Celebrex

Package Leaflet: Information for the Patient

CELEBREX, 100 mg, capsules

CELEBREX, 200 mg, capsules

Celecoxib

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, 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, thus 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 correctly and effectively. If you have any further questions, ask your doctor or pharmacist.

When not to take Celebrex

Tell 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 sinusitis, or allergic reactions (such as itching rash, facial swelling, lip swelling, tongue swelling, or throat swelling, difficulty breathing, or wheezing) after taking acetylsalicylic acid or other anti-inflammatory and analgesic drugs (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, ischaemic heart disease, or cerebrovascular disease, e.g. patients who have been diagnosed with myocardial infarction, stroke, or transient ischaemic attack (temporary reduction in blood flow to the brain, so-called mini-stroke), angina pectoris, or cardiac vessel occlusion;
• if you have had circulatory disorders (peripheral vascular disease) or have undergone vascular surgery on the legs.

Warnings and precautions

Before starting treatment with Celebrex, 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 stomach or duodenal 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 medications (e.g. warfarin/anticoagulant derivatives or new-generation anticoagulants, such as apixaban);
• if you are taking corticosteroid medications (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 medications 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, diarrhoea, or diuretic use (used to treat excess fluid in the body);
• if you have had a severe allergic reaction or severe skin reaction to any medication;
• 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), Celebrex may increase blood pressure, so your doctor may recommend regular blood pressure checks. During treatment with Celebrex, serious liver disease has been reported, including severe liver inflammation, liver damage, and liver failure (sometimes fatal or requiring liver transplantation). In cases where the period preceding the onset of the disease was known, most serious liver adverse events occurred within one month of starting treatment. Celebrex may affect fertility. Women should inform their doctor if they plan to become pregnant or are having trouble becoming pregnant (see section Pregnancy and breastfeeding).

Celebrex and other medicines

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 medications used to prevent blood clotting), including new-generation medications such as apixaban
• lithium (used to treat certain types of depression)
• other medications used to treat depression, sleep disorders, 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 can be taken with low doses of acetylsalicylic acid (75 mg or less per day). Ask your doctor before taking both medications at the same time.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, 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, stop taking Celebrex and contact your doctor to determine an alternative treatment. Breastfeeding Do not take Celebrex while breastfeeding. Fertility NSAIDs, including Celebrex, may make it more difficult to become pregnant. Women should tell their doctor if they plan to become pregnant or are having trouble becoming pregnant.

Driving and using machines

Before driving or operating machinery, observe how Celebrex affects you. If you experience dizziness or drowsiness after taking Celebrex, do 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, contact your doctor before taking Celebrex.

Celebrex contains sodium

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

3. How to take Celebrex

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. If you feel that the effect of Celebrex is too strong or too weak, ask your doctor or pharmacist. Your doctor will tell you what dose to take. Because the risk of heart-related 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. Administration Celebrex should be taken orally. 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 capsules: 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, hold it upright so that the granule contents are at the bottom. Then, gently squeeze the cap and twist it to remove it carefully, without spilling the contents. Do not chew or crush the granules. If you do not notice any benefit from taking Celebrex within two weeks of starting treatment, contact your doctor. Recommended dose Osteoarthritis: The recommended dose is 200 mg per day. Your doctor may increase the dose to a maximum of 400 mg if necessary. The recommended dose is: 200 mg once daily, or 100 mg twice daily. Rheumatoid arthritis: The recommended dose is 200 mg per day. Your doctor may increase the dose to a maximum of 400 mg if necessary. The recommended dose is: 100 mg twice daily. Ankylosing spondylitis: The recommended dose is 200 mg per day. Your doctor may increase the dose to a maximum of 400 mg if necessary. The recommended dose is: 200 mg once daily, or 100 mg twice daily. Renal and hepatic impairment: If you have liver or kidney problems, tell your doctor, as a lower dose of Celebrex may be necessary. Elderly patients, especially those with a body weight below 50 kg: In patients over 65 years old and with a body weight below 50 kg, your doctor may recommend closer monitoring. Do not exceed a dose of 400 mg per day.

Use in children

Celebrex should only be used in adults. Do not give it to children.

Overdose of Celebrex

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

Missed dose of Celebrex

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

Stopping treatment with Celebrex

Suddenly stopping treatment with Celebrex may worsen existing symptoms. Do not stop taking Celebrex unless your doctor tells you to. Your doctor may recommend gradually stopping treatment with Celebrex by reducing the dose over several days. If you have any further questions about taking this medicine, 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 a study where patients took 400 mg of Celebrex per day for up to 3 years, the following additional side effects were observed:

If you experience any of the following symptoms, 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,
• stomach problems, such as severe abdominal pain or signs of stomach or intestinal bleeding, such as black or bloody stools, or vomiting blood,
• skin reactions, such as rash, blisters, or peeling skin,
• liver failure (symptoms may include nausea, diarrhoea, 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, cold, flu-like symptoms
• dizziness, difficulty sleeping
• nausea, vomiting, abdominal pain, diarrhoea, indigestion, flatulence
• 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 heart pounding), rapid heart rate
• abnormal liver function test results
• abnormal kidney function test results
• anaemia (changes in red blood cell count, which can cause fatigue and shortness of breath)
• restlessness, 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, bloating, 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 or bleeding, or perforation of the stomach or intestines (which can cause stomach pain, fever, nausea, vomiting, bowel obstruction)
• low sodium levels in the blood (a condition called hyponatremia)
• decreased white blood cell count or platelet count (which can cause weakness, easy bruising, frequent nosebleeds, or increased risk of infection)
• coordination disturbances
• disorientation, taste disturbances
• increased sensitivity to light
• hair loss
• hallucinations
• eye bleeding
• severe reaction that can lead to pneumonia
• irregular heartbeat
• hot flashes

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 acute generalized exanthematous pustulosis (which can cause rash, blisters, or peeling skin) and acute generalized exanthematous pustulosis (symptoms include red, swollen areas of skin with numerous small blisters)
• 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 leading to death
• meningitis (inflammation of the membranes surrounding the brain and spinal cord)
• liver inflammation, liver damage, and severe liver inflammation (fulminant hepatitis) (sometimes fatal or requiring liver transplantation). Symptoms may include nausea, diarrhoea, jaundice (yellowing of the skin and 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 dark 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
• inflammation of blood vessels (which can cause fever, pain, purple spots on the skin)
• decreased red, white blood cell, and platelet count (which can cause weakness, easy bruising, frequent nosebleeds, or increased risk of infection)
• muscle pain and weakness
• disturbances of smell
• loss of taste

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

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

In clinical trials not related to arthritis or other joint diseases, where 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, diarrhoea, indigestion, and flatulence)
• 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 mainly in the legs, which can cause pain, swelling, or redness of the calf, or breathing problems)
• stomach problems: inflammation (which can cause stomach irritation and ulcers)
• lower limb fracture
• shingles, skin inflammation, eczema (dry, itchy rash), pneumonia (chest infection, possible symptoms: cough, fever, difficulty breathing)
• eye clouding, causing blurred vision or decreased vision, dizziness due to middle ear disorders, ear pain, or inflammation, bleeding gums
• nocturia (excessive urination at night), haemorrhoids (piles), frequent bowel movements
• fat deposits in the skin or other areas, tendon sheath ganglions (harmless lumps in the joints and/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 those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring, 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

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month. There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 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 (E 132) (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 Capsules are white with two blue bands marked "7767" and "100". Celebrex 200 mg Capsules are white with two gold bands 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. For more information about this medicine, 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 about this medicine is available on the website http://www.urpl.gov.pl