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APOHEALTH Paracetamol Plus Codeine and Calmative

Contains the active ingredients paracetamol, codeine phosphate and doxylamine succinate
Consumer Medicine Information
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about APOHEALTH Paracetamol Plus Codeine and Calmative. It does not contain all the information that is known about APOHEALTH Paracetamol Plus Codeine and Calmative. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What this medicine is used for

The name of your medicine is APOHEALTH Paracetamol PLUS Codeine and Calmative Tablets. It contains the active ingredient paracetamol, codeine phosphate & doxylamine succinate.
This medicine is used to provide effective temporary relief from the pain and discomfort associated with:
neck and back pain,
headache
tension headache,
toothache,
backache,
migraine headache,
muscle pain,
nerve pain,
arthritis,
rheumatics,
osteoarthritis
period pain
symptoms of
cold,
sore throat
flu
trauma
surgery
dental procedures
and other pain where a combined calmative and analgesic action is required.
This medicine also reduces fever.
Ask your doctor or pharmacist if you have any questions about why this medicine has been recommended for you. Your doctor or pharmacist may have recommended this medicine for another reason.

How it works

Paracetamol is an analgesic with antipyretic action, meaning it also reduces fever.
Doxylamine succinate is an antihistamine with pronounced sedative effects.
Codeine phosphate is an analgesic, and in combination with paracetamol and doxylamine produces greater analgesia than any of these drugs alone and avoids the side effects associated with large doses of codeine.

Use in children

This medicine should not be used in children under 17 years of age.

Before you take this medicine

When you must not take it

Do not take this medicine if:
You have or have had any of the following:
glaucoma (high pressure in the eyes)
stomach or duodenal ulcer, or other stomach problems
prostate problems
bladder problems
acute breathing difficulties such as bronchitis, unstable asthma or emphysema
chronic constipation
diarrhoea caused by antibiotics or poisoning
You have alcohol dependence
You are in labour, especially if the baby is premature.
The medicine may produce withdrawal effects in the newborn baby.
You are breastfeeding.
It passes into the breast milk and there is a possibility that the baby may be affected.
you are also taking monoamine oxidase inhibitors, a type of medicine used to treat depression.
You are hypersensitive to, or have had an allergic reaction to, paracetamol, codeine, doxylamine or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like symptoms.
If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.
The expiry date (EXP) printed on the pack has passed.
The packaging is torn, shows signs of tampering or it does not look quite right.
If you are not sure whether you should be taking this medicine, talk to your doctor or pharmacist.

Before you start to take it

Before you start taking this medicine, tell your doctor or pharmacist if:

1. You have allergies to:

any other medicines
any other substances, such as foods, preservatives or dyes.

2. You have or have had any medical conditions, especially the following:

kidney or liver problems
epilepsy
difficulty breathing,
wheezing,
chronic cough,
asthma
other chronic breathing conditions
glaucoma
urinary retention
chronic alcohol consumption
a history of drug dependence, alcohol dependence
recent surgery on the stomach or intestines
head injury
prostate problems
low blood pressure
underactive thyroid

3. You are currently pregnant or you plan to become pregnant.

Do not take this medicine whilst pregnant until you and your doctor or pharmacist have discussed the risks and benefits involved.

4. You are currently breastfeeding or you plan to breast-feed.

Do not take this medicine whilst breastfeeding until you and your doctor have discussed the risks and benefits involved.

5. You are planning to have surgery.

6. You are taking or are planning to take any other medicines.

This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.

Taking other medicines

Do not take with other medicines containing paracetamol, unless your doctor or pharmacist says you can.
Some medicines may interact with paracetamol, codeine and doxylamine.
These include:
sleeping tablets or sedatives
medicines to control fits or anti-epileptic drugs e.g. Dilantin or Tegretol
anti-depressant tablets
anti-coagulant tablets
If you are taking any of these you may need a different dose or you may need to take different medicines. Your doctor or pharmacist will advise you.
Other medicines not listed above may also interact with paracetamol, codeine and doxylamine.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking this medicine.

How to take this medicine

Follow carefully all directions given to you by your doctor or pharmacist and keep to the recommended dose. Their instructions may be different to the information in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much to take

The usual dose for adults and children over 12 years of age is one to two tablets every 4 to 6 hours, as needed for pain relief.
Do not take more than 8 tablets in a 24 hour period.
Do not give this medicine to a child under 12 years

How to take it

Swallow the tablets with a full glass of water.

When to take it

It does not matter if you take it before, with or after food.

How long to take it for

This medicine is for short term use only.
Adults:
Do not take this medicine for longer than a few days at a time unless advised by a doctor.
Adolescents:
Do not take this medicine for longer than 48 hours at a time unless advised by a doctor.
If pain persists for more than three days, please see your doctor

If you forget to take it

There is no need to take extra doses if the pain has gone away.
If the pain is still present, take your next dose if required.
Do not take a double dose to make up for missed doses.
This may increase the chance of you experiencing side effects.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.

If you take too much (overdose)

If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively, go to the Accident and Emergency department at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking this medicine

Things you must do

Tell your doctor or pharmacist that you are taking this medicine if:
you are about to be started on any new medicine
you are breastfeeding or are planning to breast-feed
you are going to have surgery or an anaesthetic or are going into hospital.
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.
Tell your doctor or pharmacist if:
you develop a skin rash or hives while taking this medicine
you become pregnant while taking this medicine

Things you must not do

Do not:
drink alcohol.
Give this medicine to anyone else, even if their symptoms seem similar to yours.
Take your medicine to treat any other condition unless your doctor or pharmacist tells you to.
Stop taking your medicine, or change the dosage, without first checking with your doctor or pharmacist.

Things to be careful of

Be careful when driving or operating machinery until you know how this medicine affects you.
This medicine may cause drowsiness or lightheadedness in some people and affect mental alertness.
Make sure you know how you react to this medicine before you drive a car, operate machinery, or do anything else that could be dangerous if you get dizzy

Possible side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking this medicine or if you have any questions or concerns.
This medicine helps most people with pain, but may have unwanted side effects in a few people.
Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Tell your doctor if you notice any of the following:
drowsiness
depression
dizziness
feeling sick or stomach pains
diarrhoea
loss of appetite, weight loss
constipation
skin rashes
Other side effects not listed above may also occur in some patients. Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.

Allergic reactions

If you think you are having an allergic reaction to this medicine, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
cough, shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue, throat or other parts of the body
rash, itching or hives on the skin
fainting
hay fever-like symptoms.

Storage and disposal

Storage

Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 30°C.
Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.
Keep this medicine where 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 doctor or pharmacist tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description

What APOHEALTH Paracetamol PLUS Codeine and Calmative Tablets looks like

Paracetamol 500mg, Codeine Phosphate 10mg and Doxylamine 5.1mg tablets:
White, capsule shaped, biconvex, bevel edged, uncoated tablets with break line on one side and plain on other side.
It is available in packs of 20 and 40 tablets.
* Not all strengths, pack types and/or pack sizes may be available.

Ingredients

Each tablet contains 500mg of paracetamol, 10mg codeine phosphate, 5.1mg doxylamine succinate as the active ingredients.
It also contains the following inactive ingredients:
Lactose,
Starch-Maize
Povidone
Ethanol,
Crospovidone,
Cellulose-microcrystalline, Stearic Acid,
Magnesium Stearate.

Australian Registration Numbers

APOHEALTH Paracetamol PLUS Codeine and Calmative Tablets (blister pack): AUST R 230135

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
APOHEALTH is a trademark used under license.
This leaflet was last updated in:
January 2015