30 mg & 60 mg & 90 mg & 120 mg film-coated tablets
etoricoxib
What Etoricoxib STADA is and what it is used for
What is Etoricoxib Stada?
- Etoricoxib Stada contains the active substance etoricoxib. Etoricoxib belongs to a group of medicines called selective cyclooxygenase -2 ( COX-2 ) inhibitors. These in turn belong to a group of drugs called non-steroidal anti-inflammatory drugs ( NSAIDs ).
What is Etoricoxib Stada used for?
- Etoricoxib Stada reduces pain and swelling ( inflammation ) in joints and muscles in people 16 years and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.
- Etoricoxib Stada is also used for short-term treatment of moderate pain after dental surgery in people 16 years and older.
What is osteoarthritis?
Osteoarthritis is a joint disease. It is caused by a gradual breakdown of cartilage that dampens the contact of the bone ends with each other. This causes swelling ( inflammation ), pain, tenderness, stiffness, and reduced mobility.
What is rheumatoid arthritis?
Rheumatoid arthritis is a long-term inflammatory disease of the joints. It causes pain, stiffness, swelling, and a decrease in mobility in the affected joints. It can also cause inflammation in other parts of the body.
What is gout?
Gout is a joint disease that involves sudden, recurrent attacks of very painful inflammation and redness of the joints.
It is caused by the storage of mineral crystals in the joint.
What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease of the spine and major joints.
Etoricoxib contained in Etoricoxib Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Etoricoxib STADA
Do not use Etoricoxib STADA
- 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 Possible side effects, section 4)
- if you have an active stomach ulcer or bleeding in your stomach or intestines
- if you have severe liver disease
- if you have severe kidney disease
- if you are or think you may be pregnant, or if you are breast-feeding (see Pregnancy, breast-feeding and fertility )
- if you are under 16 years of age
- if you have inflammatory bowel diseases such as Crohn’s disease, ulcerative colitis, or colitis
- if you have high blood pressure that is not kept under control with treatment (if you are not sure if your blood pressure is under control, ask your doctor)
- if your doctor has diagnosed you with heart problems including heart failure(moderate or severe), angina (chest pain)
- if you have had a heart attack, undergone bypass surgery, peripheral arterial disease (poor circulation in the legs or feet caused by blockage or narrowing of blood vessels)
- if you have had any kind of stroke (including mini-stroke, transient ischemic attack, so-called TIA ). Etoricoxib may cause a slightly increased risk of heart attack and stroke, which is why it should not be used by people who have previously had heart problems or strokes.
If you think any of these apply to you, do not take the tablets until you have consulted your doctor.
Warnings and cautions
Talk to your doctor or pharmacist before taking Etoricoxib Stada if:
- you have or have had to bleed in the stomach or stomach ulcers
- you are dehydrated, for example after a long period of vomiting and diarrhea
- you have swelling due to fluid retention
- you have previously had heart failure or any other heart disease
- you have had high blood pressure in the past. Etoricoxib Stada may increase blood pressure in some people, especially at high doses. Your doctor may want to check your blood pressure from time to time
- you have previously had liver or kidney disease
- you are being treated for an infection. Etoricoxib Stada may mask a fever, which is a sign of infection
- you have diabetes, high cholesterol, or if smoke, which can increase your risk of heart disease
- you are planning to get pregnant
- you are over 65 years old.
If you are not sure if any of the above applies to you, talk to your doctor to see if this medicine is suitable for you before taking Etoricoxib Stada.
Etoricoxib Stada works equally well in elderly and younger adult patients. If you are over 65, your doctor may want to monitor your treatment. No dose adjustment is necessary for patients over 65 years of age.
Children and young people
Do not give this medicine to children and adolescents under 16 years of age.
Other medicines and Etoricoxib STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor should in particular know if you are already being treated with any of the following medicines and may need to check the effect of the medication when starting treatment with Etoricoxib Stada:
- blood thinners ( anticoagulants ), such as warfarin
- rifampicin ( antibiotic )
- methotrexate (a drug for disorders of the immune system and often used in rheumatoid arthritis )
- ciclosporin or tacrolimus (so-called immunosuppressive drugs)
- lithium (medicine for certain types of depression)
- medicines for high blood pressure and heart failure, so-called ACE inhibitors such as enalapril and ramipril, and angiotensin -II receptor inhibitors such as losartan and valsartan
- diuretics ( diuretics )
- digoxin (medicine for heart failure and irregular heartbeat)
- minoxidil (medicine for high blood pressure )
- salbutamol tablets or oral solution (an asthma medicine )
- birth control pills (the combination may increase the risk of side effects )
- hormone therapy for menopausal symptoms (the combination may increase the risk of side effects )
- acetylsalicylic acid The risk of stomach bleeding is greater if you use Etoricoxib Stada at the same time as acetylsalicylic acid
- acetylsalicylic acid for the prevention of myocardial infarction or stroke: Etoricoxib Stadakan is taken concomitantly with low-dose acetylsalicylic acid. If you use low-dose acetylsalicylic acid to prevent heart attack or stroke, do not stop without talking to your doctor first. acetylsalicylic acid and other non-steroidal anti-inflammatory drugs ( NSAIDs ): Do not use higher doses of acetylsalicylic acid or other anti-inflammatory drugs while taking Etoricoxib Stada.
Etoricoxib STADA with food
The effect can be achieved faster if Etoricoxib Stada is taken without food.
Pregnancy, breastfeeding, and fertility
Pregnancy
Etoricoxib Stada tablets should not be used during pregnancy. If you are pregnant or think you may be pregnant or are planning to have a baby, do not take the tablets. Stop taking Etoricoxib Stada and talk to your doctor if you become pregnant. Talk to your doctor if you are unsure or need more advice.
Breast-feeding
It is unknown whether etoricoxib is excreted in human milk. If you are breast-feeding or planning to breast-feed, talk to your doctor before taking Etoricoxib Stada. If you are taking Etoricoxib Stada, do not breast-feed.
Fertility
The use of Etoricoxib Stada is not recommended for women trying to conceive.
Driving and using machines
Dizziness and drowsiness have been reported in some people who have used Etoricoxib Stada.
Do not drive if you feel dizzy or drowsy.
Do not use machines or tools if you feel dizzy or drowsy.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Etoricoxib STADA contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Etoricoxib STADA
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Do not take more than the recommended dose for your illness. Your doctor may occasionally want to discuss your treatment. You must use the lowest possible dose for pain relief and you should not use Etoricoxib Stada for longer than necessary as the risk of heart attack and stroke may increase with long-term treatment, especially at high doses.
There are different strengths available of this drug and depending on your illness, your doctor will prescribe the strength that is right for you.
The recommended dose is:
Arthritis
The recommended dose is 30 mg once daily. If necessary, the dose can be increased to a maximum of 60 mg once daily.
Rheumatoid arthritis
The recommended dose is 60 mg once daily. If necessary, the dose can be increased to a maximum of 90 mg once daily.
Ankylosing spondylitis
The recommended dose is 60 mg once daily. If necessary, the dose can be increased to a maximum of 90 mg once daily.
Acute pain conditions
Etoricoxib Stada should only be used during the acute period of pain.
Gout
The recommended dose is 120 mg once daily which should only be used during the acute period of pain and aches, limited to a maximum of 8 days of treatment.
Pain after dental surgery
The recommended dose is 90 mg once daily, limited to a maximum of 3 days of treatment.
People with liver disease
- 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.
Older
No dose adjustment is necessary for elderly patients. Caution should be exercised in elderly patients.
How to take this medicine
Take Etoricoxib Stada by mouth. Take the tablets once a day. Etoricoxib Stada can be taken with or without food.
Use for children and adolescents
Children and adolescents under 16 years of age should not take Etoricoxib Stada.
If you use more Etoricoxib STADA then you should
You should never take more tablets than your doctor recommends. If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center immediately for risk assessment and advice.
If you forget to use Etoricoxib STADA
You must take Etoricoxib Stada exactly as your doctor has told you. If you forget to take a dose, return to the usual schedule the next day. Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should stop taking Etoricoxib Stada and contact your doctor immediately if you get any of the following symptoms (see What you need to know before you take Etoricoxib Stada section 2):
- shortness of breath, chest pain, or swelling of the feet, or if these worsen
- yellowish skin or yellowish whites of the eyes (jaundice) – these are signs of liver problems
- severe or persistent abdominal pain or if you get black stools
- allergic reaction including skin reactions such as sores or blisters, or swelling of the face, lips, tongue, or throat which may cause difficulty breathing.
The following side effects may occur during treatment with Etoricoxib Stada:
Very common (may affect more than 1 user in 10):
- stomach ache.
Common (may affect up to 1 in 10 people):
- dry gingivitis ( inflammation and pain after tooth extraction)
- swelling of legs and/or feet due to fluid retention ( edema )
- dizziness, headache
- palpitations (fast or irregular heartbeat), irregular heartbeat ( arrhythmia )
- high blood pressure
- wheezing or shortness of breath ( bronchospasm )
- constipation, flatulence (high intestinal gas), gastritis (inflammation of the stomach), heartburn, diarrhea, indigestion ( dyspepsia ) / upset stomach, nausea, vomiting, inflammation of the esophagus, sores in the mouth
- altered liver blood levels
- bruises
- weakness and fatigue, flu-like symptoms.
Uncommon (may affect up to 1 in 100 people):
- gastroenteritis ( inflammation of the gastrointestinal tract involving both the stomach and small intestine/stomach flu), upper respiratory tract infection, urinary tract infection
- change in laboratory values (decreased number of red blood cells, decreased number of white blood cells, decreased number of platelets )
- hypersensitivity (an allergic reaction including hives which may be so serious that immediate medical attention is required)
- increased or decreased appetite, weight gain
- anxiety, depression, impaired mental acuity, seeing, feeling, or hearing things that do not exist (hallucinations)
- taste changes, difficulty sleeping, numbness or tingling, drowsiness
- blurred vision, irritation, and redness of the eyes
- ringing in the ears, dizziness (feeling of rotation when still)
- Abnormal heart rhythm ( atrial fibrillation ), rapid heartbeat, heart failure, the feeling of tightness, pressure, or heaviness over the chest ( angina pectoris ), heart attack
- hemorrhage, stroke, mini-stroke ( transient ischemic attack), severe increase in blood pressure, inflammation of the blood vessels
- cough, shortness of breath, nosebleeds
- gases in the stomach or intestines, altered bowel habits, dry mouth, stomach ulcers, gastric inflammation that can become severe and can lead to bleeding, irritable bowel syndrome, inflammation of the pancreas
- swelling of the face, rash or itchy skin, reddening of the skin
- muscle cramps / twitching, muscle pain / stiffness
- elevated blood potassium levels, altered renal or urinary levels, severe renal impairment
- chest pain.
Rare (may affect up to 1 in 1,000 people):
- angioedema (severe allergic reaction with swelling of the face, lips, tongue, and/or throat which may cause breathing or swallowing difficulties which may be so serious that immediate medical attention is required) / anaphylactic/anaphylactoid reactions including shock (a severe allergic reaction requiring immediate medical attention )
- confusion, restlessness
- liver disease ( hepatitis )
- decreased sodium content in the blood
- liver failure, yellowish skin, and/or yellowish whites of the eyes (jaundice)
- severe skin reactions.
5. How to store Etoricoxib STADA
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is etoricoxib.
Etoricoxib Stada 30 mg: One film-coated tablet contains 30 mg etoricoxib.
Etoricoxib Stada 60 mg: One film-coated tablet contains 60 mg etoricoxib.
Etoricoxib Stada 90 mg: One film-coated tablet contains 90 mg etoricoxib.
Etoricoxib Stada 120 mg: One 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 mg, 60 mg, and 120 mg tablets also contain indigo carmine aluminum lacquer (E132) and yellow iron oxide (E172).
What the medicine looks like and the contents of the pack
Etoricoxib Stada film-coated tablets are available in 4 strengths.
30 mg tablets are blue-green, round, biconvex, film-coated tablets.
60 mg tablets are dark green, round, biconvex, film-coated tablets.
90 mg tablets are white, round, biconvex, film-coated tablets.
120 mg tablets are light green, round, biconvex, film-coated tablets.
30 mg:
Pack sizes of 7, 14, 28, 30, 98 film-coated tablets in blister packs.
60 mg and 90 mg:
Pack sizes of 7, 10, 14, 20, 28, 30, 50, 98, 100 film-coated tablets in blisters.
Pack size of 100 film-coated tablets in tablet jar with a screw cap containing desiccant (silica gel). The desiccant, which is used to keep the tablets dry, should not be swallowed.
120 mg:
Pack sizes of 5, 7, 14, 20, 28, 30, 98 film-coated tablets in blister packs.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Pharmacare Premium Ltd.
HHF 003, Hal Far Industrial Estate
Birzebbuga. BBG 3000
Malta
Delorbis Pharmaceuticals Ltd.
17 Athinon Street, Ergates Industrial Area
2643 Ergates, Nicosia
Cyprus
Centrafarm Services BV
New Donk 9
4879 AC EttenLeur
Netherlands
Local representative
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark