Consumer medicine information

Codapane Xtra Tablets

Codeine phosphate hemihydrate; Paracetamol

BRAND INFORMATION

Brand name

Codapane Xtra Tablets

Active ingredient

Codeine phosphate hemihydrate; Paracetamol

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Codapane Xtra Tablets.

What is in this leaflet

This CMI answers some common questions about CODAPANE XTRA Tablets.

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 or pharmacist has weighed the risks of you taking CODAPANE XTRA Tablets against the benefits expected for you.

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

Keep this information with the medicine.

You may need to read it again.

What are CODAPANE XTRA Tablets used for

CODAPANE XTRA Tablets are used to relieve moderate to severe pain.

CODAPANE XTRA Tablets contain paracetamol and codeine. Paracetamol and codeine work together to stop the pain messages from getting through to the brain.

Paracetamol also acts in the brain to reduce fever.

Your doctor or pharmacist may have given you this medicine for another use.

This medicine may be addictive if taken for more than a few days at a time.

If you want more information, ask your doctor or pharmacist.

Before you take CODAPANE XTRA Tablets

When you must not take it

You should not take CODAPANE XTRA Tablets if you are allergic to paracetamol or codeine or any of the ingredients listed under "Product Description".

The symptoms of an allergic reaction may include a rash, asthma attack or hay fever.

Do not use CODAPANE XTRA Tablets if you are breastfeeding.

CODAPANE XTRA Tablets may be used during pregnancy. However, ask your pharmacist or doctor about the risks and benefits of taking CODAPANE XTRA Tablets while you are pregnant.

Do not use it after the expiry date (EXP) printed on the pack.

If you take it after the expiry date it may have no effect at all, or worse, have an entirely unexpected effect.

Do not use CODAPANE XTRA Tablets if the packaging is torn or shows signs of tampering.

Before you start to take it

You must tell your pharmacist or doctor if:

  • You have allergies to any ingredients listed under "Product Description" at the end of this leaflet.
  • You have any of these conditions:
  • Lung, liver or kidney problems
  • You drink large quantities of alcohol.

You should tell your pharmacist or doctor if you are using any other medicines including any of the following medicines:

  • Any medicines causing sleepiness
  • Tranquillisers (medicines for anxiety and nerves)
  • Medicines which thin the blood
  • Medicines to treat epilepsy.

These medicines may be affected by CODAPANE XTRA Tablets or affect how well CODAPANE XTRA Tablets work.

Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

Tell your pharmacist or doctor about any other medicines that you have bought without a prescription from a pharmacy, supermarket or health food shop.

If you have not told your pharmacist or doctor about any of these things, tell him/her before you take any CODAPANE XTRA Tablets.

How to take CODAPANE XTRA Tablets

The label on your pack of CODAPANE XTRA Tablets will tell you how to take your medicine and how often.

If you are unsure about the directions ask your doctor or pharmacist.

The usual dose of CODAPANE XTRA Tablets is:

Adults: 2 tablets.
This dosage may be repeated in 4-6 hours if necessary.

You should not take more than 8 tablets in a 24 hour period.

If CODAPANE XTRA Tablets are not adequately controlling your pain, do not increase the dose.

Please see your doctor.

CODAPANE XTRA Tablets are not recommended for children under 12 years.

Swallow tablets whole with a little water or other liquid.

The directions given to you by your pharmacist or doctor may be different from the information in this leaflet. If you are unsure what dose to take ask your pharmacist or doctor.

If you forget to take it

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the dose you missed, and take your next dose when you are meant to.

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

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

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 that you or anyone else may have taken too much CODAPANE XTRA Tablets.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Keep telephone numbers of these places handy.

If you take too many tablets you may feel nauseous, light headed, dizzy or drowsy.

While you are taking CODAPANE XTRA

Things you must do

Take CODAPANE XTRA Tablets exactly as your pharmacist or doctor has told you to.

Tell all your doctors, dentists and pharmacists that you are taking CODAPANE XTRA Tablets.

Tell your doctor or pharmacist if you become pregnant while taking CODAPANE XTRA Tablets.

Things you must not do

Do not use this medicine to treat any other complaint unless your doctor or pharmacist says it is safe. Do not give this medicine to anyone else even if they have the same symptoms as you.

Things to be careful of

CODAPANE XTRA Tablets may cause dizziness or drowsiness in some people, especially after the first dose.

If affected do not drive a car, operate machinery or do anything else that could be dangerous if you are dizzy or drowsy.

Do not drink alcohol.

Drinking alcohol increases the likelihood of becoming drowsy.

CODAPANE XTRA Tablets may be habit forming if taken in high doses for extended periods of time.

Please ask your doctor or pharmacist if you are concerned about this.

About 8% of people are poor metabolisers of codeine. CODAPANE XTRA Tablets may not work as well if you are one of those people.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while taking CODAPANE XTRA Tablets.

Like other medicines, CODAPANE XTRA Tablets can cause some side effects. If they occur, they are most likely minor and temporary. However, sometimes they are serious and need medical treatment.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your pharmacist or doctor if you notice any of the following and they worry you:

Stomach problems such as:

  • Nausea
  • Vomiting
  • Stomach pain
  • Constipation

If you are taking CODAPANE XTRA Tablets regularly, you may also need to take laxatives to prevent constipation.

Difficulty thinking or working because of:

  • Dizziness
  • Drowsiness

Be careful driving or operating machinery until you know how CODAPANE XTRA Tablets affect you.

Other problems such as:

  • Skin rashes

If you believe CODAPANE XTRA Tablets are not working well for you, do not increase the dose. Please see your pharmacist or doctor.

Some people may get other side effects not listed above.

Tell your pharmacist or doctor if you notice anything else that is making you feel unwell.

After taking CODAPANE XTRA Tablets

Storage

Keep your tablets in the blister pack until it is time to take them.

If you take the tablets out of the box or the blister pack they will not keep well.

Keep CODAPANE XTRA Tablets in a cool dry place where the temperature stays below 30°C.

Do not leave CODAPANE XTRA Tablets in the car on hot days.

Heat and dampness can destroy some medicines.

Do not store CODAPANE XTRA Tablets or any other medicine in the bathroom or near a sink.

Keep CODAPANE XTRA Tablets where young children cannot reach it.

A locked cupboard at least one and a half metres above the ground is a good place to store medicines.

Disposal

If your pharmacist or doctor tells you to stop taking the tablets, ask your pharmacist what to do with any tablets that are left over.

This is not all the information that is available on CODAPANE XTRA Tablets. If you have any more questions or are not sure about anything, ask your doctor or pharmacist.

Product description

CODAPANE XTRA Tablets come as white to off white capsule shaped uncoated tablets, plain on one side and breakline on the other side.

It is available in pack of 12 tablets and 24 tablets.

Ingredients

Active ingredients
Each tablet contains:

  • Paracetamol 500 mg
  • Codeine Phosphate 15 mg

Other ingredients

  • Potato starch
  • Lactose
  • Povidone
  • Docusate Sodium
  • Colloidal anhydrous silica
  • Magnesium Stearate

CODAPANE XTRA Tablets do not contain any gluten, sucrose, tartrazine or any azo dyes.

Supplier

CODAPANE XTRA Tablets are supplied in Australia by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
www.alphapharm.com.au

Medical Information
Phone: 1800 028 365

Australian registration numbers:
Codapane Xtra paracetamol 500 mg and codeine phosphate 25 mg tablets blister pack - AUST R 199680

This leaflet was prepared on
1 February 2013

BRAND INFORMATION

Brand name

Codapane Xtra Tablets

Active ingredient

Codeine phosphate hemihydrate; Paracetamol

Schedule

S4