Arcoxia 30 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
ARCOXIA 30mg film-coated tablets
ARCOXIA 60mg film-coated tablets
ARCOXIA 90mg film-coated tablets
ARCOXIA 120mg film-coated tablets
etoricoxib
Read the entire 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.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What ARCOXIA is and what it is used for
- What you need to know before taking ARCOXIA
- How to take ARCOXIA
- Possible side effects
- How to store ARCOXIA
- Contents of the pack and other information
1. What ARCOXIA is and what it is used for
What is Arcoxia?
- Arcoxia contains the active substance etoricoxib. Arcoxia belongs to a group of medicines known as 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 reduce pain and swelling (inflammation) in the joints and muscles of people aged 16 years and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.
- Arcoxia is also used for the short-term treatment of moderate pain following dental surgery in people aged 16 years and older.
What is osteoarthritis?
Osteoarthritis is a disease of the joints. It causes the gradual breakdown of the cartilage that cushions the ends of bones. This leads to swelling (inflammation), pain, tenderness, stiffness, and loss of function.
What is rheumatoid arthritis?
Rheumatoid arthritis is a long-term inflammatory disease of the joints. It causes pain, stiffness, swelling, and progressive loss of mobility in affected joints. It may also cause inflammation in other parts of the body.
What is gout?
Gout is a condition characterized by sudden and 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 taking ARCOXIA
Do not take Arcoxia
- if you are allergic (hypersensitive) to etoricoxib or to 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 currently have a stomach or duodenal ulcer or bleeding
- if you have severe liver disease
- if you have severe kidney disease
- if you are or may be pregnant, or are breastfeeding your child (see "Pregnancy, breastfeeding 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 with treatment (consult your doctor or nurse if you are unsure whether your blood pressure is adequately controlled)
- if your doctor has diagnosed you with heart problems including heart failure (moderate or severe type), angina (chest pain)
- if you have had a myocardial infarction, surgical revascularization, or peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries)
- if you have had any type of stroke (including transient ischaemic attack or ischaemic attack).
Etoricoxib may slightly increase your risk of myocardial infarction and stroke, and therefore should not be used in patients who have already had heart problems or a stroke.
If you think any of these apply 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 ulcers or gastrointestinal bleeding.
- You are dehydrated, for example due to a prolonged illness with 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 may increase blood pressure in some people, especially at high doses, and your doctor may want to check your blood pressure from time to time.
- You have a history of liver or kidney disease.
- You are being treated for an infection. Arcoxia may mask or hide fever, which is a sign of infection.
- You have diabetes, high cholesterol, or are a smoker, as these may increase your risk of developing heart disease.
- You are a woman trying to become pregnant.
- You are over 65 years of age.
If you are unsure whether any of the above situations apply to you, talk to your doctor before taking Arcoxia to confirm whether this medicine is suitable for you.
Arcoxia works equally well in younger and older adult patients. If you are over 65 years of age, your doctor will want to monitor you appropriately. Dose adjustment is not necessary in 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 need to take any other medicines, including those obtained without a prescription.
In particular, if you are taking any of the following medicines, your doctor may want to monitor you to ensure your medicines are working properly once you start taking Arcoxia:
-
medicines that thin your blood (anticoagulants), such as warfarin
-
rifampicin (an antibiotic)
-
methotrexate (a medicine used to suppress the immune system and often used in rheumatoid arthritis)
-
cyclosporine or tacrolimus (medicines used to suppress the immune system)
-
lithium (a medicine used to treat certain types of depression)
-
medicines used to help control high blood pressure and heart failure known as ACE inhibitors and angiotensin receptor blockers, for example enalapril and ramipril, losartan and valsartan
-
diuretics ("water pills")
-
digoxin (a medicine for heart failure and irregular heartbeat)
-
minoxidil (a medicine used to treat high blood pressure)
-
oral tablets or solution of salbutamol (a medicine for asthma)
-
oral contraceptives (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 higher if you take Arcoxia with aspirin.
-
Aspirin for prevention of myocardial infarction or stroke:
Arcoxia may be taken with low-dose aspirin. If you are currently taking low-dose aspirin to prevent myocardial infarction or stroke, do not stop taking aspirin without first talking to your doctor.
- Aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs):
do not take high-dose aspirin or other NSAIDs while taking Arcoxia.
Taking Arcoxia with food and drinks
The onset of action of Arcoxia may be faster if taken without food.
Pregnancy, breastfeeding and fertility
Pregnancy
Arcoxia tablets should not be taken during pregnancy. Do not take the tablets if you are pregnant, think you may be pregnant, or plan to become pregnant. If you become pregnant, stop taking the tablets and consult your doctor. Speak to your doctor if you have any doubts or need further information.
Breastfeeding
It is unknown whether Arcoxia is excreted in breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Arcoxia. If you are taking Arcoxia, you should stop breastfeeding.
Fertility
The use of Arcoxia is not recommended in women attempting to become pregnant.
Driving and using machines
Dizziness and somnolence have been reported in some patients taking Arcoxia.
Do not drive if you experience dizziness or somnolence.
Do not use tools or machinery if you experience dizziness or somnolence.
Arcoxia contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
Arcoxia contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; this is essentially "sodium-free".
3. How to take ARCOXIA
Follow exactly the instructions for taking this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.
Do not take more than the recommended dose for your condition. Your doctor will want to review your treatment from time to time. It is important to 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 may increase after long-term treatment, especially with high doses.
Different doses are available for this medicine, and depending on your condition, your doctor will prescribe the tablet with the dose appropriate for you.
The recommended dose is:
Osteoarthritis
The recommended dose is 30 mg once daily, increasing up to a maximum of 60 mg once daily if necessary.
Rheumatoid arthritis
The recommended dose is 60 mg once daily, increasing up to a maximum of 90 mg once daily if necessary.
Ankylosing spondylitis
The recommended dose is 60 mg once daily, which may be increased up to a maximum of 90 mg once daily if necessary.
Acute pain situations
Etoricoxib should only be used during the period of acute pain.
Gout
The recommended dose is 120 mg once daily, to be used only during the period of acute pain, limited to a maximum of 8 days of treatment.
Postoperative dental surgery pain
The recommended dose is 90 mg once daily, limited to a maximum of 3 days of treatment.
Patients with liver problems
- If you have mild liver disease, you must not take more than 60 mg per day.
- If you have moderate liver disease, you must not take more than 30 mg per day.
Use in children and adolescents
Children and adolescents under 16 years of age must not take Arcoxia tablets.
Patients aged 65 years and older
No dose adjustment is necessary for patients over 65 years of age. As with other medicines, caution should be exercised in elderly patients.
Method of administration
Arcoxia is administered orally. Take the tablets once daily. Arcoxia can be taken with or without food.
If you take more Arcoxia than you should
Never take more tablets than your doctor has prescribed. If you take too many Arcoxia tablets, seek immediate medical attention.
In case of overdose or accidental ingestion, you may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the medication packaging and leaflet to the healthcare professional.
If you forget to take Arcoxia
It is important that you take Arcoxia as directed by your doctor. If you miss a dose, simply resume your regular dosing schedule the next day. Do not take a double dose to make up for missed doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If you develop any of the following signs, stop taking Arcoxia and speak to your doctor immediately (see section 2. What you need to know before taking Arcoxia):
- difficulty breathing, chest pain or ankle swelling, or if these worsen
- yellowing of the skin and eyes (jaundice) – these are signs of liver problems
- severe or persistent stomach pain or if your stools become black
- an allergic reaction – which may include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue or throat that may cause difficulty breathing
The frequency of the possible adverse effects listed below is defined according to the following convention:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
The following adverse effects may occur during treatment with Arcoxia:
Very common:
- stomach pain
Common:
- dry socket (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 heart rhythm (arrhythmia)
- high blood pressure
- breathlessness or difficulty breathing (bronchospasm)
- constipation, flatulence (excessive gas), gastritis (inflammation of the inner lining of the stomach), heartburn, diarrhoea, indigestion (dyspepsia)/stomach discomfort, nausea, vomiting, inflammation of the oesophagus, mouth ulcers
- changes in liver blood tests
- bruising
- weakness and fatigue, flu-like illness
Uncommon:
- gastroenteritis (inflammation of the gastrointestinal tract affecting both stomach and small intestine/gastric flu), cold, urinary tract infection
- changes in laboratory results (reduced number of red blood cells, reduced number of white blood cells, decreased platelets)
- hypersensitivity (allergic reaction including hives, which may be severe enough to require immediate medical attention)
- increased or decreased appetite, weight gain
- anxiety, depression, decreased mental alertness; seeing, feeling or hearing things that are not there (hallucinations)
- altered taste, inability to sleep, numbness or tingling, drowsiness
- blurred vision, eye irritation and redness
- ringing in the ears, vertigo (sensation of spinning while stationary)
- abnormal heart rhythm (atrial fibrillation), rapid heartbeat, heart failure, sensation of tightness, pressure or heaviness in the chest (angina pectoris), myocardial infarction
- flushing, stroke, mini-stroke (transient ischaemic attack), severe increase in blood pressure, inflammation of blood vessels
- cough, shortness of breath, nosebleed
- stomach swelling, changes in bowel habits, dry mouth, stomach ulcer, inflammation of the inner lining of the stomach which may become severe and lead to bleeding, irritable bowel syndrome, inflammation of the pancreas
- facial swelling, skin rash or itching, skin redness
- muscle cramp/spasm, muscle pain/stiffness
- elevated potassium levels in your blood, changes in blood or urine tests related to your kidneys, serious kidney problems
- chest pain
Rare:
-
angioedema (allergic reaction with swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing, which may be severe enough to require immediate medical attention)/anaphylactic/anaphylactoid reactions including shock (severe allergic reaction requiring immediate medical attention)
-
confusion, restlessness
-
liver problems (hepatitis)
-
low sodium levels in the blood
-
liver impairment, yellowing of the skin and/or eyes (jaundice)
-
severe skin reactions
Reporting of adverse effects: If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of ARCOXIA
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
Bottles: keep the container tightly closed to protect it from moisture.
Blister packs: store in the original packaging to protect it from moisture.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.