Package leaflet: Information for the patient

Kostarox, 90 mg, film-coated tablets
Etoricoxibum
Please read the entire leaflet carefully before taking 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 further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same as yours.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Kostarox is and what it is used for
Important information before taking Kostarox
How to take Kostarox
Possible side effects
How to store Kostarox
Contents of the package 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 a group of drugs known as "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 the 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 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 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 the 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 disease 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 doctor);
if the patient has been diagnosed with heart disease, including heart failure (moderate or severe), angina (chest pain), or has had a myocardial infarction or coronary artery bypass surgery (bypass grafting);
if the patient has peripheral arterial disease (poor circulation in the legs or feet due to narrowed or blocked arteries);
if the patient has previously had any type of 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 a doctor or pharmacist if:

the patient has previously had gastrointestinal bleeding or gastric ulcer;
the patient is dehydrated, for example due to prolonged or recurrent vomiting or diarrhoea;
the patient has developed swelling due to fluid retention;
the patient has previously had heart failure or other heart disease;
the patient has previously had high blood pressure. Kostarox may increase blood pressure in some individuals, especially when used at high doses; therefore, the doctor will periodically monitor the patient's blood pressure.
the patient has previously had liver or kidney disease;
the patient is currently being treated for an infection. Kostarox may mask fever, which is a symptom 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, before
using Kostarox, consult a doctor to determine whether this medicine can be used.
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
Kostarox 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 planned for future use.
If the patient is taking any of the following medicines, the doctor may decide that monitoring is necessary to ensure that treatment with Kostarox proceeds safely:

anticoagulant medicines (blood thinners), 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 system 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 contraceptive pills (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): during treatment with Kostarox, high doses of acetylsalicylic acid or other anti-inflammatory medicines must not be taken.

Pregnancy, breastfeeding and fertility
Pregnancy
Kostarox must not be used during pregnancy. If the patient is pregnant, 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, the medicine should be discontinued and medical advice sought immediately.
If in doubt or if further information is needed, consult a doctor.
Breastfeeding
It is not known whether etoricoxib passes into breast 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 pregnancy or experiencing difficulty becoming pregnant.
Driving and using machines
Dizziness and drowsiness have been reported in some patients taking Kostarox. If such symptoms occur, the patient must 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 film-coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Kostarox

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Do not take a higher dose than recommended for the condition being treated. Your doctor may recommend periodic check-ups to review the progress of treatment. It is important to take the lowest effective dose that relieves 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 the diagnosed condition, your doctor will prescribe tablets of an 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 periods of acute pain symptoms.

Gouty arthritis The recommended dose is 120 mg once daily. This dose should be taken only during episodes of acute pain, for a maximum of 8 days.
Pain after dental surgical procedures 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 doses higher than 60 mg per day.
Patients with moderate liver disease should not take doses higher 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 of the medicine may occur faster 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.
Missing a dose of Kostarox
It is important to take the medicine as prescribed. If you miss a dose, take the next tablet the following day as scheduled. 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 will experience 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 or 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 affect more than 1 in 10 people)

stomach pain

Common (may affect up to 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, stomach discomfort, nausea, vomiting, oesophagitis, oral ulceration
changes in liver function test results
bruising
weakness or fatigue, flu-like illness

Uncommon (may affect up to 1 in 100 people)

gastrointestinal inflammation, affecting the stomach and 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, seeing, feeling or hearing things that are not there (hallucinations)
altered taste, difficulty sleeping, numbness or tingling, drowsiness
blurred vision, eye irritation and redness
ringing in the ears, sensation of spinning
irregular heart rhythm (atrial fibrillation), rapid heartbeat, heart failure, sensation of tightness, pressure or heaviness in the chest (angina), heart attack
skin redness, stroke, "mini-stroke" (transient ischaemic attack), marked 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 tests related to kidney function, severe kidney dysfunction
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 may cause difficulty breathing or swallowing (angioedema), anaphylactic or anaphylactoid reactions, including shock (serious allergic reactions requiring immediate medical attention)
confusion, restlessness, particularly motor restlessness
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 sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines should 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 pack and other information

What Kostarox contains

The active substance is etoricoxib. Each coated tablet contains 90 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 (E171), triacetin.

What Kostarox looks like and contents of the pack
Kostarox tablets are white, round, biconvex, coated tablets.
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