ETORICOXIB TEVA 90 mg FILM-COATED TABLETS

2. What you need to know before you take Etoricoxib Teva

Do not take Etoricoxib Teva:

• 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 aspirin and COX-2 inhibitors (see Possible side effects, section 4).
• if you currently have an ulcer in your stomach or intestine or if you have had this type of ulcer before.
• if you have severe liver disease.
• if you have severe kidney disease.
• if you are or may be pregnant, or are breast-feeding (see Pregnancy, breast-feeding and fertility).
• if you are under 16 years of age.
• if you have inflammatory bowel disease, such as Crohn’s disease, ulcerative colitis or colitis.
• if you have high blood pressure that is not well-controlled.
• if your doctor has diagnosed heart problems including heart failure (moderate or severe), angina (chest pain).
• if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation of the legs and feet due to narrow or blocked arteries).
• if you have had any type of stroke (including mini-stroke or transient ischaemic attack).

Etoricoxib may slightly increase your risk of heart attack and stroke, and this risk is higher if you are treated for a long time. Therefore, Etoricoxib Teva should not be used in patients who have had heart problems or a stroke.

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

Warnings and precautions

Consult your doctor or pharmacist before taking Etoricoxib Teva if:

• You have a history of stomach ulcers or bleeding.
• You are dehydrated, for example due to prolonged vomiting or diarrhoea.
• You have fluid retention (swelling) due to heart, liver or kidney disease.
• You have a history of heart failure or any other form of heart disease.
• You have a history of high blood pressure. Etoricoxib Teva may 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 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, as these can increase your risk of heart disease.
• You are a woman trying to become pregnant.
• You are over 65 years of age.

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

Etoricoxib Teva works just as well in older adults as in younger adults. If you are over 65 years of age, your doctor will want to keep a closer check on you. No dose adjustment is necessary for older adults.

Children and adolescents

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

Taking Etoricoxib Teva with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

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 safely and effectively once you start taking Etoricoxib Teva:

• medicines that thin the blood (anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a medicine used to suppress the immune system and often used in rheumatoid arthritis)
• ciclosporin or tacrolimus (medicines used to suppress the immune system)
• lithium (a medicine used to treat some types of depression)
• medicines used to help control high blood pressure and heart failure called ACE inhibitors and angiotensin receptor blockers, for example enalapril and ramipril, and losartan and valsartan
• diuretics (water tablets)
• digoxin (a medicine for heart failure and irregular heart rhythm)
• minoxidil (a medicine used to treat high blood pressure)
• tablets or oral solution of salbutamol (a medicine for asthma)
• oral contraceptives (the combination may increase your risk of side effects)
• hormone replacement therapy (the combination may increase your risk of side effects)
• aspirin, the risk of stomach ulcers is greater if you take Etoricoxib Teva with aspirin.

• aspirin for the prevention of heart attacks or stroke:
• Etoricoxib Teva can be taken with low-dose aspirin. If you are currently taking low-dose aspirin to prevent heart attacks or stroke, do not stop taking aspirin until you talk to your doctor
• aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs):
• do not take high doses of aspirin or other NSAIDs while taking Etoricoxib Teva

Pregnancy, breast-feeding and fertility

Pregnancy

Etoricoxib Teva should not be used during pregnancy. Do not take the tablets if you are pregnant, think you may be pregnant or are planning to get pregnant. If you become pregnant, stop taking the tablets and consult your doctor. Consult your doctor if you have any doubts or need more information.

Breast-feeding

It is not known whether etoricoxib is excreted in human milk. If you are breast-feeding or planning to breast-feed, consult your doctor before taking Etoricoxib Teva. If you are using Etoricoxib Teva, do not breast-feed.

Fertility

Etoricoxib Teva should not be used in women who are trying to become pregnant.

Driving and using machines

In some patients, dizziness and somnolence have been reported during treatment with Etoricoxib Teva.

Do not drive if you experience dizziness or somnolence.

Do not use tools or machines if you experience dizziness or somnolence.

3. How to take Etoricoxib Teva

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

There are different doses available for this medicine and depending on your disease, your doctor will prescribe the tablet with the dose that suits you best.

The recommended dose is:

Osteoarthritis

The recommended dose is 30 mg once daily, increased to a maximum of 60 mg once daily if needed.

Rheumatoid arthritis

The recommended dose is 60 mg once daily, increased to a maximum of 90 mg once daily if needed.

Ankylosing spondylitis

The recommended dose is 60 mg once daily, increased to a maximum of 90 mg once daily if needed.

Acute pain conditions

Etoricoxib should only be used for the acute painful period.

Gout

The recommended dose is 120 mg once daily, which should only be used during the acute painful period, limited to a maximum of 8 days of treatment.

Postoperative dental 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 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 and you should not take Etoricoxib Teva for longer than necessary. This is because the risk of heart attacks and strokes might increase after long-term treatment, especially with high doses.

Use in children and adolescents

Children or adolescents under 16 years of age should not take Etoricoxib Teva.

Elderly patients

No dose adjustment is necessary for elderly patients. As with other medicines, caution should be exercised in elderly patients.

Method of administration

Etoricoxib Teva is for oral use.

Take the tablets once daily. Etoricoxib Teva can be taken with or without food.

If you take more Etoricoxib Teva than you should

Never take more tablets than your doctor recommends. If you take too many Etoricoxib Teva tablets, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or contact the Poisons Information Centre (telephone: 91 562 04 20), indicating the medicine and the amount taken.

If you forget to take Etoricoxib Teva

It is important that you take Etoricoxib Teva as your doctor has instructed. If you forget a dose, just take the next dose at the usual time.

Do not take a double dose to make up for a forgotten dose.

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 develop any of these signs, stop taking Etoricoxib Teva and contact your doctor immediately (see section 2 What you need to know before you take Etoricoxib Teva):

• difficulty breathing, chest pain or swelling of the ankles, or if these get worse
• yellowing of the skin and eyes (jaundice) – these are signs of liver problems
• severe stomach pain or persistent black stools
• an allergic reaction – which can include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue or throat that can cause difficulty in breathing

The following side effects can 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)

• alveolar osteitis (inflammation and pain after tooth extraction)
• swelling of the legs and/or feet due to fluid retention (oedema)
• dizziness, headache
• palpitations (fast or irregular heart beat), irregular heart rhythm (arrhythmia)
• high blood pressure
• wheezing or shortness of breath (bronchospasm)
• constipation, gas (excess gas), gastritis (inflammation of the stomach lining), heartburn, diarrhoea, indigestion (dyspepsia)/stomach upset, nausea, vomiting, inflammation of the oesophagus, mouth ulcers
• changes in blood tests related to your liver
• bruising
• weakness and fatigue, flu-like symptoms

Uncommon(may affect up to 1 in 100 people)

• gastroenteritis (inflammation of the gastrointestinal tract that affects both the stomach and the small intestine/gastric flu), upper respiratory tract infection, urinary tract infection
• changes in laboratory results (decreased number of red blood cells, decreased number of white blood cells, decreased platelet count)
• hypersensitivity (an allergic reaction including hives that can be severe enough to require immediate medical attention)
• increased or decreased appetite, weight gain
• anxiety, depression, decreased mental sharpness; seeing, hearing or feeling things that are not there (hallucinations)
• altered taste, inability to sleep, numbness or tingling, somnolence
• blurred vision, eye irritation and redness
• ringing in the ears, vertigo (feeling of spinning while standing still)
• abnormal heart rhythm (atrial fibrillation), fast heart rate, heart failure, feeling of pressure, tightness or heaviness in the chest (angina pectoris), heart attack
• flushing, stroke, transient ischaemic attack (mini-stroke), severe increase in blood pressure. Inflammation of blood vessels
• cough, shortness of breath, nosebleeds
• stomach swelling or inflammation, changes in bowel movements, dry mouth, stomach ulcers, inflammation of the stomach lining that can become severe and cause bleeding, irritable bowel syndrome, pancreatitis (inflammation of the pancreas)
• swelling of the face, skin rash or itching
• muscle cramp/spasm, muscle pain/stiffness
• high levels of potassium in the blood, changes in 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 that can cause difficulty in breathing or swallowing, which can be severe enough to require immediate medical attention)/anaphylactic/anaphylactoid reactions including shock (a severe allergic reaction that requires immediate medical attention)
• confusion, restlessness
• liver problems (hepatitis)
• low levels of sodium in the blood
• liver disorder, yellowing of the skin and/or eyes (jaundice)
• severe skin reactions

Reporting of side effects

If you experience 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 Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Etoricoxib Teva

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

Store in the original package to protect from light.

Do not use this medicine if you notice signs of visible deterioration.

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. Container Content and Additional Information

Composition of Etoricoxib Teva

The active ingredient 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.

• The other components are:

Core: hydrogenated calcium 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), aluminum lake indigo carmine (30, 60, and 120 mg) (E132), aluminum lake brilliant blue (60 and 120 mg) (E133), yellow iron oxide (60 and 120 mg) (E172), black iron oxide (60 and 120 mg) (E172).

Product Appearance and Container Content

30 mg film-coated tablet, blue, round, biconvex, marked with "30" on one side and smooth on the other.

60 mg film-coated tablet, dark green, round, biconvex, marked with "60" on one side and smooth on the other.

90 mg film-coated tablet, white, round, biconvex, marked with "90" on one side and smooth on the other.

120 mg film-coated tablet, light green, round, biconvex, marked with "120" on one side and smooth on the other.

Container sizes:

30 mg

OPA/Alu/PVC blister pack – aluminum in containers containing 7, 14, 28, 28x1, 30, 98 film-coated tablets.

60 mg

OPA/Alu/PVC blister pack – aluminum in containers containing 7, 14, 20, 28, 28x1, 30, 50, 98, 100 film-coated tablets.

90 mg

OPA/Alu/PVC blister pack – aluminum in containers containing 5, 7, 7x1, 14, 20, 28, 28x1, 30, 50, 98, 100 film-coated tablets.

120 mg

OPA/Alu/PVC blister pack – aluminum in containers containing 5, 7, 7x1, 14, 16, 20, 28, 28x1, 30 film-coated tablets.

Not all container sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1ª planta.

28108 Alcobendas, Madrid

Spain

Manufacturer

Teva Gyógyszergyár Zrt.

Debrecen, Pallagi út 13,

H-4042

Hungary

or

Teva Nederland BV

Swensweg 5, Haarlem

2031 GA

Netherlands

or

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305, Opava-Komarov

74770

Czech Republic

or

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80,

Krakow, 31-546

Poland

or

Teva Pharma, S.L.U.

C/C, n. 4, Polígono Industrial Malpica,

Zaragoza, 50016

Spain

or

Merckle GmbH

Ludwig-Merckle-Straße 3,

Blaubeuren, 89143

Germany

or

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25, Zagreb

10000

Croatia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Bulgaria: ??????????? ???? 30 mg, 60 mg, 90 mg, 120 mg ????????? ????????

Croatia: Coxeta 30 mg, 60 mg, 90 mg & 120 mg film-coated tablets

Estonia: Etoricoxib Teva

Germany: Etoricox-AbZ 30 mg, 60 mg, 90 mg & 120 mg film-coated tablets

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 film-coated tablets

Lithuania: Etoricoxib Teva 30 mg, 60mg, 90 mg, 120 mg film-coated tablets

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 film-coated tablets

Slovenia: Coxeta 30 mg, 60 mg, 90 mg, 120 mg film-coated tablets

Spain: Etoricoxib Teva 30 mg, 60 mg, 90 mg y 120 mg film-coated tablets EFG

Sweden: Etoricoxib Teva 30 / 60 / 90 / 120 mg film-coated tablets

Netherlands: Etoricoxib Teva 30 mg, 60 mg, 90 mg, 120 mg, film-coated tablets

United Kingdom: Etoricoxib 30mg, 60mg, 90mg & 120mg film-coated tablets

Date of the last revision of thisleaflet: September 2016

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)