Arcoxia 120mg Film Coated Tablets
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Item No.: 70032877 | ||
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Pharma Code: 118732 | |
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Package leaflet: Information for the user
Arcoxiai® Arcoxia1®
60 mg film-coated tablets 90 mg film-coated tablets Etoricoxib Etoricoxib
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• Ifyou have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What ARCOXIA is and what it is used for
2. What you need to know before you take ARCOXIA
3. How to take ARCOXIA
4. Possible side effects
5. How to store ARCOXIA
6. Contents of the pack and other information
O MSD PROFILE
Profile: BG148x520_260
Profile Revision: 7
Profile Revision Date: 050708 Dimensions (mm): 148 x 520mm
What is ARCOXIA?
• ARCOXIA contains the active substance etoricoxib. ARCOXIA is one of a group of medicines called selective COX-2 inhibitors. These belong to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
What is ARCOXIA used for?
• ARCOXIA helps to reduce the 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.
• ARCOXIA 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 cartilage that cushions the ends of the bones.
This causes swelling (inflammation), pain, tenderness, stiffness and disability.
What is rheumatoid arthritis?
Rheumatoid arthritis is a long term inflammatory disease of the joints. It causes pain, stiffness, swelling, and increasing loss of movement in the joints it affects. It may also cause inflammation in other areas of the body.
What is gout?
Gout is a disease of sudden, recurring attacks of very painful inflammation and redness in the joints. It is caused by deposits of mineral crystals in the joint.
What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease of the spine and large joints.
2. What you need to know before you take ARCOXIA
Do not take ARCOXIA:
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 aspirin and COX-2 inhibitors (see Possible Side Effects, section 4)
if you have a current stomach ulcer or bleeding in your stomach or intestines if you have serious liver disease if you have serious kidney disease
if you are or could be pregnant or are breast-feeding (see 'Pregnancy, breast feeding and fertility') if you are under 16 years of age
if you have inflammatory bowel disease, such as Crohn's Disease, Ulcerative Colitis, or Colitis
if you have high blood pressure that has not been 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 types), angina (chest pain) if you have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrow or blocked arteries)
• if you have had any kind of stroke (including mini-stroke, transient ischaemic attack or TIA). Etoricoxib may slightly increase your
risk of heart attack and stroke and this is why it should not be used in those who have already had heart problems or stroke.
If you think any of these are relevant to you, do not take the tablets until you have consulted your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking ARCOXIA if:
You have a history of stomach bleeding or ulcers.
You are dehydrated, for example by a prolonged bout of vomiting or diarrhoea.
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. ARCOXIA can increase blood pressure in some people, especially in high doses, and your doctor will want to check your blood pressure from time to time.
You have any history of liver or kidney disease.
You are being treated for an infection. ARCOXIA can mask or hide a fever, which is a sign of infection.
You have diabetes, high cholesterol, or are a smoker. These can increase your risk of heart disease.
You are a woman trying to become 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 aRcOXIA to see if this medicine is suitable for you.
ARCOXIA works equally well in older and younger adult patients. If you are over 65 years of age, your doctor will want to appropriately keep a check on you. No dosage adjustment is necessary 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 ARCOXIA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
In particular if you are taking any of the following medicines, your doctor may want to monitor you to check that your medicines are working properly, once you start taking ARCOXIA:
• medicines that thin your blood (anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a drug used for suppressing the immune system, and often used in rheumatoid arthritis)
• ciclosporin or tacrolimus (drugs used for suppressing the immune system)
• lithium (a medicine used to treat some types of depression)
• medicines used to help control high blood pressure and heart failure called ACE inhibitors and angiotensin receptor blockers, examples include enalapril and ramipril, and losartan and valsartan
• diuretics (water tablets)
• digoxin (a medicine for heart failure and irregular heart rhythm)
• minoxidil (a drug used to treat high blood pressure)
• salbutamol tablets or oral solution (a medicine for asthma)
• birth control pills (the combination may increase your risk of side effects)
• hormone replacement therapy (the combination may increase your risk of side effects)
• aspirin, the risk of stomach ulcers is greater if you take ARCOXIA with aspirin.
- aspirin for prevention of heart attacks or stroke:
ARCOXIA can be taken with low-dose aspirin. If you are currently taking low-dose aspirin to prevent heart attacks or stroke, you should not stop taking aspirin until you talk to your doctor
- aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs):
do not take high dose aspirin or other anti-inflammatory medicines while taking ARCOXIA.
ARCOXIA with food and drink
The onset of the effect of ARCOXIA may be faster when taken without food.
Pregnancy, breast-feeding and fertility
Pregnancy
ARCOXIA tablets must not be taken during pregnancy. If you are pregnant or think you could be pregnant, or if you are planning to become pregnant, do not take the tablets. If you become pregnant, stop taking the tablets and consult your doctor. Consult your doctor if you are unsure or need more advice.
Breast-feeding
It is not known if ARCOXIA is excreted in human milk. If you are breast-feeding, or planning to breast-feed, consult your doctor before taking ARCOXIA. If you are using ARCOXIA, you must not breast-feed.
Fertility
ARCOXIA is not recommended in women attempting to become pregnant.
Driving and using machines
Dizziness and sleepiness have been reported in some patients taking ARCOXIA.
Do not drive if you experience dizziness or sleepiness.
Do not use any tools or machines if you experience dizziness or sleepiness.
ARCOXIA contains lactose
If you have been told by your doctor that you are unable to tolerate some sugars, contact your doctor before taking this medicinal product.
|3. How to take ARCOXIA
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Do not take more than the recommended dose for your condition. Your doctor will want to discuss your treatment from time to time. It is important that you use the lowest dose that controls your pain and you should not take ARCOXIA for longer than necessary. This is because the risk of heart attacks and strokes might increase after prolonged treatment, especially with high doses.
There are different strengths available for this medicinal product and depending on your disease your doctor will prescribe the tablet strength that is appropriate for you.
The recommended dose is:
Osteoarthritis
The recommended dose is 30 mg once a day, increase to a maximum of 60 mg once a day if needed.
Rheumatoid arthritis
The recommended dose is 90 mg once a day.
Ankylosing spondylitis
The recommended dose is 90 mg once a day.
Acute pain conditions
Etoricoxib should be used only for the acute painful period.
Gout
The recommended dose is 120 mg once a day which should only be used for the acute painful period, limited to a maximum of 8 days treatment.
Postoperative dental surgery pain
The recommended dose is 90 mg once daily, limited to a maximum of 3 days treatment.
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«£► MSD ARTWORK | ||
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Item No.: 70032877 | ||
|
Revision Date & No.: 290415-1 | ||
|
Pharma Code: 118732 | ||
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O — o _E |
SchawkJobNO.: 471790A01 | |
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<§> — E = E_= |
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O E |
Black | |
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Technical Info Profile | ||
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70032877/00-1
People with liver problems
• If you have mild 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
ARCOXIA tablets should not be taken by children or adolescents under 16 years of age.
Elderly
No dose adjustment is necessary for elderly patients. As with other medicines, caution should be exercised in elderly patients.
Method of administration
ARCOXIA is for oral use. Take the tablets once a day. ARCOXIA can be taken with or without food.
If you take more ARCOXIA than you should
You should never take more tablets than the doctor recommends. If you do take too many ARCOXIA tablets, you should seek medical attention immediately.
If you forget to take ARCOXIA
It is important to take ARCOXIA as your doctor has prescribed. If you miss a dose, just resume your usual schedule the following 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you develop any of these signs you should stop ARCOXIA and talk to your doctor immediately (see What you need to know before you take ARCOXIA section 2):
• shortness of breath, chest pains, or ankle swelling appear or if they get worse
• yellowing of the skin and eyes (jaundice) - these are signs of liver problems
• severe or continual stomach pain or your stools become black
• an allergic reaction- which can include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue, or throat which may cause difficulty in breathing
The frequency of possible side effects listed below is defined using the following convention:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
The following side effects can occur during treatment with ARCOXIA:
Very common
• stomach pain Common
dry socket (inflammation and pain after a tooth extraction) swelling of the legs and/or feet due to fluid retention (oedema) dizziness, headache
palpitations (fast or irregular heartbeat), irregular heart rhythm (arrhythmia), increased blood pressure
wheezing or shortness of breath (bronchospasms)
constipation, wind (excessive gas), gastritis (inflammation of the lining of the stomach), heartburn, diarrhoea, indigestion (dyspepsia)/stomach discomfort, nausea, being sick (vomiting), inflammation of the oesophagus, mouth ulcers changes in blood tests related to your liver bruising
weakness and fatigue, flu-like illness Uncommon
gastroenteritis (inflammation of the gastrointestinal tract that involves both the stomach and small intestine/stomach flu), upper respiratory infection, urinary tract infection
changes in laboratory values (decreased number of red blood cells, decreased number of white blood cells, platelets decreased) hypersensitivity (an allergic reaction including hives which may be serious enough to require immediate medical attention) appetite increases or decreases, weight gain
anxiety, depression, decreases in mental sharpness; seeing, feeling or hearing things that are not there (hallucinations) taste alteration, inability to sleep, numbness or tingling, sleepiness blurred vision, eye irritation and redness ringing in the ears, vertigo (sensation of spinning while remaining still)
abnormal heart rhythm (atrial fibrillation), fast heart rate, heart failure, feeling of tightness, pressure or heaviness in the chest (angina pectoris), heart attack
flushing, stroke, mini-stroke (transient ischaemic attack), severe increase in blood pressure, inflammation of the blood vessels cough, breathlessness, nose bleed
stomach or bowel bloating, changes in your bowel habits, dry mouth, stomach ulcer, inflammation of the stomach lining that can become serious and may lead to bleeding, irritable bowel syndrome, inflammation of the pancreas swelling of the face, skin rash or itchy skin, redness of the skin muscle cramp/spasm, muscle pain/stiffness
high levels of potassium in your blood, changes in blood or urine tests relating to your kidney, serious kidney problems chest pain
Rare
• angioedema (an allergic reaction with swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing, which may be serious enough to require immediate medical attention)/anaphylactic/anaphylactoid reactions including shock (a serious allergic reaction that requires immediate medical attention) confusion, restlessness liver problems (hepatitis) low blood levels of sodium
liver failure, yellowing of the skin and/or eyes (jaundice) severe skin reactions Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.
Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971,
Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@hpra.ie United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
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. The expiry date refers to the last day of that month. Bottles: Keep the container tightly closed in order to protect from moisture.
Blisters: Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Profile: BG148x520_260
Profile Revision: 7
Profile Revision Date: 050708 Dimensions (mm): 148 x 520mm
What ARCOXIA contains
• The active substance is etoricoxib. Each film coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.
• The other ingredients are:
Core: calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate, microcrystalline cellulose.
Tablet coating: carnauba wax, lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin. The 30-, 60- and 120-mg tablets also contain yellow ferric oxide (E172, colouring agent) and indigo carmine lake (E132, colouring agent).
What ARCOXIA looks like and contents of the pack ARCOXIA tablets are available in four strengths:
30 mg blue-green, apple-shaped, biconvex film coated tablets marked 'ACX 30' on one side and '101' on the other.
60 mg dark green, apple-shaped, biconvex film coated tablets marked 'ARCOXIA 60' on one side and '200' on the other.
90 mg white, apple-shaped, biconvex film coated tablets marked 'ARCOXIA 90' on one side and '202' on the other.
120 mg pale-green, apple-shaped, biconvex film coated tablets marked 'ARCOXIA 120' on one side and '204' on the other.
30 mg:
Pack sizes of 2, 7, 14, 20, 28, 49 tablets or multi-packs containing 98 (2 packs of 49) tablets in blisters.
60, 90, 120 mg:
Pack sizes of 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 100 tablets or multi-packs containing 98 (2 packs of 49) tablets in blisters; or 30 and 90 tablets in bottles with desiccant containers. The desiccant (one or two containers) in the bottle, used to keep the tablets dry, should not be swallowed.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder in the UK is Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Herts, EN11 9BU, UK.
The Marketing Authorisation Holder in Ireland is Merck Sharp & Dohme Ireland (Human Health) Ltd, Red Oak North, South County Business Park, Leopardstown, Dublin 18, Ireland.
Manufacturer: Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN Haarlem, The Netherlands.
Distributor: Grunenthal Ltd, Units 1 and 2 Stokenchurch Business Park, Ibstone Road, Stokenchurch, Buckinghamshire, HP14 3FE, UK This medicinal product is authorized in the Member States of the EEA under the following names:
Belgium, Luxemburg Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, comprimes pellicules
Denmark, Estonia, Iceland, Norway Arcoxia
Malta, Ireland, United Kingdom ARCOXIA 30, 60, 90 or 120 mg film-coated tablets
Arcoxia 30 mg, 60 mg, 90 mg, 120 mg-Filmtabletten ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg, potahovane tablety ARCOXIA 30, 60, 90, 120 mg Arcoxia 30, 60, 90 ja 120 mg tabletti, kalvopaallysteinen ARCOXIA 30, 60,90 mg, comprime pellicule ARCOXIA 30/60/90/120 mg Filmtabletten ARCOXIA 30 mg, 60 mg, 90 mg,120 mg film-coated tablets Arcoxia 30 mg, 60 mg, 90 mg, 120 mg filmtabletta ARCOXIA 30, 60, 90, 120 mg compresse rivestite con film Arcoxia 30 mg, 60 mg, 90 mg un 120 mg apvalkotas tablets Arcoxia 30, 60, 90, 120 mg plevele dengtos tabletes Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, filmomhulde tabletten ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg tabletki powlekane ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg comprimidos revestidos por pelicula ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg Arcoxia 30/60/90/120 mg filmsko oblozene tablete ARCOXIA 30, 60, 90 y 120 mg comprimidos recubiertos con pelicula Arcoxia 30 mg, 60 mg, 90 mg och 120 mg filmdragerade tabletter
Austria Czech Rep.
Cyprus
Finland
France
Germany
Greece
Hungary
Italy
Latvia
Lithuania
Netherlands
Poland
Portugal
Slovakia
Slovenia
Spain
Sweden
This leaflet was last revised in March 2015. PIL.ACX.15.UK.4512.IB
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