CELECOXIB

Main information

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

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210630
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210630

CELECOXIB SANDOZ celecoxib 100mg hard capsule blister pack

ARTG entry for

Medicine Registered

Sponsor

Sandoz Pty Ltd

Postal Address

54 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

12/05/2014

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 SANDOZ celecoxib 100mg hard capsule blister pack

Product Type

Single Medicine Product

Effective date

6/10/2016

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/PE/PVDC/Al

2 Years

Store below 30

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. CELECOXIB SANDOZ celecoxib 100mg hard capsule blister pack

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

100 mg Capsules: Opaque, white capsules with blue cap.

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 11.11.2017 at 10:11:48 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 SANDOZ

®

celecoxib

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about CELECOXIB

SANDOZ. 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

SANDOZ against the benefits it is

expected to have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Read this leaflet carefully before

you start CELECOXIB SANDOZ

and keep it with the medicine.

You may need to read it again.

What CELECOXIB

SANDOZ is used for

CELECOXIB SANDOZ 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 SANDOZ also

provides short-term pain relief in

conditions such as:

menstrual cramps or period pain

after surgery

muscle and joint injuries.

CELECOXIB SANDOZ belongs to a

group of medicines called Coxibs

which are used to relieve pain and

inflammation in a number of

conditions.

Although CELECOXIB SANDOZ

can relieve the symptoms of pain and

inflammation, it will not cure your

condition.

Your doctor, however, may have

prescribed CELECOXIB SANDOZ

for another purpose.

Ask your doctor if you have any

questions about why CELECOXIB

SANDOZ has been prescribed for

you.

CELECOXIB SANDOZ is not

recommended for use in children or

adolescents under 18 years of age.

This medicine is only available with

a doctor's prescription.

Before you take

CELECOXIB SANDOZ

When you must not take it

Do not take CELECOXIB

SANDOZ 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 are undergoing cardiac

surgery called coronary artery

bypass graft (CABG)

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

SANDOZ, these symptoms may

be severe.

you have an allergy to:

CELECOXIB SANDOZ

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

CELECOXIB SANDOZ

take CELECOXIB SANDOZ, 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 SANDOZ,

talk to your doctor.

Before you start to take it

You must tell your doctor if:

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 SANDOZ

during pregnancy.

CELECOXIB SANDOZ may

affect your developing baby if

taken in the last 3 months of

pregnancy.

CELECOXIB SANDOZ 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 SANDOZ passes

into breast milk in small amounts,

therefore, the use of

CELECOXIB SANDOZ 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

SANDOZ 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

SANDOZ while you have an

infection, it may hide some of the

signs of an infection.

If you have not told your doctor

or pharmacist about these things,

tell them before you start taking

CELECOXIB SANDOZ.

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

SANDOZ may interfere with each

other. 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 or similar medicines

including Eliquis (apixaban),

Xarelto (rivaroxaban) or Pradaxa

(dabigatran), a medicine used to

stop blood clots

aspirin or salicylates, medicines

used to treat pain

antacids, medicines used to treat

indigestion

some medicines used to treat

diabetes

methotrexate, a medicine used to

treat arthritis and some cancers

cyclosporin, medicine used to

suppress the immune system

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 SANDOZ.

CELECOXIB SANDOZ

How to take

CELECOXIB SANDOZ

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

200mg once daily or 100mg twice

daily.

Rheumatoid arthritis

100mg twice daily or 200mg twice

daily.

Ankylosing spondylitis

100mg twice daily or 200mg once

daily.

Menstrual cramps or period pain

200mg twice daily, you may take

CELECOXIB SANDOZ for up to 5

days.

Muscle and joint injuries or after

surgery

200mg once or twice daily as

required. You may take

CELECOXIB SANDOZ for up to 5

days.

How to take it

Swallow the capsules whole with a

glass of fluid. CELECOXIB

SANDOZ can be taken with or

without food.

How long to take it

Depending on your condition, you

may need CELECOXIB SANDOZ

for a few days or for longer periods.

CELECOXIB SANDOZ will not

cure your condition but should help

control pain, swelling and stiffness.

Keep taking CELECOXIB

SANDOZ for as long as your

doctor advises.

Do not exceed the dosage

recommended by your doctor.

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 SANDOZ.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

If you take too much CELECOXIB

SANDOZ, 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 SANDOZ,

tell your doctor immediately.

If you are about to start any new

medicines, tell your doctor and

pharmacist that you are taking

CELECOXIB SANDOZ.

Tell all doctors, dentists and

pharmacists who are treating you

that you are taking CELECOXIB

SANDOZ.

If you develop any skin rash (e.g.

hives, spots) while being treated

with CELECOXIB SANDOZ,

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

SANDOZ to anyone else, even if

they have the same symptoms or

condition as you.

Do not use CELECOXIB

SANDOZ 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

SANDOZ, even if you do not think

the problems are connected with

the medicine or are not listed in

this leaflet.

Like other medicines, CELECOXIB

SANDOZ 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.

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

CELECOXIB SANDOZ

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, flu-

like 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

SANDOZ 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 SANDOZ

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.

Keep CELECOXIB SANDOZ 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 SANDOZ, 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 SANDOZ 100mg -

opaque, white and blue capsules.

The 100mg capsules come in

blister packs of 60.

CELECOXIB SANDOZ 200mg -

opaque, white and orange

capsules.

The 200mg capsules come in

blister packs of 30.

Ingredients

Active ingredient

The active ingredient in

CELECOXIB SANDOZ is

celecoxib.

CELECOXIB SANDOZ 100mg -

100mg celecoxib/capsule

CELECOXIB SANDOZ 200mg -

200mg celecoxib/capsule

Other ingredients

Lactose monohydrate

sodium lauryl sulfate

carrageenan

- cellulose - microcrystalline

silica - colloidal anhydrous

talc - purified

magnesium stearate

gelatin

titanium dioxide

indigo carmine - / 100mg

iron oxide red / 200mg

iron oxide yellow / 200mg

CELECOXIB SANDOZ does not

contain sucrose, gluten, tartrazine

or other azo dyes.

Supplier

CELECOXIB SANDOZ is supplied

in Australia by:

Sandoz Pty Ltd

ABN 60 075 449 553

54 Waterloo Road

Macquarie Park NSW 2113

Tel: 1800 634 500

Australian Registration

Number:

CELECOXIB SANDOZ 100mg -

AUST R 210630

CELECOXIB SANDOZ 200mg -

AUST R 210632

This document was prepared August

2016.

CELECOXIB SANDOZ

There are no safety alerts related to this product.