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:

In the event of any of the above situations, you should consult your doctor before taking the tablets.

Warnings and precautions

Before starting to take Coxydyna, you should discuss it with your doctor or pharmacist:

In case of doubt as to whether any of the above situations apply, you should consult your doctor before taking Coxydynato clarify whether the medicine can be taken.
Coxydyna 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 for patients over 65 years of age.

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 you are taking now or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
In the case of taking one of the following medicines, your doctor may decide to monitor you to ensure that the treatment is going well from the start of taking Coxydyna:

• blood thinners (anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (an immunosuppressive drug, often used to treat rheumatoid arthritis)
• cyclosporine or tacrolimus (immunosuppressive drugs)
• 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 (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 (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 with a low dose of acetylsalicylic acid. If you are currently taking low dosesof acetylsalicylic acid to prevent heart attacks or strokes, do not stop taking acetylsalicylic acid without consulting your doctor;
• acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs): do not take high dosesof acetylsalicylic acid or other anti-inflammatory drugs

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 you become pregnant, stop taking the medicine and contact your doctor. If you have any doubts or need further information, consult your doctor.
Breastfeeding
It is not known whether Coxydyna is excreted in breast milk. If you are breastfeeding or planning to breastfeed, consult your doctor before taking Coxydyna. If you are taking Coxydyna, do 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 reported dizziness and drowsiness. Do not drive vehicles, if you experience dizziness and drowsiness.
Do not operate any machinery or use tools, if you experience dizziness and drowsiness.

3. How to take Coxydyna

This medicine should always be taken as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Do not take higher doses than recommended for individual diseases. From time to time, you should consult your doctor 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 with prolonged use of the medicine, especially in high doses.
There are different strengths of this medicine, and depending on the disease, your doctor will prescribe tablets of the appropriate strength for you.
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 episodes of acute pain.
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 daily.

Use in children and adolescents

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

Elderly patients

No dose adjustment is necessary for elderly patients. As with other medicines, elderly patients should be cautious.
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

Never take more tablets than your doctor has prescribed. If you have taken too many Coxydyna tablets, seek medical attention immediately.

Missing a dose of Coxydyna

Coxydyna should be taken as directed by your doctor. If you miss a dose, the next day you should return to your usual dosing schedule. Do not take a double dose to make up for the missed dose.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following symptoms, stop taking Coxydyna and contact your 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 manifest as skin problems such as ulcers, blisters, or swelling of the face, lips, tongue, or throat, which can cause difficulty breathing

Frequency of possible side effects 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 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 (rapid 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, oral ulcers
• changes in liver blood test results
• bruises
• weakness and fatigue, flu-like symptoms

Uncommon

• gastrointestinal upset and inflammation (gastrointestinal inflammation, which affects both the stomach and the small intestine and (or) gastroenteritis), upper respiratory tract infection, urinary tract infection
• 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), 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, stomach ulcers, gastritis, 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 you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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, you can help gather more information on the safety of this 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.
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 stated.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your 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),

carmellose 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 what the pack contains

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 supplied 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 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