Etoricoxib Teva

Leaflet accompanying the packaging: information for the user

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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

You should keep this leaflet, so that you can read it again if you need to.
In case of any doubts, you should consult a doctor or pharmacist.
This medicine has been prescribed to you specifically. 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 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 nonsteroidal anti-inflammatory drugs (NSAIDs).

What is Etoricoxib Teva used for?

• Etoricoxib Teva 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.
• Etoricoxib Teva is also a medicine used for the short-term treatment of moderate pain associated with a dental surgical procedure 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 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:

• 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 nonsteroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid and selective cyclooxygenase-2 (COX-2) inhibitors (see section "Possible side effects", section 4);
• if the patient has active peptic ulcer or gastrointestinal bleeding;
• if the patient has severe liver disease;
• if the patient has severe kidney disease;
• in women who are pregnant or may become pregnant, or are breastfeeding (see section "Pregnancy, breastfeeding, and fertility");
• in people under the age of 16;
• if the patient has inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or intestinal inflammation;
• 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 by a doctor with heart problems, including heart failure (moderate or severe) or angina (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 problems or stroke.

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

Warnings and precautions

Before starting treatment with Etoricoxib Teva, discuss it 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. Etoricoxib Teva 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. Etoricoxib Teva may mask fever, which is a symptom of infection;
• in the case of people with diabetes, high cholesterol, or smokers. These people are at increased risk of heart disease;
• in the case of women planning to become pregnant;
• in the case of people over 65 years old.

In case of doubt as to whether any of the above situations occur, 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 the case of patients over 65 years old, the doctor may decide on more frequent check-ups. No dose adjustment is necessary for people over 65 years old.

Children and adolescents

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

Etoricoxib Teva and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
In the case of taking one of the following medicines, the doctor may decide to monitor the patient 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 (a medicine that suppresses the immune system, often used to treat rheumatoid arthritis);
• cyclosporine or tacrolimus (medicines that suppress the immune system);
• 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 (diuretics);
• digoxin (a medicine used to treat heart failure and arrhythmias);
• 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 for the prevention of 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 attacks or strokes, do not stop taking acetylsalicylic acid without consulting your doctor;
• acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs):
• do not take high dosesof acetylsalicylic acid or other anti-inflammatory drugs while taking Etoricoxib Teva.

Pregnancy, breastfeeding, and fertility

Pregnancy
Etoricoxib Teva should not be taken by pregnant women. A pregnant woman or a woman who may be pregnant or is planning to become pregnant should not take this medicine. If you become pregnant, stop taking the medicine and consult your doctor. If you have any doubts or need further information, consult your doctor.
Breastfeeding
It is not known whether Etoricoxib Teva is excreted in breast milk. If you are breastfeeding or planning to breastfeed, consult your doctor before taking Etoricoxib Teva. If you are 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

This medicine should always be taken as directed by your doctor. In case of doubt, consult your doctor or pharmacist.
There are different strengths of this medicine, and depending on the disease, the doctor will prescribe tablets of 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 necessary.
Rheumatoid arthritis
The recommended dose is 60 mg once daily, increased to a maximum of 90 mg once daily, if necessary.
Ankylosing spondylitis
The recommended dose is 60 mg once daily, increased to a maximum of 90 mg once daily, if necessary.
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 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 individual diseases. From time to time, consult your doctor 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 after prolonged use of the medicine, especially in high doses.

Use in children and adolescents

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

Elderly patients

No dose adjustment is necessary for elderly patients. As with other medicines, elderly patients should be cautious.

Method of administration

Etoricoxib Teva is intended for oral use.
Tablets should be taken once daily. Etoricoxib Teva can be taken with or without food.

Taking a higher dose of Etoricoxib Teva than recommended

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

Missing a dose of Etoricoxib Teva

Etoricoxib Teva should be taken as directed by your doctor. If you miss a dose, the next day return to your usual dosing schedule.
Do not take a double dose to make up for a missed dose.
In case of 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 Etoricoxib Teva and seek medical attention 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 symptoms of abnormal liver function;
• severe or persistent stomach pain, or black stools;
• allergic reactions, which can manifest as 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 lower limbs and (or) feet due to fluid retention (edema)
• dizziness, headache
• palpitations (rapid or irregular heartbeat), irregular heart rhythm (arrhythmia)
• increased 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 digestive tract, which includes both the stomach and the small intestine and (or) stomach flu), upper respiratory tract infection, urinary tract infection
• changes in laboratory 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 something that does 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, feeling of tension, feeling of pressure or heaviness in the chest (angina pectoris), heart attack
• hot flashes, stroke, mini-stroke (transient ischemic attack), severe high blood pressure, vasculitis
• cough, shortness of breath, nosebleeds
• bloating (stomach or intestines), change in bowel movements, dry mouth, stomach ulcers, stomach inflammation, which can be severe and lead to bleeding, irritable bowel syndrome, pancreatitis
• facial swelling or rash or itching, skin redness
• muscle cramps/spasms, muscle pain or stiffness
• high potassium levels in the blood, changes in blood or urine test results related to kidney function, severe kidney dysfunction
• 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 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, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Etoricoxib Teva

The medicine should be stored out of 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 signs of deterioration are visible.
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 of the medicine 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 (Type 101), microcrystalline cellulose (Type 102), crospovidone (Type A), povidone K25, magnesium stearate.
Tablet 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 coated tablets with "30" embossed on one side and smooth on the other side.
60 mg: dark green, round, biconvex coated tablets with "60" embossed on one side and smooth on the other side.
90 mg: white, round, biconvex coated tablets with "90" embossed on one side and smooth on the other side.
120 mg: pale green, round, biconvex coated tablets with "120" embossed on one side and smooth on the other side.
Pack sizes:
30 mg
OPA/Aluminum/PVC/Aluminum blisters in packs of 7, 14, 28, 28x1, 30, or 98 coated tablets.
60 mg
OPA/Aluminum/PVC/Aluminum blisters in packs of 7, 14, 20, 28, 28x1, 30, 50, 98, or 100 coated tablets.
90 mg
OPA/Aluminum/PVC/Aluminum blisters in packs of 5, 7, 7x1, 14, 20, 28, 28x1, 30, 50, 98, or 100 coated tablets.
120 mg
OPA/Aluminum/PVC/Aluminum blisters in packs of 5, 7, 7x1, 14, 16, 20, 28, 28x1, or 30 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