Etoricoxib Teva-Ratiopharm 60 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

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 the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

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

Leaflet Contents

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

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

What is Etoricoxib Teva-ratiopharm?

• Etoricoxib Teva-ratiopharm contains the active substance etoricoxib. Etoricoxib Teva-ratiopharm belongs to a group of medicines known as 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 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 Teva-ratiopharm 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 causes the gradual breakdown of the cartilage that cushions the ends of bones. This leads to swelling (inflammation), pain, tenderness, stiffness, and loss of function.

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 affected joints. It may also cause inflammation in other parts of the body.

What is gout?

Gout is a condition characterized by sudden and recurrent attacks of severe painful inflammation and redness in the joints. It is caused by deposits of mineral crystals in the joint.

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-ratiopharm

Do not take Etoricoxib Teva-ratiopharm:

• 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 section 4, Possible side effects).
• if you currently have a stomach or intestinal ulcer or bleeding in the stomach or intestines
• if you have severe liver disease
• if you have 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 whether 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 myocardial infarction, surgical revascularization, or peripheral arterial disease (poor circulation in the legs or feet due to narrowed or blocked arteries)
• if you have had any type of stroke (including transient ischaemic attack or ischaemic stroke).

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

If you think any of these apply 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-ratiopharm if:

• You have a history of stomach ulcers or gastrointestinal bleeding.
• You are dehydrated, for example, due to a prolonged illness with 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. Etoricoxib Teva-ratiopharm may increase blood pressure in some people, especially at high doses, and your doctor may wish to monitor your blood pressure periodically.
• 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 developing 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 apply to you, speak with your doctor before taking Etoricoxib Teva-ratiopharm to confirm whether this medicine is suitable for you.

Etoricoxib Teva-ratiopharm works equally well in young and older adult patients. If you are over 65 years of age, your doctor will want to monitor you appropriately. Dose adjustment is not necessary in 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

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

In particular, if you are taking any of the following medicines, your doctor may wish to monitor you to ensure your medications are working properly once you start taking Etoricoxib Teva-ratiopharm:

• medicines that thin your blood (anticoagulants), such as warfarin

• rifampicin (an antibiotic)

• methotrexate (a medicine used to suppress the immune system and often used in 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 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 (water tablets)

• 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 adverse effects)

• hormone replacement therapy (the combination may increase your risk of adverse effects)

• acetylsalicylic acid (aspirin); the risk of stomach ulcers is higher if you take Etoricoxib Teva-ratiopharm with acetylsalicylic acid.

• Acetylsalicylic acid for prevention of myocardial infarction or stroke:

• Etoricoxib Teva-ratiopharm may be taken with low-dose acetylsalicylic acid. If you are currently taking low-dose acetylsalicylic acid to prevent myocardial infarction or stroke, do not stop taking acetylsalicylic acid without first speaking to your doctor.

• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs):

• do not take high-dose acetylsalicylic acid or other NSAIDs while taking Etoricoxib Teva-ratiopharm.

Pregnancy, breastfeeding and fertility

Pregnancy

Etoricoxib Teva-ratiopharm must 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. Speak to your doctor if you have any doubts or need further information.

Breastfeeding

It is not known whether etoricoxib is excreted in human milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Etoricoxib Teva-ratiopharm. If you are taking Etoricoxib Teva-ratiopharm, you must not breastfeed.

Fertility

Use of Etoricoxib Teva-ratiopharm is not recommended in women attempting to become pregnant.

Driving and using machines

Dizziness and somnolence have been reported in some patients taking Etoricoxib Teva-ratiopharm.

Do not drive if you experience dizziness or somnolence.

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

3. How to take Etoricoxib Teva-ratiopharm

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Different doses of this medicine are available, and depending on your condition, your doctor will prescribe the tablet with the dose appropriate for you.

The recommended dose is:

Osteoarthritis

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

Rheumatoid arthritis

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

Ankylosing spondylitis

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

Acute pain situations

Etoricoxib should only be used during 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 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 must not take more than 60 mg per day.
• If you have moderate liver disease, you must not take more than 30 mg per day.

Do not exceed the recommended dose for your condition. Your doctor will want to review your treatment from time to time. It is important to 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 myocardial infarction and cerebrovascular events may increase after prolonged treatment, especially with high doses.

Use in children and adolescents

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

Elderly patients

Dose adjustment is not necessary in elderly patients. However, 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

You must never take more tablets than your doctor has recommended. If you take too many Etoricoxib Teva-ratiopharm tablets, seek immediate medical attention.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 directed by your doctor. If you miss a dose, simply resume your regular dosing schedule the next day.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you develop any of the following signs, stop taking Etoricoxib Teva-ratiopharm and speak to your doctor immediately (see section 2 What you need to know before you start taking Etoricoxib Teva-ratiopharm):

• difficulty breathing, chest pain or worsening ankle swelling
• yellowing of the skin and eyes (jaundice) – these are signs 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 that may cause difficulty breathing

The following adverse 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 following tooth extraction)
• swelling of the legs and/or feet due to fluid retention (edema)
• dizziness, headache
• palpitations (fast or irregular heartbeat), irregular heart rhythm (arrhythmia)
• high blood pressure
• wheezing or difficulty breathing (bronchospasm)
• constipation, gas (excess gas), gastritis (inflammation of the inner lining of the stomach), heartburn, diarrhoea, indigestion (dyspepsia)/stomach discomfort, nausea, vomiting, inflammation of the oesophagus, mouth ulcers
• changes in blood test results 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 affecting both the stomach and small intestine/gastric flu), upper respiratory tract infection, urinary tract infection
• changes in laboratory results (reduced number of red blood cells, reduced number of white blood cells, 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, decreased mental acuity; seeing, feeling or hearing things that are not there (hallucinations)
• altered taste, inability to sleep, numbness or tingling, drowsiness
• blurred vision, eye irritation and redness
• ringing in the ears, dizziness (sensation of spinning while standing still)
• abnormal heart rhythm (atrial fibrillation), rapid heart rate, heart failure, sensation of tightness, pressure or heaviness in the chest (angina pectoris), myocardial infarction
• flushing, stroke, mini-stroke (transient ischaemic attack), 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 inner lining of the stomach which may become severe and lead to bleeding, irritable bowel syndrome, pancreatitis
• facial swelling, skin rash or itching, skin redness
• muscle cramp/spasm, muscle pain/stiffness
• elevated levels of potassium in your blood, changes in blood or urine tests related to your kidneys, serious 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 levels of sodium in the blood
• liver impairment, yellowing of the skin and/or eyes (jaundice)
• severe skin reactions

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from light.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other 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 components are:

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), indigo carmine aluminium lake (30, 60 and 120 mg) (E132), brilliant blue FCF aluminium lake (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 pack

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.

Pack sizes:

30 mg

OPA/Alu/PVC – Aluminium blisters in packs containing 7, 28, 28x1, 98 film-coated tablets.

60 mg

OPA/Alu/PVC – Aluminium blisters in packs containing 7, 20, 28, 28x1, 50, 98, 100 film-coated tablets.

90 mg

OPA/Alu/PVC – Aluminium blisters in packs containing 7, 7x1, 20, 28, 28x1, 50, 98, 100 film-coated tablets.

120 mg

OPA/Alu/PVC – Aluminium blisters in packs containing 7, 7x1, 14, 20, 28, 28x1, 98, 100 film-coated tablets.

Only some pack 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

The 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 European Economic Area (EEA) member states 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 and 120 mg film-coated tablets EFG

Date of the most recent revision of this summary: September 2016

Other sources of information

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

You can access detailed and up-to-date information about 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

QR code + URL