CELEBREX 100 mg HARD CAPSULES

2. What you need to know before you take Celebrex

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

Do not take Celebrex

Tell your doctor if any of the following apply to you, as patients with these conditions should not take Celebrex:

• if you are allergic to celecoxib or any of the other ingredients of this medicine (listed in section 6)

• if you have 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 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 or have had circulatory 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 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 cardiac protector)
• if you are taking antiplatelet therapies
• if you are receiving medicines to reduce blood clotting (e.g. warfarin/warfarin-like anticoagulants or new oral anticoagulants, e.g. apixaban)
• if you are receiving corticosteroid medicines (e.g. prednisone)
• if you are taking Celebrex 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 are not working 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, diarrhea, or due to 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 Celebrex 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 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 where the start of the event was reported, most severe liver reactions occurred within the first month of treatment.

Celebrex 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 and breastfeeding).

Using Celebrex with other medicines

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

• Dextromethorphan (used to treat cough)
• ACE inhibitors, angiotensin II receptor antagonists, beta blockers, and diuretics (medicines used to treat high blood pressure and heart failure)
• Fluconazole and rifampicin (used to treat bacterial and fungal infections)
• Warfarin or other warfarin-like anticoagulants (blood clot formation reducers), including newer 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)
• Cyclosporin and tacrolimus (used for immune system suppression, e.g. after transplants).

Celebrex 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Celebrex should not be used by pregnant women or women who may become pregnant (i.e. women of childbearing potential who do not use adequate contraception) during treatment. If you become pregnant during treatment with Celebrex, you should stop treatment and contact your doctor for alternative treatment.

Breastfeeding

Celebrex should not be used during breastfeeding.

Fertility

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

Celebrex contains lactose

This medicine contains lactose(a type of sugar). If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Celebrex contains sodium

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

3. How to take Celebrex

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 Celebrex is too strong or too weak, tell your doctor or pharmacist.

Your doctor will tell you what dose to 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 Celebrex for longer than necessary to control the symptoms.

Method of administration:

Celebrex should be taken orally.The capsules can be taken at any time of day, with or without food. However, try to take each dose of Celebrex 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 soft food (such as apple sauce, rice, yogurt, or mashed banana at room temperature) and swallow it immediately with a glass of water (approximately 240 ml).

To open the capsule, hold it in a vertical position to keep the granules at the bottom; then squeeze the top 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:

The recommended dose for the treatment of osteoarthritisis 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 a day.

The recommended dose for the treatment of rheumatoid arthritisis 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 a day.

The recommended dose for the treatment of ankylosing spondylitisis 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 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 and especially if you weigh less than 50 kg.

Do not take more than 400 mg per day.

Use in children

Celebrex is only for adults; it is not indicated in children.

If you take more Celebrex than you should

Do not take more capsules than your doctor has told you. If you take more Celebrex than you should, contact your doctor, pharmacist, or hospital immediately and take the medicine 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 make up for forgotten doses.

If you stop taking Celebrex

Stopping Celebrex treatment abruptly may cause your symptoms to worsen. Do not stop taking Celebrex 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 other 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 all people suffer from them.

The adverse effects mentioned below were observed in patients with arthritis who took Celebrex. The adverse effects marked with an asterisk (*) occurred in patients who took Celebrex for the prevention of colon polyps and have been classified taking into account the highest frequency of occurrence. The patients includedin these studies took Celebrex at high doses and for a prolonged period.

If you experience any of the following adverse effects, discontinue treatment with Celebrex 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 stools stained with blood, 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 infections
• Difficulty 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 heartbeat
• Abnormal liver function tests
• Abnormal kidney function tests
• Anemia (changes in red blood cells that can cause fatigue and difficulty breathing)
• Anxiety, depression, fatigue, numbness, tingling
• High levels of potassium 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
• Itchy rash with relief (urticarial habon)
• Eye inflammation
• Difficulty breathing
• Discoloration of the skin (bruises)
• Chest pain (generalized pain not related to the heart)
• Facial swelling

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

• Bleeding ulcers in the stomach, throat or intestines; or intestinal rupture (can cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, pancreatic inflammation, esophageal inflammation
• Low sodium levels in the blood (a condition known as hyponatremia)
• Decreased white blood cell and platelet count (increased risk of bleeding and bruising)
• Difficulty with muscle coordination
• Confusion, altered taste
• Increased sensitivity to light
• Hair loss
• Hallucinations
• Eye bleeding
• Acute reaction that can lead to lung inflammation
• Irregular heartbeat
• Redness
• Blood clots in the lungs. 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, 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, blisters 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 allergic reaction with possible symptoms such as rash, 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 that causes 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 discolored 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 (possibly more frequent and/or severe seizures)
• Blockage of an artery or vein in the eye that leads 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
• Altered sense of taste
• Loss of taste

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

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

Adverse 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 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, gas)
• Kidney stones (which can lead to 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 clots usually in the leg, which can cause pain, swelling or redness of the calf or breathing problems)
• Stomach problems: stomach infection (which can cause 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)]
• Floaters in the eye that cause vision disturbance or blurred vision, vertigo due to problems in the inner ear, ulcers, inflammation or bleeding of the gums, 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 levels of sodium 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 Celebrex

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

Do not use this medicine after the expiration date stated on the blister pack and carton. 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. Return the packaging and any unused medicine to the pharmacy's SIGRE Point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Celebrex Composition

The active ingredient is celecoxib.

Each capsule contains 100 mg of celecoxib.

The other ingredients (excipients) are:

Lactose monohydrate, sodium lauryl sulfate, povidone, sodium croscarmellose, magnesium stearate. The capsule shell contains gelatin, titanium dioxide (E-171), sodium lauryl sulfate and sorbitan monolaurate. The printing ink contains shellac lacquer, propylene glycol and indigo carmine (E-132).

Product Appearance and Package Contents

Celebrex is presented in the form of capsules.

The capsules are opaque, white, with two blue bands and bear the markings "7767" and "100".

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

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 Madrid

Spain

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

Date of last revision of this leaflet: April 2021

Other sources of information

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