Celebrex

Package leaflet: Information for the patient

CELEBREX, 100 mg, capsules
CEBREX, 200 mg, capsules
Celecoxibum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What is C and what is it used for
2. Important information before using C
3. How to use C
4. Possible side effects
5. How to store C
6. Contents of the package and other information

1. What is C and what is it used for

C 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 production of prostaglandins increases.
C works by inhibiting the production of prostaglandins, thereby reducing
pain and inflammation.
C is used in adults for the treatment of symptoms of rheumatoid arthritis,
osteoarthritis, and ankylosing spondylitis.
The patient should feel the effect of the medicine within a few hours after the first dose, but
the full effect may not be noticeable until after several days.

2. Important information before using medicine C

Medicine C is prescribed by a doctor. The following information will help ensure proper and effective use of medicine C. If you have further questions, please consult your doctor or pharmacist.

When not to use medicine C

Inform your doctor if the patient has any of the following conditions, which are contraindications for the use of medicine C:

• if the patient is allergic to celecoxib or any of the other ingredients of this medicine (listed in section 6);
• if the patient has hypersensitivity to drugs from the so-called sulfonamide group (e.g. certain antibiotics used to treat infections);
• if the patient has active gastric or duodenal ulcer disease, or gastrointestinal bleeding;
• if after taking acetylsalicylic acid or other non-steroidal anti-inflammatory and analgesic drugs (NSAIDs), the patient has experienced asthma, nasal polyps, nasal mucosal inflammation, or allergic reactions such as itchy rash, facial swelling, lip, tongue or throat swelling, breathing difficulties or wheezing;
• if the patient is pregnant. Women who may become pregnant during treatment with medicine C should discuss effective contraceptive methods with their doctor;
• if the patient is breastfeeding;
• if the patient has severe liver disease;
• if the patient has severe kidney disease;
• if the patient has inflammatory bowel disease, such as ulcerative colitis or Crohn's disease;
• if the patient has heart failure, ischemic heart disease, or cerebrovascular disease, e.g. patients who have had a heart attack, stroke, transient ischemic attack (temporary reduction of blood flow to the brain, so-called mini-stroke), angina pectoris, or arterial blockages in the heart or brain;
• if the patient has current or past circulatory disorders (peripheral vascular disease), or if the patient has undergone surgery on leg arteries.

Warnings and precautions

Before starting treatment with medicine C, discuss the following with your doctor or pharmacist:

• if the patient previously had gastric or intestinal ulcers or gastrointestinal bleeding. Medicine C should not be used in patients with active gastric or duodenal ulcer disease or gastrointestinal bleeding;
• if the patient is taking acetylsalicylic acid (even in low doses for heart protection);
• if the patient is taking antiplatelet drugs;
• if the patient is taking drugs that reduce blood clotting (e.g. warfarin/anticoagulants derived from warfarin or new-generation anticoagulants such as apixaban);
• if the patient is taking drugs known as corticosteroids (e.g. prednisone);
• if the patient intends to use medicine C together with other NSAIDs such as ibuprofen or diclofenac (other than acetylsalicylic acid). Concomitant use of these drugs should be avoided;
• if the patient smokes, has diabetes, high blood pressure, or elevated cholesterol levels;
• if the patient has heart, liver, or kidney disorders, the doctor may recommend regular monitoring tests;
• if the patient experiences fluid retention (such as swelling of ankles or feet);
• if the patient is dehydrated due to illness, diarrhea, or use of diuretics (used to treat excess fluid in the body);
• if the patient has experienced a severe allergic reaction or severe skin reaction to any drug;
• if the patient has an infection or suspects having an infection, because medicine C may mask fever or other signs of infection or inflammation;
• if the patient is over 65 years of age, the doctor may recommend regular monitoring;
• if the patient consumes alcohol or uses NSAIDs, this may increase the risk of gastrointestinal disorders.

Like other NSAIDs (e.g. ibuprofen or diclofenac), this medicine may lead to increased blood pressure; therefore, the doctor may recommend regular blood pressure monitoring.
Severe liver diseases, including severe hepatitis, liver damage, and liver failure (sometimes resulting in death or requiring liver transplantation), have been reported during treatment with medicine C. In cases where the time preceding the onset of disease was known, most severe liver-related adverse reactions occurred within one month of starting treatment.
Serious skin reactions have been reported with the use of medicine C. If the patient notices any of the symptoms of serious skin reactions described in section 4. Possible side effects, treatment with medicine C should be stopped immediately and the patient should consult a doctor without delay.
Medicine C may cause difficulties in becoming pregnant. The patient should inform the doctor if she plans to become pregnant or has difficulty becoming pregnant (see section Pregnancy and breastfeeding).

Other medicines

Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.

The doctor will use medicine C 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 (anticoagulant drugs 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, sleep disorders, high blood pressure, or cardiac arrhythmias
• neuroleptics (used to treat psychiatric 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 suppress the immune system, e.g. after organ transplants).

Medicine C may be used together with low-dose acetylsalicylic acid (75 mg or lower daily doses). Consult your doctor before starting concomitant use of both medicines.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy

Medicine C must not be used in pregnant women or women who may become pregnant (e.g. women of childbearing age who do not use effective contraception). If a patient becomes pregnant during treatment with medicine C, she should stop taking medicine C immediately and contact her doctor to discuss alternative treatment options.

Breastfeeding

Medicine C must not be used in women who are breastfeeding.

Fertility

NSAIDs, including medicine C, may impair fertility. The patient should inform her doctor if she plans to become pregnant or experiences difficulty becoming pregnant.

Driving and using machines

Before driving or operating machinery, the patient should observe how medicine C affects them. If dizziness or drowsiness occurs after taking medicine C, the patient should not drive or operate any machinery until these symptoms subside.

Medicine C contains lactose

Medicine C contains lactose (a type of sugar). If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

Medicine C contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to use medicine C

This medicine should always be used exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist. If you feel that the effect of medicine C
is too strong or too weak, you should consult your doctor or pharmacist.
Your doctor will inform you of the dose you should take. Since the risk
of adverse reactions related to heart problems may increase with
dose and duration of treatment, it is important to use medicine C at the lowest effective dose
and for no longer than necessary (to control symptoms).

Method of administration
Medicine C should be taken orally. Capsules may be taken at any time
of day, with or without food. However, it is recommended that the patient take medicine C at the
same time each day.

If you have difficulty swallowing capsules: Empty the entire contents of the capsule onto a spoon
containing a semi-solid food (e.g. cool or room-temperature applesauce, rice cereal, yogurt, or mashed banana) and swallow immediately, followed by approximately 240 ml
of water.

To open the capsule, hold it upright so that the granules inside are at the bottom. Then gently squeeze the cap and twist it to remove it, taking care not to spill the contents. The granules should not be chewed or crushed.

If you do not notice any benefit from using medicine C within two weeks
of starting treatment, you should contact your doctor.

Recommended dose
Osteoarthritis: The recommended dose is 200 mg once daily. Your doctor may increase
the dose to a maximum of 400 mg per day if necessary.
The recommended dose is:

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

Rheumatoid arthritis: The recommended dose is 200 mg once daily. Your doctor may increase
the dose to a maximum of 400 mg per day if necessary.
The recommended dose is:

• 100 mg twice daily.

Ankylosing spondylitis: The recommended dose is 200 mg once daily. Your doctor may increase
the dose to a maximum of 400 mg per day if necessary.
The recommended dose is:

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

Kidney and liver function disorders: If you have kidney or liver problems, you should inform your doctor, as a lower dose of medicine C may be required.

Elderly patients, especially those weighing less than 50 kg: In patients over 65 years of age and weighing less than 50 kg, your doctor may recommend more frequent monitoring.

Do not take more than 400 mg per day.

Use in children
Medicine C should only be used in adults. It should not be used in children.

Taking more than the recommended dose of medicine C
Do not take more than the dose recommended by your doctor. If you take too many
capsules of medicine C, contact your doctor, pharmacist, or go to hospital immediately.
Remember to bring the medicine you are taking with you.

Missing a dose of medicine C
If you forget to take a capsule of medicine C, take the missed dose
as soon as possible. Do not take a double dose to make up for a missed dose.

Stopping medicine C
Stopping medicine C suddenly may cause your existing symptoms to worsen. Do not stop taking medicine C unless your doctor advises you to stop treatment. Your doctor may recommend gradually discontinuing medicine C by
reducing the dose over several days.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The side effects listed below have been observed in patients with arthritis taking medicine C.
The side effects marked (*) listed below occurred more frequently in patients taking medicine C
for the prevention of colorectal polyps. In this study, patients took the medicine at a high dose
and for a long period. If any of the symptoms listed below occur, stop taking the medicine immediately
and contact your doctor:

• allergic reaction, such as: rash, facial swelling, wheezing or difficulty breathing,
• heart problems, such as chest pain,
• severe stomach pain or any signs of bleeding from the stomach or intestines, such as black or blood-stained stools, or vomiting blood,
• skin reactions, such as rash, blisters or peeling of the 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)

• hypertension, including worsening of existing high blood pressure*

Common (may affect up to 1 in 10 people)

• heart attack*
• fluid retention with swelling of ankles, legs and (or) hands
• urinary tract infections
• shortness of breath*, sinusitis (sinus inflammation, sinus infection, feeling of blocked or painful sinuses), stuffy nose or runny nose, sore throat, cough, cold, flu-like symptoms
• dizziness, difficulty sleeping
• vomiting*, abdominal pain, diarrhoea, indigestion, bloating with gas
• rash, itching
• muscle stiffness
• difficulty swallowing*
• headache
• nausea
• joint pain
• worsening of existing allergic symptoms
• accidental injury

Uncommon (may affect up to 1 in 100 people)

• stroke*
• heart failure, palpitations (awareness of heartbeat), rapid heartbeat
• abnormal blood test results relating to liver function
• abnormal blood test results relating to kidney function
• anaemia (changes in red blood cell count which may cause tiredness and shortness of breath)
• restlessness, depression, fatigue, drowsiness, tingling sensation
• high levels of potassium in blood tests [which may cause nausea (feeling sick), fatigue, muscle weakness or palpitations]
• blurred or distorted vision, ringing in the ears, mouth pain and inflammation, hearing disorders*
• constipation, belching, inflammation in the stomach (indigestion, stomach pain or vomiting), worsening of inflammation in the stomach or intestines
• leg cramps
• raised, itchy rash (urticaria)
• conjunctivitis
• difficulty breathing
• skin discolouration (bruising)
• chest pain (general pain not related to the heart)
• facial swelling

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

• ulceration (bleeding) of the stomach, oesophagus or duodenum; or intestinal perforation (which may cause stomach pain, fever, nausea, vomiting, bowel obstruction), tarry or black stools, pancreatitis (which may cause stomach pain), oesophagitis
• low sodium levels in the blood (a medical condition called hyponatraemia)
• reduced number of white blood cells (which help protect the body against infections) or thrombocytopenia (increased risk of bleeding or bruising)
• movement coordination disorders
• disorientation, taste disturbances
• light sensitivity
• hair loss
• hallucinations
• bleeding inside the eye
• severe reaction which may lead to lung inflammation
• irregular heartbeat
• hot flushes
• blood clots in blood vessels of the lungs. Symptoms may include sudden shortness of breath, sharp pain when breathing or collapse
• bleeding from the stomach or intestines (which may lead to bloody stools or vomiting), inflammation of the intestine or colon
• severe liver inflammation. Symptoms may include nausea (feeling sick), diarrhoea, jaundice (yellowing of the skin and whites of the eyes), dark urine, pale stools, bleeding, itching or chills
• severe kidney failure
• menstrual disorders
• swelling of the face, lips, mouth, tongue or throat, or difficulty swallowing

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

• severe allergic reactions (including anaphylactic shock, which may be fatal)
• severe skin diseases, such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (which may cause rash, blistering or peeling of the skin), and acute generalised exanthematous pustulosis (symptoms include red, swollen areas of skin with numerous small pustules)
• delayed allergic reaction with possible symptoms such as rash, facial swelling, fever, enlarged lymph nodes and abnormal test results [e.g. liver, blood (eosinophilia, increased white blood cell count)]
• intracranial haemorrhage resulting in death
• meningitis (inflammation of the membranes covering the brain and spinal cord)
• hepatitis, liver damage and severe hepatitis (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 diseases (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as pale, tarry stools, nausea and yellowing of the skin or whites of the eyes)
• kidney inflammation and other kidney diseases [such as nephrotic syndrome and lipid nephrosis, 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 epileptic seizures]
• blockage of retinal artery or vein, leading to partial or complete loss of vision
• vasculitis (inflammation of blood vessels) (may cause fever, pain, purple skin spots)
• reduced number of red and white blood cells and platelets (may cause weakness, easy bruising, frequent nosebleeds, increased risk of infection)
• muscle pain and weakness
• disturbances in smell
• loss of taste

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

• reduced fertility in women, which is usually reversible after stopping the medicine
• other severe skin diseases, such as fixed drug eruption [a characteristic allergic skin reaction which usually recurs in the same location(s) upon re-exposure to the medicine and may appear as round or oval areas of redness and swelling of the skin, blisters (urticaria), itching] and generalised bullous fixed drug eruption (may include extensive skin reactions)

In clinical studies not related to arthritis or other joint diseases,
in which medicine C was administered at a dose of 400 mg daily for up to 3 years, the following
additional adverse reactions were observed:
Common (may affect up to 1 in 10 people)

• heart disorders: angina (chest pain)
• stomach disorders: irritable bowel syndrome (may include abdominal pain, diarrhoea, indigestion, bloating with gas)
• kidney stones (may lead to abdominal or back pain, blood in urine), difficulty passing urine through the urinary tract
• weight gain

Uncommon (may affect up to 1 in 100 people)

• deep vein thrombosis (blood clots usually in the legs, which may cause pain, swelling or redness in the calf or breathing problems)
• stomach disorders: inflammation (which may cause irritation and ulceration of the stomach and intestines)
• lower limb fracture
• shingles, dermatitis, eczema (dry, itchy rash), pneumonia (infection in the chest area (possible: cough, fever, difficulty breathing)
• eye clouding causing blurred or reduced vision, dizziness caused by middle ear disorders, gum pain, inflammation or bleeding, mouth ulceration
• excessive urination at night, haemorrhoidal bleeding (haemorrhoids), frequent defecation
• lipomas in the skin or other locations, ganglion cysts of tendon sheaths [benign swellings of joints (or) areas around joints and tendons of the hand or foot], difficulty speaking, altered or very heavy vaginal bleeding, breast pain
• high sodium levels in the blood

Reporting of side effects
If any side effects occur, including any side effects not listed
in this leaflet, tell your doctor or pharmacist. Side effects can
be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Side effects can also be reported to the marketing authorisation holder or its representative.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store medicine C

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton following EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Please consult your pharmacist on how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What C medicine contains

• The active substance is celecoxib. Each capsule of C medicine contains 100 mg or 200 mg of celecoxib.
• The other ingredients are: monohydrate lactose, sodium lauryl sulfate, povidone K30, sodium croscarmellose, magnesium stearate. Capsule shell: titanium dioxide (E 171), gelatin. Printing ink: shellac, anhydrous ethanol, isopropyl alcohol, butyl alcohol, propylene glycol, concentrated ammonium hydroxide, indigo carmine lake (E 132) (100 mg capsule), yellow iron oxide (E 172) (200 mg capsule).

What C medicine looks like and contents of the pack
C medicine is available in the form of capsules.
C, 100 mg
Capsules are white with two blue bands, marked with “7767” and “100”.
C, 200 mg
Capsules are white with two gold bands, marked with “7767” and “200”.
C medicine is packed in blisters containing 10 or 30 capsules in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland

Manufacturers
Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg Im Breisgau
Germany
Klocke Verpackungs-Service GmbH
Max-Becker-Str. 6
76356 Weingarten (Baden)
Germany
Mylan Hungary Kft.
Mylan utca 1
Komárom, 2900
Hungary

For more detailed information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00