Etoricoxib Stada 120 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Etoricoxib STADA 30 mg film-coated tablets EFG

Etoricoxib STADA 60 mg film-coated tablets EFG

Etoricoxib STADA 90 mg film-coated tablets EFG

Etoricoxib STADA 120 mg film-coated tablets EFG

Read the entire 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 they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

What is Etoricoxib Stada?

• Etoricoxib Stada contains the active substance etoricoxib. Etoricoxib 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 Stada used for?

• Etoricoxib Stada helps 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 Stada 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 disease of the joints. It causes the gradual breakdown of the cartilage that cushions the ends of bones. This leads to swelling (inflammation), pain, tenderness, stiffness, and loss of function.

What is rheumatoid arthritis?

Rheumatoid arthritis is a long-term inflammatory disease of the joints. It causes pain, stiffness, swelling, and progressive loss of mobility in affected joints. It can also cause inflammation in other parts of the body.

What is gout?

Gout is a condition characterized by sudden and recurring attacks of very painful inflammation and redness in the joints.

It is caused by deposits of mineral crystals in the joint.

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 Stada

DO NOT take Etoricoxib Stada:

• 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 or duodenal ulcer or bleeding
• if you have severe liver disease
• if you have severe kidney disease
• if you are or may be pregnant, or are breastfeeding
• 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 uncontrolled high blood pressure (consult your doctor 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 myocardial infarction, surgical revascularization, or peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries)
• if you have had any type of stroke (including transient ischemic attack or ischemic stroke). Etoricoxib may slightly increase your risk of myocardial infarction and stroke, and therefore should not be used in patients who have already had heart problems or a stroke.

If you think any of these apply to you, do not take the tablets until you have consulted your doctor.

Warnings and precautions

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

• You have a history of stomach ulcers or gastrointestinal bleeding.
• You are dehydrated, for example, due to a prolonged illness with 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. Etoricoxib Stada may increase blood pressure in some people, especially at high doses, and your doctor may want to check your blood pressure from time to time.
• You have a history of liver or kidney disease.
• You are being treated for an infection. Etoricoxib Stada may mask or hide fever, which is a sign of infection.
• You have diabetes, high cholesterol, or are a smoker. These may increase your risk of heart disease.
• You are a woman trying to become pregnant.
• You are over 65 years of age.

If you are unsure whether any of the above situations apply to you, talk to your doctor before taking Etoricoxib Stada to confirm whether this medicine is suitable for you.

Etoricoxib Stada works equally well in young and adult patients. If you are over 65 years old, your doctor will want to monitor you appropriately. Dose adjustment is not necessary in patients over 65 years of age.

Children and adolescents

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

Taking Etoricoxib Stada with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

In particular, if you are taking any of the following medicines, your doctor may want to monitor you to ensure your medications are working properly once you start taking Etoricoxib Stada:

• medicines that thin your blood (anticoagulants), such as warfarin

• rifampicin (an antibiotic)

• methotrexate (a medicine used to suppress the immune system and often used in 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 known as ACE inhibitors and angiotensin receptor blockers, for example enalapril and ramipril, losartan and valsartan

• diuretics (water tablets)

• digoxin (a medicine for heart failure and irregular heartbeat)

• minoxidil (a medicine used to treat high blood pressure)

• salbutamol tablets or oral solution (a medicine for asthma)

• oral contraceptives (the combination may increase your risk of adverse effects)

• hormone replacement therapy (the combination may increase your risk of adverse effects)

• acetylsalicylic acid: the risk of stomach ulcers is higher if you take Etoricoxib Stada with acetylsalicylic acid:

• acetylsalicylic acid for prevention of myocardial infarction or stroke:

Etoricoxib Stada may be taken with low-dose acetylsalicylic acid. If you are currently taking low-dose acetylsalicylic acid to prevent myocardial infarction or stroke, do not stop taking acetylsalicylic acid without first talking to your doctor

• acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs):

do not take high doses of acetylsalicylic acid or other anti-inflammatory medicines while taking Etoricoxib Stada.

Taking Etoricoxib Stada with food

The onset of action of Etoricoxib Stada may be faster when taken on an empty stomach.

Pregnancy, breastfeeding and fertility

Pregnancy

Etoricoxib Stada tablets should not be taken during pregnancy. Do not take the tablets if you are pregnant, think you may be pregnant, or plan to become pregnant. If you become pregnant, stop taking Etoricoxib Stada and consult your doctor. Speak to your doctor if you have any doubts or need further information.

Breastfeeding

It is not known whether etoricoxib is excreted in human milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Etoricoxib Stada. If you are taking Etoricoxib Stada, you should not breastfeed.

Fertility

Etoricoxib Stada is not recommended for use in women who are trying to become pregnant.

Driving and using machines

Dizziness and drowsiness have been reported in some patients taking Etoricoxib Stada.

Do not drive if you experience dizziness or drowsiness.

Do not use tools or machines if you experience dizziness or drowsiness.

Etoricoxib Stada contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Etoricoxib Stada contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially "sodium-free".

3. How to take Etoricoxib Stada

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Do not take more than the recommended dose for your condition. Your doctor will want to review your treatment from time to time. It is important to use the lowest dose that controls your pain, and you should not take etoricoxib for longer than necessary. This is because the risk of heart attacks and strokes may increase with prolonged treatment, especially at higher doses.

Different doses of this medicine are available, and depending on your condition, your doctor will prescribe the tablet with the dose appropriate for you.

The recommended dose is:

Osteoarthritis

The recommended dose is 30 mg once daily, increased if necessary to a maximum of 60 mg once daily.

Rheumatoid arthritis

The recommended dose is 60 mg once daily, increased if necessary to a maximum of 90 mg once daily.

Ankylosing spondylitis

The recommended dose is 60 mg once daily, increased if necessary to a maximum of 90 mg once daily.

Acute pain situations

Etoricoxib should only be used 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, 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

Children or adolescents under 16 years of age must not take Etoricoxib tablets.

Patients aged 65 years and over

Dose adjustment is not necessary for patients aged 65 years and over. As with other medicines, caution should be exercised in elderly patients.

Method of administration

Etoricoxib Stada is administered orally. Take the tablets once daily. Etoricoxib Stada can be taken with or without food.

If you take more Etoricoxib Stada than you should

You must never take more tablets than your doctor has recommended. If you take too many Etoricoxib Stada tablets, seek immediate medical attention.

In case of overdose or accidental ingestion, you may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Etoricoxib Stada

It is important that you take Etoricoxib Stada as directed by your doctor. If you miss a dose, simply resume your regular dosing schedule the next day. Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you develop any of the following signs, you must stop taking Etoricoxib Stada and speak to your doctor immediately (see section 2. What you need to know before taking Etoricoxib Stada):

• If you experience shortness of breath, chest pain, or swelling of the ankles, or if these 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 that may cause difficulty breathing

The following adverse effects may occur during treatment with Etoricoxib Stada:

Very common (may affect more than 1 in 10 people):

• Stomach pain

Common (may affect up to 1 in 10 people):

• Alveolar osteitis (inflammation and pain following 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)
• High blood pressure
• Wheezing or difficulty breathing (bronchospasm)
• Constipation, flatulence (excess gas), gastritis (inflammation of the inner lining of the stomach), heartburn, diarrhoea, indigestion (dyspepsia)/stomach discomfort, nausea, vomiting, inflammation of the oesophagus, mouth ulcers
• Changes in blood tests related to your liver
• Bruising
• Weakness and fatigue, flu-like illness

Uncommon (may affect up to 1 in 100 people):

• Gastroenteritis (inflammation of the gastrointestinal tract affecting both the stomach and small intestine/gastric flu), upper respiratory tract infection, urinary tract infection
• Changes in laboratory results (reduced number of red blood cells, reduced number of white blood cells, decreased platelets)
• Hypersensitivity (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; seeing, feeling, or hearing things that are not there (hallucinations)
• Taste disturbance, inability to sleep, numbness or tingling, drowsiness
• Blurred vision, eye irritation and redness
• Ringing in the ears, dizziness (sensation of spinning while standing still)
• Abnormal heart rhythm (atrial fibrillation), rapid heart rate, heart failure, sensation of tightness, pressure, or heaviness in the chest (angina pectoris), myocardial infarction
• Redness, stroke, mini-stroke (transient ischaemic attack), severe increase in blood pressure, inflammation of blood vessels
• Cough, breathlessness, nosebleed
• Stomach swelling, changes in bowel habits, dry mouth, stomach ulcer, inflammation of the inner lining of the stomach that may become severe and lead to bleeding, irritable bowel syndrome, inflammation of the pancreas
• Facial swelling, skin rash or itching, skin redness
• Muscle cramp/spasm, muscle pain/stiffness
• Elevated potassium levels in your blood, changes in blood or urine tests related to your kidneys, serious kidney problems
• Chest pain

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

• Angioedema (allergic reaction with swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing, which may be severe enough to require immediate medical attention)/anaphylactic/anaphylactoid reactions including shock (severe allergic reaction requiring immediate medical attention)
• Confusion, restlessness
• Liver problems (hepatitis)
• Low sodium levels in blood
• Liver impairment, yellowing of the skin and/or eyes (jaundice)
• Serious skin reactions

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Etoricoxib Stada

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Etoricoxib Stada

• The active substance is etoricoxib.

• Etoricoxib Stada 30 mg: Each film-coated tablet contains 30 mg of etoricoxib.

• Etoricoxib Stada 60 mg: Each film-coated tablet contains 60 mg of etoricoxib.

• Etoricoxib Stada 90 mg: Each film-coated tablet contains 90 mg of etoricoxib.

• Etoricoxib Stada 120 mg: Each film-coated tablet contains 120 mg of etoricoxib.

• The other components are: calcium hydrogen phosphate, microcrystalline cellulose, povidone K29-32, magnesium stearate, sodium croscarmellose, hypromellose, lactose monohydrate, titanium dioxide (E171) and triacetin.

• The 30 mg, 60 mg and 120 mg tablets also contain indigo carmine aluminium lake (E132) and yellow iron oxide (E172).

Appearance of the product and pack contents

Etoricoxib Stada film-coated tablets are available in four strengths.

The 30 mg tablets are blue-green, round, biconvex and film-coated.

The 60 mg tablets are dark green, round, biconvex and film-coated.

The 90 mg tablets are white, round, biconvex and film-coated.

The 120 mg tablets are pale green, round, biconvex and film-coated.

Etoricoxib Stada 30 mg:
Pack sizes of 7, 14, 28, 30 or 98 film-coated tablets in blisters.

Etoricoxib Stada 60 mg:
Pack sizes of 7, 10, 14, 20, 28, 30, 50, 98 or 100 film-coated tablets in blisters.
Pack sizes of 100 film-coated tablets in bottles with screw cap containing a desiccant (silica gel). The desiccant, which is used to keep the tablets dry, must not be swallowed.

Etoricoxib Stada 90 mg:
Pack sizes of 7, 10, 14, 20, 28, 30, 50, 98 or 100 film-coated tablets in blisters.
Pack sizes of 100 film-coated tablets in bottles with screw cap containing a desiccant (silica gel). The desiccant, which is used to keep the tablets dry, must not be swallowed.

Etoricoxib Stada 120 mg:
Pack sizes of 5, 7, 14, 20, 28, 30 or 98 film-coated tablets in blisters.

Only some pack sizes may be commercially available.

Marketing Authorization Holder

Laboratorio STADA, S.L.
Frederic Mompou 5
08960 Sant Just Desvern (Barcelona)
Spain
[email protected]

Manufacturer

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

or

Pharmacare Premium Ltd.
HHF 003, Hal Far Industrial Estate
Birzebbuga, BBG 3000
Malta

or

Delorbis Pharmaceuticals Ltd.
17 Athinon Street, Ergates Industrial Area
2643 Ergates, Nicosia
Cyprus

This medicinal product is authorized in the European Economic Area (EEA) member states under the following names:

Germany: Etoricoxib AL 30/60/90/120 mg Filmtabletten
Belgium: Etoricoxib EG 30/60/90/120 mg filmomhulde tabletten
Slovenia: Etorikoksib STADA 30/60/90/120 mg filmsko obložene tablete
Spain: Etoricoxib STADA 30/60/90/120 mg comprimidos recubiertos con película EFG
Finland: Etoricoxib STADA 30/60/90/120 mg tabletti, kalvopäällysteinen
Netherlands: Etoricoxib CF 30/60/90/120 mg filmomhulde tabletten
Italy: ETORICOXIB EG
Luxembourg: Etoricoxib EG 30/60/90/120 mg comprimés pelliculés
Portugal: Etoricoxib Ciclum
Romania: Prietor
Sweden: Etoricoxib STADA 30/60/90/120 mg filmdragerade tabletter

Date of the most recent review of this leaflet: April 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS): http://www.aemps.gob.es/