Etoristad 90 mg. 14 tablets

What Etoristad is and what it is used for

Etoristad belongs to a group of medicines called selective cyclooxygenase-2 (COX-2) inhibitors. They belong to a family of drugs called non-steroidal anti-inflammatory drugs (NSAIDs).

Etoristad helps reduce pain and swelling (inflammation) in the joints and muscles of people with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout.

Etoristad is also used for the short-term treatment of moderate pain after dental surgery. Etoristad is indicated in people aged 16 years and older.

What is osteoarthritis?

Osteoarthritis is a disease of the joints. It results from the gradual breakdown of the cartilage that lines the ends of bones. This causes swelling (inflammation), pain, tenderness, stiffness and immobility.

What is rheumatoid arthritis?

Rheumatoid arthritis is a long-term inflammatory disease of the joints. It causes pain, stiffness, swelling and increasing loss of motion in the affected joints. It can also cause inflammation in other parts of the body.

What is gout?

Gout is a disease with sudden and repeated attacks of very painful inflammation and redness of the joints. It is caused by the deposition of mineral crystals in the joints.

What is ankylosing spondylitis?

Ankylosing spondylitis is an inflammatory disease of the spinal vertebrae and large joints.

2. What you need to know before you take Etornstad

Do not take Etoristad

if you are allergic to etoricoxib 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 acetylsalicylic acid and COX-2 inhibitors (see section 4. Possible side effects);

If you have an active stomach ulcer or bleeding from your stomach or intestines;

If you have severe liver disease;

If you have severe kidney disease;

If you are pregnant or may become pregnant or are breast-feeding (see section "Pregnancy, breast-feeding and fertility");

If you are under the age of 16;

If you have an inflammatory bowel disease such as Crohn's disease, ulcerative colitis or colitis

If your doctor has diagnosed heart problems, including heart failure (moderate or severe), angina (chest pain), if you have had a heart attack, bypass surgery, peripheral artery disease (poor blood supply to the legs due to narrowing or blockage of the arteries); if you have had a stroke (including mini-stroke, transient ischemic attack). Etoricoxib may slightly increase your risk of heart attack and stroke, and therefore should not be used by people who have had heart problems or had a stroke;

If you have high blood pressure not controlled by treatment (check with your doctor or nurse if you are not sure whether your blood pressure is adequately controlled).

If you believe that any of these conditions apply to your condition, do not take the tablets before consulting a doctor.

Warnings and precautions

Etoristad may not be suitable for you or you may need to be checked regularly if any of the conditions listed below apply to you:

If you have had a stomach or intestinal ulcer or bleeding in the past;

If you are dehydrated, for example due to prolonged diarrhea or vomiting;

If you have swelling due to fluid retention;

If you have a history of heart failure or any form of heart disease;

If you have high blood pressure. Etoristad can increase blood pressure in some people, especially at high doses, and your doctor will want to check your blood pressure values ​​periodically;

If you have a history of liver or kidney disease;

You are treating an infection. Etoristad may mask or mask a temperature condition that is a manifestation of infection;

If you have diabetes, high cholesterol or smoke. They can increase the risk of heart disease;

If you are a woman trying to conceive;

If you are elderly (over 65).

If you are not sure if any of these conditions apply to you, talk to your doctor before taking Etoristad to see if this medicine is right for you.

Etoristad works equally well in elderly and young patients. If you are over 65, your doctor will want to see you regularly. No dose adjustment is required for 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 Etoristad

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Especially if you are taking any of the following medicines, your doctor will want to monitor your condition to make sure the medicine is working well after you start taking etoristad:

Medicines to prevent blood clotting (anticoagulants), such as warfarin;

Rifampicin (antibiotic);

Methotrexate (medicine to suppress

Especially if you are taking any of the following medicines, your doctor will want to monitor your condition to make sure the medicine is working well after you start taking etoristad:

Medicines to prevent blood clotting (anticoagulants), such as warfarin;

Rifampicin (antibiotic);

Methotrexate (a medicine to suppress the immune system and often used in rheumatoid arthritis);

Cyclosporine and tacrolimus (medicines used to suppress the immune system);

Lithium (a medicine used to treat some types of depression);

Medicines used to treat high blood pressure and heart failure called ACE inhibitors and angiotensin receptor blockers, eg enalapril and ramipril, losartan and valsartan;

Diuretics (tablet to release water);

Digoxin (medicine to treat heart failure and arrhythmias);

Minoxidil (medicine to treat high blood pressure);

Salbutamol tablets or oral solution (medicine for asthma);

Birth control pills (this combination may increase the risk of side effects);

Hormone replacement therapy (this combination may increase the risk of side effects);

Aspirin. The risk of stomach ulcers is higher if you take etoristad with acetylsalicylic acid;

Etoristad can be taken with low doses of acetylsalicylic acid. If you are taking low-dose acetylsalicylic acid to prevent a heart attack or stroke, you should stop taking it until you consult your doctor.

do not take a high dose of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs while taking etoristad.

Pregnancy, lactation and fertility

Pregnancy

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

Etoristad should not be taken during pregnancy. If you are pregnant, think you may be pregnant or are planning to become pregnant, do not take these tablets. If you become pregnant during treatment with Etoristad, you should stop treatment and contact your doctor. Consult your doctor before using any medicine.

Breastfeeding

It is not known whether etoristad passes into human breast milk. If you are breast-feeding or plan to breast-feed, consult your doctor before taking Etoristad. If you are taking Etoristad, you should not breast-feed.

Fertility

Etoristad is not recommended for women who are trying to become pregnant. Driving and using machines

Dizziness and drowsiness have been reported in some patients taking etoristad. Do not drive if you feel dizzy or drowsy.

You should know how you react to Etoristad before you drive or operate machinery. If you feel dizzy or tired after taking Etoristad, do not drive or operate machinery until these reactions have disappeared.

Etoristad contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Etoristad contains sodium.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it can be said to be practically sodium-free.

3. How to take Etoristad

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Do not take more than the recommended dose for your condition. Periodically, your doctor will discuss the treatment with you. It is important to use the lowest dose that gives you pain control and you should not take Etoristad for longer than necessary. This is due to the risk of heart attack or stroke, which may increase after long-term treatment, especially at high doses.

Tablets with different amounts of the active substance are available from this medicinal product, and depending on your illness, your doctor will prescribe the appropriate tablet.

The recommended dose is:

Osteoarthritis

The recommended dose is 30 mg once daily, increased to a maximum of 60 mg once daily if necessary.

Rheumatoid arthritis

The recommended dose is 90 mg once daily.

Ankylosing spondylitis

The recommended dose is 90 mg once daily.

Acute pain states

Etoristad should only be used during periods of acute pain.

Gout

The recommended dose is 120 mg once daily, which should be administered only during periods of attack, with treatment limited to a maximum of 8 days.

Postoperative pain after dental surgery

The recommended dose is 90 mg once daily, with treatment limited to a maximum of 3 days.

People 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.

Application method

Etoristad is an oral tablet. Take the tablets once a day. Etoristad can be taken with food or on an empty stomach.

If you have taken more Etoristad than you should

You should never take more tablets than your doctor has prescribed. If you take too many tablets, you should seek medical help immediately.

If you forget to take Etoristad

It is important to take Etoristad as prescribed by your doctor. If you miss a dose, simply continue with your normal schedule the next day. Do not take a double dose to make up for a missed tablet.

If you have any further questions related to the use of this product, please ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following symptoms, you should stop taking Etoristad and tell your doctor immediately (See section 2. What you need to know before you take Etoristad):

Shortness of breath, chest pain, or swelling of the ankles, or when they get worse;

Yellowing of the skin and eyes (jaundice) - this is a manifestation of liver problems;

severe and prolonged stomach pain or black stools;

allergic reaction - may include skin problems such as ulcers or blisters, or swelling of the face, lips, tongue or throat which may make breathing difficult.

The following side effects may occur during treatment with Etoristad:

Very common

stomach ache

Frequent

dry alveolitis (inflammation and pain after tooth extraction)

swelling of the legs and/or feet due to fluid retention (oedema)

dizziness, headache

palpitations (fast or irregular heartbeat), irregular heartbeat (arrhythmia)

increased blood pressure

wheezing or shortness of breath (bronchospasm)

constipation, flatulence, gastritis (inflammation of the lining of the stomach), heartburn, diarrhoea, indigestion (dyspepsia)/stomach discomfort, nausea, vomiting, inflammation of the oesophagus, mouth ulcers

change in blood tests related to the liver

blood transfusion

weakness and fatigue, flu-like condition

Infrequent

gastroenteritis (inflammation of the gastrointestinal tract, which includes the stomach and small intestine), upper respiratory tract infection, urinary tract infection

decreased number of red blood cells, decreased number of white blood cells, decreased number of platelets

hypersensitivity (allergic reaction including hives which may be quite serious and require immediate medical attention) increased or decreased appetite, weight gain

anxiety, depression, reduced thinking ability, seeing, hearing or feeling things that are not there (hallucinations)

change in taste, insomnia, tingling or pins and needles, drowsiness blurred vision, eye irritation and redness

ringing in the ears, vertigo (spinning feeling when standing still) abnormal heart rhythm (atrial fibrillation), fast heart rate, heart failure, feeling of tightness, tightness or heaviness in the chest (angina), heart attack

facial flushing, stroke, mini-stroke (transient ischemic attack), severe increase in blood pressure, inflammation of blood vessels;

cough, shortness of breath, nosebleeds;

swelling of the stomach or intestines, changes in intestinal permeability, dry mouth, stomach ulcer, inflammation of the stomach lining, which can be complicated and lead to bleeding, irritable bowel syndrome, inflammation of the pancreas;

swelling of the face, skin rash or itching, reddening of the skin;

muscle cramps/spasms, muscle pain/spasm;

high levels of potassium in the blood, changes in blood or urine tests related to the kidneys, serious kidney problems;

chest pain.

Rare

angioedema (allergic reaction with swelling of the face, lips, tongue, and/or throat which may cause shortness of breath or difficulty swallowing which may be quite serious and require immediate medical attention)/anaphylactic/anaphylactoid reactions including shock (serious allergic a reaction that requires immediate medical attention;

confusion, restlessness;

liver problems (hepatitis);

low sodium levels;

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

severe skin reactions.

5. How to store Etoristad

Keep out of the reach of children.

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

This medicinal product does not require special storage conditions. Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What Etoristad contains

The active substance is etoricoxib.

Each Etoristad 30 mg tablet contains 30 mg etoricoxib.

Each Etoristad 60 mg tablet contains 60 mg etoricoxib.

Each Etoristad 90 mg tablet contains 90 mg etoricoxib.

Each Etoristad 120 mg tablet contains 120 mg etoricoxib.

The other ingredients (excipients) are:

Core of the tablet

Calcium hydrogen phosphate, anhydrous

Microcrystalline cellulose

Povidone K29-32

Croscarmellose sodium

Magnesium stearate

Tablet coating

Hypromellose

Lactose monohydrate

Titanium dioxide (E171)

Triacetin

Etoristad 30 mg, 60 mg and 120 mg film-coated tablets also contain: Indigo carmine (E 132) Yellow iron oxide (E 172)

What Etoristad looks like and contents of the pack Film-coated tablet

Etoristad 30 mg: Blue-green, round, biconvex film-coated tablet with a diameter of 5 mm,

Etoristad 60 mg: Dark green, round, biconvex, film-coated tablet with a diameter of 6.5 mm.

Etoristad 90 mg: White, round, biconvex, film-coated tablet with a diameter of 7.5 mm. Etoristad 120 mg: Light green, round, biconvex, film-coated tablet with a diameter of 8.5 mm.

Etoristad is packaged in ORA/Aluminium/PVC-aluminium blister or high-density polyethylene (HDPE) packaging.

The following blister packs are available:

Etoristad 30 mg film-coated tablets Packs of 7, 28, 30, 98 film-coated tablets.

Etoristad 60 mg film-coated tablets

Packs of 7, 10, 14, 20, 28, 30, 50, 98 and 100 film-coated tablets. Etoristad 90 mg film-coated tablets

Packs of 7, 10, 14, 20, 28, 30, 50, 98 and 100 film-coated tablets.

Etoristad 120 mg film-coated tablets Packs of 5, 7, 10, 20, 30, 98 film-coated tablets.

The following High Density Polyethylene (HDPE) packaging is available

Etoristad 30 mg film-coated tablets

Packs of 28, 30, 98 film-coated tablets.

Etoristad 60 mg film-coated tablets

Packs of 28, 30, 50, 90, 98 and 100 film-coated tablets.

Etoristad 90 mg film-coated tablets

Packs of 28, 30, 50, 90, 98 and 100 film-coated tablets.

Etoristad 120 mg film-coated tablets

Packs of 7, 28, 30, 90 film-coated tablets.

Not all types of packaging can be put on sale.