Package Insert: Information for the User

Celebrex 200 mg Hard Capsules

celecoxib

Read this package insert carefully before you start taking this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this package insert. See section 4.

Celebrex belongs to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs), and specifically to the subgroup known as selective cyclooxygenase-2 (COX-2) inhibitors. The body produces prostaglandins that can cause pain and inflammation. In conditions such as rheumatoid arthritis or osteoarthritis, the body produces them in greater quantities. Celebrex acts by reducing the production of prostaglandins, thereby reducing pain and inflammation.

Celebrex is indicated in adults for alleviating the symptoms and signs ofrheumatoid arthritis, osteoarthritis, andankylosing spondylitis.

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.

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

Do not take Celebrex

Inform your doctor if any of the following circumstances affect you, as patients with these conditions should not take Celebrex:

• if you are allergic to celecoxib or any of the other components of this medication (including those listed in section 6)

• if you have had any allergic reaction to any medication 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 as a result of taking acetylsalicylic acid or any other anti-inflammatory medication: asthma, nasal polyps, severe nasal congestion, or allergic symptoms such as skin rash with itching, 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 reduction in blood flow to the brain; also known as “mini-stroke”), angina, or obstruction of the heart or brain blood vessels
• if you have or have had circulatory problems (peripheral arterial disease) or if you have been operated on to clear the arteries in your legs

Warnings and precautions

Consult your doctor or pharmacist before starting to take Celebrex:

• if you have previously had a stomach or intestinal ulcer or bleeding (Do not take Celebrexif you currently have a stomach or intestinal ulcer or bleeding)
• 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/anticoagulant analogs or new oral anticoagulants, e.g. apixaban)
• if you are receiving corticosteroids (e.g. prednisone)
• if you are taking Celebrex at the same time as other non-acetylsalicylic acid anti-inflammatory medications 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 Celebrex 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

Like other anti-inflammatory medications (e.g. ibuprofen or diclofenac), this medication can increase your blood pressure, so your doctor will be able to monitor it regularly.

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).Most of the severe liver reactions occurred in the first month of treatment.

Celebrex 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 and breastfeeding).

Use of Celebrex with other medications

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 warfarin analogs (agents that reduce blood clotting), including newer 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)

Celebrex can be taken with low doses of acetylsalicylic acid (75 mg daily or less). Please 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

Celebrex 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 Celebrex, you should discontinue treatment and contact your doctor for alternative treatment.

Breastfeeding

Celebrex should not be used during breastfeeding.

Fertility

NSAIDs, including Celebrex, 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 Celebrex before driving or operating machinery. If you feel dizzy or drowsy after taking Celebrex, do not drive or operate machinery until these effects pass.

Celebrex contains lactose

This medication containslactose(a type of sugar). If your doctor has told you that you have a intolerance to certain sugars, consult with him before taking this medication.

Celebrex contains sodium

This medication contains less than 23 mg ofsodium(1 mmol) per capsule; that is, it 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 Celebrex is too strong or weak, inform your doctor or pharmacist.

Your doctor will indicate the 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 Celebrex for longer than necessary to control your symptoms.

Administration form:

Celebrex must be administered orally.The capsules are taken at any time of the day, with or without food. However, try to take each dose of Celebrex 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, rice, yogurt, or mashed banana at room temperature) and swallow it immediately with a glass of approximately 240 ml of water.

To open the capsule, hold it in a vertical position to keep the granules at the bottom; then, press the top 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 since the start of treatment, you do not experience an improvement.

Recommended dose:

The recommended dosefor the treatment of arthritisis 200mg per day, if necessary, your doctor may increase it up to a maximum of 400mg.

The usual dose is:

• one 200mg capsule once a day.

The recommended dosefor the treatment of rheumatoid arthritisis 200mg per day, if necessary, your doctor may increase it up to a maximum of 400mg.

The usual dose is:

• two 100mg capsules per day.

The recommended dosefor the treatment of ankylosing spondylitisis 200mg per day, if necessary, your doctor may increase it up to a maximum of 400mg.

The usual dose is:

• one 200mg capsule per day.

Problems in the kidney or liver:make sure your doctor knows if you have problems in the liver or kidney since you may need a lower dose.

Patients over 65 years, especially those weighing less than 50kg:your doctor may want to monitor you more closely if you are over 65years old and especially if you weigh less than50kg.

You should not take more than 400mg per day.

Use in children:

Celebrex is only for adults, it is not indicated for children.

If you take more Celebrex than you should:

You should not take more capsules than indicated by your doctor. If you take more Celebrex than you have been told, consult your doctor, pharmacist, or hospital immediately and bring the medication with you.

If you forget to take Celebrex:

If you forget 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 the treatment with Celebrex:

Stopping the treatment with Celebrex abruptly may cause a worsening of symptoms. Do not stop taking Celebrex 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 Celebrex. The side effects marked with an asterisk (*) occurred in patients taking Celebrex for the prevention of colon polyps and have been classified according to the highest frequency of occurrence. The patients includedin these studies took Celebrex at high doses and for a prolonged period of time.

If you experience any of the following side effects, discontinue treatment with Celebrex 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 [the symptoms may include nausea (feeling of discomfort), diarrhea, jaundice (your skin or the white of your eyes appears 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 infections
• 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 (rapid heart rate)
• Abnormalities in liver function tests
• Abnormalities in kidney function 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 (feeling of discomfort), fatigue, muscle weakness or palpitations]
• Blurred or altered vision, tinnitus (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
• Hives with itching and raised (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, intestinal inflammation, pancreatitis (may cause stomach pain), esophageal inflammation
• Low sodium levels in blood (a condition known as hyponatremia)
• Decreased white blood cell count (which helps protect the body from infections) and platelet count (increases the risk of bleeding and cardenales)
• Difficulty in muscle coordination of movements
• Confusion, altered sense of taste
• Increased sensitivity to light
• Hair loss
• Hallucinations
• Eye hemorrhage
• Acute reaction that may lead to pulmonary inflammation
• Irregular heart rhythm
• Rubefaction
• Thrombi in the pulmonary blood vessels. Symptoms may include sudden difficulty breathing, acute chest pain or collapse
• Stomach or intestinal hemorrhage (may cause stools or vomit with blood), intestinal or colon inflammation
• Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling of discomfort), diarrhea, jaundice (yellow discoloration of the skin and eyes), dark urine, pale stools, easy bleeding, itching or chills
• Acute kidney failure
• Menstrual disorders
• Swelling in the face, lips, mouth, tongue or throat, or difficulty swallowing

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

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

The side effects reported in clinical trials in which Celebrex was administered at doses of 400mg 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:

• Cardiac problems: angina pectoris (chest pain)
• Gastrointestinal problems: irritable bowel syndrome (may include abdominal pain, diarrhea, indigestion, gas)
• Kidney stones (which 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 clots generally in the leg, which may cause pain, swelling or redness of the calf or difficulty breathing)
• Gastrointestinal problems: stomach infection (which may cause stomach irritation or ulcers in the stomach and intestines)
• Fracture of lower limbs
• Herpes, skin infection, eczema (dry, itchy rash), pneumonia [chest 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 menstrual bleeding or hemorrhoids, 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 experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through theSpanish 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 onthe blister pack and on the packaging.The expiration date is the last day of the month indicated.

Do not store at a temperature above30 °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.

Celebrex Composition

The active ingredient is celecoxib.

Each capsule contains 200 mg of celecoxib.

The other components (excipients) are:

Lactose monohydrate, sodium lauryl sulfate, povidone, croscarmellose sodium, magnesium stearate. The capsule coating contains gelatin, titanium dioxide (E-171), sodium lauryl sulfate, and monolaurate of sorbitan. The printing ink contains shellac lacquer, propylene glycol, and iron oxide (E-172).

Appearance of the product and packaging contents

Celebrex is presented in the form of capsules.

The capsules are opaque, white, with two golden bands, and bear the marks “7767”and “200”.

The capsules are presented in a transparent or opaque PVC/aluminum blister.

Celebrex may be presented in packaging sizes of 2, 5, 6, 10, 20, 30, 40, 50, 60, 100, 10x10, 10x30, 10x50, 1x50 single-dose, 1x100 single-dose, and 5 x (10x10).

Only some packaging sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer

Klocke Verpackungs-Service GmbH

Max-Becker-Str. 6

76356 Weingarten (Baden)

Germany

or

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg Im Breisgau

Germany

or

Mylan Hungary Kft.

Mylan utca 1

Komárom, 2900

Hungary

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Last review date of this leaflet:April 2021

Other sources of information

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