What does Arcotia

Arcoxia 90 mg film-coated tablets

Patient information for Arcoxia 90 mg film-coated tablets

1.What Arcoxia 90 mg film-coated tablets is and what it is used for

1.1 What are the properties of the medicinal product?

Arcoxia 90 mg film-coated tablets contains the active ingredient tericoxib, a drug from the group of so-called anti-inflammatory drugs (anti-inflammatory drugs) and anti-inflammatory drugs (anti-inflammatory drugs, non-steroidal analgesics (NSAIDs) and coxibs.

Etericoxib is a selective cyclooxygenase-2 (COX-2) inhibitor. Cyclooxygenase is responsible for the formation of prostaglandins and has an influence on pain, inflammation and fever.

Etericoxib helps relieve the pain and swelling (inflammation) in joints and muscles that affect people with degenerative or inflammatory joint disease (osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis) or who have an attack of gout (gouty arthritis).

Osteoarthritis is a joint disease. It is caused by the gradual breakdown of the cartilage that cushions the ends of the bones. This leads to swelling (inflammation), pain, sensitivity to touch, stiffness and physical limitations.

Rheumatoid arthritis is a long-term inflammatory disease of the joints. It causes pain, stiff, swollen joints and an increasing limitation of mobility in the affected joints. The disease also causes other inflammations in the body.

Gouty arthritis is a disease characterized by sudden, repetitive, very painful attacks of gout, with inflammation and redness of the joints. Gouty arthritis is caused by the build-up of mineral crystals in the joints.

Ankylosing spondylitis (Bechterew's disease) is an inflammatory disease of the spine and large joints.

Etericoxib requires a prescription and should only be used on medical advice.

1.2. Active strength and dosage form of Arcoxia 90 mg film-coated tablets

- Film-coated tablets containing 90 mg etoricoxib.

Your doctor will determine whether this strength and dosage form are suitable for your treatment.

1.3.Etericoxib is used for

- Treatment of pain and swelling (inflammation) in joints and muscles in patients aged 16 and over with degenerative or inflammatory joint disease (osteoarthritis, rheumatoid arthritis or ankylosing spondylitis [ankylosing spondylitis]) or who have an attack of gout (gouty arthritis).

- used for short-term treatment of moderate pain after dental surgery in patients aged 16 years and over.

2. What you need to know before you take Arcoxia 90 mg film-coated tablets

2.1 Arcoxia 90 mg film-coated tablets must not be used

- if you are allergic (hypersensitive) to etoricoxib or any of the other ingredients of Arcoxia 90 mg film-coated tablets,

- if you are allergic to non-steroidal anti-inflammatory drugs (NSAIDs) including acetylsalicylic acid and COX-2 inhibitors,

- if you currently have an ulcer or bleeding in the gastrointestinal tract

- if you have severe liver disease,

- if you have severe kidney disease,

- if you are pregnant or could be pregnant or if you are breast-feeding

- if you are younger than 16 years,

- if you have an inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis or colitis),

- if your doctor has diagnosed you with a heart disease such as heart failure (moderate or severe symptoms), angina pectoris (chest pain),

- if you have ever had a heart attack, surgery on the coronary arteries (bypass surgery), peripheral arterial disease (circulatory problems in the legs or feet with narrowed or blocked arteries)

- if you have already had a stroke (including a stroke-like event called Transient Ischemic Attack TIA).

Etoricoxib may slightly increase your risk of having a heart attack or stroke, so it should not be taken in patients who have had heart disease or a stroke.

- if you have high blood pressure that is not adequately controlled by treatment (ask your doctor or nurse if you are not sure whether your blood pressure is adequately controlled).

If you think any of these conditions apply to you, do not take the tablets until you have checked with your doctor.

2.2 Special care is required when taking Arcoxia 90 mg film-coated tablets

If any of the following apply to you, talk to your doctor or pharmacist before taking Arcoxia 90 mg film-coated tablets:

- You have or have ever had gastrointestinal disorders with bleeding or ulcers.

- You are dehydrated, e.g. as a result of frequent vomiting or diarrhea.

- You have swelling due to fluid retention.

- you have or have ever had heart failure, a heart attack or other heart disease.

- you have or have ever had high blood pressure. "Etoricoxib_90 mg_Filmtablette" can cause high blood pressure in some people, especially at high doses. Your doctor will check your blood pressure from time to time.

- you have or have ever had liver or kidney disease.

- You are currently being treated for an infection. "Etoricoxib_90 mg_Filmtablette" can hide or suppress a fever, a sign of infection.

- You are a woman planning a pregnancy.

- You are already older (i.e. over 65 years of age).

- You have diabetes, high blood lipid levels or you smoke. These factors can increase your risk of heart disease.

If you are not sure whether any of the above affects you, talk to your doctor before you start taking Arcoxia 90 mg film-coated tablets to find out whether this medicine is suitable for you.

Arcoxia 90 mg film-coated tablets are equally effective and well tolerated in older and younger adult patients.

Fertility / childbearing potential: The use of Arcoxia 90 mg film-coated tablets is not recommended for women who are planning to become pregnant.

Important information about some of the ingredients: Arcoxia 90 mg film-coated tablets contains lactose. Please only take Arcoxia 90 mg film-coated tablets after consulting your doctor if you know that you are intolerant to certain sugars.

2.2.a) Children

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

2.2.b) Elderly patients

If you are older than 65 years, your doctor will monitor you accordingly. No dose adjustment is required for patients over 65 years of age.

2.2.c) Pregnancy

Arcoxia 90 mg film-coated tablets must not be used during pregnancy. If you are pregnant, think you may be pregnant, or plan to become pregnant, do not take the film-coated tablets. If you become pregnant, stop treatment and contact your doctor. Also, contact your doctor if you are unsure or have any further questions.

2.2.d) Breastfeeding

It is not known whether Arcoxia 90 mg film-coated tablets are excreted in breast milk. If you are breast-feeding or planning to breast-feed, talk to your doctor before taking Arcoxia 90 mg film-coated tablets. Do not breast-feed during treatment with Arcoxia 90 mg film-coated tablets.

2.2.e) Ability to drive and use machines

Dizziness and sleepiness have been reported in some patients during treatment with Arcoxia 90 mg film-coated tablets. Do not drive if you feel dizzy or sleepy. Do not use tools or machines if you feel dizzy or sleepy.

2.3 Which interactions with other medicinal products have to be considered?

Please inform your doctor or pharmacist if you are taking / using or have recently taken / used any other medicines, including medicines obtained without a prescription.

This is especially important if you are taking any of the following medicines, because your doctor will check whether your medicines are working properly as soon as you start treatment with Etoricoxib 90 mg film tablet:

- Medicines to thin the blood (anticoagulants) such as warfarin

- rifampicin (an antibiotic)

- methotrexate (a medicine used to suppress the immune system, often prescribed for 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 treat high blood pressure and heart failure called ACE inhibitors or angiotensin receptor blockers, such as enalapril and ramipril or losartan and valsartan

- diuretics (water tablets)

Digoxin (medicine used to treat heart failure or irregular heartbeat)

- minoxidil (medicine used to treat high blood pressure)

- salbutamol as tablets or oral suspension (medicines used to treat asthma)

- the "pill" to prevent pregnancy (the combination can increase the risk of side effects)

- hormone replacement therapy (the combination may increase the risk of side effects)

- Acetylsalicylic acid, because the risk of gastrointestinal ulcers is increased if you take acetylsalicylic acid with Arcoxia 90 mg film-coated tablets:

- Acetylsalicylic acid to prevent heart attack and stroke: Arcoxia 90 mg film-coated tablets can be taken together with low-dose acetylsalicylic acid. If you are taking low-dose acetylsalicylic acid to prevent heart attack or stroke, you should not stop taking acetylsalicylic acid without asking your doctor first.

- Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs): Do not take higher doses of acetylsalicylic acid or any other anti-inflammatory drugs during treatment with Arcoxia 90 mg film-coated tablets.

2.4 What should be thought of when taking Arcoxia 90 mg film-coated tablets together with food, beverages and tobacco?

The onset of the effect can occur faster if "Etoricoxib_90 mg_Filmtablette" is taken without food.

3. How to take Arcoxia 90 mg film-coated tablets

Always take Arcoxia 90 mg film-coated tablets exactly as your doctor has told you. Please ask your doctor or pharmacist if you are not sure.

3.1 Nature and duration of ingestion

Arcoxia 90 mg film-coated tablets is for oral use. Take the tablets once a day. Arcoxia 90 mg film-coated tablets can be taken with or without food.

It is important to use the lowest dose that will give you pain relief and not to take Arcoxia 90 mg film-coated tablets for longer than necessary. The risk of a heart attack or stroke may increase with the duration of treatment, especially at high doses.

The doctor decides on the duration of the intake.

3.2 Unless otherwise prescribed by the doctor, the usual dose is

Do not take a higher dose than recommended for your condition. Your doctor will discuss the treatment with you at regular intervals. It is important to use the lowest dose that will give you pain relief and not to take Arcoxia 90 mg film-coated tablets for longer than necessary. The risk of a heart attack or stroke may increase with the duration of treatment, especially at high doses.

This medicine is available in different strengths. Depending on your condition, your doctor will prescribe the right strength for you.

The recommended dose is:

3.2.a) Osteoarthritis

The recommended dose is 30 mg etoricoxib (equivalent to 1 film-coated tablet of 30 mg) once a day. The dose can be increased to a maximum of 60 mg etoricoxib once daily if necessary.

3.2.b) Rheumatoid arthritis or ankylosing spondylitis (Bechterew's disease)

The recommended dose is 60 mg (equivalent to 1 film-coated tablet of 60 mg) once a day. In some patients with insufficient symptom relief, a higher dose of 90 mg (equivalent to 1 90 mg film-coated tablet) once a day may improve effectiveness. Once the patient has stabilized clinically, a dose reduction to 60 mg once daily may be indicated. If there is no increase in therapeutic benefit, other treatment options should be considered.

3.2.c) Treatment of acute pain

Etoricoxib should only be taken for the duration of the acute symptoms.

3.2.c.1.Gouty arthritis

The recommended dose is 120 mg etoricoxib (corresponds to 1 film-coated tablet with 120 mg) once daily and should only be taken for the duration of the acute symptoms. The duration of treatment is limited to a maximum of 8 days.

3.2.c.2.Postoperative pain after dental surgery

The recommended dose is 90 mg etoricoxib (equivalent to 1 film-coated tablet of 90 mg) once a day. The duration of treatment is limited to a maximum of 3 days.

3.2.d) Patients with liver disease

If you suffer from mild liver disease, you should not take more than 60 mg etoricoxib (equivalent to 1 film-coated tablet of 60 mg) per day.

If you have moderate liver disease, you should not take more than 30 mg etoricoxib (equivalent to 1 film-coated tablet of 30 mg) once a day.

3.3 If you take more Arcoxia 90 mg film-coated tablets than you should

Never take more tablets than prescribed by your doctor. However, if you have taken too many tablets, you must see a doctor immediately.

3.4 If you forget to take Arcoxia 90 mg film-coated tablets

It is important to take Arcoxia 90 mg film-coated tablets as your doctor has told you. If you miss a dose, continue taking it as usual the next day. Do not take an extra dose to make up for a forgotten dose.

3.5 Effects if treatment with Arcoxia 90 mg film-coated tablets is stopped

If you want to stop the treatment, please discuss this with your doctor beforehand.

Do not end the drug treatment on your own, as this could jeopardize the success of the therapy.

4. What are the possible side effects?

Like all medicines, Arcoxia 90 mg film-coated tablets can cause side effects, although not everybody gets them.

When evaluating side effects, the following frequencies are used as a basis:

- very common: more than 1 in 10 people

- common: less than 1 in 10, but more than 1 in 100 patients

- uncommon: less than 1 in 100, but more than 1 in 1,000 patients

- rarely: less than 1 in 1,000 but more than 1 in 10,000 people treated

- very rare: less than 1 in 10,000 patients, including isolated cases

- Frequency not known: frequency cannot be calculated from the available data

4.1 Which side effects can occur in detail?

If you get one or more of the following symptoms, stop taking Arcoxia 90 mg film-coated tablets immediately and ask your doctor for advice (see under 2. What should you know before you take Arcoxia 90 mg film-coated tablets?):

- if you experience or worsen shortness of breath, chest pain or swelling in your ankles.

- yellowing of the skin and eyes (jaundice) - these are signs of possible liver disease.

- severe or persistent abdominal pain and / or black stools.

- an allergic reaction - possible signs include skin reactions such as ulcers or blisters; Swelling of the face, lips, tongue and / or throat which can make breathing difficult.

4.1.a) Very common

Stomach pain.

4.1.b) Often

- inflammation and pain after pulling a tooth (osteitis)

Swelling of the legs and / or feet due to fluid retention (edema)

- dizziness, headache

- fast or irregular heartbeat (palpitations), abnormal heart rhythm (arrhythmia)

- increase in blood pressure

Wheezing or shortness of breath (bronchospasm)

- Constipation, wind (excessive wind), gastritis (inflammation of the stomach lining), heartburn, diarrhea, indigestion (dyspepsia) / stomach problems, nausea, malaise (vomiting), inflammation of the esophagus, ulcers of the oral mucosa

- Changes in laboratory blood tests to check how well your liver is working

Bleeding into the skin

- weakness and fatigue, flu-like illness

4.1.c) Occasionally

- gastrointestinal inflammation (inflammation of the gastrointestinal tract, both in the stomach and in the small intestine / gastrointestinal flu), inflammation of the upper respiratory tract, urinary tract infection

- changes in laboratory values ​​(decreased number of red blood cells, decreased number of white blood cells, decreased number of blood platelets)

Hypersensitivity (allergic reaction, including hives, which can be severe enough to require immediate medical attention)

- increased or decreased appetite, weight gain

- Feelings of fear, depression, difficulty concentrating, perception of things that are not there (hallucinations)

- change in taste, insomnia, numbness or tingling sensation, drowsiness

- Blurred vision, irritated and red eyes

Ringing in the ears, vertigo (feeling that everything is spinning when at rest)

- abnormal heart rhythm (atrial fibrillation), fast heartbeat, heart failure, feeling of tightness, pressure or heaviness in the chest (angina pectoris), heart attack

- Hot flashes, stroke, transient stroke-like event (transient ischemic attack), excessive increase in blood pressure, inflammation of the blood vessels

- Cough, shortness of breath, nosebleeds

- bloated stomach or belly, changes in the way your bowels work, dry mouth, stomach / intestinal ulcer which can lead to breakthrough and bleeding, irritable bowel syndrome, inflammation of the pancreas

- swelling of the face, rash or itchy skin, reddening of the skin

- Muscle cramps / spasms, sore / stiff muscles

- high levels of potassium in the blood, changes in laboratory tests carried out on the blood or urine to check how well your kidneys are working, serious kidney problems

- Chest pain.

4.1.d) Rarely

- Angioedema (an allergic reaction with swelling of the face, lips, tongue and / or throat which can cause difficulty breathing or swallowing and which can be severe enough to require immediate medical attention) / anaphylactic / anaphylactoid reactions including shock (a serious allergic reaction that requires immediate medical attention)

- Confusion, restlessness

- inflammation of the liver (hepatitis)

- low levels of sodium in the blood

Liver failure, yellowing of the skin and / or eyes (jaundice)

- serious skin reactions.

4.2 What countermeasures should be taken if side effects occur?

Let your doctor know if you experience any side effects. He will decide on possible measures.

If you experience a sudden or severe side effect, inform a doctor immediately, as certain drug side effects (e.g. excessive drop in blood pressure, hypersensitivity reactions) can under certain circumstances have serious consequences. In such cases, do not continue to take the medicine without doctor's advice.

Tell your doctor or pharmacist if you notice any side effects not listed here or in the package insert. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Arcoxia 90 mg film-coated tablets

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

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

Store in the original package in order to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer need. This measure helps to protect the environment.

6. Source and processing status

Information from the SCHOLZ database based on the data approved by the Federal Office for Drugs and Medical Devices

Copyright by ePrax GmbH, Munich; July 2016 (2)