acid. If you are taking low-dose acetylsalicylic acid for the prevention of heart attacks or strokes, do not stop treatment with acetylsalicylic acid without consulting your doctor
• acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs): do not take high doses of acetylsalicylic acid or other anti-inflammatory medicines while taking ETORICOXIB TEVA

Pregnancy, breastfeeding and fertility
Pregnancy
ETORICOXIB TEVA must not be taken during pregnancy. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, do not take the tablets. If you become pregnant, stop taking the tablets and consult your doctor. If you have any doubts or need further information, consult your doctor.
Breastfeeding
It is not known whether etoricoxib is excreted in breast milk. If you are breastfeeding or think you will breastfeed, consult your doctor before taking ETORICOXIB TEVA. If you are using ETORICOXIB TEVA, you must not breastfeed.
Fertility
ETORICOXIB TEVA is not recommended for women who are planning to become pregnant.
Driving and using machines
Some patients treated with ETORICOXIB TEVA have reported dizziness and drowsiness.
Do not drive if you experience dizziness or drowsiness.
Do not operate tools or machinery if you experience dizziness or drowsiness.

3. How to take ETORICOXIB TEVA

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
This medicine is available in different strengths, and depending on your condition, your
doctor will prescribe the dose appropriate for you.
The recommended dose is:
Osteoarthritis
The recommended dose is 30 mg once daily, which may be increased, if necessary, up to a maximum
of 60 mg once daily.
Rheumatoid arthritis
The recommended dose is 60 mg once daily, which may be increased, if necessary, up to a maximum
dose of 90 mg once daily.
Ankylosing spondylitis
The recommended dose is 60 mg once daily, which may be increased, if necessary, up to a maximum
dose of 90 mg once daily.
Acute pain conditions
Etoricoxib should be used only for the duration of acute pain.
Gout
The recommended dose is 120 mg once daily, which should be used only for the
period of acute pain, limited to a maximum of 8 days of treatment.
Postoperative dental surgery pain
The recommended dose is 90 mg once daily, limited to a maximum of 3 days
of treatment.
Patients with liver problems

• If you have mild liver disease, you should not take more than 60 mg per day.
• If you have moderate liver disease, you should not take more than 30 mg per day.

Do not take a higher dose than recommended for your condition. Your doctor may occasionally wish
to discuss your treatment with you. It is important that you take the lowest effective dose that controls
your pain, and you should not take ETORICOXIB TEVA for longer than necessary. This is because the risk of
heart attacks and strokes may increase with prolonged treatment, especially at higher doses.
Use in children and adolescents
ETORICOXIB TEVA must not be used in children and adolescents under 16
years of age.
Elderly
No dose adjustment is required for elderly patients. As with other medicines,
ETORICOXIB TEVA should be used with caution in elderly patients.
Method of administration
ETORICOXIB TEVA is for oral use.
Take the tablets once daily. ETORICOXIB TEVA may be taken with or without food.
If you take more ETORICOXIB TEVA than you should
Never take more tablets than your doctor has recommended. If you take too many
tablets of ETORICOXIB TEVA, you must contact a doctor immediately.
If you forget to take ETORICOXIB TEVA
It is important to follow the prescribed ETORICOXIB TEVA dosing schedule. If you
forget a dose, simply take your next dose at the usual time.
Do not take a double dose to make up for a forgotten tablet.
If you have any further 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 experiences them.
If you experience any of the following symptoms, you must stop taking ETORICOXIB TEVA and contact your doctor immediately (see section 2, “What you need to know before taking ETORICOXIB TEVA”):

• onset or worsening of breathlessness, chest pain, or swelling of the ankles
• yellowing of the skin and eyes (jaundice) – these are symptoms of liver problems
• severe or persistent stomach pain, or black stools
• an allergic reaction which may include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue or throat, which may make breathing difficult

The following side effects may occur during treatment with ETORICOXIB TEVA:
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 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 (arrhythmia)
• increased blood pressure
• wheezing or shortness of breath (bronchospasm)
• constipation, flatulence (excess gas), gastritis (inflammation of the inner stomach lining), heartburn, diarrhoea, indigestion (dyspepsia)/stomach discomfort, nausea, vomiting, inflammation of the oesophagus, mouth ulcers
• 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)

• gastroenteritis (inflammation of the gastrointestinal tract involving both the stomach and small intestine/gastrointestinal flu), upper respiratory tract infection, urinary tract infection
• changes in laboratory test values (decreased number of red blood cells in the blood, decreased number of white blood cells in the blood, decreased platelets)
• hypersensitivity (an allergic reaction, including hives, which may be severe enough to require immediate medical attention)
• increased or decreased appetite, weight gain
• anxiety, depression, reduced mental sharpness; seeing, perceiving or hearing things that are not real (hallucinations)
• altered taste, inability to sleep, numbness or tingling, drowsiness
• blurred vision, eye irritation and redness
• ringing in the ears, vertigo (sensation of dizziness while stationary)
• abnormal heart rhythm (atrial fibrillation), increased heart rate, heart failure, feeling of tightness, pressure or heaviness in the chest (angina pectoris), heart attack
• hot flushes, stroke, mini-stroke (transient ischaemic attack), severe increase in blood pressure, inflammation of blood vessels
• cough, shortness of breath, nosebleeds
• stomach or intestinal swelling, changes in bowel habits, dry mouth, stomach ulcer, inflammation of the inner stomach lining which may become severe and lead to bleeding, irritable bowel syndrome, inflammation of the pancreas
• facial swelling, skin rash or itching, skin redness
• muscle cramps/spasms, muscle pain/stiffness
• high levels of potassium in the blood, changes in certain blood or urine tests related to kidney function, severe 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 breathing or swallowing, and which may be severe enough to require immediate medical attention)/anaphylactic/anaphylactoid reactions including shock (a severe allergic reaction requiring immediate medical attention)
• confusion, restlessness
• liver problems (hepatitis)
• low levels of sodium in the blood
• liver failure, yellowing of the skin and/or eyes (jaundice)
• severe skin reactions

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at http://www.agenziaitalianadelfarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ETORICOXIB TEVA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What ETORICOXIB TEVA Contains
The active substance is etoricoxib. Each film-coated tablet contains 30 mg of etoricoxib.
Each film-coated tablet contains 60 mg of etoricoxib.
Each film-coated tablet contains 90 mg of etoricoxib.
Each film-coated tablet contains 120 mg of etoricoxib.

• Other components are:
  Tablet core: calcium hydrogen phosphate (anhydrous), crospovidone (type A), microcrystalline cellulose, povidone K25, magnesium stearate.

Tablet coating: hypromellose, hydroxypropylcellulose, talc, medium-chain triglycerides, titanium dioxide (E171), microcrystalline cellulose (30 mg), red iron oxide (30 mg) (E172), aluminium lake containing indigo carmine (30, 60 and 120 mg) (E132), aluminium lake containing brilliant blue (60 and 120 mg) (E133), yellow iron oxide (60 and 120 mg) (E172), black iron oxide (60 and 120 mg) (E172).

Description of the Appearance of ETORICOXIB TEVA and Contents of the Package
30 mg film-coated tablets, blue, round, biconvex, with "30" engraved on one side and smooth on the other.
60 mg film-coated tablets, dark green, round, biconvex, with "60" engraved on one side and smooth on the other.
90 mg film-coated tablets, white, round, biconvex, with "90" engraved on one side and smooth on the other.
120 mg film-coated tablets, light green, round, biconvex, with "120" engraved on one side and smooth on the other.

Pack sizes:
30 mg
OPA/Al/PVC / Al blisters in packs or single-dose blisters containing 7, 14, 28, 28x1, 30, 98 film-coated tablets.

60 mg
OPA/Al/PVC / Al blisters in packs containing 7, 14, 20, 28, 28x1, 30, 50, 98, 100 film-coated tablets.

90 mg
OPA/Al/PVC / Al blisters in packs containing 5, 7, 7x1, 14, 20, 28, 28x1, 30, 50, 98, 100 film-coated tablets.

120 mg
OPA/Al/PVC / Al blisters in packs containing 5, 7, 7x1, 14, 16, 20, 28, 28x1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy

Manufacturers
TEVA Gyógyszergyár Zrt.
Debrecen, Pallagi út 13,
H-4042
Hungary
TEVA UK Ltd
Brampton Road, Hampden Park, Eastbourne, East Sussex,
BN22 9AG
United Kingdom
Teva Czech Industries s.r.o.
Ostravska 29, c.p. 305, Opava-Komarov
Czech Republic
Teva Operations Poland Sp. z.o.o
ul. Mogilska 80, Krakow
31-546
Poland
TEVA PHARMA S.L.U.
C/C, n. 4, Poligono Industrial Malpica, Zaragoza
Spain
Merckle GmbH
Ludwig-Merckle-Straße 3, Blaubeuren
Germany
Teva Pharma B.V.
Swensweg 5, Haarlem
2031 GA
The Netherlands
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25, Zagreb
Croatia
Teva Nederland B.V.
Swensweg 5, Haarlem
2031 GA
The Netherlands
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola
PLA 3000
Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Bulgaria: Еторикоксиб Тева 30 mg, 60 mg, 90 mg, 120 mg филмирани таблетки
Croatia: Coxeta 30 mg, 60 mg, 90 mg & 120 mg filmom obložene tablete
Estonia: Etoricoxib Teva
Germany: Etoricox AbZ 30 mg, 60 mg, 90 mg & 120 mg Filmtabletten
Ireland: Etoricoxib Teva 30 mg, 60 mg, 90 mg & 120 mg Film-coated Tablets
Italy: ETORICOXIB TEVA
Latvia: Etoricoxib Teva 60mg, 90 mg, 120 mg apvalkotās tabletes
Lithuania: Etoricoxib Teva 30 mg, 60mg, 90 mg, 120 mg plėvele dengtos tabletės
Malta: Etoricoxib Teva 30 mg, 60 mg, 90 mg & 120 mg Film-coated Tablets
Poland: Etoricoxib Teva
Portugal: Etoricoxib Teva
Romania: ETORICOXIB TEVA 30 mg, 60 mg, 90 mg, 120 mg comprimate fimate
Slovenia: Coxeta 30 mg, 60 mg, 90 mg, 120 mg filmsko obložene tablete
Spain: Etoricoxib Teva 30 mg, 60 mg, 90 mg & 120 mg comprimidos recubiertos con película EFG
Sweden: Etoricoxib Teva 30 / 60 / 90 / 120 mg filmdragerade tabletter
Netherlands: Etoricoxib Teva 30 mg, 60 mg, 90 mg, 120 mg, filmomhulde tabletten
United Kingdom: Etoricoxib 30mg, 60mg, 90mg & 120mg Film-coated Tablets