Celecoxib Accord

Leaflet accompanying the packaging: patient information

Celecoxib Accord, 100 mg, hard capsules

Celecoxib Accord, 200 mg, hard capsules

Celecoxib

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Celecoxib Accord and what is it used for
• 2. Important information before taking Celecoxib Accord
• 3. How to take Celecoxib Accord
• 4. Possible side effects
• 5. How to store Celecoxib Accord
• 6. Contents of the packaging and other information

1. What is Celecoxib Accord and what is it used for

Celecoxib Accord is used in adults to treat the symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. This medicine belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are also known as cyclooxygenase-2 (COX-2) inhibitors. The body produces prostaglandins, which can cause pain and inflammation. In conditions such as rheumatoid arthritis and osteoarthritis, the body produces more prostaglandins. The action of this medicine is to reduce the production of prostaglandins, thereby 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 may only be felt after a few days.

2. Important information before taking Celecoxib Accord

This medicine has been prescribed by a doctor. The following information will help to get the best results from taking this medicine. If you have any further doubts, consult a doctor or pharmacist.

When not to take Celecoxib Accord

Tell your doctor if you have any of the following conditions, which are contraindications to taking this medicine.

• if you are allergic to celecoxib or any of the other ingredients of this medicine (listed in section 6);
• if you have a known hypersensitivity to sulfonamides (e.g. certain antibiotics used to treat infections);
• if you have active stomach or duodenal ulcer, or bleeding from the stomach or duodenum;
• if you have had asthma, nasal polyps, nasal congestion, or allergic reactions (such as itching, swelling of the face, lips, tongue, or throat, difficulty breathing, or wheezing) after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs);
• if you are pregnant. If you may become pregnant during treatment, discuss 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, established ischemic heart disease, or cerebrovascular disease (e.g. diagnosed myocardial infarction, stroke, or transient ischemic attack (TIA), angina, or peripheral vascular disease), or if you have had a procedure on the arteries of the legs.

Warnings and precautions

Before starting treatment with Celecoxib Accord, discuss the following with your doctor or pharmacist:

• if you have had stomach or intestinal ulcers or bleeding in the past (do not take this medicine if you have active stomach or intestinal ulcers or bleeding);
• if you are taking aspirin (even in small doses for heart protection);
• if you are taking antiplatelet agents;
• if you are taking blood-thinning medicines (e.g. warfarin/anticoagulants or new-generation oral anticoagulants, e.g. apixaban);
• if you are taking corticosteroids (e.g. prednisone);
• if you are taking other NSAIDs (e.g. ibuprofen or diclofenac) at the same time. Avoid taking these medicines together;
• 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 (such as swelling of the ankles or feet);
• if you are dehydrated due to illness, diarrhea, or diuretic use;
• 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 this medicine may mask fever or other signs of infection or inflammation;
• if you are over 65 years old, your doctor may recommend regular check-ups;
• consumption of alcohol and taking NSAIDs 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 celecoxib, there have been reports of severe liver disease, including severe liver inflammation, liver damage, and liver failure (sometimes fatal or requiring liver transplantation). In cases where the time to onset was known, most severe liver events occurred within one month of starting treatment. This medicine may cause difficulties in getting pregnant. Women who are trying to get pregnant or have difficulty getting pregnant should tell their doctor.

Celecoxib Accord and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, and about any medicines you plan to take.

• dextromethorphan (used to treat cough)
• ACE 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 that prevent 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).

This medicine can be taken with low-dose aspirin (75 mg or less per day). Consult your doctor before taking both medicines together.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine. Pregnancy Do not take this medicine if you are pregnant or may become pregnant (i.e. women of childbearing age who do not use effective contraception) during treatment. If you become pregnant during treatment with this medicine, stop treatment and consult your doctor to discuss alternative treatment methods. Breastfeeding Do not take this medicine if you are breastfeeding. Fertility NSAIDs, including this medicine, may make it more difficult to get pregnant. Women who are trying to get pregnant or have difficulty getting pregnant should tell their doctor.

Driving and using machines

Before driving or using machines, the patient should know how this medicine affects them. If the patient experiences dizziness or drowsiness after taking this medicine, they should not drive or use machines until these symptoms have resolved.

Celecoxib Accord contains lactose

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

Celecoxib Accord contains sodium

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

3. How to take Celecoxib Accord

Take this medicine always as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. If you feel that the effect of this medicine is too strong or too weak, consult your doctor or pharmacist. Your doctor will tell you what dose to take. Since the risk of heart-related side effects may increase with dose and duration of treatment, it is important to use the smallest effective dose and not for longer than necessary to control symptoms. Method of administration: This medicine should be taken orally. Capsules can be taken at any time of day, with or without food. However, try to take each dose of this medicine at the same time every day. If you have difficulty swallowing capsules: Pour the entire contents of the capsule onto a spoonful of soft food (e.g. cold or room-temperature applesauce, rice cereal, yogurt, or mashed banana) and swallow immediately, washing it down with about 240 ml of water. 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. Make sure nothing spills out. Do not chew or crush the granules. If you do not notice any benefits within two weeks of starting treatment, consult your doctor. Recommended dose: For osteoarthritis, the usual dose is 200 mg per day, and if necessary, your doctor may increase it to a maximum of 400 mg. The usual dose is: one 200 mg capsule once daily; or one 100 mg capsule twice daily. For rheumatoid arthritis, the usual dose is 200 mg per day, and if necessary, your doctor may increase it to a maximum of 400 mg. The usual dose is: one 100 mg capsule twice daily. For ankylosing spondylitis, the usual dose is 200 mg per day, and if necessary, your doctor may increase it to a maximum of 400 mg. The usual dose is: one 200 mg capsule once daily; or one 100 mg capsule twice daily. Liver and kidney problems: If you have liver or kidney problems, tell your doctor, as a lower dose may be necessary. Elderly patients, especially those with a body weight of less than 50 kg: In patients over 65 years old and with a body weight of less than 50 kg, your doctor may recommend closer monitoring. Do not take more than 400 mg per day. Use in children and adolescents: This medicine should only be used in adults, it should not be used in children and adolescents.

Overdose of Celecoxib Accord

Do not take more capsules than your doctor has recommended. If you have taken too many capsules, consult your doctor, pharmacist, or hospital, taking the medicine packaging with you.

Missed dose of Celecoxib Accord

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 with Celecoxib Accord

Suddenly stopping treatment with celecoxib may worsen existing symptoms. Do not stop taking celecoxib unless your doctor tells you to. Your doctor may recommend gradually reducing the dose over a few days before stopping treatment completely. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Side effects listed below have been observed in patients with arthritis who took this medicine. Side effects marked with an asterisk (*) are listed below with a higher frequency, which was observed in patients taking this medicine to prevent colon polyps. These patients took this medicine in high doses and for a long time.

Patients taking part in these studies took this medicine in high doses and for a long time.

If you experience any of the following symptoms, stop taking this medicine and tell your doctor immediately:

• allergic reaction, such as: rash, swelling of the face, wheezing, or difficulty breathing,
• heart problems, such as chest pain,
• severe stomach 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, diarrhea, jaundice (yellowing of the skin and 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 (inflammation of the sinuses), stuffy nose or cold, sore throat, cough, cold, flu-like symptoms
• dizziness, difficulty sleeping
• nausea*, stomach pain, diarrhea, indigestion, bloating with gas
• 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)
• 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 pain or inflammation, hearing loss*
• constipation, belching, stomach or intestinal inflammation (indigestion, stomach pain, or vomiting), worsening of stomach or intestinal inflammation
• leg cramps
• hives (itchy, raised 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 duodenal ulcer (bleeding) or perforation of the intestine (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)
• reduced white blood cell and platelet count (which can cause weakness, easy bruising, frequent nosebleeds, increased risk of infection)
• muscle pain or weakness
• disturbances of taste or smell
• 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 many small blisters)
• delayed allergic reaction with possible symptoms such as rash, swelling of the face, fever, enlarged 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)
• liver failure, liver damage, and severe liver inflammation (fulminant hepatitis) (sometimes fatal or requiring liver transplantation). Symptoms may include: nausea, diarrhea, 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 minimal change disease, which may be accompanied by symptoms such as fluid retention (swelling), foamy urine, loss of appetite, fatigue)
• worsening of epilepsy (possible more frequent and/or severe seizures)
• closure of the retinal vein or artery, leading to partial or complete loss of vision, conjunctivitis, eye bleeding
• inflammation of blood vessels (which can cause fever, pain, purple spots on the skin)
• reduced red, white blood cell, and platelet count (which can cause weakness, easy bruising, frequent infections)
• muscle pain or weakness
• disturbances of taste or smell

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

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

In clinical trials not related to arthritis or other joint diseases, in which Celecoxib Accord 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 with gas)
• 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: inflammation (which can cause stomach irritation and ulcers)
• fracture of the lower limb
• shingles, skin inflammation, eczema (dry, itchy rash), pneumonia (chest infection, possible symptoms: cough, fever, difficulty breathing)
• eye clouding, causing blurred vision or vision loss, dizziness due to middle ear disorders, ear pain, inflammation, or bleeding, mouth ulcers
• nocturnal urination, hemorrhoidal bleeding (bleeding from hemorrhoids), frequent bowel movements
• fat deposits in the skin or other locations, ganglion cysts (harmless thickening of the joints (and/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 any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides, 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 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 Celecoxib Accord

Keep this medicine 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 the 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 packaging and other information

What Celecoxib Accord contains

The active substance is celecoxib. Celecoxib Accord, 100 mg, hard capsules: Each capsule contains 100 mg of celecoxib. Celecoxib Accord, 200 mg, hard capsules: Each capsule contains 200 mg of celecoxib. The other ingredients are: Granule: lactose monohydrate, povidone K-29/32, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate. Capsule: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172). Ink (100 mg): shellac, propylene glycol, indigo carmine, aluminum lake (E 132). Ink (200 mg): shellac, propylene glycol, yellow iron oxide (E 172).

What Celecoxib Accord looks like and contents of the pack

Celecoxib Accord is available in packs of 1, 10, 20, 30, 40, 50, 60, or 100 capsules. Celecoxib Accord, 100 mg Non-transparent, white, hard gelatin capsule. The body has a blue band with white printing "C9OX-100". Celecoxib Accord, 200 mg Non-transparent, white, hard gelatin capsule. The body has a yellow band with white printing "C9OX-200". Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o., ul. Taśmowa 7, 02-677 Warsaw

Manufacturer

Synthon BV, Microweg 22, 6545 CM, Nijmegen, Netherlands Synthon Hispania S.L., C/Castelló, n 1, Sant Boi de Llobregat, 08830 Barcelona, Spain

Date of last revision of the leaflet: November 2022