Coxient 90 mg. 14 tablets

What COXIENT is and what it is used for

What is COXIENT?

COXIENT contains the active substance etoricoxib. COXIENT belongs to a group of medicines called COX-2 inhibitors. They belong to a family of drugs called non-steroidal anti-inflammatory drugs (NSAIDs).

What is COXIENT used for?

COXIENT helps reduce pain and swelling (inflammation) in the joints and muscles of people 16 years of age and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.

COXIENT is also used for the short-term treatment of moderate pain after dental surgery in people 16 years of age and older.

What is osteoarthritis?

Osteoarthritis is a disease of the joints. It results from the gradual breakdown of the cartilage that lines the ends of bones. This causes swelling (inflammation), pain, tenderness, stiffness and immobility.

What is rheumatoid arthritis?

Rheumatoid arthritis is a long-term inflammatory disease of the joints. It causes pain, stiffness, swelling and increasing loss of motion in the affected joints. It can also cause inflammation in other parts of the body.

What is gout?

Gout is a disease with sudden and repeated attacks of very painful inflammation and redness of the joints. It is caused by the deposition of mineral crystals in the joints.

What is ankylosing spondylitis?

Ankylosing spondylitis is an inflammatory disease of the spinal vertebrae and large joints.

2. What you need to know before you take COXIENT

Do not take COXIENT:

if you are allergic to etoricoxib or any of the other ingredients of this medicine (listed in section 6);

if you are allergic to non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin and COX-2 inhibitors (see section 4, Possible side effects);

if you have an active stomach ulcer or bleeding from the stomach and intestines;

if you have severe liver disease;

if you have severe kidney disease;

if you are pregnant or may become pregnant, or are breast-feeding (see Pregnancy, breast-feeding and fertility);

if you are under the age of 16;

if you have an inflammatory bowel disease, such as Crohn's disease, ulcerative colitis or colitis;

if you have high blood pressure not controlled by treatment (check with your doctor or nurse if you are not sure whether your blood pressure is adequately controlled);

if your doctor has diagnosed heart problems, including heart failure (moderate or severe), angina (chest pain);

if you have had a heart attack, bypass surgery, peripheral arterial disease (poor blood supply to the legs due to narrowing or blockage of the arteries);

if you have had any stroke (including mini-stroke, transient ischemic attack or PIA).

Etoricoxib may slightly increase your risk of heart attack and stroke, and therefore should not be used by people who have had heart problems or have had a stroke.

If you believe that some of these conditions apply to your condition, do not take the tablets before consulting a doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking COXIENT if:

you have a history of stomach bleeding or ulcers;

you are dehydrated, for example due to prolonged diarrhea or vomiting;

you have swelling due to fluid retention;

you have a history of heart failure or any other form of heart disease;

you have a history of high blood pressure. COXIENT can increase blood pressure in some people, especially at high doses, and your doctor will want to check your blood pressure levels periodically;

you have a history of liver or kidney disease;

you are treating an infection. COXIENT may mask or mask a temperature condition that is a manifestation of infection;

you have diabetes, high cholesterol or smoke. They can increase the risk of heart disease;

you are trying to get pregnant;

you are over 65 years of age.

If you are not sure if any of these conditions apply to your condition, check with your doctor before taking COXIENT to see if this medicine is right for you.

COXIENT works equally well in elderly and young patients. If you are over 65, your doctor will want to see you regularly. No dose adjustment is required for patients over 65 years of age.

Children and adolescents

Do not give this medicine to children and adolescents under 16 years of age.

Other medicines and COXIENT

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are taking any of the following medicines, your doctor will want to monitor your condition to make sure the medicine is working well after you start taking COXIENT:

medicines to prevent blood clotting (anticoagulants), such as warfarin;

rifampicin (antibiotic);

methotrexate (a medicine to suppress the immune system and often used in rheumatoid arthritis

birth control pills (this combination may increase the risk of side effects);

hormone replacement therapy (this combination may increase the risk of side effects);

aspirin. The risk of stomach ulcers is greater if you take COXIENT with aspirin:

aspirin to prevent heart attack or stroke: COXIENT can be taken with low-dose aspirin. If you are taking low-dose aspirin to prevent heart attack and stroke, you should stop taking it until you consult your doctor.

aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs): Do not take high-dose aspirin or other anti-inflammatory drugs while taking COXIENT.

COXIENT with food and drink

The effect of COXIENT may be faster when taken without food.

Pregnancy, lactation and fertility

Pregnancy

COXIENT tablets should not be taken during pregnancy. If you are pregnant, think you may be pregnant or are planning to become pregnant, do not take these tablets. If you become pregnant, stop taking the tablets and consult your doctor. Consult your doctor before using any medicine.

Breastfeeding

It is not known whether COXIENT is excreted in human milk. If you are breast-feeding or plan to breast-feed, consult your doctor before taking COXIENT. If you are taking COXIENT, you should not breast-feed.

Fertility

COXIENT is not recommended for women trying to conceive.

Driving and using machines

Dizziness and drowsiness have been reported in some patients taking COXIENT.

Do not drive if you feel dizzy or drowsy.

Do not operate appliances or machinery if you feel dizzy or drowsy.

COXIENT contains lactose

If you know from your doctor that you have an intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take COXIENT

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Do not take more than the recommended dose for your condition. Periodically, your doctor will discuss the treatment with you. It is important to use the lowest dose that gives you pain control and you should not take COXIENT for longer than necessary. This is due to the risk of heart attack or stroke, which may increase after long-term treatment, especially with high doses.

Tablets with different amounts of the active substance are available from this medicinal product, and depending on your illness, your doctor will prescribe the appropriate tablet.

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 states

Etoricoxib should only be used during periods of flare-up pain.

Gout

The recommended dose is 120 mg once daily, which should be administered only during periods of attack, with treatment limited to a maximum of 8 days.

Postoperative pain after dental surgery

The recommended dose is 90 mg once a day, with treatment limited to a maximum of 3 days.

People with liver problems

If you have mild liver disease, you should not take more than 60 mg daily.

If you have moderate liver disease, you should not take more than 30 mg daily.

Use in children and adolescents

COXIENT should not be taken by children and adolescents under the age of 16.

Old age

No dose adjustment is required in elderly patients. Like other drugs, they should be used with caution in elderly patients.

Application method

COXIENT is for oral use. Take the tablets once a day. COXIENT can be administered with or without food.

If you have taken more than the required dose of COXIENT

You should never take more tablets than prescribed by your doctor. If you take too many COXIENT tablets, you should seek medical help immediately.

If you forget to take COXIENT

It is important to take COXIENT as prescribed by your doctor. If you miss a dose, simply continue with your normal schedule the next day. Do not take a double dose to make up for a missed tablet.

If you have any further questions related to the use of this medicine, 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 notice any of the following symptoms, you should stop taking COXIENT and inform your doctor immediately (See section 2. What you need to know before taking COXIENT):

shortness of breath, chest pain, or ankle swelling, or when they get worse;

yellowing of the skin and

Common:

dry alveolitis (inflammation and pain after tooth extraction);

swelling of the legs and/or feet due to fluid retention (oedema);

dizziness, headache;

palpitations (fast or irregular heartbeat), irregular heartbeat (arrhythmia);

increased blood pressure;

wheezing or shortness of breath (bronchospasm);

constipation, gas, gastritis (inflammation of the stomach lining), heartburn, diarrhea, indigestion (dyspepsia)/stomach discomfort, nausea, vomiting, inflammation of the esophagus, mouth ulcers;

change in blood tests related to the liver;

bloodletting;

weakness and fatigue, flu-like condition.

Uncommon:

gastroenteritis (inflammation of the gastrointestinal tract, which includes the stomach and small intestine), upper respiratory tract infection, urinary tract infection;

changes in laboratory indicators (reduced number of red blood cells, reduced number of white blood cells, reduced number of platelets);

hypersensitivity (allergic reaction, including hives, which may be quite serious and require immediate medical attention);

increased or decreased appetite, weight gain;

anxiety, depression, reduced thinking ability, seeing, hearing or feeling things that are not there (hallucinations);

change in taste, insomnia, tingling or pins and needles, drowsiness;

blurred vision, eye irritation and redness;

ringing in the ears, vertigo (spinning sensation when standing still);

abnormal heart rhythm (atrial fibrillation), fast heart rate, heart failure, feeling of tightness, pressure or heaviness in the chest (angina), heart attack;

facial flushing, stroke (stroke), mini-stroke (transient ischemic attack), severe increase in blood pressure, inflammation of blood vessels;

cough, shortness of breath, nosebleeds;

swelling of the stomach or intestines, changes in intestinal permeability, dry mouth, stomach ulcer, inflammation of the stomach lining that can be complicated and lead to bleeding, irritable bowel syndrome, inflammation of the pancreas;

swelling of the face, skin rash or itching, reddening of the skin;

muscle cramps / spasms, muscle pain / cramping;

high levels of potassium in the blood, changes in blood or urine tests related to the kidneys, serious kidney problems;

chest pain.

Rare:

angioedema (allergic reaction with swelling of the face, lips, tongue, and/or throat which may cause shortness of breath or difficulty swallowing which may be quite serious and require immediate medical attention)/anaphylactic/anaphylactoid reactions including shock (serious allergic reaction that requires immediate medical attention)

confusion, restlessness;

liver problems (hepatitis);

low blood sodium levels

liver failure, yellowing of the skin and/or eyes (jaundice);

How to store COXIENT

Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister. The expiration date corresponds to the last day of the specified month.

This medicinal product does not require special storage conditions.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What COXIENT contains:

The active substance is: etoricoxib. Each film-coated tablet contains 90 mg etoricoxib. (etoricoxib).

The other ingredients are:

Tablet core: calcium hydrogen phosphate (anhydrous), microcrystalline cellulose, povidone K29/32, magnesium stearate, croscarmellose sodium (E468);

Tablet coating: hypromellose 15 cPs (E464), lactose monohydrate, titanium dioxide (E171), triacetin (E1518).

What the packaging looks like and what it contains

White, round, biconvex film-coated tablets with a diameter of 7.5 mm.

COXIENT is packaged in cold-formed aluminum foil with an aluminum coating.

Packaging: 7, 14, 28, 30 or 100 film-coated tablets in blisters.

Not all types of packaging can be put on sale.