Leaflet: information for the user

Etoricoxib STADA 30 mg film-coated tablets

Etoricoxib STADA 60 mg film-coated tablets

Etoricoxib STADA 90 mg film-coated tablets

Etoricoxib STADA 120 mg film-coated tablets

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

• Keep this leaflet, as 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 they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Etoricoxib Stada

3.How to take Etoricoxib Stada

4.Possible side effects

5.Storage of Etoricoxib Stada

6.Contents of the pack and additional information

What is Etoricoxib Stada?

• Etoricoxib Stada contains the active ingredient 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 aged 16 years and over with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.
• Etoricoxib Stada is also used for the short-term treatment of moderate pain after dental surgery in people aged 16 years and over.

What is osteoarthritis?

Osteoarthritis is a joint disease. It causes the gradual breakdown of the cartilage that cushions the ends of the bones. This causes swelling (inflammation), pain, sensitivity, 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 mobility in the affected joints. It also causes inflammation in other areas of the body.

What is gout?

Gout is a disease of sudden and recurrent attacks of very painful and inflamed 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.

Do not take Etoricoxib Stada:

• if you are allergic to etoricoxib or to any of the other ingredients of this medication (listed in section 6)
• if you are allergic to nonsteroidal 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 a severe liver disease
• if you have a severe kidney disease
• if you are or may be pregnant, or are breastfeeding your child (see Pregnancy, breastfeeding 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 high blood pressure that has not been controlled with treatment (consult your doctor if you are unsure if 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 revascularization, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries)
• if you have had any type of stroke (including transient ischemic attack or transient 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 problems or a stroke.

If you think you fall into any of these cases, do not take the tablets until you have consulted your doctor.

Warnings and precautions

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

• You have a history of ulcers or stomach 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 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 conceal 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 affect you, talk to your doctor before taking Etoricoxib Stada to check if this medication 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 eye on you. No dose adjustment is necessary in patients over 65 years of age.

Children and adolescents

Do not administer this medication to children and adolescents under 16 years of age.

Taking Etoricoxib Stada with other medications

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

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

• blood-thinning medications, such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a medication used to suppress the immune system and is often used in rheumatoid arthritis)
• ciclosporin or tacrolimus (medications used to suppress the immune system)
• lithium (a medication used to treat certain types of depression)
• medications used to help control high blood pressure and heart failure, known as ACE inhibitors and angiotensin receptor antagonists, such as enalapril and ramipril, and losartan and valsartan
• diuretics (tablets to help you urinate)
• digoxin (a medication for heart failure and irregular heartbeat)
• minoxidil (a medication used to treat high blood pressure)
• oral tablets or solution of salbutamol (a medication 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 higher if you take Etoricoxib Stada with acetylsalicylic acid:

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

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 strokes, do not stop taking acetylsalicylic acid until you have spoken with your doctor

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

do not take high doses of acetylsalicylic acid or other anti-inflammatory medications 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, breastfeeding 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.

Breastfeeding

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

Fertility

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

Driving and operating machinery

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 machinery if you experience dizziness or somnolence.

Etoricoxib Stada contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Etoricoxib Stada contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor. In case of 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 essential to use the lowest dose that controls your pain and should not take etoricoxib for longer than necessary. This is because the risk of myocardial infarction and cerebral infarction could increase after prolonged treatment, especially with high doses.

There are different doses available for this medication, 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 a day, increasing to a maximum of 60 mg once a day if necessary.

Rheumatoid arthritis

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

Ankylosing spondylitis

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

Acute pain situations

Etoricoxib should only be used during the acute pain period.

Gout

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

Postoperative pain after dental surgery

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

Patients with liver problems

• If you have a mild liver disease, you should not take more than 60 mg per day.
• If you have a 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 should not take etoricoxib tablets.

Patients over 65 years old

No dose adjustment is necessary for patients over 65 years old.As with other medications, caution should be exercised in elderly patients.

Administration form

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

If you take more Etoricoxib Stada than you should

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 call the Toxicological Information Service, Tfno. 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Etoricoxib Stada

It is essential to take Etoricoxib Stada as your doctor has indicated. If you forget a dose, limit yourself to resuming the usual regimen the next day. Do not take a double dose to compensate for the missed doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 starting to takeEtoricoxib Stada):

• Shortness of breath, chest pain, or swelling of the ankle, or if these worsen
• Yellowing of the skin and eyes (jaundice) - these are signs of liver problems
• Intense or persistent stomach pain or black stools
• 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 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 heart rhythm (arrhythmia)
• High blood pressure
• Wheezing or difficulty breathing (bronchospasm)
• Constipation, gas (excessive gas), gastritis (inflammation of the stomach lining), heartburn, diarrhea, indigestion (dyspepsia)/stomach discomfort, nausea, vomiting, esophageal inflammation, mouth ulcers
• Changes in blood test results related to the 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 catarrh), 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 urticaria that may be severe enough to require immediate medical attention)
• Increased or decreased appetite, weight gain
• Anxiety, depression, decreased mental acuity; seeing, feeling, or hearing things that do not exist (hallucinations)
• Altered taste, inability to sleep, numbness or tingling, somnolence
• Blurred vision, eye irritation and redness
• Ear noises, vertigo (sensation of spinning while standing)
• Abnormal heart rhythm (atrial fibrillation), rapid heart rate, heart failure, sensation of tension, pressure, or heaviness in the chest (angina pectoris), myocardial infarction
• Redness, cerebral infarction, mini-stroke (transient ischemic attack), severe increase in blood pressure, inflammation of blood vessels
• Cough, shortness of breath, nasal bleeding
• Swelling of the stomach, changes in bowel habits, dry mouth, stomach ulcers, severe inflammation of the stomach lining that may cause bleeding, irritable bowel syndrome, pancreatitis
• Swelling of the face, skin rash or itching, skin redness
• Muscle cramps/spasms, muscle pain/stiffness
• Elevated potassium levels in the blood, changes in blood or urine test results related to the 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 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, nervousness
• Liver problems (hepatitis)
• Low sodium levels in the blood
• Liver damage, yellowing of the skin and/or eyes (jaundice)
• Severe skin reactions

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Etoricoxib Stada

• The active ingredient is etoricoxib.

• Etoricoxib Stada30 mg: Each film-coated tablet contains 30 mg of etoricoxib.
• Etoricoxib Stada60 mg: Each film-coated tablet contains 60 mg of etoricoxib.
• Etoricoxib Stada90 mg: Each film-coated tablet contains 90 mg of etoricoxib.
• Etoricoxib Stada120 mg: Each film-coated tablet contains 120 mg of etoricoxib.

• The other components are: calcium hydrogen phosphate, microcrystalline cellulose, povidone K29-32, magnesium stearate, croscarmellose sodium, hypromellose, lactose monohydrate, titanium dioxide (E171) andtriacetin.
• The 30 mg, 60 mg and 120 mg tablets also contain indigo carmine lake (E132) and yellow iron oxide (E172).

Appearance of the product and contents of the package

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

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 a screw cap with desiccant (silica gel). The desiccant, used to keep the tablets dry, should 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 a screw cap with desiccant (silica gel). The desiccant, used to keep the tablets dry, should 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 marketed.

Marketing authorization holder

STADA, S.L.

Frederic Mompou 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

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 member states of the European Economic Area with the following names:

GermanyEtoricoxib AL 30/60/90/120 mg Filmtabletten

BelgiumEtoricoxib EG 30/60/90/120 mg filmomhulde tabletten

SloveniaEtorikoksib STADA 30/60/90/120 mg filmsko obložene tablete

SpainEtoricoxib STADA 30/60/90/120 mg comprimidos recubiertos con película EFG

FinlandEtoricoxib STADA 30/60/90/120 mg tabletti, kalvopäällysteinen

NetherlandsEtoricoxib CF 30/60/90/120mg filmomhulde tabletten

ItalyETORICOXIB EG

LuxembourgEtoricoxib EG 30/60/90/120 mg comprimés pelliculés

PortugalEtoricoxib Ciclum

RomaniaPrietor

SwedenEtoricoxib STADA 30/60/90/120 mg filmdragerade tabletter

Last review date of this leaflet:April 2020

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/