Package Insert: Information for the Patient

Celecoxib Teva 200 mg Hard Capsules EFG

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See section 4.

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

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

3. How to take Celecoxib Teva

4. Possible adverse effects

5. Storage of Celecoxib Teva

6. Contents of the pack and additional information

Celecoxib is indicated in adults to relieve the symptoms and signs ofRheumatoid Arthritis, Osteoarthritisand Ankylosing Spondylitis.

This medication contains celecoxib as the active ingredient and belongs to a group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs), specifically the subgroup known as 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 higher amount. Celecoxib acts by reducing the production of prostaglandins and, therefore, decreases pain and inflammation.

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

DO NOT TAKE Celecoxib Teva

•if you are allergic to celecoxib or any of the other ingredients of this medicine (listed in section6).

•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 you have had an asthma attack, nasal polyps, severe nasal congestion or an allergic reaction such as skin rash, facial swelling, lip, tongue or throat swelling, breathing difficulties or wheezing after taking aspirin or any other nonsteroidal anti-inflammatory drug (NSAID).

•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 breastfeeding.

•if you have a severe liver disease.

•if you have a severe kidney disease.

•if you have an inflammatory bowel disease such as ulcerative colitis or Crohn's disease.

•if you have heart failure, diagnosed coronary heart disease or cerebrovascular disease, e.g. you have been diagnosed with a heart attack, stroke or transient ischaemic attack (temporary reduction in blood flow to the brain, also known as “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 been operated on to clear the arteries of your legs.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Celecoxib Teva

•if you have had a stomach or intestinal ulcer or bleeding in the past. Do not take Celecoxib Teva if you currently have a stomach or intestinal ulcer or bleeding.

•if you are currently taking aspirin (even in low doses as a cardioprotective treatment).

•if you are taking antiplatelet treatments

•if you are taking blood thinners (e.g. warfarin or anticoagulants such as warfarin or new anticoagulants such as apixaban).

•if you are taking corticosteroids (e.g. prednisone)

•if you are taking other NSAIDs (e.g. ibuprofen or diclofenac) at the same time as Celecoxib Teva. The use of these medicines together 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 well, your doctor may want to monitor you regularly.

•if you have fluid retention (swollen ankles and feet).

•if you are dehydrated due to vomiting, diarrhoea 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 medicine.

•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 may 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 regularly.

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 transplant) have been reported. The majority of severe liver reactions occurred during the first month of treatment.

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 have difficulty becoming pregnant (see section Pregnancy, breastfeeding and fertility).

Taking Celecoxib Teva with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine:

•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 fungal or bacterial infections (fluconazole and rifampicin)

•agents that reduce blood clotting (warfarin or other medicines like warfarin, including new medicines like apixaban);

•medicines for depression (e.g. lithium)

•medicines for sleep disorders or heart arrhythmias

•medicines for mental disorders (neuroleptics)

•some medicines for rheumatoid arthritis, psoriasis and leukaemia (methotrexate)

•some medicines for epilepsy/convulsions and some types of pain or depression (carbamazepine)

•some medicines for epilepsy/convulsions and some sleep disorders (barbiturates)

•some medicines used to suppress the immune system, e.g. after transplants (ciclosporin and tacrolimus)

•aspirin. Celecoxib Teva can be taken with low doses of aspirin (75 mg daily or less). Consult your doctor or pharmacist before starting to take both medicines together.

Celecoxib Teva can be taken with low doses of aspirin (75 mg daily or less). Consult your doctor or pharmacist before starting to take both medicines together.

Pregnancy, breastfeeding and fertility

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

Pregnancy

Celecoxib Tevashould not be usedby women who are pregnant or who may become pregnant (i.e. women of childbearing age who are not using adequate contraceptive methods) during treatment. If you become pregnant during treatment with Celecoxib Teva, stop this treatment and contact your doctor for an alternative treatment.

Breastfeeding

Celecoxib Tevashould not be takenduring breastfeeding.

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 have difficulty becoming pregnant.

Driving and operating machinery

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”

Follow exactly the administration instructions indicated by your doctor or pharmacist for this medication. In case of doubt, consult your doctor or pharmacist again.

If you consider 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. Since the risk of adverse effects associated with cardiac problems increases with the dose and duration of treatment, it is essential to take the lowest dose to control pain and not use celecoxib for longer than necessary to control symptoms.

Administration Form

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 celecoxib doses at the same time every day.

If you have difficulty swallowing capsules: The entire content of the capsule can be sprinkled over a spoonful of semi-solid food (such as apple sauce, rice porridge, yogurt, or cold or room-temperature banana puree) and swallow immediately with approximately 240 ml of water.

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

Consult 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 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
• two 100 mg capsules per day.

For rheumatoid arthritis

The recommended dose is 200 mg per 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:

• two 100 mg capsules per day.

For ankylosing spondylitis

The 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
• two 100 mg capsules per day.

Daily maximum dose:

You should not take more than 400 mg of celecoxib per day.

Problems with the kidneys or liver

Make sure your doctor knows if you have kidney or liver problems, as you will need a lower dose.

Patients over 65 years old, especially those weighing less than 50 kg

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

Use in children

Celecoxib is only for adults,it is not indicated for children.

If you take more Celecoxib Teva than you should

You should not take more capsules than indicated by your doctor. If you take too many capsules, consult your doctor, pharmacist, or hospital and bring the medication with you.

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

If you forgot to take Celecoxib Teva

If you forget to take celecoxib, take it as soon as you remember. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Celecoxib Teva

Stopping treatment with celecoxib abruptly may worsen symptoms. Do not stop taking celecoxib unless your doctor tells you to. Your doctor may instruct you to reduce the dose for a few days before stopping celecoxib treatment completely.

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

Like all medications,Celecoxib Tevamay cause side effects, although not everyone will experience them.

The following side effects have been observed in patients with arthritis. Some side effects are marked with an asterisk (*). These side effects occurred with the indicated frequency only in patients taking Celecoxib Teva at high doses and for a prolonged period of time to treat other symptoms. They were less frequent in patients with arthritic diseases.

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

• an allergic reaction such as skin rash, facial swelling, wheezing, or difficulty breathing.
• skin reactions such as rash, blisters, or skin peeling.
• heart problems such as chest pain.
• severe stomach pain or any sign of stomach or intestinal bleeding, such as dark or bloody stools, or blood in vomit.
• liver failure (symptoms may include nausea, 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):

• Myocardial infarction *
• Fluid retention with swelling of ankles, legs, and/or hands
• Urinary tract infection
• 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 heartbeats), tachycardia (rapid heart rate)
• Abnormalities in liver function tests
• Abnormalities in kidney function tests
• Anemia (changes in red blood cells that can cause fatigue and difficulty breathing)
• Anxiety, depression, fatigue, numbness, tingling
• Elevated potassium levels in blood test results (may cause nausea, fatigue, muscle weakness, or palpitations)
• Blurred or altered vision, ringing in the ears, mouth pain and ulcers, difficulty hearing*
• Constipation, belching, stomach inflammation (indigestion, stomach pain, or vomiting), worsening of stomach or intestinal inflammation
• Leg cramps
• Hives with itching and raised (urticarial hives)
• Eye inflammation
• Difficulty breathing
• Decoloration of the skin (cardenals)
• Chest pain (generalized pain not related to the heart)
• Facial swelling

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

• Ulcers (bleeding) in the stomach, throat, or intestines; or intestinal rupture (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, stomach inflammation (may cause stomach pain), esophageal inflammation
• Low sodium levels in the blood (a condition known as hyponatremia)
• Decreased white blood cell and platelet counts (increases the risk of bleeding and cardenals)
• Difficulty in coordinating muscle movements
• Confusion, altered taste
• Increased sensitivity to light
• Hair loss
• Hallucinations
• Eye bleeding
• Acute reaction that may lead to pulmonary inflammation
• Irregular heart rhythm
• Rubefaction
• Clots in the blood vessels of the lungs. Symptoms may include sudden difficulty breathing, sharp chest pain, or collapse
• Stomach or intestinal bleeding (may cause dark or bloody stools or vomit), intestinal or colon inflammation
• Severe liver inflammation (hepatitis). Symptoms may include nausea, diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy 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 alterations such as Stevens-Johnson syndrome, exfoliative dermatitis, and toxic epidermal necrolysis (may cause rash, blistering, or skin peeling) and acute generalized pustular psoriasis (symptoms include redness of the skin with swollen areas and numerous small pustules)
• A late-onset allergic reaction with possible symptoms such as rash, facial swelling, fever, swollen lymph nodes, and abnormalities in clinical test results (e.g., liver, blood cells (eosinophilia, a type of increased white blood cell count)
• Brain hemorrhage leading to death
• Meningitis (inflammation of the membrane surrounding the brain and spinal cord)
• Liver failure, liver damage, and severe liver inflammation (hepatitis fulminant) (sometimes with fatal outcome or requiring liver transplant). Symptoms may include nausea, diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy 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 (edema), foamy urine, fatigue, and loss of appetite)
• Worsening of epilepsy (convulsions 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 (may cause fever, pain, and purple spots on the skin)
• Decreased white blood cell and platelet counts (may cause fatigue, easy bleeding, 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 available data):

Decreased fertility in women, which is usually reversible if 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 side effects were observed:

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

• Cardiovascular problems: angina (chest pain);
• Gastrointestinal problems: irritable bowel syndrome (may include stomach pain, diarrhea, indigestion, gas)
• Kidney stones (may cause stomach pain or back pain, blood in urine), difficulty urinating
• Weight gain

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

• Deep vein thrombosis (blood clotting usually in the leg, which may cause pain, swelling, or redness of the calf, or breathing difficulties)
• Gastrointestinal problems: stomach infection (may cause stomach irritation or ulcers in the stomach and intestines)
• Lower limb fractures
• Herpes, skin infection, eczema (dry, itchy rash), pneumonia (lung infection, possibility of cough, fever, difficulty breathing)
• Flies in the eye causing vision disturbance or blurred vision, conjunctival hemorrhage, vertigo due to inner ear problems, ulcers, inflammation, or bleeding of the gums, mouth ulcers
• Excessive nighttime urination, heavy menstrual bleeding, frequent bowel movements
• Fatty lumps in the skin or other areas, ganglion cyst (non-painful inflammation in the joints or tendons or around them, in the hand or foot), difficulty speaking, abnormal or very heavy vaginal bleeding, chest pain
• Elevated sodium levels in blood test results

Reporting of side effects

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

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

Do not use this medication after the expiration date that appears on the label, the blister pack, or the cardboard carton after "CAD". The expiration date is the last day of the month indicated.

ALU/ALU Blister

This medication does not require any special storage conditions.

PVC/PVDC/ALU Blister

Do not store at a temperature above30 °C.

Tablet Container (bottle)

This medication does not require any special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Celecoxib Teva Composition

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

Appearance of Celecoxib Teva and packaging contents

Celecoxib Teva are hard gelatin capsules, opaque, white in color, and bearing the yellow mark “200”.

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

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid

Spain

Responsible for manufacturing

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 medicinal 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

Last review date of this leaflet: July 2024

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http: //www.aemps.gob.es/

You can access detailed and updated information on this medicinal product by scanning the QR code included in the packaging with your 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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