ETORICOXIB KERN PHARMA 120 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

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

1. What is Etoricoxib Kern Pharma and what is it used for

• This medicine contains the active substance etoricoxib and 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).
• Etoricoxib helps to reduce pain and swelling (inflammation) in the joints and muscles of people with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.
• Etoricoxib is also used for the short-term treatment of moderate pain after dental surgery.

This medicine is indicated in adults and adolescents over 16 years of age.

What is osteoarthritis?

Osteoarthritis is a disease of the joints. 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.

2. What you need to know before you take Etoricoxib Kern Pharma

Do not take Etoricoxib Kern Pharma:

• if you are allergic (hypersensitive) 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 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 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 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 the legs or feet due to narrowed or blocked arteries)
• if you have had any type of stroke (including a transient cerebral attack or a transient ischemic attack). Etoricoxib may slightly increase your risk of heart attack and stroke, and therefore should not be used in those patients who have already had heart or stroke problems.
• if you have uncontrolled high blood pressure (consult your doctor or nurse if you are not sure if your blood pressure is adequately controlled).

If you think you may be in one of these situations, do not take the tablets until you have consulted your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• if you have a history of stomach or duodenal ulcers.
• if you are dehydrated, for example, as a result of 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 elderly 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 not sure if any of the above situations apply to you, talk to your doctor before taking etoricoxib to check if this medicine is suitable for you.

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

Children and adolescents

Do not give this medicine to children and adolescents under 16 years of age.

Taking Etoricoxib Kern Pharma 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 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).
• 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.
• lithium (a medicine used to treat some types of depression).
• diuretics (water tablets).
• cyclosporin or tacrolimus (medicines used to suppress the immune system).
• 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 the risk of side effects).
• hormone replacement therapy (the combination may increase the risk of side effects).
• aspirin, the risk of stomach ulcers is greater if you take etoricoxib with aspirin.

• Aspirin for the prevention of heart attack or stroke:

Etoricoxib can be taken with low-dose aspirin. If you are currently taking low-dose aspirin to prevent heart attacks or strokes, do not stop taking aspirin until you have talked to your doctor.

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

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

Taking Etoricoxib Kern Pharma with food and drinks

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

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Etoricoxib 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 the tablets and consult your doctor.

Ask 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 planning to breast-feed, consult your doctor before taking this medicine. If you are taking etoricoxib, you should not breast-feed.

Fertility

Etoricoxib is not recommended 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 Kern Pharma contains lactose

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

Etoricoxib Kern Pharma 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 Kern Pharma

Follow exactly the administration instructions of this medicine 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 disease. 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 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, increasing if necessary to a maximum of 60 mg once daily (these doses cannot be administered with this medicine). For the treatment of osteoarthritis, another dose of this medicine is available, please consult your doctor.

Rheumatoid arthritis:

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

Ankylosing spondylitis:

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

Acute pain situations:

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

Gout:

The recommended dose is 120 mg once daily and should only be taken 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 (this dose cannot be administered with this medicine). For the treatment of postoperative dental pain, another dose of this medicine is available, please consult your doctor.

Patients with liver problems

• If you have mild liver failure, do not take more than 60 mg per day.
• If you have moderateliver failure, do not take more than 30mg per day.

Use in children and adolescents

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

Patient over 65 years

No dose adjustment is necessary in elderly patients. As with the rest of the medicines, in elderly patients, precautions should be increased.

Method of administration

This medicine is taken orally. Etoricoxib tablets should be taken once daily and can be taken with or without food.

If you take more Etoricoxib Kern Pharma than you should

Never take more tablets than your doctor recommends. If you take too many tablets of this medicine, 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 taken. It is recommended to bring the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Etoricoxib Kern Pharma

It is important that you take etoricoxib as your doctor has indicated. If you forget a dose, just resume your usual regimen 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 Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from 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 taking Etoricoxib Kern Pharma):

• difficulty breathing, chest pain, or swelling of the ankle, or if these worsen
• yellowish color of the skin and eyes (jaundice) - these are signs of liver problems
• severe or continuous stomach pain 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 breathing

The frequency of the possible side effects listed below is defined according to 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 adverse 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 difficulty breathing (bronchospasm)
• constipation, gas (excess gas), gastritis (inflammation of the stomach lining), heartburn, diarrhea, indigestion (dyspepsia)/stomach discomfort, nausea, vomiting, esophageal inflammation, mouth ulcers
• changes in blood tests related to your liver
• bruises
• weakness and fatigue, flu-like illness

Uncommon:

• gastroenteritis (inflammation of the gastrointestinal tract that affects 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 can 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, drowsiness
• blurred vision, eye irritation and redness
• ringing in the ears, vertigo (feeling of spinning while standing)
• abnormal heart rhythm (atrial fibrillation), rapid heart rate, heart failure, feeling of tension, pressure, or heaviness in the chest (angina pectoris), myocardial infarction
• redness, stroke, 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 movement habits, 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, skin redness
• muscle cramp/spasm, muscle pain/stiffness
• high potassium levels 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 alteration, yellowish color of the skin and/or eyes (jaundice)
• severe skin reactions

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

5. Storage of Etoricoxib Kern Pharma

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

Do not use this medicine 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.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

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, colorant), and indigo carmine (E132, colorant).

Appearance of Etoricoxib Kern Pharma and Package Contents

• Greenish-colored, biconvex, apple-shaped film-coated tablets with "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 package sizes may be marketed.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

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

or

Pharmadox Healthcare Ltd.

KW20A Corradino Industrial Estate,

Paola PLA3000, Malta

or

Micro Labs GmbH

Lyoner Straße 20

60528 Frankfurt/Main

Germany

This medicine is authorized in the Member States of the European Economic Area under 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 EFG tablets

Date of the last revision of this leaflet:June/2022

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