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 further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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 a group of selective cyclooxygenase-2 (COX-2) inhibitors. It belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

What is Coxydyna used for?

• Coxydyna helps reduce pain and swelling (inflammation) of the joints and muscles in people aged 16 and over with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.
• Coxydyna 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 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 you are allergic to etoricoxib or any of the other ingredients of this medicine (listed in section 6)
• if you have a hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid and selective cyclooxygenase-2 (COX-2) inhibitors (see section 4, "Possible side effects")
• if you have active stomach or intestinal ulcers, or bleeding from the stomach or intestines
• if you have severe liver dysfunction
• if you have severe kidney dysfunction
• if you are pregnant or think you may be pregnant or are breastfeeding (see "Pregnancy, breastfeeding, and fertility")
• if you are under 16 years of age
• if you have inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or intestinal inflammation
• if you have uncontrolled high blood pressure (if in doubt, consult your doctor or nurse to check your blood pressure)
• if you have ever been diagnosed by your doctor with heart problems, including heart failure (moderate or severe) or angina (chest pain)
• if you have had a heart attack, undergone a bypass grafting procedure, or have peripheral arterial disease (poor circulation in the legs or feet due to narrowed or blocked arteries)
• if you have 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 problems.

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:

• If you have had stomach bleeding or stomach ulcers in the past.
• If you are dehydrated, for example, due to prolonged, recurring vomiting or diarrhea.
• If you have swelling due to fluid retention in the body.
• If you have had heart failure or other heart disease in the past.
• If you have had high blood pressure in the past. Coxydyna may increase blood pressure in some people, especially when taking high doses, so your doctor will check your blood pressure from time to time.
• If you have had liver or kidney dysfunction in the past.
• If you are currently being treated for an infection. Coxydyna may mask fever, which is a sign of infection.
• In people with diabetes, high cholesterol, or smokers. These patients have an increased risk of heart disease.
• In women planning to become pregnant.
• In people over 65 years of age.

In case of doubt about 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. It is not necessary to adjust the dose in 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

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, 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-thinning medicines (anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a medicine that suppresses the immune system, often used to treat rheumatoid arthritis)
• cyclosporine 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 (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 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 a heart attack or stroke, do not stop taking acetylsalicylic acid without consulting your doctor;
• acetylsalicylic acid and other nonsteroidal 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 women during pregnancy. 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, you should contact your doctor.
Breastfeeding
It is not known whether Coxydyna is excreted in breast milk. If you are breastfeeding or planning to breastfeed, you should consult your doctor before taking Coxydyna. If you are taking Coxydyna, you 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 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 are unsure, you should ask your doctor or pharmacist.
Do not take more than the recommended dose for each condition. You should consult your doctor from time to time to check the treatment. It is important to use the smallest effective dose that relieves pain 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 the tablets with 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
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 in elderly patients. As with other medicines, elderly patients should be cautious when taking Coxydyna.
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 recommended. If you have taken too many Coxydyna tablets, you should seek medical attention immediately.

Missing a dose of Coxydyna

Coxydyna should be taken as directed by your doctor. If you miss a dose, you should return to your usual dosing schedule the next day. Do not take a double dose to make up for the missed dose.
If you have any further doubts about taking this medicine, you should ask 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, you should 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 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 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 (fast or irregular heartbeat), irregular heartbeat (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 (inflammation of the digestive tract, which includes 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, mini-stroke (transient ischemic attack), severe high 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 those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring, 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. You should 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.
• The 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 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 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 for use 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