Celecoxib Tevagen 200 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Celecoxib Tevagen 200 mg hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

This medicine contains the active substance celecoxib.

Celecoxib belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), specifically to the subgroup known as selective cyclooxygenase-2 (COX-2) inhibitors. Your body produces prostaglandins, which can cause pain and inflammation. In conditions such as rheumatoid arthritis and osteoarthritis, the body produces increased amounts of prostaglandins. Celecoxib works by reducing the production of prostaglandins, thereby decreasing pain and inflammation.

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

The medicine will start to work a few hours after taking the first dose, but you may not experience the 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 to any of the other ingredients of this medicine (listed in section 6).
• if you have previously had an allergic reaction to the group of medicines known as “sulfonamides” (e.g., certain antibiotics used to treat infections).
• if you currently have a stomach or intestinal ulcer or bleeding.
• if taking acetylsalicylic acid or any other nonsteroidal anti-inflammatory and painkiller drug (NSAID) has previously caused you to develop 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 could become pregnant during 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 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 in blood flow to the brain, also known as “mini-stroke”), angina, or blockage of blood vessels supplying the heart or brain.
• if you have or have had circulation problems (peripheral arterial disease) or have undergone surgery on the arteries in your legs.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• if you have previously had a gastrointestinal ulcer or gastrointestinal bleeding. Do not take celecoxib if you currently have a stomach or intestinal ulcer or bleeding.
• if you are currently taking acetylsalicylic acid (even at low doses for cardioprotection).
• if you are taking antiplatelet therapy.
• if you are taking blood-thinning medicines (e.g., warfarin/warfarin analogues or newer oral anticoagulants such as apixaban).
• if you are taking corticosteroid medicines (such as prednisone).
• if you are taking celecoxib together with other non-acetylsalicylic NSAIDs such as ibuprofen or diclofenac. The combined use of these medicines should be avoided.
• if you are a smoker, or 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 use of diuretics (used to treat excess fluid in the body).
• if you have previously had a severe allergic reaction or a serious skin reaction to any medicine.
• if you are unwell due to an infection or suspect you have an infection, as taking celecoxib may mask fever or other signs of infection or inflammation.
• if you are over 65 years of age, your doctor will want to monitor you regularly.
• alcohol consumption and NSAIDs may increase the risk of gastrointestinal problems.

This medicine may increase blood pressure, so your doctor may monitor your blood pressure periodically.

During treatment with celecoxib, there have been reports of rare but serious liver-related reactions, including severe hepatitis, liver damage, and liver failure (some of which have been fatal or required liver transplantation). Among reported cases specifying the time of onset, most serious liver reactions occurred within the first month of treatment.

Celecoxib may impair fertility. Inform your doctor if you plan to become pregnant or if you are experiencing difficulty becoming pregnant (see section Pregnancy and breastfeeding).

Other medicines and Celecoxib Tevagen

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines:

• Dextromethorphan (used to treat cough);
• ACE inhibitors, angiotensin II receptor antagonists, beta-blockers, and diuretics (medicines used to treat hypertension and heart failure);
• Fluconazole and rifampicin (used to treat bacterial and fungal infections);
• Warfarin or other warfarin analogues (agents that reduce blood clotting), including newer agents such as apixaban;
• Lithium (used to treat certain types of depression);
• Other medicines 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 for immunosuppression, e.g., after organ transplants).

This medicine may be taken with low-dose acetylsalicylic acid (75 mg daily or less). Seek advice from your doctor before taking both medicines together.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Celecoxib must not be used by pregnant women or women who may become pregnant (i.e., women of childbearing potential who are not using adequate contraception) during treatment. If you become pregnant while being treated with celecoxib, stop treatment immediately and contact your doctor to discuss alternative treatment options.

Breastfeeding

This medicine must not be taken during breastfeeding.

Fertility

NSAIDs, including celecoxib, may make it more difficult to become pregnant. Inform your doctor if you are planning to become pregnant or if you are experiencing difficulty conceiving.

Driving and using machines

You should be aware of how you react to this medicine before driving or operating 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 medicine contains lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult with him or her before taking this medicine.

Celecoxib Tevagen contains sodium

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

3. How to take Celecoxib Tevagen

Follow exactly the instructions for use of this medicine as provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. If you think the effect of celecoxib is too strong or too weak, speak with your doctor or pharmacist.

Your doctor will tell you what dose to take. Since the risk of adverse effects related to heart problems increases with dose and duration of treatment, it is important to take the lowest effective dose needed to control pain and to use celecoxib for no longer than necessary to manage symptoms.

Contact your doctor within two weeks after starting treatment if you experience no benefit.

The recommended dose is:

For osteoarthritis, the recommended dose is 200 mg daily. If necessary, your doctor may increase the dose up to a maximum of 400 mg.

The dose is generally:

• one 200 mg capsule once daily, or
• one 100 mg capsule twice daily.

For rheumatoid arthritis, the recommended dose is 200 mg daily. If necessary, your doctor may increase the dose up to a maximum of 400 mg (taken in two divided doses).

The dose is generally:

• one 100 mg capsule twice daily.

For ankylosing spondylitis, the recommended dose is 200 mg daily. If necessary, your doctor may increase the dose up to a maximum of 400 mg.

The dose is generally:

• one 200 mg capsule once daily, or
• one 100 mg capsule twice daily.

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

Patients aged 65 years and older, especially those weighing less than 50 kg: if you are over 65 years of age, and especially if you weigh less than 50 kg, your doctor may wish to monitor you more closely. You must not take more than 400 mg of celecoxib per day.

Use in children and adolescents

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

Method of administration

Celecoxib is for oral use.

The capsules can be taken at any time of day, with or without food. However, 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 prescribed by your doctor. If you take too many capsules, contact your doctor, pharmacist, or hospital immediately and bring the medicine with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine 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 missed doses.

If you stop taking Celecoxib Tevagen

Stopping treatment with celecoxib abruptly may cause your symptoms to worsen. Do not stop taking celecoxib unless instructed by your doctor. Your doctor may advise you to gradually reduce the dose over several days before completely stopping celecoxib treatment.

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

4. Possible adverse effects

Like all medicines, Celecoxib Tevagen can cause adverse effects, although not everyone experiences 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 taking celecoxib for prevention of colon polyps and have been classified according to the higher frequency of occurrence. 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 blood-stained stools, or blood in vomit.
• a skin reaction such as rash, blisters or peeling of the skin.
• liver failure [symptoms may include nausea (feeling unwell), diarrhoea, 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 pre-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 sinuses, sinus blockage or pain), stuffy or runny nose, sore throat, cough, cold, flu-like symptoms
• Dizziness, difficulty sleeping
• Vomiting*, stomach pain, diarrhoea, indigestion, gas
• Rash, itching
• Muscle stiffness
• Difficulty swallowing*
• Headache
• Nausea (feeling unwell)
• Joint pain
• Worsening of existing allergies
• Accidental injury

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

• Stroke*
• Heart failure, palpitations (awareness of heartbeat), rapid heartbeat
• Abnormalities in blood tests related to the liver
• Abnormalities in blood tests related to the kidney
• Anaemia (changes in red blood cells which may cause fatigue and difficulty breathing)
• Anxiety, depression, tiredness, numbness, tingling sensation
• Elevated levels of potassium in blood test results (may cause nausea (feeling unwell), fatigue, muscle weakness or palpitations)
• Blurred or altered vision, ringing in the ears, mouth pain and ulcers, hearing difficulty*
• Constipation, belching, inflammation of the stomach (indigestion, stomach pain or vomiting), worsening of stomach or intestinal inflammation
• Leg cramps
• Itchy, raised rash (urticarial wheal)
• Eye inflammation
• Difficulty breathing
• Skin discolouration (bruising)
• Chest pain (generalised 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 intestinal perforation (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, inflammation of the pancreas (may cause stomach pain), inflammation of the throat (oesophagus)
• Low levels of sodium in the blood (a condition known as hyponatraemia)
• Decrease in the number of white blood cells (which help protect the body from infections) and platelets (increased risk of bleeding and bruising)
• Difficulty with muscular coordination of movements
• Feeling confused, taste disturbances
• Increased sensitivity to light
• Hair loss
• Hallucinations
• Eye haemorrhage
• Acute reaction that may lead to lung inflammation
• Irregular heartbeat
• Flushing
• Blood clots in blood vessels of the lungs. Symptoms may include sudden shortness of breath, sharp pain when breathing or collapse
• Stomach or intestinal bleeding (may result in blood in stools or vomit), inflammation of the intestine or colon
• Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bruising or bleeding, itching or chills
• Acute kidney failure
• Menstrual disorders
• Swelling of 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 life-threatening anaphylactic shock)
• Severe skin reactions such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (may cause rash, blistering or peeling of the skin) and acute generalized exanthematous pustulosis (symptoms include reddening of the skin with swollen areas and numerous small pustules)
• A delayed 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 causing death
• Meningitis (inflammation of the membrane surrounding the brain and spinal cord)
• Liver failure, liver damage and severe liver inflammation (fulminant hepatitis) (sometimes fatal or requiring liver transplantation). Symptoms may include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bruising or bleeding, itching or chills
• Liver problems (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as pale stools, nausea and yellowing of the skin or eyes)
• Kidney inflammation and other kidney problems (such as nephrotic syndrome and minimal change disease which may be accompanied by symptoms such as fluid retention (oedema), foamy urine, fatigue and loss of appetite)
• Worsening of epilepsy (possibly more frequent and/or severe seizures)
• Blockage of an artery or vein in the eye leading to partial or complete loss of vision
• Inflammation of blood vessels (may cause fever, aches, purple spots on the skin)
• Reduction in the number of red and white blood cells and platelets (may cause tiredness, easy bruising, frequent nosebleeds and increased risk of infections)
• Muscle pain and weakness
• Disturbance of the sense of smell
• Loss of taste sensation

Frequency not known (frequency cannot be estimated from available data):

• Decrease in fertility in women, which is usually reversible if the medicine is discontinued

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

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

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

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

• Deep vein thrombosis (blood clots usually in the leg, which may cause pain, swelling or redness in the calf or breathing problems)
• Stomach problems: stomach infection (which may cause irritation or ulcers in the stomach and intestine)
• Fracture of lower limbs
• Herpes, skin infection, eczema (dry, itchy rash), pneumonia (infection in the chest (possible cough, fever, difficulty breathing))
• Eye floaters causing visual disturbance or blurred vision, vertigo due to inner ear problems, ulcers, inflammation or bleeding of the gums, mouth ulcers
• Excessive urination at night, haemorrhoid/anal bleeding, frequent bowel movements
• Fatty lumps in the skin or other sites, ganglion cyst (non-painful swelling in joints or tendons or around them, in the hand or foot), difficulty speaking, abnormal or very heavy vaginal bleeding, chest pain
• Elevated levels of sodium in blood test results
• Eye haemorrhage

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 not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the blister and on the carton after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of any unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Celecoxib Tevagen

• The active substance is celecoxib.

Each capsule contains 200 mg of celecoxib.

• The other components (excipients) are:

Capsule contents: sodium lauryl sulfate, monohydrate lactose, 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).

Appearance of Celecoxib Tevagen and contents of the pack

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5, Haarlem, 2031 GA,

The Netherlands

Manufacturer

Balkanpharma Dupnitsa AD,

Samokovsko Shosse 3,

2600 Dupnitsa,

Bulgaria

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108, Madrid (Spain)

This medicinal product is authorized in the European Economic Area member states under 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

The Netherlands: Celecoteva 200 mg, harde capsules

Portugal: Celecoxib ratiopharm

Romania: Celecoxib Teva BV 200 mg capsule

Date of the most recent review of this leaflet: November 2024

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

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. 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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