Etoricoxib Kern Pharma 60 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Etoricoxib Kern Pharma 60 mg film-coated tablets EFG

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

• This medicine contains the active substance etoricoxib and belongs to a group of medicines known as selective COX-2 inhibitors. These belong to a family of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
• Etoricoxib helps 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 following dental surgery.

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

What is osteoarthritis?

Osteoarthritis is a joint disease. It causes the gradual breakdown of the cartilage that cushions the ends of bones. This leads to swelling (inflammation), pain, tenderness, stiffness, and loss of function.

What is rheumatoid arthritis?

Rheumatoid arthritis is a chronic inflammatory joint disease. It causes pain, stiffness, swelling, and progressive loss of mobility in affected joints. It may also cause inflammation in other parts of the body.

What is gout?

Gout is a condition characterized by sudden and recurrent attacks of very painful inflammation and redness in the joints. It is caused by deposits of mineral crystals in the joint.

What is ankylosing spondylitis?

Ankylosing spondylitis is an inflammatory disease affecting the spine and large joints.

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

Do not take Etoricoxib Kern Pharma:

• if you are allergic (hypersensitive) to the active substance or to 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 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 heart failure (moderate or severe), or angina (chest pain).
• if you have had a myocardial infarction, surgical revascularization, or 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 transient ischaemic attack or ischaemic stroke). Etoricoxib may slightly increase your risk of myocardial infarction 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 whether your blood pressure is adequately controlled).

If you think any of these situations apply to you, do not take the tablets until you have consulted your doctor.

Warnings and precautions

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

• if you have a history of stomach ulcers or gastrointestinal bleeding.
• if you are dehydrated, for example, due to a prolonged illness with vomiting or diarrhoea.
• 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 may 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 elderly (e.g. over 65 years of age).
• if you have diabetes, high cholesterol, or are a smoker, as these may increase your risk of developing heart disease.

If you are unsure whether any of the above situations apply to you, speak with your doctor before taking etoricoxib to confirm whether this medicine is suitable for you.

Etoricoxib works equally well in younger adult and elderly patients. If you are elderly (e.g. over 65 years of age), your doctor will want to monitor you appropriately. Dose adjustment is not 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 need to 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 ensure your medicines continue to work properly 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).

• medicines used to help control high blood pressure and heart failure called ACE inhibitors and angiotensin receptor blockers, for example enalapril and ramipril, losartan and valsartan.

• lithium (a medicine used to treat certain types of depression).

• diuretics (water tablets).

• cyclosporine 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 higher if you take etoricoxib with aspirin.

• Aspirin for prevention of myocardial infarction or stroke:

Etoricoxib may be taken with low-dose aspirin. If you are currently taking low-dose aspirin to prevent myocardial infarction or stroke, do not stop taking aspirin without first talking to your doctor.

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

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

Taking Etoricoxib Kern Pharma with food and drink

The onset of action of etoricoxib may be faster when 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 medicine.

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.

Speak to your doctor if you have any doubts or need further information.

Breastfeeding

It is not known whether etoricoxib is excreted in human milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking this medicine. If you are taking etoricoxib, you should not breastfeed.

Fertility

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

Driving and using machines

Dizziness and somnolence have been reported in some patients taking etoricoxib.

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 diagnosed you with an intolerance to certain sugars, consult him or her before taking this medicine.

Etoricoxib Kern Pharma contains sodium

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

3. How to take Etoricoxib Kern Pharma

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Do not take more than the recommended dose for your condition. Your doctor will want to review your treatment from time to time. It is important that you use the lowest dose that controls your pain and that you do not take etoricoxib for longer than necessary. This is because the risk of heart attacks and strokes may increase after long-term treatment, especially with high doses.

Different doses of this medicine are available, and depending on your condition, your doctor will prescribe the tablet with the dose appropriate for you.

The recommended dose is:

Osteoarthritis:

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

Rheumatoid arthritis:

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

Ankylosing spondylitis:

The recommended dose is 60 mg once daily, which may be increased if necessary up to a maximum of 90 mg once daily (this dose cannot be administered with this medicine). Another dosage strength of this medicine is available for the treatment of ankylosing spondylitis; please consult your doctor.

Acute pain conditions:

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

Gout:

The recommended dose is 120 mg (equivalent to 2 tablets of this medicine) once daily and should only be taken 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 daily, limited to a maximum of 3 days of treatment (this dose cannot be administered with this medicine). Another dosage strength of this medicine is available for the treatment of postoperative dental surgery pain; please consult your doctor.

Patients with liver problems

• If you have mild hepatic impairment, you should not take more than 60 mg per day.
• If you have moderate hepatic impairment, you should not take more than 30 mg per day.

Use in children and adolescents

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

Patients over 65 years of age

Dosage adjustment is not required in elderly patients. However, as with all other medications, increased caution should be exercised in elderly patients.

Method of administration

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

If you take more Etoricoxib Kern Pharma than you should

Never take more tablets than your doctor has prescribed. If you take too many tablets of this medicine, seek immediate medical attention.

In case of overdose or accidental ingestion, you may also call the Toxicology Information Service at phone number 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Etoricoxib Kern Pharma

It is important that you take etoricoxib as directed by your doctor. If you miss a dose, simply resume your regular dosing schedule the next day. Do not take a double dose to make up for the missed dose.

If you have any further questions about 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 everyone will experience them.

If you develop any of the following signs, stop taking Etoricoxib Kern Pharma and speak with your doctor immediately (see section 2: What you need to know before you start taking Etoricoxib Kern Pharma):

• difficulty breathing, chest pain or ankle swelling, 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 may include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue or throat that may 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 following tooth extraction)
• swelling of the legs and/or feet due to fluid retention (edema)
• dizziness, headache
• palpitations (fast 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, 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 affecting both the stomach and small intestine/gastric flu), cold, urinary tract infection
• Changes in laboratory results (reduced red blood cell count, reduced white blood cell count, decreased platelets)
• hypersensitivity (allergic reaction including hives, which may be severe enough to require immediate medical attention)
• increased or decreased appetite, weight gain
• anxiety, depression, reduced mental sharpness; seeing, feeling or hearing things that are not there (hallucinations)
• altered taste, inability to sleep, numbness or tingling, drowsiness
• blurred vision, eye irritation and redness
• ringing in the ears, dizziness (sensation of spinning while standing still)
• abnormal heart rhythm (atrial fibrillation), rapid heart rate, heart failure, feeling of tightness, pressure or heaviness in the chest (angina), myocardial infarction
• redness, stroke, mini-stroke (transient ischemic attack), severe increase in blood pressure, inflammation of blood vessels
• cough, shortness of breath, nosebleed
• stomach swelling, changes in bowel habits, dry mouth, stomach ulcer, inflammation of the stomach lining which may become severe and lead to bleeding, irritable bowel syndrome, pancreatitis
• facial swelling, skin rash or itching, skin redness
• muscle cramps/spasms, muscle pain/stiffness
• elevated potassium levels in your blood, changes in blood or urine tests related to your kidneys, serious 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, restlessness
• liver problems (hepatitis)
• low sodium levels in blood
• liver impairment, yellowing of the skin and/or eyes (jaundice)
• serious 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 adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Etoricoxib Kern Pharma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Etoricoxib Kern Pharma

• The active substance 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), triacetin, yellow iron oxide (E172, colouring agent), and indigotine (E132, colouring agent).

Appearance of Etoricoxib Kern Pharma and contents of the pack

• Film-coated, biconvex, apple-shaped tablets, light green in colour, with the number «120» engraved on one side and nothing on the other. The 120 mg strength is available in blisters containing 5, 7, 10, 14, 28, 30, 50, and 100 tablets.

Only certain pack 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 medicinal product 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 comprimate filmate

Spain: Etoricoxib Kern Pharma 120mg comprimidos EFG

Date of the most recent review of this leaflet: June 2022

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