Package leaflet: 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
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, 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

What Coxitex is and what it is used for
Important information before taking Coxitex
How to take Coxitex
Possible side effects
How to store Coxitex
Contents of the pack and other information

1. What Coxitex is and what it is used for

What is Coxitex?

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

What is Coxitex used for?

Coxitex helps reduce pain and swelling (inflammation) in joints and muscles in people aged 16 years and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gouty arthritis.
Coxitex 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 results from the gradual breakdown of cartilage that lines the ends of bones. This leads to swelling (inflammation), pain, tenderness, stiffness, and reduced mobility.
What is rheumatoid arthritis?
Rheumatoid arthritis is a chronic inflammatory disease affecting the joints. It causes pain, stiffness, swelling, and limits mobility of 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 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, or selective cyclooxygenase-2 (COX-2) inhibitors (see section 4. Possible side effects);
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, women who may be pregnant, or breastfeeding women (see subsection "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 (in case of doubt, consult a doctor or nurse to have blood pressure checked);
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 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 ischemic attack TIA). Etoricoxib may slightly increase the risk of heart attack and stroke, and therefore should not be used in individuals with a history of 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 Coxitex, discuss with your doctor or pharmacist:

if the patient has previously experienced stomach bleeding or gastric ulcer;
if the patient is dehydrated, for example due to prolonged recurrent vomiting or diarrhea;
if the patient has fluid retention leading to swelling;
if the patient has previously had heart failure or other heart disease;
if the patient has previously had high blood pressure. Coxitex may increase blood pressure in some individuals, especially when high doses are used; therefore, the doctor will 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. Coxitex may mask fever, which is a symptom of infection;
in patients with diabetes, high cholesterol levels, or who smoke. These patients have an increased risk of heart disease;
in women planning pregnancy;
in individuals over 65 years of age.

If in doubt whether any of the above conditions apply, you must consult a doctor before taking Coxitex to determine whether the medicine can be used.
Coxitex is equally effective in elderly patients and 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 patients over 65 years of age.
Children and adolescents
This medicine must not be given to children and adolescents under 16 years of age.
Coxitex and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take, including those available without 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 Coxitex:

blood-thinning medicines (anticoagulants), such as warfarin;
rifampicin (an antibiotic);
methotrexate (a medicine that suppresses immune system function, often used in the treatment of rheumatoid arthritis);
cyclosporine or tacrolimus (immunosuppressive medicines);
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 Coxitex is taken together with acetylsalicylic acid;
acetylsalicylic acid used for prevention of heart attack or stroke: Coxitex may be taken together with low-dose acetylsalicylic acid. If you are currently taking low-dose acetylsalicylic acid to prevent heart attack or stroke, do not stop taking it without consulting your doctor;
acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs): do not use high doses of acetylsalicylic acid or other anti-inflammatory medicines 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 must not be used during pregnancy. Women who are pregnant, may be pregnant, or planning pregnancy must not take this medicine. If pregnancy occurs, discontinue the medicine and contact your doctor. In case of doubt or need for further information, consult your doctor.
Breastfeeding
It is not known whether Coxitex is excreted in breast milk. If you are breastfeeding or planning to breastfeed, consult your doctor before taking Coxitex. Breastfeeding is not allowed while taking Coxitex.
Fertility
Use of Coxitex is not recommended in women planning pregnancy.
Driving and using machines
Dizziness and drowsiness have been reported in some patients taking this medicine.
Do not drive a vehicle if dizziness or drowsiness occurs.
Do not operate any machinery or use tools if dizziness or drowsiness occurs.
Coxitex contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".
3. How to take Coxitex
This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Do not take higher doses than recommended for specific conditions. Periodically consult your doctor to monitor treatment. It is important to use the lowest effective dose providing pain relief and not to use Coxitex longer than necessary. The risk of heart attack and stroke increases with prolonged use, especially at high doses.
Different strengths of this medicine are available, and depending on the condition, your doctor will prescribe the appropriate strength for you.
Recommended dose
Osteoarthritis
The recommended dose is 30 mg once daily, increased if necessary up to a maximum of 60 mg once daily.
Rheumatoid arthritis
The recommended dose is 60 mg once daily, increased if necessary up to a maximum of 90 mg once daily.
Ankylosing spondylitis
The recommended dose is 60 mg once daily, increased if necessary up to a maximum of 90 mg once daily.
Acute pain episodes
Etoricoxib should be used only during episodes of acute pain symptoms.
Gout
The recommended dose is 120 mg once daily; this should be used only during acute pain episodes, for a maximum of 8 days.
Pain after dental surgery
The recommended dose is 90 mg once daily; treatment with this dose may last up to 3 days maximum.
Patients with liver function impairment

In patients with mild liver function impairment, doses higher than 60 mg once daily must not be used.
In patients with moderate liver function impairment, doses higher than 30 mg per day must not be used.

Use in children and adolescents
Coxitex must not be used in children and adolescents under 16 years of age.
Elderly patients
Dose adjustment is not required in elderly patients. As with other medicines, caution should be exercised in elderly patients.
Method of administration
Coxitex is for oral use. Tablets should be taken once daily.
Coxitex can be taken with or without food.
Taking more Coxitex than recommended
Never take more tablets than prescribed by your doctor. If you have taken too much Coxitex, seek immediate medical help.
Missing a dose of Coxitex
Take Coxitex as prescribed by your doctor. If you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
If you have any further questions about using 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 Coxitex immediately
and contact your doctor without delay (see section 2. Important information before
using Coxitex):

Shortness of breath, chest pain, or development of swelling around the ankles, or worsening of existing swelling;
Yellowing of the skin or eyes (jaundice) – signs of abnormal liver function;
Severe or persistent stomach pain, or appearance of black stools;
Hypersensitivity reactions, which may present as skin problems such as ulcers, blisters, or swelling of the face, lips, tongue, or throat, possibly causing difficulty in breathing.

The frequency of possible adverse reactions is classified as follows:
Very common: occurs in more than 1 in 10 patients
Common: occurs in less than 1 in 10 patients
Uncommon: occurs in less than 1 in 100 patients
Rare: occurs in less than 1 in 1,000 patients
Very rare: occurs in less than 1 in 10,000 patients

The following adverse reactions may occur during treatment with Coxitex:
Very common:

Stomach pain.

Common:

Dry socket (inflammation and pain following 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 liver function blood tests;
Bruising;
Weakness and fatigue, flu-like symptoms.

Uncommon:

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 number of platelets);
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 or hearing things that are not real (hallucinations);
Taste disturbances, insomnia, numbness or tingling, drowsiness;
Blurred vision, eye irritation and redness;
Tinnitus, vertigo (sensation of spinning at rest);
Heart rhythm disorders (atrial fibrillation), rapid heartbeat, heart failure, sensation of tightness, pressure or heaviness in the chest (angina), heart attack;
Hot flushes, stroke, mini-stroke (transient ischaemic attack), severe increase in blood pressure, vasculitis;
Cough, breathlessness, nosebleeds;
Abdominal distension, change in bowel habits, dryness of the oral mucosa, peptic ulcer, gastritis 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:

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 intervention); anaphylactic or anaphylactoid reactions, including shock (a serious allergic reaction requiring immediate medical intervention);
Disorientation, restlessness;
Liver problems (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 or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Coxitex

Keep this medicine 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 stated month.
The marking 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 requirements regarding storage temperature. Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Coxitex contains

The active substance is etoricoxib. Each coated tablet contains 30 mg, 60 mg, 90 mg, or 120 mg of etoricoxib, respectively.
The other ingredients are:
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate.
Tablet coating: Coxitex 30 mg, 60 mg, 120 mg: polyvinyl alcohol, titanium dioxide (E 171), glycerol monostearate, indigo carmine aluminium lake (E 132), yellow iron oxide (E 172), talc, sodium lauryl sulphate.
Coxitex 90 mg: polyvinyl alcohol, titanium dioxide (E 171), glycerol monostearate, talc, sodium lauryl sulphate.

What Coxitex looks like and contents of the pack
Coxitex tablets are available in four strengths:
30 mg: bluish-green coated tablets, shaped like an apple cross-section,
biconvex, with the engraved mark '30' on one side and smooth on the other,
measuring 5.8 x 5.9 mm ± 7.5%.
60 mg: dark green coated tablets, shaped like an apple cross-section, biconvex,
with the engraved mark '60' on one side and smooth on the other, measuring 7.1 x 7.3 mm ± 7.5%.
90 mg: white coated tablets, shaped like an apple cross-section, biconvex,
with the engraved mark '90' on one side and smooth on the other, measuring 8.1 x 8.3 mm ± 7.5%.
120 mg: light green coated tablets, shaped like an apple cross-section, biconvex,
with the engraved mark '120' on one side and smooth on the other, measuring 8.9 x 9.2 mm ± 7.5%.
Unit-dose aluminium-aluminium blisters in a cardboard box.
The pack contains 7 or 28 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

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