Etoricoxib PensA: detailed information

Package leaflet: Information for the user

ETORICOXIB PENSA 60 mg film-coated tablets, 90 mg film-coated tablets, 120 mg film-coated tablets

Etoricoxib
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 side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What ETORICOXIB PENSA is and what it is used for

What is ETORICOXIB PENSA?

ETORICOXIB PENSA contains the active substance etoricoxib. ETORICOXIB PENSA 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 ETORICOXIB PENSA used for?

ETORICOXIB PENSA helps reduce pain and swelling (inflammation) in the joints and muscles of people aged 16 years and older who have osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, or gout.
ETORICOXIB PENSA is also used for the short-term treatment of moderate pain following dental surgery in people aged 16 years and older.

What is osteoarthritis (OA)?
Osteoarthritis is a joint disease. It is caused by the progressive breakdown 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 joint movement. 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 in the joints. It is caused by the deposition of mineral crystals in the joints.
What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease affecting the spine and large joints.

2. What you need to know before taking ETORICOXIB PENSA

Do not take ETORICOXIB PENSA:

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 section 4, Possible side effects)
if you currently have a stomach ulcer or active bleeding in the stomach or intestines
if you have severe liver disease
if you have severe kidney disease
if you are pregnant or suspect 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 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 circulation in legs and feet due to narrowed or blocked arteries)
if you have ever had a stroke (including mini-stroke, transient ischemic 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 apply to you, do not take these tablets before consulting your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking ETORICOXIB PENSA 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 PENSA, especially at high doses, may increase blood pressure; 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 PENSA 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 PENSA to confirm whether this medicine is suitable for you.

ETORICOXIB PENSA has the same efficacy 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 and adolescents under 16 years of age.

Other medicines and ETORICOXIB PENSA

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 once you start taking ETORICOXIB PENSA:

blood-thinning medicines (anticoagulants), such as warfarin
rifampicin (an antibiotic)
methotrexate (a medicine used to suppress the immune system and often used in the treatment of rheumatoid arthritis)
ciclosporin 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
digoxin (a medicine for the treatment of heart failure and irregular heartbeat)
minoxidil (a medicine used to treat high blood pressure)
oral 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 ETORICOXIB PENSA with aspirin.
- aspirin for the prevention of heart attacks or strokes: ETORICOXIB PENSA may be taken with a low dose of aspirin. If you are being treated with low-dose aspirin to prevent heart attacks or strokes, do not stop taking aspirin without consulting your doctor.
- aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs): You must not take a high dose of aspirin or other NSAIDs while taking ETORICOXIB PENSA.

ETORICOXIB PENSA with food and drink

The onset of action of ETORICOXIB PENSA may be faster when taken without food.

Pregnancy, breastfeeding and fertility

Pregnancy

ETORICOXIB PENSA tablets must not be taken during pregnancy. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, 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 PENSA is excreted in human milk. If you are breastfeeding or planning to breastfeed, contact your doctor before taking ETORICOXIB PENSA. If you are using ETORICOXIB PENSA, you must not breastfeed.

Fertility

ETORICOXIB PENSA is not recommended for women intending to become pregnant.

Driving or using machinery

Dizziness and drowsiness have been reported in patients taking ETORICOXIB PENSA. 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 PENSA

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Do not take more than the recommended dose for your condition. Your doctor will periodically review your treatment. It is important that you take the lowest effective dose needed to control your pain and that you do not take ETORICOXIB PENSA for longer than necessary. This is because the risk of heart attack and stroke may increase with prolonged use, especially at higher doses.
Different strengths of this medicine are available, and your doctor will prescribe the dose appropriate for 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 for the duration of acute pain.

Gout:

The recommended dose is 120 mg once daily, which should be used only during the period of acute pain and 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 PENSA 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 used when treating elderly patients.

Method of administration
ETORICOXIB PENSA is for oral use. Take the tablets once daily. ETORICOXIB PENSA may be taken with or without food.

If you take more ETORICOXIB PENSA than you should
Never take more tablets than your doctor has recommended. If you take too many tablets of ETORICOXIB PENSA, contact a doctor immediately.

If you forget to take ETORICOXIB PENSA
It is important to take ETORICOXIB PENSA as prescribed by your doctor. If you forget a dose, simply take your next dose at the usual time. Do not take a double dose to make up for the missed tablet.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience any of the following symptoms, you must stop treatment with ETORICOXIB PENSA and
contact your doctor immediately (see “What you should know before taking ETORICOXIB PENSA”,
section 2):

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 cause difficulty breathing.

The frequency of the 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 in 100 people)
Uncommon (affects 1 to 10 in 1,000 people)
Rare (affects 1 to 10 in 10,000 people)
Very rare (affects less than 1 in 10,000 people)

The following side effects may occur during treatment with ETORICOXIB PENSA:

Very common

stomach pain

Common

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, indigestion (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:

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 (decrease in red blood cell count, decrease in white blood cell count, 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 that are not real (hallucinations)
altered taste, difficulty sleeping, tingling or numbness, drowsiness
blurred vision, eye irritation and redness
ringing in the ears, vertigo (a sensation of dizziness while remaining still)
abnormal heart rhythm (atrial fibrillation), increased heart rate, heart failure, feeling 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 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, severe kidney problems
chest pain

Rare

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 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: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ETORICOXIB PENSA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What ETORICOXIB PENSA contains

The active substance is etoricoxib.

Each film-coated tablet contains 60 mg of etoricoxib.
Each film-coated tablet contains 90 mg of etoricoxib.
Each film-coated tablet contains 120 mg of etoricoxib.
The other components are:
Tablet core: Microcrystalline Cellulose (E460), Calcium Hydrogen Phosphate (anhydrous),
Sodium Croscarmellose, Magnesium Stearate (E470).
Tablet coating: Polyvinyl Alcohol (E1203), Titanium Dioxide (E171), Glycerol Monostearate (E471),
Indigotine Aluminium Lake (E132) [only for 60 mg and 120 mg], Iron Oxide Yellow (E172) [only for 60 mg and 120 mg], Talc (E553b), Sodium Lauryl Sulfate.

What ETORICOXIB PENSA looks like and contents of the pack

Film-coated tablet.
ETORICOXIB PENSA 60 mg film-coated tablets
Film-coated, biconvex, dark green, apple-shaped tablet, engraved with '60' on one side and smooth on the other, size 7.1 x 7.3 mm ± 7.5%.
ETORICOXIB PENSA 90 mg film-coated tablets
Film-coated, biconvex, white, apple-shaped tablet, engraved with '90' on one side and smooth on the other, size 8.1 x 8.3 mm ± 7.5%.
ETORICOXIB PENSA 120 mg film-coated tablets
Film-coated, biconvex, light green, apple-shaped tablet, engraved with '120' on one side and smooth on the other, size 8.9 x 9.2 mm ± 7.5%.
ETORICOXIB PENSA film-coated tablets are available in perforated single-dose blisters.
For 60 mg:
7x1, 20x1, 28x1 film-coated tablets
For 90 mg:
7x1, 20x1, 28x1 film-coated tablets
For 120 mg:
5x1, 7x1, 28x1 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan
Italy

Manufacturer
Rontis Hellas Medical and Pharmaceutical Products S.A.
Larissa Industrial Area, P.O. Box 3012
Larissa 41500
Greece

This medicinal product is authorized in the European Economic Area countries under the following names:
Portugal: Etoricoxib toLife
Italy:
Etoricoxib Pensa 60 mg film-coated tablets
Etoricoxib Pensa 90 mg film-coated tablets
Etoricoxib Pensa 120 mg film-coated tablets
Spain:
Etoricoxib Pensa 30 mg film-coated tablets EFG
Etoricoxib Pensa 60 mg film-coated tablets EFG
Etoricoxib Pensa 90 mg film-coated tablets EFG
Etoricoxib Pensa 120 mg film-coated tablets EFG