Etoricoxib Sandoz 90 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Etoricoxib Sandoz 60 mg film-coated tablets EFG

Etoricoxib Sandoz 90 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. 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 others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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 adverse 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 known as selective COX-2 inhibitors. These belong to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

What is Etoricoxib Sandoz used for?

• Etoricoxib 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 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 disease of the joints. 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 the affected joints. It can also cause inflammation in other parts of the body.

What is ankylosing spondylitis?

Ankylosing spondylitis is an inflammatory disease of the spine and the long joints.

What is gout?

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

2. What you need to 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 currently have a stomach or duodenal ulcer or bleeding,
• if you have severe liver disease,
• if you have severe kidney disease,
• if you are or may be pregnant, or are breastfeeding your child (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 uncontrolled high blood pressure (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 conditions apply to you, do not take this medicine until you have consulted your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Etoricoxib Sandoz 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 may increase blood pressure in some people, especially at high doses, and your doctor may 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 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 an elderly patient (e.g., over 65 years of age).

If you are unsure whether any of the above situations apply to you, talk to your doctor before taking etoricoxib to confirm whether this medicine is suitable for you.

Etoricoxib works equally well in younger adult patients and elderly patients. If you are an elderly patient over 65 years of age, your doctor may want to monitor you regularly. Dose adjustment is not necessary in elderly 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 Sandoz with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might need to take any other medicines.

In particular, if you are taking any of the following medicines, your doctor may want to monitor you to ensure your medicines are working properly once you start taking etoricoxib:

• medicines that make your blood thinner (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 called ACE inhibitors and angiotensin receptor antagonists, for example enalapril and ramipril, losartan and valsartan,
• diuretics (water tablets),
• digoxin (a medicine used 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: the risk of stomach ulcers is higher if you take etoricoxib with acetylsalicylic acid,
• acetylsalicylic acid for prevention of myocardial infarction or stroke: Etoricoxib Sandoz can 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 talking 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 Sandoz.

Pregnancy, breastfeeding and fertility

Pregnancy

Etoricoxib should not be taken during pregnancy. If you are pregnant or breastfeeding, think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine. 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 unknown whether etoricoxib is excreted in breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking etoricoxib. If you are taking etoricoxib, you should not breastfeed.

Fertility

Etoricoxib may make it more difficult to become pregnant. The use of etoricoxib is not recommended in women who are trying to become pregnant.

You should inform your doctor if you are planning a pregnancy or if you have difficulty becoming pregnant.

Driving and using machines

Dizziness and somnolence have been reported in some patients taking etoricoxib.

Do not drive if you experience dizziness or somnolence.

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

Etoricoxib Sandoz contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Etoricoxib Sandoz

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

Do not take more than 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 not to take etoricoxib for longer than necessary. This is because the risk of heart attacks and strokes may increase after prolonged treatment, especially with high doses.

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, 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 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' treatment.

• Postoperative dental surgery pain

The recommended dose is 90 mg once daily, limited to a maximum of 3 days' treatment.

Elderly patients

Dose adjustment is not necessary 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 should not take more than 60 mg per day.
• If you have moderate liver disease, you should not take more than 30 mg per day.

Method of administration

Etoricoxib Sandoz is taken orally. Take the tablets once daily. Etoricoxib can be taken with or without food. The onset of etoricoxib's effect may be faster when taken without food.

If you take more Etoricoxib Sandoz than you should

Never take more tablets than prescribed by your doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Etoricoxib Sandoz

It is important to take etoricoxib as prescribed by your doctor. If you miss a dose, take the next dose at your usual time the following 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 will experience them.

If you develop any of the following signs, stop taking Etoricoxib Sandoz and speak to your doctor immediately:

• difficulty breathing, chest pain, or swelling of the ankle, or if these worsen,
• yellowing of the skin and eyes (jaundice) – these are signs of liver problems,
• severe or persistent stomach pain or your stools become black,
• 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:

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 legs and/or feet due to fluid retention (oedema),
• dizziness, headache,
• awareness of heartbeat, irregular heartbeat,
• high blood pressure,
• wheezing or difficulty breathing (bronchospasm),
• constipation, gas (excess gas), inflammation of the inner lining of the stomach (gastritis), heartburn, diarrhoea, indigestion (dyspepsia)/stomach discomfort, nausea, feeling unwell (vomiting), inflammation of the oesophagus, 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)

• inflammation of the gastrointestinal tract affecting both the stomach and small intestine (gastroenteritis),
• upper respiratory tract infection,
• urinary tract infection,
• reduction in red blood cells which may cause paleness of the skin and lead to weakness or difficulty breathing,
• reduction in white blood cells,
• decrease in platelets, which increases the risk of bleeding or bruising,
• hypersensitivity (allergic reaction including hives, which may be severe enough to require immediate medical attention),
• increased or decreased appetite, weight gain,
• anxiety, depression, reduced mental sharpness; seeing, feeling or hearing things that are not there (hallucinations),
• altered taste, difficulty sleeping, 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 heartbeat, heart failure, sensation of tightness, pressure or heaviness in the chest (angina), myocardial infarction,
• flushing, stroke, mini-stroke (transient ischaemic attack [TIA]), severe increase in blood pressure, inflammation of blood vessels, often with itching,
• cough, shortness of breath, nosebleed,
• stomach swelling, changes in bowel habits, dry mouth, stomach or small intestine ulcer, inflammation of the inner lining of the stomach which may become severe and lead to bleeding, irritable bowel syndrome, inflammation of the pancreas,
• swelling of the face, skin rash or itching, redness of the skin,
• muscle cramp/spasm, muscle pain/stiffness,
• high levels of potassium in your blood which may cause abnormal heart rhythm, changes in blood or urine tests related to your kidneys, serious kidney problems,
• chest pain.

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

• allergic reaction with swelling of the face, lips, tongue, and/or throat which may cause difficulty breathing or swallowing (angioedema/anaphylactic/anaphylactoid reactions including shock (severe allergic reaction requiring immediate medical attention)),
• confusion, restlessness,
• inflammation of the liver (hepatitis), liver dysfunction, 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,
• serious 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 can 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 Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Etoricoxib Sandoz

• The active substance is etoricoxib.

Each film-coated tablet contains 60 mg of etoricoxib.

Each film-coated tablet contains 90 mg of etoricoxib.

• The other components (excipients) are: calcium hydrogen phosphate anhydrous, microcrystalline cellulose, povidone K29-32, magnesium stearate, sodium croscarmellose, hypromellose, lactose monohydrate, titanium dioxide (E171), triacetin.

The 60 mg tablets also contain aluminium lake (Indigo carmine) (E132) and yellow iron oxide (E172).

Appearance of the product and contents of the pack

The 60 mg film-coated tablets are dark green, round and biconvex.

The 90 mg film-coated tablets are white, round and biconvex.

The tablets are packed in blisters or in tablet bottles with polypropylene screw caps containing a desiccant (silica gel). The desiccant used to keep the tablets dry must not be swallowed.

Pack sizes:

5, 7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

Sachsen-Anhalt, 39179 Barleben

Germany

or

Delorbis Pharmaceuticals Ltd

17 Athinon Street, Ergates Industrial Area,

2643 Ergates, Lefkosia,

Cyprus

This medicinal product is authorized in the European Economic Area member states under the following names:

Austria Etoricoxib Sandoz 30 mg, 60 mg, 90 mg, 120 mg – Filmtabletten

Belgium Etoricoxib Sandoz 30 mg, 60 mg, 90 mg, 120 mg filmomhulde tabletten

Bulgaria ????????? 60 mg, 90 mg, 120 mg ????????? ????????

Croatia Kostarox 60 mg, 90 mg filmom obložene tablete

Estonia Coxitor

Finland Etoricoxib Sandoz 30 mg, 60 mg, 90 mg, 120 mg tabletti, kalvopäällysteinen

France Etoricoxib Sandoz 30 mg, 60 mg comprimé pelliculé

Ireland Etoricoxib 30 mg, 60 mg, 90 mg, 120 mg Film-coated tablets

Latvia Coxitor 60 mg, 90 mg, 120 mg apvalkotas tabletes

Lithuania Coxitor 30 mg, 60 mg, 90 mg, 120 mg plevele dengtos tabletes

Luxembourg Etoricoxib Sandoz 30 mg, 60 mg, 90 mg, 120 mg comprimé pelliculé

Netherlands Etoricoxib Sandoz 30 mg, 60 mg, 90 mg, 120 mg filmomhulde tabletten

Norway Etoricoxib Sandoz 60 mg, 90 mg, 120 mg filmdrasjerte tabletter

Poland Kostarox, 60 mg, 90 mg, 120 mg, tabletki powlekane

Romania Kostarox 30 mg, 60 mg, 90 mg, 120 mg comprimate filmate

Slovenia Etorikoksib Lek 30 mg, 60 mg, 90 mg, 120 mg filmsko obložene tablete

Sweden Etoricoxib Sandoz 30 mg, 60 mg, 90 mg, 120 mg filmdragerad tablett

Germany Etoricoxib Hexal 30 mg, 60 mg, 90 mg, 120 mg Filmtabletten

Italy ETORICOXIB SANDOZ

Date of the most recent review of this leaflet: November 2020.

Detailed and up-to-date 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/