Etoricoxib Sandoz

Patient Information Leaflet

Etoricoxib Sandoz 30 mg film-coated tablets, 60 mg film-coated tablets, 90 mg film-coated tablets, 120 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Etoricoxib Sandoz is and what it is used for

What is Etoricoxib Sandoz?

• Etoricoxib Sandoz contains the active substance etoricoxib. Etoricoxib Sandoz belongs to a group of medicines called selective COX-2 inhibitors. These belong to a family of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

What is Etoricoxib Sandoz used for?

• Etoricoxib Sandoz helps reduce pain and swelling (inflammation) in the joints and muscles of people aged 16 years and older who have osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, or gout.
• Etoricoxib Sandoz 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 is caused by the progressive deterioration of the cartilage that covers the ends of bones. This leads to swelling (inflammation), pain, tenderness, 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 joint movement. It may also cause inflammation in other parts of the body.
What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease of the spine and large joints.
What is gout?
Gout is a disease characterized by sudden and recurring attacks of very painful inflammation and redness in the joints. It is caused by the deposition of mineral crystals in the joints.

2. What you should know before taking Etoricoxib Sandoz

Do not take Etoricoxib Sandoz:

• 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 and COX-2 inhibitors (see section 4 “Possible side effects”)
• if you have an active stomach ulcer or active bleeding in the stomach or intestines
• if you have severe liver disease
• if you have severe kidney disease
• if you are pregnant or there is a possibility that you may 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 (consult your doctor if you are unsure whether your blood pressure is adequately controlled)
• if your doctor has diagnosed you with heart problems such as heart failure (moderate or severe), angina (chest pain), or if you have had a heart attack or bypass surgery
• if you have peripheral arterial disease (reduced circulation in the legs and feet due to narrowed or blocked arteries)
• if you have ever had a stroke (including mini-stroke, transient ischemic attack or TIA). Etoricoxib may slightly increase the risk of heart attack and stroke, and for this reason it must not be used in people who have already had heart problems or stroke

If you think any of these conditions apply to you, do not take this medicine before consulting your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Etoricoxib Sandoz if:

• you have a history of stomach bleeding or stomach ulcers.
• you are dehydrated, for example due to a prolonged episode of 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. In some people, Etoricoxib Sandoz, especially at high doses, can increase blood pressure, and your doctor will periodically check your blood pressure.
• you have a history of liver or kidney disease.
• you are being treated for an infection. Etoricoxib Sandoz may mask or hide fever, which is a sign of infection.
• you have diabetes, high cholesterol or are a smoker. These are conditions that may increase the risk of heart disease.
• you are a woman trying to become pregnant.
• you are over 65 years of age.

If you have any doubts whether any of the above conditions apply to you, talk to your doctor
before taking Etoricoxib Sandoz to determine whether this medicine is suitable for you.
Etoricoxib Sandoz has the same efficacy in elderly patients as in younger ones. If you are over 65 years of age, your doctor will monitor you appropriately. 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.
Other medicines and Etoricoxib Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, if you are taking any of the following medicines, your doctor may carry out checks to see whether these medicines are working properly once you have started taking Etoricoxib Sandoz:

• blood thinners (anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a medicine used to suppress the immune system and often used in the treatment of rheumatoid arthritis)
• cyclosporine or tacrolimus (medicines used to suppress the immune system, for example after an organ transplant)
• 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, and losartan and valsartan
• diuretics (water tablets)
• digoxin (a medicine for the treatment of heart failure and irregular heartbeat)
• minoxidil (a medicine for the treatment of high blood pressure)
• oral salbutamol tablets or oral solution (a medicine for the treatment of asthma)
• oral contraceptives (combination therapy may increase the risk of side effects)
• hormone replacement therapy (combination therapy may increase the risk of side effects)
• acetylsalicylic acid; the risk of stomach ulcers is higher if you take Etoricoxib Sandoz with acetylsalicylic acid.
• acetylsalicylic acid for the prevention of heart attacks or strokes: Etoricoxib Sandoz may be taken with low doses of acetylsalicylic acid. If you are taking low-dose acetylsalicylic acid for the prevention of heart attacks or strokes, do not stop treatment with acetylsalicylic acid without consulting 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 during treatment with Etoricoxib Sandoz.

Pregnancy, breastfeeding and fertility
Pregnancy
Etoricoxib Sandoz must not be taken during pregnancy. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, do not take this medicine. If you become pregnant, stop taking Etoricoxib Sandoz and consult your doctor. If you are unsure or need more information, consult your doctor.
Breastfeeding
It is not known whether etoricoxib is excreted in human milk. If you are breastfeeding or think you may breastfeed, contact your doctor before taking Etoricoxib Sandoz. If you are using Etoricoxib Sandoz, you must not breastfeed.
Fertility
Etoricoxib may make it more difficult to become pregnant. Etoricoxib Sandoz is not recommended for women who are planning to become pregnant.
You must inform your doctor if you are planning a pregnancy or if you have difficulty becoming pregnant.
Driving and using machines
Dizziness and drowsiness have been reported in some patients taking Etoricoxib Sandoz.
Do not drive if you experience dizziness or drowsiness.
Do not use tools or machinery if you experience dizziness or drowsiness.
Etoricoxib Sandoz contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Etoricoxib Sandoz

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
Do not take more than the recommended dose for the treatment of your condition. Your doctor will
periodically assess your treatment. It is important that you use the lowest effective dose capable of controlling your
pain and that you do not take Etoricoxib Sandoz for longer than necessary. This is because the risk of
heart attacks and strokes may increase with prolonged treatment, especially at higher doses.
Different strengths of this medicine are available, and depending on your condition, your doctor
will prescribe the tablet strength most suitable for you.
The recommended dose is:
Osteoarthritis
The recommended dose is 30 mg once daily, which may be increased, if necessary, up to a maximum
dose of 60 mg once daily.
Rheumatoid arthritis
The recommended dose is 60 mg once daily, which may be increased, if necessary, up to a maximum
dose of 90 mg once daily.
Ankylosing spondylitis
The recommended dose is 60 mg once daily, which may be increased, if necessary, up to a maximum
dose of 90 mg once daily.
Acute pain conditions
Etoricoxib Sandoz should only be used for the duration of acute pain.

• Gout The recommended dose is 120 mg once daily, which should only be used for the duration 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.

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

Method of administration
Etoricoxib Sandoz should be taken by mouth.
Take the tablets once daily.
Etoricoxib Sandoz may be taken with or without food. The onset of effect of Etoricoxib Sandoz
may be faster when taken without food.
If you take more Etoricoxib Sandoz than you should
Never take more tablets than recommended by your doctor. If you take too many
tablets, contact your doctor immediately.
If you forget to take Etoricoxib Sandoz
It is important to take Etoricoxib Sandoz as prescribed by your doctor. If you miss a
dose, take your next dose at the usual time according to your regular schedule. Do not take a double
dose to make up for the missed dose.
If you have any questions about 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 experience any of the following symptoms, stop taking Etoricoxib Sandoz and contact your
doctor immediately:

• shortness of breath, chest pain, or new or worsening swelling of the ankles
• yellowing of the skin and eyes (jaundice) – these are symptoms 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 which may make breathing difficult.

The following side effects may occur during treatment with Etoricoxib Sandoz:

Very common (may affect more than 1 in 10 people):

• stomach pain

Common (may affect up to 1 in 10 people):

• alveolitis (inflammation and pain following tooth extraction)
• swelling of the legs and/or feet due to fluid retention (oedema)
• dizziness, headache
• awareness of heartbeat, irregular heartbeat
• increased blood pressure
• wheezing or shortness of breath (bronchospasm)
• constipation, flatulence (excess gas), inflammation of the inner lining of the stomach (gastritis), heartburn, diarrhoea, difficulty in digestion (dyspepsia)/stomach discomfort, nausea, malaise (vomiting), inflammation of the oesophagus, mouth ulcers
• changes in certain blood tests related to liver function
• bruising
• weakness and fatigue, flu-like illness

Uncommon (may affect up to 1 in 100 people):

• inflammation of the gastrointestinal tract involving both the stomach and the small intestine/infectious gastroenteritis (gastroenteritis)
• upper respiratory tract infection
• urinary tract infection
• decrease in the number of red blood cells in the blood which may make the skin pale and cause weakness and breathlessness
• decrease in the number of white blood cells in the blood
• decrease in platelets which increases the risk of bleeding or bruising
• hypersensitivity (an allergic reaction including urticaria which may be severe enough to require immediate medical attention)
• increased or decreased appetite, weight gain
• anxiety, depression, reduced mental sharpness, seeing, hearing or sensing things that are not real (hallucinations)
• altered taste, difficulty sleeping, tingling or numbness, drowsiness
• blurred vision, eye irritation and redness
• ringing in the ears, vertigo (persistent sensation of dizziness when standing)
• abnormal heart rhythm (atrial fibrillation), increased heart rate, heart failure, sensation of tightness, pressure or heaviness in the chest (angina pectoris), heart attack
• hot flushes, stroke, mini-stroke (transient ischaemic attack [TIA]), severe increase in blood pressure, inflammation of blood vessels often accompanied by skin rash
• cough, difficulty breathing, nosebleeds
• stomach or intestinal bloating, changes in bowel habits, dry mouth, stomach or small intestine ulcer, inflammation of the inner lining of the stomach which may become severe and may 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
• elevated levels of potassium in the blood which may cause abnormal heart rhythm, changes in certain blood or urine tests related to kidney function, severe kidney problems
• chest pain

Rare (may affect up to 1 in 1,000 people):

• severe allergic reaction with swelling of the face, lips, tongue and/or throat which may cause difficulty breathing and swallowing (angioedema), anaphylactic/anaphylactoid reactions including shock (severe allergic reactions requiring immediate medical attention)
• confusion, restlessness
• inflammation of the liver (hepatitis), liver failure, yellowing of the skin and/or eyes (jaundice)
• low levels of sodium in the blood which may cause tiredness and confusion, muscle spasms, seizures and coma
• severe skin reactions

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Etoricoxib Sandoz

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 that month.
This medicine requires no special storage conditions.
Do not dispose of medicines 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 Sandoz contains

• The active substance is etoricoxib.
• Etoricoxib Sandoz 30 mg film-coated tablets: each film-coated tablet contains 30 mg of etoricoxib.
• Etoricoxib Sandoz 60 mg film-coated tablets: each film-coated tablet contains 60 mg of etoricoxib.
• Etoricoxib Sandoz 90 mg film-coated tablets: each film-coated tablet contains 90 mg of etoricoxib.
• Etoricoxib Sandoz 120 mg film-coated tablets: each film-coated tablet contains 120 mg of etoricoxib.
• The other ingredients are: anhydrous calcium hydrogen phosphate, microcrystalline cellulose, povidone K29-32, magnesium stearate, sodium croscarmellose, hypromellose, lactose monohydrate, titanium dioxide (E171), triacetin. The 30 mg, 60 mg and 120 mg tablets also contain indigo carmine aluminium lake (E132) and yellow iron oxide (E172).

Description of the appearance of Etoricoxib Sandoz and package contents

Etoricoxib Sandoz film-coated tablets are available in 4 dosage strengths.
The 30 mg tablets are blue-green, round, biconvex and film-coated.
The 60 mg tablets are dark green, round, biconvex and film-coated.
The 90 mg tablets are white, round, biconvex and film-coated.
The 120 mg tablets are light green, round, biconvex and film-coated.
Pack sizes of 2, 5, 7, 14, 20, 28, 49, 50, 98, 100 film-coated tablets in blisters or in tablet containers with screw cap containing desiccant (silica gel). The desiccant, used to keep the tablets dry, must not be ingested.
Not all pack sizes may be marketed.

Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA)
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Pharmacare Premium Ltd., HHF 003, Hal Far Industrial Estate, Birzebbuga, BBG 3000, Malta
Germany Etoricox Hexal 30 mg, 60 mg, 90 mg, 120 mg Film Tablets
Italy Etoricoxib Sandoz