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Doloxib 90 mg. 14 tablets

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

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What Doloxib is and what it is used for

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

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

Doloxib can be used for the short-term treatment of moderate pain after dental surgery in people over 16 years of age.

What is osteoarthritis?

Osteoarthritis is a chronic disease. It is due to the continuous destruction of the articular cartilage. This causes inflammatory swelling, pain, tenderness, stiffness and immobility.

What is rheumatoid arthritis?

Rheumatoid arthritis is a long-term inflammatory disease of the joints. It causes stiffness, swelling and increased 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, recurrent attacks of inflammation with severe pain and redness of the joints. It is due to 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 Doloxib

Do not take Doloxib:

if you are allergic (hypersensitive) to etoricoxib or any of the other ingredients of this medicine (see Further information, section 6). if you are allergic to non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid and COX-2 inhibitors (see Possible side effects, section 4).

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 'Pregnancy and breast-feeding').

if you are under the age of 16.

if you have 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 disease, including heart failure (moderate or severe), angina (chest pain).

if you have had a heart attack, coronary bypass surgery, peripheral arterial disease (poor blood supply to the legs due to narrowing or blockage of the arteries).

if you have had a stroke (including a 'mini-stroke' or transient ischemic attack (TIA)). Eterocoxib may increase your risk of heart attack and stroke and therefore should not be used in individuals who already have problems with the heart or have had a stroke.

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

Take special care when using Doloxib

Talk to your doctor or pharmacist before taking Doloxib if:

you have had stomach bleeding or ulcers.

you are dehydrated (dehydrated, e.g. with prolonged diarrhea or vomiting, you have swelling due to fluid retention.

you have had or have heart failure, a heart attack or other heart disease, you have had a stroke

you have high blood pressure. Doloxib can raise blood pressure in some people, especially at high doses, and your doctor will want to check your blood pressure regularly, you have liver or kidney disease.

you are being treated for an infection. Doloxib can mask or mask

a temperature condition that is a sign of infection, you have diabetes, high cholesterol or smoke. They may increase the risk of:

heart disease.

you are a woman trying to conceive, you are elderly (ie, over 65).

If you are not convinced that any of these conditions correspond to your condition, consult your doctor before taking Doloxib to see if this medicine is suitable for you.

Doloxib works well in elderly and young patients. If you are elderly (ie over 65), your doctor will see you regularly. No dose adjustment is required for elderly patients.

Children and adolescents

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

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

In particular, 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 Doloxib:

medicines to prevent blood clotting (anticoagulants), such as warfarin rifampicin (an antibiotic)

methotrexate (a medicine to suppress the immune system, and often used in rheumatoid arthritis)

cyclosporine or tacrolimus (medicines that suppress the immune system)

lithium (medicine for some types of depression)

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

diuretics (for increased urine output)

digoxin (medicine to treat heart failure and arrhythmias)

minoxidil (medicine to treat high blood pressure)

salbutamol tablets or solution (medicine for asthma)

birth control pills (increased risk of side effects)

hormone replacement therapy (increased risk of side effects) acetylsalicylic acid, to prevent heart attack or stroke:

Doloxib can be taken with a low dose 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

acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs): do not take high doses of aspirin or other anti-inflammatory drugs while taking Doloxib.

Doloxib with food, drink and alcohol

The effect of Doloxib is faster when taken without food.

Pregnancy and breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, talk to your doctor or pharmacist before taking '

the medicine

Pregnancy

Doloxib tablets should not be taken during pregnancy. If you are pregnant or

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. Consult your doctor before using any medicine.

Breastfeeding

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

Fertiliteg

Doloxib is not recommended for women trying to conceive.

Driving and using machines

Dizziness and drowsiness have been reported in some patients taking Doloxib.

Do not drive if you feel dizzy or drowsy.

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

3. How to take Doloxib

Always take Doloxib 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 Doloxib 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.

There are different concentrations of this medicinal product and depending on your illness your doctor will prescribe a tablet with the concentration that is right for you.

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.

Conditions with acute pain

Etoricoxib should only be used during acute pain

Gout

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

Pain after dental surgery

The recommended dose is 90 mg, once a day, which can be taken for up to 3 days.

People with liver disease

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

Doloxib tablets should not be taken by children or adolescents under 16 years of age. In adults

No dose adjustment is required in elderly patients. As with other drugs, use in elderly patients should be done with caution

Application method

Doloxib is intended for oral use. Take the tablets once a day.

Doloxib can be taken with or without food.

If you take more Doloxib than you should

Do not take more tablets than prescribed by the doctor. When taking more tablets

Common (may affect up to 1 in 10 people)

inflammation and pain after tooth extraction

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

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

increased blood pressure wheezing and shortness of breath (bronchospasm)

constipation, flatulence (excessive passing of gas), gastritis (inflammation of the lining of the stomach), heartburn, diarrhoea, indigestion (dyspepsia), stomach pain, discomfort, nausea, feeling sick (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 more than 1 in 100 people)

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

change in laboratory results (reduced red blood cell count, decreased white blood cell count, decreased platelets,

hypersensitivity (allergic reaction which may include fever enough

serious enough to require 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, disturbed sleep, tingling or pins and needles, drowsiness, blurred vision, eye irritation and redness, ringing in the ears, dizziness,

irregular heartbeat, rapid heart rate, heart failure, non-specific ECG changes, fatigue, heaviness in the chest area (angina pectoris), heart attack,

flushing, stroke, "mini-stroke" or transient ischemic attack (TIA)), severe increase in blood pressure, inflammation of the blood vessels, cough, shortness of breath, nosebleeds,

bloating, changes in bowel movements including, dry mouth, stomach ulcer, inflammation of the stomach lining, bleeding from the digestive system, irritable bowel syndrome, inflammation of the pancreas, swelling of the face, flushing of the face, skin rash or itching, 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, increased levels of uric acid and creatine phosphokinase, chest pain

Rare (may affect more than 1 in 1,000 people)

angioedema (an allergic reaction with swelling of the face, lips, tongue and/or throat that may cause difficulty breathing or swallowing, which may be serious enough to require immediate medical attention)

anaphylactic/anaphylactoid reactions including shock (serious allergic reaction requiring immediate medical attention),

confusion, anxiety,

liver problems,

low blood sodium levels,

liver failure, yellowing of the skin and/or eyes (jaundice), severe skin reactions (may include ulcers in the mouth, throat, nose and genitals; the rash may progress to widespread blistering and peeling of the skin).

5. How to store Doloxib

Keep out of the reach of children.

Do not use Doloxib after the expiry date which is stated on the package. 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 Doloxib contains

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

The other ingredients are:

Tablet core: Calcium hydrogen phosphate, anhydrous; Cellulose, microcrystalline; Croscarmellose sodium; Silica, colloidal anhydrous; Talc; Magnesium stearate.

Tablet coating: Hypromellose, Hydroxypropyl cellulose, Macrogol 6000, Talc, Titanium dioxide (E 171).

The 60 mg tablets also contain brown iron oxide (E 172), the 90 mg tablets contain yellow iron oxide (E 172) and the 120 mg tablets contain red iron oxide (E 172).

What Doloxib looks like and contents of the pack

Doloxib 60 mg film-coated tablets:

Light brown round biconvex film-coated tablets, approximately 8 mm in diameter.

Doloxib 90 mg film-coated tablets:

Light yellow round biconvex film-coated tablets, approximately 9 mm in diameter.

Doloxib 120 mg film-coated tablets:

Light pink round biconvex film-coated tablets, approximately 10 mm in diameter.

Types of packaging:

Doloxib 60 and 90 mg film-coated tablets 7, 14, 20, 28, 50 and 100 film-coated tablets

Doloxib 120 mg film-coated tablets 5, 7, 14, 20, 28, 50 and 100 film-coated tablets

Not all types of packaging can be put on sale.

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