Kostarox

Package leaflet: Information for the patient

Kostarox, 60 mg, coated tablets
Etoricoxib
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Kostarox is and what it is 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 pack and other information

1. What Kostarox is and what it is used for

What is Kostarox?

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

What is Kostarox used for?

• Kostarox helps relieve pain and reduce swelling (inflammation) in joints and muscles in people aged 16 years and older with osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and gouty arthritis.
• Kostarox is also used for 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 develops as a result of gradual breakdown of the cartilage lining the ends of bones. This leads to swelling (inflammation), pain, tenderness, stiffness, and impaired function.
What is rheumatoid arthritis?
Rheumatoid arthritis is a chronic inflammatory joint disease. It causes pain, stiffness, swelling, and reduced mobility of affected joints. It may also cause inflammation in other parts of the body.
What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease affecting the spine and large joints.
What is gout?
Gout is a disease characterized by sudden, recurring attacks of very painful joint inflammation and redness. It is caused by the deposition of crystalline deposits in the joint.

2. Important information before using Kostarox

When not to use Kostarox

• if the patient is allergic to etoricoxib or to 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 may be pregnant, or is breastfeeding (see section "Pregnancy, breastfeeding and fertility");
• in individuals under 16 years of age;
• if the patient has inflammatory bowel disease, such as Crohn's disease, ulcerative colitis or colitis;
• if the patient has uncontrolled high blood pressure (if in doubt whether the patient's blood pressure is adequately controlled, consult a physician);
• if the patient has been diagnosed with heart disorders, including heart failure (moderate or severe), angina pectoris (chest pain), or has had a myocardial infarction, coronary artery bypass surgery (bypass grafting);
• if the patient has peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries);
• if the patient has ever had a stroke (including "mini-stroke", transient ischaemic attack [TIA]). Etoricoxib may slightly increase the risk of heart attack and stroke; therefore, it should not be used in patients who have already experienced heart problems or stroke.

If in doubt whether any of the above conditions apply to the patient,
do not take this medicine until consulting a doctor.
Warnings and precautions
Before using Kostarox, discuss with your doctor or pharmacist if:

• the patient previously had gastrointestinal bleeding or gastric ulcer;
• the patient is dehydrated, e.g. due to prolonged or recurrent vomiting or diarrhoea;
• if the patient has fluid retention causing oedema;
• the patient previously had heart failure or other heart disease;
• the patient previously had high blood pressure. Kostarox may increase blood pressure in some individuals, especially when used at high doses; therefore, your doctor will periodically monitor your blood pressure.
• the patient previously had liver or kidney disease;
• 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 levels, or smokes. These patients have an increased risk of heart disease;
• the patient plans to become pregnant;
• the patient is elderly (over 65 years of age).

If in doubt whether any of the above situations apply to the patient, consult a doctor before using Kostarox
to determine whether this medicine can be taken.
The effect of Kostarox is similar in elderly patients and younger adults.
In patients over 65 years of age, the doctor will carefully monitor treatment.
Dose adjustment in patients over 65 years of age is not necessary.
Children and adolescents
This medicine must not be used in children and adolescents under 16 years of age.
Kostarox and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
If the patient is taking any of the following medicines, the doctor may decide to monitor the patient's condition to ensure treatment proceeds correctly after starting Kostarox:

• anticoagulants (blood-thinning medicines), such as warfarin;
• rifampicin (an antibiotic);
• methotrexate (a medicine used to suppress the immune system, often used in the treatment of rheumatoid arthritis);
• cyclosporine or tacrolimus (medicines used to suppress immune function, 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, known as ACE inhibitors and angiotensin receptor blockers (e.g. enalapril and ramipril, losartan and valsartan);
• diuretics;
• digoxin (a medicine used to treat heart failure and heart rhythm disorders);
• minoxidil (a medicine used to treat high blood pressure);
• oral tablets or oral solution of salbutamol (a medicine used to treat asthma);
• oral contraceptives (combination with Kostarox may increase the risk of adverse effects);
• hormone replacement therapy (combination with Kostarox may increase the risk of adverse effects);
• acetylsalicylic acid (the risk of stomach ulcers is higher when Kostarox is used together with acetylsalicylic acid);
• acetylsalicylic acid used to prevent heart attack or stroke: Kostarox may be taken together with low-dose acetylsalicylic acid. If the patient is currently taking low-dose acetylsalicylic acid to prevent heart attack or stroke, do not stop taking it without consulting a doctor.
• acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs): while taking Kostarox, do not take high doses of acetylsalicylic acid or other anti-inflammatory medicines.

Pregnancy, breastfeeding and fertility
Pregnancy
Kostarox must not be used during pregnancy. If the patient is pregnant or suspects she may be pregnant, or is planning to become pregnant, she must not use this medicine. If the patient becomes pregnant while taking Kostarox, stop the medicine immediately and contact a doctor.
If in doubt or requiring further information, consult a doctor.
Breastfeeding
It is not known whether etoricoxib passes into human milk. If the patient is breastfeeding or planning to breastfeed, she should consult a doctor before using Kostarox.
Breastfeeding is not allowed while taking this medicine.
Effect on fertility
Kostarox may impair fertility. Therefore, its use is not recommended in women planning pregnancy.
Inform your doctor if you are planning a pregnancy or experiencing difficulty becoming pregnant.
Driving and using machines
Dizziness and drowsiness have been reported in some patients taking Kostarox. If these symptoms occur, do not drive or operate tools or machinery.
Kostarox contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Kostarox

This medicine should always be used as directed by a doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Do not take a higher dose than recommended for your condition. Your doctor may recommend periodic
check-ups to review your treatment progress. It is important to take the lowest effective dose that
relieves your pain. Do not use Kostarox for longer than necessary, as long-term treatment, especially
at high doses, may increase the risk of heart attack and stroke.
This medicine is available in different strengths, and depending on your diagnosis, your doctor will
prescribe the appropriate strength for you.

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

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

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

Acute pain episodes
Kostarox should be used only during episodes of acute pain.

• Gout The recommended dose is 120 mg once daily. This dose should be taken only during an acute painful attack, for a maximum of 8 days.
• Pain after dental surgery The recommended dose is 90 mg once daily, for up to 3 days.

Elderly patients
Dose adjustment is not required in elderly patients. However, 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 moderate liver disease should not take more than 30 mg per day.

Method of administration
Kostarox is intended for oral administration.
Tablets should be taken once daily. They may be taken with food or on an empty stomach, although
the effect may occur more quickly if taken without food.

Taking more Kostarox than recommended
Never take more tablets than prescribed by your doctor. If you take too much medicine, seek
immediate medical help.

Missed dose of Kostarox
It is important to take this medicine as prescribed. If you miss a dose, take the next tablet the
following day according to your dosing schedule. 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, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the symptoms listed below occur, stop using Kostarox immediately and consult a doctor:

• shortness of breath, chest pain or swelling of the ankles, or worsening of these symptoms
• yellowing of the skin and eyes (jaundice) – these may be signs of liver dysfunction
• severe or persistent abdominal pain or black, tarry stools
• allergic reaction with symptoms such as skin changes (ulceration or blistering), swelling of the face, lips, tongue or throat, leading to difficulty breathing.

The following adverse reactions may occur during treatment with Kostarox:
Very common (may occur in more than 1 in 10 people)

• stomach pain

Common (may occur in less than 1 in 10 people)

• dry socket (inflammation and pain following tooth extraction)
• swelling of the legs and/or feet due to fluid retention
• dizziness, headache
• palpitations, irregular heartbeat
• increased blood pressure
• wheezing or shortness of breath (bronchospasm)
• constipation, flatulence, gastritis, heartburn, diarrhoea, indigestion, gastric discomfort, nausea, vomiting, oesophagitis, oral ulceration
• changes in liver function test results
• bruising
• weakness or fatigue, flu-like illness

Uncommon (may occur in less than 1 in 100 people)

• inflammation of the gastrointestinal tract affecting the stomach and/or small intestine and/or "stomach flu"
• upper respiratory tract infection
• urinary tract infection
• decreased number of red blood cells, which may cause pale skin, weakness or shortness of breath
• decreased number of white blood cells
• decreased number of platelets, increasing the risk of bleeding or bruising
• hypersensitivity (allergic reaction with urticaria, which may be severe enough to require immediate medical attention)
• increased or decreased appetite, weight gain
• anxiety, depression, impaired mental performance, hallucinations (seeing, feeling or hearing things that are not real)
• altered taste, difficulty falling asleep, numbness or tingling, drowsiness
• blurred vision, eye irritation and redness
• tinnitus, sensation of spinning
• irregular heart rhythm (atrial fibrillation), increased heart rate, heart failure, sensation of tightness, pressure or heaviness in the chest (angina), heart attack
• skin redness, stroke, "mini-stroke" (transient ischaemic attack), significant increase in blood pressure, vasculitis, often with skin rash
• cough, breathlessness, nosebleeds
• bloating, changes in bowel frequency, dry mouth, gastric or small intestinal ulceration, gastritis which may be severe and lead to bleeding, irritable bowel syndrome, pancreatitis
• facial swelling, skin rash or itching, skin redness
• muscle cramps/spasms, muscle pain/stiffness
• high potassium levels in the blood, which may cause heart rhythm disturbances, changes in blood or urine test results related to kidney function, severe kidney dysfunction
• chest pain

Rare (may occur in less than 1 in 1,000 people)

• severe allergic reaction with swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing (angioedema), anaphylactic or anaphylactoid reactions, including shock (serious allergic reactions requiring immediate medical attention)
• confusion, restlessness, especially motor agitation
• hepatitis, liver failure, yellowing of the skin and/or eyes (jaundice)
• low sodium levels in the blood, which may cause fatigue, confusion, muscle twitching, seizures and coma
• severe skin reactions

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Kostarox

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Kostarox contains

• The active substance is etoricoxib. Each coated tablet contains 60 mg of etoricoxib.
• Other ingredients are: Core: calcium hydrogen phosphate anhydrous, microcrystalline cellulose, povidone K29-32, magnesium stearate, sodium croscarmellose. Coating: hypromellose, monohydrate lactose, titanium dioxide (E 171), triacetin, indigo carmine, lac (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 packed in blisters or in a tablet container with a screw cap containing a desiccant (silica gel). The desiccant must not be swallowed.
Pack 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 Authorisation Holder and Manufacturer
Marketing Authorisation 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 further information about the medicinal product 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