Etoricoxib Doc Generici

Package leaflet: Information for the user

ETORICOXIB DOC Generici 60 mg film-coated tablets, 90 mg film-coated tablets, 120 mg film-coated tablets

Equivalent medicine
Please 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What ETORICOXIB DOC Generici is and what it is used for
2. What you need to know before taking ETORICOXIB DOC Generici
3. How to take ETORICOXIB DOC Generici
4. Possible side effects
5. How to store ETORICOXIB DOC Generici
6. Contents of the pack and other information

1. What ETORICOXIB DOC Generici is and what it is used for

• ETORICOXIB DOC Generici contains the active substance etoricoxib and 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).
• Etoricoxib helps reduce pain and swelling (inflammation) in the joints and muscles of people over 16 years of age with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.
• Etoricoxib is also used for the short-term treatment of moderate pain following dental surgery in people over 16 years of age.

What is osteoarthritis?
Osteoarthritis is a disease of the joints. It is caused by the progressive deterioration of the cartilage covering 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 disease of the joints. It causes pain, stiffness, swelling, and progressive loss of movement 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 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 DOC Generici

Do not take ETORICOXIB DOC Generici:

• 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 and COX-2 inhibitors (see section 4 “Possible side effects”)
• if you currently have a stomach ulcer or active bleeding in the stomach or intestine
• 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 an 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 nurse if you are unsure whether your blood pressure is adequately controlled), or if your doctor has diagnosed heart problems such as heart failure (moderate or severe), angina (chest pain)
• if you have had a heart attack; or if you have undergone coronary artery bypass surgery; if you have had peripheral arterial disease (reduced circulation in legs and feet due to narrowed or blocked blood vessels)
• if you have ever had any type of stroke (including mini-stroke, transient ischemic attack or TIA). Etoricoxib may slightly increase the risk of heart attack and stroke; for this reason, it should not be used in people who have already had heart problems or stroke.

If you think any of these conditions apply to you, do not take these tablets before
consulting your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking etoricoxib if:

• you have a history of stomach bleeding or stomach ulcers
• you are dehydrated , for example due to prolonged vomiting or diarrhea
• 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, 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 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
• if you are over 65 years of age .

If you have any doubts about any of the conditions mentioned above, discuss them with your doctor before
taking etoricoxib to determine whether this medicine is suitable for you.
Etoricoxib has the same efficacy in younger and older patients. If you are elderly (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 DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
In particular, if you are taking any of the following medicines, your doctor may require monitoring to ensure these medicines remain effective after you start taking ETORICOXIB DOC Generici:

• blood thinners (anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a drug used for immune system suppression and often used in the treatment of rheumatoid arthritis)
• ciclosporin or tacrolimus (drugs used for immune system suppression), lithium (a drug used for certain types of depression)
• drugs used for high blood pressure and heart failure called ACE inhibitors and angiotensin receptor blockers, such as enalapril and ramipril , and losartan and valsartan
• diuretics
• digoxin (a drug for the treatment of heart failure and irregular heartbeat)
• minoxidil (a drug for the treatment of high blood pressure)
• oral salbutamol tablets or oral solution (a drug for the treatment of asthma)
• oral contraceptives (the combination may increase the risk of side effects)
• hormone replacement therapy (the combination may increase the risk of side effects)
• aspirin (acetylsalicylic acid) the risk of stomach ulcers is higher if you take etoricoxib with aspirin.
  • aspirin for prevention of heart attacks and strokes: etoricoxib may be taken with low-dose aspirin. If you are being treated with low-dose aspirin for prevention of heart attacks or strokes, do not stop taking aspirin without consulting your doctor
  • aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs): do not take high doses of aspirin or other NSAIDs while taking

etoricoxib.
ETORICOXIB DOC Generici with food and drink
The onset of etoricoxib's effect may be faster when taken without food.
Pregnancy, breastfeeding and fertility
Pregnancy
Etoricoxib tablets should not be taken during pregnancy.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding with
breast milk, do not take this medicine.
If you become pregnant, stop taking this medicine and consult your doctor.
If you are unsure or need further information, consult your doctor or pharmacist.
Breastfeeding
It is not known whether etoricoxib is excreted in human milk. If you are breastfeeding or plan to breastfeed,
contact your doctor before taking etoricoxib. If you are using etoricoxib, you should not breastfeed.
Fertility
Etoricoxib tablets are not recommended for women planning pregnancy.
Driving and using machines
Some patients who have taken etoricoxib have reported dizziness and drowsiness.
Do not drive if you experience dizziness or drowsiness.
Do not operate tools or machinery if you experience dizziness or drowsiness.
ETORICOXIB DOC Generici contains lactose
ETORICOXIB DOC Generici contains lactose, a milk sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take ETORICOXIB DOC Generici

Take this medicine exactly as your doctor has told you. If you have any doubts,
consult your doctor or pharmacist.
Do not take more than the recommended dose for the treatment of your condition. Your doctor will
periodically evaluate the treatment. It is important that you use the lowest effective dose capable of controlling your
pain and that you do not take etoricoxib for longer than necessary. This is because the risk of heart
attacks and strokes may increase with prolonged treatment, especially at high doses.
This medicine is available in different strengths, and your doctor will prescribe the appropriate
dose based on your condition.
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 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, for a
maximum of 8 days of treatment.
Postoperative dental surgery pain
The recommended dose is 90 mg once daily, for 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.

Children and adolescents
Etoricoxib must not be used in children or adolescents under 16 years of age.
Elderly
Dosage adjustment is not required in the elderly. As with other medicines, caution is necessary when
administering this medicine to elderly patients.
Method of administration
Etoricoxib is for oral use. Take the tablets once daily. Etoricoxib may be taken with or without food.
If you take more ETORICOXIB DOC Generici than you should
Never take more tablets than recommended by your doctor. If you take too many
etoricoxib tablets, contact a doctor immediately.
If you forget to take ETORICOXIB DOC Generici
It is important to follow the etoricoxib dose prescribed by your doctor. If you forget a dose,
simply resume your usual dosing schedule the next day. Do not take a double dose to make up for
the missed 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 everybody gets them.
If you experience any of the following symptoms, you must stop treatment with ETORICOXIB DOC Generics and immediately contact your doctor:

• 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 signs 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:

Very common side effects (may occur in more than 1 in 10 people)

• stomach pain

Common side effects (may occur in up to 1 in 10 people)

• alveolitis (inflammation and pain following 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 (bronchospasm)
• constipation, flatulence (excess gas), gastritis (inflammation of the inner stomach lining), heartburn, diarrhoea, difficulty digesting (dyspepsia)/stomach discomfort, nausea, vomiting, inflammation of the oesophagus, mouth ulcers
• changes in certain blood tests related to liver function
• bruising
• weakness and fatigue, flu-like illness

Uncommon side effects (may occur in up to 1 in 100 people)

• gastroenteritis (inflammation of the gastrointestinal tract involving both the stomach and small intestine), upper respiratory tract infection, urinary tract infection
• 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 hives, 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, shortness of breath, 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 itchy skin, 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, severe kidney problems
• chest pain

Rare side effects (may occur in up to 1 in 1000 people)

• angioedema (an allergic reaction with swelling of the face, lips, tongue and/or throat which may cause difficulty 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 sodium levels 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
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ETORICOXIB DOC Generics

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 that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What ETORICOXIB DOC Generics contains

• The active substance is etoricoxib. Each film-coated tablet contains 60 mg, 90 mg or 120 mg of etoricoxib.
• The other components are:
  Tablet core: microcrystalline cellulose (E460), magnesium stearate (E572), sodium croscarmellose (E468), anhydrous dicalcium phosphate (E341).
  Tablet coating: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518).

Description of the appearance of ETORICOXIB DOC Generics and contents of the pack

ETORICOXIB DOC Generics tablets are available in three strengths:
60 mg tablets: white, round (approximately 8 mm), engraved with ‘E90X’ on one side and ‘60’ on the other;
90 mg tablets: white, round (approximately 9 mm), engraved with ‘E90X’ on one side and ‘90’ on the other;
120 mg tablets: white, round (approximately 10 mm), engraved with ‘E90X’ on one side and ‘120’ on the other.

ETORICOXIB DOC Generics 60 mg film-coated tablets: 20 tablets
ETORICOXIB DOC Generics 90 mg film-coated tablets: 20 tablets
ETORICOXIB DOC Generics 120 mg film-coated tablets: 5 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan – Italy

Manufacturer
Synthon s.r.o. - Blansko, Brnenskà 32/cp. 597 - 67801 Blansko - Czech Republic
Synthon Hispania SL - C/Castellò n. 1, Pol. Las Salinas, Sant Boi de Llobregat - 08830 Barcelona – Spain