KOSTAROX 60 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Kostarox, 60 mg, coated tablets
   1. Read the entire leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Kostarox and what is it used for
   1. What is Kostarox?
   2. What is Kostarox used for?
   3. What is osteoarthritis?
   4. What is rheumatoid arthritis?
   5. What is ankylosing spondylitis?
   6. What is gout?
4. Important information before taking Kostarox
   1. When not to take Kostarox
   2. Warnings and precautions
   3. Children and adolescents
   4. Kostarox and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Kostarox contains lactose and sodium
5. How to take Kostarox
   1. Osteoarthritis
   2. Rheumatoid arthritis
   3. Ankylosing spondylitis
   4. Acute pain conditions
   5. Elderly patients
   6. Patients with hepatic impairment
   7. Method of administration
   8. Taking a higher dose of Kostarox than recommended
   9. Missing a dose of Kostarox
6. Possible side effects
   1. If the patient experiences any of the following symptoms, they should stop taking Kostarox and consult a doctor immediately:
   2. Reporting side effects
7. How to store Kostarox
8. Contents of the packaging and other information
   1. What Kostarox contains
   2. What Kostarox looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. For more information on the medicine and its names in the Member States of the European Economic Area, please contact:

Leaflet accompanying the packaging: patient information

Kostarox, 60 mg, coated tablets

Etoricoxib

Read the entire leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Kostarox and what is it used for
• 2. Important information before taking Kostarox
• 3. How to take Kostarox
• 4. Possible side effects
• 5. How to store Kostarox
• 6. Contents of the packaging and other information

1. What is Kostarox and what is it used for

What is Kostarox?

• Kostarox contains the active substance etoricoxib. Kostarox is a medicine from the group of so-called "selective cyclooxygenase-2 (COX-2) inhibitors". These medicines belong to the class of non-steroidal anti-inflammatory drugs (NSAIDs).

What is Kostarox used for?

• Kostarox helps to relieve pain and reduce swelling (inflammation) of the joints and muscles in people aged 16 and over with osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and gout.
• Kostarox is also used for short-term treatment of moderate pain after dental surgery in people aged 16 and over.

What is osteoarthritis?

Osteoarthritis is a disease that affects the joints. It develops as a result of the gradual breakdown of cartilage lining the ends of bones. This causes swelling (inflammation), pain, tenderness, stiffness, and impaired mobility.

What is rheumatoid arthritis?

Rheumatoid arthritis is a long-lasting inflammatory disease of the joints. It causes pain, stiffness, swelling, and limited mobility of 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 large joints.

What is gout?

Gout is a disease characterized by sudden, recurring attacks of very painful inflammation and redness of the joints. It is caused by the deposition of crystalline deposits in the joint.

2. Important information before taking Kostarox

When not to take Kostarox

• if the patient is allergic to etoricoxib or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid and COX-2 inhibitors (see section 4 "Possible side effects");
• if the patient has active peptic ulcer or gastrointestinal bleeding;
• if the patient has severe liver disease;
• if the patient has severe kidney disease;
• if the patient is pregnant or breastfeeding or thinks she may be pregnant (see "Pregnancy, breastfeeding, and fertility");
• in people under 16 years of age;
• if the patient has inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or proctitis;
• if the patient has uncontrolled high blood pressure (if in doubt, consult a doctor);
• if the patient has been diagnosed with heart disease, including moderate or severe heart failure, angina pectoris (chest pain), or has had a heart attack, coronary artery bypass grafting (CABG);
• if the patient has had peripheral arterial disease (poor circulation in the legs or feet due to narrowed or blocked arteries);
• if the patient has had any type of stroke (including "mini-stroke", transient ischaemic attack [TIA]). Etoricoxib may slightly increase the risk of heart attack and stroke, so it should not be taken by people who have already had heart or stroke problems.

In case of doubt about any of the above points, the patient should not take this medicine until they have consulted a doctor.

Warnings and precautions

Before taking Kostarox, the patient should discuss it with their doctor or pharmacist if:

• the patient has had stomach ulcers or bleeding in the past;
• the patient is dehydrated, e.g., due to prolonged, recurring vomiting or diarrhea;
• the patient has swelling due to fluid retention;
• the patient has had heart failure or other heart disease in the past;
• the patient has had high blood pressure in the past. Kostarox may increase blood pressure in some people, especially when taken in high doses, so the doctor will check the patient's blood pressure from time to time.
• the patient has had liver or kidney disease in the past;
• the patient is currently being treated for an infection. Kostarox may mask fever, which is a sign of infection;
• the patient has diabetes, high cholesterol, or smokes. These people are at increased risk of heart disease;
• the patient is planning to become pregnant;
• the patient is elderly (over 65 years old).

In case of doubt about any of the above situations, the patient should consult a doctor before taking Kostarox.

Children and adolescents

The medicine should not be taken by children and adolescents under 16 years of age.

Kostarox and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.

• blood thinners (anticoagulants), such as warfarin;
• rifampicin (an antibiotic);
• methotrexate (a medicine used to suppress the immune system and is often used to treat rheumatoid arthritis);
• cyclosporin or tacrolimus (medicines used to suppress the immune system, e.g., after organ transplantation);
• lithium (a medicine used to treat certain types of depression);
• medicines used to control high blood pressure and heart failure, called ACE inhibitors and angiotensin receptor blockers (e.g., enalapril and ramipril, and losartan and valsartan);
• diuretics;
• digoxin (a medicine used to treat heart failure and irregular heartbeat);
• minoxidil (a medicine used to treat high blood pressure);
• salbutamol in tablets or oral solution (a medicine used to treat asthma);
• oral contraceptives (combination with Kostarox may increase the risk of side effects);
• hormone replacement therapy (combination with Kostarox may increase the risk of side effects);
• acetylsalicylic acid (the risk of stomach ulcers is higher when Kostarox is taken with acetylsalicylic acid);
• acetylsalicylic acid used to prevent heart attack or stroke: Kostarox can be taken with a low doseof acetylsalicylic acid. If the patient is currently taking low doses of acetylsalicylic acid to prevent heart attack or stroke, they should not stop taking them without consulting a doctor.
• acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs): when taking Kostarox, the patient should not take high dosesof acetylsalicylic acid or other anti-inflammatory medicines.

Pregnancy, breastfeeding, and fertility

Pregnancy
Kostarox should not be taken during pregnancy. If the patient is pregnant or thinks she may be pregnant or is planning to have a baby, she should not take this medicine. If the patient becomes pregnant while taking Kostarox, she should stop taking the medicine and consult a doctor.
In case of doubt or need for additional information, the patient should consult a doctor.
Breastfeeding
It is not known whether etoricoxib passes into breast milk. If the patient is breastfeeding or plans to breastfeed, she should consult a doctor before taking Kostarox.
The patient should not breastfeed while taking this medicine.
Fertility
Kostarox may make it harder to get pregnant. Therefore, it is not recommended for women planning a pregnancy.
The patient should inform their doctor if they are planning a pregnancy or having trouble getting pregnant.

Driving and using machines

Some patients taking Kostarox have reported dizziness and drowsiness. If these symptoms occur, the patient should not drive or operate tools or machines.

Kostarox contains lactose and sodium

If the patient has been told they have an intolerance to some sugars, they should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is essentially "sodium-free".

3. How to take Kostarox

This medicine should always be taken exactly as prescribed by a doctor or pharmacist. In case of doubt, the patient should consult a doctor or pharmacist.
The patient should not take a higher dose than recommended for their condition. The doctor will prescribe follow-up visits from time to time to discuss the treatment. It is important to take the smallest dose that relieves the pain. The patient should not take Kostarox for longer than necessary, as prolonged treatment, especially with high doses, may increase the risk of heart attack and stroke.
This medicine is available in different strengths, and depending on the diagnosed disease, the doctor will prescribe tablets of the appropriate strength for the patient.
The recommended dose is:

Osteoarthritis

The recommended dose is 30 mg once daily. If necessary, the doctor may increase the dose to a maximum of 60 mg once daily.

Rheumatoid arthritis

The recommended dose is 60 mg once daily. If necessary, the doctor may increase the dose to a maximum of 90 mg once daily.

Ankylosing spondylitis

The recommended dose is 60 mg once daily. If necessary, the doctor may increase the dose to a maximum of 90 mg once daily.

Acute pain conditions

Kostarox should only be taken during periods of acute pain.

• GoutThe recommended dose is 120 mg once daily. This dose should only be taken during periods of acute pain, for a maximum of 8 days.
• Pain after dental surgeryThe recommended dose is 90 mg once daily, for a maximum of 3 days.

Elderly patients

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

Patients with hepatic impairment

• Patients with mild liver disease should not take more than 60 mg per day.
• Patients with moderateliver disease should not take more than 30 mg per day.

Method of administration

Kostarox is intended for oral use.
The tablets should be taken once daily. They can be taken with or without food, but the effect of the medicine may be faster if taken without food.

Taking a higher dose of Kostarox than recommended

The patient should never take more tablets than prescribed by their doctor. If they take too much of the medicine, they should seek medical help immediately.

Missing a dose of Kostarox

It is important to take the medicine as prescribed by the doctor. If the patient misses a dose, they should take the next tablet at the next scheduled dose. They should not take a double dose to make up for the missed dose.
In case of any further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Kostarox can cause side effects, although not everybody gets them.

If the patient experiences any of the following symptoms, they should stop taking Kostarox and consult a doctor immediately:

• shortness of breath, chest pain, or swelling of the ankles or feet, or worsening of these symptoms
• yellowing of the skin and eyes (jaundice), which can be a sign of liver problems
• severe or persistent stomach pain or black stools
• allergic reaction with symptoms such as skin changes (ulcers or blisters), swelling of the face, lips, tongue, or throat, leading to difficulty breathing.

When taking Kostarox, the following side effects may occur:
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 feet and (or) ankles due to fluid retention
• dizziness, headache
• palpitations, irregular heartbeat
• high blood pressure
• wheezing or shortness of breath (bronchospasm)
• constipation, gas, stomach inflammation, heartburn, diarrhea, nausea, vomiting, esophagitis, oral ulcers
• changes in liver function tests
• bruising
• weakness or fatigue, flu-like illness

Uncommon(may affect up to 1 in 100 people)

• gastrointestinal inflammation, including stomach and small intestine and (or) "stomach flu"
• upper respiratory tract infection
• urinary tract infection
• decreased red blood cell count, which can cause pale skin, weakness, or shortness of breath
• decreased white blood cell count
• decreased platelet count, which can increase the risk of bleeding or bruising
• hypersensitivity (allergic reaction with hives, which can be severe enough to require immediate medical attention)
• increased or decreased appetite, weight gain
• anxiety, depression, impaired mental performance, seeing, feeling, or hearing things that do not exist (hallucinations)
• changes in taste, difficulty sleeping, numbness or tingling, drowsiness
• blurred vision, eye irritation and redness
• ringing in the ears, feeling of spinning
• abnormal heart rhythm (atrial fibrillation), rapid heart rate, heart failure, feeling of tightness, pressure, or heaviness in the chest (angina pectoris), heart attack
• redness of the skin, stroke, "mini-stroke" (transient ischaemic attack), significant increase in blood pressure, vasculitis, often with skin rash
• cough, shortness of breath, nosebleeds
• bloating, changes in bowel movements, dry mouth, stomach ulcers, stomach inflammation, which can be severe and lead to bleeding, irritable bowel syndrome, pancreatitis
• swelling of the face, skin rash or itching, redness of the skin
• muscle cramps/spasms, muscle pain/stiffness
• high potassium levels in the blood, which can cause heart rhythm disturbances, changes in blood or urine tests related to kidney function, severe kidney problems
• chest pain

Rare(may affect up to 1 in 1000 people)

• severe allergic reaction with swelling of the face, lips, tongue, and (or) throat, which can cause difficulty breathing or swallowing (angioedema), anaphylactic or anaphylactoid reactions, including shock (serious allergic reactions that require immediate medical attention)
• confusion, restlessness, especially agitation
• hepatitis, liver failure, yellowing of the skin and (or) eyes (jaundice);
• low sodium levels in the blood, which can cause feelings of tiredness and confusion, muscle twitching, convulsions, and coma
• severe skin reactions.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Kostarox

The medicine should be stored out of sight and reach of children.
The patient should not take this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Kostarox contains

• The active substance of the medicine is etoricoxib. Each coated tablet contains 60 mg of etoricoxib.
• The other ingredients are: Core:calcium hydrogen phosphate anhydrous, microcrystalline cellulose, povidone K29-32, magnesium stearate, sodium croscarmellose. Coating: hypromellose, lactose monohydrate, titanium dioxide (E 171), triacetin, indigo carmine, lake (E 132), yellow iron oxide (E 172)

What Kostarox looks like and contents of the pack

Kostarox tablets are dark green, round, and biconvex.
The coated tablets are packaged in blisters or in a container with a desiccant (silica gel). The desiccant should not be swallowed.
Package sizes:
10, 14, 15, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100 coated tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer/Importer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Delorbis Pharmaceuticals Ltd
17 Athinon Street, Ergates Industrial Area,
2643 Ergates, Lefkosia, Cyprus

For more information on the medicine and its names in the Member States of the European Economic Area, please contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet: 06/2023
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