CELECOXIB TEVAGEN 200 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Celecoxib Tevagen 200 mg Hard Capsules EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Celecoxib Tevagen and what is it used for
2. What you need to know before taking Celecoxib Tevagen
3. How to take Celecoxib Tevagen
4. Possible side effects
5. Storage of Celecoxib Tevagen
6. Package Contents and Additional Information

1. What is Celecoxib Tevagen and what is it used for

This medication contains the active substance celecoxib.

Celecoxib belongs to the group of medications known as non-steroidal anti-inflammatory drugs (NSAIDs), specifically to the subgroup known as selective cyclooxygenase-2 (COX-2) inhibitors. Your body produces prostaglandins that can cause pain and inflammation. In conditions such as rheumatoid arthritis and osteoarthritis, the body produces a greater amount. Celecoxib works by reducing the production of prostaglandins, and thus reduces pain and inflammation.

Celecoxib is indicated in adults to relieve the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

The medication will start to take effect a few hours after taking the first dose, but you may not experience a full effect until several days have passed.

2. What you need to know before taking Celecoxib Tevagen

Do not take Celecoxib Tevagen

• if you are allergic to celecoxib or any of the other components of this medication (listed in section 6).
• if you have had an allergic reaction to the group of medications known as "sulfonamides" (e.g., some antibiotics used to treat infections).
• if you currently have a stomach or intestinal ulcer or bleeding.
• if, as a result of taking acetylsalicylic acid or any other anti-inflammatory and analgesic medication (NSAID), you have experienced asthma, nasal polyps, severe nasal congestion, or an allergic reaction such as skin rash, swelling of the face, lips, tongue, or throat, difficulty breathing, or wheezing.
• if you are pregnant. If you may become pregnant during this treatment, you should discuss the use of contraceptive methods with your doctor.
• if you are breastfeeding.
• if you have severe liver disease.
• if you have severe kidney disease.
• if you have an inflammatory bowel disease such as ulcerative colitis or Crohn's disease.
• if you have heart failure, diagnosed ischemic heart disease, or cerebrovascular disease, e.g., you have been diagnosed with a heart attack, stroke, or transient ischemic attack (temporary reduction of blood flow to the brain, also known as a "mini-stroke"), angina, or obstruction of the blood vessels that supply the heart or brain.
• if you have or have had blood circulation problems (peripheral arterial disease) or if you have undergone surgery on the arteries in your legs.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take this medication:

• if you have previously suffered from a stomach or gastrointestinal bleeding. Do not take celecoxibif you currently have a stomach or intestinal ulcer or bleeding.
• if you are currently taking acetylsalicylic acid (even in low doses as cardioprotective therapy).
• if you are taking antiplatelet treatments.
• if you are taking medications to reduce blood coagulation (e.g., warfarin/ warfarin-like anticoagulants or newer oral anticoagulants such as apixaban).
• if you are taking corticosteroid medications (such as prednisone).
• if you are taking celecoxib at the same time as other non-acetylsalicylic NSAIDs such as ibuprofen or diclofenac. The concomitant use of these medications should be avoided.
• if you are a smoker, if you have diabetes, high blood pressure, or high cholesterol.
• if your heart, liver, or kidneys do not function properly, your doctor may want to monitor you regularly.
• if you have fluid retention (such as swollen ankles and feet).
• if you are dehydrated due to vomiting, diarrhea, or the use of diuretics (used to treat excess fluid in the body).
• if you have had a severe allergic reaction or a severe skin reaction to any medication.
• if you feel unwell due to an infection or think you may have an infection, as taking celecoxib may mask fever or other signs of infection or inflammation.
• if you are over 65 years old, your doctor will want to monitor you regularly.
• the consumption of alcohol and NSAIDs can increase the risk of gastrointestinal problems.

This medication may increase blood pressure, and your doctor may want to monitor it periodically.

During treatment with celecoxib, some cases of severe liver reactions, such as severe liver inflammation, liver damage, and liver failure (some with fatal consequences or requiring liver transplantation), have been reported. Of the cases that specified the time of onset, most severe liver reactions occurred during the first month of treatment.

Celecoxib may make it more difficult to become pregnant. You should inform your doctor if you plan to become pregnant or if you have problems becoming pregnant (see section Pregnancy and Breastfeeding).

Other Medications and Celecoxib Tevagen

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication:

• Dextromethorphan (used to treat cough);
• ACE inhibitors, angiotensin II receptor antagonists, beta-blockers, and diuretics (medications used to treat hypertension and heart failure);
• Fluconazole and rifampicin (used to treat bacterial and fungal infections).
• Warfarin or other warfarin-like anticoagulants (agents that reduce blood clot formation), including newer oral anticoagulants such as apixaban.
• Lithium (used to treat certain types of depression).
• Other medications used to treat depression, sleep disorders, high blood pressure, or irregular heartbeat.
• Neuroleptics (used to treat certain mental disorders).
• Methotrexate (used in rheumatoid arthritis, psoriasis, and leukemia).
• Carbamazepine (used to treat epilepsy/seizures and certain types of pain or depression).
• Barbiturates (used to treat epilepsy/seizures and certain sleep disorders).
• Cyclosporine and tacrolimus (used to suppress the immune system, e.g., after transplants).

This medication can be taken with low doses of acetylsalicylic acid (75 mg daily or less). Ask your doctor for advice before taking both medications together.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Celecoxib should not be used by pregnant women or women who may become pregnant (i.e., women of childbearing age who do not use adequate contraceptive methods) during treatment. If you become pregnant during treatment with celecoxib, stop treatment and contact your doctor for alternative treatment.

Breastfeeding

This medication should not be taken during breastfeeding.

Fertility

NSAIDs, including celecoxib, may make it more difficult to become pregnant. You should inform your doctor if you plan to become pregnant or if you have problems becoming pregnant.

Driving and Using Machines

You should know how you react to this medication before driving or using machinery. If you feel dizzy or drowsy after taking celecoxib, do not drive or operate machinery until these effects have passed.

Celecoxib Tevagen Contains Lactose

This medication contains lactose(a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Celecoxib Tevagen Contains Sodium

This medication contains less than 1 mmol of sodium(23 mg) per tablet; this is essentially "sodium-free."

3. How to Take Celecoxib Tevagen

Follow the exact instructions for administration of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. If you think the effect of celecoxib is too strong or too weak, talk to your doctor or pharmacist.

Your doctor will tell you what dose you should take. Since the risk of side effects associated with heart problems increases with the dose and duration of treatment, it is important that you take the lowest dose to control the pain and that you do not use celecoxib for longer than necessary to control the symptoms.

Contact your doctor within two weeks after starting treatment if you do not experience any benefit.

The recommended dose is:

For Osteoarthritisthe recommended dose is 200 mg per day, if necessary, your doctor may increase the dose up to a maximum of 400 mg.

The dose is usually:

• one 200 mg capsule once a day, or
• one 100 mg capsule twice a day.

For Rheumatoid Arthritisthe recommended dose is 200 mg per day, if necessary, your doctor may increase the dose up to a maximum of 400 mg (taken in two divided doses).

The dose is usually:

• one 100 mg capsule twice a day.

For Ankylosing Spondylitisthe recommended dose is 200 mg per day, if necessary, your doctor may increase the dose up to a maximum of 400 mg.

The dose is usually:

• one 200 mg capsule once a day, or
• one 100 mg capsule twice a day.

Kidney or Liver Problems:make sure your doctor knows if you have kidney or liver problems, as you may need a lower dose.

Patient Over 65 Years Old, Especially Those Weighing Less Than50 kg: if you are over 65 years old and especially weigh less than 50 kg, your doctor may want to monitor you more closely. You should not take more than 400 mg of celecoxib per day.

Use in Children and Adolescents

Celecoxib is for adults only, it is not indicated in children and adolescents.

Method of Administration

Celecoxib is for oral use.

The capsules can be taken at any time of the day, with or without food. But try to take all doses of celecoxib at the same time each day.

If You Take More Celecoxib Tevagen Than You Should

Do not take more capsules than indicated by your doctor. If you take too many capsules, contact your doctor, pharmacist, or hospital and take the medication with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medication and the amount taken.

If You Forget to Take Celecoxib Tevagen

If you forget to take celecoxib, take it as soon as you remember. Do not take a double dose to make up for forgotten doses.

If You Stop Treatment with Celecoxib Tevagen

Sudden interruption of treatment with celecoxib may cause symptoms to worsen. Do not stop taking celecoxib unless your doctor tells you to. Your doctor may advise you to reduce the dose for a few days before stopping treatment with celecoxib completely.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Celecoxib Tevagen can cause adverse effects, although not all people suffer from them.

The following adverse effects have been observed in patients with arthritis who were taking celecoxib. The adverse effects marked with an asterisk (*) occurred in patients who were taking celecoxib for the prevention of colon polyps and have been classified taking into account the highest frequency of occurrence. The patients included in these studies were taking celecoxib at high doses and for a prolonged period of time.

If you experience any of the following adverse effects, stop taking celecoxib and inform your doctor immediately:

• An allergic reaction such as skin rash, swelling of the face, wheezing or difficulty breathing.
• Heart problems such as chest pain
• Severe stomach pain or any sign of bleeding in the stomach or intestines, such as dark urine or stools stained with blood, or blood in the vomit.
• A skin reaction such as rash, blisters or peeling of the skin.
• Liver failure [symptoms may include nausea (feeling of discomfort), diarrhea, jaundice (your skin or the whites of your eyes appear yellow)].

Very Common (may affect more than 1 in 10 people):

• Increased blood pressure, including worsening of existing hypertension*.

Common (may affect up to 1 in 10 people):

• Heart attack*
• Fluid retention with swelling of ankles, legs and/or hands
• Urinary tract infections
• Difficulty breathing*, sinusitis (inflammation and infection of the paranasal sinuses, obstruction or pain of the paranasal sinuses), stuffy nose or runny nose, sore throat, cough, cold, flu-like symptoms
• Dizziness, difficulty sleeping
• Vomiting*, stomach pain, diarrhea, indigestion, gas
• Rash, itching
• Muscle stiffness
• Difficulty swallowing*
• Headache
• Nausea (feeling of discomfort)
• Joint pain
• Worsening of existing allergies
• Accidental injury

Uncommon (may affect up to 1 in 100 people):

• Stroke*
• Heart failure, palpitations (perception of heartbeat), rapid heartbeat
• Abnormalities in blood tests related to the liver
• Abnormalities in blood tests related to the kidneys
• Anemia (changes in red blood cells that can cause fatigue and difficulty breathing)
• Anxiety, depression, fatigue, numbness, tingling sensation
• High levels of potassium in blood test results (can cause nausea, fatigue, muscle weakness or palpitations)
• Blurred or altered vision, ringing in the ears, mouth ulcers, difficulty hearing*
• Constipation, belching, stomach inflammation (indigestion, stomach pain or vomiting), worsening of stomach or intestinal inflammation
• Leg cramps
• Rash with itching and relief (urticarial habon)
• Eye inflammation
• Difficulty breathing
• Discoloration of the skin (bruises)
• Chest pain (generalized pain not related to the heart)
• Swelling of the face

Rare (may affect up to 1 in 1,000 people):

• Ulcers (bleeding) in the stomach, throat or intestines; or rupture of the intestine (can cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, pancreatitis (can cause stomach pain), esophagitis (inflammation of the esophagus)
• Low sodium levels in the blood (a disease known as hyponatremia)
• Decrease in the number of white blood cells and platelets in the blood (which can increase the risk of bleeding and bruising)
• Difficulty in muscle coordination
• Feeling of confusion, taste disturbances
• Increased sensitivity to light
• Hair loss
• Hallucinations
• Eye bleeding
• Acute reaction that can lead to pulmonary inflammation
• Irregular heartbeat
• Redness of the skin
• Blood clots in the blood vessels of the lungs. Symptoms may include sudden difficulty breathing, sharp chest pain or collapse
• Gastrointestinal bleeding (can cause stools or vomit with blood), intestinal or colon inflammation
• Severe liver inflammation (hepatitis). Symptoms may include nausea, diarrhea, jaundice, dark urine, pale stools, ease of bleeding, itching or chills
• Acute kidney failure
• Menstrual disorders
• Swelling in the face, lips, mouth, tongue or throat, or difficulty swallowing

Very Rare (may affect up to 1 in 10,000 people):

• Severe allergic reactions (including potentially fatal anaphylactic shock)
• Severe skin reactions such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (can cause rash, blistering or peeling of the skin) and acute generalized exanthematous pustulosis (symptoms include redness of the skin with swollen areas and numerous small pustules)
• A late allergic reaction with possible symptoms such as rash, swelling of the face, fever, swollen glands and abnormalities in clinical test results (e.g. liver, blood cells (eosinophilia, a type of increase in blood cell count)
• Bleeding in the brain that causes death
• Meningitis (inflammation of the membrane that surrounds the brain and spinal cord)
• Liver failure, liver damage and severe liver inflammation (fulminant hepatitis) (sometimes with fatal outcome or requiring liver transplant). Symptoms may include nausea, diarrhea, jaundice, dark urine, pale stools, ease of bleeding, itching or chills
• Liver problems (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as discolored stools, nausea and yellowing of the skin or eyes)
• Kidney problems (such as nephrotic syndrome and minimal change disease, which may be accompanied by symptoms such as fluid retention, foamy urine, fatigue and loss of appetite)
• Worsening of epilepsy (possibly more frequent and/or severe seizures)
• Obstruction of an artery or vein in the eye that leads to partial or complete loss of vision
• Inflammation of the blood vessels (can cause fever, pain, purple spots on the skin)
• Decrease in the number of red and white blood cells and platelets in the blood (can cause fatigue, ease of bruising, frequent nosebleeds and increased risk of infections)
• Muscle pain and weakness
• Disturbance of the sense of smell
• Loss of the sense of taste

Frequency Not Known (frequency cannot be estimated from available data):

• Decrease in fertility in women, which is normally reversible if the medication is discontinued

In clinical trials not related to arthritis or other arthritic conditions, in which celecoxib was taken at a dose of 400 mg per day for a period of up to 3 years, the following additional adverse effects were observed:

Common (may affect up to 1 in 10 people):

• Cardiac problems: angina pectoris (chest pain);
• Stomach problems: irritable bowel syndrome (may include stomach pain, diarrhea, indigestion, gas)
• Kidney stones (which can lead to stomach or back pain, blood in the urine), difficulty urinating
• Weight gain
• Abnormalities in kidney-related blood tests

Uncommon (may affect up to 1 in 100 people):

• Deep vein thrombosis (blood clots usually in the leg, which can cause pain, swelling or redness of the calf or breathing problems)
• Stomach problems: stomach infection (which can cause irritation or ulcers in the stomach and intestine)
• Fracture of lower limbs
• Herpes, skin infection, eczema (dry rash with itching), pneumonia (infection in the chest, possibility of cough, fever, difficulty breathing)
• Floaters in the eye that cause vision disturbance or blurred vision, vertigo due to problems in the inner ear, ulcers, inflammation or bleeding of the gums, mouth ulcers
• Excessive urination at night, bleeding from hemorrhoids, frequent bowel movement
• Fat lumps on the skin or other areas, ganglion cyst (painless inflammation in the joints or tendons or around them, in the hand or foot), difficulty speaking, abnormal or very heavy vaginal bleeding, chest pain
• High levels of sodium in blood test results
• Eye bleeding

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Celecoxib Tevagen

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the blister pack and on the carton after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines that you no longer need in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Celecoxib Tevagen Composition

• The active ingredient is celecoxib.

Each capsule contains 200 mg of celecoxib.

• The other ingredients (excipients) are:

Capsule content: sodium lauryl sulfate, lactose monohydrate, crospovidone (type A), povidone K29-32, and magnesium stearate.

Capsule shell: gelatin, titanium dioxide (E171), and sodium lauryl sulfate.

Printing ink: shellac and yellow iron oxide (E172).

Celecoxib Tevagen Appearance and Package Contents

The 200 mg capsules are hard gelatin capsules consisting of a white opaque cap with a yellow band and a white opaque body with the inscription '200' printed on the reverse of the yellow band.

Celecoxib Tevagen may be presented in packages of 10, 20, 30, 40, 50, 60, 90, and 100 hard capsules.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5, Haarlem, 2031 GA,

Netherlands

Manufacturer

Balkanpharma Dupnitsa AD,

Samokovsko Shosse 3,

2600 Dupnitsa,

Bulgaria

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edifício Albatros B, 1ª planta,

Alcobendas, 28108, Madrid (Spain)

This pharmaceutical product is authorized in the Member States of the European Economic Area with the following names:

Austria: Celecoxib ratiopharm GmbH 200 mg Hartkapseln

Belgium: Celecoxib Teva 200 mg harde capsules / gélules / Hartkapseln

Croatia: Celekoksib Pliva 200 mg tvrde kapsule

Germany: Celecoxib-ratiopharm 200 mg Hartkapseln

Spain: Celecoxib Tevagen 200 mg cápsulas duras EFG

France: CELECOXIB TEVA SANTE 200 mg, gélule

Iceland: Celecoxib Teva

Italy: CELECOXIB TEVA ITALIA

Netherlands: Celecoteva 200 mg, harde capsules

Portugal: Celecoxib ratiopharm

Romania: Celecoxib Teva BV 200 mg capsule

Date of the Last Revision of this Leaflet: November 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http: //www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/90093/P_90093.html

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