Etoricoxib Krka 120 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Etoricoxib Krka 30 mg film-coated tablets EFG

Etoricoxib Krka 60 mg film-coated tablets EFG

Etoricoxib Krka 90 mg film-coated tablets EFG

Etoricoxib Krka 120 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 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 must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

What is Etoricoxib Krka?

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

• Etoricoxib Krka 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 Krka 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 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 joint disease. It causes pain, stiffness, swelling, and progressive loss of mobility in affected joints. It may also cause inflammation in other parts of the body.

What is gout?

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

What is ankylosing spondylitis?

Ankylosing spondylitis is an inflammatory disease affecting the spine and large joints.

2. What you need to know before taking Etoricoxib Krka

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 non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin 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
• 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 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 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 apply to you, do not take the tablets until you have consulted your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Etoricoxib Krka 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 higher 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 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 young and adult patients. If you are over 65 years of age, your doctor will want to monitor you appropriately. Dose adjustment is not necessary in 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 Krka

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

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 thin your blood (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, losartan and valsartan

• diuretics (water tablets)

• digoxin (a medicine for heart failure and irregular heartbeat)

• minoxidil (a medicine used to treat high blood pressure)

• salbutamol tablets or oral solution (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)

• aspirin — the risk of stomach ulcers is higher if you take Etoricoxib with aspirin.

• Aspirin for prevention of myocardial infarction or stroke:

Etoricoxib may be taken with low doses of aspirin. If you are currently taking low-dose aspirin to prevent myocardial infarction or stroke, do not stop taking aspirin without first talking to your doctor.

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

do not take high doses of aspirin or other NSAIDs 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 plan to become pregnant. If you become pregnant, stop taking the tablets and consult your doctor. Speak to your doctor if you have any doubts or need more information.

Breastfeeding

It is not known whether etoricoxib is excreted in human 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 is not recommended for use in women who are trying to become 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 use tools or machines if you experience dizziness or somnolence.

Etoricoxib Krka contains sodium

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

3. How to take Etoricoxib Krka

Follow exactly the instructions for use of this medicine given by your doctor. 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 that you use the lowest dose that controls your pain and that you do not take etoricoxib for longer than necessary. This is because the risk of heart attacks and strokes may increase after long-term treatment, especially with high doses.

Different doses are available for this medicine, 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, which may be increased up to a maximum of 90 mg once daily if necessary.

Acute pain situations

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

Gout

The recommended dose is 120 mg once daily, to be used only during the period 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.

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.

Use in children and adolescents

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

Patients over 65 years of age

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

Method of administration

Etoricoxib is administered orally. Take the tablets once daily. Etoricoxib may be taken with or without food.

If you take more Etoricoxib Krka than you should

You must never take more tablets than your doctor has recommended. If you take too many etoricoxib tablets, seek immediate medical attention.

In case of overdose or accidental ingestion, you may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Etoricoxib Krka

It is important that you take etoricoxib as directed by your doctor. If you forget a dose, simply resume your regular dosing schedule the next 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 Krka and speak to your doctor immediately (see section 2: "What you need to know before you start taking Etoricoxib Krka"):

• difficulty breathing, chest pain or ankle swelling, or if these worsen
• yellowing of the skin and eyes (jaundice) – these are signs 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 that may cause difficulty breathing

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 after tooth extraction)
• swelling of the legs and/or feet due to fluid retention (edema)
• dizziness, headache
• palpitations (fast or irregular heartbeat), irregular heart rhythm (arrhythmia)
• high blood pressure
• wheezing or difficulty breathing (bronchospasm)
• constipation, gas (excess gas), gastritis (inflammation of the inner lining of the stomach), heartburn, diarrhea, indigestion (dyspepsia)/stomach discomfort, nausea, 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)

• gastroenteritis (inflammation of the gastrointestinal tract affecting both the stomach and small intestine/gastric flu), 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 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, inability to sleep, 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 ischemic attack), severe increase in blood pressure, inflammation of blood vessels
• cough, shortness of breath, nosebleed
• stomach swelling, changes in bowel habits, dry mouth, stomach ulcer, inflammation of the inner lining of the stomach which may become severe and lead to bleeding, irritable bowel syndrome, inflammation of the pancreas
• facial swelling, skin rash or itching, skin redness
• muscle cramp/spasm, muscle pain/stiffness
• elevated potassium levels in your blood, 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)

• angioedema (allergic reaction with swelling of the face, lips, tongue, and/or throat that may 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, restlessness
• liver problems (hepatitis)
• low sodium levels in blood
• liver impairment, yellowing of the skin and/or eyes (jaundice)
• serious skin reactions

Reporting of adverse effects:

If you experience any type of 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 Krka

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 packaging after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

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

6. Contents of the pack and other information

Composition of Etoricoxib Krka

• The active substance 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), sodium croscarmellose, sodium stearyl fumarate, colloidal anhydrous silica in the core; and poly(vinyl alcohol), titanium dioxide (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”.

Nature of the product and pack contents

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

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

Etoricoxib Krka 60 mg film-coated tablets EFG: slightly yellow, round (diameter: 8 mm), biconvex film-coated tablet with bevelled edges, marked with "60" on one side.

Etoricoxib Krka 90 mg film-coated tablets EFG: pink, round (diameter: 9 mm), biconvex film-coated tablet with bevelled edges, marked with "90" on one side.

Etoricoxib Krka 120 mg film-coated tablets EFG: brownish-red, round (diameter: 10 mm), slightly biconvex film-coated tablets with bevelled edges, scored on one side. The score line is not intended to divide the tablet into equal doses.

Pack sizes:

30 mg film-coated tablets

Blister packs containing 7, 14, 28, 30, 56, 60, 84, 98 or 100 tablets.

60 mg film-coated tablets

Blister packs containing 7, 14, 20, 28, 30, 50, 56, 60, 84, 98 or 100 tablets.

90 mg film-coated tablets

Blister packs containing 5, 7, 14, 20, 28, 30, 50, 56, 60, 84, 98 or 100 tablets.

120 mg film-coated tablets

Blister packs containing 5, 7, 14, 20, 28, 30, 50, 56, 60, 84, 98 or 100 tablets.

Only some pack sizes may be marketed.

Marketing Authorization 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

For more information about this medicine, contact the local representative of the Marketing Authorization Holder:

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

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

Date of the most recent review of this leaflet: December 2021

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