Roticox

Leaflet attached to 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

You should carefully read the contents of this 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 you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell 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 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 a group of selective cyclooxygenase-2 (COX-2) inhibitors. It belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

What is Roticox used for?

• Roticox helps to 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 a medicine used for the 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 bone ends. 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 you are allergic to etoricoxib or any of the other ingredients of this medicine (listed in section 6);
• if you have hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid and selective cyclooxygenase-2 (COX-2) inhibitors (see Possible side effects, section 4);
• if you have active peptic ulcer or bleeding from the stomach or intestines;
• if you have severe liver dysfunction;
• if you have 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 you have inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or intestinal inflammation;
• if you have uncontrolled high blood pressure (if in doubt, consult your doctor or nurse if you are not sure if your blood pressure is well controlled).
• if you have ever been diagnosed by your doctor with heart problems, including moderate or severe heart failure or angina pectoris (chest pain);
• if you have had a heart attack, undergone coronary artery bypass grafting, or have peripheral arterial disease (poor circulation in the legs or feet due to narrowed or blocked arteries);
• if you have had any type of stroke (including mini-stroke or 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 problems.

In the event of any of the above situations, you should consult your doctor before taking the tablets.

Warnings and precautions

Before starting treatment with Roticox, you should discuss it with your doctor or pharmacist:

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

In case of uncertainty as to whether any of the above situations exist, you should
consult your 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 years of age, 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

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take, including those available without a prescription.
In the case of taking one of the following medicines, your doctor may decide to monitor you to ensure that the treatment is proceeding correctly from the start of taking Roticox :

• blood thinners (anticoagulants), such as warfarin;
• rifampicin (an antibiotic);
• methotrexate (an immunosuppressive drug, often used to treat rheumatoid arthritis);
• cyclosporine or tacrolimus (immunosuppressive drugs);
• 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 arrhythmias);
• 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 you are currently taking low dosesof acetylsalicylic acid to prevent heart attacks or strokes, do not stop taking acetylsalicylic acid without consulting your doctor;
• acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs):

do not take high dosesof acetylsalicylic acid or other anti-inflammatory drugs 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 pregnant women. A pregnant woman or a woman who may be pregnant or is planning to become pregnant should not take this medicine. If you become pregnant, stop taking the medicine and contact your doctor. If you have any doubts or need further information, you should contact your doctor.
Breastfeeding
It is not known whether Roticox passes into breast milk. If you are breastfeeding or planning to breastfeed, you should consult your doctor before taking Roticox. If you are 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 reported dizziness and drowsiness.
Do not drive vehicles, if you experience dizziness and drowsiness.
Do not operate any machinery or use tools, if you experience dizziness and drowsiness.

Roticox contains sodium

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

3. How to take Roticox

This medicine should always be taken exactly as directed by your doctor. If you are unsure, you should ask your doctor or pharmacist.
Do not take more than the recommended dose for each condition. You should consult your doctor from time to time 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 at high doses.
There are different strengths of this medicine, and depending on the disease, your doctor will prescribe the strength that is right for you.
Recommended dose
Osteoarthritis
The recommended dose is 30 mg of etoricoxib, once daily, increased to a maximum of 60 mg once daily, if necessary.
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 necessary.
Acute pain conditions
Etoricoxib should only be used during periods of acute pain symptoms.
Gout
The recommended dose is 120 mg once daily; it should only be used during periods 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 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 daily.
• In patients with moderate liver dysfunction, the dose should not exceed 30 mg daily.

Use in children and adolescents

Roticox should not be used in 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 daily.
Roticox can be taken with or without food.

Taking a higher dose of Roticox than recommended

Never take more tablets than your doctor has recommended. If you have taken too many Roticox tablets, you should seek medical attention immediately.

Missing a dose of Roticox

Roticox should be taken as directed by your doctor. If you miss a dose, the next day you should return to your usual dosing schedule. Do not take a double dose to make up for a missed dose.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following symptoms, you should stop taking Roticox and contact your doctor 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;
• palpitations, irregular heartbeat;
• increased blood pressure;
• wheezing, shortness of breath (bronchospasm);
• constipation, gas (excess gas in the intestines), gastritis (inflammation of the stomach lining), heartburn, diarrhea, indigestion (dyspepsia), and (or) discomfort in the stomach, nausea, vomiting, esophagitis, oral ulcers;
• changes in liver-related blood test results;
• bruises;
• weakness and fatigue, flu-like symptoms.

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

• gastrointestinal inflammation (gastrointestinal disease that affects both the stomach and the small intestine and (or) stomach flu), upper respiratory tract infection, urinary tract infection;
• changes in laboratory 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, feeling, or hearing something that does 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, vasculitis;
• cough, shortness of breath;
• bloating, change in bowel movements, dryness of the mucous membranes, stomach ulcers, gastritis, which can be severe and lead to bleeding, irritable bowel syndrome, pancreatitis;
• facial swelling, rash, or itching;
• muscle cramps, muscle pain, or stiffness;
• high potassium levels in the blood, changes in kidney-related blood or urine test results, severe kidney dysfunction;
• chest pain.

Rare (may affect up to 1 in 1000 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 you experience any side effects, including those not listed in this leaflet, you should tell your 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Roticox

The medicine should be stored out of 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 month stated.
The batch number is stated on the packaging after the abbreviation "Lot".
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 packaging

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 yellow-brown, 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
Packaging 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 packaging 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 detailed information on this medicine, you should contact 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: