CELECOXIB SUN 200 mg HARD CAPSULES

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

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

Do not take Celecoxib SUN

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

• if you are allergic to this medicine or to any of the other ingredients of this medicine (listed in section 6);
• if you have had any allergic reaction to any medicine of the group called "sulfonamides" (e.g. some antibiotics used to treat infections)
• if you currentlyhave 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 anti-inflammatory and analgesic medicine (NSAIDs): asthma, nasal polyps, severe nasal congestion, or allergic symptoms such as skin rash with itching, swelling of the face, lips, tongue, or throat, 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 Breast-feeding")
• if you are breast-feeding your child (see section "Fertility, Pregnancy and Breast-feeding")
• 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 pectoris, or obstruction of the blood vessels to the heart or brain;
• if you have or have had circulation problems (peripheral arterial disease) or if you have had surgery on the arteries in your legs

Warnings and precautions

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

• if you have previouslyhad a stomach or intestinal ulcer or bleeding ( Do not take Celecoxibif you currentlyhave a stomach or intestinal ulcer or bleeding)
• if you are taking acetylsalicylic acid (even at low doses as a cardiac protector)
• if you are taking medicines to reduce blood clotting (e.g.: warfarin / warfarin-like anticoagulants or new oral anticoagulants, e.g.: apixaban )
• if you are taking antiplatelet therapies
• if you are taking corticosteroid medicines (e.g.: 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 medicines should be avoided
• if you are a smoker, have diabetes, high blood pressure, or high cholesterol
• if your heart, liver, or kidneys are not working properly, your doctor may want to monitor you regularly
• if you have fluid retention (such as swollen feet or ankles)
• if you are dehydrated, for example, as a result of an illness 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 medicine
• 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 can increase the risk of gastrointestinal problems.

As with other anti-inflammatory drugs (e.g. ibuprofen or diclofenac), this medicine may increase your blood pressure, so your doctor may perform periodic blood pressure checks.

Some cases of severe liver reactions have been reported with celecoxib, including severe liver inflammation, liver damage, liver failure (some with a fatal outcome or requiring liver transplantation). Of the cases in which the event was reported when it started, most severe liver reactions occurred within 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 had problems becoming pregnant (see section Pregnancy, Breast-feeding and Fertility).

Taking Celecoxib SUN with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines:

• Dextromethorphan (used to treat cough)
• ACE inhibitors or angiotensin II receptor antagonists, beta-blockers, and diuretics (medicines used to treat high blood pressure 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 some types of depression)
• Other medicines used to treat depression, sleep disorders, high blood pressure, or irregular heartbeat
• Antipsychotics (used to treat some mental disorders)
• Methotrexate (used in rheumatoid arthritis, psoriasis, and leukemia)
• Carbamazepine (used to treat epilepsy/seizures and some forms of pain or depression)
• Barbiturates (used to treat epilepsy/seizures and some sleep disorders)
• Ciclosporin and tacrolimus (used to suppress the immune system, e.g. after transplants)

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

Breast-feeding

This medicine should not be used during breast-feeding.

Fertility

NSAIDs, including this medicine, may make it more difficult to become pregnant (see section Warnings and Precautions). You should inform your doctor if you plan to become pregnant or if you have had problems becoming pregnant.

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

Celecoxib Sun contains lactose and sodium

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

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

3. How to take Celecoxib SUN

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

If you think the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

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

Method of administration:

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

If you have difficulty swallowing the capsules: you can sprinkle the entire contents of the capsule into a

level teaspoon of some semi-solid food (such as apple sauce, rice, yogurt, or mashed banana cold or at room temperature) 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 squeeze the top and twist it to remove it, being careful not to spill the contents. Do not chew or crush the granules.

Contact your doctor if, after two weeks of 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 achieved with this medicine. 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, as you may need a lower dose.

Elderly 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, it is not indicated in children.

If you take more Celecoxib SUN than you should

Do not take more capsules than your doctor has told you. If you take more Celecoxib SUN than you should, consult your doctor, pharmacist, or hospital immediately and take the medicine 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 make up for forgotten doses.

If you stop taking Celecoxib SUN

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

If you experience any of the following adverse effects, stop treatment with Celecoxib and inform your doctor immediately:

If you have:

• 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 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, ease of bleeding, or chills)

Very common:may affect more than 1 in 10 patients

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

Common:may affect up to 1 in 10 patients

• Heart attack*
• 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)
• Pain in the joints
• Worsening of existing allergies
• Accidental injury

Uncommon:may affect up to 1 in 100 patients

• 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 patients

• 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, pancreatic inflammation (esophagus, can lead to stomach pain)
• Inflammation of the throat (esophagus)
• Low sodium levels in the blood (a disease known as hyponatremia)
• Decreased number of white blood cells or platelets (increases the possibility of bleeding and bruising)
• Difficulty in muscular 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
• Blood clots in the blood vessels of the lungs. Symptoms may include sudden difficulty breathing, sharp chest pain, or collapse
• Bleeding in the stomach or intestine (can lead to stools or vomit with blood), inflammation of the intestine or colon
• Severe liver inflammation (hepatitis). Symptoms may include nausea, diarrhea, jaundice, dark urine, pale stools, ease of bleeding, 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 reactions such as Stevens-Johnson syndrome, exfoliative dermatitis, and toxic epidermal necrolysis (can cause rash, blistering, or peeling of the skin) and generalized acute pustular exanthema (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 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, diarrhea, jaundice, dark urine, pale stools, ease of bleeding, 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
• Reduction 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
• Taste disturbance

Frequency not known:frequency cannot be estimated from available data

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

Adverse effects reported in clinical trials in which Celecoxib was administered at a dose of 400 mg per day for a period of up to 3 years, in patients with diseases unrelated to arthritis or other arthritic conditions, were:

Common:may affect up to 1 in 10 patients

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

Uncommon:may affect up to 1 in 100 patients

• Deep vein thrombosis (blood clotting, usually in the leg, which can cause pain, swelling, or redness of the calf or breathing problems)
• Stomach problems: stomach infection (can cause irritation or ulcers in the stomach and intestine)
• Fracture of lower limbs
• Herpes, skin infection, eczema (dry rash with itching), pneumonia (chest infection, 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, mouth ulcers, gum inflammation or bleeding.
• Excessive urination at night, bleeding 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 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 is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Celecoxib SUN

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

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Celecoxib SUN composition

The active ingredient is celecoxib.

Each capsule contains 200 mg of celecoxib.

The other components (excipients) are:

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

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

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

Appearance of Celecoxib SUN and package contents

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

They are presented in PVC/Aclar-Aluminum blisters.

Available in packages of 10, 20, 30, or 40 hard capsules packaged in a box.

Only some package sizes may be marketed.

Marketing authorization holder and 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

This medicine is authorized in the member states of the European Economic Area under the following names:

Italy: Celecoxib SUN

Spain: Celecoxib SUN 200 mg hard capsules EFG

France: Celecoxib SUN 200 mg, capsule

Lithuania: Celecoxib Ranbaxy 200 mg hard capsules

Romania: Celecoxib Terapia 200 mg capsules

Date of the last revision of this prospectus: October 2023

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