CELECOXIB TEVA 200 mg HARD CAPSULES

2. What you need to know before you take Celecoxib Teva

DO NOTtake Celecoxib Teva

• if you are allergic to celecoxib or any of the other ingredients of this medicine (listed in section 6).
• if you have had an allergic reaction to the group of medicines called “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 non-steroidal anti-inflammatory and analgesic drug (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 can become pregnant during this treatment, you should discuss the use of contraceptive methods with your doctor.
• if you are breast-feeding.
• 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, ischemic heart disease diagnosed, 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 problems with blood circulation (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 treatment with Celecoxib Teva

• if you have previously suffered from stomach or intestinal ulcers or bleeding. Do not take Celecoxib Teva if you currently have an ulcer or bleeding in your stomach or intestine.
• if you are currently taking acetylsalicylic acid (even in low doses as cardioprotective therapy).
• if you are taking antiplatelet agents.
• if you are taking medications to reduce blood clotting (e.g. warfarin/anticoagulants such as warfarin or new anticoagulant medications like apixaban).
• if you are taking corticosteroid medications (such as prednisone).
• if you are taking Celecoxib Teva 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 are not functioning 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 Teva may mask fever or other symptoms 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.

Like other NSAIDs (e.g. ibuprofen or diclofenac), this medicine may increase blood pressure, and your doctor may want to monitor this periodically.

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

Celecoxib Teva may make it more difficult for you to become pregnant. You should inform your doctor if you are planning to become pregnant or if you are having trouble becoming pregnant (see section Pregnancy, breast-feeding, and fertility).

Taking Celecoxib Teva with other medicines

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

• some medicines for coughs (dextromethorphan);
• medicines used to treat high blood pressure and heart failure (e.g. ACE inhibitors, angiotensin II receptor antagonists, beta blockers, and diuretics);
• some medicines for treating fungal or bacterial infections (fluconazole and rifampicin).
• agents that reduce blood clotting (warfarin or other warfarin-like medications, including new medications like apixaban);
• medicines for treating depression (e.g. lithium).
• medicines for treating sleep disorders or cardiac arrhythmias.
• medicines for treating mental disorders (neuroleptics).
• some medicines for treating rheumatoid arthritis, psoriasis, and leukemia (methotrexate).
• some medicines for treating epilepsy/seizures and some types of pain or depression (carbamazepine).
• some medicines for treating epilepsy/seizures and some sleep disorders (barbiturics).
• some medicines used to suppress the immune system, e.g. after transplants (cyclosporin and tacrolimus).
• acetylsalicylic acid. Celecoxib Teva can be administered concomitantly with acetylsalicylic acid in daily doses of 75 mg or less. Consult your doctor or pharmacist before starting to take both medicines together.

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

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breast-feeding

Celecoxib Teva must notbe taken during breast-feeding.

Fertility

NSAIDs, including Celecoxib Teva, may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you are having trouble becoming pregnant.

Driving and using machines

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

Celecoxib Teva 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 Teva

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

If you think that the effect of celecoxib is too strong or too weak, talk to your doctor or pharmacist.

Your doctor will tell you what dose to take. Because 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 your pain and that you do not use celecoxib for longer than necessary to control your symptoms.

Method of administration

Celecoxib is for oral use. The capsules can be taken at any time of the day, with or without food. However, try to take all doses of celecoxib at the same time each day.

If you have difficulty swallowing capsules: The entire contents of the capsule can be sprinkled onto a spoonful of soft food (such as apple sauce, rice porridge, yogurt, or cold or room temperature banana puree) and swallowed immediately with a glass of approximately 240 ml of water.

To open the capsule, hold it in an upright position to contain the powder in the bottom and then gently press the top and twist to remove it, being careful not to spill the contents.

Contact your doctor if you do not notice improvement within two weeks of starting treatment.

The recommended dose is:

For osteoarthritis

The recommended dose is 200 mg each 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 arthritis

The recommended dose is 200 mg each day (taken in two divided doses), 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 spondylitis

The recommended dose is 200 mg each 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.

Maximum daily dose:

You must not take more than 400 mg of celecoxib per 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 of age, especially those weighing less than 50 kg

If you are over 65 years old, especially if you weigh less than 50 kg, your doctor may want to monitor you more closely.

Use in children

Celecoxib is only for adults, it is notindicated in children.

If you take more Celecoxib Teva than you should

Do not take more capsules than your doctor has told you to. If you take too many capsules, contact your doctor, pharmacist, or hospital and take the medicine 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 medicine and the amount taken.

If you forget to take Celecoxib Teva

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 taking Celecoxib Teva

Stopping treatment with celecoxib abruptly may cause your 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 further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

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

The following adverse effects have been observed in patients with arthritis. Some adverse effects are marked with an asterisk (*). These adverse effects occurred with the indicated frequency only in patients who took Celecoxib Teva in high doses and for a prolonged period to treat other symptoms. They occurred less frequently in patients with arthritic diseases.

Stop taking Celecoxib Teva and inform your doctor immediately if you have:

• an allergic reaction such as skin rash, swelling of the face, wheezing or difficulty breathing.
• skin reactions such as rash, blisters or peeling of the skin.
• heart problems such as chest pain.
• severe stomach pain or any sign of bleeding in the stomach or intestine, such as dark or bloody stools, or blood in vomit.
• liver failure (symptoms may include nausea (feeling of discomfort), diarrhea, jaundice (yellowing of the skin or eyes)).

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 infection
• Difficult 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)
• Pain in the joints
• 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 (feeling of discomfort), fatigue, muscle weakness or palpitations)
• Blurred or altered vision, ringing in the ears, mouth pain or 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, pancreas inflammation (can lead to stomach pain), throat inflammation (esophagus)
• Low levels of sodium 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 infection and bleeding)
• Difficulty in muscle coordination of movements
• Feeling of confusion, taste disturbances
• Increased sensitivity to light
• Hair loss
• Hallucinations
• Eye bleeding
• Acute reaction that can lead to lung inflammation
• Irregular heartbeat
• Redness of the skin
• Blood clots in the blood vessels of the lungs. Symptoms may include sudden difficulty breathing, sharp pain when breathing or collapse
• Stomach or intestinal bleeding (can lead to bloody stools or vomit), intestinal or colon inflammation
• Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling of discomfort), diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, ease of bleeding, itching or chills
• Acute kidney failure
• Menstrual disorders
• Swelling in the face, lips, mouth, tongue or throat, wheezing 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-onset 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 surrounding 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 (feeling of discomfort), diarrhea, jaundice (yellowing of the skin and eyes), 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 inflammation and other kidney problems (such as nephrotic syndrome and minimal change disease, which may be accompanied by symptoms such as fluid retention (edema), foamy urine, fatigue and loss of appetite)
• Worsening of epilepsy (seizures possibly more frequent and/or severe)
• Obstruction of an artery or vein in the eye leading to partial or complete loss of vision
• Inflammation of blood vessels (can cause fever, pain, purple spots on the skin)
• Decrease in the number of red and white blood cells and platelets (can cause fatigue, ease of bruising, frequent nosebleeds and increased risk of infections)
• Muscle pain and weakness
• Alteration of the sense of smell
• Alteration of the sense of taste

Frequency Not Known (cannot be estimated from the 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 maximum of 3 years, the following 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

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

• Deep vein thrombosis (blood clotting generally 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, conjunctival bleeding, vertigo due to problems in the inner ear, ulcers, inflammation or bleeding of the gums, ulcers in the mouth
• 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

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 does not appear in this prospectus. 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.

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5. Conservation of Celecoxib Teva

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

Do not use this medicine after the expiration date that appears on the label, blister or cardboard box after "EXP". The expiration date is the last day of the month indicated.

ALU/ALU Blister

This medicine does not require any special storage conditions.

PVC/PVDC/ALU Blister

Do not store above 30 °C.

Tablet Container (bottle)

This medicine does not require any special storage conditions.

Medicines should not be thrown down the drain or into the trash. Deposit the containers and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Celecoxib Teva Composition

• The active ingredient is celecoxib. Each capsule contains 200 mg of celecoxib.
• The other components (excipients) are: Calcium phosphate dihydrate, sodium lauryl sulfate, crospovidone (type B), povidone (K30), povidone (K90), magnesium stearate, gelatin, shellac, propylene glycol, purified water, titanium dioxide (E171), yellow iron oxide (E172).

Appearance of Celecoxib Teva and Package Contents

Celecoxib Teva are hard gelatin capsules, opaque, white in color and bear the yellow mark "200".

Celecoxib Teva may be presented in packages of 5, 10, 20, 30, 50, 60, 90 and 100 hard capsules in blister packs, 30 x 1 and 50 x 1 hard capsules in monodose perforated blister packs and 100 hard capsules in tablet containers.

Only some package sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid

Spain

Manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 3, 89143 Blaubeuren

Germany

or

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen,

Hungary

or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

or

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305, 74770 Opava-Komarov

Czech Republic

or

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80,

31-546 Krakow

Poland

or

HBM Pharma s.r.o.

03680 Martin,

Slabinská 30

Slovakia

This pharmaceutical product is authorized in the EEA Member States under the following names:

Belgium: Celecoxib Teva 200 mg capsules, hard

France: Celecoxib TEVA 200 mg, gélules

Germany: Celecoxib AbZ 200 mg Hartkapseln

Italy: Celecoxib Teva

Netherlands: Celecoxib Teva 200 mg, capsules, hard

Spain: Celecoxib Teva 200 mg hard capsules EFG

Date of the last revision of this prospectus: July 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 packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76749/P_76749.html

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