Roticox 90 mg. 14 tablets
Roticox contains the active substance etoricoxib. Rotikox belongs to a group of medicines called COX-2 inhibitors. They belong to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Roticox 90 mg. 14 tablets
What Roticox is and what it is used for
What is Roticox used for?
• Rotikox contains the active substance etoricoxib. Rotikox belongs to a group of medicines called COX-2 inhibitors. They belong to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
What is Roticox used for?
• Rotikox helps reduce the pain and swelling in the joints and muscles of people aged 16 and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout.
• Rotikox is also used for 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 develops as a result of the gradual degradation of the cartilage that binds the end 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. It causes pain, stiffness, swelling and increasing loss of movement 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 recurrent seizures 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 vertebrae and large joints.
2. What do you need to know before taking Rotikox?
Do not take Rotikox:
if you are allergic (hypersensitive) 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 Possible side effects, section 4);
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 you may become 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 that is not controlled by treatment (check with your doctor or nurse 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);
if you have suffered a heart attack, bypass surgery, peripheral arterial disease (poor blood supply to the legs or feet due to narrowing or blockage of the arteries);
if you have ever had a stroke (including a mini stroke, a transient ischemic attack, or a PIA). Etoricoxib may slightly increase your risk of heart attack and stroke and should therefore not be used by those who have already had heart or stroke problems.
If you think that some of these conditions match your condition, do not take the tablets before consulting a doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rotikox if:
have a history of stomach bleeding or an ulcer;
you are dehydrated, for example due to prolonged vomiting or diarrhea;
you have edema due to fluid retention;
have a history of heart failure or any other form of heart disease;
have a history of high blood pressure. Rotikox may increase blood pressure in some people, especially in high doses, and your doctor will periodically check your blood pressure;
have a history of liver or kidney disease;
you are treating an infection. Rotikox may mask or mask the temperature that is a sign of infection;
you have diabetes, raised cholesterol, or are a smoker. They may increase your 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 applies to you, talk to your doctor before taking Rotix to see if this medicine is right for you.
Rotikox works equally well in older and younger adult patients. If you are over 65 years old, 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 Drugs and Roticox
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Especially if you are taking any of the following medicines, your doctor may want to check your condition to make sure the medicine works well once you start taking Rotix:
anti-blood clotting (anticoagulants),
3. How to take Rotikox?
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 your treatment with you. It is important to use the lowest dose to control your pain, and you should not take Rotikox for longer than necessary. This is due to the risk of a heart attack or stroke that can increase after prolonged treatment, especially with high doses.
This tablet contains tablets with varying amounts of the active substance and depending on your condition. Your doctor will prescribe the appropriate dosage.
The recommended dose is:
The recommended dose is 30 mg once a day, increased to a maximum of 60 mg once a day as needed.
The recommended dose is 60 mg etoricoxib once a day. The dose may be increased to a maximum of 90 mg.
The recommended dose is 60 mg etoricoxib once a day. If necessary, the dose may be increased to a maximum of 90 mg.
Treatment of acute pain
Etoricoxib should be used only in periods of pain.
The recommended dose is 120 mg once a day, which should be given only in 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 and the treatment is limited to a maximum of 3 days.
People with liver problems
If you have a mild form of liver disease, you should not take more than 60 mg a day.
If you have moderate liver disease, you should not take more than 30 mg a day.
Use in children and adolescents
Rotikox tablets should not be taken by children and adolescents under 16 years of age.
No dose adjustment is required in the elderly. Like other medicines, they should be used with caution in the elderly.
Rotikox is for oral use. Take the tablets once a day. Rotikox can be given with or without food.
If you take more Rotikox than you should
You should never take more tablets than prescribed by your doctor. If you take too many rotix tablets, you should immediately seek medical attention.
If you forget to take Rotikox
It is important to take Rotix as your doctor prescribed. If you miss a dose, simply continue with the usual schedule the next day. Do not take a double dose to make up for the forgotten tablet.
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 develop any of the following symptoms, you should stop taking Rotikox and tell your doctor immediately (See "What you need to know before taking Roticox", section 2):
shortness of breath, chest pain or swelling of the ankle or if they get worse;
yellowing of the skin and eyes (jaundice) - this is a manifestation of liver;
problems with severe or persistent stomach pain or if your stools become black;
an allergic reaction - may include skin problems such as ulcers or bubbles, or swelling of the face, lips, tongue or throat that may make breathing difficult.
Other side effects that may occur during treatment Rotikox:
Very common (may affect more than 1 in 10 people):
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);
palpitations (rapid or irregular heart rhythm), irregular heart rhythm (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, malaise, inflammation of the esophagus, mouth ulcers;
changes in blood tests related to the liver;
weakness and fatigue, a flu-like condition.
Uncommon (may affect up to 1 in 100 people):
gastroenteritis (inflammation of the gastrointestinal tract including stomach and small intestine / gastroenteritis), upper respiratory tract infection, urinary tract infection;
changes in laboratory performance (reduced red blood cell count, decreased white blood cell count, decreased platelet count);
hypersensitivity (allergic reaction, including urticaria, which may be serious and require immediate medical attention);
increased or decreased appetite, weight gain;
anxiety, depression, impaired thinking ability, seeing, hearing or feeling things that do not exist
5. How to store Rotikox?
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not dispose of medicines in the sewer 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 does Rotikox contain?
The active substance is etoricoxib (etoricoxib).
Each film-coated tablet contains 30 mg, 60 mg, 90 mg or 120 mg etoricoxib (etoricoxib).
The other ingredients are microcrystalline cellulose, anhydrous calcium hydrogenphosphate, croscarmellose sodium, sodium stearic fumarate, colloidal anhydrous silica in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol 3000, talc, yellow iron oxide E172 (60 mg tablets ) and red iron oxide E172 (90 mg and 120 mg tablets) in the film coat.
What does Rotikox look like and what does it contain?
Rotikox film-coated tablets are available in four doses:
30 mg film-coated tablets: white to off-white, round (diameter: 6 mm), slightly biconvex, film-coated tablets with bevelled edges.
60 mg film-coated tablets: pale brownish-yellow, round (diameter: 8 mm), biconvex, film-coated tablets with bevelled edges, embossed "60" on one side of the tablet.
90 mg film-coated tablets: pink, round (diameter: 9 mm), biconvex, film-coated tablets with bevelled edges, embossed "90" on one side of the tablet.
120 mg film-coated tablets: brown-red, round (diameter: 10 mm), slightly biconvex, film-coated tablets with bevelled edges, scored on one side of the tablet. The score line is not intended to break the tablet.
30 mg film-coated tablets
Packs of 7, 14, 28, 30, 56, 60, 84, 98 or 100 tablets in blisters are available.
60 mg film-coated tablets
Packs of 7, 14, 20, 28, 30, 50, 56, 60, 84, 98 or 100 tablets in blisters are available.
90 mg film-coated tablets
Boxes containing 5, 7, 14, 20, 28, 30, 50, 56, 60, 84, 98 or 100 tablets in blisters are available.
120 mg film-coated tablets
Boxes containing 5, 7, 14, 20, 28, 30, 56, 60, 84, 98 or 100 tablets in blisters are available.
Not all pack sizes may be marketed.