Roticox

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Roticox (Etoricoxib Krka)

60 mg, coated tablets

Etoricoxib
Roticox and Etoricoxib Krka are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 (OA), rheumatoid arthritis (RA), 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-standing 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 bleeding from the stomach or intestines;
• if the patient has severe liver dysfunction;
• if the patient has severe kidney dysfunction;
• in women who are pregnant or may become pregnant, or are breastfeeding (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 colitis;
• 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 disease, including heart failure (moderate or severe) or angina pectoris (chest pain);
• if the patient has had a heart attack, undergone coronary artery bypass grafting, 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 disease or stroke.

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

Warnings and precautions

Before starting to take Roticox, the patient should discuss it with their doctor or pharmacist:

• if the patient has had stomach ulcers or stomach bleeding in the past;
• 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 had heart failure or other heart disease in the past;
• if the patient has had high blood pressure in the past. Roticox may increase blood pressure in some people, especially after taking high doses of the medicine, so the doctor will check the patient's blood pressure from time to time;
• if the patient has had liver or kidney dysfunction in the past;
• if the patient is currently being treated for an infection. Roticox may mask fever, which is a sign of infection;
• in people with diabetes, high cholesterol, or smokers. These people are at increased risk of heart disease;
• in women planning to become pregnant;

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• in people over 65 years of age.

In case of doubt, whether any of the above situations occur, the patient should
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

The patient should tell their doctor or pharmacist about all medicines they are taking, or have recently taken, and about any medicines they plan to take, including those obtained without a prescription.
In case of taking any of the following medicines, the doctor may decide to monitor the patient to ensure that the treatment is going well from the start of taking Roticox:

• 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 irregular heart rhythms);
• minoxidil (a medicine used to treat high blood pressure);
• salbutamol in tablet or oral solution form (a medicine used to treat asthma);
• oral contraceptives (combination may increase the risk of side effects);
• hormone replacement therapy (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 the patient is currently taking low dosesof acetylsalicylic acid to prevent heart attacks or strokes, they should not stop taking acetylsalicylic acid without consulting their doctor;
• acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs): high dosesof acetylsalicylic acid or other anti-inflammatory drugs should not be taken 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
Roticox should not be taken by women who are pregnant. A pregnant woman or a woman who may be pregnant or is planning to become pregnant should not take this medicine. If the patient becomes pregnant, they should stop taking the medicine and consult their doctor. In case of doubt or need for additional information, the patient should consult their doctor.
Breastfeeding
It is not known whether Roticox passes into breast milk. If the patient is breastfeeding or planning to breastfeed, they should consult their doctor before taking Roticox. If the patient is taking Roticox, they should not breastfeed.
Fertility
Roticox is not recommended for use in women who are planning to become pregnant.

Driving and using machines

Some patients taking Roticox have reported dizziness and drowsiness.
The patient should not drive vehicles, if they experience dizziness and drowsiness.
The patient should not operate any machinery or use tools, if they experience dizziness and drowsiness.

Roticox contains sodium

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

3. How to take Roticox

This medicine should always be taken exactly as prescribed by the doctor.
In case of doubt, the patient should consult their doctor or pharmacist.
The patient should not take more than the recommended dose for each condition. The patient should consult their doctor from time to time to check the treatment. It is important to use the smallest effective dose that relieves pain 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.
There are different strengths of this medicine, 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 a day, increased to a maximum of 60 mg once a day, if necessary.
Rheumatoid arthritis
The recommended dose is 60 mg of etoricoxib, once a day. The dose may be increased to a maximum of 90 mg.
Ankylosing spondylitis
The recommended dose is 60 mg of etoricoxib, once a day. The dose may be increased to a maximum of 90 mg once a day, if necessary.
Acute pain conditions
Etoricoxib should only be used during episodes of acute pain symptoms.
Gout
The recommended dose is 120 mg once a day; it should only be used during episodes of acute pain, for a maximum of 8 days of treatment.
Pain after surgical dental procedures
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The recommended dose is 90 mg once a day, and treatment with this dose may last for a maximum of 3 days.

Patients with liver dysfunction

• In patients with mild liver dysfunction, the dose should not exceed 60 mg once a day.
• In patients with moderate liver dysfunction, the dose should not exceed 30 mg per day.

Use in children and adolescents

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

Elderly patients

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

Method of administration

Roticox is intended for oral use. The tablets should be taken once a day.
Roticox can be taken with or without food.

Taking a higher dose of Roticox than recommended

The patient should never take more tablets than prescribed by the doctor. If the patient takes too many Roticox tablets, they should seek medical help immediately.

Missing a dose of Roticox

Roticox should be taken as prescribed by the doctor. If a dose is missed, the patient should return to their usual dosing schedule the next day. The patient 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 their doctor or pharmacist.

4. Possible side effects

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

If any of the following symptoms occur, the patient should stop taking Roticox and seek medical help immediately (see section 2 Important information before taking Roticox):

• shortness of breath, chest pain, or swelling of 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;

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• palpitations, irregular heartbeat (arrhythmia);
• increased blood pressure;
• wheezing, 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, esophagitis, mouth ulcers;
• changes in liver blood test results;
• bruises;
• weakness and fatigue, flu-like symptoms.

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

• inflammation of the stomach and intestines (gastrointestinal disorders, which include both stomach and small intestine and (or) gastroenteritis), upper respiratory tract infections, urinary tract infections;
• changes in laboratory test results (decreased red blood cell count, decreased white blood cell count, decreased platelet count);
• allergic reactions (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, feeling, or hearing 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, TIA), significant increase in blood pressure, vasculitis;
• cough, shortness of breath, nosebleeds;
• bloating, change in bowel movements, dry mouth, stomach ulcers, stomach inflammation, which can be severe and lead to bleeding, irritable bowel syndrome, pancreatitis;
• facial swelling, 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Roticox

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage.
The patient should not take this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 60 mg of etoricoxib.
• The other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose, sodium stearyl fumarate, colloidal anhydrous silica in the tablet core, and polyvinyl alcohol, titanium dioxide (E 171), macrogol 3000, talc, and yellow iron oxide (E 172) in the coating. See section 2 "Roticox contains sodium".

What Roticox looks like and contents of the pack

The tablets are light yellow-brown, round (diameter 8 mm), biconvex, with beveled edges, with the inscription "60" on one side.
Pack sizes:
7, 14, 28, 56, 84, or 98 coated tablets in a blister pack OPA/Aluminum/PVC/Aluminum, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Ireland, the country of export:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Ireland export license number: PA1347/064/002

Parallel import license number: 386/19

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

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Approval date of the leaflet: 15.10.2024

[Information about the trademark]

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