ETORICOXIB TEVA-RATIOPHARM 30 mg FILM-COATED TABLETS

Introduction

Package Leaflet:Information for the User

Etoricoxib Teva-ratiopharm 30 mg film-coated tablets EFG

Etoricoxib Teva-ratiopharm 60 mg film-coated tablets EFG

Etoricoxib Teva-ratiopharm 90 mg film-coated tablets EFG

Etoricoxib Teva-ratiopharm 120 mg film-coated tablets EFG

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 further questions, ask your doctor or pharmacist.

• 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, even if they are not listed in this leaflet. See section 4.

Contents of the pack

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

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

What is Etoricoxib Teva-ratiopharm?

• Etoricoxib Teva-ratiopharm contains the active substance etoricoxib. Etoricoxib Teva-ratiopharm belongs 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-ratiopharm helps to reduce pain and swelling (inflammation) in the joints and muscles in people 16 years of age and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.
• Etoricoxib Teva-ratiopharm is also used for short-term treatment of moderate pain following dental surgery in people 16 years of age and older.

What is osteoarthritis?

Osteoarthritis is a disease of the joints. It leads to 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 movement in the affected joints. It also causes inflammation in other areas of the body.

What is gout?

Gout is a disease of sudden and recurring attacks of very painful and red swelling of 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 long joints.

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

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 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 or intestinal ulcer or bleeding
• 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 uncontrolled high blood pressure (check with your doctor or nurse if you are not sure if your blood pressure is controlled)
• if your doctor has diagnosed you with heart problems, including heart failure (of moderate or severe type), angina (chest pain)
• if you have had a heart attack, revascularization surgery, peripheral arterial disease (poor circulation in the legs or feet due to narrow or blocked arteries)
• if you have had any type of stroke (including a transient cerebral attack or a transient ischemic attack).

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

If you think you are at risk of any of these conditions, do not take the tablets until you have spoken to your doctor.

Warnings and precautions

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

• You have a history of stomach or intestinal ulcers or bleeding.
• You are dehydrated, for example, as a result of 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 hide 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 not sure if any of the above applies to you, talk to your doctor before taking Etoricoxib Teva-ratiopharm to check if this medicine is suitable for you.

Etoricoxib Teva-ratiopharm works just as well in adult and elderly patients. If you are over 65 years of age, your doctor will want to keep a close check on you. 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.

Taking Etoricoxib Teva-ratiopharm 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 adequately once you start taking Etoricoxib Teva-ratiopharm:

• medicines that make your blood less likely to clot (anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a medicine used to suppress the immune system and often used in rheumatoid arthritis)
• cyclosporin 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 heartbeat)
• 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)
• acetylsalicylic acid (aspirin), the risk of stomach ulcers is greater if you take Etoricoxib Teva-ratiopharm with acetylsalicylic acid.

• acetylsalicylic acid for the prevention of heart attacks or stroke:
• Etoricoxib Teva-ratiopharm can be taken with low doses of acetylsalicylic acid. If you are currently taking low doses of acetylsalicylic acid to prevent heart attacks or stroke, do not stop taking acetylsalicylic acid until you have talked to 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-ratiopharm

Pregnancy, breast-feeding, 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 plan 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.

Breast-feeding

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

Fertility

Etoricoxib Teva-ratiopharm is not recommended for use in women who are trying to become pregnant.

Driving and using machines

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 machines if you experience dizziness or somnolence.

3. How to take Etoricoxib Teva-ratiopharm

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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

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 period of acute pain.

Gout

The recommended dose is 120 mg once daily, which should only be used during the period of acute pain, 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, do not take more than 60 mg per day.
• If you have moderate liver disease, do not take more than 30 mg per day.

Do not take more than the recommended dose for your disease. 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-ratiopharm for longer than necessary. This is because the risk of heart attacks and strokes might 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.

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-ratiopharm is administered orally.

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

If you take more Etoricoxib Teva-ratiopharm than 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 Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Etoricoxib Teva-ratiopharm

It is important that you take Etoricoxib Teva-ratiopharm as your doctor has instructed. If you forget a dose, just resume your normal schedule the next day.

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

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-ratiopharm and talk to your doctor immediately (see section 2 What you need to know before you take Etoricoxib Teva-ratiopharm):

• difficulty breathing, chest pain, or swelling of the ankle, or if these get worse
• yellowing of the skin and eyes (jaundice) – these are signs of liver problems
• severe stomach pain or persistent stomach pain or your stools turn black
• an allergic reaction – which can include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue, or throat which can cause difficulty in 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 heartbeat (arrhythmia)
• high blood pressure
• wheezing or difficulty breathing (bronchospasm)
• constipation, gas (excess gas), gastritis (inflammation of the stomach lining), heartburn, diarrhea, indigestion (dyspepsia)/stomach upset, nausea, vomiting, esophagitis (inflammation of the esophagus), 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 affects both the stomach and the small intestine/gastric flu), upper respiratory tract infection, urinary tract infection
• changes in laboratory results (decreased red blood cells, decreased white blood cells, decreased platelets)
• 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 heartbeat (atrial fibrillation), rapid heartbeat, heart failure, feeling of pressure or heaviness in the chest (angina)
• myocardial infarction, stroke, transient ischemic attack (mini-stroke), severe increase in blood pressure. Inflammation of blood vessels
• cough, difficulty breathing, nosebleed
• stomach or intestinal swelling, changes in bowel habits, dry mouth, stomach ulcer, inflammation of the stomach lining that can be severe and can cause bleeding, irritable bowel syndrome, pancreatitis (inflammation of the pancreas)
• swelling of the face, rash or itching of the skin
• muscle cramp/spasm, muscle pain/stiffness
• high levels of potassium in the blood, changes in blood or urine tests related to your kidneys, 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 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, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: 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-ratiopharm

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 CAD. The expiry date is the last day of the month indicated.

Store in the original package to protect from light.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Etoricoxib Teva-ratiopharm

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.

• The other ingredients 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).

Appearance of the Product and Package Contents

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.

Package sizes:

30 mg

OPA/Alu/PVC - Aluminum blister packs containing 7, 28, 28x1, 98 film-coated tablets.

60 mg

OPA/Alu/PVC - Aluminum blister packs containing 7, 20, 28, 28x1, 50, 98, 100 film-coated tablets.

90 mg

OPA/Alu/PVC - Aluminum blister packs containing 7, 7x1, 20, 28, 28x1, 50, 98, 100 film-coated tablets.

120 mg

OPA/Alu/PVC - Aluminum blister packs containing 7, 7x1, 14, 20, 28, 28x1, 98, 100 film-coated tablets.

Not all pack 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 medicine is authorized in the Member States of the European Economic Area under the following names:

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

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

Iceland:Etoricoxib ratiopharm 30 mg, 60 mg, 90 mg & 120 mg filmuhúðaðar töflur

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

Portugal:Etoricoxib ratiopharm

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

Date of the last revision of thisleaflet:September 2016

Other sources of information

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

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). 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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