Exxiv 90 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
EXXIV 30mg film-coated tablets
EXXIV 60mg film-coated tablets
EXXIV 90mg film-coated tablets
EXXIV 120mg film-coated tablets
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.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may 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 EXXIV is and what it is used for
- What you need to know before taking EXXIV
- How to take EXXIV
- Possible side effects
- How to store EXXIV
- Contents of the pack and other information
1. What Exxiv is and what it is used for
What is Exxiv?
- Exxiv contains the active substance etoricoxib. Exxiv 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 Exxiv used for?
- Exxiv 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.
- Exxiv 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 joint disease. 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 the 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 affecting the spine and large joints.
2. What you need to know before taking EXXIV
Do not take Exxiv
- 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 might be pregnant, or are breastfeeding (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 the legs or feet due to narrowed or blocked arteries)
- if you have had any type of stroke (including transient ischaemic attack or ischaemic stroke).
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 Exxiv 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. Exxiv may increase blood pressure in some people, especially at high doses, and your doctor may want to monitor your blood pressure from time to time.
- You have a history of liver or kidney disease.
- You are being treated for an infection. Exxiv 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 Exxiv to check whether this medicine is suitable for you.
Exxiv works equally well in young and 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 Exxiv
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 Exxiv:
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medicines that thin your blood (anticoagulants), such as warfarin
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rifampicin (an antibiotic)
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methotrexate (a medicine used to suppress the immune system and often used in rheumatoid arthritis)
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cyclosporine or tacrolimus (medicines used to suppress the immune system)
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lithium (a medicine used to treat certain types of depression)
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medicines used to help control high blood pressure and heart failure called ACE inhibitors and angiotensin receptor blockers, for example enalapril and ramipril, and losartan and valsartan
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diuretics ("water tablets")
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digoxin (a medicine for heart failure and irregular heartbeat)
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minoxidil (a medicine used to treat high blood pressure)
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salbutamol tablets or oral solution (a medicine for asthma)
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oral contraceptives (the combination may increase your risk of adverse effects)
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hormone replacement therapy (the combination may increase your risk of adverse effects)
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aspirin — the risk of stomach ulcers is higher if you take Exxiv with aspirin.
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Aspirin for prevention of myocardial infarction or stroke:
Exxiv may be taken with low doses of 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 doses of aspirin or other anti-inflammatory medicines while taking Exxiv.
Taking Exxiv with food and drink
The onset of action of Exxiv may be faster if taken without food.
Pregnancy, breastfeeding and fertility
Pregnancy
Exxiv 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 more information.
Breastfeeding
It is unknown whether Exxiv is excreted in breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Exxiv. If you are taking Exxiv, you must stop breastfeeding.
Fertility
Use of Exxiv is not recommended in women attempting to become pregnant.
Driving and using machines
Dizziness and somnolence have been reported in some patients taking Exxiv.
Do not drive if you experience dizziness or somnolence.
Do not use tools or machines if you experience dizziness or somnolence.
Exxiv contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
Exxiv 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 EXXIV
Follow exactly the instructions given by your doctor for administering this medicine. If in doubt, 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 that you use the lowest dose that controls your pain and that you do not take Exxiv for longer than necessary. This is because the risk of myocardial infarction and stroke 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, increased if necessary to a maximum of 60 mg once daily.
Rheumatoid arthritis
The recommended dose is 60 mg once daily, increased if necessary to a maximum of 90 mg once daily.
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, which should only be used 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 should not take more than 60 mg per day.
- If you have moderate liver disease, you should not take more than 30 mg per day.
Use in children and adolescents
Children and adolescents under 16 years of age must not take Exxiv tablets.
Patients over 65 years of age
No dose adjustment is necessary in patients over 65 years of age. As with other medicines, caution should be exercised in elderly patients.
Method of administration
Exxiv is administered orally. Take the tablets once daily. Exxiv may be taken with or without food.
If you take more Exxiv than you should
You must never take more tablets than your doctor has recommended. If you take too many Exxiv 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 container and package leaflet to the healthcare professional.
If you forget to take Exxiv
It is important that you take Exxiv 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 a missed dose.
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 will experience them.
If you develop any of the following signs, stop taking Exxiv and speak to your doctor immediately (see section 2. What you need to know before you start taking Exxiv):
- 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 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 Exxiv:
Very common:
- stomach pain
Common:
- alveolar osteitis (inflammation and pain following tooth extraction)
- swelling of the legs and/or feet due to fluid retention (oedema)
- dizziness, headache
- palpitations (rapid or irregular heartbeat), irregular heart rhythm (arrhythmia)
- high blood pressure
- wheezing or difficulty breathing (bronchospasm)
- constipation, flatulence (excess gas), gastritis (inflammation of the inner lining of the stomach), heartburn, diarrhoea, indigestion (dyspepsia)/stomach discomfort, nausea, vomiting, oesophagitis, mouth ulcers
- changes in liver blood tests
- bruising
- weakness and fatigue, flu-like illness
Uncommon:
- gastroenteritis (inflammation of the gastrointestinal tract affecting both the stomach and small intestine/gastric flu), cold, urinary tract infection
- changes in laboratory test 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, reduced mental sharpness; seeing, feeling or hearing things that are not there (hallucinations)
- taste disturbance, 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 heart rate, 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 may lead to bleeding, irritable bowel syndrome, pancreatitis
- swelling of the face, 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 which 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 blood
- liver impairment, yellowing of the skin and/or eyes (jaundice)
- serious 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 EXXIV
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the month indicated.
Vials: 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 packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and packaging. This helps protect the environment.
6. Contents of the pack and other information
Composition of Exxiv
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The active substance is etoricoxib. Each film-coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.
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The other components are:
Tablet core: calcium hydrogen phosphate (anhydrous), sodium croscarmellose, magnesium stearate, microcrystalline cellulose.
Tablet coating: carnauba wax, lactose monohydrate, hypromellose, titanium dioxide (E-171), triacetin. The 30, 60 and 120 mg tablets also contain yellow iron oxide (E-172, colouring agent) and indigo carmine lake (E-132, colouring agent).
Nature of the product and contents of the pack
Exxiv tablets are available in four strengths:
Film-coated 30 mg tablets, bluish-green, apple-shaped, biconvex, engraved with ‘ACX 30’ on one side and ‘101’ on the other.
Film-coated 60 mg tablets, dark green, apple-shaped, biconvex, engraved with ‘200’ on one side and smooth on the other.
Film-coated 90 mg tablets, white, apple-shaped, biconvex, engraved with ‘202’ on one side and smooth on the other.
Film-coated 120 mg tablets, pale green, apple-shaped, biconvex, engraved with ‘204’ on one side and smooth on the other.
Pack sizes:
30 mg:
Pack sizes of 2, 7, 14, 20, 28, 49, 98 tablets or multi-packs containing 98 (2 packs of 49) tablets in blisters.
60 mg:
Pack sizes of 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98, 100 tablets or multi-packs containing 98 (2 packs of 49) tablets in blisters; or 30 and 90 tablets in bottles with desiccant. The desiccant (one or two units) in the bottle, used to keep the tablets dry, must not be swallowed.
90 and 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. The desiccant (one or two units) in the bottle, used to keep the tablets dry, must not be swallowed.
60, 90 and 120 mg:
Aluminium/aluminium blisters (single dose) in packs of 50 or 100 tablets.
Only some pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder Organon Salud, S.L. Paseo de la Castellana, 77 28046 Madrid Spain Tel.: 915911279 |
Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands
or
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
This medicinal product is authorized in the European Economic Area member states under the following names:
Italy | EXINEF 30, 60, 90, 120 mg film-coated tablets |
Portugal | EXXIV 30 mg, 60 mg, 90 mg, 120 mg film-coated tablets |
Spain | EXXIV 30, 60, 90, 120 mg film-coated tablets |
Date of the most recent review of this leaflet: 05/2021.
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)