Celecoxib Aurovitas 200 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Celecoxib Aurovitas 200 mg hard capsules EFG

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

• Keep this leaflet as 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, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Celecoxib Aurovitas is indicated in adults for the relief of 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 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 Aurovitas 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 Aurovitas

Do not take Celecoxib Aurovitas

• if you are allergic to celecoxib or to any of the other ingredients 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 are 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 drug: 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,
• 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 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 have undergone surgery on the arteries in your legs.

Warnings and precautions

Talk to 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 such as for heart protection),
• if you are taking antiplatelet therapies,
• if you are taking medicines to reduce blood clotting (e.g., warfarin, anticoagulants such as warfarin or new oral anticoagulants, e.g., apixaban),
• 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 combined 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, 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 of age, your doctor will 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 monitor it periodically.

There have been reports of serious liver reactions with celecoxib, including severe liver inflammation, liver damage, and liver failure (some fatal or requiring liver transplantation). In cases where the onset of the event was reported, most serious 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 taking, have recently taken, or might need to take any other medicines:

• Dextromethorphan (used to treat cough).
• ACE inhibitors, angiotensin II receptor antagonists, beta-blockers, and diuretics (medicines used to treat hypertension and heart failure).
• Fluconazole and rifampicin (used to treat infections caused by bacteria and fungi).
• Warfarin or other oral anticoagulants (agents that reduce blood clot formation), including newer medicines 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 can 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 Aurovitas 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 to discuss alternative treatment.

Breastfeeding

Celecoxib Aurovitas must not be used during breastfeeding.

Fertility

NSAIDs, including celecoxib, may make it more difficult to become pregnant. You should inform your doctor if you intend to become pregnant or if you are experiencing difficulties in becoming pregnant.

Driving and using machines

You should be aware of 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 have passed.

Celecoxib Aurovitas contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him or her before taking this medicine.

Celecoxib Aurovitas contains sodium

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

3. How to take Celecoxib Aurovitas

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. If you think or believe that the effect of celecoxib is too strong or too weak, inform your doctor or pharmacist.

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

Celecoxib Aurovitas is not suitable for doses below 200 mg/day. Other celecoxib medicines with appropriate dosing 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 may sprinkle the entire contents of the capsule onto a level teaspoon of 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 vertically to keep the granules at the bottom, then press the top cap 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 after two weeks of starting treatment.

Recommended dose:

For the treatment of osteoarthritis:

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

The dose is usually:

• one 200 mg capsule once daily, or
• one 100 mg capsule twice daily.

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 dose is usually:

• one 100 mg capsule twice daily (if this is the dose recommended by your doctor, this dose cannot be administered with this medicine; other celecoxib medicines are available that allow achieving 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 up to a maximum of 400 mg.

The dose is usually:

• one 200 mg capsule once daily, or
• one 100 mg capsule twice daily.

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

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

Maximum dose is 400 mg per day.

Use in children: Celecoxib Aurovitas is for adults only and is not indicated for use in children.

If you take more Celecoxib Aurovitas than you should

Do not take more capsules than prescribed by your doctor. If you take more Celecoxib Aurovitas than prescribed, contact your doctor, pharmacist, or hospital immediately and bring the medicine with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 missed doses.

If you stop taking Celecoxib Aurovitas

Abruptly stopping treatment with celecoxib may cause worsening of symptoms.

Do not stop taking celecoxib unless instructed by your doctor. Your doctor will advise you to gradually reduce the dose over several days before completely stopping treatment.

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 will experience 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 celecoxib for the prevention of colon polyps and have been classified according to 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 adverse effects, stop 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 blood-stained stools, or blood in vomit.
• a skin reaction such as rash, blisters or skin peeling.
• liver failure (symptoms may include nausea (feeling unwell), diarrhoea, jaundice (your skin or the whites of your eyes appear yellow)).

Very common adverse effects: may affect more than 1 in 10 people

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

Common adverse effects: 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, diarrhoea, indigestion, flatulence.
• Rash, itching.
• Muscle stiffness.
• Difficulty swallowing*.
• Headache.
• Nausea (feeling unwell).
• Joint pain, worsening of existing allergies.
• Accidental injury.

Uncommon adverse effects: may affect up to 1 in 100 people

• Stroke*.
• Heart failure, palpitations (awareness of heartbeat), rapid heartbeat.
• Abnormal blood test results related to the liver.
• Abnormal blood test results related to the kidney.
• Anaemia (changes in red blood cells which may cause fatigue and difficulty breathing).
• 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, difficulty hearing*.
• Constipation, belching, stomach inflammation (indigestion, stomach pain or vomiting), worsening of stomach or intestinal inflammation.
• Leg cramps.
• Itchy, raised rash (urticarial weals).
• Eye inflammation.
• Difficulty breathing.
• Skin discolouration (bruising).
• Chest pain (generalised pain not related to the heart).
• Facial swelling.

Rare adverse effects: may affect up to 1 in 1,000 people

• Ulcers (bleeding) in the stomach, throat or intestines; or intestinal perforation (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), black or tarry stools, pancreatitis (may cause stomach pain), inflammation of the throat (oesophagus).
• Low levels of sodium in blood test results (a condition known as hyponatraemia).
• Decrease in the number of white blood cells (which help protect the body from infections) or platelets (increased risk of bleeding and bruising).
• Difficulty in 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 intestines (may result in blood in stools or vomit), intestinal or colon inflammation.
• Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling unwell), diarrhoea, 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, wheezing or difficulty swallowing.

Very rare adverse effects: 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 skin peeling), and acute generalised 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 increase in 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), diarrhoea, 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).
• Kidney inflammation and other kidney problems (such as nephrotic syndrome and minimal change disease which may be accompanied by symptoms such as fluid retention (oedema), 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.
• Inflammation of blood vessels (may cause fever, aches, purple spots on the skin).
• 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.
• Loss of taste.

Adverse effects with unknown frequency: cannot be estimated from the available data

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

Adverse effects reported in clinical trials where Celecoxib Aurovitas was administered at a dose of 400 mg daily for up to 3 years in patients with conditions unrelated to arthritis or other arthritic conditions were:

Common adverse effects: may affect up to 1 in 10 people

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

Uncommon adverse effects: may affect up to 1 in 100 people

• Deep vein thrombosis (blood clotting usually in the leg, which may cause pain, swelling or redness in the calf or breathing problems).
• Stomach problems: stomach infection (may cause irritation or ulcers in the stomach and intestine).
• Fracture of lower limbs.
• Herpes, skin infection, eczema (dry, itchy rash), pneumonia (infection in the chest (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, bleeding from haemorrhoids, frequent bowel movements.
• Fatty lumps in the skin or other sites, ganglion cyst (non-painful swelling in or around joints or tendons, usually 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: http://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Celecoxib Aurovitas

• The active substance is celecoxib.

Each hard capsule contains 200 mg of celecoxib.

• The other components (excipients) are:

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

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

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

Nature of the product and contents of the pack

Hard capsule.

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

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

Only certain 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

Telephone: 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 medicinal product 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 most recent review of this leaflet: March 2021

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