Patient Information Leaflet

Etoricoxib Viso Pharmaceutical 30 mg Film-Coated Tablets

Etoricoxib Viso Pharmaceutical 60 mg Film-Coated Tablets

Etoricoxib Viso Pharmaceutical 90 mg Film-Coated Tablets

Etoricoxib Viso Pharmaceutical 120 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine. 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 give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Etoricoxib Viso Pharmaceutical and what is it used for

2. What you need to know before you start taking Etoricoxib Viso Pharmaceutical

3. How to take Etoricoxib Viso Pharmaceutical

4. Possible side effects

5. Storage of Etoricoxib Viso Pharmaceutical

6. Contents of the pack and additional information

What is Etoricoxib?

• Etoricoxib 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).

For what is Etoricoxib used?

• Etoricoxib 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 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 Viso pharmaceutical:

• if you are allergic (hypersensitive) to etoricoxib or to any of the other components of this medication (including those listed in section6)
• if you are allergic to nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin and COX-2 inhibitors (see Possible side effects, section4)
• 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, lactation, and fertility")
• if you are under 16years 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 or nurse if you are unsure if your blood pressure is adequately 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 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 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 if:

• You have a history of ulcers or stomach bleeding.
• You are dehydrated, for example, as a result of a prolonged illness with vomiting or diarrhea.
• You have swelling due to fluid retention.
• You have a history of heart failure or any other type 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 conceal 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 65years of age.

If you are unsure whether any of the above situations affect you,talk to your doctor before taking this medicationto check if etoricoxib is suitable for you.

Etoricoxib works just as well in adult and young patients. If you are over 65years of age, your doctor will want to keep a close eye on you. No dose adjustment is necessary in patients over 65years of age.

Children and adolescents

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

Taking Etoricoxib Viso Farmacéutica with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

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:

• blood-thinning medications (anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a medication used to suppress the immune system and 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 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)
• aspirin, the risk of stomach ulcers is higher if you take Etoricoxib with aspirin.

• Aspirin for the prevention of heart attacks or strokes:

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

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

do not takehigh dosesof aspirin or other anti-inflammatory medications while taking this medication.

Taking Etoricoxib Viso Farmacéutica with food and drinks

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

Pregnancy, lactation, 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 are planning 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.

Lactation

We do not know if Etoricoxib is excreted in human milk. If you are breastfeeding or plan to do so, consult your doctor before taking Etoricoxib. If you are using this medication, do not breastfeed.

Fertility

We do not recommend using Etoricoxib in women trying to become pregnant.

Driving and operating machinery

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 machinery if you experience dizziness or somnolence.

Follow exactly the administration instructions of this medication as 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 do 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 period of acute pain.

Gout

The recommended dose is 120 mg once a day, which should only be used 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 a day, limited to a maximum of 3 days of treatment.

Patients with Liver Problems

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

Patients over 65 years

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

Administration Form

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

If you take more Etoricoxib than you should

You should never take more tablets than your doctor recommends. If you take too many Etoricoxib 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

It is essential to take this medication as your doctor has indicated. If you forget a dose, simply resume 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 this medicine and talk to your doctor immediately (see section2.What you need to know before starting to take Etoricoxib):

• difficulty breathing, chest pain, or swelling of the ankle, 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 can include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue, or throat that can cause difficulty breathing

The frequency of possible side effects included below is defined according to the following convention:

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

Common (may affect up to 1 in 10people)

Uncommon (may affect up to 1 in 100people)

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

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

The following side effects may occur during treatment withEtoricoxib:

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
• shortness of breath or difficulty breathing (bronchospasm)
• constipation, gas (excessive gas), gastritis (inflammation of the stomach lining), heartburn, diarrhea, indigestion (dyspepsia)/stomach discomfort,nausea, vomiting, esophagitis, mouth ulcers
• changes in blood test results related to the liver
• bruising
• weakness and fatigue, flu-like illness

Uncommon::

• gastroenteritis (inflammation of the gastrointestinal tract affecting both the stomach and small intestine/gastric catarrh), cold, 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, hearing, or feeling things that are not there (hallucinations)
• alteration of taste, inability to sleep, numbness or tingling, drowsiness
• blurred vision, eye irritation and redness
• ringing in the ears, vertigo (sensation of spinning while standing)
• abnormal heart rhythm (fibrillation), rapid heartbeat, 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, redness of the skin
• muscle cramp/spasm, 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::

• 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 indicated on the packaging. The expiration date refers to the last day of the month.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition ofEtoricoxib Viso Pharmaceutical

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

• The other components are:

Core of the tablet: Dicalcium phosphate anhydrous (Calipharm A), microcrystalline cellulose (Avicel PH 101), croscarmellose sodium (Ac-di-sol), magnesium stearate, microcrystalline cellulose (Avicel PH 200 LM)

Coating of the tablet:

For 30 mg, 60 mg, and 120 mg

Hydroxypropyl methylcellulose, titanium dioxide (E171), macrogol, aluminium lake of carmine (E132), iron oxide yellow (E172), isopropyl alcohol, methylene chloride (dichloromethane)

For 90 mg

Hydroxypropyl methylcellulose, titanium dioxide (E171), macrogol, isopropyl alcohol, methylene chloride (dichloromethane)

Appearance of the product and content of the package

Etoricoxib Viso Pharmaceutical tablets are available in four concentrations:

30 mg tablets: green-blue, biconvex, round film-coated tablets with the mark “11” on one side and “G” on the other, approximately 6 mm in diameter.

60 mg tablets: dark green, biconvex, round film-coated tablets with the mark “76” on one side and “G” on the other, approximately 8 mm in diameter.

90 mg tablets: white, biconvex, round film-coated tablets with the mark “757” on one side and “G” on the other, approximately 9 mm in diameter.

120 mg tablets: light green, biconvex, round film-coated tablets with the mark “758” on one side and “G” on the other, approximately 10.5 mm in diameter.

30 mg tablets: package sizes of 5, 28, 30, 90, 98 tablets in blister packs.

60 mg, 90 mg tablets: package sizes of 7, 14, 20, 28, 30, 50, 90, 100 tablets in blister packs.

120 mg tablets: package sizes of 2, 5, 7, 14, 20, 28, 30, 90 tablets in blister packs.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Glenmark Arzneimittel GmbH

Industriestr. 31,

82194 Gröbenzell,

Germany

Responsible manufacturer

Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA3000,
Malta

Glenmark Pharmaceuticals s.r.o

Fibichova, 143

56617 Vysoke Myto, Czech Republic

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7th Floor,

28045 Madrid,

Spain

This medicinal product is authorized in the EEA member states with the following names:

Last review date of the package insert: November 2016

For detailed information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)