Acoxxel 120 mg film-coated tablets

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

ACOXXEL 30mg Film-coated Tablets

ACOXXEL 60mg Film-coated Tablets

ACOXXEL 90mg Film-coated Tablets

ACOXXEL 120mg Film-coated Tablets

etoricoxib

Read the entire leaflet carefully before you start taking this medicine, as 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 others, 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 effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What ACOXXEL is and what it is used for

What is Acoxxel?

• Acoxxel contains the active substance etoricoxib. Acoxxel belongs to a group of medicines known as selective COX-2 inhibitors. These belong to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

What is Acoxxel used for?

• Acoxxel helps reduce pain and swelling (inflammation) in the joints and muscles of people aged 16 years and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout.
• Acoxxel is also used for the short-term treatment of moderate pain following dental surgery in people aged 16 years and older.

What is osteoarthritis?

Osteoarthritis is a disease of the joints. 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 long-term inflammatory disease of the joints. It causes pain, stiffness, swelling, and progressive loss of mobility in the affected joints. It can also cause inflammation in other areas of the body.

What is gout?

Gout is a disease characterized by sudden and recurring attacks of very painful inflammation and redness of the 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 large joints.

2. What you need to know before taking ACOXXEL

Do not take Acoxxel

• 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 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 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 myocardial infarction, surgical revascularization, or peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries)
• if you have had any type of stroke (including a transient ischaemic attack or ischaemic stroke).

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 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 taking Acoxxel if:

• You have a history of stomach ulcers or gastrointestinal bleeding.
• You are dehydrated, for example due to 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. Acoxxel 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. Acoxxel 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 developing 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 apply to you, talk to your doctor before taking Acoxxel to check whether this medicine is suitable for you.

Acoxxel works equally well in young and adult patients. If you are over 65 years of age, your doctor will want to monitor you appropriately. Dose adjustment is not necessary in patients over 65 years of age.

Children and adolescents

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

Other medicines and Acoxxel

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 are working properly once you start taking Acoxxel:

• 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)

• cyclosporine 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 blockers, for example enalapril and ramipril, losartan and valsartan

• diuretics (water tablets)

• 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 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 Acoxxel with aspirin.

• Aspirin for prevention of heart attacks or stroke:

Acoxxel may be taken with low doses of aspirin. If you are currently taking low-dose aspirin to prevent heart attacks 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 doses of aspirin or other anti-inflammatory medicines while taking Acoxxel.

Taking Acoxxel with food and drink

The onset of action of Acoxxel may be faster if taken without food.

Pregnancy, breastfeeding and fertility

Pregnancy

Acoxxel 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 unknown whether Acoxxel is excreted in breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Acoxxel. If you are taking Acoxxel, you must stop breastfeeding.

Fertility

The use of Acoxxel is not recommended in women attempting to become pregnant.

Driving and using machines

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

Do not drive if you experience dizziness or somnolence.

Do not use tools or machines if you experience dizziness or somnolence.

Acoxxel contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

Acoxxel contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; this is essentially “sodium-free”.

3. How to take ACOXXEL

Follow exactly the instructions for using this medicine given by your doctor. If you are unsure, 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 to use the lowest dose that controls your pain, and you should not take ACOXXEL 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, increased if necessary up to a maximum of 60 mg once daily.

Rheumatoid arthritis

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

Ankylosing spondylitis

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

Acute pain situations

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

Gout

The recommended dose is 120 mg once daily, 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 daily, limited to a maximum of 3 days of treatment.

Patients with liver problems

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

Use in children and adolescents

Children or adolescents under 16 years of age must not take ACOXXEL tablets.

Patients over 65 years of age

Dose adjustment is not necessary in patients over 65 years of age. However, as with other medicines, caution should be exercised in elderly patients.

Method of administration

ACOXXEL is administered orally. Take the tablets once daily. ACOXXEL can be taken with or without food.

If you take more ACOXXEL than you should

You must never take more tablets than your doctor has recommended. If you take too many ACOXXEL tablets, seek immediate medical attention.

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

If you forget to take ACOXXEL

It is important that you take ACOXXEL 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 a missed dose.

If you have any further questions about the use of this medicine, 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 symptoms, stop taking Acoxxel and speak to your doctor immediately (see section 2. What you need to know before taking Acoxxel):

• 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 your stools become black
• 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 adverse 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 Acoxxel:

Very common:

• stomach pain

Common:

• dry socket (inflammation and pain following tooth extraction)
• swelling of the legs and/or feet due to fluid retention (oedema)
• 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 inner lining of the stomach), heartburn, diarrhoea, indigestion (dyspepsia)/stomach discomfort, nausea, vomiting, oesophagitis, 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 (decreased number of red blood cells, decreased number of white blood cells, 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 alertness; seeing, feeling or hearing things that are not there (hallucinations)
• taste disturbances, inability to sleep, numbness or tingling, drowsiness
• blurred vision, eye irritation and redness
• ringing in the ears, vertigo (sensation of spinning while standing still)
• abnormal heart rhythm (atrial fibrillation), rapid heart rate, heart failure, sensation of tightness, pressure or heaviness in the chest (angina pectoris), myocardial infarction
• flushing, stroke, mini-stroke (transient ischaemic attack), severe increase in blood pressure, inflammation of blood vessels
• cough, shortness of breath, nosebleeds
• stomach swelling, changes in bowel habits, dry mouth, stomach ulcer, inflammation of the inner lining of the stomach which may become severe and may cause bleeding, irritable bowel syndrome, inflammation of the pancreas
• facial swelling, skin rash or itching, redness of the skin
• muscle cramp/spasm, muscle pain/stiffness
• elevated potassium levels in your blood, changes in blood or urine tests related to your kidney, 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 adverse effect, talk to 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ACOXXEL

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

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

Vials: keep the container tightly closed to protect it from moisture.

Blister packs: store in the original packaging to protect it from moisture.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Acoxxel

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

• The other components are:

Tablet core: calcium hydrogen phosphate (anhydrous), sodium croscarmellose, magnesium stearate, microcrystalline cellulose.

Tablet coating: carnauba wax, lactose monohydrate, hypromellose, titanium dioxide (E-171), triacetin. The 30, 60 and 120 mg tablets also contain yellow iron oxide (E-172, colouring agent) and indigo carmine lake (E-132, colouring agent).

Appearance of the product and contents of the pack

Acoxxel tablets are available in four strengths:

30 mg film-coated tablets, blue-green, apple-shaped, biconvex, marked with ‘ACX 30’ on one side and ‘101’ on the other.

60 mg film-coated tablets, dark green, apple-shaped, biconvex, marked with ‘200’ on one side and plain on the other.

90 mg film-coated tablets, white, apple-shaped, biconvex, marked with ‘202’ on one side and plain on the other.

120 mg film-coated tablets, pale green, apple-shaped, biconvex, marked with ‘204’ on one side and plain on the other.

Pack sizes:

30 mg:

Pack sizes of 2, 7, 14, 20, 28, 49, 98 tablets or multi-packs containing 98 tablets (2 packs of 49) in blisters.

60 mg:

Pack sizes of 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98, 100 tablets or multi-packs containing 98 tablets (2 packs of 49) in blisters; or 30 and 90 tablets in bottles with desiccant. The desiccant (one or two units) in the bottle, used to keep the tablets dry, must not be swallowed.

90 and 120 mg:

Pack sizes of 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 100 tablets or multi-packs containing 98 tablets (2 packs of 49) in blisters; or 30 and 90 tablets in bottles with desiccant. The desiccant (one or two units) in the bottle, used to keep the tablets dry, must not be swallowed.

60, 90 and 120 mg:

Aluminium/aluminium blisters (unit dose) in packs of 50 or 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorization Holder Organon Salud, S.L. Paseo de la Castellana, 77 28046 Madrid Spain Tel.: 915911279

Manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

or

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany ACOXXEL 30, 60, 90, 120 mg Film-coated Tablets

Spain ACOXXEL 30, 60, 90, 120 mg film-coated tablets

Portugal ACOXXEL 30, 60, 90, 120 mg film-coated tablets

Date of the most recent review of this leaflet: 05/2021.

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