Celebrex

Leaflet attached to the packaging: patient information

CELEBREX, 100 mg, capsules

CELEBREX, 200 mg, capsules

Celecoxib

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Celebrex and what is it used for
• 2. Important information 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 is Celebrex and what is it used for

Celebrex belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) and is a specific inhibitor of cyclooxygenase-2 (COX-2). The human body produces prostaglandins, which can cause pain and inflammation. In diseases such as rheumatoid arthritis and osteoarthritis, the amount of prostaglandins produced increases. Celebrex works by inhibiting the production of prostaglandins, thereby reducing pain and inflammation. Celebrex is used in adults to treat symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. The patient should feel the effect of the medicine within a few hours of taking the first dose, but the full effect may only be felt after a few days.

2. Important information before taking Celebrex

Celebrex is prescribed by a doctor. The following information will help you use Celebrex properly and effectively. If you have any further questions, you should ask your doctor or pharmacist.

When not to take Celebrex

You should inform your doctor if you have any of the following conditions that are contraindications to taking Celebrex.

• if you are allergic to celecoxib or any of the other ingredients of this medicine (listed in section 6);
• if you have been diagnosed with hypersensitivity to sulfonamide drugs (e.g. certain antibiotics used to treat infections);
• if you have active stomach or duodenal ulcer, or stomach or duodenal bleeding;
• if you have had asthma, nasal polyps, nasal congestion, or allergic reactions (such as itchy rash, facial swelling, lip swelling, tongue swelling, or throat swelling, difficulty breathing, or wheezing) after taking acetylsalicylic acid or other anti-inflammatory and pain-relieving medicines (NSAIDs);
• if you are pregnant. Women who may become pregnant during treatment with Celebrex should discuss effective contraception with their 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, ischemic heart disease, or cerebrovascular disease, e.g. patients who have been diagnosed with myocardial infarction, stroke, or transient ischemic attack (temporary reduction in blood flow to the brain, so-called mini-stroke), angina pectoris, or coronary artery occlusion;
• if you have had circulatory problems (peripheral arterial disease) or have undergone surgery on the arteries of the legs.

Warnings and precautions

Before starting treatment with Celebrex, you should discuss the following with your doctor or pharmacist:

• if you have had stomach or intestinal ulcers or bleeding in the past (do not take Celebrex if you have active stomach or duodenal ulcers or bleeding);
• if you are taking acetylsalicylic acid (even in small doses for heart protection);
• if you are taking antiplatelet agents;
• if you are taking anticoagulant medicines (e.g. warfarin/anticoagulant derivatives or new-generation anticoagulants, e.g. apixaban);
• if you are taking corticosteroids (e.g. prednisone);
• if you plan to take other NSAIDs with Celebrex, such as ibuprofen or diclofenac (other than acetylsalicylic acid). You should avoid taking these medicines at the same time;
• if you smoke, have diabetes, high blood pressure, or high cholesterol levels;
• if you have heart, liver, or kidney problems, your doctor may recommend regular check-ups;
• if you have fluid retention (e.g. swelling of the ankles or feet);
• if you are dehydrated due to illness, diarrhea, or taking diuretic medicines (used to treat excess fluid in the body);
• if you have had a severe allergic reaction or severe skin reaction to any medicine;
• if you have an infection or suspect you have an infection, as Celebrex may mask fever or other signs of infection or inflammation;
• if you are over 65 years old, your doctor may recommend regular check-ups;
• if you consume alcohol or take NSAIDs, this may increase the risk of gastrointestinal disorders.

Like other NSAIDs (e.g. ibuprofen or diclofenac), this medicine may increase blood pressure, so your doctor may recommend regular blood pressure checks. During treatment with Celebrex, cases of severe liver disease, including severe hepatitis, liver damage, and liver failure (sometimes fatal or requiring liver transplantation), have been reported. In cases where the period preceding the onset of the disease was known, most severe liver-related adverse events occurred within a month of starting treatment. Celebrex may cause difficulties in getting pregnant. Women who are trying to get pregnant or are having trouble getting pregnant should tell their doctor (see section Pregnancy, breastfeeding, and fertility).

Celebrex and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Your doctor will use Celebrex with caution in patients taking the following medicines:

• dextromethorphan (used to treat cough)
• ACE inhibitors (angiotensin-converting enzyme inhibitors), angiotensin II receptor antagonists, beta-blockers, and diuretics (used to treat high blood pressure and heart failure)
• fluconazole and rifampicin (used to treat fungal and bacterial infections)
• warfarin or other warfarin derivatives (blood-thinning medicines used to prevent blood clotting), including new-generation anticoagulants such as apixaban
• lithium (used to treat certain types of depression)
• other medicines used to treat depression, insomnia, high blood pressure, or heart rhythm disorders
• antipsychotics (used to treat mental disorders)
• methotrexate (used to treat 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 to weaken the immune system, e.g. after transplants).

Celebrex may be taken with low doses of acetylsalicylic acid (75 mg or less per day). You should ask your doctor before taking both medicines at the same time.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine. Pregnancy Do not take Celebrex if you are pregnant or may become pregnant (e.g. women of childbearing age who do not use effective contraception). If you become pregnant during treatment with Celebrex, you should stop taking Celebrex and contact your doctor to determine an alternative treatment method. Breastfeeding Do not take Celebrex if you are breastfeeding. Fertility NSAIDs, including Celebrex, may make it more difficult to get pregnant. Women who are trying to get pregnant or are having trouble getting pregnant should tell their doctor.

Driving and using machines

Before driving or operating machinery, you should observe how Celebrex affects you. If you experience dizziness or drowsiness after taking Celebrex, you should not drive or operate any machinery until these symptoms have resolved.

Celebrex contains lactose

Celebrex contains lactose (a type of sugar). If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking Celebrex.

Celebrex contains sodium

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

3. How to take Celebrex

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist. If you feel that the effect of Celebrex is too strong or too weak, you should ask your doctor or pharmacist. Your doctor will tell you what dose of Celebrex to take. Since the risk of cardiovascular side effects may increase with dose and duration of treatment, it is important to use the lowest effective dose for the shortest duration necessary to control symptoms. Method of administration Celebrex should be taken orally. The capsules can be taken at any time of day, with or without food. However, it is recommended that you take Celebrex at the same time every day. If you have difficulty swallowing the capsules: You should pour the entire contents of the capsule onto a spoon containing a semi-solid food (e.g. cold or room-temperature applesauce, rice cereal, yogurt, or mashed banana) and swallow immediately, followed by a glass of water (about 240 ml). To open the capsule, you should hold it upright so that the granule contents are at the bottom. Then, you should gently squeeze the cap and twist it to remove it carefully, without spilling the contents. The granules should not be chewed or crushed. If you do not notice any benefits from taking Celebrex within two weeks of starting treatment, you should contact your doctor.

• Recommended dose for osteoarthritis: The recommended dose is 200 mg per day. Your doctor may increase the dose of Celebrex to a maximum of 400 mg if necessary. The recommended dose is:
• 200 mg once daily, or
• 100 mg twice daily.

Recommended dose for rheumatoid arthritis: The recommended dose is 200 mg per day. Your doctor may increase the dose of Celebrex to a maximum of 400 mg if necessary. The recommended dose is:

• 100 mg twice daily.

Recommended dose for ankylosing spondylitis: The recommended dose is 200 mg per day. Your doctor may increase the dose of Celebrex to a maximum of 400 mg if necessary. The recommended dose is:

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

Impaired renal or hepatic function: If you have impaired liver or kidney function, you should tell your doctor, as a lower dose of Celebrex may be necessary. Elderly patients, particularly those with a body weight of less than 50 kg: In patients over 65 years of age and with a body weight of less than 50 kg, your doctor may recommend more frequent monitoring of your condition. Do not take more than 400 mg per day.

Use in children

Celebrex should only be used in adults. It should not be used in children.

Overdose

Do not take more than the recommended dose of Celebrex. If you have taken too many Celebrex capsules, you should contact your doctor, pharmacist, or go to the hospital immediately. Remember to take the medicine with you.

Missed dose

If you forget to take a Celebrex capsule, you should take the missed capsule as soon as possible. Do not take a double dose to make up for the missed dose.

Stopping treatment

Suddenly stopping treatment with Celebrex may worsen existing symptoms. Do not stop taking Celebrex unless your doctor tells you to. Your doctor may recommend stopping treatment with Celebrex gradually by reducing the dose over a few days. If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Celebrex can cause side effects, although not everybody gets them.

The following side effects have been reported in patients with arthritis taking Celebrex. The side effects marked with (*) were more frequently reported in patients taking Celebrex for the prevention of colon polyps. In this study, patients took the medicine at a high dose and for a long period.

If you experience any of the following symptoms, you should stop taking Celebrex and contact your doctor immediately:

• allergic reaction, such as: rash, facial swelling, wheezing, or difficulty breathing,
• heart problems, such as: chest pain,
• severe stomach pain or signs of stomach or intestinal bleeding, such as: black or blood-stained stools, or vomiting blood,
• skin reactions, such as: rash, blisters, or peeling skin,
• liver failure (symptoms may include: nausea, diarrhea, jaundice (yellowing of the skin or whites of the eyes)).

Very common(may affect more than 1 in 10 people)

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

Common(may affect up to 1 in 10 people)

• heart attack*
• fluid retention with swelling of the ankles, feet, and/or hands
• urinary tract infections
• respiratory tract infections, sinusitis (sinus infection), stuffy nose or runny nose, sore throat, cough, common cold, flu-like symptoms
• dizziness, difficulty sleeping
• nausea, vomiting, abdominal pain, diarrhea, indigestion, bloating
• rash, itching
• muscle stiffness
• difficulty swallowing*
• headache
• nausea
• joint pain
• worsening of existing allergic symptoms
• accidental injuries

Uncommon(may affect up to 1 in 100 people)

• stroke*
• heart failure, palpitations (feeling of heartbeat), rapid heartbeat
• abnormal liver function test results
• abnormal kidney function test results
• anemia (changes in red blood cell count, which can cause fatigue and shortness of breath)
• anxiety, depression, fatigue, drowsiness, tingling sensation
• high potassium levels in the blood (which can cause nausea, fatigue, weakness, or palpitations)
• vision disturbances or blurred vision, ringing in the ears, mouth ulcers, hearing disturbances*
• constipation, flatulence, stomach inflammation (indigestion, abdominal pain, or vomiting), worsening of stomach or intestinal inflammation
• leg cramps
• hives (itchy rash)
• conjunctivitis
• breathing difficulties
• skin discoloration (bruising)
• chest pain (general chest pain not related to the heart)
• facial swelling

Rare(may affect up to 1 in 1,000 people)

• stomach or intestinal ulcers (bleeding) or perforation of the intestines (which can cause stomach pain, fever, nausea, vomiting, intestinal obstruction), black or tarry stools, pancreatitis (which can cause stomach pain)
• low sodium levels in the blood (a condition called hyponatremia)
• reduced white blood cell or platelet count (which can cause weakness, easy bruising, frequent nosebleeds, or increased risk of infection)
• coordination disturbances
• disorientation, taste disturbances
• photosensitivity
• hair loss
• hallucinations
• eye bleeding
• severe reaction that can lead to pneumonia
• irregular heartbeat
• hot flashes
• blood clots in the lungs. Symptoms may include sudden shortness of breath, sharp pain when breathing, or collapse
• stomach or intestinal bleeding (which can lead to black or bloody stools or vomiting blood), intestinal inflammation
• severe liver disease. Symptoms may include nausea, diarrhea, jaundice (yellowing of the skin or whites of the eyes), dark urine, pale stools, bleeding, itching, or chills
• severe kidney failure
• menstrual disorders
• facial swelling, lip swelling, mouth swelling, tongue swelling, or throat swelling, or difficulty swallowing

Very rare(may affect up to 1 in 10,000 people)

• severe allergic reactions (including anaphylactic shock, which can be fatal)
• severe skin diseases, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme (which can cause rash, blisters, or peeling skin) and acute generalized exanthematous pustulosis (symptoms include red, swollen areas of skin with many small pus-filled bumps)
• delayed allergic reaction with possible symptoms such as rash, facial swelling, fever, swollen lymph nodes, and abnormal test results (e.g. liver, blood (eosinophilia, increased white blood cell count))
• intracranial bleeding that can be fatal
• meningitis (inflammation of the membranes surrounding the brain and spinal cord)
• hepatitis, liver damage, and severe hepatitis (sometimes fatal or requiring liver transplantation). Symptoms may include nausea, diarrhea, jaundice (yellowing of the skin or whites of the eyes), dark urine, pale stools, bleeding, itching, or chills
• liver disease (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as black stools, nausea, and yellowing of the skin or whites of the eyes)
• kidney disease (such as nephrotic syndrome and nephrotic lipidosis, which may be accompanied by symptoms such as fluid retention, foamy urine, fatigue, and loss of appetite)
• worsening of epilepsy (more frequent and/or severe seizures)
• closure of the retinal vein or artery, leading to partial or complete loss of vision
• vasculitis (which can cause fever, pain, purple spots on the skin)
• reduced red and white blood cell and platelet count (which can cause weakness, easy bruising, frequent nosebleeds, or increased risk of infection)
• muscle pain and weakness
• smell disturbances
• taste disturbances

Frequency not known(cannot be estimated from the available data)

• reduced fertility in women, which is usually reversible after stopping treatment

In clinical trials not related to arthritis or other joint diseases, in which Celebrex was taken at a dose of 400 mg per day for up to 3 years, the following additional side effects were observed:

Common(may affect up to 1 in 10 people)

• heart disease: angina pectoris (chest pain)
• stomach problems: irritable bowel syndrome (which may include abdominal pain, diarrhea, indigestion, bloating)
• kidney stones (which can cause abdominal or back pain, blood in the urine), difficulty urinating
• weight gain

Uncommon(may affect up to 1 in 100 people)

• deep vein thrombosis (blood clots that occur most commonly in the legs, which can cause pain, swelling, or redness of the calf, or breathing problems)
• stomach problems: inflammation (which can cause stomach upset and ulcers)
• fracture of the lower limb
• shingles, skin inflammation, eczema (dry, itchy rash), pneumonia (chest infection, which may include cough, fever, difficulty breathing)
• eye clouding, causing blurred vision or vision loss, dizziness caused by middle ear disorders, mouth ulcers, gum inflammation or bleeding
• nocturnal urination, hemorrhoid bleeding (bleeding piles), frequent bowel movements
• fat deposits in the skin or other areas, ganglion cysts (harmless lumps on the joints or tendons of the hands or feet), difficulty speaking, changed or very heavy menstrual bleeding, breast pain
• high sodium levels in the blood

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder or its representative. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Celebrex

Medicines should be kept out of the sight and reach of children. Do not take this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of that month. There are no special precautions for storage. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Celebrex contains

• The active substance of Celebrex is celecoxib. Each Celebrex capsule contains 100 mg or 200 mg of celecoxib.
• The other ingredients are: lactose monohydrate, sodium lauryl sulfate, povidone K30, croscarmellose sodium, magnesium stearate. Capsule: titanium dioxide (E171), gelatin. Ink: shellac, anhydrous ethanol, isopropyl alcohol, butyl alcohol, propylene glycol, concentrated ammonia solution, indigo carmine lake (E132) (100 mg capsule), yellow iron oxide (E172) (200 mg capsule).

What Celebrex looks like and contents of the pack

Celebrex is available as capsules. Celebrex 100 mg The capsules are white with two blue stripes marked "7767" and "100". Celebrex 200 mg The capsules are white with two gold stripes marked "7767" and "200". Celebrex is packaged in blisters containing 10 or 30 capsules in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands

Manufacturer

Pfizer Manufacturing Deutschland GmbH, Betriebsstätte Freiburg Mooswaldallee 1, 79090 Freiburg, Germany, Klocke Verpackungs-Service GmbH, Max-Becker-Str. 6, 76356 Weingarten (Baden), Germany, Mylan Hungary Kft., Mylan utca 1, Komárom, 2900, Hungary

To obtain more detailed information on this medicine, you should contact your local representative of the marketing authorization holder:

Mylan Healthcare Sp. z o.o.

tel. 22 546 64 00 Date of last revision of the leaflet:12/2023

Other sources of information

Detailed information on this medicine is available on the website http://www.urpl.gov.pl