What Kostarox is and what it is used for
What is Costa Rica?
• Kostarox contains the active substance etoricoxib. Cistarox is a medicine from a group of medicines called selective COX-2 inhibitors. They belong to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
What is it used for?
• Asthma helps to reduce the pain and swelling of the joints and muscles in people over 16 years of age for osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout.
• Kostarox is also used for short-term treatment of moderate pain after dental surgery in people over 16 years of age.
What is osteoarthritis?
Osteoarthritis is a disease of the joints. It occurs as a result of the continuous destruction of the cartilage that covers the ends of the bones. This causes swelling (inflammation), pain, tenderness, stiffness and immobilization.
What is rheumatoid arthritis?
Rheumatoid arthritis is a prolonged inflammatory disease of the joints. Causes pain, stiffness, swelling, and increased loss of movement in the affected joints. It can also cause inflammation in other parts of the body.
What is Ankylosing Sondanitis?
Ankylosing spondylitis is an inflammatory disease of the vertebrae and large joints.
What is gout?
Gout is a disease with sudden, recurrent seizures of severely painful inflammation and redness of the joints. It is caused by the deposition of mineral crystals in the joints.
2. What you need to know before you take Kostarox
Do not take Kostarox
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 acetylsalicylic acid and COX-2 inhibitors (see section 4 "Possible side effects");
if you have active stomach ulcer or gastrointestinal bleeding;
if you have severe liver disease;
if you have severe kidney disease;
if you are pregnant, you are likely to be pregnant or 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 uncontrolled with treatment (talk to your doctor if you are not sure if your blood pressure is adequately controlled);
if your doctor has diagnosed heart problems including heart failure (moderate or severe), angina (chest pain) or if you have had a heart attack or a bypass surgery;
if you have peripheral arterial disease (impaired blood supply to the legs because of narrowing or blockage of the arteries);
if you have had some type of stroke (including a mini stroke or a transient ischemic attack [PIA]). Etoricoxib may slightly increase the 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 think any of the above applies to you, do not take this medicine before consulting a doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Costistax if:
you have had stomach bleeding or an ulcer;
you are dehydrated, for example due to prolonged vomiting or diarrhea;
you have edema due to fluid retention;
have heart failure or any other form of heart disease;
you have had high blood pressure. Cistarox may increase blood pressure in some people, especially in high doses, and your doctor will therefore need to check your blood pressure regularly;
you have had liver or kidney disease;
you are treating an infection. Cistarox may mask or mask a fever, which is a sign of infection;
you have diabetes, high cholesterol, or you smoke. This may increase the risk of heart disease.
You are a woman trying to get pregnant;
You are over 65 years of age.
If you are not sure if any of the above apply to you, talk to your doctor before taking Costistax if this medicine is right for you.
Kostarox works equally well in adults and young patients. If you are elderly (ie over 65 years of age), your doctor will tell you that it is necessary to see you regularly. No dose adjustment is required in patients over 65 years of age.
Children and adolescents
Do not use this medicine in children and adolescents under 16 years of age.
Other medicines and Costa Rats
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Your doctor will tell you that it is necessary to check your condition to make sure that the medicine works well after you start taking Costa Rats, especially if you are taking any of the following medicines:
• anti-blood clotting (anticoagulants) such as warfarin;
acetylsalicylic acid for the prevention of heart attack or stroke: Kostarox can be taken with a low dose of acetylsalicylic acid. If you take a low dose of acetylsalicylic acid to prevent a heart attack or stroke, you should not stop taking acetylsalicylic acid until you have consulted your 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 Costa Rica.
Pregnancy, breastfeeding and fertility
Pregnancy
Cistarox should not be taken during pregnancy. If you are pregnant, think you may be pregnant or plan to become pregnant, do not take this medicine. If you become pregnant, stop taking Cistarox and talk to your doctor. Ask your doctor if you are not sure or need more advice.
Breastfeeding
It is not known whether etoricoxib is excreted in human milk. If you are breast-feeding or planning to breast-feed, talk to your doctor before taking Costista. If you are taking Costa Rica, you should not breast-feed.
Fertility
Etoricoxib can make conception difficult. Therefore, it is not recommended for women attempting to conceive.
You should tell your doctor if you are planning a pregnancy or have problems getting pregnant.
Driving and using machines
Dizziness and somnolence have been reported in some patients taking Coxtrox.
Do not drive if you experience dizziness or drowsiness.
Do not work with appliances or machines if you experience dizziness or drowsiness.
Quest contains lactose
If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
3. How to take Kostarox
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Do not take more than the recommended dose for your condition. Your doctor will tell you that it is necessary to periodically discuss your treatment with you. It is important to use the lowest dose to control pain, and you should not take Costa Rats longer than necessary. This is due to the risk of a heart attack or stroke that can increase after prolonged treatment, especially at high doses.
Dose forms of varying concentrations are available from this medicine, and depending on your illness, your doctor will prescribe the tablets with a concentration that is right for you.
The recommended dose is:
Osteoarthritis
The recommended dose is 30 mg once a day, which can be increased to a maximum of 60 mg once a day, if necessary.
Rheumatoid arthritis
The recommended dose is 60 mg once a day, which can be increased to a maximum of 90 mg once a day, if necessary.
Ankylosing spondylitis
The recommended dose is 60 mg once a day, which can be increased to a maximum of 90 mg once a day, if necessary.
Conditions with acute pain
Cistarox should only be used during periods of pain.
Gone
The recommended dose is 120 mg once a day, which should only be used in periods of severe pain, and the treatment is limited to a maximum of 8 days.
Postoperative pain after dental surgery
The recommended dose is 90 mg once a day and treatment is limited to up to 3 days.
Elderly
No dose adjustment is necessary in elderly patients. As with other medicines, caution should be exercised in elderly patients.
People with liver problems
• If you have a 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.
Application method
Costa rax is for oral use.
Take the tablets once a day.
Cistarox may be taken with or without food. The onset of the action of Costa Rats may be faster when taken in the fasted state.
If you take more than the necessary dose of Kostarox
You should never take more tablets than the number prescribed by your doctor. If you take too many tablets, you should immediately seek medical attention.
If you forget to take Kostarox
It is important that you take Costa Rica as prescribed by your doctor. If you miss a dose, simply continue with the normal schedule the next day. Do not take a double dose to make up for the missed dose.
If you have any further questions on 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 everyone gets them.
If you notice any of the following symptoms, you should stop taking Cistarox and tell your doctor immediately:
• shortness of breath, chest pain or swelling of the ankle or worsening;
• yellowing of the skin and eyes (jaundice) - this is the case
The following side effects may occur with KOSTAROX
Very common (may affect more than 1 in 10 people):
stomach ache.
Common (may affect up to 1 in 10 people):
dry alveolitis (inflammation and pain after tooth extraction);
swelling of the feet and / or feet due to fluid retention (swelling);
dizziness, headache;
feeling of heart beats, irregular heartbeat;
increased blood pressure;
wheezing or shortness of breath (bronchospasm);
constipation, gas (increased gas), inflammation of the stomach lining (gastritis), heartburn, diarrhea, indigestion (dyspepsia) / stomach upset, nausea, vomiting, inflammation of the esophagus, ulcers in the mouth;
changes in blood tests related to the liver;
bruising;
weakness and fatigue, flu-like condition;
Uncommon (may affect up to 1 in 100 people):
inflammation of the gastrointestinal tract, including stomach and small intestine / stomach flu (gastroenteritis);
Upper respiratory tract infection;
urinary tract infection;
reducing red blood cells, which may cause skin pallor, weakness or shortness of breath;
decreased number of white blood cells;
platelet reduction, which may increase the risk of bleeding or bruising (allergic reaction, including urticaria, which may be very serious and require immediate medical attention);
increased or decreased appetite, weight gain;
anxiety, depression, decreased mental ability; seeing, feeling or hearing things that do not exist (hallucinations);
change in taste, difficulty falling asleep, tingling or tingling, drowsiness;
blurred vision, irritation of eyes and redness;
ringing in the ears, vertigo (vertigo in motion);
abnormal heart rhythm (atrial fibrillation), increased heart rhythm, heart failure, tightness, tension or weight in the chest (angina), heart attack;
facial flushing, stroke, mini stroke (transient ischemic attack (PIA)), marked increase in blood pressure, inflammation of the blood vessels, often with rash;
cough, shortness of breath, bleeding from the nose;
stomach or bowel swelling, changes in defecation, dry mouth, stomach or small intestine ulcers, inflammation of the stomach lining, which may be serious and may lead to bleeding, irritable bowel syndrome, inflammation of the pancreas;
swelling of the face, skin rash or itching, reddening of the skin;
muscle cramps / cramps, muscle pain / stiffness;
high potassium levels in the blood that may cause irregular heartbeat, changes in blood or urine tests associated with the kidneys, serious kidney problems;
chest pain.
Rare (may affect up to 1 in 1,000 people):
severe allergic reaction with swelling of the face, lips, tongue and / or throat which may cause shortness of breath or difficulty in swallowing (angioedema) / anaphylactic / anaphylactoid reactions including shock (serious allergic reactions requiring immediate medical attention);
confusion, anxiety;
inflammation of the liver (hepatitis), liver failure, yellowing of the skin and / or eyes (jaundice);
low levels of sodium in the blood, which can cause fatigue and confusion, muscle twitching, seizures and coma;
severe skin reactions.
How to store Costa Rica
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines in the sewers or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Asthma contains
- The active substance is etoricoxib (etoricoxib).
- KOSTAROX 30 mg: Each film-coated tablet contains 30 mg etoricoxib.
- KOSTAROX 60 mg: Each film-coated tablet contains 60 mg etoricoxib.
- KOSTAROX 90 mg: Each film-coated tablet contains 90 mg etoricoxib.
- KOSTAROX 120 mg: Each film-coated tablet contains 120 mg etoricoxib.
- The other ingredients are: anhydrous calcium hydrogen phosphate, microcrystalline cellulose, povidone K29-32, magnesium stearate, croscarmellose sodium, hypromellose, lactose monohydrate, titanium dioxide (E171), triacetin.
The 30, 60 and 120 mg tablets also contain indigo carmine aluminum lacquer (E 132) and yellow iron oxide (EI 72).
What KOSTAROX looks like and what the package contains
KOSTAROX film-coated tablets are available in four concentrations.
The 30 mg tablets are blue-green, round, biconvex film-coated tablets.
The 60 mg tablets are dark green, round, biconvex film-coated tablets.
The 90 mg tablets are white, round, biconvex film-coated tablets.
The 120 mg tablets are light green, round, biconvex film-coated tablets.
Pack sizes of 5, 7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100 film-coated tablets in blister packs or in tablet packs with a screw cap containing a desiccant silica gel). The desiccant is designed to keep the tablets dry and should not be swallowed.
Not all pack sizes may be marketed.