Prospect:Information for the User

Etoricoxib Teva-ratiopharm 30 mg Film-Coated Tablets

Etoricoxib Teva-ratiopharm 60 mg Film-Coated Tablets

Etoricoxib Teva-ratiopharm 90 mg Film-Coated Tablets

Etoricoxib Teva-ratiopharm 120 mg Film-Coated Tablets

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Etoricoxib Teva-ratiopharm and what is it used for

2.What you need to know before starting to take Etoricoxib Teva-ratiopharm

3.How to take Etoricoxib Teva-ratiopharm

4.Possible adverse effects

5.Storage of Etoricoxib Teva-ratiopharm

6.Contents of the pack and additional information

What is Etoricoxib Teva-ratiopharm?

• Etoricoxib Teva-ratiopharmcontains the active ingredient etoricoxib. Etoricoxib Teva-ratiopharmbelongs to a group of medicines called selective COX-2 inhibitors. These belong to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

What is Etoricoxib Teva-ratiopharm used for?

• Etoricoxib Teva-ratiopharmhelps to reduce pain and swelling (inflammation) in the joints and muscles of people aged 16 years and over with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.
• Etoricoxib Teva-ratiopharmis also used for the short-term treatment of moderate pain after dental surgery in people aged 16 years and over.

What is osteoarthritis?

Osteoarthritis is a disease of the joints. It causes the gradual breakdown of the cartilage that cushions the ends of the bones. This causes swelling (inflammation), pain, sensitivity, 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 mobility in the affected joints. It also causes inflammation in other areas of the body.

What is gout?

Gout is a disease of sudden and recurrent attacks of very painful and inflamed 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 long joints.

Do not take Etoricoxib Teva-ratiopharm:

• if you are allergic to etoricoxib or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to nonsteroidal 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 stomach or intestinal bleeding.
• if you have a severe liver disease.
• if you have a severe kidney disease.
• if you are or may be pregnant, or are breastfeeding (see "Pregnancy, breastfeeding 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 has not been controlled with treatment (consult your doctor or nurse if you are unsure if your blood pressure is adequately controlled).
• 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, coronary revascularization, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries).
• if you have had any type of stroke (including transient ischaemic attack or transient ischaemic attack).

Etoricoxib may slightly increase your risk of heart attack and stroke, and therefore should not be used in patients who have had heart problems or a stroke.

If you think you fall into any of these cases, do not take the tablets until you have consulted your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Etoricoxib Teva-ratiopharm if:

• You have a history of ulcers or stomach bleeding.
• You are dehydrated, for example, as a result of a prolonged illness with vomiting or diarrhea.
• 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 Teva-ratiopharm may increase blood pressure in some people, especially at 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-ratiopharm may mask or conceal fever, which is a sign of infection.
• You have diabetes, high cholesterol, or are a smoker, as these 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 above situations affect you, speak to your doctor before taking Etoricoxib Teva-ratiopharm to check if this medicine is suitable for you.

Etoricoxib Teva-ratiopharm works equally well in adult and young patients. If you are over 65 years of age, your doctor will want to keep a close eye on you. No adjustment of the dose is necessary in patients over 65 years of age.

Children and adolescents

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

Taking Etoricoxib Teva-ratiopharm with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, 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 ensure that your medicines are working properly once you start taking Etoricoxib Teva-ratiopharm:

• blood-thinning medicines (anticoagulants), such as warfarin.
• rifampicin (an antibiotic).
• methotrexate (a medicine used to suppress the immune system and is often used in rheumatoid arthritis).
• ciclosporin or tacrolimus (medicines used to suppress the immune system).
• lithium (a medicine used to treat certain types of depression).
• medicines used to help control high blood pressure and heart failure, known as ACE inhibitors and angiotensin receptor blockers, for example enalapril and ramipril, and losartan and valsartan.
• diuretics (tablets to help you urinate).
• digoxin (a medicine for heart failure and irregular heartbeat).
• minoxidil (a medicine used to treat high blood pressure).
• oral tablets or 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).
• acetylsalicylic acid (aspirin), the risk of stomach ulcers is higher if you take Etoricoxib Teva-ratiopharm with acetylsalicylic acid.

-acetylsalicylic acid for the prevention of heart attacks or strokes:

- Etoricoxib Teva-ratiopharm may be taken withlow dosesof acetylsalicylic acid. If you are currently taking low doses of acetylsalicylic acid to prevent heart attacks or strokes, do not stop taking acetylsalicylic acid until you have spoken with your doctor.

- acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs):

- do not takehigh dosesof acetylsalicylic acid or other NSAIDs while taking Etoricoxib Teva-ratiopharm.

Pregnancy,breastfeeding and fertility

Pregnancy

Etoricoxib Teva-ratiopharm should not be taken during pregnancy. Do not take the tablets if you are pregnant, think you may be pregnant or are planning to become 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.

Breastfeeding

We do not know if etoricoxib is excreted in human milk. If you are breastfeeding or plan to do so, consult your doctor before taking Etoricoxib Teva-ratiopharm. If you are taking Etoricoxib Teva-ratiopharm, do not breastfeed.

Fertility

We do not recommend using Etoricoxib Teva-ratiopharm in women who are trying to become pregnant.

Driving and operating machinery

In some patients taking Etoricoxib Teva-ratiopharm, dizziness and somnolence have been reported.

Do not drive if you experience dizziness or somnolence.

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication should be taken as directed by your doctor or pharmacist.If you are unsure, consult your doctor or pharmacist again.

There are different dosages available for this medication, and depending on your condition, your doctor will prescribe the tablet with the dosage that is suitable for you.

Recommended dosageis:

Artrosis

The recommended dosage is 30 mg once a day, increasing up to a maximum of 60 mg once a day if necessary.

Artritis reumatoide

The recommended dosage is 60 mg once a day, increasing up to a maximum of 90 mg once a day if necessary.

Espondilitis anquilosante

The recommended dosage is 60 mg once a day, increasing up to a maximum of 90 mg once a day if necessary.

Situaciones de dolor agudo

Etoricoxib should only be used during the acute pain period.

Gota

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

Dolor postoperatorio tras cirugía dental

The recommended dosage is 90 mg once a day, limited to a maximum of 3 days of treatment.

Patients with liver problems

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

Do not take more than the recommended dosage for your condition. Your doctor will want to discuss your treatment from time to time. It is essential to use the lowest dosage that controls your pain and do not take Etoricoxib Teva-ratiopharm for longer than necessary. This is because the risk of myocardial infarction and cerebral infarction may increase after prolonged treatment, especially with high doses.

Use in children and adolescents

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

Older patients

No dosage adjustment is necessary in older patients. As with other medications, caution should be exercised in older patients.

Administration form

Etoricoxib Teva-ratiopharm is administered orally.

Take the tablets once a day. Etoricoxib Teva-ratiopharm can be taken with or without food.

If you take more Etoricoxib Teva-ratiopharm than you should

You should never take more tablets than your doctor recommends. If you take too many tablets of Etoricoxib Teva-ratiopharm, seek medical attention immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Etoricoxib Teva-ratiopharm

It is essential to take Etoricoxib Teva-ratiopharm as your doctor has indicated. If you forget a dose, simply resume the usual regimen the next day.

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

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

The following side effects may occur during treatment with Etoricoxib Teva-ratiopharm:

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 (edema)
• dizziness, headache
• palpitations (rapid or irregular heartbeat), irregular heart rhythm (arrhythmia)
• high blood pressure
• shortness of breath or difficulty breathing (bronchospasm)
• constipation, gas (excessive gas), gastritis (inflammation of the stomach lining), heartburn, stomach discomfort, nausea, vomiting, esophageal inflammation, mouth ulcers
• changes in blood test results related to the liver
• bruising
• weakness and fatigue, flu-like illness

Uncommon(may affect up to 1 in 100 people)

• gastroenteritis (inflammation of the gastrointestinal tract affecting both the stomach and small intestine/gastric catarrh), upper respiratory tract infection, urinary tract infection
• changes in laboratory results (decreased red blood cell count, decreased white blood cell count, decreased platelet count)
• hypersensitivity (an allergic reaction including urticaria that may be severe enough to require immediate medical attention)
• increased or decreased appetite, weight gain
• anxiety, depression, decreased mental acuity; seeing, hearing or feeling things that do not exist (hallucinations)
• alteration of taste, inability to sleep, numbness or tingling, drowsiness
• blurred vision, eye irritation and redness
• ringing in the ears, vertigo (sensation of spinning while standing)
• abnormal heart rhythm (atrial fibrillation), rapid heart rate, heart failure, sensation of tension, pressure or heaviness in the chest (angina pectoris), myocardial infarction
• redness, cerebral infarction, mini-stroke (transient ischemic attack), severe increase in blood pressure. Inflammation of blood vessels
• cough, difficulty breathing, nasal bleeding
• swelling of the stomach or intestine, changes in bowel habits, dry mouth, stomach ulcers, severe inflammation of the stomach lining that may cause bleeding, irritable bowel syndrome, pancreatitis
• swelling of the face, skin rash or itching, skin redness
• muscle cramp/spasm, muscle pain/stiffness
• elevated potassium levels in the blood, changes in blood or urine test results related to the kidneys, severe kidney problems
• chest pain

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

• angioedema (an allergic reaction with swelling of the face, lips, tongue and/or throat that may cause difficulty breathing or swallowing, 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 sodium levels in the blood
• liver damage, yellowing of the skin and/or eyes (jaundice)
• severe skin reactions

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on thebox and the blister packafter CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Do not usethis medicationif you observe visible signs of deterioration.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE point of the pharmacy.In case of doubt,please ask your pharmacisthow to dispose ofthecontainers and themedicines you no longerneed.This will help protect the environment.

Composition of Etoricoxib Teva-ratiopharm

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: calcium hydrogen phosphate (anhydrous), crospovidone (type A), microcrystalline cellulose, povidone K25, magnesium stearate.

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

Appearance of the product and contents of the package

Film-coated tablet of 30 mg, blue, round, biconvex, marked with “30” on one face and smooth on the other.

Film-coated tablet of 60 mg, dark green, round, biconvex, marked with “60” on one face and smooth on the other.

Film-coated tablet of 90 mg, white, round, biconvex, marked with “90” on one face and smooth on the other.

Film-coated tablet of 120 mg, light green, round, biconvex, marked with “120” on one face and smooth on the other.

Package sizes:

30 mg

OPA/Alu/PVC – Alu blister pack in packages containing 7, 28, 28x1, 98 film-coated tablets.

60 mg

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

90 mg

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

120 mg

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

Only some package sizes may be marketed.

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1st floor.

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 with the following names:

Germany:Etoricoxib-ratiopharm 30 mg, 60 mg, 90 mg & 120 mgFilmtabletten

Finland:Etoricoxib ratiopharm 30 mg, 60 mg, 90 mg & 120 mgtabletti, kalvopäällysteinen

Island:Etoricoxib ratiopharm 30 mg, 60 mg, 90 mg & 120 mgfilmuhúðaðar töflur

Luxembourg:Etoricoxib-ratiopharm 30 mg, 60 mg, 90 mg & 120 mgFilmtabletten

Portugal:Etoricoxib ratiopharm

Spain:Etoricoxib Teva-ratiopharm 30 mg, 60 mg, 90 mg and 120 mgcomprimidos recubiertos con película EFG

Last revision date of thisleaflet:September 2016

Other sources of information

The detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

You can access detailed and updated information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80961/P_80961.html

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