Coxitex

Leaflet accompanying the packaging: information for the user

Coxitex, 30 mg, coated tablets

Coxitex, 60 mg, coated tablets

Coxitex, 90 mg, coated tablets

Coxitex, 120 mg, coated tablets

Etoricoxib

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• 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 inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Coxitex and what is it used for
• 2. Important information before taking Coxitex
• 3. How to take Coxitex
• 4. Possible side effects
• 5. How to store Coxitex
• 6. Contents of the packaging and other information

1. What is Coxitex and what is it used for

What is Coxitex?

• Coxitex contains the active substance etoricoxib. Coxitex is a medicine belonging to the group of selective cyclooxygenase 2 (COX-2) inhibitors. It belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs).

What is Coxitex used for?

• Coxitex helps reduce pain and swelling (inflammation) of the joints and muscles in people aged 16 and over with osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and gout.
• Coxitex 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 affecting the joints. It occurs due to 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 limited mobility of the affected joints. 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 of the joints. 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 Coxitex

When not to take Coxitex:

• 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 nonsteroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid and selective cyclooxygenase 2 (COX-2) inhibitors (see section 4. Possible side effects);
• if the patient has active gastric or intestinal ulcers, or 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 subsection "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 (in case of doubt, consult a doctor or nurse to check blood pressure);
• if the patient has ever been diagnosed with heart disorders, including heart failure (moderate or severe) or angina pectoris (chest pain);
• if the patient has had a heart attack, undergone bypass surgery, 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 any of the above situations, before taking the tablets, consult a doctor.

Warnings and precautions

Before starting to take Coxitex, discuss it with a doctor or pharmacist:

• if the patient has a history of stomach ulcers or gastric 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. Coxitex 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. Coxitex may mask fever, which is a symptom of infection;
• in case of patients with diabetes, high cholesterol, or smokers. These patients are at increased risk of heart disease;
• in case of women planning pregnancy;
• in case of people over 65 years of age.

In case of doubt whether any of the above situations occur, consult a doctor before taking Coxitexto clarify whether the medicine can be used.
Coxitex 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 patients over 65 years of age.

Children and adolescents

This medicine should not be given to children and adolescents under 16 years of age.

Coxitex and other medicines

Tell the 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 using one of the following medicines, the doctor may decide to monitor the patient to ensure that the treatment is proceeding correctly from the start of using Coxitex:

• blood thinners (anticoagulants), such as warfarin;
• rifampicin (an antibiotic);
• methotrexate (an immunosuppressant, often used to treat rheumatoid arthritis);
• cyclosporine or tacrolimus (immunosuppressants);
• 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 using Coxitex with acetylsalicylic acid;
• acetylsalicylic acid used for the prevention of heart attacks or strokes: Coxitex can be taken at the same time as 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 a doctor;
• acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs): high dosesof acetylsalicylic acid or other anti-inflammatory drugs should not be used while taking Coxitex.

Coxitex with food and drink

The effect of the medicine may start faster if Coxitex is taken on an empty stomach.

Pregnancy, breastfeeding, and fertility

Pregnancy
Coxitex should not be used in pregnant women. A pregnant woman or a woman who may be pregnant or is planning to become pregnant should not use this medicine. If pregnancy occurs, the medicine should be stopped and a doctor consulted. In case of doubt or need for additional information, consult a doctor.
Breastfeeding
It is not known whether Coxitex is excreted in breast milk. If breastfeeding or planning to breastfeed, consult a doctor before taking Coxitex. If taking Coxitex, breastfeeding should not be done.
Fertility
Coxitex is not recommended for use in women planning to become pregnant.

Driving and using machines

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

Coxitex 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 Coxitex

This medicine should always be used as directed by the doctor. In case of doubt, consult a doctor or pharmacist.
Do not take higher doses than recommended for individual diseases. From time to time, consult a doctor to monitor the treatment. It is important to use the smallest effective dose that relieves pain and not to use Coxitex for longer than necessary. There is an increased risk of heart attacks and strokes after prolonged use of the medicine, especially in high doses.
There are different strengths of this medicine, and depending on the disease, the doctor will prescribe tablets of the appropriate strength for the patient.
Recommended dose
Osteoarthritis
The recommended dose is 30 mg once daily, increased to a maximum of 60 mg once daily if necessary.
Rheumatoid arthritis
The recommended dose is 60 mg once daily, increased to a maximum of 90 mg once daily if necessary.
Ankylosing spondylitis.
The recommended dose is 60 mg once daily, increased to a maximum of 90 mg once daily if necessary.
Acute pain
Etoricoxib should only be used during episodes of acute pain symptoms.
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.
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 moderateliver dysfunction, the dose should not exceed 30 mg per day.

Use in children and adolescents

Coxitex 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
Coxitex is intended for oral use. The tablets should be taken once daily.
Coxitex can be taken with or without food.

Taking a higher dose of Coxitex than recommended

Never take more tablets than the doctor has prescribed. If too many Coxitex tablets have been taken, seek medical help immediately.

Missing a dose of Coxitex

Coxitex should be taken as directed 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 the missed dose.
In case of any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

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

• shortness of breath, chest pain, or swelling of the ankles or feet, 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 cause skin problems such as ulcers, blisters, or swelling of the face, lips, tongue, or throat, which can cause difficulty breathing.

The frequency of possible side effects is classified as follows:
Very common:
occurring in more than 1 in 10 patients
Common:
occurring in less than 1 in 10 patients
Uncommon:
occurring in less than 1 in 100 patients
Rare:
occurring in less than 1 in 1,000 patients
Very rare:
occurring in less than 1 in 10,000 patients
The following side effects may occur during treatment with Coxitex:

Very common:

• stomach pain.

Common:

• 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);
• increased blood pressure;
• wheezing or 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 blood test results;
• bruising;
• weakness and fatigue, flu-like symptoms.

Uncommon:

• gastritis and enteritis (inflammation of the digestive tract, which includes both the stomach and the 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);
• 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; 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), severe increase in blood pressure, vasculitis;
• cough, shortness of breath, nosebleeds;
• bloating, change in bowel movements, dry mouth, gastric 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 blood or urine test results related to the kidneys, severe kidney dysfunction;
• chest pain.

Rare:

• 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 problems (hepatitis);
• low sodium levels in the blood;
• liver failure, yellowing of the skin and eyes (jaundice);
• severe skin reactions.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, inform a doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 the medicine.

5. How to store Coxitex

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT indicates the batch number.
There are no special precautions for storing the medicine at a certain temperature. Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Coxitex contains

• The active substance of Coxitex is etoricoxib. Each coated tablet contains 30 mg, 60 mg, 90 mg, or 120 mg of etoricoxib.
• Other ingredients are:
• Core of the tablet: microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate.
• Coating of the tablet: Coxitex 30 mg, 60 mg, 120 mg:polyvinyl alcohol, titanium dioxide (E 171), glycerol monostearate, aluminum lake of indigo carmine (E 132), yellow iron oxide (E 172), talc, sodium lauryl sulfate. Coxitex 90 mg:polyvinyl alcohol, titanium dioxide (E 171), glycerol monostearate, talc, sodium lauryl sulfate.

What Coxitex looks like and contents of the packaging

Coxitex is available in four strengths:
30 mg: blue-green coated tablets, apple-shaped, biconvex, with the inscription '30' on one side and smooth on the other, 5.8 x 5.9 mm ± 7.5% in size.
60 mg: dark green coated tablets, apple-shaped, biconvex, with the inscription '60' on one side and smooth on the other, 7.1 x 7.3 mm ± 7.5% in size.
90 mg: white coated tablets, apple-shaped, biconvex, with the inscription '90' on one side and smooth on the other, 8.1 x 8.3 mm ± 7.5% in size.
120 mg: light green coated tablets, apple-shaped, biconvex, with the inscription '120' on one side and smooth on the other, 8.9 x 9.2 mm ± 7.5% in size.
Aluminum-Aluminum single-dose blisters in a cardboard box.
The packaging contains 7 or 28 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Pharmaceutical Works POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Rontis Hellas S.A., Medical and Pharmaceutical Products
P.O. Box 3012 Larisa Industrial Area
Larisa, 41004
Greece

Date of last revision of the leaflet: