ETORICOXIB STADA 120 mg FILM-COATED TABLETS

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 package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

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

What is Etoricoxib Stada?

• Etoricoxib Stada contains the active substance etoricoxib. Etoricoxib belongs to a group of medicines called 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 to reduce pain and swelling (inflammation) in the joints and muscles of people 16 years of age 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 16 years of age and older.

What is osteoarthritis?

Osteoarthritis is a disease of the joints. It leads to the gradual breakdown of the cartilage that cushions the ends of the bones. This causes 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 also causes inflammation in other areas of the body.

What is gout?

Gout is a disease of sudden and recurring attacks of very painful and red inflammation of 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 long joints.

2. What you need to know before you take Etoricoxib Stada

Do not take Etoricoxib Stada:

• if you are allergic 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 acetylsalicylic acid and COX-2 inhibitors (see Possible side effects, section 4)
• if you currently have an ulcer or bleeding in your stomach or duodenum
• if you have severe liver disease
• if you have severe kidney disease
• if you are or may be pregnant, or are breast-feeding (see "Pregnancy, breast-feeding, and fertility")
• 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 not sure if your blood pressure is controlled)
• if your doctor has diagnosed you with heart problems, including moderate or severe heart failure, angina (chest pain)
• if you have had a heart attack, revascularization surgery, peripheral arterial disease (poor circulation in the legs or feet due to narrow or blocked arteries)
• if you have had any type of stroke (including a transient ischemic attack or a transient cerebral ischemic attack). Etoricoxib may slightly increase your risk of heart attack and stroke, and therefore should not be used in patients who have already had heart or stroke problems.

If you think you may be affected by any of these conditions, do not take the tablets until you have spoken to your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Etoricoxib Stada if:

• You have a history of stomach ulcers or bleeding.
• You are dehydrated, for example, as a result of 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 will 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 not sure if any of the above applies to you, talk to your doctor before taking Etoricoxib Stadato check if this medicine is suitable for you.

Etoricoxib Stada works just as well in adult and young patients. If you are over 65 years of age, your doctor will want to keep a close check on you. 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.

Taking Etoricoxib Stada with other medicines

Tell 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 want to monitor you to check that your medicines are working adequately once you start taking Etoricoxib Stada:

• medicines that make your blood less thick (anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a medicine used to suppress the immune system and often used in rheumatoid arthritis)
• cyclosporin or tacrolimus (medicines used to suppress 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 antagonists, such as enalapril and ramipril, and losartan and valsartan
• diuretics (water tablets)
• digoxin (a medicine for heart failure and irregular heartbeat)
• minoxidil (a medicine used to treat high blood pressure)
• tablets or oral solution of salbutamol (a medicine for asthma)
• oral contraceptives (the combination may increase your risk of side effects)
• hormone replacement therapy (the combination may increase your risk of side effects)
• acetylsalicylic acid, the risk of stomach ulcers is greater if you take Etoricoxib Stada with acetylsalicylic acid:

• acetylsalicylic acid for the prevention of heart attacks or stroke:

Etoricoxib Stada can be taken with low doses of acetylsalicylic acid. If you are currently taking low doses of acetylsalicylic acid to prevent heart attacks or stroke, do not stop taking acetylsalicylic acid until you have spoken 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 the effect of Etoricoxib Stada may be faster if taken without food.

Pregnancy, breast-feeding, and fertility

Pregnancy

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

Breast-feeding

It is not known if etoricoxib is excreted in human milk. If you are breast-feeding or plan to breast-feed, consult your doctor before taking Etoricoxib Stada. If you are using Etoricoxib Stada, do not breast-feed.

Fertility

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

Driving and using machines

In some patients taking Etoricoxib Stada, dizziness and somnolence have been reported.

Do not drive if you experience dizziness or somnolence.

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

Etoricoxib Stada contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Etoricoxib Stada contains sodium

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

3. How to take Etoricoxib Stada

Follow the exact administration instructions of this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Do not take more than the recommended dose for your condition. Your doctor will want to discuss your treatment from time to time. It is important that you 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 could increase after prolonged treatment, especially with high doses.

There are different doses available for this medicine, and depending on your condition, your doctor will prescribe the tablet with the dose that is suitable for you.

The recommended dose is:

Osteoarthritis

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

Rheumatoid arthritis

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

Ankylosing spondylitis

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

Acute pain conditions

Etoricoxib should only be used for the period of acute pain.

Gout

The recommended dose is 120 mg once daily, which should only be used during the period of acute pain, limited to a maximum of 8 days of treatment.

Postoperative dental 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, do not take more than 60 mg per day.
• If you have moderateliver disease, do not take more than 30 mg per day.

Use in children and adolescents

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

Patients over 65 years of age

No dose adjustment is necessary for patients over 65 years of age. 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

Never take more tablets than your doctor recommends. If you take too many Etoricoxib Stada tablets, seek medical attention immediately.

In case of overdose or accidental ingestion, you can also contact the Toxicology Information Service, Phone: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the packaging and the package leaflet of the medicine to the healthcare professional.

If you forget to take Etoricoxib Stada

It is important that you take Etoricoxib Stada as your doctor has indicated. If you forget a dose, just resume your normal schedule the next day. Do not take a double dose to make up for forgotten doses.

If you have any other 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 everybody gets them.

If you develop any of these signs, stop taking Etoricoxib Stada and talk to your doctor immediately(see section2.What you need to know before you take Etoricoxib Stada):

• If you experience shortness of breath, chest pain, or ankle swelling, or if these worsen
• yellowing of the skin and eyes (jaundice) - these are signs of liver problems
• severe stomach pain or persistent stomach pain or black stools
• an allergic reaction - which can include skin problems such as ulcers or blisters, or swelling of the face, lips, tongue, or throat that can cause difficulty breathing

The following side 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 after tooth extraction)
• swelling of the legs and/or feet due to fluid retention (edema)
• dizziness, headache
• palpitations (rapid or irregular heartbeat), irregular heartbeat (arrhythmia)
• high blood pressure
• wheezing or difficulty breathing (bronchospasm)
• constipation, gas (excess gas), gastritis (inflammation of the stomach lining), heartburn, diarrhea, indigestion (dyspepsia)/stomach upset, nausea, vomiting, esophagitis, 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 that affects both the stomach and the small intestine/gastric flu), upper respiratory tract infection, urinary tract infection
• changes in laboratory results (decreased red blood cell count, decreased white blood cell count, decreased platelet count)
• hypersensitivity (allergic reaction including hives that can be severe enough to require immediate medical attention)
• increased or decreased appetite, weight gain
• anxiety, depression, decreased mental sharpness; seeing, feeling, or hearing things that do not exist (hallucinations)
• altered taste, insomnia, numbness or tingling, somnolence
• blurred vision, eye irritation and redness
• ringing in the ears, vertigo (feeling of spinning while standing)
• abnormal heartbeat (atrial fibrillation), rapid heartbeat, heart failure, feeling of pressure or heaviness in the chest (angina pectoris), heart attack
• flushing, stroke, transient ischemic attack (mini-stroke), severe increase in blood pressure, inflammation of blood vessels
• cough, shortness of breath, nosebleed
• stomach swelling, changes in bowel movements, dry mouth, stomach ulcer, inflammation of the stomach lining that can be severe and can cause bleeding, irritable bowel syndrome, pancreatitis
• swelling of the face, skin rash or itching
• muscle cramp/spasm, muscle pain/stiffness
• high levels of potassium in your blood, changes in blood or urine tests related to your kidneys, severe 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 can cause difficulty breathing or swallowing, which can be severe enough to require immediate medical attention)/anaphylactic/anaphylactoid reactions including shock (severe allergic reaction that requires immediate medical attention)
• confusion, nervousness
• liver problems (hepatitis)
• low sodium levels in the blood
• liver changes, yellowing of the skin and/or eyes (jaundice)
• severe skin reactions

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is stated on the carton, after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional 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 ingredients 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 aluminum lake indigo carmine (E132) and yellow iron oxide (E172).

Appearance of the Product and Package Contents

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

The 30 mg tablets are greenish-blue, 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:

Package sizes of 7, 14, 28, 30, or 98 film-coated tablets in blisters.

Etoricoxib Stada 60 mg:

Package sizes of 7, 10, 14, 20, 28, 30, 50, 98, or 100 film-coated tablets in blisters.

Package sizes of 100 film-coated tablets in screw-capped bottles with a desiccant (silica gel). The desiccant, which is used to keep the tablets dry, should not be swallowed.

Etoricoxib Stada 90 mg:

Package sizes of 7, 10, 14, 20, 28, 30, 50, 98, or 100 film-coated tablets in blisters.

Package sizes of 100 film-coated tablets in screw-capped bottles with a desiccant (silica gel). The desiccant, which is used to keep the tablets dry, should not be swallowed.

Etoricoxib Stada 120 mg:

Package sizes of 5, 7, 14, 20, 28, 30, or 98 film-coated tablets in blisters.

Not all pack sizes may be marketed.

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 medicine is authorized in the Member States of the European Economic Area 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 last revision of this leaflet:April 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/