Celebrex 200 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Celebrex 200 mg hard capsules

celecoxib

Read the 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 and should not be given to other people, even if they have the same symptoms as you, because it may 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.

Leaflet contents

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

1. What Celebrex is and what it is used for

Celebrex belongs to a class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), and more 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 higher levels of prostaglandins. Celebrex works by reducing the production of prostaglandins, thereby decreasing pain and inflammation.

Celebrex is indicated in adults for the relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

The medicine will begin to work several hours after taking the first dose, but a full effect may not be felt until several days have passed.

2. What you need to know before taking Celebrex

Your doctor has prescribed Celebrex. The following information will help you get the best results with Celebrex. If you have any further 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 to 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 drug: asthma, nasal polyps, severe nasal congestion, or allergic symptoms such as itchy 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

• 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 “mini-stroke”), angina, or blockage of blood vessels to the heart or brain

• if you have or have had circulation problems (peripheral arterial disease) or have had surgery on the arteries in your legs.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Celebrex:

• if you have previously had a stomach or intestinal ulcer or bleeding (Do not take Celebrex 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 receiving medications to reduce blood clotting (e.g., warfarin/warfarin analogues 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 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 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 Celebrex may mask fever or other signs of infection and inflammation

• if you are over 65 years old, your doctor may 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. Serious liver reactions have been reported with celecoxib, including severe hepatitis, liver damage, and liver failure (some fatal or requiring liver transplantation). Among cases where the onset was reported, most serious liver reactions occurred within the first month of treatment.

Serious skin reactions have been reported with Celebrex treatment. Stop taking Celebrex and contact your doctor immediately if you notice any of the symptoms of serious skin reactions described in section 4, Possible side effects.

Celebrex may make it more 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).

Taking Celebrex with other medicines

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 high blood pressure and heart failure)

• Fluconazole and rifampicin (used to treat infections caused by bacteria and fungi)

• Warfarin or other warfarin analogues (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 organ transplants).

Celebrex may be taken with low-dose 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Celebrex 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 Celebrex, you must stop treatment and contact your doctor for an alternative treatment.

Breastfeeding

Celebrex must not be used during breastfeeding.

Fertility

NSAIDs, including Celebrex, may impair fertility. You should inform your doctor if you plan to become pregnant or if you are experiencing difficulty becoming pregnant.

Driving and using machines

You should be aware of 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 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 certain 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 instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. If you think or believe that the effect of Celebrex is too strong or too weak, inform your doctor or pharmacist.

Your doctor will tell you the dose you should 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 you should not take Celebrex longer than necessary to control your symptoms.

Method of administration:

Celebrex should be taken orally. The capsules may 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 may sprinkle the entire contents of the capsule onto a teaspoonful of soft, semi-solid food (such as applesauce, rice, yogurt, or cold or room temperature mashed banana) 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 squeeze the top and twist to remove it, 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:

The recommended dose for the treatment of osteoarthritis 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.

The recommended dose for the treatment of rheumatoid arthritis 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.

The recommended dose for the treatment of ankylosing spondylitis 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.

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 and especially if you weigh less than 50 kg.

Do not take more than 400 mg per day.

Use in children

Celebrex is for adults only and is not indicated in children.

If you take more Celebrex than you should

Do not take more capsules than prescribed by your doctor. If you take more Celebrex than prescribed, contact your doctor, pharmacist, or hospital immediately and bring 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 missed doses.

If you stop taking Celebrex

Stopping treatment with Celebrex abruptly may cause worsening of symptoms. Do not stop taking Celebrex unless instructed by your doctor. Your doctor will advise you to gradually reduce the dose over several days before stopping treatment completely.

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 Celebrex. The adverse 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 included in these studies took Celebrex at high doses and for a prolonged period of time.

If you experience any of the following adverse effects, stop treatment with Celebrex and inform your doctor immediately:

If you have:

• an allergic reaction such as 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 blood-stained stools, or blood in vomit.
• a skin reaction such as rash, blisters or peeling of the skin.
• 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 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
• Breathing difficulty*, 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, gas
• 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 patients:

• 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
• Elevated 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, hearing difficulty*
• Constipation, burping, stomach inflammation (indigestion, stomach pain or vomiting), worsening of stomach or intestinal inflammation
• Leg cramps
• Itchy, raised rash (urticarial wheals)
• Eye inflammation
• Difficulty breathing
• Skin discolouration (bruising)
• Chest pain (generalised 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 (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, inflammation of the pancreas (may cause stomach pain), inflammation of the throat (oesophagus)
• Low levels of sodium in the blood (a condition known as hyponatraemia)
• Decrease in the number of white blood cells (which help protect the body from infections) and platelets (increased risk of bleeding and bruising)
• Difficulty with muscular coordination of movements
• Confusion, 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 the 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 bloody stools or vomit), inflammation of the intestine or colon
• Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bruising or bleeding, itching or chills
• Acute kidney failure
• Menstrual disorders
• Swelling of 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 life-threatening anaphylactic shock)
• Severe skin reactions such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (may cause rash, blistering or peeling of the skin) and generalised exanthematous pustulosis (symptoms include reddening 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 increased 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 bruising or 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)
• Inflammation of the kidneys 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: frequency cannot be estimated from available data:

• Decreased fertility in women, which is usually reversible if the medicine is discontinued
• Other serious skin conditions such as drug-induced fixed drug eruption (a characteristic allergic skin reaction that typically recurs in the same location(s) upon re-exposure to the medicine and may present as round or oval-shaped red and swollen patches of skin, blisters (urticaria), itching), and generalised bullous fixed drug eruption (may involve widespread skin reactions).

Adverse effects reported in clinical trials where Celebrex 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 patients:

• Heart problems: angina (chest pain)
• Stomach problems: irritable bowel syndrome (may include abdominal pain, diarrhoea, indigestion, 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 patients:

• Deep vein thrombosis (blood clots 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/piles, frequent bowel movements
• Fatty lumps in the skin or elsewhere, ganglion cyst (non-painful swelling in or around joints or tendons, in the hand or foot), difficulty speaking, abnormal or very heavy vaginal bleeding, chest pain
• Elevated 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 Celebrex

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

Do not use this medicine after the expiry date stated on the blister pack and on the outer packaging. 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 collection point at your pharmacy. If you are unsure, 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 Celebrex

The active substance is celecoxib.

Each capsule contains 200 mg of celecoxib.

The other components (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, propylene glycol and iron oxide (E-172).

Nature of the product and contents of the pack

Celebrex is presented in the form of capsules.

The capsules are opaque, white in colour, with two golden bands and marked with “7767” and “200”.

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

Celebrex may be available in pack sizes of 2, 5, 6, 10, 20, 30, 40, 50, 60, 100, 10x10, 10x30, 10x50, 1x50 unit doses, 1x100 unit doses, and 5 x (10x10).

Only certain 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

Further information about this medicinal product is available from 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 and in the United Kingdom (Northern Ireland) under the following names:

Date of the most recent review of this leaflet: September 2025

Other sources of information

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