Package Insert: Information for the Patient

Etoricoxib Sandoz 60 mg Film-Coated Tablets

Etoricoxib Sandoz 90 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult 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, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

2. What you need to know before starting to take Etoricoxib Sandoz

3. How to take Etoricoxib Sandoz

4. Possible side effects

5. Storage of Etoricoxib Sandoz

6. Contents of the pack and additional information

What is Etoricoxib Sandoz?

• Etoricoxib Sandoz contains the active ingredient etoricoxib. Etoricoxib Sandoz belongs to a group of medicines called 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 to reduce pain and swelling (inflammation) in the joints and muscles of people aged 16 years and over with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.
• Etoricoxib is also used for the short-term treatment of moderate pain after dental surgery in people aged 16 years and over.

What is osteoarthritis?

Osteoarthritis is a disease of the joints. It causes the gradual breakdown of the cartilage that cushions the ends of the bones. This causes swelling (inflammation), pain, sensitivity, 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 mobility in the affected joints. It also causes inflammation in other parts of the body.

What is ankylosing spondylitis?

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

What is gout?

Gout is a disease of sudden and recurrent attacks of very painful and inflamed joints. It is caused by deposits of mineral crystals in the joint.

Do not take Etoricoxib Sandoz:

• if you are allergic to etoricoxib or any of the other ingredients of this medication (listed in section 6),
• if you are allergic to nonsteroidal 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 a severe liver disease,
• if you have a 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 if your blood pressure is adequately controlled),
• if your doctor has diagnosed you with heart problems, including heart failure (moderate or severe), angina pectoris (chest pain),
• if you have had a myocardial infarction, revascularization surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries),
• if you have had any type of stroke (including transient ischemic attack or transient ischemic attack).

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

If you think any of these conditions apply to you, do not take this medication until you have consulted your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeEtoricoxib Sandoz if:

• you have a history of ulcers or stomach bleeding,
• you are dehydrated, for example, as a result of a prolonged illness with vomiting or diarrhea,
• 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 will 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 conceal 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 old).

If you are unsure whether any of the above situations apply to you,talk to your doctor before taking etoricoxibto check if this medication is suitable for you.

Etoricoxib works just as well in young adult patients and elderly patients. If you are an elderly patient over 65 years old, your doctor will want to check you regularly. No dose adjustment is necessary for elderly patients over 65 years old.

Children and adolescents

Do not administer this medication to children and adolescents under 16 years of age.

Taking Etoricoxib Sandoz with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

• blood-thinning medications (anticoagulants), such as warfarin,
• rifampicin (an antibiotic),
• methotrexate (a medication used to suppress the immune system and is often used for rheumatoid arthritis),
• ciclosporin or tacrolimus (medications used to suppress the immune system),
• lithium (a medication used to treat certain types of depression),
• medications used to help control high blood pressure and heart failure, known as ACE inhibitors and angiotensin receptor antagonists, for example enalapril and ramipril, and losartan and valsartan,
• diuretics (tablets to urinate),
• digoxin (a medication used for heart failure and irregular heartbeat),
• minoxidil (a medication used to treat high blood pressure),
• oral tablets or solution of salbutamol (a medication for asthma),
• oral contraceptives (the combination may increase your risk of side effects),
• hormone replacement therapy (the combination may increase your risk of side effects),
• acetylsalicylic acid, the risk of stomach ulcers is higher if you take etoricoxib with acetylsalicylic acid,
• acetylsalicylic acid for the prevention of myocardial infarction or stroke:
  Etoricoxib Sandoz can be taken withlow dosesof acetylsalicylic acid. If you are currently taking low doses of acetylsalicylic acid to prevent myocardial infarction or stroke, do not stop taking acetylsalicylic acid until you have spoken with your doctor,
• acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs):

Do not take high doses of acetylsalicylic acid or other NSAIDs while taking Etoricoxib Sandoz.

Pregnancy,breastfeedingand fertility

Pregnancy

Etoricoxib should not be taken during pregnancy. If you are pregnant or breastfeeding, consultyour doctor or pharmacist before using this medication.If you become pregnant, stop taking the tablets and consult your doctor.Consult your doctor if you have any doubts or need more information.

Breastfeeding

It is unknown whether etoricoxib is excreted in breast milk. If you are breastfeeding or plan to do so, consult your doctor before taking etoricoxib. If you are taking etoricoxib, do not breastfeed.

Fertility

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

You should inform your doctor if you are planning to become pregnant or have difficulty becoming pregnant.

Driving and operating machinery

In some patients taking etoricoxib, dizziness and somnolence have been reported.

Do not drive if you experience dizziness or somnolence.

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

Etoricoxib Sandoz contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication should be taken as directed by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.Consult your doctor or pharmacist if you have any questions or concerns.

Do not take more than the recommended dose for your condition. Your doctor will want to discuss your treatment from time to time. It is essential to use the lowest dose that controls your pain and do not take etoricoxib for longer than necessary. This is because the risk of myocardial infarction and stroke may increase after prolonged treatment, especially with high doses.

There are different doses available for this medication, and depending on your condition, your doctor will prescribe the tablet with the dose that is suitable for you.

The recommended dose is:

Arthritis

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

Rheumatoid Arthritis

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

Ankylosing Spondylitis

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

Acute Pain

Etoricoxib should only be used during the acute pain period.

• Gout

The recommended dose is 120 mg once a day, which should only be used during the acute pain period, limited to a maximum of 8 days of treatment.

• Dental Surgery Postoperative Pain

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

Advanced Age

No dose adjustment is necessary in elderly patients. As with other medications, caution should be exercised in elderly patients.

Liver Problems

• If you have a mild liver disease, do not take more than 60 mg per day.
• If you have a moderate liver disease, do not take more than 30 mg per day.

Administration Form

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

If you take more Etoricoxib Sandoz than you should

You should never take more tablets than indicated by your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeEtoricoxib Sandoz

It is essential to take etoricoxib as prescribed by your doctor. If you forgot to take a dose, take the corresponding dose the next day at your usual time. Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you develop any of these signs, stop taking Etoricoxib Sandoz and talk 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 turn black,
• an allergic reaction - which can include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue, or throat that can cause difficulty breathing.

The following side 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)

• alveolar osteitis (inflammation and pain after tooth extraction),
• swelling of the legs and/or feet due to fluid retention (edema),
• dizziness, headache,
• feeling the heartbeat, irregular heartbeat,
• high blood pressure,
• choking or difficulty breathing (bronchospasm),
• constipation, gas (excessive gas), inflammation of the inner lining of the stomach (gastritis), burning, diarrhea, indigestion (dyspepsia)/stomach discomfort, nausea, feeling sick (vomiting), inflammation of the esophagus, mouth ulcers,
• changes in blood tests related to the 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 of red blood cells that can cause pale skin and cause weakness or difficulty breathing,
• reduction of white blood cells,
• decrease in platelets, which increases the risk of bleeding or bruising,
• hypersensitivity (allergic reaction including urticaria that 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 do not exist (hallucinations),
• alteration of taste, difficulty sleeping, numbness or tingling, drowsiness,
• blurred vision, eye irritation and redness,
• ringing in the ears, vertigo (sensation of spinning while standing),
• abnormal heart rhythm (atrial fibrillation), rapid heart rate, heart failure, sensation of tension, pressure, or heaviness in the chest (angina pectoris), myocardial infarction,
• redness, cerebral infarction, mini-stroke (transient ischemic attack [TIA]), severe increase in blood pressure, inflammation of blood vessels, often with itching,
• cough, shortness of breath, nasal bleeding,
• swelling of the stomach, changes in bowel movements, dry mouth, stomach or small intestine ulcers, inflammation of the inner lining of the stomach that can be severe and cause bleeding, irritable bowel syndrome, pancreatitis,
• swelling of the face, skin rash or itching, redness of the skin,
• muscle cramp/spasm, muscle pain/stiffness,
• elevated potassium levels in the blood that can cause abnormal heart rhythm, changes in blood or urine tests related to the kidneys, severe 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 that can cause difficulty breathing or swallowing (angioedema/allergic reactions/anaphylactoid reactions including shock (severe allergic reaction that requires immediate medical attention),
• confusion, nervousness,
• inflammation of the liver (hepatitis), liver damage, yellowing of the skin and/or eyes (jaundice),
• low sodium levels in the blood that can cause fatigue and confusion, muscle spasms, convulsions, and coma,
• severe skin reactions.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe packagingafter CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Etoricoxib Sandoz

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

The 60 mg tablets also containaluminium lake (Carmín de índigo) (E132) and yellow iron oxide (E172).

Appearance of the product and contents of the package

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 packaged in blisters or bottles with a polypropylene screw cap with a desiccant (silica gel). Do not swallow the desiccant used to keep the tablets dry.

Package sizes:

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

Only some package sizes may be marketed.

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

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 medicine is authorized in the member states of the European Economic Area with the following names:

AustriaEtoricoxib Sandoz 30 mg, 60 mg, 90 mg, 120 mg – Filmtabletten

BélgicaEtoricoxib Sandoz 30 mg, 60 mg, 90 mg, 120 mg filmomhulde tabletten

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

CroaciaKostarox 60, mg 90 mg filmom obložene tablete

EstoniaCoxitor

FinlandiaEtoricoxib Sandoz 30 mg, 60 mg, 90 mg, 120 mg tabletti, kalvopäällysteinen

FranciaEtoricoxib Sandoz 30 mg, 60 mg comprimé pelliculé

IrlandaEtoricoxib 30 mg, 60 mg, 90 mg, 120 mg Film-coated tablets

LetoniaCoxitor 60 mg, 90 mg, 120 mg apvalkotas tabletes

LituaniaCoxitor 30 mg, 60 mg, 90 mg, 120 mg plevele dengtos tabletes

LuxemburgoEtoricoxib Sandoz 30 mg, 60 mg, 90mg, 120 mg comprimé pelliculé

HolandaEtoricoxib Sandoz 30 mg, 60 mg, 90 mg, 120 mg filmomhulde tabletten

NoruegaEtoricoxib Sandoz 60 mg, 90 mg, 120 mg filmdrasjerte tabletter

PoloniaKostarox, 60 mg, 90 mg, 120 mg, tabletki powlekane

RumaniaKostarox 30 mg, 60 mg, 90 mg, 120 mg comprimate filmate

EsloveniaEtorikoksib Lek 30 mg, 60 mg, 90 mg, 120 mg filmsko obložene tablete

SueciaEtoricoxib Sandoz 30 mg, 60 mg, 90 mg, 120 mg filmdragerad tablett

AlemaniaEtoricoxib Hexal 30 mg, 60 mg, 90 mg, 120 mg Filmtabletten

ItaliaETORICOXIB SANDOZ

Last review date of this leaflet:November 2020.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/