CELECOXIB

Main information

  • Trade name:
  • CELECOXIB RBX celecoxib 100 mg capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CELECOXIB RBX celecoxib 100 mg capsule blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 212791
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

212791

CELECOXIB RBX celecoxib 100 mg capsule blister pack

ARTG entry for

Medicine Registered

Sponsor

Sun Pharma ANZ Pty Ltd

Postal Address

Suite 2 02 Level 2 12 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

29/05/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. CELECOXIB RBX celecoxib 100 mg capsule blister pack

Product Type

Single Medicine Product

Effective date

8/09/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

For the symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.,For the treatment of primary dysmenorrhoea in

adults.,For the short-term treatment of acute pain in adults following surgery or musculoskeletal and/or soft tissue injury.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PCTFE (Aclar)/Al

18 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. CELECOXIB RBX celecoxib 100 mg capsule blister pack

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Opaque, white to off-white capsules imprinted with 'CC' and '100' in black

ink.

Active Ingredients

Celecoxib

100 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 11:59:08 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

CELECOXIB RBX CMI Version 1

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CELECOXIB RBX

Celecoxib

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about CELECOXIB RBX. It does not contain

all the available information. It does not take the place of talking to your doctor or

pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you

taking CELECOXIB RBX against the benefits it is expected to have for you.

This leaflet was last updated on the date at the end of this leaflet. More recent information

may be available. The latest Consumer Medicine Information is available from

https://www.ebs.tga.gov.au/ and may contain important information about the medicine and

its use of which you should be aware.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Read this leaflet carefully before you start CELECOXIB RBX and keep it with the

medicine.

You may need to read it again.

What CELECOXIB RBX is used for

CELECOXIB RBX is used to relieve the symptoms of joint pain, tenderness, swelling and

stiffness in:

osteoarthritis

rheumatoid arthritis and

ankylosing spondylitis, a chronic inflammatory rheumatic disorder that primarily

affects, but is not limited to, the spine.

CELECOXIB RBX also provides short-term pain relief in conditions such as:

menstrual cramps or period pain

after surgery

muscle and joint injuries.

CELECOXIB RBX belongs to a group of medicines called Coxibs which are used to relieve

pain and inflammation in a number of conditions.

Although CELECOXIB RBX can relieve the symptoms of pain and inflammation, it will not

cure your condition.

Your doctor, however, may have prescribed CELECOXIB RBX for another purpose.

Ask your doctor if you have any questions about why CELECOXIB RBX has been

prescribed for you.

CELECOXIB RBX is not recommended for use in children or adolescents under 18 years of

age. This medicine is only available with a doctor's prescription.

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Before you take CELECOXIB RBX

When you must not take it

Do not take CELECOXIB RBX if:

your doctor has told you that you have severe heart or blood vessel disease

affecting the circulation in your brain or limbs

you have severe liver problems

Your doctor will decide if your condition is too severe to take this medicine.

you have problems with your kidney function

you have had an attack of asthma, hives, itching, skin rash or a runny nose after

taking aspirin or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs, medicines

used to treat pain and inflammation), including other Coxib medicines

Many medicines used to treat headache, period pain and other aches and pains contain

aspirin or an NSAID.

If you are allergic to aspirin, NSAIDs, or other Coxib medicines and use

CELECOXIB RBX, these symptoms may be severe.

you have an allergy to:

CELECOXIB RBX

any of the ingredients listed at the end of this leaflet

sulfonamides, a group of medicines which include, for example, certain

antibiotics (if you are not sure if you are taking one of these medicines ask

your Pharmacist).

Symptoms of an allergic reaction to these medicines may include:

asthma, wheezing or shortness of breath

swelling of the face, lips or tongue which may cause difficulty in swallowing or

breathing

hives, itching or skin rash

fainting.

If you are allergic to sulfonamides or any of the capsule ingredients and take CELECOXIB

RBX, these symptoms may be severe.

Ask your doctor or pharmacist if any of this applies to you.

you are already taking an NSAID

you have an ulcer or gastric bleeding

you have Irritable Bowel Disease

you have heart failure

the expiry date printed on the packaging has passed, even though the capsules

may look alright

If you take this medicine after the expiry date has passed, it may not work as well.

the packaging is torn or shows signs of tampering.

If you are not sure if you should be taking CELECOXIB RBX, talk to your doctor.

Before you start to take it

You must tell your doctor if:

CELECOXIB RBX CMI Version 1

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you currently have diabetes, high blood pressure, high cholesterol levels, heart

failure or have a history of heart problems or stroke, or problems with the

circulation in your limbs

you have any allergies to:

any other medicines

any other substances such as foods, dyes or preservatives.

you are pregnant or intend to become pregnant

Related medicines, NSAIDs, have been associated with reversible infertility in some

women.

Use of NSAIDs in early pregnancy can increase the risk of spontaneous abortion.

There is no information on the use of CELECOXIB RBX during pregnancy.

CELECOXIB RBX may affect your developing baby if taken in the last 3 months of

pregnancy.

CELECOXIB RBX use is not recommended in pregnancy unless your doctor

considers it essential.

Discuss this with your doctor.

you are breast-feeding or intend to breast-feed

CELECOXIB RBX passes into breast milk in small amounts, therefore, the use of

CELECOXIB RBX during breastfeeding should be discussed with your doctor.

you have any other health problems including:

liver or kidney problems

asthma, hives, itching, skin rash or a runny nose

high blood pressure or fluid retention

peptic ulcer (i.e. stomach or duodenal ulcer), a recent history of one, or have

had peptic ulcers before vomiting blood or material that looks like coffee

grounds

bleeding from the rectum (back passage), have black sticky bowel motions

(stools) or bloody diarrhoea.

you are taking CELECOXIB RBX together with any medicines used to treat

high blood pressure and some other heart problems such as ACE inhibitors,

angiotensin receptor antagonists and diuretics (also called fluid or water tablets).

When taken together these medicines can cause kidney problems.

you drink large amounts of alcohol

you are a smoker

you currently have an infection

If you are given CELECOXIB RBX while you have an infection, it may hide some of

the signs of an infection.

you have Lapp lactase deficiency, galactose intolerance or glucose-galactose

malabsorption (rare hereditary intolerances to particular sugars)

If you have not told your doctor or pharmacist about these things, tell them before you

start taking CELECOXIB RBX.

Taking other medicines

Tell your doctor or your pharmacist if you are taking any other medicines, including

medicines you buy without a prescription from a pharmacy, supermarket or health food

shop.

Some medicines and CELECOXIB RBX may interfere with each other.

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These include:

any medicines used to treat high blood pressure and some other heart problems such

as ACE inhibitors, angiotensin receptor antagonists or diuretics (also called fluid or

water tablets)

fluconazole, an antifungal agent

lithium, a medicine used to treat some types of depression

warfarin, a medicine used to stop blood clots

antacids, medicines used to treat indigestion

certain medicines used to treat pain and inflammation called non-steroidal anti-

inflammatories (NSAIDs) or (cortico) steroids.

Your doctor may need to adjust the dosage of these medicines, or provide additional advice if

you are also taking CELECOXIB RBX.

How to take CELECOXIB RBX

Follow all directions given to you by your doctor and pharmacist carefully.

They may

differ from the information in this leaflet.

If you do not understand the instructions on the label, ask your doctor or pharmacist

for help.

How much to take

Osteoarthritis

200 mg once daily or 100 mg twice daily.

Rheumatoid arthritis

100 mg twice daily or 200 mg twice daily.

Ankylosing spondylitis

100 mg twice daily or 200 mg once daily.

Menstrual cramps or period pain

400 mg as a single dose on the first day and 200 mg twice daily on following days. You may

take CELECOXIB RBX for up to 5 days.

Muscle and joint injuries or after surgery

400 mg as a first dose followed by 200 mg once or twice daily as required. You may take

CELECOXIB RBX for up to 5 days.

How to take it

Swallow the capsules whole with a glass of fluid. CELECOXIB RBX can be taken with

or without food.

How long to take it

Depending on your condition, you may need CELECOXIB RBX for a few days or for longer

periods.

CELECOXIB RBX will not cure your condition but should help control pain, swelling and

stiffness.

Keep taking CELECOXIB RBX for as long as your doctor advises.

Do not exceed the dosage recommended by your doctor.

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If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose

when you are meant to. Otherwise, take it as soon as you remember, then go back to

taking your capsules as you would normally.

Do not take a double dose to make up for the dose you missed.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26)

for advice, or go to Accident and Emergency at your nearest hospital if you think

you or anyone else may have taken too much CELECOXIB RBX. Do this even if there

are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too much CELECOXIB RBX, you may feel tired, drowsy, sick, vomit, and have

stomach pain. You may also have difficulty breathing and feel faint.

While you are taking it

Things you must do

If you become pregnant while taking CELECOXIB RBX, tell your doctor immediately.

If you are about to start any new medicines, tell your doctor and pharmacist that you

are taking CELECOXIB RBX.

Tell all doctors, dentists and pharmacists who are treating you that you are taking

CELECOXIB RBX.

If you develop any skin rash (e.g. hives, spots) while being treated with CELECOXIB

RBX, contact your doctor immediately.

The onset of these events, if they occur, can occur at any time, but most often occur in the

first month of treatment.

Things you must not do

Do not give CELECOXIB RBX to anyone else, even if they have the same symptoms or

condition as you.

Do not use CELECOXIB RBX to treat any other complaints unless your doctor tells

you to.

Side effects

Check with your doctor as soon as possible if you have any problems while taking

CELECOXIB RBX, even if you do not think the problems are connected with the

medicine or are not listed in this leaflet.

Like other medicines, CELECOXIB RBX can cause some side effects. If they occur, most

are likely to be minor and temporary.

Ask your doctor or pharmacist any questions you may have.

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Tell your doctor if you notice any of the following:

stomach pain, diarrhoea, indigestion, wind

swollen hands, ankles and feet, unexplained weight gain

dizziness

sore throat, runny nose, sinusitis, upper respiratory tract infection.

Tell your doctor immediately if you notice any of the following:

skin rash, including hives, raised red, itchy spots

blistering and bleeding in the lips, eyes, mouth, nose and genitals

swelling, blistering or peeling of the skin, which may be accompanied by fever, chills,

headache, sore throat, diarrhoea, aching joints and muscles

other signs of allergic reaction such as wheezing, swelling of the face, lips, mouth,

tongue or throat which may cause difficulty in swallowing or breathing collapse or

fainting, shortness of breath or tiredness, irregular heartbeat, chest pain, swollen or

sore leg veins

severe stomach or throat pain, vomiting blood or black sticky bowel motions

bleeding or bruising more than usual, reddish or purple blotches under the skin

nausea, lethargy, itchiness, flulike symptoms or yellowing of the skin or eyes

(jaundice)

signs of anaemia such as tiredness, being short of breath and looking pale

loss or deterioration of hearing

confusion

redness, irritation or watering of the eye(s)

experience sensations with any of the senses (sight, sound, touch, taste or feel) which

may not be real

severe or persistent headache, fever, stiff neck, sensitivity to light and vomiting.

These are serious side effects. You may need urgent medical attention.

Not all of these side effects have been reported with CELECOXIB RBX but have been seen

with similar medicines.

Other side effects not listed above may occur in some people.

Do not be alarmed by this list of possible side effects.

You may not get any of them.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is

not on this list.

After taking CELECOXIB RBX

Storage

Keep your capsules where young children cannot reach them.

A locked cupboard at least

one-and-a-half metres above the ground is a good place to store medicines.

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Keep CELECOXIB RBX in a cool, dry place where the temperature stays at or below

25°C. Do not store it, or any other medicine, in the bathroom or near a sink. Do not

leave it in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep your capsules in their blister pack until it is time to take them.

If you take the

capsules out of their container they may not keep well.

Disposal

If your doctor tells you to stop taking CELECOXIB RBX, or the capsules have passed

their expiry date, ask your pharmacist what to do with any left over.

Product description

What it looks like

CELECOXIB RBX (celecoxib) 100 mg capsules are opaque, white to off-white capsules

imprinted with ‘CC’ and ‘100’ in black ink. Available in blister packs of 60.

CELECOXIB RBX (celecoxib) 200 mg capsules are white to off-white capsules imprinted

with ‘CC’ and ‘200’ in black ink. Available in blister packs of 30.

Ingredients

Active ingredient

The active ingredient in CELECOXIB RBX is celecoxib.

CELECOXIB RBX 100 mg contains 100 mg celecoxib in each capsule.

CELECOXIB RBX 200 mg contains 200 mg celecoxib in each capsule.

Other ingredients

lactose

povidone

colloidal anhydrous silica

sodium lauryl sulfate

croscarmellose sodium

magnesium stearate

gelatin

titanium dioxide

TekPrint SW-9008 Black Ink (Proprietary ingredient # 2328)

CELECOXIB RBX does not contain gluten.

Supplier

CELECOXIB RBX is supplied in Australia by:

Ranbaxy Australia Pty Ltd

9-13 Waterloo Road

Macquarie Park NSW 2113

Australia

CELECOXIB RBX CMI Version 1

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Australian Registration Numbers

CELECOXIB RBX 100mg - AUST R 212791

CELECOXIB RBX 200mg - AUST R 212789

This leaflet was prepared in July 2013.

There are no safety alerts related to this product.