Leaflet: information for the user

CelecoxibSUN 200 mg hard capsules EFG

Read this leaflet carefully before you start taking the 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 should not be given to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Celecoxib SUN

4. Possible side effects

5. Storage of Celecoxib SUN

6. Contents of the pack and additional information

Celecoxib SUN is indicated for adultsto relieve the symptoms and signs ofrheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

This medication contains the active ingredient celecoxib. Celecoxib belongs to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs), specifically to 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 or osteoarthritis, your body produces them in greater quantities. Celecoxibacts by reducing the production of prostaglandins, thereby reducing 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.

Your doctor has prescribed this medication for you. The following information will help you get the best results with Celecoxib. If you have any other questions, please ask your doctor or pharmacist.

Do not take Celecoxib SUN

Inform your doctor if any of the following situations affect you, as patients with these conditions should not take Celecoxib.

• if you are allergic to this medication or to any of the other components of this medication (including those listed in section 6);
• if you have had any allergic reaction to any medication in the group called “sulfonamides” (e.g. some antibiotics used to treat infections)
• if you currently have a stomach or intestinal ulcer or bleeding;
• if you have previously experienced any of the following symptoms as a result of taking acetylsalicylic acid or any other nonsteroidal anti-inflammatory drug (NSAID): asthma, nasal polyps, severe nasal congestion, or allergic symptoms such as skin rash with itching, facial swelling, lip, tongue, or throat swelling, difficulty breathing, or wheezing;
• if you are pregnant. If you can become pregnant during treatment, you should discuss the use of contraceptive methods with your doctor (see section “Fertility, Pregnancy, and Breastfeeding”)
• if you are breastfeeding your child (see section “Fertility, Pregnancy, and 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 coronary artery disease, or cerebrovascular disease, for example, if you have been diagnosed with a heart attack, stroke, or transient ischemic attack (temporary decrease in blood flow to the brain; also known as “mini-stroke”), angina, or obstruction of the blood vessels to the heart or brain;
• if you have or have had peripheral artery disease or if you have been operated on to clear the arteries in your legs

Warning and Precautions

Consult your doctor or pharmacist before starting to take Celecoxib SUN:

• if you have previously had a stomach or intestinal ulcer or bleeding (Do not take Celecoxib if you currently have a stomach or intestinal ulcer or bleeding)
• if you are taking acetylsalicylic acid (even at low doses as a heart protector)
• if you are receiving medications to reduce blood clotting (e.g. warfarin/anticoagulant analogs or new oral anticoagulants, e.g. apixaban)
• if you are taking antiplatelet therapies
• if you are receiving corticosteroids (e.g. prednisone)
• if you are taking Celecoxib at the same time as other non-acetylsalicylic acid NSAIDs such as ibuprofen or diclofenac. The concurrent use of these medications should be avoided
• if you are a smoker, 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 (e.g. swollen feet or ankles)
• if you are dehydrated, for example, due to a disease with 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 have an infection, as taking Celecoxib may mask fever or other signs of infection and inflammation
• if you are over 65 years old, your doctor may want to monitor you regularly.
• The consumption of alcohol and NSAIDs may increase the risk of gastrointestinal problems.

Like other anti-inflammatory medications (e.g. ibuprofen or diclofenac), this medication may increase your blood pressure, so your doctor will be able to perform regular checks.

Some cases of severe liver reactions have been reported with celecoxib, including severe liver inflammation, liver damage, and liver failure (some with fatal outcome or requiring liver transplant). The majority of severe liver reactions occurred in the first month of treatment.

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

Taking Celecoxib SUN with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication:

• Dextromethorphan (used to treat cough)
• ACE inhibitors or angiotensin receptor antagonists, beta-blockers, and diuretics (medications used to treat hypertension and heart failure)

• Fluconazole and rifampicin (used to treat infections caused by bacteria and fungi)
• Warfarin or other warfarin analogs (agents that reduce blood clotting), including newer medications 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/convulsions and certain types of pain or depression)
• Barbiturates (used to treat epilepsy/convulsions and certain sleep disorders)
• Ciclosporin and tacrolimus (used to treat immunosuppression, e.g. after transplants)

Celecoxib can be taken with low doses of acetylsalicylic acid (75 mg daily or less). Consult your doctor before taking both medications 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 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 an adequate contraceptive method) during treatment. If you become pregnant during treatment with Celecoxib, you should discontinue treatment and contact your doctor for alternative treatment.

Breastfeeding

This medication should not be used during breastfeeding.

Fertility

NSAIDs, including this medication, may make it difficult to become pregnant. You should inform your doctor if you plan to become pregnant or if you have difficulty becoming pregnant.

Driving and Operating MachineryYou should know how you react to this medicationbefore driving or operating machinery. If you feel dizzy or drowsy after taking this medication, do not drive or operate machinery until these effects pass.

Celecoxib Sun contains lactose and sodium

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

This medication contains less than 23 mg of sodium (1 mmol) per capsule; that is, it is essentially “sodium-free”.

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

If you think or believe that the action of this medication is too strong or weak, inform your doctor or pharmacist.

Your doctor will indicate the dose you should take. Since the risk of adverse effects associated with heart problems may increase with the dose and duration of treatment, it is essential to use the lowest dose that controls your pain. Do not take Celecoxib SUN for longer than necessary to control your symptoms.

Administration form:

Celecoxib SUN must be administered orally and swallowed whole with a glass of water. The capsules are taken orally at any time of the day, with or without food. However, try to take each dose of the medication at the same time every day.

If you have difficulty swallowing the capsules: you can spread the entire content of the capsule on a

teaspoon of some semi-solid food (such as apple sauce, rice, yogurt, or cold or room temperature mashed banana) and swallow it immediately with a glass of water of approximately 240 ml.

To open the capsule, hold it in a vertical position to keep the granules at the bottom; then, press the top and turn it to extract it, being careful not to spill the content.Do not chew or crush the granules.

Contact your doctor if, after two weeks of starting treatment, you do not experience an improvement.

The recommended dose is:

For the treatment of osteoarthritis

Theusual dose is 200 mg per day (1 capsule of 200 mg once a day). If necessary, your doctor may increase the dose up to a maximum of 400 mg (1 capsule of 200 mg twice a day).

For the treatment of rheumatoid arthritis

The initial recommended dose is 200 mg per day (administered in two doses), if necessary, your doctor may increase the dose up to a maximum of 400 mg (administered in two doses).

The initial dose of 200 mg (administered as 1 capsule of 100 mg twice a day) cannot be obtained with this medication. Consult your doctor.

For the treatment of ankylosing spondylitis

The recommended dose is 200 mg per day (1 capsule of 200 mg once a day). If necessary, your doctor may increase it up to a maximum of 400 mg (1 capsule of 200 mg twice a day).

Maximum daily dose:

You should not take more than 400 mg (2 capsules with 200 mg of celecoxib) per day.

Patients with kidney or liver problems

Make sure your doctor knows if you have liver or kidney problems since you may need a lower dose.

Older patients, especially those weighing less than 50 kg

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

Use in children

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

IfYouTakeCelecoxib SUN MoreThanYouShould

You should not take more capsules than indicated by your doctor. If you take more Celecoxib SUN than you have been told, consult your doctor, pharmacist, or hospital immediately and bring the medication with you.

If You Forget to Take Celecoxib SUN

If you forget to take a capsule, 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 SUN

Stopping treatment with Celecoxib abruptly may cause a worsening of symptoms. Do not stop taking Celecoxib SUN unless your doctor tells you to. Your doctor will indicate that you reduce the dose over a few days before stopping treatment completely.

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

Like all medications,thismedication may cause side effects, although not everyone will experience them.

The side effects listed below were observed in patients with arthritis who took Celecoxib. The side effects marked with an asterisk (*) occurred in patients taking this medication for the prevention of colon polyps and have been classified based on the highest frequency of occurrence. Patients included in these studies took this medicationat high doses and for a prolonged period of time.

If you experience any of the following side effects,stop taking Celecoxiband inform your doctor immediately:

If you have:

• a severe allergic reaction such as skin rash, facial swelling, hives, 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 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, diarrhea, jaundice, dark urine, pale stools, easy bruising, or itching).

Very common:may affect more than 1 in 10 patients

• Increased blood pressure, including worsening of existing high blood pressure*

Common:mayaffectup to 1in 10 patients

• 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), nasal congestion or discharge, sore throat, cough, cold, flu-like symptoms.
• Dizziness, difficulty sleeping
• Vomiting*, stomach pain, diarrhea, indigestion, gas
• Rash, itching
• Muscle stiffness
• Difficulty swallowing*
• Headache
• Nausea (sensation of discomfort)
• Joint pain
• Worsening of existing allergies
• Accidental injury

Rare:mayaffectup to 1in 1,000 patients

• Ulcers (bleeding) in the stomach, esophagus, or intestines; or intestinal rupture (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, esophageal inflammation (may lead to stomach pain)
• Esophageal inflammation
• Low sodium levels in the blood (a condition known as hyponatremia)
• Decreased white blood cell count or platelet count (may cause fatigue, easy bruising, frequent nosebleeds, and increased risk of infections)
• Difficulty in coordinating muscle movements
• Confusion, altered sense of taste
• Increased sensitivity to light
• Hair loss
• Hallucinations
• Eye hemorrhage
• Acute reaction that may lead to pulmonary inflammation
• Irregular heart rhythm
• Rubefaction
• Clots in the pulmonary blood vessels. Symptoms may include sudden difficulty breathing, sharp chest pain, or collapse
• Stomach or intestinal hemorrhage (may cause stools or vomit with blood), intestinal or colon inflammation
• Severe liver inflammation (hepatitis). Symptoms may include nausea, diarrhea, jaundice, dark urine, pale stools, easy bruising, 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 patients

• 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 peeling of the skin) 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)]
• Cerebral hemorrhage leading to death
• Meningitis (inflammation of the membrane surrounding the brain and spinal cord)
• Acute liver failure, liver damage, and severe liver inflammation (hepatitis fulminans) (sometimes with fatal outcome or requiring liver transplant). Symptoms may include nausea, diarrhea, jaundice, dark urine, pale stools, easy bruising, itching, or chills
• Liver problems (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as dark-colored stools, nausea, and yellow discoloration of the skin or eyes)
• Renal inflammation and other 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 (seizures possibly more frequent and/or severe)
• Obstruction of an artery or vein in the eye leading to partial or complete loss of vision
• Decreased white blood cell, red blood cell, and platelet count (may cause fatigue, easy bruising, frequent nosebleeds, and increased risk of infections)
• Muscle pain and weakness
• Altered sense of taste

Frequency not known:its frequency cannot be estimated from available data

• Decreased fertility in women, which is usually reversible if medication is discontinued

The side effectsreportedin clinical trials in which Celecoxib was administered at doses of 400mg per day fora period ofup to 3 years in patients with non-arthritis-related diseases or other arthritic conditions were:

Common:mayaffectup to 1in 10 patients

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

Rare:mayaffectup to 1in 100 patients

• 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 irritationor 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, 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 heavy vaginal bleeding, chest pain
• High sodium levels in blood test results.

Reporting side effects

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

Keep thismedicationout ofthesightandreach of children.

Do not usethismedication after the expiration date that appears on the packagingafter CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Celecoxib CompositionSUN

The active ingredient is celecoxib.

Each capsule contains 200 mg of celecoxib.

The other components (excipients) are:

Lactose monohydrate, povidone (K30), colloidal anhydrous silica, sodium lauryl sulfate, croscarmellose sodium, magnesium stearate.

The capsule coating contains: gelatin, sodium lauryl sulfate, titanium dioxide (E-171).

The printing ink contains: shellac lacquer, propylene glycol, iron oxide black (E-172), potassium hydroxide.

Appearance of Celecoxib SUNand packaging contents

Hard gelatin capsules, opaque, white to off-white in color with black ink printing of "CC" on the cap and "200" on the body of the capsule, containing a white granular powder.

Presented in PVC/Aclar-Aluminum blisters.

Available in packs of 10, 20, 30 or 40 hard gelatin capsules in a carton.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Local Representative:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 – Barcelona

Spain

Tel.: +34 93 342 7890

ThismedicineisauthorizedinthememberstatesoftheEuropeanEconomicAreawiththefollowingnames:

Italy: Celecoxib SUN

Spain: Celecoxib SUN 200 mg hard gelatin capsules EFG

France: Celecoxib SUN 200 mg, gel capsule

Lithuania: Celecoxib Ranbaxy 200 mg kietosios kapsulès

Romania: Celecoxib Terapia 200 mg capsule

Last review date of this leaflet: October 2023

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/