Etoricoxib teva

Package leaflet: Information for the user

Etoricoxib Teva, 30 mg, coated tablets
Etoricoxib Teva, 60 mg, coated tablets
Etoricoxib Teva, 90 mg, coated tablets
Etoricoxibum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.
Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents

1. What Etoricoxib Teva is and what it is used for
2. Important information 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 inhibitors of cyclooxygenase-2 (COX-2). It is a member of the 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 joints and muscles in patients aged 16 years and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gouty arthritis.
• 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 caused by the gradual breakdown of the cartilage that lines the ends of bones. This leads to swelling (inflammation), pain, tenderness, stiffness, and impaired function.

What is rheumatoid arthritis?
Rheumatoid arthritis is a chronic inflammatory disease of the joints. It causes pain, stiffness, swelling, and limits mobility of the affected joints. It may also cause inflammation in other parts of the body.

What is gout?
Gout is a disease characterized by sudden, recurring attacks of very painful inflammation and redness in the joints. This condition is caused by the deposition of crystalline deposits in the joint.

What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease affecting the spine and large joints.

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2. Information before using Etoricoxib Teva

When not to use Etoricoxib Teva:

• if the patient is allergic to etoricoxib or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, or selective cyclooxygenase-2 (COX-2) inhibitors (see section "Possible side effects", section 4);
• if the patient has active peptic ulceration or gastrointestinal bleeding;
• if the patient has severe liver disease;
• if the patient has severe kidney disease;
• in women who are pregnant, may be pregnant, or who are breastfeeding (see section "Pregnancy, breastfeeding and fertility");
• in individuals under 16 years of age;
• if the patient has inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or colitis;
• if the patient has untreated high blood pressure (if in doubt, consult a doctor or nurse to have blood pressure checked);
• if the patient has ever been diagnosed by a doctor with heart problems, including heart failure (moderate or severe) or angina pectoris (chest pain);
• if the patient has had a heart attack, coronary artery bypass surgery, or peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries);
• if the patient has ever had any type of stroke (including mini-stroke, transient ischaemic attack, TIA). Etoricoxib may slightly increase the risk of heart attack and stroke and therefore should not be used in individuals who have had heart problems or stroke.

If any of the above situations apply, consult a doctor before taking the tablets.

Warnings and precautions

Before starting treatment with Etoricoxib Teva, discuss with your doctor or pharmacist:

• if the patient has previously had stomach bleeding or peptic ulcer disease;
• if the patient is dehydrated, for example due to prolonged or recurring vomiting or diarrhoea;
• if the patient has swelling due to fluid retention;
• if the patient has previously had heart failure or other heart disease;
• if the patient has previously had high blood pressure. Etoricoxib Teva may increase blood pressure in some people, especially when high doses are used, so your doctor may monitor your blood pressure periodically;
• if the patient has previously had liver or kidney disease;
• if the patient is currently being treated for infection. Etoricoxib Teva may mask fever, which is a symptom of infection;
• in patients with diabetes, high cholesterol levels, or who are tobacco smokers. These individuals have an increased risk of heart disease;

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• in women planning pregnancy;
• in individuals over 65 years of age.

If in doubt whether any of the above conditions apply, you should consult your doctor before using Etoricoxib Teva to determine whether the medicine can be used.

Etoricoxib Teva is equally effective in elderly patients and in younger adult patients. For patients over 65 years of age, the doctor may decide on more frequent follow-up visits. Dose adjustment is not necessary in individuals over 65 years of age.

Children and adolescents

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

Etoricoxib Teva and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including medicines obtained without a prescription.

If you are taking any of the following medicines, your doctor may decide to monitor you to ensure treatment is proceeding correctly after starting Etoricoxib Teva:

• blood-thinning medicines (anticoagulants), such as warfarin;
• rifampicin (an antibiotic);
• methotrexate (a medicine that suppresses immune system function, often used in the treatment of rheumatoid arthritis);
• cyclosporine or tacrolimus (medicines that suppress immune system function);
• lithium (a medicine used to treat certain types of depression);
• medicines used to control high blood pressure and heart failure, called ACE inhibitors and angiotensin receptor blockers, such as enalapril and ramipril, or losartan and valsartan;
• diuretics (water tablets);
• digoxin (a medicine used in heart failure and heart rhythm disorders);
• minoxidil (a medicine used to treat high blood pressure);
• oral salbutamol tablets or oral solution (a medicine used in asthma);
• oral contraceptives (combination may increase the risk of side effects);
• hormone replacement therapy (combination may increase the risk of side effects);
• acetylsalicylic acid: the risk of stomach ulcers is higher when Etoricoxib Teva is taken together with acetylsalicylic acid; acetylsalicylic acid used for prevention of heart attacks or stroke: Etoricoxib Teva may be taken together with low-dose acetylsalicylic acid. If you are currently taking low-dose acetylsalicylic acid to prevent heart attack or stroke, do not stop taking it without consulting your doctor; acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs): do not take high-dose acetylsalicylic acid or other anti-inflammatory medicines while taking Etoricoxib Teva.

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Pregnancy, breastfeeding and fertility

Pregnancy

Etoricoxib Teva must not be used in women who are pregnant. If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she must not use this medicine. If pregnancy occurs, stop taking the medicine and contact your doctor. If in doubt or if you need further information, contact your doctor.

Breastfeeding

It is not known whether etoricoxib passes into human milk. If you are breastfeeding or planning to breastfeed, consult your doctor before using Etoricoxib Teva. While taking Etoricoxib Teva, breastfeeding is not allowed.

Fertility

Use of Etoricoxib Teva is not recommended in women planning to become pregnant.

Driving and using machines

Dizziness and drowsiness have been reported in some patients taking Etoricoxib Teva.

Do not drive if you experience dizziness or drowsiness.

Do not operate any machinery or tools if you experience dizziness or drowsiness.

3. How to use Etoricoxib Teva

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Different strengths of this medicine are available, and depending on the condition being treated, the doctor will prescribe the strength appropriate for the patient.
Recommended dose:
Osteoarthritis
The recommended dose is 30 mg once daily, increased if necessary up to a maximum of 60 mg once daily.
Rheumatoid arthritis
The recommended dose is 60 mg once daily, increased if necessary up to a maximum of 90 mg once daily.
Ankylosing spondylitis
The recommended dose is 60 mg once daily, increased if necessary up to a maximum of 90 mg once daily.
Acute pain
Etoricoxib should be used only during episodes of acute pain symptoms.
Gouty arthritis (gout)
The recommended dose is 120 mg once daily, which should be used only during episodes of acute pain, for a maximum of 8 days.
Pain following dental surgery
The recommended dose is 90 mg once daily, and treatment at this dose may last
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up to a maximum of 3 days.
Patients with liver problems
In patients with mild hepatic impairment, doses greater than 60 mg once daily should not be used.
In patients with moderate hepatic impairment, doses greater than 30 mg once daily should not be used.
Do not take higher doses than those recommended for individual conditions. Treatment should be reviewed periodically with your doctor. It is important to use the lowest effective dose providing pain relief and not to use Etoricoxib Teva longer than necessary. Prolonged use of the medicine, particularly at high doses, increases the risk of heart attacks and strokes.
Use in children and adolescents
Etoricoxib Teva should not be used in children and adolescents under 16 years of age.
Elderly patients
Dosage adjustment is not necessary in elderly patients. However, as with other medicines, caution should be exercised in elderly patients.
Method of administration
Etoricoxib Teva is intended for oral use.
Tablets should be taken once daily. Etoricoxib Teva may be taken with food or independently of meals.
Overdose of Etoricoxib Teva
Never take more tablets than prescribed by your doctor. If too many tablets of Etoricoxib Teva have been taken, seek immediate medical help.
Missed dose of Etoricoxib Teva
Etoricoxib Teva should be taken as directed by the physician. If a dose is missed, resume the usual 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, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If any of the following symptoms occur, stop taking Etoricoxib Teva
and contact your doctor immediately (see section 2 "Important information before
taking Etoricoxib Teva"):
shortness of breath, chest pain, or appearance of swelling around the ankles, or worsening of existing swelling;
yellowing of the skin or eyes (jaundice) – these are signs of liver dysfunction;
severe or persistent stomach pain, or appearance of black stools;
allergic reaction, which may manifest as skin changes such as ulcers, blisters, or swelling of the face, lips, tongue, or throat, which may cause difficulty breathing.

The following side effects may occur during treatment with Etoricoxib Teva:
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Very common (may affect more than 1 in 10 people)
stomach pain

Common (may affect up to 1 in 10 people)
dry socket (inflammation and pain following tooth extraction)
swelling of the lower limbs 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 intestinal gas), gastritis (inflammation of the stomach lining), heartburn, diarrhoea, indigestion (dyspepsia) and/or discomfort in the stomach, nausea, vomiting, oesophagitis, mouth ulcers
changes in blood test results related to the liver
bruising
weakness and fatigue, flu-like symptoms

Uncommon (may affect up to 1 in 100 people)
gastroenteritis (inflammation of the gastrointestinal tract involving both the stomach and small intestine and/or stomach flu), upper respiratory tract infection, urinary tract infection
changes in laboratory test results (reduced number of red blood cells, reduced number of white blood cells, reduced number of platelets)
hypersensitivity (allergic reaction, including urticaria, which may be severe enough to require immediate medical attention)
increased or decreased appetite, weight gain
anxiety, depression, reduced mental performance; seeing, feeling or hearing things that do not exist (hallucinations)
taste disturbances, insomnia, numbness or tingling, drowsiness
blurred vision, eye irritation and redness
tinnitus, dizziness (sensation of spinning while at rest)
heart rhythm disorders (atrial fibrillation), rapid heartbeat, heart failure, feeling of tightness, pressure or heaviness in the chest (angina), heart attack
hot flushes, stroke, mini-stroke (transient ischaemic attack), severe increase in blood pressure, vasculitis (inflammation of blood vessels)
cough, shortness of breath, nosebleeds
abdominal distension (of the stomach or intestines), change in bowel habits, dryness of the oral mucosa, peptic ulcer, gastritis which may be severe and lead to bleeding, irritable bowel syndrome, pancreatitis
facial swelling, rash or itching, skin redness
muscle cramps/spasms, muscle pain or stiffness
high potassium levels in the blood, changes in blood or urine tests related to the kidneys, severe kidney function impairment
chest pain

Rare (may affect up to 1 in 1000 people)
angioedema (an allergic reaction characterized by swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing, which may be severe enough to require immediate medical attention); anaphylactic or anaphylactoid reactions, including shock (a severe allergic reaction requiring immediate medical intervention)
disorientation, restlessness
liver problems (hepatitis)
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low sodium levels in the blood
liver failure, yellowing of the skin and/or eyes (jaundice)
severe skin reactions

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps 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 after "EXP". The expiry date refers to the last day of the stated month.
Store in the original packaging in order to protect from light.
Do not use the medicine if signs of deterioration are visible.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Etoricoxib Teva contains
The active substance is etoricoxib.
Each coated tablet contains 30 mg, 60 mg or 90 mg of etoricoxib, respectively.
The other ingredients are:
Tablet core: calcium hydrogen phosphate anhydrous, microcrystalline cellulose (Type 101), microcrystalline cellulose (Type 102), crospovidone (Type A), povidone K25, magnesium stearate.
Tablet coating: hypromellose, hydroxypropylcellulose, talc, medium-chain triglycerides, titanium dioxide (E 171), microcrystalline cellulose (30 mg), iron oxide red (30 mg) (E172), indigo carmine (30, 60 mg) (E132), aluminium lake, brilliant blue FCF (60 mg) (E133), aluminium lake, iron oxide yellow (60 mg) (E172), iron oxide black (60 mg) (E172).

What Etoricoxib Teva looks like and contents of the pack
30 mg: blue, round, biconvex coated tablets with "30" debossed on one side and smooth on the other side.
60 mg: dark green, round, biconvex coated tablets with "60" debossed on one side and smooth on the other side.
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90 mg: white, round, biconvex coated tablets with "90" debossed on one side and smooth on the other side.

Pack sizes:
30 mg
Blister packs made of OPA/Aluminium/PVC/Aluminium containing 7, 14, 28, 28x1, 30 or 98 coated tablets.
60 mg
Blister packs made of OPA/Aluminium/PVC/Aluminium containing 7, 14, 20, 28, 28x1, 30, 50, 98 or 100 coated tablets.
90 mg
Blister packs made of OPA/Aluminium/PVC/Aluminium containing 5, 7, 7x1, 14, 20, 28, 28x1, 30, 50, 98 or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
Tel. (22) 345 93 00

Manufacturer/Importer
TEVA Gyógyszergyár Zrt.
Pallagi út 134042 Debrecen,
Hungary
Teva Nederland BV
Swensweg 5
2031 GA Haarlem
The Netherlands
Teva Czech Industries s.r.o.
Ostravska 29, c.p. 305
74770 Opava-Komarov
Czech Republic
Teva Operations Poland Sp. z.o.o
ul. Mogilska 80,
31-546 Kraków
TEVA PHARMA S.L.U.
C/C, n. 4, Poligono Industrial Malpica
50016 Zaragoza
Spain
Merckle GmbH
Ludwig-Merckle-Straße 3,
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89143 Blaubeuren
Germany
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25
10000 Zagreb
Croatia
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