Leaflet: information for the user

Etoricoxib Krka 30 mg film-coated tablets

Etoricoxib Krka 60 mg film-coated tablets

Etoricoxib Krka 90 mg film-coated tablets

Etoricoxib Krka 120 mg film-coated tablets

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Etoricoxib Krka

3.How to take Etoricoxib Krka

4.Possible side effects

5.Storage of Etoricoxib Krka

6. Contents of the pack and additional information

What is Etoricoxib Krka?

• Etoricoxib Krka contains the active ingredient etoricoxib. Etoricoxib 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 Krka used for?

• Etoricoxib Krka 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 Krka 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 areas of the body.

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.

What is ankylosing spondylitis?

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

Do not take Etoricoxib Krka:

• 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 nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin and COX-2 inhibitors (see Possible side effects, section 4)
• 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 high blood pressure that has not been controlled with treatment (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 (chest pain)
• if you have had a heart attack, 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 ischaemic attack or transient ischaemic attack)

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

If you think you fall into any of these cases, do not take the tablets until you have consulted your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Etoricoxib Krka 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 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 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 over 65 years of age.

If you are unsure whether any of the above situations affect you, speak with your doctor before taking etoricoxib to check if this medicine is suitable for you.

Etoricoxib works just as well in adult and young patients. If you are over 65 years of age, your doctor will want to keep a close eye on you. No dose adjustment is necessary for patients over 65 years of age.

Children and adolescents

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

Other medicines and Etoricoxib Krka

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine, including those bought without a prescription.

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

• blood-thinning medicines (anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a medicine used to suppress the immune system and often used in rheumatoid arthritis)
• ciclosporin 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, and losartan and valsartan
• diuretics (tablets to help you urinate)
• digoxin (a medicine 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 side effects)
• hormone replacement therapy (the combination may increase your risk of side effects)
• aspirin, the risk of stomach ulcers is higher if you take Etoricoxib with aspirin.

• Aspirin for the prevention of heart attacks or strokes:

Etoricoxib can be taken withlow dosesof aspirin. If you are currently taking low doses of aspirin to prevent heart attacks or strokes, do not stop taking aspirin until you have spoken with your doctor.

• Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs):

Do not takehigh dosesof aspirin or other anti-inflammatory medicines while taking Etoricoxib.

Taking Etoricoxib Krka with food and drink

The onset of Etoricoxib's effect may be faster if taken without food.

Pregnancy, breastfeeding and fertility

Pregnancy

Etoricoxib tablets should not be taken during pregnancy. Do not take the tablets if you are pregnant, think you may be pregnant or are planning to become pregnant. 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

We do not know if 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

We do not recommend using etoricoxib in women who are trying to become 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 Krka contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. 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 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 cerebral infarction could 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:

Osteoarthritis

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

Rheumatoid arthritis

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

Ankylosing spondylitis

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

Acute pain situations

Etoricoxib should only be used during the acute pain period.

Gout

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

Postoperative pain after dental surgery

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

Patients with liver problems

• If you have a mild liver disease, do not take more than 60mg per day.
• If you have amoderateliver disease, do not take more than30mg per day.

Use in children and adolescents

Children or adolescents under 16years of age should not take etoricoxib tablets.

Patients over 65years

No dose adjustment is necessary in patients over 65years. As with other medications, caution should be exercised in elderly patients.

Administration form

Etoricoxib is administered orally. Take the tablets once a day. Etoricoxib can be taken with or without food.

If you take more Etoricoxib Krka than you should

You should never take more tablets than your doctor recommends. If you take too many etoricoxib tablets, seek medical attention immediately.

In case of overdose or accidental ingestion, you can also call the Toxicological Information Service, Tfno. 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Etoricoxib Krka

It is essential to take etoricoxib as your doctor has indicated. If you forget a dose, limit yourself to resuming the usual regimen the next day.Do not take a double dose to compensate for the missed doses.

If you have any other doubts 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 takingEtoricoxib Krkaand talk to your doctor immediately (see section2: “What you need to know before starting to take Etoricoxib Krka”):

• 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
• intense 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

Very common(can affect more than 1 in 10people)

• stomach pain

Common(can affect up to 1 in 10people)

• alveolar osteitis (inflammation and pain after tooth extraction)
• swelling of the legs and/or feet due to fluid retention (edema)
• dizziness, headache
• palpitations (rapid or irregular heartbeat), irregular heartbeat rhythm (arrhythmia)
• high blood pressure
• choking or difficulty breathing (bronchospasm)
• constipation, gas (excessive gas), gastritis (inflammation of the stomach lining), heartburn, diarrhea, indigestion (dyspepsia)/stomach discomfort,nausea, vomiting, esophageal inflammation, mouth ulcers
• changes in blood test results related to the liver
• bruises
• weakness and fatigue, flu-like illness

Uncommon(can affect up to 1 in 100people)

• gastroenteritis (inflammation of the gastrointestinal tract affecting both the stomach and small intestine/gastric catarrh), common cold, urinary tract infection
• changes in laboratory results (decreased red blood cell count, decreased white blood cell count, decreased platelet count)
• 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, hearing, or feeling 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 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), severe increase in blood pressure, inflammation of blood vessels
• cough, shortness of breath, nasal bleeding
• stomach swelling, changes in bowel movements, dry mouth, stomach ulcers, severe inflammation of the stomach lining that may cause bleeding, irritable bowel syndrome, pancreatitis
• swelling of the face, skin rash, or itching, skin redness
• muscle cramps/spasms, muscle pain/stiffness
• elevated potassium levels in the blood, changes in blood or urine test results related to the kidneys, severe kidney problems
• chest pain

Rare(can affect up to 1 in 1,000people)

• angioedema (allergic reaction with swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing, which may be severe enough to require immediate medical attention)/anaphylactic/anaphylactoid reactions including shock (severe allergic reaction requiring immediate medical attention)
• confusion, nervousness
• liver problems (hepatitis)
• low sodium levels in the blood
• liver damage, yellowing of the skin and/or eyes (jaundice)
• severe skin reactions

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Etoricoxib Krka

• The active ingredient is etoricoxib. Each film-coated tablet contains 30 mg, 60 mg, 90 mg or 120 mg of etoricoxib.

• The other components (excipients) are: microcrystalline cellulose, Calcium Hydrogen Phosphate (anhydrous), croscarmellose sodium, sodium stearyl fumarate, colloidal anhydrous silica in the core and poly(vinyl alcohol), di-iron oxide (E171), macrogol 3000, talc, yellow iron oxide E172 (in Etoricoxib Krka 30 mg film-coated tablets EFG ) and red iron oxide E172 (in Etoricoxib Krka 90 mg film-coated tablets EFG and Etoricoxib Krka 120 mg film-coated tablets EFG ). See section 2 “Etoricoxib Krka contains sodium”.

Appearance of the product and contents of the pack

Etoricoxib Krka film-coated tablets are available in four doses:

Etoricoxib Krka 30 mg film-coated tablets EFG : film-coated tablet white or almost white, round (diameter: 6 mm), slightly biconvex with bisected edges.

Etoricoxib Krka 60 mg film-coated tablets EFG : film-coated tablet slightly yellow, round (diameter: 8 mm), biconvex with bisected edges, marked with a mark “60” on one face of the tablet.

Etoricoxib Krka 90 mg film-coated tablets EFG : film-coated tablet pink, round (diameter: 9 mm), biconvex with bisected edges, marked with a mark “90” on one face of the tablet.

Etoricoxib Krka 120 mg film-coated tablets EFG : film-coated tablet reddish-brown, round (diameter: 10 mm), slightly biconvex with bisected edges, scored on one face of the tablet. The score does not serve to divide the tablet.

Pack sizes:

30 mg film-coated tablets

Are available in blister packs of 7, 14, 28, 30, 56, 60, 84, 98 or 100 film-coated tablets.

60 mg film-coated tablets

Are available in blister packs of 7, 14, 20, 28, 30, 50, 56, 60, 84, 98 or 100 film-coated tablets.

90 mg film-coated tablets

Are available in blister packs of 5, 7, 14, 20, 28, 30, 50, 56, 60, 84, 98 or 100 film-coated tablets.

120 mg film-coated tablets

Are available in blister packs of 5, 7, 14, 20, 28, 30, 50, 56, 60, 84, 98 or 100 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

or

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorisation holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura, 10, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Last update of the summary of product characteristics: December 2021

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