Coxydyna

Package leaflet: Information for the user

Coxydyna, 30 mg, coated tablets
Coxydyna, 60 mg, coated tablets
Coxydyna, 90 mg, coated tablets
Coxydyna, 120 mg, coated tablets
Etoricoxib
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any 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 someone else, even if their symptoms are similar.
• 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 Coxydyna is and what it is used for
2. Important information before taking Coxydyna
3. How to take Coxydyna
4. Possible side effects
5. How to store Coxydyna
6. Contents of the pack and other information

1. What Coxydyna is and what it is used for

What is Coxydyna?

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

What is Coxydyna used for?

• Coxydyna 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.
• Coxydyna 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 gradual breakdown of the cartilage lining the ends of bones. This leads to swelling (inflammation), pain, tenderness, stiffness, and impaired function.
What is rheumatoid arthritis?
Rheumatoid arthritis is a chronic inflammatory joint disease. It causes pain, stiffness, swelling, and reduced 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 joint inflammation and redness. This condition is caused by the deposition of crystalline 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 Coxydyna

When not to take Coxydyna:

• 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 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
• if the patient is pregnant or suspects she may be pregnant, or is breastfeeding (see "Pregnancy, breastfeeding and fertility")
• if the patient is 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) or angina (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 patients 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 Coxydyna, discuss the following 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 or recurring 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. Coxydyna may increase blood pressure in some people, especially when high doses are used; therefore, your 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. Coxydyna 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 patients aged 65 years or older.

If in doubt whether any of the above situations apply, you must consult a doctor before taking Coxydyna to determine whether the medicine can be used.
Coxydyna is equally effective in elderly patients and younger adult patients. In patients aged 65 years or older, the doctor may recommend more frequent follow-up visits. Dose adjustment is not necessary in patients aged 65 years or older.
Children and adolescents
Do not give this medicine to children and adolescents under 16 years of age.
Coxydyna and 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 taken, the doctor may decide that monitoring is necessary to ensure safe treatment after starting Coxydyna:

• anticoagulants (blood thinners), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (an immunosuppressive medicine, 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 (water pills)
• 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 (combination may increase the risk of side effects)
• hormone replacement therapy (combination may increase the risk of side effects)
• acetylsalicylic acid; the risk of gastric ulcers is higher when Coxydyna is taken together with acetylsalicylic acid
  • acetylsalicylic acid used for prevention of heart attack or stroke: Coxydyna 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 doses of acetylsalicylic acid or other anti-inflammatory medicines while taking Coxydyna.

Coxydyna with food and drink
The effect may start faster if Coxydyna is taken on an empty stomach.
Pregnancy, breastfeeding and fertility
Pregnancy
Coxydyna must not be used during pregnancy. Women who are pregnant, may be pregnant, or are planning pregnancy must not take this medicine. If pregnancy occurs, discontinue the medicine and contact a doctor. In case of doubt or need for further information, consult a doctor.
Breastfeeding
It is not known whether Coxydyna is excreted in breast milk. If breastfeeding or planning to breastfeed, consult a doctor before taking Coxydyna. Breastfeeding is not allowed while taking Coxydyna.
Effect on fertility
Coxydyna is not recommended for women planning pregnancy.
Driving and operating machinery
Dizziness and drowsiness have been reported in some patients taking this medicine.
Do not drive if dizziness or drowsiness occurs.
Do not operate any machinery or tools if dizziness or drowsiness occurs.

3. How to take Coxydyna
This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult the doctor or pharmacist.
Do not take higher doses than recommended for specific conditions. Treatment should be reviewed periodically with the doctor. It is important to use the lowest effective dose for pain relief and not to use Coxydyna 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, the doctor will prescribe the appropriate strength for the patient.
Recommended dose:
Osteoarthritis
Recommended dose is 30 mg once daily, increased if necessary up to a maximum of 60 mg once daily.
Rheumatoid arthritis
Recommended dose is 60 mg once daily, increased if necessary up to a maximum of 90 mg once daily.
Ankylosing spondylitis
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.
Gout
Recommended dose is 120 mg once daily; this should be used only during episodes of acute pain, for a maximum of 8 days.
Pain after dental surgery
Recommended dose is 90 mg once daily; treatment with this dose may last up to 3 days.
Patients with liver function impairment

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

Use in children and adolescents
Coxydyna must not be used in children and adolescents under 16 years of age.
Elderly patients
Dose adjustment is not necessary in elderly patients. As with other medicines, caution should be exercised in elderly patients.
Method of administration
Coxydyna is intended for oral use. Tablets should be taken once daily.
Coxydyna can be taken with or without food.
Overdose
Never take more tablets than prescribed by the doctor. If an overdose of Coxydyna is taken, seek medical help immediately.
Missed dose
Coxydyna should be taken as prescribed by the doctor. 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 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, discontinue Coxydyna and
contact your doctor immediately (see section 2, "Important information before taking
Coxydyna"):

• 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 impaired liver function
• severe or persistent stomach pain, or appearance of black stools
• hypersensitivity reactions, which may manifest as skin problems such as ulcers, blisters, or swelling of the face, lips, tongue, or throat, which may cause difficulty in

breathing.
The frequency of possible adverse reactions is classified as follows:
Very common (affects more than 1 in 10 people)
Common (affects 1 to 10 in 100 people)
Uncommon (affects 1 to 10 in 1,000 people)
Rare (affects 1 to 10 in 10,000 people)
Very rare (affects less than 1 in 10,000 people)

The following adverse reactions may occur during treatment with Coxydyna:
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 (edema)
• dizziness, headache
• palpitations (fast or irregular heartbeat), irregular heart rhythm (arrhythmia)
• increased blood pressure
• wheezing or shortness of breath (bronchospasm)
• constipation, gas (excess intestinal gas), gastritis (inflammation of the stomach lining), heartburn, diarrhea, indigestion (dyspepsia) and/or discomfort in the stomach, nausea, vomiting, esophagitis, oral ulceration
• changes in blood test results related to the liver
• 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, dizziness (spinning sensation 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 ischemic attack), severe increase in blood pressure, vasculitis
• cough, breathlessness, nosebleeds
• bloating, change in bowel habits, dryness of the oral mucosa, gastric ulcer disease, 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/spasms, 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 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Coxydyna

Keep this medicine out of the 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.
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. Such measures help protect the environment.

6. Contents of the pack and other information

What Coxydyna contains

• The active substance is etoricoxib. Each coated tablet contains 30 mg of etoricoxib. Each coated tablet contains 60 mg of etoricoxib. Each coated tablet contains 90 mg of etoricoxib. Each coated tablet contains 120 mg of etoricoxib.
• Other ingredients are:
  Tablet core: microcrystalline cellulose (E 460), calcium hydrogen phosphate (anhydrous),
  sodium croscarmellose, magnesium stearate (E 470b).
  Tablet coating: polyvinyl alcohol (E 1203), titanium dioxide (E 171), glycerol monostearate (E 471), indigo carmine (E 132), aluminium lake of indigo carmine [only for 30 mg, 60 mg and 120 mg], yellow iron oxide (E 172) [only for 30 mg, 60 mg and 120 mg], talc (E 553b), sodium lauryl sulfate.

What Coxydyna looks like and contents of the pack
Coated tablets.

Coxydyna 30 mg, coated tablets
Blue-green, biconvex, film-coated tablet in the shape of an apple, with the imprint "30" on one side and smooth on the other, measuring 5.8 x 5.9 mm ± 7.5%.

Coxydyna 60 mg, coated tablets
Dark green, biconvex, film-coated tablet in the shape of an apple, with the imprint "60" on one side and smooth on the other, measuring 7.1 x 7.3 mm ± 7.5%.

Coxydyna 90 mg, coated tablets
White, biconvex, film-coated tablet in the shape of an apple, with the imprint "90" on one side and smooth on the other, measuring 8.1 x 8.3 mm ± 7.5%.

Coxydyna 120 mg, coated tablets
Light green, biconvex, film-coated tablet in the shape of an apple, with the imprint "120" on one side and smooth on the other, measuring 8.9 x 9.2 mm ± 7.5%.

Coxydyna coated tablets are supplied in blisters containing 7, 14, 20, 28, 30, 50, 98 and 100 coated tablets, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
e-mail: [email protected]

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

For 30 mg, 60 mg and 90 mg doses:
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium: Etoricoxib AB 30 mg/60 mg/90 mg/120 mg film-coated tablets
Germany: Etoricoxib PUREN 30 mg/60 mg/90 mg/120 mg Filmtabletten
France: Etoricoxib Arrow 30 mg/60 mg film-coated tablets
Netherlands: Etoricoxib Aurobindo 30 mg/60 mg/90 mg/120 mg, filmomhulde tabletten
Poland: Coxydyna
Portugal: Etoricoxib Generis
Romania: Etoricoxib Aurobindo 30 mg/60 mg/90 mg/120 mg comprimate filmate
Spain: Etoricoxib Aurobindo 30 mg/60 mg/90 mg/120 mg comprimidos recubiertos con película EFG