TRUST IBUPROFEN PLUS CODEINE film coated tablet blister pack

Main information

  • Trade name:
  • TRUST IBUPROFEN PLUS CODEINE film coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TRUST IBUPROFEN PLUS CODEINE film coated tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 175264
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

175264

TRUST IBUPROFEN PLUS CODEINE film coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Pharmacor Pty Ltd

Postal Address

Suite 501,7 Oaks Ave,Dee Why, NSW, 2099

Australia

ARTG Start Date

1/09/2010

Product category

Medicine

Status

Active

Approval area

Non-Prescription Medicines

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. TRUST IBUPROFEN PLUS CODEINE film coated tablet blister pack

Product Type

Single Medicine Product

Effective date

23/03/2016

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For temporary relief of strong pain and/or inflammation associated with headache (including migraine and tension headache), period pain, dental pain,

back pain, neuralgia, rheumatic and arthritic pain, muscular pain.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC

3 Years

Store below 30

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S3) Pharmacist Only Medicine

(S3) Pharmacist Only Medicine

(S3) Pharmacist Only Medicine

(S3) Pharmacist Only Medicine

(S3) Pharmacist Only Medicine

(S3) Pharmacist Only Medicine

(S3) Pharmacist Only Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

white to off-white capsule-shaped, biconvex, film-coated tablet

Active Ingredients

codeine phosphate hemihydrate

12.8 mg

Ibuprofen

200 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 29.11.2017 at 02:08:32 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: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

December 2017

Pharmacor Pty Ltd

TRUST IBUPROFEN PLUS CODEINE

Ibuprofen 200mg and Codeine phosphate hemihydrate 12.8mg

CONSUMER MEDICINE INFORMATION

What is in this Leaflet?

This leaflet answers some common questions about Trust Ibuprofen Plus Codeine. It does not

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

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

taking Trust Ibuprofen Plus Codeine against the benefits this medicine is expected to have for

you.

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

Keep this leaflet with the medicine. You may need to read it again.

What Trust Ibuprofen Plus Codeine is used for

Trust Ibuprofen Plus Codeine tablets contain two active ingredients:

Ibuprofen and Codeine phosphate hemihydrate.

Ibuprofen belongs to a family of medicines called non-steroidal anti-inflammatory drugs

(NSAIDS). This group of medicines work by relieving pain, inflammation (swelling, redness,

soreness) and fever.

Codeine is an opioid analgesic that works in the brain and spinal cord to relieve pain.

Trust Ibuprofen Plus Codeine tablets are indicated for temporary relief of acute, moderate

pain and inflammation.

Do not use Trust Ibuprofen Plus Codeine in children under the age of 12 years.

Before You Take Trust Ibuprofen Plus Codeine

When you must not take it

Do not take Trust Ibuprofen Plus Codeine if you have an allergy to:

Ibuprofen, codeine or other opioid analgesics such as morphine or pethidine, or any of

the ingredients of Trust Ibuprofen Plus Codeine, listed at the end of this leaflet.

Aspirin;

any other NSAID or anti-inflammatory medicines.

Symptoms of an allergic reaction to these medicines may include:

asthma, wheezing or shortness of breath,

swelling of the face, lips, or tongue; this may affect swallowing or breathing,

hives, itching or skin rash,

fainting.

December 2017

Pharmacor Pty Ltd

If you are allergic to Aspirin or NSAID group of medicines and take Trust Ibuprofen Plus

Codeine tablets, these symptoms may be severe.

Do not take Trust Ibuprofen Plus Codeine tablets if you are also taking any other

medicines that contain one or more NSAID medicine, whether prescribed by your doctor

or obtained without prescription.

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

aspirin or NSAIDs. If you are not sure if the medicines you are taking contain these

ingredients, ask your doctor.

Do not take Trust Ibuprofen Plus Codeine during the last 3 months of pregnancy including

the last few days before expected birth.

Do not take Trust Ibuprofen Plus Codeine during labour, especially if the baby is

premature. This medicine may produce withdrawal effects in the newborn baby.

Unless advised by a medical doctor, do not take Trust Ibuprofen Plus Codeine tablets during

the first 6 months of pregnancy.

Do not use Trust Ibuprofen Plus Codeine tablets if you are breastfeeding or planning to

breastfeed. This medicine passes into breastmilk and may affect the baby.

Do not take Trust Ibuprofen Plus Codeine:

if you are vomiting blood or material that looks like coffee grounds

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

(stools) or bloody diarrhoea

if you have a stomach ulcer

if you have chronic constipation or shallow breathing, or severe diarrhoea

if you consume heavy amounts of alcohol regularly

if you are an Ultra-rapid metaboliser of CYP2D6

if you are aged below 18 years of age and have had your tonsils or adenoids removed

to treat sleep apnoea

if the packaging is torn or shows signs of tampering

if the expiry date (EXP) printed on the pack has passed; it may not work as well

if you are not sure whether you should start taking Trust Ibuprofen Plus Codeine,

contact your doctor.

Before you start to take Trust Ibuprofen Plus Codeine

Tell your doctor:

if you are pregnant or intend to become pregnant. Trust Ibuprofen Plus Codeine is not

recommended for use during the first 6 months of pregnancy. Your doctor will decide

if you should take Trust Ibuprofen Plus Codeine tablets. Do not take Trust Ibuprofen

Plus Codeine tablets at all during the last 3 months of pregnancy.

if you are breast-feeding or plan to breast-feed. Trust Ibuprofen Plus Codeine is not

recommended while you are breast-feeding.

If you are aged 65 years or over. Unless your doctor tells you to, you should not use

December 2017

Pharmacor Pty Ltd

Trust Ibuprofen Plus Codeine tablets.

if you have any medical conditions, especially the following:

a history of stomach ulcer,

liver disease,

kidney disease,

heart failure,

swelling of ankles or feet,

asthma, or have suffered in the past from asthma,

thyroid problems or low blood pressure,

a head injury or intercranial pressure,

prostate problems,

stomach problems or recent stomach surgery

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without

a prescription from your pharmacy, supermarket or health food shop. Some medicines

may interfere with each other. These include:

aspirin, salicylates or other NSAID medicines,

warfarin or other medicines used to stop blood clots or thin the blood,

medicines that are used to treat high blood pressure eg. diuretics (fluid tablets) or heart

problems including heart failure,

methotrexate a medicine used to treat arthritis and some type of cancers,

zidovudine a medicine used to treat HIV infection,

lithium and other medicines used to treat depression or anxiety eg. MAOIs (even if taken

within the last 14 days),

medicines used to relieve stomach cramps or spasms,

medicines used to treat diarrhoea (eg. kaolin, pectin, loperamide),

metoclopramide a medicine used to treat nausea and vomiting,

medicines such as prednisone, prednisolone and cortisone, which reduce the activity of your

immune system,.

medicines used to help you relax, sleep or relieve anxiety, such as barbiturates and

sedatives.

Quinidine, a medicine used to treat abnormal or irregular heartbeat,

phenothiazines and antipsychotic agents, medicines used to treat mental disorders,

medicines used to treat diabetes,

medicines used to treat Parkinson’s disease,

medicines used to prevent travel sickness,

other opiods to treat pain or supress cough,

These medicines may be affected by Trust Ibuprofen Plus Codeine tablets or may affect how

well it works. You may need to take different amounts of your medicine, or you may need to

take different medicines. Your doctor will advise you. Your doctor has more information on

medicines to avoid or be careful with while taking Trust Ibuprofen Plus Codeine tablets.

How to Take Trust Ibuprofen Plus Codeine tablets

December 2017

Pharmacor Pty Ltd

How much to take

The usual dose of Trust Ibuprofen Plus Codeine tablets for adults and children over 12 years of

age is 2 tablets followed by, if necessary 1 or 2 tablets every 4 hours. Do not take more than

6 tablets in 24 hours. Trust Ibuprofen Plus Codeine is not recommended for children under 12

years of age. If you do not understand the instructions on the pack, ask your doctor for help.

How to take it

Take Trust Ibuprofen Plus Codeine tablets by mouth with fluid. It may also be taken before,

or after food.

How long to take it

Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed

the recommended dose. Excessive use can be harmful and increase the risk of heart attack,

stroke or liver damage.

If your symptoms persist, worsen or new symptoms develop, talk to your doctor.

If you take too much (overdose)

If you take too much of this medicine you may experience nausea or upset stomach, vomiting

and gastric irritation, drowsiness, dizziness or very slow, laboured breathing. You may also

experience blurred vision, ringing in the ears, or rapid uncontrollable movements of the eyes.

Excitability, convulsions and unconsciousness may be experienced in rare cases. If you think

you have taken too many Trust Ibuprofen Plus Codeine tablets, talk to your pharmacist or

doctor, or contact the Poisons Information Centre (in Australia Tel 13 11 26 and in New

Zealand 0800-764 766) for advice.

While You Are Using Trust Ibuprofen Plus Codeine

Things you must do

If you become pregnant while taking Trust Ibuprofen Plus Codeine tablets talk to your

doctor immediately.

If you are about to be started on any new medicine tell your doctor that you are

taking Trust Ibuprofen Plus Codeine tablets.

Tell all of the doctors, dentists and pharmacists that are treating you that you are

taking Trust Ibuprofen Plus Codeine tablets.

If you are going to have surgery, tell your doctor you are taking Trust Ibuprofen Plus

Codeine tablets.

Talk to your doctor if your symptoms do not improve.

Things you must not do

Do not give Trust Ibuprofen Plus Codeine tablets to anyone else, even if they have the

same condition as you

Do not use Trust Ibuprofen Plus Codeine tablets to treat any other complaints

Do not take Trust Ibuprofen Plus Codeine tablets with any other product containing

ibuprofen and or codeine/ other opioid unless your doctor tells you.

December 2017

Pharmacor Pty Ltd

Do not take for more than 3 days at a time unless your doctor tells you to. Do not

exceed the recommended dose. Excessive use of ibuprofen can be harmful and

increase the risk of heart attack, stroke or liver damage.

Things to be careful of

Be careful driving or operating machinery until you know how Trust Ibuprofen Plus

Codeine tablets affects you.

Trust Ibuprofen Plus Codeine tablets may cause dizziness, light-headedness or

drowsiness in some people. If this occurs, do not drive or operate machinery. If you

drink alcohol, dizziness, light-headedness or drowsiness may be worse.

Products containing codeine should not be taken for prolonged periods; Codeine may

be habit forming.

Side Effects

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

Ibuprofen Plus Codeine tablets, even if you do not think the problems are connected with the

medicine or are not listed in this leaflet.

Like other medicines, Trust Ibuprofen Plus Codeine tablets can cause some side effects in rare

cases. If they occur, most are likely to be minor and temporary. However, some may be

serious and need medical attention. Ask your doctor to answer any questions you may have.

Tell your doctor if you notice any of the following symptoms that worry you:

stomach upset including nausea (feeling sick), vomiting,

heartburn, indigestion,

diarrhoea, pain in the stomach,

dizziness, light-headedness, drowsiness,

constipation,

cough suppression,

headache,

hearing disturbance

nervousness

fatigue

These are the more common side effects of Trust Ibuprofen Plus Codeine tablets and are

usually mild and short lived.

Tell your doctor as soon as possible if you notice any of the following:

get sunburnt more quickly than usual

unusual or extreme mood swings

flushing of the face

fast heart beat

The above list includes serious side effects that may require medical attention. Serious side

effects are rare for low doses of this medicine and when used for a short period of time.

If any of the following happen, stop taking Trust Ibuprofen Plus Codeine and tell your

doctor immediately or go to casualty at your nearest hospital:

December 2017

Pharmacor Pty Ltd

vomiting blood or material that looks like coffee grounds,

bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea,

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

asthma, wheezing, shortness of breath, pain or tightness in the chest,

sudden or severe itching, skin rash, hives, skin peeling,

easy bruising

shallow breathing

fluid retention

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

These side effects are rare. Some people may get other side effects while taking Trust

Ibuprofen Plus Codeine tablets. Tell your doctor if you notice anything else that worries you.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After Using Trust Ibuprofen Plus Codeine

Storage

Keep the tablets in the pack until it is time to take the dose. If you take them out they will

not keep well.

Keep the tablets in a cool dry place where the temperature stays below 30°C.

Do not store Trust Ibuprofen Plus Codeine tablets or any other medicine in the bathroom

or near a sink.

Do not leave the tablets in the car or on windowsills. Heat and dampness can destroy

some medicines.

Keep the tablets where children cannot reach them. A locked cupboard at least one-and-a-

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

Disposal

When you stop taking Trust Ibuprofen Plus Codeine or it has passed its expiry date, ask your

pharmacist what to do with any tablets that are left over.

More Information

If you have any further questions or if you are not sure about anything relating to the use of

Trust Ibuprofen Plus Codeine tablets, your doctor or pharmacist can best assist you.

Product Description

What it looks like?

Trust Ibuprofen Plus Codeine tablet is white to off-white capsule-shaped, biconvex, film-

coated tablet.

Ingredients

Trust Ibuprofen Plus Codeine contains 200mg Ibuprofen and 12.8mg Codeine phosphate

hemihydrate as the active ingredients.

The other ingredients in Trust Ibuprofen Plus Codeine are:

starch – pregelatinised maize

December 2017

Pharmacor Pty Ltd

cellulose microcrystalline

croscarmellose sodium

silica colloidal anhydrous

water purified

opadry white colouring

Trust Ibuprofen Plus Codeine tablets do not contain gluten, lactose or preservatives.

Presentation:

Trust Ibuprofen Plus Codeine tablets are available in Australia in blister packs of 10, 12, 15,

18, 20, 24, and 30 tablets.

Distributor:

Pharmacor Pty Ltd

Suite 501, 7 Oaks Ave

DEE WHY NSW 2099

AUST R 175264

This leaflet was prepared in December 2017.