Etoricoxib Aurobindo

Patient Information Leaflet

ETORICOXIB AUROBINDO 30 mg film-coated tablets, 60 mg film-coated tablets, 90 mg film-coated tablets, 120 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is ETORICOXIB AUROBINDO and what is it used for

What is ETORICOXIB AUROBINDO?

• Etoricoxib Aurobindo contains the active substance etoricoxib. ETORICOXIB AUROBINDO 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 AUROBINDO used for?

• ETORICOXIB AUROBINDO helps reduce pain and swelling (inflammation) in the joints and muscles of patients aged 16 years and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.
• ETORICOXIB AUROBINDO 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. It occurs due to the gradual breakdown of the cartilage that cushions the ends of bones. This process causes swelling (inflammation), pain, tenderness, stiffness, and disability.

What is rheumatoid arthritis?
Rheumatoid arthritis is a long-term inflammatory joint disease. It causes pain, stiffness, swelling, and increasing loss of movement in the affected joints. It may also cause inflammation in other areas of the body.

What is gout?
Gout is a sudden condition characterized by recurrent attacks of very painful inflammation and redness in the joints. It is caused by deposits of crystals in the joints.

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

2. What you should know before taking ETORICOXIB AUROBINDO

Do not take ETORICOXIB AUROBINDO

• if you are allergic (hypersensitive) 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 aspirin and COX-2 inhibitors (see Possible side effects, section 4)
• if you suffer from recurrent gastric ulcer or bleeding from the stomach or intestines
• if you have severe liver disease
• if you have severe kidney disease
• if you are or might be pregnant or if you are breastfeeding (see "Pregnancy, breastfeeding and fertility")
• if you are under 16 years of age
• if you have an inflammatory bowel disease, such as Crohn's disease, ulcerative colitis or colitis
• if you have uncontrolled high blood pressure despite 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 heart attack, undergone coronary bypass surgery, or have peripheral arterial disease (poor circulation in the legs and feet due to narrowing or blockage of arteries)
• if you have had any type of heart attack (including mini heart attack, transient ischemic attack or TIA). Etoricoxib may slightly increase the risk of heart attack and stroke, and for this reason should not be used in patients who have already had heart problems or stroke.

If you think any of these conditions apply to you, do not take the tablets before consulting your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking ETORICOXIB AUROBINDO:

• if you have a history of stomach bleeding or ulcer
• if you are dehydrated, for example after prolonged vomiting or diarrhoea
• if you have swelling due to fluid retention
• if you have a history of heart failure or any other form of heart disease
• if you have a history of high blood pressure. ETORICOXIB AUROBINDO may increase blood pressure in some people, especially at higher doses. Your doctor will monitor your blood pressure from time to time
• if you have a history of liver or kidney disease
• if you are being treated for an infection. ETORICOXIB AUROBINDO may mask or hide fever, which is a symptom of infection
• if you have diabetes, high cholesterol, or are a smoker. These conditions may increase the risk of heart disease
• if you are a woman trying to become pregnant
• if you are over 65 years of age

If you are unsure whether any of the above conditions apply to you, inform your doctor before taking ETORICOXIB AUROBINDO to check whether this medicine is suitable for you.

ETORICOXIB AUROBINDO works well in both elderly and younger patients. If you are over 65 years of age, your doctor will monitor you appropriately. Dose adjustment is not 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.

Other medicines and ETORICOXIB AUROBINDO

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

In particular, if you are taking any of the following medicines, your doctor will monitor you once you start treatment with ETORICOXIB AUROBINDO to ensure that the medicines are working adequately:

• 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 and tacrolimus (medicines used to suppress the immune system)
• lithium (a medicine used to treat certain types of depression)
• medicines used to help control blood pressure and heart failure called ACE inhibitors and angiotensin receptor blockers, such as enalapril, ramipril, 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 solutions containing salbutamol (a medicine for asthma)
• oral contraceptive pill (the combination may increase the risk of adverse effects)
• hormone replacement therapy (the combination may increase the risk of adverse effects)
• aspirin: the risk of stomach ulcer is higher if you take ETORICOXIB AUROBINDO with aspirin
• aspirin for prevention of heart attacks or stroke: ETORICOXIB AUROBINDO may be taken together with low doses of aspirin. If you are taking low-dose aspirin at the same time to prevent heart failure or stroke, do not stop taking aspirin before consulting your doctor.
• aspirin and other non-steroidal drugs (NSAIDs): do not take high doses of aspirin or other anti-inflammatory medicines while taking ETORICOXIB AUROBINDO.

ETORICOXIB AUROBINDO with food and drink

The onset of action of ETORICOXIB AUROBINDO may be faster when taken away from meals.

Pregnancy, breastfeeding and fertility

Pregnancy

ETORICOXIB AUROBINDO must not be taken during pregnancy. If you are pregnant or breastfeeding, if you suspect you are pregnant or are planning to become pregnant, do not take the tablets. If you become pregnant, stop taking the tablets and consult your doctor. Consult your doctor if you are unsure or need further information.

Breastfeeding

It is not known whether ETORICOXIB AUROBINDO is excreted in breast milk. If you are breastfeeding or intend to breastfeed, consult your doctor before taking ETORICOXIB AUROBINDO. You must not breastfeed while taking ETORICOXIB AUROBINDO.

Fertility

ETORICOXIB AUROBINDO is not recommended for women attempting to conceive.

Driving and using machines

Dizziness and drowsiness have been reported in some patients taking ETORICOXIB AUROBINDO.

Do not drive if you experience dizziness or drowsiness.

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

3. How to take ETORICOXIB AUROBINDO

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Do not take more than the recommended dose for your condition. Your doctor will review your treatment as appropriate. It is important that you use the lowest effective dose to control your pain and that you do not take ETORICOXIB AUROBINDO for longer than necessary, as the risk of heart attack and stroke may increase with prolonged treatment, especially at higher doses.
Different dosage strengths of this medicine are available depending on your condition; your doctor will prescribe the most appropriate dose for you.
The recommended doses are:

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

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

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

Acute pain
Etoricoxib should only be used for the duration of the acute pain.

Gout
The recommended dose is 120 mg once daily, to be used only for the duration of the acute pain, for a maximum of 8 days of treatment.

Postoperative dental pain
The recommended dose is 90 mg once daily, for a maximum of 3 days of treatment.

Patients with liver problems

• If you have mild hepatic impairment, you should not take more than 60 mg per day.
• If you have moderate hepatic impairment, you should not take more than 30 mg per day.

Use in children and adolescents
ETORICOXIB AUROBINDO must not be taken by children or adolescents under 16 years of age.

Elderly
Dosage adjustment is not required in elderly patients. However, as with other medicines, caution should be exercised when treating elderly patients.

Method of administration
ETORICOXIB AUROBINDO is for oral use. Take one tablet once daily.
ETORICOXIB AUROBINDO can be taken with or without food.

If you take more ETORICOXIB AUROBINDO than you should
Do not take more tablets than the dose recommended by your doctor. If you take too many ETORICOXIB AUROBINDO tablets, contact your doctor immediately.

If you forget to take ETORICOXIB AUROBINDO
It is important to take ETORICOXIB AUROBINDO as prescribed by your doctor. If you miss a dose, simply take your next dose at the usual time the following day. Do not take a double dose to make up for the missed dose.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you develop any of the following symptoms, stop taking ETORICOXIB AUROBINDO and inform your doctor immediately (see section 2, What you need to know before taking ETORICOXIB AUROBINDO):

• if you experience difficulty breathing, chest pain, swelling of the ankles, or if these symptoms worsen
• yellowing of the skin and eyes (jaundice) – signs of liver problems
• severe or persistent stomach pain or if your stools become dark
• allergic reaction which may include skin problems such as ulcers, blistering, swelling of the face, lips, tongue or throat which may cause difficulty breathing

The frequency of the possible side effects listed below is defined using the following convention:
Very common (affects more than 1 in 10 people)
Common (affects 1 to 10 in 100 people)
Uncommon (affects 1 to 10 in 1,000 people)
Rare (affects 1 to 10 in 10,000 people)
Very rare (affects less than 1 in 10,000 people)

The following side effects may occur during treatment with ETORICOXIB AUROBINDO:

Very common

• Stomach pain

Common

• Dry mouth (inflammation and pain after tooth extraction)
• Swelling of legs and/or feet due to fluid retention (oedema)
• Dizziness, headache
• Palpitations (fast and irregular heartbeat), irregular heartbeat (arrhythmia)
• Increased blood pressure
• Wheezing or difficulty breathing (bronchospasm)
• Constipation, flatulence (excess gas), gastritis (inflammation of the stomach lining), heartburn, diarrhoea, indigestion (dyspepsia)/stomach pain, nausea, feeling unwell (vomiting), inflammation of the oesophagus, mouth ulcers
• Changes in liver-related blood test values
• Bruising
• Weakness and fatigue, flu-like symptoms

Uncommon

• Gastroenteritis (inflammation of the gastrointestinal tract involving both stomach and small intestine/intestinal flu), upper respiratory tract infections, urinary tract infections
• Changes in laboratory test values (decreased number of red blood cells, decreased number of white blood cells, decreased platelets)
• Hypersensitivity (an allergic reaction including hives, which may be serious enough to require immediate medical attention)
• Increased or decreased appetite, weight gain
• Anxiety, depression, reduced mental alertness; seeing, sensing or hearing things that do not exist (hallucinations)
• Altered taste, inability to sleep, numbness or tingling, drowsiness
• Blurred vision, eye irritation and redness
• Ringing in the ears, vertigo (sensation of spinning while stationary)
• Irregular heartbeat (atrial fibrillation), rapid heartbeat, heart failure, sensation of tightness, pressure or heaviness in the chest (angina pectoris), heart attack
• Flushing, stroke, mini-stroke (transient ischaemic attack), marked increase in blood pressure, inflammation of blood vessels
• Cough, shortness of breath, nosebleeds
• Stomach or intestinal bleeding, changes in bowel habits, dry mouth, gastric ulcer, inflammation of the stomach lining which may become severe and lead to bleeding, irritable bowel syndrome, inflammation of the pancreas
• Facial swelling, skin rash or skin itching, skin redness
• Muscle cramps/spasms, muscle pain/stiffness or high levels of potassium in the blood, changes in blood or urine tests related to the kidneys, serious kidney problems
• Chest pain

Rare

• Angioedema (an allergic reaction with swelling of the face, lips, tongue and/or throat which may cause difficulty breathing or swallowing, which may be serious enough to require immediate medical attention), anaphylactic/anaphylactoid reaction including shock (serious allergic reaction requiring immediate medical attention)
• Confusion, restlessness
• Liver problems (hepatitis)
• Low levels of sodium in the blood
• Liver failure, yellowing of the skin and/or eyes (jaundice)
• Serious skin reactions

Reporting of side effects
If you experience any side effect, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet. Side effects can also be reported directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store ETORICOXIB AUROBINDO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ETORICOXIB AUROBINDO contains

• The active substance is etoricoxib. Each coated tablet contains 30 mg of etoricoxib. Each coated tablet contains 60 mg of etoricoxib. Each coated tablet contains 90 mg of etoricoxib. Each coated tablet contains 120 mg of etoricoxib.
• The other components are: Tablet core: microcrystalline cellulose (E460), calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate (E470b). Tablet coating: polyvinyl alcohol (E1203), titanium dioxide (E171), glycerol monostearate (E471), aluminium lake containing indigo carmine (E132) [only for 30 mg, 60 mg and 120 mg], yellow iron oxide (E172) [only for 30 mg, 60 mg and 120 mg], talc (E553b), sodium lauryl sulfate.

Description of the appearance of ETORICOXIB AUROBINDO and package contents
Film-coated tablets.
ETORICOXIB AUROBINDO 30 mg film-coated tablets
Blue-green, apple-shaped, biconvex, film-coated tablets, marked “30” on one side and smooth on the other side, with dimensions of 5.8 x 5.9 mm ± 7.5%.
ETORICOXIB AUROBINDO 60 mg film-coated tablets
Dark green, apple-shaped, biconvex, film-coated tablets, marked “60” on one side and smooth on the other side, with dimensions of 7.1 x 7.3 mm ± 7.5%.
ETORICOXIB AUROBINDO 90 mg film-coated tablets
White, apple-shaped, biconvex, film-coated tablets, marked “90” on one side and smooth on the other side, with dimensions of 8.1 x 8.3 mm ± 7.5%.
ETORICOXIB AUROBINDO 120 mg film-coated tablets
Light green, apple-shaped, biconvex, film-coated tablets, marked “120” on one side and smooth on the other side, with dimensions of 8.9 x 9.2 mm ± 7.5%.
ETORICOXIB AUROBINDO film-coated tablets are supplied in blister packs containing:
30 mg: 7, 20, 28 film-coated tablets
60 mg: 20, 28 film-coated tablets
90 mg: 5, 20, 28 film-coated tablets
120 mg: 5, 7, 20 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Aurobindo Pharma (Italia) s.r.l. – Via San Giuseppe, 102 – 21047 Saronno (Varese), Italy

Manufacturer:
Rontis Hellas Medical and Pharmaceutical Products S.A. - P.O. Box 3012 Larisa Industrial Area
41004 Greece

This medicinal product is authorized in the European Economic Area Member States under the following names:
Portugal: Etoricoxib Empower
Italy: Etoricoxib Aurobindo
Spain: Etoricoxib Aurovitas 30 mg/60 mg/90 mg/120 mg film-coated tablets EFG