Roticox

Leaflet accompanying the packaging: patient information

Roticox, 30 mg, coated tablets

Roticox, 60 mg, coated tablets

Roticox, 90 mg, coated tablets

Roticox, 120 mg, coated tablets

Etoricoxib

Read the 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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 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 packaging 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 cyclooxygenase-2 (COX-2) inhibitors. It belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).

What is Roticox used for?

• Roticox helps reduce pain and swelling (inflammatory conditions) of the joints and muscles in people aged 16 and over with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.
• Roticox is also used for short-term treatment of moderate pain associated with surgical dental procedures in people aged 16 and over.

What is osteoarthritis?

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

What is rheumatoid arthritis?

Rheumatoid arthritis is a long-lasting inflammatory disease of the joints. It causes pain, stiffness, swelling, and increased loss of range of motion in the joints it affects. It also causes 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 joint area. This disease is caused by the deposition of crystalline deposits in the joint.

What is ankylosing spondylitis?

Ankylosing spondylitis is an inflammatory disease of the spine and large joints.

2. Important information before taking Roticox

When not to take 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 and 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 dysfunction;
• if the patient has severe kidney dysfunction;
• in pregnant or breastfeeding women, or women who 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 intestinal inflammation;
• if the patient has uncontrolled high blood pressure (if in doubt, consult a doctor or nurse if the patient is not sure if their blood pressure is well controlled).
• if the patient has ever been diagnosed with heart disorders, including moderate or severe heart failure or angina pectoris (chest pain);
• if the patient has had a heart attack, undergone a bypass graft, or has 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 ischemic attack TIA). Etoricoxib may slightly increase the risk of heart attack and stroke, and therefore should not be used in people who have had heart or stroke disorders.

In case of the above situations, consult a doctor before taking the tablets.

Warnings and precautions

Before starting Roticox, discuss with your doctor or pharmacist:

• if the patient has a history of stomach bleeding or stomach ulcers;
• if the patient is dehydrated, e.g., due to prolonged, recurring vomiting or diarrhea;
• if the patient has swelling due to fluid retention;
• if the patient has a history of heart failure or other heart disease;
• if the patient has a history of high blood pressure. Roticox may increase blood pressure in some people, especially after taking high doses of the medicine, so the doctor will check blood pressure from time to time;
• if the patient has a history of liver or kidney dysfunction;
• if the patient is currently being treated for an infection. Roticox may mask fever, which is a sign of infection;
• in case of people with diabetes, high cholesterol, or smokers. These people are at increased risk of heart disease;
• in case of women planning to become pregnant;
• in case of people over 65 years of age.

In case of uncertainty about any of the above situations, consult a doctor before taking Roticoxto clarify whether the medicine can be taken.
Roticox is equally effective in both elderly and younger adult patients. In patients over 65, the doctor may decide on more frequent check-ups. No dose adjustment is necessary in people over 65 years of age.

Children and adolescents

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

Roticox and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take, including those obtained without a prescription.
In case of taking one of the following medicines, the doctor may decide to monitor the patient to ensure that the treatment is going well from the start of Roticox treatment :

• blood thinners (anticoagulants), such as warfarin;
• rifampicin (an antibiotic);
• methotrexate (a medicine that suppresses the immune system, often used to treat rheumatoid arthritis);
• cyclosporine or tacrolimus (medicines that suppress the immune system);
• lithium (a medicine used to treat certain types of depression);
• medicines that 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 used to treat heart failure and heart rhythm disorders);
• minoxidil (a medicine used to treat high blood pressure);
• salbutamol in tablet or oral solution form (a medicine used to treat asthma);
• oral contraceptives (the combination may increase the risk of side effects);
• hormone replacement therapy (the combination may increase the risk of side effects);
• acetylsalicylic acid, the risk of stomach ulcers is higher when taking Roticox with acetylsalicylic acid;
• acetylsalicylic acid used for the prevention of heart attacks or strokes: Roticox can be taken with a low dose of acetylsalicylic acid. If currently taking low-doseacetylsalicylic 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 dosesof 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 take Roticox if pregnant. A pregnant woman or a woman who may be pregnant or is planning to become pregnant should not take this medicine. If pregnancy occurs, stop taking the medicine and consult a doctor. In case of doubts or need for additional information, consult a doctor.
Breastfeeding
It is not known whether Roticox passes into breast milk. If breastfeeding or planning to breastfeed, consult a doctor before taking Roticox. If taking Roticox, do not breastfeed.
Fertility
Roticox is not recommended for use in women planning to become pregnant.

Driving and using machines

Some patients taking Roticox have experienced dizziness and drowsiness.
Do not drive vehicles, if dizziness and drowsiness occur.
Do not operate any machinery or tools, if dizziness and drowsiness occur.

Roticox contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is essentially 'sodium-free'.

3. How to take Roticox

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Do not take more than the recommended dose for each condition. From time to time, consult your doctor to check the treatment. It is important to use the smallest effective dose that provides pain relief and not to take Roticox for longer than necessary. There is an increased risk of heart attacks and strokes with prolonged use of the medicine, especially with high doses.
Different strengths of this medicine are available, and depending on the disease, the doctor will prescribe the tablets with the appropriate strength for the patient.
Recommended dose
Osteoarthritis
The recommended dose is 30 mg of etoricoxib, once daily, increased to a maximum of 60 mg once daily, if needed.
Rheumatoid arthritis
The recommended dose is 60 mg of etoricoxib, once daily. The dose may be increased to a maximum of 90 mg.
Ankylosing spondylitis
The recommended dose is 60 mg of etoricoxib, once daily. The dose may be increased to a maximum of 90 mg, once daily, if needed.
Acute pain conditions
Etoricoxib should only be used during episodes of acute pain.
Gout
The recommended dose is 120 mg once daily; it should only be used during episodes of acute pain, for a maximum of 8 days of treatment.
Pain after surgical dental procedures
The recommended dose is 90 mg once daily, and treatment with this dose should not exceed 3 days.

Patients with liver dysfunction

• In patients with mild liver dysfunction, do not take a dose higher than 60 mg once daily.
• In patients with moderate liver dysfunction, do not take a dose higher than 30 mg daily.

Use in children and adolescents

Do not give Roticox to children and adolescents under 16 years of age.

Patients over 65 years of age

No dose adjustment is necessary in patients over 65 years of age. As with other medicines, caution should be exercised in patients over 65 years of age.
Method of administration
Roticox is for oral use. The tablets should be taken once daily.
Roticox can be taken with or without food.

Overdose of Roticox

Never take more tablets than the doctor has prescribed. If too many tablets of Roticox are taken, seek medical help immediately.

Missed dose of Roticox

Take Roticox as prescribed by the doctor. If a dose is missed, the next day return to the usual dosing schedule. Do not take a double dose to make up for a missed dose.
In case of further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

If any of the following symptoms occur, stop taking Roticox and consult a doctor immediately (see section 2 Important information before taking Roticox):

• shortness of breath, chest pain, or swelling around the ankles, or worsening of existing swelling;
• yellowing of the skin and eyes (jaundice) - these are signs of abnormal liver function;
• severe or persistent stomach pain, or black stools;
• allergic reactions, which can manifest as skin diseases, such as ulcers, blisters, or swelling of the face, lips, tongue, or throat, which can cause difficulty breathing.

The following side effects 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, irregular heartbeat (arrhythmia);
• high blood pressure;
• wheezing or shortness of breath (bronchospasm);
• constipation, gas (excess gas in the intestines), stomach inflammation (gastritis), heartburn, diarrhea, indigestion (dyspepsia), and (or) discomfort in the stomach, nausea, vomiting, esophageal inflammation, mouth ulcers;
• changes in liver blood test results;
• bruising;
• weakness and fatigue, flu-like symptoms.

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

• gastrointestinal and upper respiratory tract infections, urinary tract infections;
• changes in blood test results (decreased red blood cell count, decreased white blood cell count, decreased platelet count);
• hypersensitivity (allergic reaction, including hives, which can be severe enough to require immediate medical attention);
• increased or decreased appetite, weight gain;
• anxiety, depression, decreased mental performance; seeing, hearing, or feeling things that do not exist (hallucinations);
• taste disorders, insomnia, numbness or tingling;
• blurred vision, eye irritation and redness;
• ringing in the ears, dizziness (feeling of spinning while at rest);
• heart rhythm disorders (atrial fibrillation), rapid heartbeat, heart failure, feeling of tension, feeling of pressure or heaviness in the chest (angina pectoris), heart attack;
• hot flashes, stroke, mini-stroke (transient ischemic attack), significant increase in blood pressure, blood vessel inflammation;
• cough, shortness of breath;
• bloating, change in bowel habits, dry mouth, stomach ulcers, stomach inflammation, which can be severe and lead to bleeding, irritable bowel syndrome, pancreatitis;
• face swelling or rash or itching, redness of the skin;
• muscle cramps, muscle pain or stiffness;
• high potassium levels in the blood, changes in blood or urine test results related to kidney function, severe kidney dysfunction;
• 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 can cause difficulty breathing or swallowing, which can be severe enough to require immediate medical attention); anaphylactic or anaphylactoid reactions, including shock (a severe allergic reaction that requires immediate medical attention);
• disorientation, restlessness;
• liver disease (hepatitis);
• low sodium levels in the blood;
• liver failure, yellowing of the skin and eyes (jaundice);
• severe skin reactions.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, tell a doctor or pharmacist. 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,
Phone: +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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Roticox

Keep the 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 month stated.
The batch number is stated on the packaging after "Lot".
This medicine does not require special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Roticox contains

• The active substance of Roticox 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, and 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 convex on both sides, with beveled edges.
Roticox, 60 mg, coated tablets: light brown-yellow, round (8 mm in diameter), convex on both sides, with beveled edges, with the inscription "60" on one side.
Roticox, 90 mg, coated tablets: pink, round (9 mm in diameter), convex on both sides, with beveled edges, with the inscription "90" on one side.
Roticox, 120 mg, coated tablets: brown-red, round (10 mm in diameter), slightly convex on both sides, with beveled edges, with a dividing line on one side. The dividing line is not intended for breaking the tablet
Pack sizes:
Roticox, 30 mg, coated tablets:
Packaging: 7, 14, 28, 30, 56, 60, 84, 98, or 100 tablets in blisters.
Roticox, 60 mg, coated tablets:
Packaging: 7, 14, 20, 28, 30, 50, 56, 60, 84, 98, or 100 tablets in blisters.
Roticox, 90 mg, coated tablets:
Packaging: 5, 7, 14, 20, 28, 30, 50, 56, 60, 84, 98, or 100 tablets in blisters.
Roticox, 120 mg, coated tablets:
Packaging: 5, 7, 14, 20, 28, 30, 56, 60, 84, 98, or 100 tablets in blisters.
Not all pack sizes may be marketed.

Marketing authorization 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 medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

For more information about this medicine, consult the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500

Date of last revision of the leaflet: