Etoricoxib Zentiva: detailed information

Package leaflet: Information for the patient

Etoricoxib Zentiva 60 mg film-coated tablets, 90 mg film-coated tablets

Generic medicine
Please read 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, because it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Etoricoxib Zentiva is and what it is used for
What you need to know before taking Etoricoxib Zentiva
How to take Etoricoxib Zentiva
Possible side effects
How to store Etoricoxib Zentiva
Contents of the pack and other information

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

Etoricoxib Zentiva contains the active substance etoricoxib. Etoricoxib Zentiva 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 Zentiva helps to 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.
Etoricoxib Zentiva 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 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 disease 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 Zentiva

Do not take Etoricoxib Zentiva:

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 acetylsalicylic acid and COX-2 inhibitors (see “Possible side effects”, section 4).
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 might 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 pharmacist if you are unsure whether your blood pressure is adequately controlled).
if your doctor has diagnosed you with heart problems such as heart failure (moderate or severe), angina (chest pain).
if you have had a heart attack, or have undergone coronary artery bypass surgery, or if you have peripheral arterial disease (reduced circulation to legs and feet due to narrowed or blocked blood vessels).
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 must not be used in people who have already had heart problems or a 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 Zentiva 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 Zentiva may increase blood pressure, especially at high doses, 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. Etoricoxib Zentiva 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 whether any of the conditions listed above may apply to you, talk to your doctor
before taking Etoricoxib Zentiva to check whether the medicine is suitable for you.
Etoricoxib Zentiva has the same efficacy in older patients as in younger ones. 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 16 years of age.
Other medicines and Etoricoxib Zentiva
Inform 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 require monitoring to check whether these medicines are working properly once you have started taking Etoricoxib Zentiva:

medicines that thin the blood (anticoagulants), such as warfarin
rifampicin (an antibiotic)
methotrexate (a medicine used for immune system suppression and often used in the treatment of rheumatoid arthritis)
ciclosporin or tacrolimus (medicines used for immune system suppression)
lithium (a medicine used to treat certain types of depression)
medicines used to 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 for the treatment of heart failure and irregular heartbeat)
minoxidil (a medicine for the treatment of high blood pressure)
salbutamol tablets or oral solution (a medicine for the treatment of asthma)
oral contraceptive pill (the combination may increase the risk of side effects)
hormone replacement therapy (the combination may increase the risk of side effects)
acetylsalicylic acid; the risk of stomach ulcers is higher if you take Etoricoxib Zentiva with acetylsalicylic acid
acetylsalicylic acid for the prevention of heart attacks or strokes: Etoricoxib Zentiva may be taken with low-dose acetylsalicylic acid. If you are being treated with low-dose acetylsalicylic acid for the prevention of heart attacks or strokes, do not stop treatment with acetylsalicylic acid without consulting your doctor
acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs): do not take high doses of acetylsalicylic acid or other NSAIDs while taking Etoricoxib Zentiva.

Etoricoxib Zentiva with food and drink
The onset of action of Etoricoxib Zentiva may be faster when taken without food.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Etoricoxib Zentiva must not be taken during pregnancy. If you are pregnant, think you may be pregnant, or are planning to 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 further information, consult your doctor.
Breastfeeding
It is not known whether Etoricoxib Zentiva is excreted in human milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Etoricoxib Zentiva. If you are taking Etoricoxib Zentiva, you must not breastfeed.
Fertility
Etoricoxib Zentiva is not recommended for women intending to become pregnant.
Driving and using machines
Some patients taking Etoricoxib Zentiva 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.

3. How to take Etoricoxib Zentiva

Take this medicine exactly as your doctor has instructed you. If you have any doubts, consult your
doctor or pharmacist.
Do not take more than the recommended dose for your condition. Your doctor will periodically assess
your treatment. It is important that you use the lowest effective dose to control your pain and that you do not take Etoricoxib Zentiva 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 most appropriate strength.
The recommended dose is:
Osteoarthritis
The recommended dose is 30 mg once daily (this dosage is not available with Etoricoxib Zentiva), which
can 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 can 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 can 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 (equivalent to 2 tablets of Etoricoxib Zentiva 60 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, 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 (in this case, use an
alternative medicine to Etoricoxib Zentiva, as this product does not come in such a low dosage).
Use in children and adolescents
Etoricoxib Zentiva must not be taken by children or adolescents under 16 years of age.
Elderly
Dose adjustment is not required in elderly patients. However, caution should be exercised in elderly
patients.
Method of administration
Etoricoxib Zentiva is for oral use. Take the tablets once daily. Etoricoxib Zentiva can be taken with or
without food.
If you take more Etoricoxib Zentiva than you should
Never take more tablets than recommended by your doctor. If you take too many tablets of Etoricoxib
Zentiva, contact a doctor immediately.
If you forget to take Etoricoxib Zentiva
It is important to take Etoricoxib Zentiva as prescribed by your doctor. If you miss a dose, simply take
your next dose at the usual time according to your regular schedule. Do not take a double dose to make
up for a forgotten dose.
If you have any questions about the use of this medicine, ask 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 Zentiva and contact your doctor immediately (see "What you should know before taking Etoricoxib Zentiva", section 2):

shortness of breath, chest pain, or swelling of the ankles that develop or 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 Zentiva:
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 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 in digestion (dyspepsia)/stomach discomfort, nausea, malaise (vomiting), inflammation of the oesophagus, mouth ulcers,
changes in certain blood tests related to liver function,
bruising,
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/gastrointestinal flu), upper respiratory tract infection, urinary tract infection,
abnormal laboratory tests (decreased number of red blood cells in the blood, decreased number of white blood cells in the blood, decreased 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, inability to sleep, tingling or numbness, drowsiness,
blurred vision, eye irritation and redness,
ringing in the ears, vertigo (sensation of spinning while remaining still),
abnormal heart rhythm (atrial fibrillation), increased heart rate, heart failure, non-specific changes in ECG, 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 swelling, 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 itching, redness of the skin,
muscle cramps/spasms, muscle pain/stiffness,
high levels of potassium in the blood, changes in certain blood or urine tests related to kidney function, serious kidney problems, increased levels of uric acid and creatine phosphokinase,
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 (these reactions may include ulcers of the mouth, throat, nose and genitals; the skin rash may progress with widespread blistering and peeling of the skin).

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/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Etoricoxib Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP. 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Etoricoxib Zentiva contains
The active substance is etoricoxib.
Each film-coated tablet contains 60 mg or 90 mg of etoricoxib.
The other components are:
Tablet core: dibasic calcium phosphate anhydrous, microcrystalline cellulose, croscarmellose sodium,
anhydrous colloidal silica, talc, magnesium stearate.
Tablet coating: hypromellose, hydroxypropylcellulose, macrogol 6000, talc, titanium dioxide E171.
The 60 mg tablets also contain brown iron oxide E172 and the 90 mg tablets also contain yellow iron oxide E172.

Description of the appearance of Etoricoxib Zentiva and package contents
Etoricoxib Zentiva 60 mg film-coated tablets:
Light brown, round, biconvex, film-coated tablets with a diameter of approximately 8 mm.
Etoricoxib Zentiva 90 mg film-coated tablets:
Light yellow, round, biconvex, film-coated tablets with a diameter of approximately 9 mm.

Pack sizes:
Etoricoxib Zentiva 60 mg and 90 mg film-coated tablets:
7, 14, 20, 28, 50, 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Zentiva Italia S.r.l. – Viale L. Bodio 37/B, 20158 Milan, Italy

Manufacturers:
Zentiva k.s.,
U Kabelovny 130,
Dolní Měcholupy, 102 37 Prague
Czech Republic
Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park, Paola
PLA3000 Malta
Winthrop Arzneimittel GmbH
Brüningstraße 50
65926 Frankfurt am Main
Germany

This medicinal product is authorised in other EEA Member States under the following names:
Estonia, Germany, Italy, Lithuania, Latvia, Malta, Portugal: Etoricoxib Zentiva
Bulgaria: Долоксиб
Poland, Romania: Doloxib
Spain, United Kingdom: Etoricoxib