ETORICOXIB SANDOZ 60 mg FILM-COATED TABLETS

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

Do not take Etoricoxib Sandoz:

• if you are allergic to etoricoxib or 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 section 4 “Possible side effects”),
• if you currently have an ulcer or bleeding in your stomach or duodenum,
• if you have severe liver disease,
• if you have severe kidney disease,
• if you are or may be pregnant, or are breast-feeding (see “Pregnancy, breast-feeding, 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 not sure if your blood pressure is controlled),
• if your doctor has diagnosed you with heart problems, including heart failure (of moderate or severe type), angina (chest pain),
• if you have had a heart attack, surgical revascularization, peripheral arterial disease (poor circulation in your legs or feet due to narrow or blocked arteries),
• if you have had any type of stroke (including transient ischaemic attack or transient cerebral ischaemia).

Etoricoxib may slightly increase your risk of heart attack and stroke, and for this reason, it should not be used in patients who have already had heart or stroke problems.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Etoricoxib Sandoz if:

• you have a history of stomach ulcers or bleeding,
• you are dehydrated, for example, due to 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 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 not sure if any of the above applies to you, talk to your doctor before taking etoricoxibto check if this medicine 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 of age, your doctor will want to monitor you regularly. No dose adjustment is 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 take any other medicines.

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

• medicines that make your blood less likely to clot (anticoagulants), such as warfarin,
• rifampicin (an antibiotic),
• methotrexate (a medicine used to suppress the immune system and often used in rheumatoid arthritis),
• cyclosporin or tacrolimus (medicines used to suppress the immune system),
• lithium (a medicine used to treat some 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, and 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),
• tablets or oral solution of salbutamol (a medicine 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),
• aspirin, the risk of stomach ulcers is greater if you take etoricoxib with aspirin,
• aspirin for the prevention of heart attacks or stroke: Etoricoxib Sandoz can be taken with low dosesof aspirin. If you are currently taking low doses of aspirin to prevent heart attacks or stroke, do not stop taking aspirin until you talk to your doctor,
• aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs):

Do not take high doses of aspirin or other anti-inflammatory medicines while taking Etoricoxib Sandoz.

Pregnancy, breast-feeding, and fertility

Pregnancy

Etoricoxib should not be taken during pregnancy. If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you become pregnant, stop taking the tablets and consult your doctor. Consult your doctor if you have any doubts or need more information.

Breast-feeding

It is not known if etoricoxib is excreted in breast milk. If you are breast-feeding or plan to breast-feed, consult your doctor before taking etoricoxib. If you are taking etoricoxib, you should not breast-feed.

Fertility

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

You should tell your doctor if you are planning or trying to become pregnant.

Driving and using machines

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 machines if you experience dizziness or somnolence.

Etoricoxib Sandoz contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor 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 of administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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 important that you use the lowest dose that controls your pain and you should not take etoricoxib for longer than necessary. This is because the risk of heart attacks and strokes might increase after prolonged treatment, especially with high doses.

There are different doses available for this medicine, and depending on your disease, your doctor will prescribe the tablet with the dose that is right for you.

The recommended dose is:

Osteoarthritis

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

Rheumatoid arthritis

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

Ankylosing spondylitis

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

Acute pain situations

Etoricoxib should only be used during the period of acute pain.

• Gout

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

• Postoperative dental pain

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

Elderly

No dose adjustment is necessary in elderly patients. 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 moderateliver disease, you should not take more than 30 mg per day.

Method of administration

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

If you take more Etoricoxib Sandoz than you should

Never take more tablets than your doctor has told you to take.

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

If you forget to take Etoricoxib Sandoz

It is important to take etoricoxib as your doctor has prescribed. If you forget to take a dose, take the next dose at your normal time. Do not take a double dose to make up for forgotten doses.

If you have any further questions on 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 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 get worse,
• yellowing of the skin and eyes (jaundice) - these are signs of liver problems,
• severe stomach pain 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 which can cause difficulty in 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 your heartbeat, irregular heartbeat,
• high blood pressure,
• wheezing or shortness of breath (bronchospasm),
• constipation, gas (excess gas), inflammation of the stomach lining (gastritis), heartburn, diarrhea, indigestion (dyspepsia)/stomach upset, nausea, feeling sick (vomiting), inflammation of the esophagus, 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 that affects both the stomach and the small intestine/gastroenteritis,
• upper respiratory tract infection,
• urinary tract infection,
• reduction in red blood cells that can cause pale skin and cause weakness or shortness of breath,
• reduction in white blood cells,
• decrease in platelets, which increases the risk of bleeding or bruising,
• hypersensitivity (allergic reaction including hives that can be severe enough to require immediate medical attention),
• increased or decreased appetite, weight gain,
• anxiety, depression, decreased mental sharpness; seeing, hearing, or feeling things that are not there (hallucinations),
• altered taste, difficulty sleeping, numbness or tingling, somnolence,
• blurred vision, eye irritation and redness,
• ringing in the ears, vertigo (feeling of spinning while standing),
• abnormal heartbeat (atrial fibrillation), rapid heartbeat, heart failure, feeling of tension, pressure, or heaviness in the chest (angina), heart attack,
• redness, 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 movements, dry mouth, stomach ulcer or small intestine ulcer, inflammation of the stomach lining that can become severe and can cause bleeding, irritable bowel syndrome, pancreatitis,
• swelling of the face, rash, or itching of the skin,
• muscle cramp/spasm, muscle pain/stiffness,
• high levels of potassium in your blood that can cause abnormal heartbeat, changes in blood or urine tests related to your 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/anaphylactic/anaphylactoid reactions including shock [severe allergic reaction that requires immediate medical attention]),
• confusion, nervousness,
• inflammation of the liver (hepatitis), liver disorder, yellowing of the skin and/or eyes (jaundice),
• low levels of sodium in the blood that can cause tiredness and confusion, muscle spasms, convulsions, and coma,
• severe skin reactions.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side 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 which is stated on the carton after CAD. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

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

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

Appearance of the Product and Package Contents

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 and desiccant (silica gel). Do not swallow the desiccant used to keep the tablets dry.

Package sizes:

Etoricoxib Sandoz 60 mg:

Blister

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

Bottle:

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

Etoricoxib Sandoz 90 mg:

Blister and Bottle:

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

Not all 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

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 medicine is authorized in the Member States of the European Economic Area 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 last revision of this leaflet:November 2020.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/