Celbic

Package Leaflet: Information for the User

CELBIC, 100 mg, hard capsules

CELBIC, 200 mg, hard 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 CELBIC and what is it used for
• 2. Important information before taking CELBIC
• 3. How to take CELBIC
• 4. Possible side effects
• 5. How to store CELBIC
• 6. Contents of the pack and other information

1. What is CELBIC and what is it used for

CELBIC is used in adults for the treatment of symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. CELBIC belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), specifically to a subgroup of medicines called cyclooxygenase-2 (COX-2) inhibitors. 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. CELBIC works by inhibiting the production of prostaglandins, thus reducing pain and inflammation. The patient should feel the effect of the medicine within a few hours of taking the first dose, but the full effect of the medicine may not be noticeable for several days.

2. Important information before taking CELBIC

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

When not to take CELBIC

Tell your doctor if you have any of the following conditions that are contraindications to taking CELBIC.

• if you are allergic to celecoxib or any of the other ingredients of this medicine (listed in section 6);
• if you have ever had an allergic reaction to sulfonamide medicines (e.g., certain antibiotics used to treat infections);
• if you have active stomach or intestinal ulcers, or bleeding from the stomach or intestines;
• if you have had asthma, nasal polyps, nasal congestion, or allergic reactions (such as hives, facial swelling, tongue 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 CELBIC should discuss contraception methods 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 of blood flow to the brain, so-called mini-stroke), angina pectoris, or blockage of heart or brain blood vessels;
• if you have or have had circulation disorders (peripheral arterial disease) or if you have had a procedure on the arteries of the legs.

Warnings and precautions

Before starting treatment with CELBIC, discuss the following with your doctor:

• if you have ever had stomach or intestinal ulcers or bleeding (do not take CELBIC if you have active stomach or intestinal ulcers, or bleeding);
• if you are taking acetylsalicylic acid (even in small doses for heart protection);
• if you are taking medicines that reduce blood clotting (e.g., warfarin/anticoagulant derivatives or new-generation anticoagulants, e.g., apixaban);
• if you are taking corticosteroid medicines (e.g., prednisone);
• if you are taking CELBIC at the same time as other NSAIDs, 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;
• if you have heart, liver, or kidney problems, your doctor may recommend regular check-ups;
• if you have fluid retention (such as 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 feel unwell due to infection or suspect you have an infection, as CELBIC may mask fever or other symptoms of infection or inflammation;
• if you are over 65 years old, your doctor may recommend regular check-ups;
• taking alcohol at the same time as taking NSAID medicines may increase the risk of stomach and intestinal 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 celecoxib, cases of severe liver disorders, 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 one month of starting treatment.

CELBIC may cause difficulty in becoming pregnant. Women who are trying to become pregnant or are having difficulty becoming pregnant should tell their doctor (see section Pregnancy and breastfeeding).

CELBIC 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.

• 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 reduce blood clotting), including new-generation medicines such as apixaban
• Lithium (used to treat certain types of depression)
• Other medicines 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).

CELBIC can be taken with low doses of acetylsalicylic acid (daily dose 75 mg or less). 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, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take CELBIC if you are pregnant or may become pregnant (i.e., women of childbearing age who do not use effective contraception). If you become pregnant during treatment with CELBIC, stop treatment and consult your doctor to determine an alternative treatment method.

Breastfeeding

Do not take CELBIC if you are breastfeeding.

Fertility

NSAIDs, including CELBIC, may cause difficulty in becoming pregnant. Women who are trying to become pregnant or are having difficulty becoming pregnant should tell their doctor.

Driving and using machines

Before driving or using machines, observe how you react to CELBIC. If you experience dizziness or drowsiness after taking CELBIC, do not drive or operate any machines until these symptoms have resolved.

CELBIC contains lactose

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

CELBIC 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 CELBIC

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. If you feel that the effect of CELBIC is too strong or too weak, ask your doctor or pharmacist. Your doctor will tell you what dose 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.

How to take CELBIC

Take CELBIC orally.Swallow the capsules whole with water.The capsules can be taken at any time of day, with or without food. However, it is recommended to try to take CELBIC at the same time every day. If you do not notice any benefit from taking CELBIC within two weeks of starting treatment, consult 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 if necessary.

• one 200 mg capsule once daily; or
• one 100 mg capsule twice daily.

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

• one 100 mg capsule twice daily.

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

• one 200 mg capsule once daily; or
• one 100 mg capsule twice daily.

Impaired renal or hepatic function:if you have impaired liver or kidney function, tell your doctor, as a lower dose of CELBIC may be necessary.

Elderly patients, particularly 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 of your condition.

Do not take more than 400 mg per day.

Use in children

CELBIC is intended for use in adults only. Do not give it to children.

Overdose

Do not take more capsules than your doctor has recommended. If you have taken too many capsules, 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 capsule, take it as soon as you remember. Do not take a double dose to make up for a missed dose.

Stopping treatment

Suddenly stopping treatment with CELBIC may lead to worsening of symptoms. Do not stop taking CELBIC without consulting your doctor. Your doctor may recommend gradually stopping treatment with CELBIC 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, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported in patients with arthritis taking CELBIC. Side effects marked with an asterisk (*) were reported more frequently than in patients taking CELBIC for the prevention of colon polyps.

In studies where patients took CELBIC at a dose of 400 mg per day for up to 3 years, the following additional side effects were observed:

If you experience any of the following symptoms, stop taking CELBIC and tell 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 bleeding from the stomach or intestines, such as black or bloody stools, or vomiting blood,
• skin reactions, such as rash, blisters, or peeling of the skin,
• liver failure (symptoms may include nausea, diarrhea, 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, legs, and (or) hands;
• urinary tract infections;
• respiratory tract infections, sinusitis (sinus infection), stuffy or runny nose, sore throat, cough, cold, flu-like symptoms;
• dizziness, difficulty sleeping;
• nausea*, stomach pain, diarrhea, indigestion, bloating;
• rash, itching;
• muscle stiffness;
• difficulty swallowing*;
• headache;
• nausea (feeling sick);
• joint pain;
• worsening of existing allergic symptoms;
• accidental injuries.

Uncommon (may affect up to 1 in 100 people)

• stroke*;
• heart failure, palpitations, rapid heart rate;
• 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);
• restlessness, depression, fatigue, drowsiness, tingling sensation;
• high potassium levels in the blood (which can cause nausea, fatigue, weakness, or palpitations);
• vision or hearing disturbances, ringing in the ears, mouth ulcers, hearing loss*;
• constipation, belching, stomach or intestinal inflammation (indigestion, stomach 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, perforation of the stomach or intestines, or bleeding from the stomach or intestines; or intestinal perforation (which can cause stomach pain, fever, nausea, vomiting, intestinal obstruction), black or tarry stools, pancreatitis (which can cause stomach pain), esophagitis;
• low sodium levels in the blood (a condition called hyponatremia);
• decreased white blood cell or platelet count (which can cause weakness, easy bruising, frequent nosebleeds, or increased risk of infection);
• coordination problems;
• 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 chest pain during breathing, or collapse;
• bleeding from the stomach or intestines (which can lead to black or bloody stools or vomiting blood), intestinal or colon inflammation;
• severe liver inflammation. Symptoms may include nausea, diarrhea, 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 acute generalized exanthematous pustulosis (which can cause rash, blisters, or peeling of the skin) and drug rash with eosinophilia and systemic symptoms (DRESS);
• 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);
• hepatitis, liver damage, and severe liver inflammation (fulminant hepatitis) (sometimes fatal or requiring liver transplantation). Symptoms may include nausea, diarrhea, 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);
• retinal vein or artery occlusion, leading to partial or complete loss of vision;
• vasculitis (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 infections);
• muscle pain and weakness;
• smell disturbances;
• taste loss.

Frequency not known: frequency cannot be estimated from the available data

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

In clinical trials unrelated to arthritis or other joint diseases, where CELBIC 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 stomach pain, diarrhea, indigestion, bloating);
• kidney stones (which can cause stomach 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: stomach infection (which can cause stomach irritation and ulcers), stomach or intestinal inflammation;
• fracture of the lower limb;
• shingles, skin infection, eczema (dry, itchy rash), pneumonia (chest infection, possible cough, fever, difficulty breathing);
• eye problems, blurred vision, dizziness due to middle ear disorders, ear pain, mouth ulcers, gum inflammation or bleeding;
• nocturia (excessive urination at night), hemorrhoids (piles), frequent bowel movements;
• fat deposits in the skin or other areas, ganglion cysts (harmless lumps in the joints or tendons of the hands or feet), difficulty speaking, changes in 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CELBIC

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of that month. Do not store above 30°C. 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 CELBIC contains

The active substance is celecoxib. One capsule contains 100 mg or 200 mg of celecoxib. The other ingredients are lactose monohydrate, hydroxypropyl cellulose, croscarmellose sodium, povidone, sodium lauryl sulfate, magnesium stearate. Capsole shell: titanium dioxide (E171), gelatin, sodium lauryl sulfate. Printing ink: shellac, indigo carmine, lake (E 132) (100 mg capsules) and iron oxide yellow (E172) (200 mg capsules).

What CELBIC looks like and contents of the pack

CELBIC 100 mg:capsules size 4 containing white or almost white powder, with a white matte cap and a white matte body with a blue stripe on the cap and a blue stripe on the body with "C5" printed on the cap and "100mg" printed on the body. CELBIC 200 mg:capsules size 2 containing white or almost white powder, with a white matte cap and a white matte body with a yellow stripe on the cap and a yellow stripe on the body with "C6" printed on the cap and "200mg" printed on the body. The capsules are packaged in transparent PVC/PVdC/Aluminum blisters. The pack contains: CELBIC 100 mg: 10, 30, 60, or 100 capsules. CELBIC 200 mg: 10, 30, 60, or 100 capsules. Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A., Pieńków, ul. M. Adamkiewicza 6A, 05-152 Czosnów

Importer

Adamed Pharma S.A., ul. Marszałka Józefa Piłsudskiego 5, 95-200 Pabianice Date of last revision of the leaflet:January 2021