Roticox

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Roticox (Etoricoxib Krka)
60 mg, coated tablets
Etoricoxibum
Roticox and Etoricoxib Krka are different brand 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 further questions, please 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, pharmacist, or nurse. See section 4.

Contents of the leaflet

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 called selective cyclooxygenase-2 (COX-2) inhibitors. It belongs to a class of medicines known as 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 gout.
• 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 occurs due to 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 long-lasting inflammatory joint disease. It causes pain, stiffness, swelling, and increased loss of joint mobility. It may also cause inflammation in other parts of the body.
What is gout?
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Gout is a disease characterized by sudden, recurring attacks of very painful inflammation and redness in and around 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, 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 function impairment;
• if the patient has severe kidney function impairment;
• in pregnant women or 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) or angina pectoris (chest pain);
• if the patient has had a heart attack, coronary artery bypass surgery, 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, 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 gastrointestinal 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 individuals have an increased risk of heart disease;
• in women planning pregnancy;

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• in individuals over 65 years of age.

If in doubt whether any of the above conditions apply, consult a doctor before using Roticox to determine whether the medicine can be used.

Roticox is equally effective in elderly patients and in younger adult patients. For patients over 65 years of age, the doctor may recommend 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 with other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription.

If any of the following medicines are being used, the doctor may decide that monitoring is necessary to ensure safe and effective 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 currently being treated with 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. A woman who is pregnant, may be pregnant, or planning pregnancy must not use this medicine. If pregnancy occurs, stop taking the medicine and contact a doctor. If in doubt or if further 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.

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 vehicle if dizziness or drowsiness occurs.

Do not operate machinery or use tools if dizziness or drowsiness occurs.

Roticox contains sodium

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

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3. How to use Roticox

This medicine should always be used as directed by a physician.
If in doubt, consult a doctor or pharmacist.
Do not take higher doses than those recommended for individual conditions. Treatment should be reviewed periodically with a 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 this medicine increases the risk of heart attacks and strokes, particularly at higher doses.
Different strengths of this medicine are available, and depending on the condition being treated, the doctor will prescribe the appropriate strength for the patient.

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, 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 should be used only during episodes of acute pain, for a maximum of 8 days of treatment.
Pain following dental surgery
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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 should 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 food or independently of meals.
Overdose of Roticox
Never take more tablets than prescribed by a doctor. If an excessive amount of Roticox has been taken, seek immediate medical help.
Missed dose of Roticox
Roticox should be taken as directed by a physician. If a dose is missed, resume the usual dosing schedule the next day. Do not take a double dose to make up for a missed dose.
If there are any further questions regarding the use of this medicine, consult a 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 development of swelling around the ankles, or worsening of existing swelling;
• Yellowing of the skin and 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 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;

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• 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, weight gain;
• Anxiety, depression, reduced mental performance; seeing, feeling or hearing something that does not exist (hallucinations);
• Taste disturbances, insomnia, numbness or tingling, drowsiness;
• Blurred vision, eye irritation and redness;
• Tinnitus, dizziness (sensation of spinning while 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;
• Cough, breathlessness, nosebleeds;
• Bloating, change in bowel habits, dryness of the oral mucosa, peptic ulcer, inflammation of the gastric mucosa 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 fewer than 1 in 1,000 people):

• Angioedema (an allergic reaction characterized by swelling of the face, lips, tongue and (or) throat, which may cause difficulty breathing or swallowing, which may be severe enough to require immediate medical intervention); 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 not listed
in this leaflet, inform your doctor, pharmacist or nurse. 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
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Roticox

Keep this medicine out of the sight and reach of children.
No special storage instructions apply.
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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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, and anhydrous colloidal silica in the tablet core; 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
Round, slightly brownish-yellow, biconvex tablets with bevelled edges (8 mm in diameter),
with the inscription "60" embossed on one side.
Pack sizes:
7, 14, 28, 56, 84 or 98 coated tablets in OPA/Aluminium/PVC/Aluminium blisters,
packaged in a cardboard carton.
For more detailed information, please contact the responsible party 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged by:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation number in Ireland, the country of export: PA1347/064/002
Parallel Import Authorisation number: 386/19
This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
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