Doloxib

Package leaflet: Information for the patient

Doloxib, 30 mg, coated tablets
Doloxib, 60 mg, coated tablets
Doloxib, 90 mg, coated tablets
Doloxib, 120 mg, coated tablets
Etoricoxibum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific person only. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Doloxib is and what it is used for

Doloxib contains the active substance etoricoxib. Doloxib is a medicine belonging to the group of selective cyclooxygenase-2 (COX-2) inhibitors. These belong to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Doloxib helps reduce pain and swelling (inflammation) in joints and muscles in people aged 16 years and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gouty arthritis.
Doloxib 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 joint disease. It occurs due to gradual breakdown of the cartilage lining the ends of bones. This leads to swelling (inflammation), pain, tenderness, stiffness, and impaired function.

What is rheumatoid arthritis?
Rheumatoid arthritis is a chronic inflammatory joint disease. It causes pain, stiffness, swelling, and increased loss of joint mobility in the affected joints. It may also cause inflammation in other parts of the body.

What is gout?
Gout is a disease characterized by sudden, recurring attacks of very painful inflammation and redness of joints. This disease is caused by the deposition of crystalline deposits in the joint.

What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease of the spine and large joints.

2. Important information before using Doloxib

When not to use Doloxib:

• if the patient is allergic to etoricoxib or any of the other ingredients of this medicine (listed in section 6);
• if the patient has hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, or selective inhibitors of cyclooxygenase-2 (COX-2) (see "Possible side effects", section 4);
• if the patient has active gastric or duodenal ulcer or gastrointestinal bleeding;
• if the patient has severe liver disease;
• if the patient has severe kidney disease;
• in women who are pregnant, may be pregnant, or who are breastfeeding (see "Pregnancy, breastfeeding and fertility");
• in individuals under 16 years of age;
• if the patient has inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or colitis;
• if the patient has untreated high blood pressure (if in doubt, consult a doctor or nurse to check blood pressure);
• if the patient has ever been diagnosed by a doctor with heart problems, including heart failure (moderate or severe type) or angina pectoris (chest pain);
• if the patient has had a heart attack, coronary artery bypass surgery, or peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries);
• if the patient has ever had any type of stroke (including mini-stroke, transient ischaemic attack - TIA). Etoricoxib may slightly increase the risk of heart attack and stroke and therefore should not be used in individuals who have had heart problems or stroke.

If any of the above situations apply, the patient should consult a doctor before taking the tablets.

Warnings and precautions

Before starting treatment with Doloxib, discuss with your doctor or pharmacist:

• if the patient has previously had stomach bleeding or peptic ulcer disease;
• if the patient is dehydrated, for example due to prolonged or recurrent vomiting or diarrhoea;
• if the patient has swelling due to fluid retention;
• if the patient has previously had heart failure or other heart disease;
• if the patient has previously had high blood pressure. Doloxib may increase blood pressure in some people, especially when high doses are used, so the doctor may monitor blood pressure periodically;
• if the patient has previously had liver or kidney disease;
• if the patient is currently being treated for an infection. Doloxib may mask or hide fever, which is a sign of infection;
• in patients with diabetes, high cholesterol levels, or who smoke. These patients have an increased risk of heart disease;
• in women planning pregnancy;
• in individuals over 65 years of age.

If in doubt whether any of the above conditions apply, the patient should consult a doctor before using Doloxib to determine whether the medicine can be used.

Doloxib is equally effective in elderly patients and younger adult patients. For patients over 65 years of age, the doctor may recommend more frequent check-ups. Dose adjustment is not necessary in individuals over 65 years of age.

Children and adolescents

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

Doloxib and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for use, including those available without prescription.

When taking any of the following medicines, the doctor may decide that monitoring is necessary to ensure safe and effective treatment with Doloxib:

• blood-thinning medicines (anticoagulants), such as warfarin;
• rifampicin (an antibiotic);
• methotrexate (a medicine that suppresses immune system function, often used in the treatment of rheumatoid arthritis);
• cyclosporine or tacrolimus (immunosuppressive medicines);
• lithium (a medicine used to treat certain types of depression);
• medicines used to control high blood pressure and heart failure, called ACE inhibitors and angiotensin receptor blockers, such as enalapril and ramipril, or losartan and valsartan;
• diuretics (water pills);
• digoxin (a medicine used in heart failure and heart rhythm disorders);
• minoxidil (a medicine used to treat high blood pressure);
• oral salbutamol tablets or oral solution (a medicine used in asthma);
• oral contraceptives (combination may increase the risk of side effects);
• hormone replacement therapy (combination may increase the risk of side effects);
• acetylsalicylic acid – the risk of developing stomach ulcers is greater when Doloxib is taken together with acetylsalicylic acid;
• acetylsalicylic acid used for prevention of heart attack or stroke. Doloxib may be taken together with low-dose acetylsalicylic acid. If currently taking low-dose acetylsalicylic acid to prevent heart attack or stroke, do not stop taking acetylsalicylic acid without consulting your doctor;
• acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs): do not take high doses of acetylsalicylic acid or other anti-inflammatory medicines while taking Doloxib.

Doloxib with food and drink

The effect of the medicine may start faster if Doloxib is taken on an empty stomach.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Pregnancy

Doloxib must not be used during pregnancy. A woman who is pregnant, may be pregnant, or planning pregnancy should not use this medicine. If pregnancy occurs, the medicine should be discontinued and the patient should contact her doctor. In case of doubt or need for further information, contact a doctor.

Breastfeeding

It is not known whether Doloxib is excreted in human breast milk. If the patient is breastfeeding or planning to breastfeed, she should consult a doctor before using Doloxib. While taking Doloxib, breastfeeding is not recommended.

Fertility

Use of Doloxib is not recommended in women who are trying to become pregnant.

Driving and operating machinery

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

Do not drive if dizziness or drowsiness occurs.

Do not operate machinery or use tools if dizziness or drowsiness occurs.

3. How to use Doloxib

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Do not take higher doses than those recommended for individual conditions. Treatment should be reviewed periodically with your doctor. It is important to use the lowest effective dose providing pain relief, and Doloxib should not be used for longer than necessary. Prolonged use of this medicine, especially at high doses, increases the risk of heart attack and stroke.
This medicinal product is available in different strengths, and depending on the condition being treated, your doctor will prescribe the appropriate strength for you.

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

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

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

Acute pain
Etoricoxib should be used only during episodes of acute pain.

Acute gouty arthritis
The recommended dose is 120 mg once daily; this dose should be used only during an acute painful flare-up, for a maximum of 8 days.

Pain following dental surgery
The recommended dose is 90 mg once daily, and treatment with this dose may last for a maximum of 3 days.

Patients with liver impairment
In patients with mild liver disease, doses higher than 60 mg once daily should not be used.
In patients with moderate liver disease, doses higher than 30 mg per day should not be used.

Use in children and adolescents
Doloxib must not be used in children and adolescents under 16 years of age.

Elderly patients
Dose adjustment is not usually required in elderly patients. However, caution should be exercised in this age group.

Method of administration
Doloxib is for oral use. Tablets should be taken once daily.
Doloxib can be taken with or without food.

If you take more Doloxib than you should
Never take more tablets than prescribed by your doctor. If you have taken too many Doloxib tablets, seek immediate medical help.

If you forget to take Doloxib
Take Doloxib exactly as prescribed by your doctor. If you miss a dose, take your next dose the following day according to your usual dosing schedule. 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, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur, Doloxib must be discontinued immediately
and you should contact your doctor without delay (see section 2. "Important information before taking Doloxib"):

• shortness of breath, chest pain, or development of swelling around the ankles or worsening of existing swelling;
• yellowing of the skin and eyes (jaundice) – signs of liver function disorders;
• severe or persistent stomach pain or appearance of black-coloured stools;
• hypersensitivity reaction, which may manifest as skin changes such as ulcers, blisters, or swelling of the face, lips, tongue, or throat, possibly causing breathing difficulties.

The following adverse reactions may occur during treatment with Doloxib:
Very common (may affect more than 1 in 10 people)

• stomach pain.

Common (may affect up to 1 in 10 people)

• dry socket (inflammation and pain following tooth extraction),
• swelling of legs and/or feet due to fluid retention (oedema),
• dizziness, headache,
• palpitations (fast or irregular heartbeat), irregular heart rhythm (arrhythmia),
• increased blood pressure,
• wheezing or shortness of breath (bronchospasm),
• constipation, flatulence (excess intestinal gas), gastritis (inflammation of the stomach lining), heartburn, diarrhoea, indigestion (dyspepsia) and/or stomach discomfort, nausea, vomiting, oesophagitis, oral ulcers,
• changes in blood test results related to the liver,
• bruising,
• weakness and fatigue, influenza-like symptoms.

Uncommon (may affect up to 1 in 100 people)

• gastroenteritis (inflammation of the gastrointestinal tract involving both the stomach and small intestine and/or stomach flu), upper respiratory tract infection, urinary tract infection,
• changes in laboratory test results (reduced number of red blood cells, reduced number of white blood cells, reduced number of platelets),
• hypersensitivity (allergic reaction, including urticaria, which may be severe enough to require immediate medical intervention),
• increased or decreased appetite, weight gain,
• anxiety, depression, reduced mental performance; seeing or hearing things that do not exist (hallucinations),
• taste disturbances, insomnia, numbness or tingling sensations, drowsiness,
• blurred vision, eye irritation and redness,
• tinnitus, vertigo (spinning sensation at rest),
• heart rhythm disorders (atrial fibrillation), rapid heartbeat, heart failure, non-specific changes in ECG recording, sensation of tightness, pressure, or heaviness in the chest (angina), heart attack,
• hot flushes, stroke, mini-stroke (transient ischaemic attack), marked increase in blood pressure,
• vasculitis (inflammation of blood vessels),
• cough, breathlessness, nosebleeds,
• bloating, change in bowel habits, dryness of the oral mucosa, peptic ulcer, gastritis which may be severe and lead to bleeding, irritable bowel syndrome, pancreatitis,
• facial swelling, skin rash or itching, skin redness,
• muscle cramps, muscle pain or stiffness,
• high potassium levels in blood, changes in blood or urine tests related to kidneys, severe kidney function disorders, increased levels of uric acid and creatine phosphokinase,
• chest pain.

Rare (may affect up to 1 in 1000 people)

• angioedema (an allergic reaction characterized by swelling of the face, lips, tongue and/or throat, which may cause breathing or swallowing difficulties, potentially severe enough to require immediate medical intervention); anaphylactic or anaphylactoid reactions, including shock (severe allergic reaction requiring immediate medical intervention);
• disorientation, restlessness;
• liver function disorders (hepatitis);
• low sodium levels in blood;
• liver failure, yellowing of the skin and/or eyes (jaundice);
• severe skin reactions (including ulceration of the mouth, throat, nose, and genital organs; rash may progress to extensive blistering and skin peeling).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
Al. Jerozolimskie 181C, 02-222 Warsaw.
Tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected]
Adverse reactions may also be reported to the marketing authorisation holder or its representative in Poland.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Doloxib

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the pack and other information

What Doloxib contains
The active substance is etoricoxib.
Each coated tablet contains 30 mg, 60 mg, 90 mg or 120 mg of etoricoxib.
The other ingredients are:
Tablet core: calcium hydrogen phosphate anhydrous, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, talc, magnesium stearate.
Tablet coating: hypromellose, hydroxypropylcellulose, macrogol 6000, talc, titanium dioxide (E 171).
The 60 mg tablets also contain iron oxide brown (E 172); the 90 mg tablets also contain iron oxide yellow (E 172); the 120 mg tablets also contain iron oxide red (E 172).

What Doloxib looks like and contents of the pack
Doloxib 30 mg, coated tablets:
White or almost white, round, biconvex coated tablets with a diameter of approximately 6 mm.
Doloxib 60 mg, coated tablets:
Light brown, round, biconvex coated tablets with a diameter of approximately 8 mm.
Doloxib 90 mg, coated tablets:
Light yellow, round, biconvex coated tablets with a diameter of approximately 9 mm.
Doloxib 120 mg, coated tablets:
Light pink, round, biconvex coated tablets with a diameter of approximately 10 mm.

Pack sizes:
Doloxib 30 mg, coated tablets:
7, 20, 28, 50, 98 or 100 coated tablets
Doloxib 60 mg and 90 mg, coated tablets:
7, 14, 20, 28, 50, 100 coated tablets
Doloxib 120 mg, coated tablets:
5, 7, 14, 20, 28, 50 or 100 coated tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

Manufacturer/Importer
Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic
Pharmadox Healthcare Ltd, KW20A Kordin Industrial Park, Paola PLA 3000, Malta
Winthrop Arzneimittel GmbH, Brüningstraße 50, 65926 Frankfurt am Main, Germany
S.C. Zentiva S.A., 50 Theodor Pallady Blvd., District 3, 032266 Bucharest, Romania

For more detailed information about the medicine and its names in the European Economic Area countries, please contact the representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00