CELECOXIB AUROVITAS 200 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Celecoxib Aurovitas 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

Celecoxib Aurovitas 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 that can cause pain and inflammation. In conditions such as rheumatoid arthritis or osteoarthritis, your body produces them in larger quantities. Celecoxib Aurovitas works by reducing the production of prostaglandins, thus reducing pain and inflammation.

The medicine 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.

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

Do not take Celecoxib Aurovitas

• if you are allergic to celecoxib or any of the other ingredients of this medicine (listed in section 6),
• if you have had any allergic reaction to any medicine in the group known as "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 anti-inflammatory medicine: 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,
• if you are 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 obstruction of the blood vessels to the heart or brain,
• if you 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 Aurovitas:

• if you have previously had a stomach or intestinal ulcer or bleeding (do not take Celecoxib Aurovitas if you currently have 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 antiplatelet therapies,
• if you are receiving medicines to reduce blood clotting (e.g. warfarin, anticoagulants such as warfarin or new oral anticoagulants, e.g. apixaban),
• if you are taking corticosteroids (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 do not function 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 can mask fever or other signs of infection and 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.

As with other anti-inflammatory medicines (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 it was reported when the event started, most severe liver reactions occurred within the first month of treatment.

Celecoxib Aurovitas may make it more difficult 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").

Other medicines and Celecoxib Aurovitas

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

• Dextromethorphan (used to treat coughs).
• ACE inhibitors, angiotensin II receptor antagonists, beta blockers, and diuretics (medicines used to treat hypertension and heart failure).
• Fluconazole and rifampicin (used to treat bacterial and fungal infections).
• Warfarin or other oral anticoagulants (agents that reduce blood clot formation), including new medicines 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.
• Neuroleptics (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, breastfeeding, and fertility

If you are pregnant or breastfeeding, 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 Aurovitas 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.

Breastfeeding

Celecoxib Aurovitas should not be used during breastfeeding.

Fertility

NSAIDs, including celecoxib, may make it more difficult to become pregnant. You should inform your doctor if you plan to become pregnant or if you are having difficulty becoming pregnant.

Driving and using machines

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

Celecoxib Aurovitas contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Celecoxib Aurovitas contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule, i.e. it is essentially 'sodium-free'.

3. How to take Celecoxib Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. If you think the effect of celecoxib is too strong or too weak, tell your doctor or pharmacist.

Your doctor will tell you what dose you should 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 and do not take Celecoxib Aurovitas for longer than necessary to control the symptoms.

Celecoxib Aurovitas is not suitable for doses below 200 mg/day. Other celecoxib medicines with the appropriate dose are available.

Method of administration

Celecoxib Aurovitas is administered orally. The capsules can be taken at any time of day, with or without food. However, try to take each dose of celecoxib at the same time each day.

If you have difficulty swallowing the capsules: you can sprinkle the entire contents of the capsule onto a level teaspoon of some semi-solid food (such as apple sauce, rice porridge, yogurt, or mashed banana, at cold or room temperature) and swallow it immediately with a glass of water of approximately 240 ml.

To open the capsule, hold it upright to keep the granules at the bottom, then press the top cap 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:

The usual dose is 200 mg per day, if necessary, your doctor may increase it 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 the treatment of rheumatoid arthritis:

The usual dose is 200 mg per day, if necessary, your doctor may increase it to a maximum of 400 mg.

The dose is usually:

• one 100 mg capsule twice a day (if this is the dose recommended by your doctor, this dose cannot be administered with this medicine, other celecoxib medicines are available to achieve this prescribed dose. Please consult your doctor).

For the treatment of ankylosing spondylitis:

The recommended dose is 200 mg per day, if necessary, your doctor may increase it 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.

Kidney or liver problems:make sure your doctor knows if you have liver or kidney problems, as you may need a lower dose.

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

The maximum dose is 400 mg per day.

Use in children:Celecoxib Aurovitas is only for adults, it is not indicated in children.

If you take more Celecoxib Aurovitas than you should

Do not take more capsules than your doctor has told you. If you take more Celecoxib Aurovitas than you should, contact your doctor, pharmacist, or hospital immediately and take the medicine with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Celecoxib Aurovitas

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 Aurovitas

Stopping treatment with celecoxib abruptly may cause a worsening of symptoms.

Do not stop taking celecoxib unless your doctor tells you to. Your doctor will tell you to reduce the dose over a few days before stopping treatment completely.

If you have any further questions on 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 celecoxib 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 Celecoxib Aurovitas at high doses and for a prolonged period.

If you experience any of the following adverse effects, discontinue treatment with Celecoxib Aurovitas 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 of the skin.
• Liver failure (symptoms may include nausea, diarrhea, jaundice, or yellowing of the skin and eyes).

Very Common Adverse Effects:may affect more than 1 in 10 patients

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

Common Adverse Effects:may affect up to 1 in 10 patients

• Heart attack*.
• Fluid retention with swelling of ankles, legs, and/or hands.
• Urinary tract infection.
• Difficult breathing*, sinusitis, nasal congestion 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.
• Joint pain, worsening of existing allergies.
• Accidental injury.

Uncommon Adverse Effects:may affect up to 1 in 100 patients

• Stroke*.
• Heart failure, palpitations, rapid heart rate.
• Abnormal liver blood tests.
• Abnormal kidney blood tests.
• Anemia (changes in red blood cells that can cause fatigue and difficulty breathing).
• Anxiety, depression, fatigue, numbness, tingling.
• High potassium levels in blood tests (can cause nausea, fatigue, muscle weakness, or palpitations).
• Blurred or altered vision, ringing in the ears, mouth ulcers, difficulty hearing*.
• Constipation, belching, stomach inflammation, 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 Adverse Effects:may affect up to 1 in 1,000 patients

• Ulcers (bleeding) in the stomach, throat, or intestines; or intestinal rupture (can cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, pancreatitis (can cause stomach pain), esophagitis (inflammation of the esophagus).
• Low sodium levels in blood tests (a condition known as hyponatremia).
• Decreased white blood cell count or platelet count (increased risk of bleeding and bruising).
• Difficulty with muscle coordination.
• Feeling of confusion, taste disturbances.
• Increased sensitivity to light.
• Hair loss.
• Hallucinations.
• Eye bleeding.
• Acute reaction that can lead to lung inflammation.
• Irregular heart rhythm.
• Flush.
• Blood clots in the pulmonary blood vessels. Symptoms may include sudden difficulty breathing, sharp chest pain, or collapse.
• Stomach or intestinal bleeding (can cause bloody stools or vomit), 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, wheezing, or difficulty swallowing.

Very Rare Adverse Effects: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-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).
• Bleeding in the brain that can cause 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, easy bruising, 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 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 (more frequent and/or severe seizures).
• Blockage of an artery or vein in the eye that can lead to partial or complete loss of vision.
• Inflammation of blood vessels (can cause fever, pain, purple spots on the skin).
• Decreased red, white blood cell, and platelet count (can cause fatigue, easy bruising, frequent nosebleeds, and increased risk of infection).
• Muscle pain and weakness.
• Taste disturbance.
• Loss of taste.

Adverse Effects of Unknown 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 Aurovitas 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 Adverse Effects:may affect up to 1 in 10 patients

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

Uncommon Adverse Effects: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 stomach irritation or ulcers).
• 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, mouth ulcers.
• Excessive urination at night, bleeding hemorrhoids, frequent bowel movements.
• 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 sodium levels in blood tests.

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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Celecoxib Aurovitas

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

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

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Celecoxib Aurovitas Composition

• The active ingredient is celecoxib.

Each hard capsule contains 200 mg of celecoxib.

• The other ingredients (excipients) are:

Capsule content: lactose monohydrate, hydroxypropyl cellulose, crospovidone (type B) (E1202), sodium lauryl sulfate (E487), povidone (K-30) (E1201), sodium stearyl fumarate.

Capsule body: titanium dioxide (E171) and gelatin (E441).

Printing ink: lacquer (E904) and yellow iron oxide (E172).

Product Appearance and Package Contents

Hard capsule.

Hard gelatin capsules, white body and cap, size 2, filled with a white or off-white powder, and printed with golden ink with 'Y' on the cap and '200' on the body.

Celecoxib Aurovitas capsules are available in blister packs of 20 and 30 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91-630.86.45

Fax: 91-630.26.64

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19, 2700-487

Amadora, Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain: Celecoxib Aurovitas 200 mg hard capsules EFG

Italy: Celecoxib Aurobindo

Portugal: Celecoxib Generis Phar

Date of the last revision of this leaflet:March 2021

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