Etoricoxib Teva

Leaflet accompanying the packaging: information for the user

Etoricoxib Teva, 30 mg, film-coated tablets
Etoricoxib Teva, 60 mg, film-coated tablets
Etoricoxib Teva, 90 mg, film-coated tablets
Etoricoxib Teva, 120 mg, film-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.
In case of any doubts, consult a 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 not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Etoricoxib Teva and what is it used for

What is Etoricoxib Teva?

• Etoricoxib Teva contains the active substance etoricoxib. Etoricoxib Teva is a medicine belonging to the group of selective cyclooxygenase-2 (COX-2) inhibitors. It belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).

What is Etoricoxib Teva used for?

• Etoricoxib Teva helps reduce pain and swelling (inflammatory conditions) of the joints and muscles in people 16 years of age and older with osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and gout.
• Etoricoxib Teva is also used for the short-term treatment of moderate pain associated with surgical dental procedures in people 16 years of age and older.

What is osteoarthritis?

Osteoarthritis is a disease that affects the joints. It occurs due to 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-lasting inflammatory disease of the joints. It causes pain, stiffness, swelling, and limited mobility of the affected joints. 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 Etoricoxib Teva

When not to take Etoricoxib Teva:

• in women who are pregnant or may become pregnant, or are breastfeeding (see section "Pregnancy, breastfeeding, and fertility");
• in people under 16 years of age;

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

Warnings and precautions

Before starting treatment with Etoricoxib Teva, discuss it with a doctor or pharmacist:

• 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 doubt about any of the above situations, consult a doctor before taking Etoricoxib Tevato clarify whether the medicine can be taken.
Etoricoxib Teva 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.

Etoricoxib Teva 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 any of the following medicines, the doctor may decide to monitor you to ensure that the treatment is going well from the start of taking Etoricoxib Teva :

• 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 (water pills);
• 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 (combination may increase the risk of side effects);
• hormone replacement therapy (combination may increase the risk of side effects);
• acetylsalicylic acid (aspirin), the risk of stomach ulcers is higher when taking Etoricoxib Teva with acetylsalicylic acid;
• acetylsalicylic acid used to prevent heart attacks or strokes:
• Etoricoxib Teva can be taken with low-doseacetylsalicylic acid. If you are currently taking low-dose acetylsalicylic acid to prevent heart attack or stroke, do not stop taking it without consulting your doctor;
• acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs):
• do not take high-doseacetylsalicylic acid or other anti-inflammatory medicines while taking Etoricoxib Teva.

Pregnancy, breastfeeding, and fertility

Pregnancy
Etoricoxib Teva should not be taken by women who are pregnant. Women who are pregnant or may become pregnant or are planning to become pregnant should not take this medicine. If you become pregnant, stop taking the medicine and consult a doctor. If in doubt or need further information, consult a doctor.
Breastfeeding
It is not known whether Etoricoxib Teva is excreted in breast milk. If breastfeeding or planning to breastfeed, consult a doctor before taking Etoricoxib Teva. If taking Etoricoxib Teva, do not breastfeed.
Fertility
Etoricoxib Teva is not recommended for women planning to become pregnant.

Driving and using machines

Some patients taking Etoricoxib Teva have reported dizziness and drowsiness.
Do not drive vehicles, if you experience dizziness and drowsiness.
Do not operate any machinery or use tools, if you experience dizziness and drowsiness.

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.
There are different strengths of this medicine, and depending on the disease, the doctor will prescribe the tablets with the appropriate strength for you.
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 surgical dental procedures
The recommended dose is 90 mg once daily, and treatment with this dose should not exceed 3 days.

Patients with liver problems

• In patients with mild liver impairment, the dose should not exceed 60 mg once daily.
• In patients with moderate liver impairment, the dose should not exceed 30 mg daily.

Do not take higher doses than recommended for each condition. Consult your doctor from time to time to monitor treatment. It is important to use the smallest effective dose that provides pain relief and not to take Etoricoxib Teva for longer than necessary. There is an increased risk of heart attacks and strokes with prolonged use of the medicine, especially at high doses.

Use in children and adolescents

Etoricoxib Teva should not be used in children and adolescents under 16 years of age.

Elderly patients

No dose adjustment is necessary in elderly patients. As with other medicines, caution should be exercised in elderly patients.

Method of administration

Etoricoxib Teva is for oral use.
Take one tablet once daily. Etoricoxib Teva can be taken with or without food.

Taking more than the recommended dose of Etoricoxib Teva

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

Missing a dose of Etoricoxib Teva

Take Etoricoxib Teva as recommended by your doctor. If you miss a dose, continue with 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 a doctor or pharmacist.

4. Possible side effects

Like all medicines, Etoricoxib Teva can cause side effects, although not everybody gets them.

If you experience any of the following symptoms, stop taking Etoricoxib Teva and contact your doctor immediately (see section 2 "Important information before taking Etoricoxib Teva"):

• shortness of breath, chest pain, or swelling of the ankles, or worsening of existing swelling;
• yellowing of the skin and eyes (jaundice) - these are signs of abnormal liver function;
• severe or persistent stomach pain, or black stools;
• allergic reactions, which can cause skin problems 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 Etoricoxib Teva:
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 legs and (or) feet due to fluid retention (edema)
• dizziness, headache
• palpitations, irregular heartbeat
• increased blood pressure
• wheezing or shortness of breath (bronchospasm)
• constipation, gas, stomach upset, heartburn, diarrhea, indigestion, and (or) discomfort in the stomach, nausea, vomiting, esophageal inflammation, 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, 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, feeling, or hearing things that do not exist (hallucinations)
• taste disorders, insomnia, numbness or tingling, drowsiness
• 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, feeling of tension, feeling of pressure or heaviness in the chest (angina), heart attack
• hot flashes, stroke, mini-stroke (transient ischemic attack), severe high blood pressure, blood vessel inflammation
• cough, shortness of breath, nosebleeds
• bloating (stomach or intestines), change in bowel movements, dry mouth, stomach ulcers, stomach inflammation, which can be severe and cause bleeding, irritable bowel syndrome, pancreatitis
• face swelling, rash, or itching, skin redness
• muscle cramps/spasms, muscle pain or stiffness
• high potassium levels in the blood, changes in kidney-related blood or urine test results, severe kidney problems
• 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)

anaphylactic or anaphylactoid reactions, including shock (a severe allergic reaction that requires immediate medical attention)

• disorientation, restlessness
• liver problems (hepatitis)
• low sodium levels in the blood
• liver failure, yellowing of the skin and eyes (jaundice)
• severe skin reactions

Reporting side effects

If you experience any side effects, including any not listed in this 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, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Etoricoxib Teva

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month.
Store in the original packaging to protect from light.
Do not use the medicine if it shows signs of deterioration.
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 Etoricoxib Teva contains

The active substance is etoricoxib.
Each film-coated tablet contains 30 mg, 60 mg, 90 mg, or 120 mg of etoricoxib.
The other ingredients are:
Core: calcium hydrogen phosphate anhydrous, microcrystalline cellulose (Type 101), microcrystalline cellulose (Type 102), crospovidone (Type A), povidone K25, magnesium stearate.
Coating: hypromellose, hydroxypropylcellulose, talc, saturated fatty acid triglycerides, titanium dioxide (E 171), microcrystalline cellulose (30 mg), iron oxide red (30 mg) (E172), indigo carmine (30, 60, and 120 mg) (E132), aluminum lake, brilliant blue FCF (60 and 120 mg) (E 133), aluminum lake, iron oxide yellow (60 and 120 mg) (E 172), iron oxide black (60 and 120 mg) (E 172).

What Etoricoxib Teva looks like and contents of the pack

30 mg: blue, round, biconvex film-coated tablets with "30" engraved on one side and smooth on the other.
60 mg: dark green, round, biconvex film-coated tablets with "60" engraved on one side and smooth on the other.
90 mg: white, round, biconvex film-coated tablets with "90" engraved on one side and smooth on the other.
120 mg: pale green, round, biconvex film-coated tablets with "120" engraved on one side and smooth on the other.
Pack sizes:
30 mg
OPA/Aluminum/PVC/Aluminum blisters in packs of 7, 14, 28, 28x1, 30, or 98 film-coated tablets.
60 mg
OPA/Aluminum/PVC/Aluminum blisters in packs of 7, 14, 20, 28, 28x1, 30, 50, 98, or 100 film-coated tablets.
90 mg
OPA/Aluminum/PVC/Aluminum blisters in packs of 5, 7, 7x1, 14, 20, 28, 28x1, 30, 50, 98, or 100 film-coated tablets.
120 mg
OPA/Aluminum/PVC/Aluminum blisters in packs of 5, 7, 7x1, 14, 16, 20, 28, 28x1, or 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
Tel. (22) 345 93 00

Manufacturer/Importer

TEVA Gyógyszergyár Zrt.
Pallagi út 13 4042 Debrecen,
Hungary
Teva Nederland BV
Swensweg 5
2031 GA Haarlem
Netherlands
Teva Czech Industries s.r.o.
Ostravska 29, c.p. 305
74770 Opava-Komarov
Czech Republic
Teva Operations Poland Sp. z.o.o
ul. Mogilska 80,
31-546 Kraków
TEVA PHARMA S.L.U.
C/C, n. 4, Poligono Industrial Malpica
50016 Zaragoza
Spain
Merckle GmbH
Ludwig-Merckle-Straße 3,
89143 Blaubeuren
Germany
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25
10000 Zagreb
Croatia
Date of last revision of the leaflet:July 2024