Celecoxib accord

Package leaflet: Information for the patient

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

• Keep this leaflet, as you may need to read it again.
• If you have any further 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 effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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 pack and other information

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

Celecoxib Accord is used in adults to treat the signs and symptoms of
rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.
This medicine belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), specifically within the subgroup known as cyclooxygenase-2 (COX-2) inhibitors. The body produces prostaglandins, which may contribute to pain and inflammation. In conditions such as rheumatoid arthritis and osteoarthritis, the body produces increased levels of prostaglandins. This medicine works by reducing the production of prostaglandins, thereby reducing pain and inflammation.
You should feel the effect of the medicine within a few hours of taking the first dose, but the full effect may not be noticeable until after several days.

2. Important information before using Celecoxib Accord

This medicine has been prescribed by your doctor. The following information will help you achieve the best results from using this medicine. If you have any further questions, please consult your doctor or pharmacist.

When not to use Celecoxib Accord

Please inform your doctor if the patient has any of the following conditions, which are contraindications for using this medicine:

• 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 sulfonamide drugs (e.g. certain antibiotics used to treat infections);
• if the patient has active peptic ulcer disease or active gastrointestinal bleeding;
• if the patient has experienced asthma, nasal polyps, nasal mucosal inflammation, or allergic reactions such as itchy rash, facial swelling, swelling of lips, tongue or throat, breathing difficulties or wheezing after taking acetylsalicylic acid or other non-steroidal anti-inflammatory and pain-relieving drugs (NSAIDs);
• if the patient is pregnant. If the patient may become pregnant during treatment, discuss contraceptive methods with the 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, diagnosed ischaemic heart disease or cerebrovascular disease, e.g. diagnosed myocardial infarction, stroke or transient ischaemic attack (temporary reduction in blood supply to the brain, also known as a mini-stroke), angina or blockage of blood vessels supplying the heart or brain;
• if the patient has current or past circulation problems (peripheral arterial disease), or if the patient has undergone surgery on arteries in the legs.

Warnings and precautions

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

• if the patient has previously had peptic ulcer disease or gastrointestinal bleeding. (Do not take this medicine in case of active peptic ulcer disease or active gastrointestinal bleeding);
• if the patient is taking acetylsalicylic acid (even in low doses for heart protection);
• if the patient is taking antiplatelet medicines;
• if the patient is taking anticoagulant medicines (e.g. warfarin/warfarin derivatives or new oral anticoagulants such as apixaban);
• if the patient is taking corticosteroids (e.g. prednisone);
• if the patient is taking other NSAIDs such as ibuprofen or diclofenac. Concomitant use of these medicines should be avoided;
• if the patient smokes, has diabetes, high blood pressure or elevated cholesterol levels;
• if the patient has heart, liver or kidney problems, the doctor may recommend regular monitoring;
• if the patient experiences fluid retention (such as swelling of ankles or feet);
• if the patient is dehydrated due to illness, diarrhoea or use of diuretics (medicines used to treat excess fluid in the body);
• if the patient has previously experienced a severe allergic reaction or severe skin reaction to any medicine;
• if the patient has an infection or suspects having an infection, as this medicine 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;
• alcohol consumption and use of NSAIDs 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 disorders, including severe hepatitis, liver damage and liver failure (sometimes fatal or requiring liver transplantation), have been reported during treatment with celecoxib. In cases where the time between starting treatment and onset of disease was known, most serious liver-related adverse events occurred within one month of starting treatment.
This medicine may cause difficulty in becoming pregnant. The patient should inform the doctor if she plans to become pregnant or experiences difficulty in conceiving (see section Pregnancy, breastfeeding and fertility).

Celecoxib Accord and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken or 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 thinners 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 heart rhythm disorders
• neuroleptics (used to treat psychiatric disorders)
• methotrexate (used to treat rheumatoid arthritis, psoriasis and leukaemia)
• 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)

This medicine may be used with low-dose acetylsalicylic acid (75 mg or lower daily doses). Please consult your doctor before taking both medicines together.

Pregnancy, breastfeeding and fertility

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

Pregnancy

Do not use this medicine in pregnant women or women who may become pregnant (i.e. women of childbearing age who are not using effective contraception) during treatment. If the patient becomes pregnant while taking this medicine, she should stop treatment immediately and contact her doctor to discuss alternative treatment options.

Breastfeeding

This medicine should not be used in breastfeeding women.

Fertility

NSAIDs, including this medicine, may impair fertility. The patient should inform her doctor if she plans to become pregnant or is experiencing difficulty in becoming pregnant.

Driving and using machines

Before driving or operating machinery, the patient should be aware of how this medicine affects them. If the patient experiences dizziness or drowsiness after taking this medicine, they should not drive or operate machinery until these symptoms have resolved.

Celecoxib Accord contains lactose

Celecoxib Accord 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.

Celecoxib Accord contains sodium

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

3. How to use Celecoxib Accord

This medicine should always be taken as instructed by the doctor or pharmacist. If in doubt, consult
the 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 inform you what dose of the medicine to take. Since the risk of heart-related
adverse 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:
This medicine is to be taken orally. Capsules may be taken at any time of day, with or without food. However, it is advisable to take each dose at approximately the same time every day.
In case of difficulty swallowing capsules: Empty the entire contents of the capsule onto a teaspoon containing a semi-solid food (e.g. cold or room temperature apple sauce, rice cereal, yoghurt, or mashed banana) and swallow immediately, followed by about 240 ml of water.
To open the capsule, hold it upright so that the granules are at the bottom. Then gently squeeze the cap and twist it off. Ensure no spillage occurs. The granules must not be chewed or crushed.
If no benefit is observed within two weeks of starting treatment, contact your doctor.
Recommended dose:
In osteoarthritis, the usual dose is 200 mg daily, and if necessary, the doctor may increase it up to a maximum of 400 mg.
Typically, the dose is:

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

In rheumatoid arthritis, the usual dose is 200 mg daily, and if needed, the doctor may increase it up to a maximum of 400 mg.
Typically, the dose is:

• one 100 mg capsule twice daily.

In ankylosing spondylitis, the usual dose is 200 mg daily, and if needed, the doctor may increase it up to a maximum of 400 mg.
Typically, the dose is:

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

Renal and hepatic impairment: If the patient has impaired kidney or liver function, inform the doctor, as a lower dose may be required.
Elderly patients, particularly those weighing less than 50 kg: In patients over 65 years of age and weighing less than 50 kg, the doctor may recommend closer monitoring.
Do not exceed a daily dose of 400 mg.
Use in children and adolescents: This medicine should only be used in adults. It is not recommended for use in children and adolescents.
Taking more Celecoxib Accord than prescribed
Do not take more capsules than prescribed by the doctor. If you accidentally take too many capsules, seek immediate medical advice from a doctor, pharmacist, or hospital, and bring the medicine package with you.
Missing a 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
Stopping celecoxib treatment suddenly may cause worsening of existing symptoms. Do not discontinue celecoxib unless instructed by your doctor. Your doctor may advise gradually reducing the dose over several days before stopping completely.
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 get them.
The side effects listed below have been observed in patients with arthritis
who have taken this medicine. Side effects marked with an asterisk (*) are listed below
with a higher frequency as observed in patients taking this medicine to
prevent the occurrence of colorectal polyps. Patients participating in these studies
took this medicine in high doses and for a long time.
If any of the symptoms listed below occur, stop taking this medicine 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 any 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, diarrhoea, jaundice (yellowing of the skin or whites of the eyes)].

Very common (may occur in more than 1 in 10 patients)

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

Common (may occur in less than 1 in 10 patients)

• heart attack*
• fluid retention with swelling of ankles, legs and (or) hands
• urinary tract infections
• shortness of breath*, sinusitis (sinus inflammation, sinus infection, stuffy or painful sinuses), stuffy nose or runny nose, sore throat, cough, cold symptoms, 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 injuries

Uncommon (may occur in less than 1 in 100 patients)

• stroke*
• heart failure, palpitations (awareness of heartbeat), rapid heartbeat
• abnormal blood test results indicating liver function problems
• abnormal blood test results indicating kidney function problems
• anaemia (changes in red blood cell count which may cause fatigue and shortness of breath)
• restlessness, depression, fatigue, drowsiness, tingling sensation
• high potassium levels in the blood (which may cause nausea, fatigue, muscle weakness or palpitations)
• blurred or impaired vision, ringing in the ears, mouth pain and inflammation, hearing disorders*
• constipation, regurgitation of food, inflammation in the stomach (indigestion, stomach pain or vomiting), worsening of stomach or intestinal inflammation
• 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 occur in less than 1 in 1,000 patients)

• ulceration (bleeding) of the stomach, oesophagus, or duodenum; or intestinal perforation (which may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), tarry or black stools, pancreatitis (which may cause stomach pain), oesophagitis

• low sodium levels in the blood (a condition called hyponatraemia)

• decreased white blood cell count (which help protect the body against infections) and thrombocytopenia (increased risk of bleeding or bruising)

• movement coordination disorders

• disorientation, taste disturbances

• light sensitivity

• hair loss

• hallucinations

• intraocular haemorrhage

• 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 during breathing or collapse

• bleeding from the stomach or intestines (which may lead to bloody stools or vomiting), intestinal or colonic inflammation

• severe liver inflammation. Symptoms may include nausea, 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 occur in less than 1 in 10,000 patients)

• 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, swollen lymph nodes and abnormal test results [e.g. liver, blood (eosinophilia, increased white blood cell count)]
• fatal intracranial haemorrhage
• 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 transplant). 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 tarry stools, nausea and yellowing of the skin or whites of the eyes)
• kidney inflammation and other kidney diseases (such as nephrotic syndrome and minimal change disease, which may be accompanied by symptoms such as fluid retention (oedema), foamy urine, loss of appetite, fatigue)
• worsening of epilepsy (possibly more frequent and (or) severe epileptic seizures)
• occlusion of retinal artery or vein, leading to partial or complete loss of vision, conjunctivitis, intraocular haemorrhage
• vasculitis (inflammation of blood vessels) (may cause fever, pain, purple spots on the skin)
• decreased red and white blood cells and platelets (may cause weakness, easy bruising, frequent nosebleeds, increased risk of infection)
• muscle pain and weakness
• smell disturbances
• loss of taste

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

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

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

• 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 urinary tract
• weight gain

Uncommon (may occur in less than 1 in 100 patients)

• deep vein thrombosis (blood clots most commonly 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)
• fracture of lower limb
• 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 due to middle ear disorders, pain, inflammation or bleeding of gums, mouth ulceration
• excessive urination at night, haemorrhoidal bleeding (bleeding piles), frequent bowel movements
• 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), speech difficulties, altered or very heavy vaginal bleeding, breast pain
• high sodium levels in blood test results

Reporting of adverse reactions
If you experience any adverse effects, including any not listed
in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products at
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorisation holder or its representative.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Celecoxib Accord

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack 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:
Granulate: lactose monohydrate, povidone K-29/32, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate.
Capsule shell: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172).
Ink (100 mg): shellac, propylene glycol, indigo carmine, aluminium lake of indigo carmine (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 containing 1, 10, 20, 30, 40, 50, 60 or 100 capsules.

Celecoxib Accord 100 mg
Opaque, white, hard gelatin capsule. A blue band on the body with the white imprint “C9OX-100”.

Celecoxib Accord 200 mg
Opaque, white, hard gelatin capsule. A yellow band on the body with the white imprint “C9OX-200”.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw
Poland

Manufacturer
Synthon BV
Microweg 22
6545 CM, Nijmegen
The Netherlands

Synthon Hispania S.L.
C/Castelló, n 1
Sant Boi de Llobregat
08830 Barcelona
Spain