Package Insert: Patient Information

Etoricoxib Kern Pharma 60 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

This medicine is indicated for adults and adolescents over 16 years old.

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-lasting 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 Kern Pharma:

• if you are allergic (hypersensitive) to the active ingredient or to any of the other components of this medication (listed in section 6).
• if you are allergic to nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin 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 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 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 narrowed or blocked arteries),
• if you have had any type of stroke (including a 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 have uncontrolled high blood pressure (consult your doctor or nurse if you are unsure if your blood pressure is adequately controlled).

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 this medication:

• if you have a history of stomach ulcers or bleeding.
• if you are dehydrated, for example, as a result of a prolonged illness with vomiting or diarrhea.
• if you have swelling due to fluid retention.
• if you have a history of heart failure or any other form of heart disease.
• if 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.
• if you have a history of liver or kidney disease.
• if you are being treated for an infection. Etoricoxib may mask or hide fever, which is a sign of infection.
• if you are a woman trying to become pregnant.
• if you are an older person (e.g. over 65 years).
• if you have diabetes, high cholesterol, or are a smoker, as these may increase your risk of heart disease.

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

Etoricoxib works just as well in young adult patients and the elderly. If you are an older person (e.g. over 65 years), your doctor will want to keep a close eye on you. No dose adjustment is necessary in elderly patients.

Children and adolescents

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

Taking Etoricoxib Kern Pharma 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 is often used in rheumatoid arthritis).
• 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.
• lithium (a medication used to treat certain types of depression).
• diuretics (tablets to help you urinate).
• ciclosporin or tacrolimus (medications used to suppress the immune system).
• 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 the risk of side effects).
• hormone replacement therapy (the combination may increase the risk of side effects).
• aspirin, the risk of stomach ulcers is higher if you take etoricoxib with aspirin.

• Aspirin for the prevention of heart attack or stroke:

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

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

Do not take high doses of aspirin or other anti-inflammatory medications while taking etoricoxib.

Taking Etoricoxib Kern Pharma with food and drinks

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medication.

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.

Breastfeeding

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 this medication. If you are taking etoricoxib, do not breastfeed.

Fertility

Etoricoxib is not recommended for 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.

Etoricoxib Kern Pharma contains lactose

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

Etoricoxib Kern Pharma contains sodium

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

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 should not take etoricoxib for longer than necessary. This is because the risk of myocardial infarction and stroke 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:

Arthritis:

The recommended dose is 30mg once a day (this dose cannot be administered with this medication), increasing up to a maximum of 60mg once a day, if necessary.

Rheumatoid Arthritis:

The recommended dose is 60 mg per day, increasing if necessary up to a maximum of 90mg once a day (this dose cannot be administered with this medication). For the treatment of rheumatoid arthritis, another dose of this medication is available, please consult your doctor.

Ankylosing Spondylitis:

The recommended dose is 60 mg once a day, increasing if necessary up to a maximum of 90mg once a day (this dose cannot be administered with this medication). For the treatment of ankylosing spondylitis, another dose of this medication is available, please consult your doctor.

Acute Pain:

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

Gout:

The recommended dose is 120mg (equivalent to 2 tablets of this medication) once a day and should only be taken during the period of acute pain, limited to a maximum of 8days of treatment.

Postoperative Pain after Dental Surgery:

The recommended dose is 90mg once a day, limited to a maximum of 3days of treatment (this dose cannot be administered with this medication). For the treatment of postoperative pain after dental surgery, another dose of this medication is available, please consult your doctor.

Patients with Liver Problems

• If you have mild liver insufficiency, you should not take more than 60mg per day.
• If you have moderate liver insufficiency, you should not take more than30mg per day.

Use in Children and Adolescents

Etoricoxib should not be used in children or adolescents under 16years.

Patients over 65 years old

No dose adjustment is necessary in elderly patients. As with other medications, caution should be increased in elderly patients.

Administration Form

This medication is taken orally. Etoricoxib tablets should be taken once a day and can be taken with or without food.

If you take more Etoricoxib Kern Pharma than you should

You should never take more tablets than your doctor recommends. If you take too many tablets of this medication, 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 Kern Pharma

It is essential to take etoricoxib 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 product, 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 takingEtoricoxib Kern Pharmaand talk to your doctor immediately(see section 2 What you need to know before starting to take Etoricoxib Kern Pharma):

• 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 your stools turn 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 breathing

The frequency of the possible side effects listed below is defined in accordance with 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
• shortness of breath or difficulty breathing (bronchospasm)
• constipation, gas (excessive gas), gastritis (inflammation of the stomach lining), heartburn, 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, feeling, or hearing things that do not exist (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)
• irregular heart rhythm (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
• stomach swelling, 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::

• 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 that requires 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 Medicinal Products 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.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Etoricoxib Kern Pharma

• The active ingredient is etoricoxib. Each coated tablet contains 120 milligrams of etoricoxib.
• The other components (excipients) are: Tablet core: calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate, microcrystalline cellulose, lactose monohydrate, and hydroxypropylcellulose. Tablet coating: lactose monohydrate, hypromellose, titanium dioxide (E171), and triacetin, yellow iron oxide (E172, coloring agent), and indigotin (E132, coloring agent).

Appearance of Etoricoxib Kern Pharma and contents of the packaging

• Coated tablets with biconvex, apple-shaped, light green color, with the number "120" engraved on one side and nothing on the other. The 120 mg concentration is presented in blisters containing 5, 7, 10, 14, 28, 30, 50, and 100 tablets.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for Manufacturing

Chanelle Medical Unlimited Company, Loughrea, Co. Galway, Ireland.

or

Pharmadox Healthcare Ltd.

KW20A Corradino Industrial Estate,

Paola PLA3000, Malta

or

Micro Labs GmbH

Lyoner Straβe 14

60528 Frankfurt am Main

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany: Etoricoxib Chanelle 120mg Filmtabletten

Ireland: Etoricoxib 120mg Film-coated Tablets

Italy: Etoricoxib Chanelle

Malta: Etoricoxib 120mg Film-coated Tablets

Portugal: Etoricoxib Azevedos

Romania: Etoricoxib Chanelle Medical 120mg film-coated tablets

Spain: Etoricoxib Kern Pharma 120mg tablets EFG

Last review date of this leaflet:June/2022

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