Package Insert: Information for the Patient

Etoricoxib Normon 30 mg Film-Coated Tablets

Etoricoxib Normon 60 mg Film-Coated Tablets

Etoricoxib Normon 90 mg Film-Coated Tablets

Etoricoxib Normon 120 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 only for you, and you should not give it to others who may 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.

1. What isEtoricoxibNormonand what is it used for

2. What you need to know before starting to takeEtoricoxibNormon

3. How to takeEtoricoxibNormon

4. Possible adverse effects

5. Storage ofEtoricoxibNormon

6. Contents of the package 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).

What is Etoricoxib used for?

• 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 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.

Do not take Etoricoxib:

• if you are allergic (hypersensitive) to etoricoxib 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 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, 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 you have high blood pressure that has not been controlled with treatment (consult your doctor or nurse if you are unsure whether your blood pressure is adequately controlled)
• if your doctor has diagnosed you with heart problems, including heart failure (moderate or severe), 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 a transient ischaemic attack or transient ischaemic 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 diarrhoea.
• 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 unsure whether any of the above situations affect you, speak with your doctor before taking this medicine to check whether etoricoxib is suitable for you.

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

Children and adolescents

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

Taking Etoricoxib with other medicines

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

Particularly if you are using any of the following medicines, your doctor may want to monitor you to ensure that your medicines work properly once you start taking Etoricoxib:

• blood-thinning medicines (anticoagulants), such as warfarin
• rifampicin (an antibiotic)
• methotrexate (a medicine used to suppress the immune system and often used in rheumatoid arthritis)
• ciclosporin or tacrolimus (medicines used to suppress the immune system)
• lithium (a medicine used to treat certain types of depression)
• medicines used to help control high blood pressure and heart failure called ACE inhibitors and angiotensin receptor antagonists, for example enalapril and ramipril, and losartan and valsartan
• diuretics (tablets to help you urinate)
• digoxin (a medicine for heart failure and irregular heartbeat)
• minoxidil (a medicine used to treat high blood pressure)
• oral tablets or 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 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 non-steroidal anti-inflammatory drugs (NSAIDs):

Do not takehigh dosesof aspirin or other anti-inflammatory medicines while taking this medicine.

Taking Etoricoxib with food and drink

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

Pregnancy, breastfeeding 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.

Breastfeeding

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

Fertility

We do not recommend using Etoricoxib in women who are 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 Normon contains sodium.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; 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 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 30mg once a day, increasing up to a maximum of 60mg once a day if necessary.

Rheumatoid Arthritis

The recommended dose is 60mg once a day, increasing up to a maximum of 90mg once a day if necessary.

Ankylosing Spondylitis

The recommended dose is 60mg once a day, increasing up to a maximum of 90mg once a day if necessary.

Acute Pain Situations

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

Gout

The recommended dose is 120mg once a day, which should only be used 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.

Patients with Liver Problems

• If you have a mild liver disease, do not take more than 60mg per day.
• If you have a moderate liver disease, do not take more than30mg per day.

Use in Children and Adolescents

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

Patients over 65years

No dose adjustment is necessary for patients over 65years. 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, 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 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 takingthis medicineand 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 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 following side effects may occur during treatment with Etoricoxib:

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

• stomach pain

Common(may affect up to 1 in 10people):

• 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, esophageal inflammation, mouth ulcers
• changes in blood test results related to the liver
• bruising
• weakness and fatigue, flu-like illness

Uncommon(may affect up to 1 in 100people):

• 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)
• altered 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 (atrial 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 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(may affect up to 1 in 1,000people):

• 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.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from moisture.

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

Composition of Etoricoxib Normon

• The active ingredient is etoricoxib. Each film-coated tablet contains 30 mg, 60 mg, 90 mg or 120 mg of etoricoxib.
• The other components (excipients) are:
• • Tablet core: sodium croscarmellose (E468), microcrystalline cellulose (E460) and magnesium stearate (E470b).
  • Film coating: hypromellose (E464), titanium dioxide (E171), triacetin (E1518), talc (E553b), indigo carmine lake (E132) (this excipient is not used in Etoricoxib Normon 90 mg) and yellow iron oxide (E172) (this excipient is not used in Etoricoxib Normon 90 mg).

Appearance of the product and contents of the package

• Etoricoxib Normon 30 mg film-coated tablets:

They are presented in the form of green-blue film-coated, round and biconvex tablets.

Each pack contains 28 film-coated tablets.

• Etoricoxib Normon 60 mg film-coated tablets:

They are presented in the form of dark green film-coated, round and biconvex tablets.

Each pack contains 28 film-coated tablets.

• Etoricoxib Normon 90 mg film-coated tablets:

They are presented in the form of white film-coated, round and biconvex tablets.

Each pack contains 28 film-coated tablets.

• Etoricoxib Normon 120 mg film-coated tablets:

They are presented in the form of pale green film-coated, round and biconvex tablets.

Each pack contains 7 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Normon Laboratories, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos — Madrid

Spain

Last review date of this leaflet: April 2021

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