Etoricoxib Krka

Package leaflet: Information for the patient

Etoricoxib Krka 30 mg film-coated tablets, 60 mg film-coated tablets, 90 mg film-coated tablets, 120 mg film-coated tablets

Etoricoxib
Generic medicine
Please read all of this 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. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this 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 Etoricoxib Krka is
Etoricoxib Krka contains the active substance etoricoxib. Etoricoxib Krka belongs to a group of
medicines called selective COX-2 inhibitors.
These belong to the family of medicines known as 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 is caused by the progressive deterioration of the cartilage covering the ends of bones. This causes swelling (inflammation), pain, tenderness, stiffness, and disability.
What is rheumatoid arthritis?
Rheumatoid arthritis is a long-term inflammatory joint disease. It causes pain, stiffness, swelling, and progressive loss of movement 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 of the joints. It is caused by the deposition of mineral crystals in the joints.
What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease affecting the spine and large joints.

2. What you should know before taking Etoricoxib Krka

Do not take Etoricoxib Krka:

• 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 ulcer or bleeding in the stomach or intestines
• if you have severe liver disease
• if you have severe kidney disease
• if you are pregnant or think you might be pregnant, or if you are breastfeeding (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 is not controlled by 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 mild), angina (chest pain)
• if you have had a heart attack, coronary artery bypass surgery, or peripheral arterial disease (reduced circulation in the legs and feet due to narrowed or blocked arteries)
• if you have ever had any type of stroke (including mini-stroke, transient ischemic attack or TIA). Etoricoxib may slightly increase the risk of heart attack and stroke, and for this reason it should not be used in people who have already had heart problems or stroke.

If you think any of these conditions apply to you, do not take the tablets before consulting your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Etoricoxib Krka if:

• You have a history of stomach bleeding or stomach ulcers.
• You are dehydrated, for example due to a prolonged episode of 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. In some people, Etoricoxib Krka, especially at high doses, may increase blood pressure, and your doctor will periodically check your blood pressure.
• You have a history of liver or kidney disease.
• You are being treated for an infection. Etoricoxib Krka may mask or hide fever, which is a sign of infection.
• You have diabetes, high cholesterol, or are a smoker. These are conditions that may increase your risk of heart disease.
• You are a woman trying to become pregnant.
• You are over 65 years of age.

If you have any doubts about any of the conditions listed above, inform your doctor before taking Etoricoxib Krka to check whether this medicine is suitable for you.

Etoricoxib Krka has the same efficacy in younger and older patients. If you are over 65 years of age, your doctor will monitor you appropriately. No dose adjustment is necessary for patients over 65 years of age.

Children and adolescents

Do not give this medicine to children or adolescents under 16 years of age.

Other medicines and Etoricoxib Krka

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 require monitoring to check whether these medicines are working properly once you have started taking Etoricoxib Krka:

• medicines that thin the blood (anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a medicine used for immune system suppression and often used in the treatment of rheumatoid arthritis)
• ciclosporin or tacrolimus (medicines used for immune system suppression)
• 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 blockers, such as enalapril and ramipril, and losartan and valsartan
• diuretics
• digoxin (a medicine for the treatment of heart failure and irregular heartbeat)
• minoxidil (a medicine used to treat high blood pressure)
• oral salbutamol tablets or oral solution (a medicine for the treatment of asthma)
• oral contraceptives (combination therapy may increase the risk of side effects)
• hormone replacement therapy (combination therapy may increase the risk of side effects)
• acetylsalicylic acid — the risk of stomach ulcers is higher if you take Etoricoxib Krka with acetylsalicylic acid
• Acetylsalicylic acid for prevention of heart attacks or strokes: Etoricoxib Krka may be taken with a low dose of acetylsalicylic acid. If you are taking a low dose of acetylsalicylic acid for prevention of heart attacks or strokes, do not stop taking acetylsalicylic acid without first consulting your doctor.
• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs):
• do not take a high dose of acetylsalicylic acid or other anti-inflammatory medicines while taking Etoricoxib Krka.

Etoricoxib Krka with food and drink

The onset of effect of Etoricoxib Krka may be faster when taken on an empty stomach.

Pregnancy, breastfeeding and fertility

Pregnancy

Etoricoxib Krka tablets must not be taken during pregnancy. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, do not take the tablets. If you become pregnant, stop taking the tablets and consult your doctor. Ask your doctor for advice if you are unsure or need more information.

Breastfeeding

It is not known whether Etoricoxib Krka is excreted in human milk. If you are breastfeeding or planning to breastfeed, contact your doctor before taking Etoricoxib Krka. You must not breastfeed while using Etoricoxib Krka.

Fertility

Etoricoxib Krka is not recommended for women intending to become pregnant.

Driving and using machines

Some patients taking Etoricoxib Krka have reported dizziness and somnolence.

Do not drive if you experience dizziness or somnolence.

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

3. How to take Etoricoxib Krka

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Do not take more than the recommended dose for the treatment of your condition. Your doctor will
periodically evaluate your treatment. It is important that you take the lowest effective dose needed to control your pain
and that you do not take Etoricoxib Krka longer than necessary. This is because the risk of heart attacks
and strokes may increase with prolonged treatment, especially at higher doses.
Different dosage strengths are available for this medicine, and your doctor will prescribe the appropriate tablet strength depending on your condition.
The recommended doses are:
Osteoarthritis
The recommended dose is 30 mg once daily, which may be increased up to a maximum of 60 mg once
daily if necessary.
Rheumatoid arthritis
The recommended dose is 60 mg once daily. The dose may be increased up to a maximum of
90 mg.
Ankylosing spondylitis
The recommended dose is 60 mg once daily. The dose may be increased up to a maximum of
90 mg once daily if necessary.
Acute pain treatment
Etoricoxib should be used only for the duration of acute pain.
Gout
The recommended dose is 120 mg once daily, which should 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
Etoricoxib Krka tablets must not be taken by children and adolescents under 16 years of age.
Elderly
Dose adjustment is not required in elderly patients. However, as with other medicines, caution should be
exercised in elderly patients.
Method of administration
Etoricoxib Krka is for oral use. Take the tablets once daily. Etoricoxib Krka may be taken with or without food.
If you take more Etoricoxib Krka than you should
Never take more tablets than recommended by your doctor. If you take too many Etoricoxib Krka tablets, you must contact your doctor immediately.
If you forget to take Etoricoxib Krka
It is important to take Etoricoxib Krka as prescribed by your doctor. If you miss a dose, take your next dose according to your usual schedule the following day. Do not take a double dose to make up for the missed tablet.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following, you must stop treatment with Etoricoxib Krka and contact your doctor immediately (see section 2 “What you need to know before taking Etoricoxib Krka”):

• shortness of breath, chest pain, or swelling of the ankles that develop or start to worsen
• yellowing of the skin or eyes (jaundice) – these are symptoms 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 which may make breathing difficult.

Other side effects that may occur during treatment with Etoricoxib Krka:
Very common (may affect more than 1 in 10 people)

• stomach pain

Common (may affect up to 1 in 10 people)

• alveolitis (inflammation and pain after a tooth extraction)
• swelling of the legs and/or feet due to fluid retention (oedema)
• dizziness, headache
• palpitations (fast or irregular heartbeat), irregular heart rhythm (arrhythmia)
• increased blood pressure
• wheezing or shortness of breath (bronchospasm)
• constipation, flatulence (excess gas), gastritis (inflammation of the inner stomach lining), heartburn, diarrhoea, difficulty in digestion (dyspepsia)/stomach discomfort, nausea, vomiting, inflammation of the oesophagus, mouth ulcers
• changes in certain blood tests related to liver function
• bruising
• weakness and fatigue, flu-like illness

Uncommon (may affect up to 1 in 100 people)

• gastroenteritis (inflammation of the gastrointestinal tract involving both the stomach and small intestine/intestinal flu), upper respiratory tract infection, urinary tract infection
• changes in laboratory test values (decrease in the number of red blood cells in the blood, decrease in the number of white blood cells in the blood, decrease in platelets)
• hypersensitivity (an allergic reaction including urticaria which may be severe enough to require immediate medical attention)
• increased or decreased appetite, weight gain
• anxiety, depression, reduced mental sharpness, visual, sensory or auditory perceptions not caused by real stimuli (hallucinations)
• altered taste, difficulty sleeping, tingling or numbness, drowsiness
• blurred vision, eye irritation and redness
• ringing in the ears, vertigo (sensation of dizziness while remaining still)
• abnormal heart rhythm (atrial fibrillation), increased heart rate, heart failure, feeling of tightness, pressure or heaviness in the chest (angina pectoris), heart attack
• hot flushes, stroke, mini-stroke (transient ischaemic attack), severe increase in blood pressure, inflammation of blood vessels
• cough, shortness of breath, nosebleed
• stomach or intestinal bloating, changes in bowel habits, dry mouth, stomach ulcer, inflammation of the inner stomach lining which may become severe and may lead to bleeding, irritable bowel syndrome, inflammation of the pancreas
• facial swelling, skin rash or skin itching, skin redness
• muscle cramps/spasms, muscle pain/stiffness
• high levels of potassium in the blood, changes in certain blood or urine tests related to kidney function, severe kidney problems
• chest pain.

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Etoricoxib Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Etoricoxib Krka contains

• The active substance is etoricoxib. Each film-coated tablet contains 30 mg, 60 mg, 90 mg, or 120 mg of etoricoxib.
• The other components are: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, sodium stearyl fumarate, anhydrous colloidal silica in the tablet core; and polyvinyl alcohol, titanium dioxide (E171), macrogol 3000, talc, yellow iron oxide E172 (in the 60 mg tablets), red iron oxide E172 (in the 90 mg and 120 mg tablets) in the tablet coating.

Description of the appearance of Etoricoxib Krka and pack contents
Etoricoxib Krka film-coated tablets are available in four strengths:
30 mg film-coated tablets are white or almost white, round (diameter: 6 mm), slightly biconvex, with bevelled edges.
60 mg film-coated tablets are yellowish-brown, round (diameter: 8 mm), biconvex, with bevelled edges, with the number "60" engraved on one side of the tablet.
90 mg film-coated tablets are pink, round (diameter: 9 mm), biconvex, with bevelled edges, with the number "90" engraved on one side of the tablet.
120 mg film-coated tablets are reddish-brown, round (diameter: 10 mm), slightly biconvex, with bevelled edges, engraved on one side of the tablet. The engraved line is not intended to allow division of the tablet.
30 mg film-coated tablets: packs of 28 tablets in blister packs are available.
60 mg and 90 mg film-coated tablets: packs of 20 tablets in blister packs are available.
120 mg film-coated tablets: packs of 5 tablets in blister packs are available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local representative in Italy
Krka Farmaceutici Milano S.r.l. – Italy

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

This medicinal product is authorised in the European Economic Area countries under the following names:

This leaflet was last reviewed on: