Roticox

Package leaflet: Information for the patient

Roticox, 30 mg, film-coated tablets
Roticox, 60 mg, film-coated tablets
Roticox, 90 mg, film-coated tablets
Roticox, 120 mg, film-coated tablets
Etoricoxib
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• 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

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

1. What is Roticox and what is it used for

What is Roticox?

• Roticox contains the active substance etoricoxib. Roticox is a medicine belonging to the group of selective inhibitors of cyclooxygenase-2 (COX-2). It belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

What is Roticox used for?

• Roticox helps reduce pain and swelling (inflammation) in joints and muscles in people aged 16 years and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gouty arthritis.
• Roticox 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 results from the gradual breakdown of 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 range of motion in the affected joints. It may also cause inflammation in other parts of the body.
What is gout?
Gout is a disease characterized by sudden, recurring attacks of very painful inflammation and redness in the joints. This condition is caused by the deposition of crystal deposits in the joint.
What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease affecting the spine and large joints.

2. Important information before using Roticox

When not to use Roticox:

• if the patient is allergic to etoricoxib or any of the other ingredients of this medicine (listed in section 6);
• if the patient has hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, or selective cyclooxygenase-2 (COX-2) inhibitors (see Possible side effects, section 4);
• if the patient has active peptic ulcer or gastrointestinal bleeding;
• if the patient has severe liver function disorders;
• if the patient has severe kidney function disorders;
• in pregnant women, women who may be pregnant, or breastfeeding women (see 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 untreated high blood pressure (if in doubt, consult a doctor or nurse if the patient is unsure whether blood pressure is adequately controlled);
• if the patient has ever been diagnosed by a doctor with heart problems, including heart failure (moderate or severe type) or angina pectoris (chest pain);
• if the patient has had a heart attack, coronary artery bypass grafting, or peripheral artery disease (poor circulation in legs or feet due to narrowed or blocked arteries);
• if the patient has ever had any type of stroke (including mini-stroke, transient ischaemic attack TIA). Etoricoxib may slightly increase the risk of heart attack and stroke and therefore should not be used in individuals who have had heart problems or stroke.

If any of the above conditions apply, the patient should
consult a doctor before taking Roticox tablets.
Warnings and precautions
Before starting treatment with Roticox, discuss with a doctor or pharmacist:

• if the patient has previously had stomach bleeding or peptic ulcer disease;
• if the patient is dehydrated, for example due to prolonged or recurrent vomiting or diarrhoea;
• if the patient has swelling due to fluid retention;
• if the patient has previously had heart failure or other heart disease;
• if the patient has previously had high blood pressure. Roticox may increase blood pressure in some individuals, especially when high doses are used; therefore, the doctor may monitor blood pressure periodically;
• if the patient has previously had liver or kidney function disorders;
• if the patient is currently being treated for an infection. Roticox may mask fever, which is a sign of infection;
• in patients with diabetes, high cholesterol levels, or who smoke. These patients have an increased risk of heart disease;
• in women planning pregnancy;
• in individuals aged 65 years or older.

If there is any uncertainty whether any of the above conditions apply, the patient should
consult a doctor before using Roticox to determine whether the medicine can be used.
Roticox is equally effective in elderly individuals and younger adult patients. For patients over 65 years of age, the doctor may recommend more frequent check-ups. Dose adjustment is not necessary for individuals over 65 years of age.
Children and adolescents
Do not give this medicine to children or adolescents under 16 years of age.
Roticox and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
When taking any of the following medicines, the doctor may decide that monitoring is necessary to ensure safe and effective treatment after starting Roticox:

• anticoagulants (blood thinners), such as warfarin;
• rifampicin (an antibiotic);
• methotrexate (a drug that suppresses immune system function, often used in the treatment of rheumatoid arthritis);
• cyclosporine or tacrolimus (immunosuppressive drugs);
• 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, for example enalapril and ramipril, or losartan and valsartan;
• diuretics;
• digoxin (a medicine used in heart failure and heart rhythm disorders);
• minoxidil (a medicine used to treat high blood pressure);
• oral salbutamol tablets or oral solution (a medicine used in asthma);
• oral contraceptives (combination may increase the risk of adverse effects);
• hormone replacement therapy (combination may increase the risk of adverse effects);
• acetylsalicylic acid: the risk of gastric ulcers is higher when Roticox is taken together with acetylsalicylic acid;
• acetylsalicylic acid used for prevention of heart attacks or strokes: Roticox 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 acetylsalicylic acid without consulting a doctor;
• acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs):

do not take high doses of acetylsalicylic acid or other anti-inflammatory medicines
while taking Roticox.
Roticox with food and drink
The effect of the medicine may start faster if Roticox is taken on an empty stomach.
Pregnancy, breastfeeding and fertility
Pregnancy
Do not use Roticox in pregnant women. Women who are pregnant, may be pregnant, or are planning pregnancy must not use this medicine. If pregnancy occurs, stop taking the medicine and contact a doctor. If in doubt or if additional information is needed, consult a doctor.
Breastfeeding
It is not known whether Roticox passes into breast milk. If breastfeeding or planning to breastfeed, consult a doctor before using Roticox. Do not breastfeed while taking Roticox.
Effect on fertility
Roticox is not recommended for use in women planning pregnancy.
Driving and operating machinery
Dizziness and drowsiness have been reported in some patients taking Roticox.
Do not drive if dizziness or drowsiness occurs.
Do not operate machinery or use tools if dizziness or drowsiness occurs.
Roticox contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Roticox

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult
your doctor or pharmacist.
Do not take more than the recommended dose for each condition. Treatment should be reviewed
periodically by your doctor. It is important to use the lowest effective dose that provides pain relief,
and Roticox should not be used for longer than necessary. Prolonged use of this medicine,
particularly at high doses, increases the risk of heart attacks and strokes.
This medicine is available in different strengths, and depending on the condition being treated,
your doctor will prescribe the appropriate strength for you.

Recommended dose
Osteoarthritis
The recommended dose is 30 mg of etoricoxib once daily, increased if necessary to a maximum of 60 mg once daily.
Rheumatoid arthritis
The recommended dose is 60 mg of etoricoxib once daily. The dose may be increased up to a maximum of 90 mg.
Ankylosing spondylitis
The recommended dose is 60 mg of etoricoxib once daily. The dose may be increased, if necessary, to a maximum of 90 mg once daily.
Acute pain conditions
Etoricoxib should be used only during episodes of acute pain symptoms.
Gouty arthritis
The recommended dose is 120 mg once daily; this should be used only during acute painful episodes and for no more than 8 days of treatment.
Pain after dental surgery
The recommended dose is 90 mg once daily, and treatment with this dose may last up to a maximum of 3 days.

Patients with hepatic impairment

• In patients with mild hepatic impairment, doses greater than 60 mg once daily should not be used.
• In patients with moderate hepatic impairment, doses greater than 30 mg per day should not be used.

Use in children and adolescents
Roticox should not be used in children and adolescents under 16 years of age.

Elderly patients
Dose adjustment is not usually required in elderly patients. However, as with other medicines, caution should be exercised when treating elderly patients.

Method of administration
Roticox is intended for oral use. Tablets should be taken once daily.
Roticox may be taken with food or independently of meals.

Overdose of Roticox
Never take more tablets than prescribed by your doctor. If you have taken too many Roticox tablets, seek immediate medical attention.

Missed dose of Roticox
Roticox should be taken as prescribed by your doctor. If you miss a dose, take the next dose the following day at your usual time. 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 following symptoms occur, discontinue Roticox and
contact your doctor immediately (see section 2 Important information before using Roticox):

• Shortness of breath, chest pain, or development of swelling around the ankles, or worsening of existing swelling;
• Yellowing of the skin or eyes (jaundice) – signs of liver dysfunction;
• Severe or persistent stomach pain, or appearance of black stools;
• Hypersensitivity reactions, which may manifest as skin disorders such as ulcers, blisters, or swelling of the face, lips, tongue, or throat, which may cause difficulty in breathing.

The following adverse reactions may occur during treatment with Roticox:
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 lower limbs and (or) feet due to fluid retention (edema);
• Dizziness, headache;
• Palpitations (fast or irregular heartbeat), irregular heart rhythm (arrhythmia);
• Increased blood pressure;
• Wheezing or shortness of breath (bronchospasm);
• Constipation, flatulence (excess intestinal gas), gastritis (inflammation of the stomach lining), heartburn, diarrhea, indigestion (dyspepsia) and (or) feeling of discomfort in the stomach, nausea, vomiting, esophagitis, oral ulcers;
• Changes in blood test results related to the liver;
• Bruising;
• Weakness and fatigue, flu-like symptoms.

Uncommon (may affect up to 1 in 100 people):

• Gastroenteritis (inflammation of the gastrointestinal tract involving both the stomach and small intestine and (or) stomach flu), upper respiratory tract infection, urinary tract infection;
• Changes in laboratory test results (decreased number of red blood cells, decreased number of white blood cells, decreased platelet count);
• Hypersensitivity (allergic reaction, including urticaria, which may be severe enough to require immediate medical intervention);
• Increased or decreased appetite, increased body weight;
• Anxiety, depression, reduced mental performance; seeing, feeling or hearing something that is not there (hallucinations);
• Taste disturbances, insomnia, numbness or tingling, drowsiness;
• Blurred vision, eye irritation and redness;
• Tinnitus, vertigo (spinning sensation at rest);
• Heart rhythm disorders (atrial fibrillation), rapid heartbeat, heart failure, feeling of tightness, pressure or heaviness in the chest (angina pectoris), heart attack;
• Hot flushes, stroke, mini-stroke (transient ischemic attack), marked increase in blood pressure, vasculitis (inflammation of blood vessels);
• Cough, dyspnea, nosebleeds;
• Bloating, change in bowel habits, dryness of the oral mucosa, peptic ulcer, inflammation of the stomach lining which may be severe and lead to bleeding, irritable bowel syndrome, pancreatitis;
• Facial swelling, rash or itching, skin redness;
• Muscle cramps, muscle pain or stiffness;
• High potassium levels in blood, changes in blood or urine tests related to kidneys, severe kidney function impairment;
• Chest pain.

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

• Angioedema (an allergic reaction characterized by swelling of the face, lips, tongue and (or) throat, which may cause difficulty in breathing or swallowing, which may be severe enough to require immediate medical intervention); anaphylactic or anaphylactoid reactions, including shock (a severe allergic reaction requiring immediate medical intervention);
• Disorientation, restlessness;
• Liver disease (hepatitis);
• Low sodium levels in blood;
• Liver failure, yellowing of the skin and eyes (jaundice);
• Severe skin reactions.

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

5. How to store the medicine Roticox

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 the abbreviation
EXP. The expiry date refers to the last day of the stated month.
The batch number is indicated on the packaging after the abbreviation "Lot".
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help
protect the environment.

6. Contents of the pack and other information

What Roticox contains

• The active substance is etoricoxib. Each coated tablet contains 30 mg, 60 mg, 90 mg, or 120 mg of etoricoxib.
• The other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose, sodium stearyl fumarate, anhydrous colloidal silica in the tablet core; and polyvinyl alcohol, titanium dioxide (E 171), macrogol 3000, talc, yellow iron oxide (E 172) (in Roticox 60 mg coated tablets), and red iron oxide (E 172) (in Roticox 90 mg and 120 mg coated tablets). See section 2, "Roticox contains sodium".

What Roticox looks like and contents of the pack
Roticox 30 mg coated tablets: white or almost white, round (6 mm in diameter), slightly biconvex, with bevelled edges.
Roticox 60 mg coated tablets: light brownish-yellow, round (8 mm in diameter), biconvex, with bevelled edges, with the imprint "60" on one side.
Roticox 90 mg coated tablets: pink, round (9 mm in diameter), biconvex, with bevelled edges, with the imprint "90" on one side.
Roticox 120 mg coated tablets: brownish-red, round (10 mm in diameter), slightly biconvex, with bevelled edges, with a breakline on one side. The breakline is not intended for dividing the tablet.

Pack sizes:
Roticox 30 mg, coated tablets:
Blister packs containing 7, 14, 28, 30, 56, 60, 84, 98, or 100 tablets.
Roticox 60 mg, coated tablets:
Blister packs containing 7, 14, 20, 28, 30, 50, 56, 60, 84, 98, or 100 tablets.
Roticox 90 mg, coated tablets:
Blister packs containing 5, 7, 14, 20, 28, 30, 50, 56, 60, 84, 98, or 100 tablets.
Roticox 120 mg, coated tablets:
Blister packs containing 5, 7, 14, 20, 28, 30, 56, 60, 84, 98, or 100 tablets.
Not all pack sizes may be marketed.

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

Manufacturer/Importer:
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 for marketing in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

For more detailed information about this medicinal product, please contact the local representative of the marketing authorisation holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Tel. 22 57 37 500