Celecoxib Krka 100mg capsules, hard

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
Celecoxib
Available from:
Krka d.d., Novo mesto
ATC code:
M01AH; M01AH01
INN (International Name):
Celecoxib
Dosage:
100 milligram(s)
Pharmaceutical form:
Capsule, hard
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Coxibs; celecoxib
Authorization status:
Marketed
Authorization number:
PA1347/033/001
Authorization date:
2013-11-29

PACKAGE LEAFLET

Package leaflet: Information for the user

Celecoxib Krka 100 mg capsules, hard

Celecoxib Krka 200 mg capsules, hard

celecoxib

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

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 signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Celecoxib Krka is and what it is used for

What you need to know before you take Celecoxib Krka

How to take Celecoxib Krka

Possible side effects

How to store Celecoxib Krka

Contents of the pack and other information

1.

What Celecoxib Krka is and what it is used for

Celecoxib Krka is used in adults for the relief of signs and symptoms of

rheumatoid arthritis

osteoarthritis

ankylosing spondylitis

Celecoxib Krka belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAID)

and specifically a sub-group known as cyclooxygenase-2 (COX-2) inhibitors. Your body makes

prostaglandins that may cause pain and inflammation. In conditions such as rheumatoid arthritis and

osteoarthritis your body makes more of these. Celecoxib Krka acts by reducing the production of

prostaglandins, thereby reducing the pain and inflammation.

You should expect your medicine to start working within hours of taking the first dose, but you may

not experience a full effect for several days.

2.

What you need to know before you take Celecoxib Krka

You have been prescribed Celecoxib Krka by your doctor. The following information will help you

get the best results with Celecoxib Krka. If you have any further questions please ask your doctor or

pharmacist.

Do not take Celecoxib Krka

Tell your doctor if any of the following are true for you as patients with these conditions should

not take Celecoxib Krka.

if you are allergic to celecoxib or any of the other ingredients of this medicine (listed in section

if you have had an allergic reaction to a group of medicines called “sulfonamides” (e.g. some

antibiotics used to treat infections)

if you

currently

have an ulcer in your stomach or intestines, or bleeding in your stomach or

intestines

if as a result of taking acetylsalicylic acid or any other anti-inflammatory and pain-relieving

medicine (NSAID) you have had asthma, nose polyps, severe nose congestion, or an allergic

reaction such as an itchy skin rash, swelling of the face, lips, tongue or throat, breathing

difficulties or wheezing

if you are pregnant. If you can become pregnant during ongoing treatment you should discuss

methods of contraception with your doctor

if you are breast-feeding

if you have severe liver disease

if you have severe kidney disease

if you have an inflammatory disease of the intestines such as ulcerative colitis or Crohn’s

disease

if you have heart failure, established ischaemic heart disease or cerebrovascular disease, e.g.

you have been diagnosed with a heart attack, stroke or transient ischaemic attack (temporary

reduction of blood flow to the brain; also known as “mini-stroke”), angina or blockages of

blood vessels to the heart or brain

if you have or have had problems with your blood circulation (peripheral arterial disease) or if

you have had surgery on the arteries of your legs

Warnings and precautions

Talk to your doctor or pharmacist before taking Celecoxib Krka:

if you have

previously

had an ulcer or bleeding in your stomach or intestines.

(Do not take Celecoxib Krka

if you

currently

have an ulcer or bleeding in your stomach or

intestine)

if you are taking acetylsalicylic acid (even at low dose for heart protective purposes)

if you are taking antiplatelet therapies

if you use medicines to reduce blood clotting (e.g. warfarin/warfarin like anticoagulants or novel

oral anti-clotting medicines, e.g. apixaban)

if you use medicines called corticosteroids (e.g. prednisone)

if you are using Celecoxib Krka at the same time as other non-acetylsalicylic NSAIDs such as

ibuprofen or diclofenac. The use of these medicines together should be avoided

if you smoke, have diabetes, raised blood pressure or raised cholesterol

if your heart, liver or kidneys are not working well your doctor may want to keep a regular check

on you

if you have fluid retention (such as swollen ankles and feet)

if you are dehydrated, for instance due to sickness, diarrhoea or the use of diuretics (used to treat

excess fluid in the body)

if you have had a serious allergic reaction or a serious skin reaction to any medicines

if you feel ill due to an infection or think you have an infection, as Celecoxib Krka may mask a

fever or other signs of infection and inflammation

if you are over 65 years of age your doctor will want to monitor you regularly

the consumption of alcohol and NSAIDs may increase the risk of gastrointestinal problems

As with other NSAIDs (e.g. ibuprofen or diclofenac) this medicine may lead to an increase in blood

pressure, and so your doctor may ask to monitor your blood pressure on a regular basis.

Some cases of severe liver reactions, including severe liver inflammation, liver damage, liver failure

(some with fatal outcome or requiring liver transplant), have been reported with celecoxib. Of the

cases that reported time to onset, most severe liver reactions occurred within one month of start of

treatment.

Celecoxib Krka may make it more difficult to become pregnant. You should inform your doctor if you

are planning to become pregnant or if you have problems to become pregnant (see section on Pregnancy

and breast-feeding).

Other medicines and Celecoxib Krka

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines:

Dextromethorphan (used to treat coughs)

ACE inhibitors, angiotensin II antagonists, beta blockers and diuretics (used for high blood

pressure and heart failure)

Fluconazole and rifampicin (used to treat fungal and bacterial infections)

Warfarin or other warfarin like medicines (

blood-thinning” agents that reduce blood clotting)

including newer medicines like apixaban

Lithium (used to treat some types of depression)

Other medicines to treat depression, sleep disorders, high blood pressure or an irregular heartbeat

Neuroleptics (used to treat some mental disorders)

Methotrexate (used to treat rheumatoid arthritis, psoriasis and leukaemia)

Carbamazepine (used to treat epilepsy/seizures and some forms of pain or depression)

Barbiturates (used to treat epilepsy/seizures and some sleep disorders)

Ciclosporin and tacrolimus (used for immune system suppression e.g. after transplants)

Celecoxib Krka can be taken with low dose acetylsalicylic acid (75 mg or less daily). Ask your doctor

for advice before taking both medicines together.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Celecoxib Krka must not be used by women who are pregnant or can become pregnant

(i.e. women of

child bearing potential who are not using adequate contraception) during ongoing treatment. If you

become pregnant during treatment with Celecoxib Krka you should discontinue the treatment and

contact your doctor for alternative treatment.

Breast-feeding

Celecoxib Krka must not be used during breast-feeding.

Fertility

NSAIDs, including Celecoxib Krka, may make it more difficult to become pregnant. You should tell

your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Driving and using machines

You should be aware of how you react to Celecoxib Krka before you drive or operate machinery. If you

feel dizzy or drowsy after taking Celecoxib Krka, do not drive or operate machinery until these effects

wear off.

Celecoxib Krka contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor

before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially

‘sodium-free’.

3.

How to take Celecoxib Krka

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure. If you think or feel that the effect of Celecoxib Krka is too strong or

too weak, talk to your doctor or pharmacist.

Your doctor will tell you what dose you should take. As the risk of side effects associated with heart

problems may increase with dose and duration of use, it is important that you use the lowest dose that

controls your pain and you should not take Celecoxib Krka for longer than necessary to control

symptoms.

Celecoxib Krka should be swallowed whole with a drink of water.

The capsules can be taken at

any time of the day, with or without food. However, try to take each dose of Celecoxib Krka at the

same time each day.

Contact your doctor within two weeks of starting treatment if you do not experience any benefit.

The recommended dose is:

For osteoarthritis

the recommended dose is 200 mg each day, increased by your doctor to a

maximum of 400 mg, if needed.

The dose is usually:

one 200 mg capsule once a day; or

one 100 mg capsule twice a day.

For

rheumatoid arthritis

the recommended dose is 200 mg each day, increased by your doctor to a

maximum of 400 mg, if needed.

The dose is usually:

one 100 mg capsule twice a day.

For

ankylosing spondylitis

the recommended dose is 200 mg each day, increased by your doctor to a

maximum of 400 mg, if needed.

The dose is usually:

one 200 mg capsule once a day; or

one 100 mg capsule twice a day.

Kidney or liver problems

: make sure your doctor knows if you have liver or kidney problems as you

may need a lower dose.

The elderly, especially those with a weight less than 50 kg:

if you are over 65 years of age and

especially if you weigh less than 50 kg, your doctor may want to monitor you more closely.

Use in children

: Celecoxib Krka is for adults only, it is not for use in children.

Maximum daily dose:

You should not take more than 400 mg per day (4 capsules of Celecoxib Krka 100 mg or 2 capsules of

Celecoxib Krka 200 mg).

If you take more Celecoxib Krka than you should

You should not take more capsules than your doctor tells you to. If you take too many capsules contact

your doctor, pharmacist or hospital and take your medicine with you.

If you forget to take Celecoxib Krka

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 forgotten dose.

If you stop taking Celecoxib Krka

Suddenly stopping your treatment with Celecoxib Krka may lead to your symptoms getting worse. Do

not stop taking Celecoxib Krka unless your doctor tells you to. Your doctor may tell you to reduce the

dose over a few days before stopping completely.

If you have any further questions on the use of 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.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your

doctor or pharmacist.

The side effects listed below were observed in arthritis patients who took Celecoxib Krka. Side

effects marked with an asterisk (*) are listed below at the higher frequencies that occurred in

patients who took Celecoxib Krka to prevent colon polyps. Patients in these studies took Celecoxib

Krka at high doses and for a long duration.

If any of the following happen, stop taking Celecoxib Krka

and tell your doctor immediately:

If you have:

an allergic reaction such as skin rash, swelling of the face, wheezing or difficulty breathing

heart problems such as pain in the chest

severe stomach pain or any sign of bleeding in the stomach or intestines, such as passing black

or bloodstained stools, or vomiting blood

a skin reaction such as rash, blistering or peeling of the skin

liver failure (symptoms may include nausea (feeling sick), diarrhoea, jaundice (your skin or the

whites of your eyes look yellow))

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 build up with swollen ankles, legs and/or hands

Urinary infections

Shortness of breath*, sinusitis (sinus inflammation, sinus infection, blocked or painful sinuses),

blocked or runny nose, sore throat, coughs, colds, flu-like symptoms

Dizziness, difficulty sleeping

Vomiting*, stomach ache, diarrhoea, indigestion, wind

Rash, itching

Muscle stiffness

Difficulty swallowing*

Headache

Nausea (feeling sick)

Painful joints

Worsening of existing allergies

Accidental injury

Uncommon: may affect up to 1 in 100 people:

Stroke*

Heart failure, palpitations (awareness of heart beat), fast heart rate

Abnormalities in liver-related blood tests

Abnormalities in kidney-related blood tests

Anaemia (changes in red blood cells that can cause fatigue and breathlessness)

Anxiety, depression, tiredness, drowsiness, tingling sensations (pins and needles)

High levels of potassium in blood test results (can cause nausea (feeling sick), fatigue, muscle

weakness or palpitations)

Impaired or blurred vision, ringing in the ears, mouth pain and sores, difficulty hearing*

Constipation, burping, stomach inflammation (indigestion, stomach ache or vomiting), worsening

of inflammation of the stomach or intestine

Leg cramps

Raised itchy rash (hives)

Eye inflammation

Difficulty breathing

Skin discolouration (bruising)

Chest pain (generalised pain not related to the heart)

Face swelling

Rare: may affect up to 1 in 1,000 people:

Ulcers (bleeding) in the stomach, gullet or intestines; or rupture of the intestine (can cause

stomach ache, fever, nausea, vomiting, intestinal blockage), dark or black stools, inflammation of

the pancreas (can lead to stomach pain), inflammation of the gullet (oesophagus)

Low levels of sodium in the blood (a condition known as hyponatraemia)

Reduced number of white blood cells (which help protect the body from infection) and blood

platelets (increased chance of bleeding or bruising)

Difficulty coordinating muscular movements

Feeling confused, changes in the way things taste

Increased sensitivity to light

Loss of hair

Hallucinations

Bleeding in the eye

Acute reaction that may lead to lung inflammation

Irregular heartbeat

Flushing

Blood clot in the blood vessels in the lungs. Symptoms may include sudden breathlessness, sharp

pains when you breathe or collapse

Bleeding of the stomach or intestines (can lead to bloody stools or vomiting), inflammation of the

intestine or colon

Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling sick), diarrhoea,

jaundice (yellow discolouration of the skin or eyes), dark urine, pale stools, bleeding easily,

itching or chills

Acute kidney failure

Menstrual disturbances

Swelling of the face, lips, mouth, tongue or throat, or difficulty swallowing

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

Serious allergic reactions (including potentially fatal anaphylactic shock)

Serious skin conditions such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic

epidermal necrolysis (can cause rash, blistering or peeling of the skin) and acute generalised

exanthematous pustulosis (symptoms include the skin becoming red with swollen areas covered

in numerous small pustules)

A delayed allergic reaction with possible symptoms such as rash, swelling of the face, fever,

swollen glands and abnormal test results (e.g., liver, blood cell (eosinophilia, a type of raised

white blood cell count))

Bleeding within the brain causing death

Meningitis (inflammation of the membrane around 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 (feeling sick), diarrhoea, jaundice

(yellow discolouration of the skin or eyes), dark urine, pale stools, bleeding easily, itching or

chills

Liver problems (such as cholestasis and cholestatic hepatitis, which may be accompanied by

symptoms such as discoloured stools, nausea and yellowing of the skin or eyes)

Inflammation of the kidneys and other kidney problems (such as nephrotic syndrome and minimal

change disease, which may be accompanied by symptoms such as water retention (oedema),

foamy urine, fatigue and a loss of appetite)

Worsening of epilepsy (possible more frequent and/or severe seizures)

Blockage of an artery or vein in the eye leading to partial or complete loss of vision

Inflamed blood vessels (can cause fever, aches, purple blotches on the skin)

A reduction in the number of red and white blood cells and platelets (may cause tiredness, easy

bruising, frequent nose bleeds and increased risk of infections)

Muscle pain and weakness

Impaired sense of smell

Loss of taste

Not known: frequency

cannot be estimated from the available data:

Decreased fertility in females, which is usually reversible on discontinuation of the medicine

In clinical studies not associated with Arthritis or other arthritic conditions, where Celecoxib

Krka was taken at doses of 400 mg per day for up to 3 years, the following additional side effects

have been observed:

Common: may affect up to 1 in 10 people:

Heart problems: angina (chest pain)

Stomach problems: irritable bowel syndrome (can include stomach ache, diarrhoea, indigestion,

wind)

Kidney stones (which may lead to stomach or back pain, blood in urine), difficulty passing urine

Weight gain

Uncommon: may affect up to 1 in 100 people:

Deep vein thrombosis (blood clot usually in the leg, which may cause pain, swelling or redness

of the calf or breathing problems)

Stomach problems: stomach infection (which can cause irritation and ulcers of the stomach and

intestines),

Lower limb fracture

Shingles, skin infection, eczema (dry itchy rash), pneumonia (chest infection (possible cough,

fever, difficulty breathing))

Floaters in the eye causing blurred or impaired vision, vertigo due to inner ear troubles, sore,

inflamed or bleeding gums, mouth sores

Excessive urination at night, bleeding from piles/ haemorrhoids, frequent bowel movements

Fatty lumps in skin or elsewhere, ganglion cyst (harmless swellings on or around joints and

tendons in the hand or foot), difficulty speaking, abnormal or very heavy bleeding from the

vagina, breast pain

High levels of sodium in blood test results

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

E-mail: medsafety@hpra.ie

By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Celecoxib Krka

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 box and blister after EXP. The

expiry date refers to the last day of that month.

Do not store above 25

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Celecoxib Krka contains

The active substance is celecoxib.

Each 100 mg hard capsule contains 100 mg celecoxib.

Each 200 mg hard capsule contains 200 mg celecoxib.

The other ingredients (excipients) of 100 mg hard capsule are: lactose monohydrate, povidone

K30, croscarmellose sodium, sodium laurilsulfate and magnesium stearate (E470b) in the

capsule core and gelatin and titanium dioxide (E171) in the capsule shell.

The other ingredients (excipients) of 200 mg hard capsule are: lactose monohydrate, povidone

K30, croscarmellose sodium, sodium laurilsulfate and magnesium stearate (E470b) in the

capsule core and gelatin, titanium dioxide (E171) and iron oxide, yellow (E172) in the capsule

shell.

What Celecoxib Krka looks like and contents of the pack

The body and the cap of 100 mg hard capsules are white, of length 15.4 mm – 16.2 mm. The capsules

contain white or almost white granulate.

The body and the cap of 200 mg hard capsules are brownish yellow, of length 18.9 mm – 19.7 mm.

The capsules contain white or almost white granulate.

The 100 mg and 200 mg capsules are available in boxes of 10, 20, 30, 40, 50, 60, 90 and 100 capsules

in blister packs.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven , Germany

This medicinal product is authorised in the Member States of the EEA under the following

names:

Estonia, Latvia, Lithuania,

Slovenia, Slovakia, Czech

Republic, Poland, Hungary,

Romania, Bulgaria, Malta

Aclexa

Germany

Celecoxib TAD

Italy, Spain, Portugal, Denmark,

Sweden, Finland, Ireland,

Belgium, Netherlands

Celecoxib Krka

France

CÉLÉCOXIB HCS

United Kingdom

Celecoxib

This leaflet was last revised in

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Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Celecoxib Krka 100mg capsules, hard

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each hard capsule contains 100 mg celecoxib.

Excipient with known effect:

Lactose: 24 mg

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Capsule, hard (capsule)

Each capsule has a white body and the cap, of length 15.4 mm – 16.2 mm; the capsules contain white or almost white granulate.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Celecoxib Krka is indicated in adults for the symptomatic relief in the treatment of osteoarthritis, rheumatoid arthritis and

ankylosing spondylitis.

The decision to prescribe a selective cyclooxygenase-2 (COX-2) inhibitor should be based on an assessment of the individual

patient's overall risks (see sections 4.3 and 4.4).

4.2 Posology and method of administration

Posology

As the cardiovascular (CV) risks of celecoxib may increase with dose and duration of exposure, the shortest duration possible

and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should

be re-evaluated periodically, especially in patients with osteoarthritis (see sections 4.3, 4.4, 4.8 and 5.1).

Osteoarthritis

The usual recommended daily dose is 200 mg taken once daily or in two divided doses. In some patients, with insufficient

relief from symptoms, an increased dose of 200 mg twice daily may increase efficacy. In the absence of an increase in

therapeutic benefit after two weeks, other therapeutic options should be considered.

Rheumatoid arthritis

The initial recommended daily dose is 200 mg taken in two divided doses. The dose may, if needed, later be increased to

200 mg twice daily. In the absence of an increase in therapeutic benefit after two weeks, other therapeutic options should be

considered.

Ankylosing Spondylitis

The recommended daily dose is 200 mg taken once daily or in two divided doses. In a few patients, with insufficient relief

from symptoms, an increased dose of 400 mg once daily or in two divided doses may increase efficacy. In the absence of

an increase in therapeutic benefit after two weeks, other therapeutic options should be considered.

The maximum recommended daily dose is 400 mg for all indications.

Special populations

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Elderly

As in younger adults, 200 mg per day should be used initially. The dose may, if needed, later be increased to 200 mg twice

daily. Particular caution should be exercised in elderly with a body weight less than 50 kg. (see sections 4.4 and 5.2).

Hepatic impairment

Treatment should be initiated at half the recommended dosein patients with establishedmoderate liver impairment with a

serumalbumin of25-35 g/l. Experience in such patients is limited to cirrhotic patients (see sections 4.3, 4.4 and 5.2).

Renal impairment

Experience with celecoxib in patients with mild or moderate renal impairment is limited; therefore such patients should be

treated with caution (see sections 4.3, 4.4 and 5.2).

Paediatric population

Celecoxib is not indicated for use in children.

CYP2C9 poor metabolisers

Patients who are known, or suspected to be CYP2C9 poor metabolisers based on genotyping or previous history/experience

with other CYP2C9 substrates should be administered celecoxib with caution as the risk of dose-dependent adverse effects is

increased. Consider reducing the dose to half the lowest recommended dose(see section 5.2).

Method of administration

Oral use

Capsules should be swallowed whole with a drink of water.

Celecoxib Krka may be taken with or without food.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Known hypersensitivity to sulfonamides.

Active peptic ulceration or gastrointestinal (GI) bleeding.

Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type

reactions after taking acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2

inhibitors.

In pregnancy and in women of childbearing potential unless using an effective method of contraception (see section 4.6).

Celecoxib has been shown to cause malformations in the two animal species studied (see sections 4.6 and 5.3). The potential

for human risk in pregnancy is unknown, but cannot be excluded.

Breast-feeding (see sections 4.6 and 5.3).

Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ≥10).

Patients with estimatedcreatinine clearance <30 ml/min.

Inflammatory bowel disease.

Congestive heart failure (NYHA II-IV).

Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.

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4.4 Special warnings and precautions for use

Gastrointestinal (GI) effects

Upper and lower gastrointestinal complications [perforations, ulcers or bleedings (PUBs)], some of them resulting in fatal

outcome, have occurred in patients treated with celecoxib. Caution is advised with treatment of patients most at risk of

developing a gastrointestinal complication with NSAIDs; the elderly, patients using any other NSAID or antiplatelet drugs (such

as acetylsalicylic acid) or glucocorticoids concomitantly, patients using alcohol, or patients with a prior history of

gastrointestinal disease, such as ulceration and GI bleeding.

There is further increase in the risk of gastrointestinal adverse effects for celecoxib(gastrointestinal ulceration or other

gastrointestinal complications), when celecoxib is taken concomitantly with acetylsalicylic acid (even at low doses).

A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs. NSAIDs + acetylsalicylic acid has

not been demonstrated in long-term clinical trials (see section 5.1).

Concomitant NSAID use

The concomitant use of celecoxib and a non-aspirin NSAID should be avoided.

Cardiovascular effects

Increased number of serious cardiovascular (CV) events, mainly myocardial infarction, has been found in a long-term

placebo-controlled study in subjects with sporadic adenomatous polyps treated with celecoxib at doses of 200 mg BID and

400 mg BID compared to placebo (see section 5.1).

As the cardiovascular risks of celecoxib may increase with dose and duration of exposure, the shortest duration possible and

the lowest effective daily dose should be used. NSAIDs, including COX-2 selective inhibitors, have been associated with

increased risk of cardiovascular and thrombotic adverse events when taken long term. The exact magnitude of the risk

associated with a single dose has not been determined, nor has the exact duration of therapy associated with increased

risk.The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in

patients with osteoarthritis (see sections 4.2, 4.3, 4.8 and 5.1).

Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking)

should only be treated with celecoxib after careful consideration (see section 5.1).

COX-2 selective inhibitors are not a substitute for acetylsalicylic acid for prophylaxis of cardiovascular thrombo-embolic

diseases because of their lack of antiplatelet effects. Therefore, antiplatelet therapies should not be discontinued (see section

5.1).

Fluid retention and oedema

As with other medicinal products known to inhibit prostaglandin synthesis, fluid retention and oedema have been observed in

patients taking celecoxib. Therefore, celecoxib should be used with caution in patients with history of cardiac failure, left

ventricular dysfunction or hypertension, and in patients with pre-existing oedema from any other reason, since prostaglandin

inhibition may result in deterioration of renal function and fluid retention. Caution is also required in patients taking diuretic

treatment or otherwise at risk of hypovolaemia.

Hypertension

As with all NSAIDS, celecoxib can lead to the onset of new hypertension or worsening of pre-existing hypertension, either of

which may contribute to the increased incidence of cardiovascular events. Therefore, blood pressure should be monitored

closely during the initiation of therapy with celecoxib and throughout the course of therapy.

Hepatic and renal effects

Compromised renal or hepatic function and especially cardiac dysfunction are more likely in the elderly and therefore medically

appropriate supervision should be maintained.

NSAIDs, including celecoxib, may cause renal toxicity. Clinical trials with celecoxib have shown renal effects similar to those

observed with comparator NSAIDs. Patients at greatest risk for renal toxicity are those with impaired renal function, heart

failure, liver dysfunction, those taking diuretics, angiotensin converting enzyme (ACE)-inhibitors, angiotensin II receptor

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antagonists, and the elderly (see section 4.5). Such patients should be carefully monitored while receiving treatment with

celecoxib.

Some cases of severe hepatic reactions, including fulminant hepatitis (some with fatal outcome), liver necrosis and hepatic

failure (some with fatal outcome or requiring liver transplant), have been reported with celecoxib. Among the cases that

reported time to onset, most of the severe adverse hepatic events developed within one month after initiation of celecoxib

treatment (see section 4.8).

If during treatment, patients deteriorate in any of the organ system functions described above, appropriate measures should

be taken and discontinuation of celecoxib therapy should be considered.

CYP2D6 inhibition

Celecoxib inhibits CYP2D6. Although it is not a strong inhibitor of this enzyme, a dose reduction may be necessary for

individually dose-titrated medicinal products that are metabolised by CYP2D6 (see section 4.5).

CYP2C9 poor metabolisers

Patients known to be CYP2C9 poor metabolisers should be treated with caution (see section 5.2).

Skin and systemic hypersensitivity reactions

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal

necrolysis have been reported very rarely in association with the use of celecoxib (see section 4.8). Patients appear to be at

highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within

the first month of treatment. Serious hypersensitivity reactions (including anaphylaxis, angioedema and drug rash with

eosinophilia and systemic symptoms (DRESS), or hypersensitivity syndrome) have been reported in patients receiving celecoxib

(see section 4.8). Patients with a history of sulfonamide allergy or any drug allergy may be at greater risk of serious skin

reactions or hypersensitivity reactions (see section 4.3). Celecoxib should be discontinued at the first appearance of skin rash,

mucosal lesions, or any other sign of hypersensitivity.

General

Celecoxib may mask fever and other signs of inflammation.

Use with oral anticoagulants

In patients on concurrent therapy with warfarin, serious bleeding events, some of them fatal, have been reported. Increased

prothrombin time (INR) with concurrent therapy has been reported. Therefore, this should be closely monitored in patients

receiving warfarin/coumarin-type oral anticoagulants, particularly when therapy with celecoxib is initiated or celecoxib dose is

changed (see section 4.5). Concomitant use of anticoagulants with NSAIDS may increase the risk of bleeding.

Caution should be exercised when combining celecoxib with warfarin or other oral anticoagulants, including novel

anticoagulants (e.g. apixaban, dabigatran, and rivaroxaban).

Excipients

Celecoxib Krka contains lactose and sodium.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption

should not take this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free'.

4.5 Interaction with other medicinal products and other forms of interactions

Pharmacodynamic interactions

Anticoagulants

Anticoagulant activity should be monitored particularly in the first few days after initiating or changing the dose of celecoxib in

patients receiving warfarin or other anticoagulants since these patients have an increased risk of bleeding complications.

Therefore, patients receiving oral anticoagulants should be closely monitored for their prothrombin time INR, particularly in the

first few days when therapy with celecoxib is initiated or the dose of celecoxib is changed (see section 4.4). Bleeding events in

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association with increases in prothrombin time have been reported, predominantly in the elderly, in patients receiving

celecoxib concurrently with warfarin, some of them fatal.

Anti-hypertensives

NSAIDs may reduce the effect of anti-hypertensive medicinal products including ACE-inhibitors, angiotensin II receptor

antagonists, diuretics and beta-blockers. As for NSAIDs, the risk of acute renal insufficiency, which is usually reversible, may be

increased in some patients with compromised renal function (e.g. dehydrated patients, patients on diuretics, or elderly patients)

when ACE-inhibitors, angiotensin II receptor antagonists, and/or diuretics are combined with NSAIDs, including celecoxib (see

section 4.4). Therefore, the combination should be administered with caution, especially in the elderly. Patients should be

adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy,

and periodically thereafter.

In a 28-day clinical study in patients with lisinopril-controlled Stage I and II hypertension, administration of celecoxib

200 mg BID resulted in no clinically significant increases, when compared to placebo treatment, in mean daily systolic or

diastolic blood pressure as determined using 24-hour ambulatory blood pressure monitoring. Among patients treated with

celecoxib 200 mg BID, 48% were considered unresponsive to lisinopril at the final clinic visit (defined as either cuff diastolic

blood pressure >90 mmHg or cuff diastolic blood pressure increased >10% compared to baseline), compared to 27% of

patients treated with placebo; this difference was statistically significant.

Ciclosporin and tacrolimus

Co-administration of NSAIDs and ciclosporin or tacrolimus may increase the nephrotoxic effect of ciclosporin or tacrolimus,

respectively. Renal function should be monitored when celecoxib and any of these medicinal products are combined.

Acetylsalicylic acid

Celecoxib can be used with low-dose acetylsalicylic acid but is not a substitute for acetylsalicylic acid for CV prophylaxis.In the

submitted studies, as with other NSAIDs, an increased risk of gastrointestinal ulceration or other gastrointestinal complications

compared to use of celecoxib alone was shown for concomitant administration of low-dose acetylsalicylic acid (see section 5.1).

Pharmacokinetic interactions

Effects of celecoxib on other medicinal products

CYP2D6 inhibition

Celecoxib is an inhibitor of CYP2D6. The plasma concentrations of medicinal products that are substrates of this enzyme may

be increased when celecoxib is used concomitantly. Examples of medicinal products which are metabolised by CYP2D6 are

antidepressants (tricyclics and SSRIs), neuroleptics, anti-arrhythmic medicinal products, etc. The dose of individually

dose-titrated CYP2D6 substrates may need to be reduced when treatment with celecoxib is initiated or increased if treatment

with celecoxib is terminated.

Concomitant administration of celecoxib 200 mg twice daily resulted in 2.6-fold and 1.5-fold increases in plasma

concentrations of dextromethorphan and metoprolol (CYP2D6 substrates), respectively. These increases are due to celecoxib

inhibition of the CYP2D6 substrate metabolism.

CYP2C19 inhibition

In vitro studies have shown some potential for celecoxib to inhibit CYP2C19 catalysed metabolism. The clinical significance of

this in vitro finding is unknown. Examples of medicinal products which are metabolised by CYP2C19 are diazepam, citalopram

and imipramine.

Oral contraceptives

In an interaction study, celecoxib had no clinically relevant effects on the pharmacokinetics of oral contraceptives (1 mg

norethistherone /35 microg ethinylestradiol).

Glibenclamide/tolbutamide

Celecoxib does not affect the pharmacokinetics of tolbutamide (CYP2C9 substrate), or glibenclamideto a clinically relevant

extent.

Methotrexate

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In patients with rheumatoid arthritis celecoxib had no statistically significant effect on the pharmacokinetics (plasma or renal

clearance) of methotrexate (in rheumatologic doses). However, adequate monitoring for methotrexate-related toxicity should

be considered when combining these two medicinal products.

Lithium

In healthy subjects, co-administration of celecoxib 200 mg twice daily with 450 mg twice daily of lithium resulted in a mean

increase in Cmax of 16% and in area under the curve (AUC) of 18% of lithium. Therefore, patients on lithium treatment should

be closely monitored when celecoxib is introduced or withdrawn.

Effects of other medicinal products on celecoxib

CYP2C9 poor metabolisers

In individuals who are CYP2C9 poor metabolisers and demonstrate increased systemic exposure to celecoxib, concomitant

treatment with CYP2C9 inhibitors such as fluconazole could result in further increases in celecoxib exposure. Such

combinations should be avoided in known CYP2C9 poor metabolisers (see sections 4.2 and 5.2).

CYP2C9 inhibitors and inducers

Since celecoxib is predominantly metabolised by CYP2C9 it should be used at half the recommended dose in patients receiving

fluconazole. Concomitant use of 200 mg single dose of celecoxib and 200 mg once daily of fluconazole, a potent CYP2C9

inhibitor, resulted in a mean increase in celecoxib Cmax of 60% and in AUC of 130%. Concomitant use of inducers of CYP2C9

such as rifampicin, carbamazepine and barbiturates may reduce plasma concentrations of celecoxib.

Ketoconazole and antacids

Ketoconazole or antacids have not been observed to affect the pharmacokinetics of celecoxib.

Paediatric population

Interaction studies have only been performed in adults.

4.6 Fertility, pregnancy and lactation

Pregnancy

Studies in animals (rats and rabbits) have shown reproductive toxicity, including malformations (see sections 4.3 and 5.3).

Inhibition of prostaglandin synthesis might adversely affect pregnancy. Data from epidemiological studies suggest an

increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. The potential for

human risk in pregnancy is unknown, but cannot be excluded. Celecoxib, as with other medicinal products inhibiting

prostaglandin synthesis, may cause uterine inertia and premature closure of the ductus arteriosus during the last trimester.

During the second or third trimester of pregnancy, NSAIDs including celecoxib may cause fetal renal dysfunction which may

result in reduction of amniotic fluid volume or oligohydramnios in severe cases. Such effects may occur shortly after treatment

initiation and are usually reversible.

Celecoxib is contraindicated in pregnancy and in women who can become pregnant (see sections 4.3 and 4.4). If a woman

becomes pregnant during treatment, celecoxib should be discontinued.

Breast-feeding

Celecoxib is excreted in the milk of lactating rats at concentrations similar to those in plasma. Administration of celecoxib to a

limited number of lactating women has shown a very low transfer of celecoxib into breast milk. Women who take celecoxib

should not breast-feed.

Fertility

Based on the mechanism of action, the use of NSAIDs, including celecoxib, may delay or prevent rupture of ovarian follicles,

which has been associated with reversible infertility in some women.

4.7 Effects on ability to drive and use machines

Patients who experience dizziness, vertigo or somnolence while taking celecoxib should refrain from driving or operating

machinery.

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4.8 Undesirable effects

Adverse reactions are listed by system organ class and ranked by frequency in Table 1

, reflecting data from the following

sources:

- Adverse reactions reported in osteoarthritis patients and rheumatoid arthritis patients at incidence rates greater than 0.01%

and greater than those reported for placebo during 12 placebo- and/or active-controlled clinical trials of duration up to 12

weeks at celecoxib daily doses from 100 mg up to 800 mg. In additional studies using non-selective NSAID comparators,

approximately 7400 arthritis patients have been treated with celecoxib at daily doses up to 800 mg, including approximately

2300 patients treated for 1 year or longer. The adverse reactions observed with celecoxib in these additional studies were

consistent with those for osteoarthritis and rheumatoid arthritis patients listed in Table 1.

- Adverse reactions reported at incidence rates greater than placebo for subjects treated with celecoxib 400 mg daily in

long-term polyp prevention trials of duration up to 3 years (the Adenoma Prevention with Celecoxib (APC) and Prevention of

Colorectal Sporadic Adenomatous Polyps (PreSAP) trials; see section 5.1 Cardiovascular safety – long-term studies involving

patients with sporadic adenomatous polyps).

- Adverse drug reactions from post-marketing surveillance as spontaneously reported during a period in which an estimated >

70 million patients were treated with celecoxib (various doses, durations, and indications). Even though these were identified as

reactions from post-marketing reports, trial data was consulted to estimate frequency. Frequencies are based on a cumulative

meta-analysis with pooling of trials representing exposure in 38102 patients.

The following table summarises adverse drug reactions of celecoxib divided into groups according to MedDRA terminology

together with their frequency:

- Very common (≥ 1/10)

- Common (≥ 1/100 to < 1/10)

- Uncommon (≥ 1/1,000 to < 1/100)

- Rare (≥ 1/10,000 to < 1/1,000)

- Very rare (< 1/10,000)

- Not known (cannot be estimated from the available data)

Table 1. Adverse Drug Reactions in Celecoxib Clinical Trials and Surveillance Experience (MedDRA Preferred Terms)

1,2

Very

Common

Common

Uncommon

Rare

Very rare

Not

known

Infections and

infestations

Sinusitis,

upper

respiratory

tract infection,

pharyngitis,

urinary

tract infection

Blood and

lymphatic

system disorders

Anaemia

Leucopenia,

thrombocytopenia

Pancytopenia

Immune system

disorders

Hypersensitivit

Anaphylactic

shock

anaphylactic

reaction

Metabolism and

nutrition

disorders

Hyperkalaemia

Psychiatric

disorders

Insomnia

Anxiety,

depression,

fatigue

Confusional state,

hallucinations

Nervous system

disorders

Dizziness,

hypertonia,

headache

Cerebral

infarction

paraesthesia,

somnolence

Ataxia, dysgeusia

Haemorrhage

intracranial

(including fatal

intracranial

haemorrhage)

meningitis aseptic

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epilepsy (including

aggravated

epilepsy)

ageusia

, anosmia

Eye disorders

Vision blurred,

conjunctivitis

Eye haemorrhage

Retinal artery

occlusion

, retinal

vein occlusion

Ear and

labyrinth

disorders

Tinnitus,

hypoacusis

Cardiac

disorders

Myocardial

infarction

Cardiac failure,

palpitations,

tachycardia

Arrhythmia

Vascular

disorders

Hypertension

(including

aggravated

hypertension)

Pulmonary

embolism

flushing

Vasculitis

Respiratory,

thoracic and

mediastinal

disorders

Rhinitis, cough,

dyspnoea

Bronchospasm

Pneumonitis

Gastrointestinal

disorders

Nausea

abdominal

pain,

diarrhoea,

dyspepsia,

flatulence,

vomiting

dysphagia

Constipation,

gastritis,

stomatitis,

gastrointestinal

inflammation

(including

aggravation of

gastrointestinal

inflammation),

eructation

Gastro-intestinal

haemorrhage

duodenal ulcer,

gastric ulcer,

oesophageal ulcer,

intestinal ulcer,

large intestinal

ulcer, intestinal

perforation,

oesophagitis,

melaena;

pancreatitis,

colitis

Hepatobiliary

disorders

Hepatic

function

abnormal,

hepatic enzyme

increased

(including

increased SGOT

and SGPT)

Hepatitis

Hepatic failure

(sometimes fatal or

requiring liver

transplant),

hepatitis fulminant

(some with fatal

outcome), hepatic

necrosis

cholestasis

hepatitis

cholestatic

jaundice

Skin and

subcutaneous

tissue disorders

Rash, pruritus

(includes

pruritus

generalised)

Urticaria,

ecchymosis

Angioedema

alopecia,

photosensitivity

Dermatitis

exfoliative

erythema

multiforme

Stevens-Johnson

syndrome

, toxic

epidermal

necrolysis

, drug

reaction with

eosinophilia and

systemic symptoms

(DRESS)

, acute

generalised

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exanthematous

pustulosis (AGEP)

dermatitis bullous

Musculoskeletal

and connective

tissue disorders

Arthralgia

Muscle spasms

(leg cramps)

Myositis

Renal and

urinary

disorders

Blood

creatinine

increased,

blood urea

increased

Renal failure

acute

hyponatraemia

Tubulointerstitial

nephritis

nephrotic

syndrome

glomerulonephritis

minimal lesion

Reproductive

system and

breast disorders

Menstrual

disorder

Infertility

female

(female

fertility

decreased)

General

disorders and

administration

site conditions

Influenza-like

illness,

oedema

peripheral/

fluid retention

Face oedema,

chest pain

Injury,

poisoning and

procedural

complications

Injury

(accidental

injury)

Adverse drug reactions that occurred in polyp prevention trials, representing subjects treated with

celecoxib 400 mg daily in 2 clinical trials of duration up to 3 years (the APC and PreSAP trials). The adverse

drug reactions listed above for the polyp prevention trials are only those that have been previously

recognized in the post-marketing surveillance experience, or have occurred more frequently than in the

arthritis trials. ​

Furthermore, the following

previously unknown

adverse reactions occurred in polyp prevention trials,

representing subjects treated with celecoxib 400 mg daily in 2 clinical trials of duration up to 3 years (the

APC and PreSAP trials):

Common:

angina pectoris, irritable bowel syndrome, nephrolithiasis, blood creatinine increased, benign

prostatic hyperplasia, weight increased.

Uncommon:

helicobacter infection, herpes zoster, erysipelas,

bronchopneumonia, labyrinthitis, gingival infection, lipoma, vitreous floaters, conjunctival haemorrhage,

deep

vein

thrombosis,

dysphonia,

haemorrhoidal

haemorrhage,

frequent

bowel

movements,

mouth

ulceration, allergic dermatitis, ganglion, nocturia, vaginal haemorrhage, breast tenderness, lower limb

fracture, blood sodium increased.

Women intending to become pregnant are excluded from all trials, thus consultation of the trial database

for the frequency of this event was not reasonable. ​

Frequencies are based on cumulative meta-analysis with pooling of trials representing exposure in 38102

patients. ​

In final data (adjudicated) from the APC and PreSAP trials in patients treated with celecoxib 400 mg daily for up to 3 years

(pooled data from both trials; see section 5.1 for results from individual trials), the excess rate over placebo for myocardial

infarction was 7.6 events per 1000 patients (uncommon) and there was no excess rate for stroke (types not differentiated) over

placebo.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected

adverse reactions via the national reporting system:

HPRA Pharmacovigilance

Website: www.hpra.ie

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4.9 Overdose

There is no clinical experience of overdose. Single doses up to 1200 mg and multiple doses up to 1200 mg twice daily have

been administered to healthy subjects for nine days without clinically significant adverse effects.

Management

In the event of suspected overdose, appropriate supportive medical care should be provided e.g. by eliminating the gastric

contents, clinical supervision and, if necessary, the institution of symptomatic treatment. Dialysis is unlikely to be an efficient

method of medicinal product removal due to high protein binding.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: antiinflammatory and antirheumatic products, non-steroids, coxibs; ATC code: M01AH01.

Mechanism of action

Celecoxib is an oral, selective, cyclooxygenase-2 (COX-2) inhibitor within the clinical dose range (200-400 mg daily). No

statistically significant inhibition of COX-1 (assessed as ex vivo inhibition of thromboxane B

[TxB

] formation) was observed in

this dose range in healthy volunteers.

Pharmacodynamic effects

Cyclooxygenase is responsible for generation of prostaglandins. Two isoforms, COX-1 and COX-2, have been identified. COX-2

is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be

primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. COX-2 is also involved in

ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and central nervous system functions

(fever induction, pain perception and cognitive function). It may also play a role in ulcer healing. COX-2 has been identified in

tissue around gastric ulcers in humans but its relevance to ulcer healing has not been established.

The difference in antiplatelet activity between some COX‑1 inhibiting NSAIDs and COX‑2 selective inhibitors may be of clinical

significance in patients at risk of thrombo-embolic reactions. COX-2 selective inhibitors reduce the formation of systemic (and

therefore possibly endothelial) prostacyclin without affecting platelet thromboxane.

Celecoxib is a diaryl-substituted pyrazole, chemically similar to other non-arylamine sulfonamides (e.g. thiazides, furosemide)

but differs from arylamine sulfonamides (e.g. sulfamethoxizole and other sulfonamide antibiotics).

A dose dependent effect on TxB

formation has been observed after high doses of celecoxib. However, in healthy subjects, in

small multiple dose studies with 600 mg BID (three times the highest recommended dose) celecoxib had no effect on platelet

aggregation and bleeding time compared to placebo.

Clinical efficacy and safety

Several clinical studies have been performed confirming efficacy and safety in osteoarthritis, rheumatoid arthritis and

ankylosing spondylitis. Celecoxib was evaluated for the treatment of the inflammation and pain of OA of the knee and hip in

approximately 4200 patients in placebo and active controlled trials of up to 12 weeks duration. It was also evaluated for

treatment of the inflammation and pain of RA in approximately 2100 patients in placebo and active controlled trials of up to 24

weeks duration. Celecoxib at daily doses of 200 mg – 400 mg provided pain relief within 24 hours of dosing. Celecoxib was

evaluated for the symptomatic treatment of ankylosing spondylitis in 896 patients in placebo and active controlled trials of up

to 12 weeks duration. Celecoxib at doses of 100 mg BID, 200 mg QD, 200 mg BID and 400 mg QD in these studies

demonstrated significant improvement in pain, global disease activity and function in ankylosing spondylitis.

Five randomised double-blind controlled studies have been conducted including scheduled upper gastrointestinal endoscopy

in approximately 4500 patients free from initial ulceration (celecoxib doses from 50 mg-400 mg BID). In twelve week

endoscopy studies celecoxib (100-800 mg per day) was associated with a significantly lower risk of gastroduodenal ulcers

compared with naproxen (1000 mg per day) and ibuprofen (2400 mg per day). The data were inconsistent in comparison with

diclofenac (150 mg per day). In two of the 12-week studies the percentage of patients with endoscopic gastroduodenal

ulceration was not significantly different between placebo and celecoxib 200 mg BID and 400 mg BID.

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