Celecoxib Sun 200 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

CelecoxibSUN 200 mg hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask 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. It could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Celecoxib SUN is indicated in adults to relieve the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

This medicine contains the active substance celecoxib. Celecoxib belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), and more 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 or osteoarthritis, your body produces them in higher amounts. Celecoxib works by reducing the production of prostaglandins, thereby decreasing pain and inflammation.

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 SUN

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

Do not take Celecoxib SUN

Inform 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 components of this medicine (listed in section 6);
• if you have previously had an allergic reaction to any medicine 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 after taking acetylsalicylic acid or any other non-steroidal anti-inflammatory and pain-relieving drugs (NSAIDs): asthma, nasal polyps, severe nasal congestion, or allergic symptoms such as itchy 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 (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 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 a "mini-stroke"), angina pectoris, or blockage of blood vessels to the heart or brain;
• if you have or have had circulation problems (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 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 such as for heart protection);
• if you are taking medications to reduce blood clotting (e.g., warfarin, warfarin-like anticoagulants, or newer oral anticoagulants, e.g., apixaban);
• if you are taking antiplatelet therapies;
• if you are taking 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 combined use of these medicines should be avoided;
• if you are a smoker, or 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 feet or ankles);
• if you are dehydrated, for example, due to an illness with vomiting or diarrhea, or due to the 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 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;
• alcohol consumption and NSAIDs may increase the risk of gastrointestinal problems.

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

There have been reports of serious liver reactions with celecoxib, including severe hepatitis, liver damage, and liver failure (some of which were fatal or required liver transplantation). Among the cases where the onset was reported, most serious liver reactions occurred within the first month of treatment.

Celecoxib may make it harder to become pregnant. You should inform your doctor if you plan to become pregnant or if you are having difficulty becoming pregnant (see section Pregnancy, breastfeeding and fertility).

Taking Celecoxib SUN with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to 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 infections caused by bacteria and fungi);
• Warfarin or other warfarin analogues (agents that reduce blood clot formation), 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 transplants).

Celecoxib 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 an adequate contraceptive method) during treatment. If you become pregnant while taking Celecoxib, you must stop treatment and contact your doctor for an alternative treatment.

Breastfeeding

This medicine must not be used during breastfeeding.

Fertility

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

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 this medicine, do not drive or operate machinery until these effects have passed.

Celecoxib Sun contains lactose and sodium

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 before taking this medicine.

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

3. How to take Celecoxib SUN

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Your doctor will determine the dose you should take. Since the risk of adverse effects related to heart problems may increase with dose and duration of treatment, it is important to 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 must be administered orally and swallowed whole with a glass of water. Capsules are taken orally at any time of day, with or without food. However, try to take each dose of the medicine at the same time every day.

If you have difficulty swallowing the capsules: you may sprinkle the entire contents of the capsule onto a level teaspoon of semisolid food (such as applesauce, 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 vertically to keep the granules at the bottom; then press the top and twist it off, taking care not to spill the contents. Do not chew or crush the granules.

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

Recommended dose:

For the treatment of osteoarthritis

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

For the treatment of rheumatoid arthritis

The recommended initial dose is 200 mg daily (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 daily) cannot be achieved with this medicine. Consult your doctor.

For the treatment of ankylosing spondylitis

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

Maximum daily dose:

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

Patients with kidney or liver problems

Ensure your doctor knows if you have liver or kidney problems, as you may require a lower dose.

Elderly patients, especially those weighing less than 50 kg

Your doctor may wish to monitor you more closely if you are over 65 years of age, and especially if you weigh less than 50 kg.

Use in children

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

If you take more Celecoxib SUN than you should

Do not take more capsules than indicated by your doctor. If you take more Celecoxib SUN than prescribed, contact your doctor, pharmacist, or hospital immediately and bring 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

Abruptly stopping treatment with Celecoxib may cause a worsening of symptoms. Do not stop taking Celecoxib SUN unless instructed by your doctor. Your doctor will advise you to gradually reduce the dose over several days before stopping treatment completely.

If you have any further 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 everyone gets them.

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

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 bloody stools, or blood in vomit.
• a skin reaction such as rash, blisters or peeling skin.
• liver failure (symptoms may include nausea (feeling unwell), diarrhea, 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 existing high blood pressure*

Common: may affect up to 1 in 10 people

• Heart attack*
• Fluid retention with swelling of ankles, legs and/or hands
• Urinary tract infection
• 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, diarrhea, 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
• Abnormal liver blood test results
• Abnormal kidney blood test results
• Anaemia (changes in red blood cells which may cause fatigue and shortness of breath)
• Anxiety, depression, tiredness, numbness, tingling sensation
• High 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, burping, stomach inflammation (indigestion, stomach pain or vomiting), worsening of stomach or intestinal inflammation
• Leg cramps
• Itchy, raised rash (urticarial rash)
• Eye inflammation
• Difficulty breathing
• Skin discoloration (bruising)
• 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 intestinal rupture (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, pancreatitis (esophagus, may lead to stomach pain)
• inflammation of the throat (esophagus)
• Low levels of sodium in the blood (a condition known as hyponatremia)
• Decrease in the number of white blood cells (which help protect the body from infections) or 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 bleeding
• 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
• Bleeding from the stomach or intestine (may result in bloody stools or vomit), inflammation of the intestine or colon
• Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy 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 redness of the skin with swollen areas and numerous small pustules)
• A delayed allergic reaction with possible symptoms such as rashes, facial swelling, fever, swollen glands and abnormalities in clinical test results [e.g.: liver, blood cells (eosinophilia, a type of increased 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), 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)
• Swelling of the kidneys 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 (possibly more frequent and/or severe seizures)
• Blockage of an artery or vein in the eye leading to partial or complete loss of vision
• 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 taste

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

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

Adverse effects reported in clinical trials where Celecoxib was administered at a dose of 400 mg per day for a period of up to 3 years in patients with diseases not related to arthritis or other arthritic conditions were:

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• Deep vein thrombosis (blood clot 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 (chest infection with 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, hemorrhoid/anal bleeding, frequent bowel movements
• Fatty lumps in the skin or other sites, ganglion cyst (non-painful swelling in or around joints or tendons, 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 adverse effect, talk to 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: www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date is 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 containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of CelecoxibSUN

The active substance is celecoxib.

Each capsule contains 200 mg of celecoxib.

The other components (excipients) are:

Monohydrate lactose, 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 glaze, propylene glycol, black iron oxide (E-172), potassium hydroxide.

Appearance of Celecoxib SUN and contents of the pack

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

Presented in PVC/Aclar-aluminum blisters.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

The 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 kietosios kapsulès

Romania: Celecoxib Terapia 200 mg capsule

Date of latest review of this leaflet: October 2023

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