Etoricoxib Alter

Italy
Brand name Etoricoxib Alter
Form tablets, film-coated
Active substance / Dosage
ETORICOXIB
Prescription type Prescription only
ATC code
M01AH05
Registration number 045221
Manufacturer LABORATORI ALTER S.R.L.
Etoricoxib Alter tablets, film-coated

Table of Contents

Package leaflet: Information for the user

Etoricoxib Alter 30 mg film-coated tablets, 60 mg film-coated tablets, 90 mg film-coated tablets, 120 mg film-coated tablets

Etoricoxib
Generic medicine
Please read all of this leaflet carefully before 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 their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
    1. What Etoricoxib Alter is and what it is used for
    2. What you need to know before taking Etoricoxib Alter
    3. How to take Etoricoxib Alter
    4. Possible side effects
    5. How to store Etoricoxib Alter
    6. Contents of the pack and other information

1. What Etoricoxib Alter is and what it is used for

Etoricoxib Alter contains the active substance etoricoxib. Etoricoxib Alter belongs to a group
of medicines called selective COX-2 inhibitors. These belong to a family of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
What is Etoricoxib Alter used for?

    • Etoricoxib Alter helps reduce pain and swelling (inflammation) in the joints and muscles in people aged 16 years and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.
    • Etoricoxib Alter 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 is caused by the progressive deterioration of the cartilage that covers the ends of bones. This leads to swelling (inflammation), pain, tenderness, stiffness, and disability. What is rheumatoid arthritis? Rheumatoid arthritis is a long-term inflammatory joint disease. It causes pain, stiffness, swelling, and progressive loss of movement 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 recurrent attacks 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 spine and large joints.

2. What you need to know before taking Etoricoxib Alter

Do not take Etoricoxib Alter:

    • if you are allergic 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 or COX-2 inhibitors (see section 4, "Possible side effects")
    • if you currently have a stomach ulcer or bleeding in your stomach or intestines
    • if you have severe liver disease
    • if you have severe kidney disease
    • if you are pregnant or think you may be pregnant, or if you 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 is not controlled by treatment (consult your doctor or pharmacist 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), angina (chest pain)
    • if you have had a heart attack, coronary artery bypass surgery, or peripheral arterial disease (reduced blood flow to legs and feet due to narrowed or blocked arteries)
    • if you have ever had any type of stroke (including mini-stroke, transient ischaemic attack or TIA). Etoricoxib may slightly increase the risk of heart attack and stroke, and therefore should not be used in people who have already had heart problems or stroke.

If you think any of these conditions applies to you, do not take this medicine until you have consulted your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Etoricoxib Alter if:

    • you have a history of stomach bleeding or stomach ulcers.
    • you are dehydrated, for example due to a prolonged episode 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. In some people, Etoricoxib Alter, especially at high doses, may increase blood pressure, and your doctor will periodically monitor your blood pressure.
    • you have a history of liver or kidney disease.
    • you are being treated for an infection. Etoricoxib Alter may mask or hide fever, which is a sign of infection.
    • you have diabetes, high cholesterol, or are a smoker. These are conditions that may increase your risk of heart disease.
    • you are a woman trying to become pregnant.
    • you are over 65 years of age.

If you have any doubts about any of the conditions listed above, talk to your doctor
before taking Etoricoxib Alter to determine whether the medicine is suitable for you.

Etoricoxib Alter is equally effective in younger and older patients. If you are over 65 years of age, your doctor will monitor you appropriately. No dose adjustment is necessary for patients over 65 years of age.

Children and adolescents

Do not give this medicine to children or adolescents under 16 years of age.

Other medicines and Etoricoxib Alter

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, if you are taking any of the following medicines, your doctor may need to monitor whether these medicines remain effective after you start taking Etoricoxib Alter:

    • medicines that thin the blood (anticoagulants), such as warfarin
    • rifampicin (an antibiotic)
    • methotrexate (a medicine used to suppress the immune system, often used in the treatment of 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 called ACE inhibitors and angiotensin receptor blockers, such as enalapril and ramipril, and losartan and valsartan
    • diuretics (water tablets)
    • digoxin (a medicine used to treat heart failure and irregular heartbeat)
    • minoxidil (a medicine used to treat high blood pressure)
    • oral salbutamol tablets or oral solution (a medicine used to treat asthma)
    • oral contraceptives (combination therapy may increase the risk of side effects)
    • hormone replacement therapy (combination therapy may increase the risk of side effects)
    • aspirin: the risk of stomach ulcers is higher if you take Etoricoxib Alter with aspirin.
    • aspirin for prevention of heart attacks or strokes: Etoricoxib Alter may be taken with a low dose of aspirin. If you are taking low-dose aspirin to prevent heart attacks or strokes, do not stop taking it without consulting your doctor.
    • aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs): you must not take a high dose of aspirin or other anti-inflammatory medicines while taking Etoricoxib Alter.

Etoricoxib Alter with food and drink

The onset of action of Etoricoxib Alter may be faster when taken without food.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Etoricoxib Alter tablets must not be taken during pregnancy. If you are pregnant, suspect you may be pregnant, or think you could become pregnant, do not take the tablets. If you become pregnant, stop taking the tablets and consult your doctor. If you are unsure or need more information, consult your doctor.

Breastfeeding

It is not known whether Etoricoxib Alter is excreted in breast milk. If you are breastfeeding or planning to breastfeed, contact your doctor before taking Etoricoxib Alter. You must not breastfeed while taking Etoricoxib Alter.

Fertility

Etoricoxib Alter is not recommended for women who are trying to become pregnant.

Driving and using machines

Some patients taking Etoricoxib Alter have reported dizziness and drowsiness. Do not drive if you experience dizziness or drowsiness. Do not use tools or machinery if you experience dizziness or drowsiness.

3. How to take Etoricoxib Alter

Take this medicine exactly as prescribed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
Do not take more than the dose recommended for your condition. Your doctor
will periodically review your treatment.
It is important that you use the lowest effective dose needed to control your pain and that you do not take Etoricoxib Alter longer than necessary. This is because the risk of heart attacks and strokes may increase with prolonged treatment, especially at higher doses.
Different strengths of this medicine are available, and depending on your condition, your doctor will prescribe the tablet with the appropriate dose for you.
The recommended dose is:
Osteoarthritis
The recommended dose is 30 mg once daily, which may be increased, if necessary, up to a maximum dose of 60 mg once daily.
Rheumatoid arthritis
The recommended dose is 60 mg once daily, which may be increased, if necessary, up to a maximum dose of 90 mg once daily.
Ankylosing spondylitis
The recommended dose is 60 mg once daily, which may be increased, if necessary, up to a maximum dose of 90 mg once daily.
Acute pain conditions
Etoricoxib should be used only for the duration of acute pain.
Gout
The recommended dose is 120 mg once daily, which should be used only for the duration 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
Etoricoxib Alter tablets must not be taken by children or adolescents under 16 years of age.
Elderly
Dose adjustment is not required in elderly patients. However, as with other medicines, caution should be exercised when treating elderly patients.
Method of administration
Etoricoxib Alter is for oral use. Take the tablets once daily. Etoricoxib Alter may be taken with or without food.
If you take more Etoricoxib Alter than you should
Never take more tablets than recommended by your doctor. If you take too many Etoricoxib Alter tablets, contact a doctor immediately.
If you forget to take Etoricoxib Alter
It is important to take Etoricoxib Alter as directed by your doctor. If you forget a dose, simply take your next dose at the usual time according to your regular dosing schedule.
Do not take a double dose to make up for a forgotten tablet.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following symptoms, you must stop taking Etoricoxib
Alter and contact your doctor immediately (see section 2 “What you need to know before
taking Etoricoxib Alter”):

    • shortness of breath, chest pain, or swelling of the ankles that develop or begin to worsen
    • yellowing of the skin and eyes (jaundice) – these are symptoms of liver problems
    • severe or persistent stomach pain or black stools
    • an allergic reaction – which may include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue, or throat, which may make breathing difficult.

The following side effects may occur during treatment with Etoricoxib Alter:
Very Common (may affect more than 1 in 10 people)

  • stomach pain Common (may affect up to 1 in 10 people)
      • alveolitis (inflammation and pain after dental 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 (bronchospasm)
    • constipation, flatulence (excess gas), gastritis (inflammation of the inner stomach lining), heartburn, diarrhoea, difficulty in digestion (dyspepsia)/stomach discomfort, nausea, vomiting, inflammation of the oesophagus, mouth ulcers
    • changes in certain blood tests related to liver function
    • appearance of bruises
    • weakness and fatigue, flu-like illness

Uncommon (may affect up to 1 in 100 people)

    • gastroenteritis (inflammation of the gastrointestinal tract involving both the stomach and small intestine/intestinal flu), upper respiratory tract infection, urinary tract infection
    • changes in laboratory test values (decrease in the number of red blood cells in the blood, decrease in the number of white blood cells in the blood, decrease in platelets)
    • hypersensitivity (an allergic reaction including urticaria, which may be severe enough to require immediate medical attention)
    • increased or decreased appetite, weight gain
    • anxiety, depression, reduced mental sharpness, visual, sensory or auditory perceptions not caused by real stimuli (hallucinations)
    • altered taste, difficulty sleeping, tingling or numbness, drowsiness
    • blurred vision, eye irritation and redness
    • ringing in the ears, vertigo (persistent sensation of dizziness)
    • abnormal heart rhythm (atrial fibrillation), increased heart rate, heart failure, sensation of tightness, pressure or heaviness in the chest (angina pectoris), heart attack
    • hot flushes, stroke, mini-stroke (transient ischaemic attack), severe increase in blood pressure, inflammation of blood vessels
    • cough, breathlessness, nosebleeds
    • stomach or intestinal bloating, changes in bowel habits, dry mouth, stomach ulcer, inflammation of the inner stomach lining which may become severe and may lead to bleeding, irritable bowel syndrome, inflammation of the pancreas
    • facial swelling, skin rash or skin itching, skin redness
    • muscle cramps/spasms, muscle pain/stiffness
    • elevated potassium levels in the blood, changes in certain blood or urine tests related to kidney function, serious kidney problems
    • chest pain

Rare (may affect up to 1 in 1,000 people)

    • angioedema (an allergic reaction with swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing and swallowing, which may be severe enough to require immediate medical attention)/anaphylactic/anaphylactoid reactions including shock (a severe allergic reaction requiring immediate medical attention)
    • confusion, restlessness
    • liver problems (hepatitis)
    • low levels of sodium in the blood
    • liver failure, yellowing of the skin and/or eyes (jaundice)
    • severe skin reactions

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Etoricoxib Alter

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging (“Exp.”).
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Etoricoxib Alter contains

  • The active substance is etoricoxib. Each film-coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.
  • The other components are:
    Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate.
    Tablet coating: hypromellose, titanium dioxide (E171), glycerol triacetate.
    The 30 mg, 60 mg and 120 mg tablets also contain iron oxide yellow (E172) and indigo carmine lake (E132).

Description of the appearance of Etoricoxib Alter and contents of the pack
Etoricoxib Alter tablets are available in four strengths:

  • 30 mg film-coated tablets, blue-green, round, biconvex.
  • 60 mg film-coated tablets, dark green, round, biconvex.
  • 90 mg film-coated tablets, white, round, biconvex.
  • 120 mg film-coated tablets, light green, round, biconvex.

Etoricoxib Alter is available in the following pack sizes:

  • 30 mg: 28 film-coated tablets
  • 60 mg: 20 and 28 film-coated tablets
  • 90 mg: 2, 20 and 28 film-coated tablets
  • 120 mg: 5 and 7 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Laboratori Alter S.r.l. - Via Egadi 7 - 20144, Milan, Italy.

Manufacturer
Laboratorios Alter S.A.
C/Mateo Inurria, 30, 28036
Madrid (Spain)

This medicinal product is authorised in the European Economic Area countries under the following names:

  • Spain: Etoricoxib Alter 30 mg / 60 mg / 90 mg / 120 mg film-coated tablets EFG
  • Italy: Etoricoxib Alter