Prospect: information for the user

Celecoxib Aurovitas 200 mg hard capsules EFG

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

• Keep this prospect as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people, 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 prospect. See section 4.

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

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

3.How to take Celecoxib Aurovitas

4.Possible adverse effects

5.Storage of Celecoxib Aurovitas

6.Contents of the pack and additional information

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

Celecoxib Aurovitas 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. Celecoxib Aurovitas acts 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.

Do not take Celecoxib Aurovitas

• if you are allergic to celecoxib or any of the other ingredients of this medication (listed in section 6),
• if you have had any allergic reaction to any medication in the group called “sulfonamides” (e.g. some are antibiotics used to treat infections),
• if you havecurrentlyan ulcer or bleeding in your stomach or intestine,
• if you have previously experienced any of the following symptoms as a result of taking acetylsalicylic acid or any other anti-inflammatory medication: asthma, nasal polyps, severe nasal congestion, or allergic symptoms such as itchy skin rash, 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,
• if you are breastfeeding your child,
• 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, e.g. 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 blood vessels to the heart or brain,
• if you have or have had problems with blood circulation (peripheral arterial disease) or if you have been operated on your leg arteries.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeCelecoxib Aurovitas:

• if you have previously had an ulcer or bleeding in your stomach or intestine (Do not take Celecoxib Aurovitas if you currently have an ulcer or bleeding in your stomach or intestine),

• if you are taking acetylsalicylic acid (even at low doses as a heart protector),
• if you are taking antiplatelet therapies,
• if you are receiving medications to reduce blood clotting (e.g. warfarin, anticoagulants such as warfarin or new oral anticoagulants, e.g. apixaban),
• if you are receiving medications called corticosteroids (e.g. prednisone),
• if you are taking celecoxib at the same time as other non-acetylsalicylic acid anti-inflammatory drugs such as ibuprofen or diclofenac. You should avoid using these medications together,
• 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 will 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 may perform regular checks.

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

Celecoxib Aurovitas 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”).

Other medications and Celecoxib Aurovitas

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, angiotensin II receptor antagonists, beta-blockers, and diuretics (medications used to treat high blood pressure and heart failure).
• Fluconazole and rifampicin (used to treat infections caused by bacteria and fungi).
• Warfarin or other oral anticoagulants (agents that reduce blood clotting), including new 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 suppress the immune system, 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 Aurovitas 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

Celecoxib Aurovitas should not be used during breastfeeding.

Fertility

NSAIDs, including celecoxib, may make it 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 operating machinery

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

Celecoxib Aurovitas contains lactose

This medication containslactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Celecoxib Aurovitas contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. If you think or believe that the action of celecoxib is too strong or weak, inform your doctor or pharmacist.

Your doctor will indicate what 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 and do not take Celecoxib Aurovitas for longer than necessary to control symptoms.

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

Administration Form

Celecoxib Aurovitas is administered orally.The capsules can be taken at any time of the day, with or without food. However, try to take each dose of celecoxib 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, oatmeal, yogurt, or mashed banana, at cold or room temperature) and swallow it immediately with a glass of approximately 240 ml of water.

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

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

The usual dose is:

• one 200 mg capsule once a day, or
• two 100 mg capsules per day.

For the treatment of rheumatoid arthritis:

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

The usual dose is:

• two 100 mg capsules per day (if this is the dose recommended by your doctor, this dose cannot be administered with this medication, other celecoxib medications with the appropriate dose are available. 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 up to a maximum of 400 mg.

The usual dose is:

• one 200 mg capsule per day, or
• two 100 mg capsules per day.

Problems with the kidneys or liver:Make sure your doctor knows if you have problems with the liver or kidneys since you may need a lower dose.

Patients over 65 years old, 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.

The maximum dose is 400 mg per day.

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

If you take more Celecoxib Aurovitas than you should

You should not take more capsules than indicated by your doctor. If you take more Celecoxib Aurovitas than you have been told, consult your doctor, pharmacist, or hospital immediately 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 ingested.

If you forgot to take Celecoxib Aurovitas

If you forgot 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 Aurovitas

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

Do not stop taking celecoxib 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, this medication 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 celecoxib for the prevention of colon polyps and have been classified based on the highest frequency of occurrence. Patients included in these studies took Celecoxib Aurovitas at high doses and for a prolonged period of time.

If you experience any of the following side effects, discontinue treatment with Celecoxib Aurovitas and inform your doctor immediately.

If you have:

• an allergic reaction such as skin rash, facial swelling, 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 the vomit.
• a skin reaction such as rash, blisters, or peeling of the skin.
• liver failure (symptoms may include nausea, diarrhea, jaundice, dark skin or white eyes appear yellow).

Very common side effects:may affect more than 1 in 10 patients

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

Common side effects:may affect up to 1 in 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 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.

Rare side effects:may affect up to 1 in 100 patients

• Stroke*.
• Heart failure, palpitations (perception of heartbeats), tachycardia.
• Abnormalities in liver-related blood tests.
• Abnormalities in kidney-related blood tests.
• Anemia (changes in red blood cells that may cause fatigue and difficulty breathing).
• Anxiety, depression, fatigue, numbness, tingling.
• High 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.
• Rash with itching and elevation (urticarial hives).
• Eye inflammation.
• Difficulty breathing.
• Decoloration of the skin (cardenales).
• Chest pain (generalized pain not related to the heart).
• Facial swelling.

Very rare side effects:may affect up to 1 in 10,000 patients

• 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 (may cause stomach pain), esophagitis (inflammation of the esophagus).
• Low sodium levels in blood test results (a condition known as hyponatremia).
• Decreased white blood cell count or platelet count (may cause increased risk of bleeding and petechiae).
• Difficulty in coordinating muscle movements.
• Confusion, altered taste.
• Increased sensitivity to light.
• Hair loss.
• Hallucinations.
• Eye hemorrhage.
• Acute reaction that may lead to pulmonary inflammation.
• Irregular heart rhythm.
• Rubefaction.
• Pulmonary embolism (blood clots in the lungs). Symptoms may include sudden difficulty breathing, sharp chest pain, or collapse.
• Gastrointestinal 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 bleeding, itching, or chills.
• Acute kidney failure.
• M menstrual disorders.
• Facial swelling, lips, mouth, tongue, or throat, wheezing, or difficulty swallowing.

Side effects of unknown frequency:cannot be estimated from available data

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

The side 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 non-arthritis-related diseases or other arthritic conditions were:

Common side effects:may affect up to 1 in 10 patients

• Cardiovascular 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 side effects:may affect up to 1 in 100 patients

• Deep vein thrombosis (blood clotting generally 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 that cause vision disturbance or blurred vision, vertigo due to inner ear problems, ulcers, inflammation, or bleeding of the gums, mouth ulcers.
• Excessive nighttime urination, heavy vaginal 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.
• High 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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:http:\\www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

Do not store at a temperature above 30 °C.

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

Composition of Celecoxib Aurovitas

• The active ingredient is celecoxib.

Each hard capsule contains 200 mg of celecoxib.

• The other components (excipients) are:

Cap content: lactose monohydrate, hydroxypropylcellulose, crospovidone (type B) (E1202), sodium lauryl sulfate (E487), povidone (K-30) (E1201), stearic acid fumarate and sodium.

Body of the capsule: titanium dioxide (E171) and gelatin (E441).

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

Appearance of the product and contents of the packaging

Hard capsule.

White to off-white hard gelatin capsules, size 2, filled with a powder (white to off-white), 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.

Only some sizes of packaging may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Telephone: 91-630.86.45

Fax: 91-630.26.64

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

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 with the following names:

Spain:Celecoxib Aurovitas 200 mg hard capsules EFG

Italy:Celecoxib Aurobindo

Portugal:Celecoxib Generis Phar

Last review date of this leaflet:March 2021

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