Coxidina

Leaflet accompanying the packaging: 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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Coxydyna and what is it 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 packaging and other information

1. What is Coxydyna and what is it used for

What is Coxydyna?

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

What is Coxydyna used for?

• Coxydyna helps to reduce pain and swelling (inflammatory conditions) of the joints and muscles in people aged 16 and over with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.
• Coxydyna is also a medicine used for the short-term treatment of moderate pain associated with surgical dental procedures in people aged 16 and over.

What is osteoarthritis?

Osteoarthritis is a disease that affects the joints. It occurs as a result of 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 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 and 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 dysfunction
• if the patient has severe kidney dysfunction
• if the patient is pregnant or thinks 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 intestinal inflammation
• if the patient has uncontrolled high blood pressure (if in doubt, the patient should consult a doctor or nurse to check blood pressure)
• if the patient has ever been diagnosed by a doctor with heart problems, including moderate or severe heart failure or angina pectoris (chest pain)
• if the patient has had a heart attack, undergone a bypass grafting procedure, 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 transient ischaemic attack, TIA). Etoricoxib may slightly increase the risk of heart attack and stroke, and therefore should not be used in patients with heart or stroke problems.

In the event of any of the above situations, the patient should consult a doctor before taking the tablets.

Warnings and precautions

Before starting to take Coxydyna, the patient should discuss it with their doctor or pharmacist:

• If the patient has a history of stomach bleeding or stomach 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. Coxydyna 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. Coxydyna may mask fever, which is a sign of infection.
• In the case of patients with diabetes, high cholesterol, or smokers. These patients are at increased risk of heart disease.
• In the case of women planning to become pregnant.
• In the case of patients over 65 years of age.

In case of doubt as to whether any of the above situations apply, the patient should
consult a doctor before taking Coxydynato clarify whether the medicine can be taken.
Coxydyna is equally effective in both elderly and younger adult patients. In the case of patients over 65 years of age, the doctor may decide on more frequent check-ups. No dose adjustment is necessary for patients over 65 years of age.

Children and adolescents

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

Coxydyna and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, or have recently taken, and about any medicines they plan to take, including those obtained without a prescription.
In the case of taking 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 taking Coxydyna:

• blood-thinning medicines (anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a medicine that suppresses the immune system, often used to treat rheumatoid arthritis)
• cyclosporin 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, called ACE inhibitors and angiotensin receptor blockers, such as enalapril and ramipril, and losartan and valsartan
• diuretics (water tablets)
• digoxin (a medicine used to treat heart failure and irregular heart rhythm)
• minoxidil (a medicine used to treat high blood pressure)
• salbutamol in tablet or oral solution form (a medicine used to treat 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 taking Coxydyna with acetylsalicylic acid
• acetylsalicylic acid used for the prevention of heart attacks or strokes: Coxydyna 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 a heart attack or stroke, they should not stop taking acetylsalicylic acid without consulting a doctor;
• acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs): high dosesof acetylsalicylic acid or other

anti-inflammatory medicines should not be taken while taking Coxydyna.

Coxydyna with food and drink

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

Pregnancy, breastfeeding, and fertility

Pregnancy
Coxydyna should not be taken by pregnant women. A pregnant woman or a woman who may be pregnant or is planning to become pregnant should not take this medicine. If the patient becomes pregnant, they should stop taking the medicine and contact their doctor. If in doubt or if additional information is needed, the patient should contact their doctor.
Breastfeeding
It is not known whether Coxydyna is excreted in breast milk. If the patient is breastfeeding or planning to breastfeed, they should consult their doctor before taking Coxydyna. If the patient is taking Coxydyna, they should not breastfeed.
Fertility
It is not recommended to take Coxydyna in women planning to become pregnant.

Driving and using machines

Some patients taking this medicine have experienced dizziness and drowsiness.
The patient should not drive vehicles or operate machinery if they experience dizziness and drowsiness.
The patient should not operate any mechanical equipment or use tools if they experience dizziness and drowsiness.

3. How to take Coxydyna

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, the patient should consult their doctor or pharmacist.
The patient should not take higher doses than recommended for individual diseases. The patient should consult their doctor from time to time to monitor the treatment. It is important to use the smallest effective dose that provides pain relief and not to take Coxydyna 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.
The recommended dose is:
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 conditions
Etoricoxib should only be used during periods of acute pain symptoms.
Gout
The recommended dose is 120 mg once daily; it should only be used during periods 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 daily.

Use in children and adolescents

Coxydyna should not be taken by children and adolescents under 16 years of age.

Patients over 65 years of age

No dose adjustment is necessary for patients over 65 years of age. As with other medicines, caution should be exercised in patients over 65 years of age.
Method of administration
Coxydyna is intended for oral use. The tablets should be taken once daily.
Coxydyna can be taken with or without food.

Taking a higher dose of Coxydyna than recommended

The patient should never take more tablets than prescribed by the doctor. If the patient takes too many Coxydyna tablets, they should seek medical help immediately.

Missing a dose of Coxydyna

Coxydyna should be taken as prescribed by the doctor. If a dose is missed, the patient should return to their usual dosing schedule the next day. The patient should not take a double dose to make up for a missed dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

If any of the following symptoms occur, the patient should stop taking Coxydyna and contact their doctor immediately (see section 2, "Important information before taking Coxydyna"):

• shortness of breath, chest pain, or swelling of the ankles, 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 (affects more than 1 in 10 patients)
Common (affects 1 to 10 in 100 patients)
Uncommon (affects 1 to 10 in 1,000 patients)
Rare (affects 1 to 10 in 10,000 patients)
Very rare (affects less than 1 in 10,000 patients)
The following side effects may occur during treatment with Coxydyna:
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 (fast or irregular heartbeat), irregular heart rhythm (arrhythmia)
• increased blood pressure
• wheezing or shortness of breath (bronchospasm)
• constipation, gas (excess gas in the intestines), stomach upset (gastritis), heartburn, diarrhea, indigestion (dyspepsia), and (or) discomfort in the stomach, nausea, vomiting, esophagitis, mouth ulcers
• changes in liver function test results
• bruising
• weakness and fatigue, flu-like symptoms

Uncommon

• gastrointestinal upset and inflammation (gastroenteritis, which affects both the stomach and the small and (or) large intestine), 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; seeing or hearing things that do not exist (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), fast heartbeat, heart failure, feeling of tension, feeling of pressure or heaviness in the chest (angina pectoris), heart attack
• hot flashes, stroke, transient ischaemic attack (TIA), severe high blood pressure, vasculitis
• cough, shortness of breath, nosebleeds
• bloating, change in bowel movements, dry mouth, stomach ulcers, stomach inflammation, which can be severe and lead to bleeding, irritable bowel syndrome, pancreatitis
• facial swelling, rash, or itching, redness of the skin
• muscle cramps/spasms, muscle pain or stiffness
• high potassium levels in the blood, changes in blood or urine test results related to kidney function, 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 disease (hepatitis)
• low sodium levels in the blood
• liver failure, yellowing of the skin and eyes (jaundice)
• severe skin reactions

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 side effects, more information can be gathered on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Coxydyna

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the month stated.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Coxydyna contains

• The active substance of Coxydyna 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),

croscarmellose sodium, magnesium stearate (E 470b).
Tablet coating:polyvinyl alcohol (E 1203), titanium dioxide (E 171), glycerol monostearate (E 471), indigo carmine (E 132), aluminum lake [only for 30 mg, 60 mg, and 120 mg], yellow iron oxide (E 172) [only 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, coated tablet in the shape of an apple, with the inscription "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, coated tablet in the shape of an apple, with the inscription "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, coated tablet in the shape of an apple, with the inscription "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, coated tablet in the shape of an apple, with the inscription "120" on one side and smooth on the other, measuring 8.9 x 9.2 mm ± 7.5%.
Coxydyna coated tablets are available in blisters containing 7, 14, 20, 28, 30, 50, 98, and 100 coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
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 medicine is authorized 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 film-coated tablets
France
Etoricoxib Arrow 30 mg/60 mg film-coated tablets
Netherlands
Etoricoxib Aurobindo 30 mg/60 mg/90 mg/120 mg film-coated tablets
Poland
Coxydyna
Portugal
Etoricoxib Generis
Romania
Etoricoxib Aurobindo 30 mg/60 mg/90 mg/120 mg film-coated tablets
Spain
Etoricoxib Aurobindo 30 mg/60 mg/90 mg/120 mg film-coated tablets EFG

Date of last revision of the leaflet: 04/2023