Etoricoxib 90 mg. 14 tablets

1. What Etoricoxib is and what it is used for

What is Etoricoxib?

Etoricoxib contains the active substance etoricoxib, Etoricoxib Teva belongs to the group of medicines called COX-2 inhibitors. They belong to a family of drugs called non-steroidal anti-inflammatory drugs (NSAIDs).

What is etoricoxib Teva used for?

Etoricoxib Teva helps to reduce pain and swelling (inflammation) in joints and muscles in people aged 16 years and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout.

Etoricoxib Teva is also used for the short-term treatment of moderate pain after dental surgery 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 disability.

What is rheumatoid arthritis?

Rheumatoid arthritis is a long-term inflammatory disease of the joints. It causes stiffness, swelling and a progressive loss of mobility 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 spine and large joints

2. What you need to know before you take Etoricoxib Teva

Do not take Etoricoxib Teva:

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 (aspirin) and COX-2 inhibitors (see section 4, Possible side effects)

if you have an active stomach ulcer or bleeding from your stomach and 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 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 you have high blood pressure uncontrolled with treatment (check with your doctor or nurse if you are not sure whether your blood pressure is adequately controlled)

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 or TIA). 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 have had a stroke.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Etoricoxib Teva if:

you have a history of stomach bleeding or ulcers.

You are dehydrated, for example due to prolonged diarrhea or vomiting, 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 Teva can increase blood pressure in some people, especially at high doses, and your doctor will want to check your blood pressure regularly, you have a history of liver or kidney disease.

you are treating an infection. Etoricoxib Teva may mask or mask a temperature condition that is a sign of infection.

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

You are a woman trying to conceive.

You are over the age of 65

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

Etoricoxib Teva 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.

Children and adolescents

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

Other medicines and Etoricoxib Teva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

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

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 or 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, for example enalapril and ramipril, and losartan and valsartan

diuretics (water tablets)

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)

acetylsalicylic acid (aspirin). The risk of stomach ulcers is greater if you take Etoricoxib Teva with acetylsalicylic acid.

- acetylsalicylic acid for the prevention of heart attack or stroke: Etoricoxib Teva can be taken with low doses of acetylsalicylic acid. If you are taking low-dose acetylsalicylic acid to prevent heart attack and stroke, you should not stop taking it until you have consulted your doctor.

- acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs):

do not take a high dose of acetylsalicylic acid or other anti-inflammatory medicines while taking etoricoxib Teva

Pregnancy, lactation and fertility

Pregnancy

Etoricoxib Teva 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, stop taking the tablets and consult your doctor. Ask your doctor if you are unsure or need further advice.

Breastfeeding

It is not known whether etoricoxib is excreted in human milk. If you are breast-feeding or planning to breast-feed, consult your doctor before taking Etoricoxib Teva. If you are taking etoricoxib Teva, you should not breast-feed.

Fertility

Etoricoxib Teva 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 etoricoxib Teva.

Do not drive if you feel dizzy or drowsy.

Do not operate appliances or machinery if you feel dizzy or drowsy.

3. How to take Etoricoxib Teva

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

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 as needed.

Rheumatoid arthritis

The recommended dose is 60 mg once daily, increased to a maximum of 90 mg once daily as needed.

Ankylosing spondylitis

The recommended dose is 60 mg once daily, increased to a maximum of 90 mg once daily as needed.

Acute pain states

Etoricoxib should only be used during periods of flare-up 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.

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 Etoricoxib Teva for longer than necessary. This is due to the risk of heart attack or stroke, which may increase after long-term treatment, especially with high doses.

Use in children and adolescents

Etoricoxib Teva should not be taken by children and adolescents under 16 years of age.

Old age

No dose adjustment is required in elderly patients. Like other drugs, they should be used with caution in elderly patients.

Application method

Etoricoxib Teva is for oral use.

Take the tablets once a day. Etoricoxib Teva can be administered with or without food.

If you have taken more Etoricoxib Teva than you should

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

If you forget to take Etoricoxib Teva

It is important to take Etoricoxib Teva 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 medicine, 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 Etoricoxib Teva immediately and tell your doctor (See section 2 "What you need to know before you take Etoricoxib Teva"):

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 sores or blisters, or swelling of the face, lips, tongue or throat that may make breathing difficult

The following side effects may occur during treatment with Etoricoxib Teva:

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

stomach ache

Common (may affect up to 1 in 10 people)

dry alveolitis (inflammation and pain after tooth extraction) swelling of the legs and/or feet due to fluid retention (oedema) dizziness, headache

palpitations (palpitations), irregular heart rhythm (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 clotting

weakness and fatigue, flu-like condition

Uncommon (may affect up to 1 in 100 people)

gastroenteritis (inflammation of the gastrointestinal tract, which includes the stomach and small intestine), upper respiratory tract infection, urinary tract infection changes in laboratory tests (decrease in red blood cells, decrease in white blood cells, decrease in 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 (stroke), mini stroke (transient ischemic attack TIA), severe increase in blood pressure, inflammation of blood vessels cough, shortness of breath, nosebleeds

swelling of the stomach or bowels, changes in bowel movements, dry mouth, stomach ulcer, inflammation of the lining of the stomach which can be serious and may 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/cramping

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

chest pain

5. How to store Etoricoxib Teva

Keep out of the reach of children.

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

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

Do not use this medicine if you notice any visible signs of deterioration.

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 Etoricoxib Teva contains

The active substance is etoricoxib. Each film-coated tablet contains 90 mg etoricoxib.

The other ingredients are:

Tablet core: calcium hydrogen phosphate (anhydrous), crospovidone (type A), microcrystalline cellulose, povidone K25, magnesium stearate.

Tablet coating: hypromellose, hydroxypropylcellulose, talc, medium-chain triglycerides, titanium dioxide (E171).

What Etoricoxib Teva looks like and contents of the pack

90 mg white, round, biconvex, film-coated tablet, debossed with "90" on one side and plain on the other.

Packaging:

OPA/A1/PVC / A1 blisters in packs containing 5, 7,7x1,14,20,28,28x1, 30, 50, 98, 100 film-coated tablets

Not all types of packaging can be put on sale.