Doloxib

Leaflet accompanying the packaging: patient information

Doloxib, 30 mg, coated tablets
Doloxib, 60 mg, coated tablets
Doloxib, 90 mg, coated tablets
Doloxib, 120 mg, coated tablets
Etoricoxib

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Doloxib and what is it 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 packaging and other information

1. What is Doloxib and what is it used for

Doloxib contains the active substance etoricoxib. Doloxib is a medicine belonging to the group of selective cyclooxygenase 2 (COX-2) inhibitors. They belong to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Doloxib helps to reduce pain and swelling (inflammation) of the joints and muscles in people aged 16 and over with osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and gout.
Doloxib is also a medicine used for short-term treatment of moderate pain associated with dental surgery in people aged 16 and over.

What is osteoarthritis?

Osteoarthritis is a disease that affects the joints. It occurs as a result of the gradual breakdown of cartilage lining the ends of bones. This causes swelling (inflammation), pain, tenderness, stiffness, and disability.

What is rheumatoid arthritis?

Rheumatoid arthritis is a long-standing inflammatory disease of the joints. It causes pain, stiffness, swelling, and increased loss of range of motion in the joints it affects. It also causes 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 the 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 taking Doloxib

When not to take 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 and selective cyclooxygenase 2 (COX-2) inhibitors (see "Possible side effects", section 4);
• if the patient has active gastric or intestinal ulcer or bleeding;
• if the patient has severe liver disease;
• if the patient has severe kidney disease;
• in pregnant or breastfeeding women, or women who may be pregnant (see "Pregnancy, breastfeeding, and fertility");
• in people under 16 years of age;
• if the patient has inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or intestinal colitis;
• if the patient has uncontrolled high blood pressure (if in doubt, consult a doctor or nurse to check blood pressure);
• if the patient has ever been diagnosed with heart disease, including heart failure (moderate or severe) or angina pectoris (chest pain);
• if the patient has had a heart attack, undergone a bypass grafting procedure, or has peripheral arterial disease (poor circulation in the legs or feet due to narrowed or blocked arteries);
• if the patient has had any type of stroke (including mini-stroke, transient ischemic attack - TIA). Etoricoxib may slightly increase the risk of heart attack and stroke, and therefore should not be used in people who have had heart or stroke problems.

In case of the above situations, consult a doctor before taking the tablets.

Warnings and precautions

Before starting Doloxib, discuss with your doctor or pharmacist:

• if the patient has a history of stomach ulcers or stomach bleeding;
• if the patient is dehydrated, e.g., due to prolonged, recurring vomiting or diarrhea;
• if the patient has swelling due to fluid retention;
• if the patient has a history of heart failure or other heart disease;
• if the patient has a history of high blood pressure. Doloxib may increase blood pressure in some people, especially after taking high doses of the medicine, so the doctor will check blood pressure from time to time;
• if the patient has a history of 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 people with diabetes, high cholesterol, or smokers. These people are at increased risk of heart disease;
• in women planning to become pregnant;
• in people over 65 years of age.

In case of uncertainty about any of the above situations, consult a doctor before taking Doloxibto clarify whether the medicine can be taken.
Doloxib is equally effective in both elderly and younger adult patients. In patients over 65 years of age, the doctor may decide on more frequent check-ups. No dose adjustment is necessary in people over 65 years of age.

Children and adolescents

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

Doloxib and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.
In case of taking one of the following medicines, the doctor may decide to monitor the patient to ensure that the treatment is proceeding correctly from the start of Doloxib treatment :

• blood thinners (anticoagulants), such as warfarin;
• rifampicin (an antibiotic);
• methotrexate (an immunosuppressant, often used to treat rheumatoid arthritis);
• cyclosporine or tacrolimus (immunosuppressants);
• lithium (a medicine used to treat certain types of depression);
• medicines that help control high blood pressure and heart failure, called ACE inhibitors and angiotensin receptor blockers, such as enalapril and ramipril, and losartan and valsartan;
• diuretics;
• digoxin (a medicine used to treat heart failure and irregular heartbeat);
• minoxidil (a medicine used to treat high blood pressure);
• salbutamol in tablet or oral solution form (a medicine used to treat asthma);
• oral contraceptives (the combination may increase the risk of side effects);
• hormone replacement therapy (the combination may increase the risk of side effects);
• acetylsalicylic acid, the risk of stomach ulcers is higher when taking Doloxib with acetylsalicylic acid;
• acetylsalicylic acid used to prevent heart attacks or strokes. Doloxib can be taken with a low dose of acetylsalicylic acid. If you are currently taking low doses of acetylsalicylic acid to prevent heart attacks or strokes, 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Doloxib if you are pregnant. Women who are pregnant or think they may be pregnant or are planning to become pregnant should not take this medicine. If you become pregnant, stop taking the medicine and contact your doctor. If in doubt or need further information, contact your doctor.
Breastfeeding
It is not known whether Doloxib is excreted in breast milk. If you are breastfeeding or planning to breastfeed, consult your doctor before taking Doloxib. If you are taking Doloxib, do not breastfeed.
Fertility
It is not recommended to take Doloxib if you are planning to become pregnant.

Driving and using machines

Some patients taking Doloxib have reported dizziness and drowsiness.
Do not drive or operate machinery if you experience dizziness and drowsiness.
Do not operate any machinery or tools if you experience dizziness and drowsiness.

3. How to take Doloxib

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Do not take more than the recommended dose for each condition. Check with your doctor from time to time to monitor your treatment. It is important to use the smallest effective dose that relieves pain and not to take Doloxib for longer than necessary. There is an increased risk of heart attack and stroke with prolonged use of the medicine, especially with high doses.
There are different strengths of this medicinal product, and depending on the disease, the doctor will prescribe the tablets with the appropriate strength for the patient.
Recommended dose:
Osteoarthritis
The recommended dose is 30 mg once daily, increased to a maximum of 60 mg once daily if needed.
Rheumatoid arthritis
The recommended dose is 60 mg once daily, increased to a maximum of 90 mg once daily if needed.
Ankylosing spondylitis
The recommended dose is 60 mg once daily, increased to a maximum of 90 mg once daily if needed..
Acute pain
Etoricoxib should only be used during episodes of acute pain.
Gout
The recommended dose is 120 mg once daily; it should only be used during episodes of acute pain, for a maximum of 8 days.
Pain after 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 function disorders

In patients with mild liver disease, do not take more than 60 mg once daily.
In patients with moderateliver disease, do not take more than 30 mg per day.

Use in children and adolescents

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

Elderly patients

No dose adjustment is necessary in elderly patients. Elderly patients should be cautious.

Method of administration

Doloxib is intended for oral use. The tablets should be taken once daily.
Doloxib can be taken with or without food.

Taking more than the recommended dose of Doloxib

Never take more tablets than your doctor has recommended. If you have taken too many Doloxib tablets, seek medical attention immediately.

Missing a dose of Doloxib

Take Doloxib as recommended by your doctor. If you miss a dose, resume your normal dosing schedule the next day. Do not take a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following symptoms, stop taking Doloxib

and contact your doctor immediately(see section 2. "Important information before taking Doloxib"):

• shortness of breath, chest pain, or swelling of the ankles or feet;
• yellowing of the skin and eyes (jaundice) - these are signs of liver problems;
• severe or persistent stomach pain or black stools;
• allergic reaction, which can cause skin changes such as ulcers, blisters, or swelling of the face, lips, tongue, or throat, which can cause difficulty breathing.

The following side effects 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 after tooth extraction),
• swelling of the feet and (or) ankles due to fluid retention (edema),
• dizziness, headache,
• palpitations, irregular heartbeat (arrhythmia),
• high blood pressure,
• wheezing or shortness of breath (bronchospasm),
• constipation, gas (excess gas in the intestines), stomach upset (gastritis), heartburn, diarrhea, indigestion (dyspepsia) and (or) discomfort in the stomach, nausea, vomiting, esophagitis, mouth ulcers,
• changes in liver blood test results,
• bruising,
• weakness and fatigue, flu-like symptoms.

Uncommon(may affect up to 1 in 100 people)

• gastroenteritis (inflammation of the stomach and intestines, which can include both the stomach and the small intestine and (or) gastroenteritis), upper respiratory tract infection, urinary tract infection,
• changes in blood test results (decreased red blood cell count, decreased white blood cell count, decreased platelet count),
• hypersensitivity (allergic reaction, including hives, which can be severe enough to require immediate medical attention),
• increased or decreased appetite, weight gain,
• anxiety, depression, decreased mental performance; seeing or hearing things that do not exist (hallucinations),
• taste disorders, insomnia, numbness or tingling,
• blurred vision, eye irritation and redness,
• ringing in the ears, dizziness (feeling of spinning while at rest),
• heart rhythm disorders (atrial fibrillation), rapid heartbeat, heart failure, non-specific changes in ECG, feeling of tension, feeling of pressure or heaviness in the chest (angina pectoris), heart attack,
• hot flashes, stroke, mini-stroke (transient ischemic attack), significant increase in blood pressure,
• vasculitis,
• cough, shortness of breath, nosebleeds,
• bloating, change in bowel habits, dry mouth, stomach ulcer, stomach inflammation, which can be severe and lead to bleeding, irritable bowel syndrome, pancreatitis,
• facial swelling, skin rash or itching, redness of the skin,
• muscle spasms, muscle pain or stiffness,
• high potassium levels in the blood, changes in blood or urine test results related to the 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 can cause difficulty breathing or swallowing, which can be severe enough to require immediate medical attention); anaphylactic or anaphylactoid reactions, including shock (a severe allergic reaction that requires immediate medical attention);
• disorientation, restlessness;
• liver function disorders (hepatitis);
• low sodium levels in the blood;
• liver failure, yellowing of the skin and (or) eyes (jaundice);
• severe skin reactions (including mouth ulcers, throat, nose, and genital ulcers; rash may lead to widespread blisters and peeling of the skin).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
Al. Jerozolimskie 181C, 02-222 Warsaw.
Phone: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Doloxib

Keep the medicine out of the 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.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Doloxib contains

The active substance of Doloxib is etoricoxib.
Each coated tablet contains 30 mg, 60 mg, 90 mg, or 120 mg of etoricoxib.
The other ingredients are:
Core: calcium phosphate anhydrous, microcrystalline cellulose, sodium croscarmellose, silicon dioxide anhydrous, talc, magnesium stearate.
Coating: hypromellose, hydroxypropyl cellulose, 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 about 6 mm.
Doloxib, 60 mg, coated tablets:
Light brown, round, biconvex coated tablets with a diameter of about 8 mm.
Doloxib, 90 mg, coated tablets:
Light yellow, round, biconvex coated tablets with a diameter of about 9 mm.
Doloxib, 120 mg, coated tablets:
Light pink, round, biconvex coated tablets with a diameter of about 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 authorization 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

To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
phone: +48 22 375 92 00
Date of last revision of the leaflet:April 2021