TAUXIB 60 mg Фильм-Coated Таблетки

Содержание инструкции

1. TAUXIB 30 mg film-coated tablets, 60 mg film-coated tablets, 90 mg film-coated tablets, 120 mg film-coated tablets
   1. What TAUXIB is and what it is used for
   2. What you need to know before taking TAUXIB
   3. How to take TAUXIB
   4. Possible side effects
   5. How to store TAUXIB
   6. Package contents and other information

TAUXIB 30 mg film-coated tablets, 60 mg film-coated tablets, 90 mg film-coated tablets, 120 mg film-coated tablets

Etoricoxib

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What TAUXIB is and what it is used for

What is TAUXIB?

• TAUXIB contains the active ingredient etoricoxib. TAUXIB 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 TAUXIB used for?
• TAUXIB helps to reduce pain and swelling (inflammation) in the joints and muscles of people aged 16 years and over with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout.
• TAUXIB is also used for the short-term treatment of moderate pain following dental surgery in people aged 16 years and over.

What is osteoarthritis (OA)?
Osteoarthritis is a disease of the joints. It is caused by the progressive deterioration of the cartilage
that covers the ends of the bones. This results in 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 can also cause
inflammation in other parts of the body.

What is gout?
Gout is a disease with sudden and recurrent attacks of very painful and reddening
inflammation 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 TAUXIB

Do not take TAUXIB:

• 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 an active stomach ulcer or active bleeding from the stomach or intestine
• if you have a severe liver disease
• if you have a severe kidney disease
• if you are pregnant or there is a possibility that you are pregnant, or if you are breastfeeding (see “Pregnancy, breastfeeding and fertility”)
• if you are under the age of 16
• 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 (ask your doctor or pharmacist if you are not sure if your blood pressure is adequately controlled)
• if your doctor has diagnosed you with heart problems including heart failure (moderate or severe grade), angina (chest pain)
• if you have had a heart attack, coronary artery bypass surgery, peripheral artery disease (reduced circulation in the legs and feet due to narrowed or blocked arteries)
• if you have had any type of stroke (including mini-stroke, transient ischemic attack or TIA). Etoricoxib may slightly increase the risk of heart attack and stroke and for this reason it should not be used in people who have already had heart problems or stroke.

If you think that 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 TAUXIB if:

• You have a history of bleeding or stomach ulcers.
• You are dehydrated, for example due to a prolonged episode of 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 TAUXIB, especially at high doses, may increase blood pressure, and your doctor will periodically check your blood pressure.
• You have a history of liver or kidney disease.
• You are being treated for an infection. TAUXIB may mask or hide a fever, which is a sign of infection.
• You have diabetes, high cholesterol or a smoking habit. 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 just mentioned, talk to your doctor before taking
TAUXIBto verify if the medicine is suitable for you.
TAUXIB has the same efficacy in both 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 and adolescents under the age of 16.

Other medicines and TAUXIB
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those you can buy without a prescription.
In particular, if you are taking any of the following medicines, your doctor may require
checks to see if these medicines are working well once you have started taking
TAUXIB:

• medicines that thin the blood (anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a medicine used for the suppression of the immune system and often used in the treatment of rheumatoid arthritis)
• cyclosporine or tacrolimus (medicines used for the suppression of 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, such as enalapril and ramipril, and losartan and valsartan
• diuretics
• digoxin (a medicine for the treatment of heart failure and irregular heartbeat)
• minoxidil (a medicine used to treat high blood pressure)
• salbutamol tablets or oral solution (a medicine for the treatment of 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 TAUXIB with aspirin.
• aspirin for the prevention of heart attacks or stroke: TAUXIB can be taken with a low doseof aspirin. If you are being treated with low-dose aspirin for the prevention of heart attacks or stroke, you should not stop the aspirin treatment without consulting your doctor.
• aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs): You should not take a high doseof aspirin or anti-inflammatory medicines while taking TAUXIB.

TAUXIBwith food and drink
The onset of the effect of TAUXIB may be faster when taken without food.

Pregnancy, breastfeeding and fertility

Pregnancy
TAUXIB tablets should not be taken during pregnancy. If you are pregnant or suspect you are
pregnant, or if you think you may 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 about this,
consult your doctor.

Breastfeeding
It is not known whether TAUXIB is excreted in human milk. If you are breastfeeding or planning to breastfeed,
contact your doctor before taking TAUXIB. If you are using TAUXIB you should not breastfeed.

Fertility
TAUXIB is not recommended in women who are trying to become pregnant.

Driving and operating machinery
Some patients taking TAUXIB 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.

TAUXIB contains lactose
If your doctor has told you that you are unable to tolerate some sugars, contact your doctor before taking
this medicine.

3. How to take TAUXIB

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
Do not take more than the recommended dose for treating your condition. Your doctor will periodically assess
your treatment. It is important that you use the lowest dose capable of controlling the pain and
that you do not take TAUXIB for longer than necessary. This is because the risk of heart attacks and strokes may
increase after prolonged treatment, especially with high doses.
There are different strengths available for this medicine and, depending on the condition, your doctor will prescribe the
tablet with the dosage that is appropriate for you.
The recommended dose is:

Osteoarthritis
The recommended dose is 30 mg once a day, which can be increased, if necessary, to a maximum dose
of 60 mg once a day.

Rheumatoid arthritis
The recommended dose is 60 mg once a day, which can be increased, if necessary, to a maximum dose
of 90 mg once a day.

Ankylosing spondylitis
The recommended dose is 60 mg once a day, which can be increased, if necessary, to a maximum dose
of 90 mg once a day.

Acute pain conditions
Etoricoxib should only be used for the duration of the acute pain.

Gout
The recommended dose is 120 mg once a day, which should only be used for the duration of the
acute pain, limited to a maximum of 8 days of treatment.

Postoperative pain fromdental surgery
The recommended dose is 90 mg once a day, limited to a maximum of 3 days of
treatment.

People with liver problems

• If you have mild liver disease, you should not take more than 60 mg per day.
• If you have moderateliver disease, you should not take more than 30 mg per day.

Use in children and adolescents
TAUXIB tablets should not be taken by children or adolescents under 16 years of age.

Elderly
No dose adjustments are necessary in elderly patients. As with other medicines, caution should be exercised
in elderly patients.
Method of administration
TAUXIB is for oral use. Take the tablets once a day. TAUXIB can be taken with or
without food.

If you take more TAUXIB than you should
You should never take more tablets than recommended by your doctor. If you take too many tablets of
TAUXIB, contact a doctor immediately.

If you forget to take TAUXIB
It is important to adhere to the dose of TAUXIB indicated by your doctor. If you forget a dose, the next
day simply resume your usual dosing schedule. Do not take a double dose to make up for the
tablet you forgot.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

If you experience any of the following symptoms, stop taking TAUXIB and immediately contact your doctor (see “What you need to know before taking TAUXIB”,
paragraph 2):

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

The frequency of possible side effects listed below is defined using the following convention:
Very common (affects more than 1 in 10 people)
Common (affects 1 to 10 people in 100)
Uncommon (affects 1 to 10 people in 1,000)
Rare (affects 1 to 10 people in 10,000)
Very rare (affects less than 1 in 10,000)
The following side effects may occur during treatment with TAUXIB:

Very Common:

• stomach pain

Common:

• alveolitis (inflammation and pain after a tooth extraction)
• swelling of the legs and/or feet due to fluid retention (edema)
• 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 stomach lining), heartburn, diarrhea, difficulty digesting food (dyspepsia)/stomach discomfort, nausea, vomiting, inflammation of the esophagus, mouth ulcers
• changes in some blood tests related to liver function
• bruising
• weakness and fatigue, flu-like illness

Uncommon:

• gastroenteritis (inflammation of the gastrointestinal tract involving both the stomach and small intestine), upper respiratory tract infection, urinary tract infection
• changes in laboratory test values (decreased number of red blood cells, decreased number of white blood cells, decreased platelets)
• hypersensitivity (an allergic reaction including hives that may be severe enough to require immediate medical attention)
• increases or decreases in appetite, weight gain
• anxiety, depression, decreased mental acuity, 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 dizziness)
• abnormal heart rhythm (atrial fibrillation), fast heart rate, heart failure, feeling of oppression, pressure or heaviness in the chest (angina pectoris), heart attack
• hot flashes, stroke, mini-stroke (transient ischemic attack), severe increase in blood pressure, inflammation of blood vessels
• cough, shortness of breath, nosebleeds
• bloating or intestinal swelling, changes in bowel habits, dry mouth, stomach ulcer, inflammation of the stomach lining which can become severe and can lead to bleeding, irritable bowel syndrome, inflammation of the pancreas
• facial swelling, skin rash or itching, skin redness
• muscle cramps/spasms, muscle pain/stiffness
• high potassium levels in the blood, changes in some blood or urine tests related to kidney function, severe kidney problems
• chest pain

Rare:

• angioedema (an allergic reaction with swelling of the face, lips, tongue and/or throat that can cause difficulty breathing and swallowing, which may be severe enough to require immediate medical attention)/ anaphylactic/anaphylactoid reactions including shock (a severe allergic reaction that requires 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 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 through the national reporting system at: 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 TAUXIB

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Bottle: keep the container tightly closed to protect the medicine from moisture.
Blister: store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in 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 TAUXIB contains

• The active ingredient is etoricoxib. Each film-coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.
• The other ingredients are: Inside the tablets: anhydrous dibasic calcium phosphate, sodium croscarmellose, 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 iron oxide (colorant E172) and indigotine lacquer (colorant E132).

What TAUXIB looks like and contents of the pack
TAUXIB tablets are available in four formulations:
30 mg tablets biconvex, apple-shaped, green-blue in color, with “ACX 30” inscribed on one side and
‘101’ on the other;
60 mg tablets, biconvex, apple-shaped, dark green in color, with ‘200’ inscribed on one side and smooth
on the other;
90 mg tablets, biconvex, apple-shaped, white in color, with ‘202’ inscribed on one side and smooth
on the other;
120 mg tablets, biconvex, apple-shaped, light green in color, with ‘204’ inscribed on one side and smooth
on the other.
Packs:
30 mg:
Packs of 2, 7, 14, 20, 28, 49, 98 tablets or multi-packs of 98 (2 packs of 49) tablets in
blisters.
60 mg:
Packs of 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98, 100 tablets or multi-packs of 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, must not be swallowed.

90 and 120 mg
Packs of 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 100 tablets or multi-packs of 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, must not be swallowed.
60, 90 and 120 mg
Aluminum/aluminum blisters (single dose) in packs of 50 and 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer
Marketing authorization holder
ADDENDA PHARMA S.r.l.
Viale Shakespeare, 47 - 00144 Rome

Sales concessionaire
SIGMA-TAU Industrie Farmaceutiche Riunite S.p.A.
Via Pontina km 30,400 - 00071 Pomezia (Rome)

Manufacturers
30, 60, 90 and 120 mg
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem,
Netherlands

60, 90 and 120 mg
Merck Sharp & Dohme Ltd.
Shotton Lane
Cramlington
Northumberland NE23 3JU
United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
France
Germany
Italy
Netherlands
Portugal
Spain
Sweden
United Kingdom
TUROX
TAUXIB
ALGIX, TAUXIB, TAUXIB
AUXIB
EXXIV, TUROX
EXXIV, ACOXXEL
TUROX
AUXIB, EXXIV, TUROX, ACOXXEL