Roticox

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language
Roticox (Etoricoxib Krka)
60 mg, coated tablets
Etoricoxibum
Roticox and Etoricoxib Krka are different trade names for the same medicine.
Please read this leaflet carefully 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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific person only. Do not give it to others. It 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

1. What Roticox is and what it is 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 Roticox is and what it is used for

What is Roticox?

• Roticox contains the active substance etoricoxib. Roticox belongs to a group of medicines known as selective cyclooxygenase-2 (COX-2) inhibitors. It is a member of a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

What is Roticox used for?

• Roticox helps reduce pain and swelling (inflammation) in the 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 develops as a result of the gradual breakdown of the cartilage that lines the ends of bones. This leads to swelling (inflammation), pain, tenderness, stiffness, and loss of function.
What is rheumatoid arthritis?
Rheumatoid arthritis is a chronic inflammatory disease of the joints. 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. It 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 arterial 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 the 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;
• the patient is dehydrated, for example due to prolonged recurrent vomiting or diarrhoea;
• the patient has fluid retention causing swelling (oedema);
• the patient has previously had heart failure or other heart disease;
• the patient has previously had high blood pressure. Roticox may increase blood pressure in some people, especially when high doses are used; therefore, the doctor will periodically monitor blood pressure;
• the patient has previously had liver or kidney function disorders;
• the patient is currently being treated for an infection. Roticox may mask fever, which is a symptom of infection;
• the patient has diabetes, high cholesterol levels, or is a smoker. These patients have an increased risk of heart disease;
• in women planning pregnancy;
• in individuals over 65 years of age.

If in doubt about 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 patients and in younger adults. For patients over 65 years of age, the doctor may decide on more frequent follow-up visits. Dose adjustment is not necessary in individuals 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 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.

If the patient is taking any of the following medicines, the doctor may decide that monitoring is necessary to ensure proper treatment after starting Roticox:

• blood-thinning medicines (anticoagulants), such as warfarin;
• rifampicin (an antibiotic);
• methotrexate (a medicine that suppresses the immune system, often used in the treatment of rheumatoid arthritis);
• cyclosporine or tacrolimus (medicines that suppress the immune system);
• 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 (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 Roticox is taken together with acetylsalicylic acid;
• acetylsalicylic acid used for prevention of heart attack or stroke: 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-dose 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. A woman who is pregnant, who may be pregnant, or who is 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, contact 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.

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 a motor vehicle if dizziness or drowsiness occurs.

Do not operate any 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 the medicine is considered "sodium-free".

3. How to use Roticox

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Roticox is available in the following strengths: 30 mg, 60 mg, 90 mg, 120 mg.
Do not take higher doses than recommended for individual conditions. Treatment should be reviewed periodically with your doctor. It is important to use the lowest effective dose providing pain relief, and Roticox should not be used for longer than necessary. Prolonged use of the medicine increases the risk of heart attacks and strokes, especially at higher doses.
Different strengths of this medicine are available, 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 once daily.

Ankylosing spondylitis
The recommended dose is 60 mg of etoricoxib, once daily. The dose may be increased, if necessary, up 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 dose should be used only during episodes of acute pain, for a maximum of 8 days of treatment.

Pain following dental surgery
The recommended dose is 90 mg once daily, and treatment with this dose may last for 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 must not be used in children and adolescents under 16 years of age.

Elderly patients
Dosage adjustment is not necessary in elderly patients. However, as with other medicines, caution should be exercised in elderly patients.

Method of administration
Roticox is intended for oral use. Tablets should be taken once daily.
Roticox may be taken with or without food.

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

Missed dose of Roticox
Roticox should be taken as directed 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, stop taking Roticox and
contact your doctor immediately (see section 2 Important information before using Roticox):

• shortness of breath, chest pain, or new or worsening swelling around the ankles;
• yellowing of the skin or eyes (jaundice) – signs of liver problems;
• severe or persistent stomach pain, or appearance of black stools;
• allergic reactions, which may present 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 (oedema);
• 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, diarrhoea, indigestion (dyspepsia) and/or discomfort in the stomach, nausea, vomiting, oesophagitis, 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):

• inflammation of the stomach and intestines (gastroenteritis, affecting both the stomach and small intestine and/or stomach flu), upper respiratory tract infection, urinary tract infection;
• changes in laboratory test results (reduced number of red blood cells, reduced number of white blood cells, reduced number of platelets);
• hypersensitivity (allergic reaction, including urticaria, which may be severe enough to require immediate medical attention);
• increased or decreased appetite, weight gain;
• anxiety, depression, reduced mental performance; seeing, feeling or hearing things that are not real (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 tension, pressure or heaviness in the chest (angina), heart attack;
• hot flushes, stroke, mini-stroke (transient ischaemic attack), significant increase in blood pressure, vasculitis;
• cough, breathlessness, 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 disorders;
• chest pain.

Rare (may affect fewer than 1 in 1000 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 attention); anaphylactic or anaphylactoid reactions, including shock (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 adverse reactions 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 may also be reported to the marketing authorisation holder or parallel importer.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Roticox

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in 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 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, yellow iron oxide (E 172) in the tablet coating. See section 2 "Roticox contains sodium".

What Roticox looks like and contents of the pack
Roticox tablets are light brownish-yellow, round (8 mm in diameter), biconvex, with bevelled edges, and have the inscription "60" embossed on one side.
Pack sizes:
7, 14, 28, 56, 84 or 98 tablets in blister packs.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in Ireland, the country of export: PA1347/064/002
Parallel Import Authorisation Number: 340/25
This medicinal product is authorised for sale in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: