ETORICOXIB AUROVITAS 120 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Etoricoxib Aurovitas 30 mg film-coated tablets EFG

Etoricoxib Aurovitas 60 mg film-coated tablets EFG

Etoricoxib Aurovitas 90 mg film-coated tablets EFG

Etoricoxib Aurovitas 120 mg film-coated tablets EFG

Read all of this 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 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

What is Etoricoxib Aurovitas?

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

• Etoricoxib helps to reduce pain and swelling (inflammation) in the joints and muscles in people 16 years of age and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.
• Etoricoxib is also used for short-term treatment of moderate pain after dental surgery in people 16 years of age and older.

What is osteoarthritis?

Osteoarthritis is a disease of the joints. It leads to the breakdown of cartilage, the tissue that cushions the ends of 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 characterized by sudden, 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 large joints.

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

Do not take Etoricoxib Aurovitas:

• if you are allergic to the active substance 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 aspirin 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 (check with your doctor or nurse if you are not sure if your blood pressure is controlled),
• if your doctor has diagnosed you with heart problems, including heart failure (of moderate or severe type), angina (chest pain),
• if you have had a heart attack, surgical revascularization, peripheral arterial disease (poor circulation in your legs or feet due to narrow or blocked arteries),
• if you have had any type of stroke (including transient ischaemic attack or transient cerebral ischaemia).

Etoricoxib may slightly increase your risk of heart attack and stroke, and this is why it should not be used in patients who already have heart or stroke problems.

If you think you may be at risk 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 if:

• you have a history of stomach ulcers or bleeding.
• 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. Etoricoxib 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 may mask or hide fever, which is a sign of infection.
• you have diabetes, high cholesterol, or are a smoker, as 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 Etoricoxibto check if this medicine is suitable for you.

Etoricoxib works just as well in older patients as in younger patients. If you are over 65 years of age, your doctor will want to keep a closer 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 Aurovitas with other medicines

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

• 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),
• 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 blockers, for example 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),
• aspirin (the risk of stomach ulcers is greater if you take Etoricoxib with aspirin).

• aspirin for the prevention of heart attacks or stroke:

Etoricoxib can be taken with low dosesof aspirin. If you are currently taking low doses of aspirin to prevent heart attacks or stroke, do not stop taking aspirin until you talk to your doctor

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

do not take high dosesof aspirin or other anti-inflammatory medicines while taking this medicine.

Taking Etoricoxib Aurovitas with food and drink

The onset of effect of Etoricoxib may be faster if taken without food.

Pregnancy, breast-feeding and fertility

Pregnancy

Etoricoxib 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 the tablets 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. If you are using this medicine, do not breast-feed.

Fertility

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

Driving and using machines

In some patients taking Etoricoxib, 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 Aurovitas contains sodium

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

3. How to take Etoricoxib Aurovitas

Follow exactly the instructions of administration of this medicine given to you 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 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 might increase after prolonged treatment, especially with high doses.

There are different doses available for this medicine, and depending on your disease, 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 needed.

Rheumatoid arthritis

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

Ankylosing spondylitis

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

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.

Post-operative 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 daily.
• If you have moderate liver disease, do not take more than 30 mg daily.

Use in children and adolescents

Children or adolescents under 16 years of age should not take the tablets of etoricoxib.

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

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

If you take more Etoricoxib Aurovitas than you should

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

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

If you forget to take Etoricoxib Aurovitas

It is important that you take this medicine as your doctor has told you. 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 further questions on the use of this product, 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 this medicine and talk to your doctor immediately (see section 2. What you need to know before you take Etoricoxib Aurovitas):

• difficulty breathing, chest pain or ankle swelling, or if these get worse
• yellowing of the skin and eyes (jaundice) - these are signs of liver problems
• severe stomach pain or persistent vomiting, or if your stools become black
• an allergic reaction - which can include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue or throat that can cause difficulty in breathing

The frequency of possible side effects listed below is defined using the following convention:

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

Common (may affect up to 1 in 10 people)

Uncommon (may affect up to 1 in 100 people)

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

Very rare (may affect up to 1 in 10,000 people)

The following side effects may occur during treatment with etoricoxib:

Very common:

• stomach pain

Common:

• 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 shortness of breath (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:

• gastroenteritis (inflammation of the gastrointestinal tract that affects both the stomach and the small intestine/common cold), cold, urinary tract infection
• changes in laboratory results (decreased red blood cells, decreased white blood cells, decreased platelets)
• 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, hearing, or feeling things that are not there (hallucinations)
• altered taste, inability to sleep, numbness or tingling, somnolence
• blurred vision, eye irritation and redness
• ringing in the ears, vertigo (feeling of spinning while standing still)
• abnormal heart rhythm (atrial fibrillation), rapid heart rate, heart failure, feeling of tension, pressure, or heaviness in the chest (angina), 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 ulcers, inflammation of the stomach lining that can be severe and can cause bleeding, irritable bowel syndrome, pancreatitis
• swelling of the face, rash or itching of the skin
• 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:

• 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 effectsIf you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 Aurovitas

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 CAD. The expiry date is the last day of the month indicated.

Store in the original packaging to protect from moisture.

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

6. Package Contents and Additional Information

Composition of Etoricoxib Aurovitas

• The active ingredient is etoricoxib. Each film-coated tablet contains 30 mg, 60 mg, 90 mg, or 120 mg of etoricoxib.
• The other ingredients are:

Tablet core: microcrystalline cellulose (E460), calcium hydrogen phosphate, sodium croscarmellose, and magnesium stearate (E470b).

Coating: polyvinyl alcohol (E1203), titanium dioxide (E171), glycerol monostearate (E471), aluminum lake carmine indigo (E132) [only for 30 mg, 60 mg, and 120 mg doses], yellow iron oxide (E172) [only for 30 mg, 60 mg, and 120 mg doses], talc (E553b), and sodium lauryl sulfate.

Appearance and Package Contents of the Product

Film-coated tablet.

Etoricoxib Aurovitas 30 mg film-coated tablets EFG

Film-coated tablets, biconvex, blue-green in color, and apple-shaped, engraved with '30' on one side and smooth on the other, with dimensions of 5.8 x 5.9 mm ± 7.5%.

Etoricoxib Aurovitas 60 mg film-coated tablets EFG

Film-coated tablets, biconvex, dark green in color, and apple-shaped, engraved with '60' on one side and smooth on the other, with dimensions of 7.1 x 7.3 mm ± 7.5%.

Etoricoxib Aurovitas 90 mg film-coated tablets EFG

Film-coated tablets, biconvex, white, and apple-shaped, engraved with '90' on one side and smooth on the other, with dimensions of 8.1 x 8.3 mm ± 7.5%.

Etoricoxib Aurovitas 120 mg film-coated tablets EFG

Film-coated tablets, biconvex, pale green in color, and apple-shaped, engraved with '120' on one side and smooth on the other, with dimensions of 8.9 x 9.2 mm ± 7.5%.

Etoricoxib Aurovitas film-coated tablets are available in blister packs.

Package sizes:

30 mg:7, 20, 28 film-coated tablets.

60 mg:20, 28 film-coated tablets.

90 mg:5, 20, 28 film-coated tablets.

120 mg:5, 7, 20 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A.

P.O. Box 3012 Larisa Industrial Area

Larisa - 41004

Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain Etoricoxib Aurovitas 30 mg, 60 mg, 90 mg, 120 mg film-coated tablets EFG

Italy Etoricoxib Aurobindo

Portugal Etoricoxib Aurobindo

Date of the last revision of this leaflet:March 2021

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)