Paracetamol and codeine phosphate hemihydrate
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common questions about Codapane Forte.
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 Codapane Forte against the benefits this medicine is expected to have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What Codapane Forte is used for
Codapane Forte is used to relieve moderate to severe pain, and fever.
Codapane Forte contains paracetamol and codeine. These ingredients work together to stop the pain messages from reaching the brain.
Paracetamol also acts in the brain to reduce fever.
Ask your doctor if you have any questions about why Codapane Forte has been prescribed for you.
Your doctor may have prescribed Codapane Forte for another reason.
This medicine may be addictive after repeated administration.
Codapane Forte is not recommended for children under 12 years of age.
This medicine is available only with a doctor's prescription.
Before you take Codapane Forte
When you must not take it
Do not take Codapane Forte if you have an allergy to:
any medicine containing paracetamol or codeine
any of the ingredients listed at the end of this leaflet
any other similar medicines, such as morphine and oxycodone.
Aspirin or any other NSAID medicine.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not take Codapane Forte if you have:
breathing difficulties, such as asthma, bronchitis or emphysema
Glucose-6-phosphate dehydrogenase deficiency (an enzyme deficiency)
Ultra-rapid metaboliser of CYP2D6
diarrhoea caused by poisoning or antibiotic therapy
history of intolerance to paracetamol and/or codeine
Liver failure
Alcohol dependence.
Do not take Codapane Forte if you are aged between 12 to 18 years of age and have had your tonsils or adenoids removed to treat sleep apnoea.
Do not take Codapane Forte during the third trimester of pregnancy.
Do not take Codapane Forte during labour especially if the baby is premature.
This medicine contains codeine, which may produce withdrawal effects in the newborn baby.
Do not take Codapane Forte if you are breastfeeding or planning to breastfeed.
This medicine passes into breast milk and may affect the baby. If you require Codapane Forte therapy, breastfeeding should be stopped and alternative arrangements should be made for feeding the baby during treatment period.
Do not take Codapane Forte after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Codapane Forte is not recommended for children under 12 years.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
lung disease, such as asthma, bronchitis or emphysema
liver disease, hepatitis, or are taking other drugs that may affect the liver
kidney disease or difficulty urinating
irritable bowel syndrome or other bowel problems
diarrhoea caused by poisoning
recent gastrointestinal or urinary tract surgery
prostate problems
history of fits, convulsions or seizures
depression
a history of drug dependence, including alcohol dependence
you drink large quantities of alcohol
recent cessation of alcohol
low glutathione reserves
Gilbert's syndrome
Gall bladder problems or your gall bladder has been removed
Multiple sclerosis
an underactive thyroid gland or adrenal glands not working properly (e.g. Addison's disease)
head injury or brain tumour
if you are under 18 and have undergone adenoidectomy and/or tonsillectomy
if you know you are a CYP 2D6 ultra-rapid metaboliser.
Your doctor may want to take special care if you have any of these conditions.
Tell your doctor if you are pregnant or plan to become pregnant.
Your doctor can discuss with you the risks and benefits of taking Codapane Forte while being pregnant.
Tell your doctor if you plan to have surgery that requires a general anaesthetic.
Codapane Forte may affect other medicines used during surgery.
If you have not told your doctor about any of the above, tell him/her before you start taking Codapane Forte.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Codapane Forte may interfere with each other. These include:
any medicine causing sleepiness or drowsiness
tranquillisers (medications for anxiety and nerves)
benzodiazepines (medicines used as sedatives or to treat anxiety)
medicines containing alcohol (ethanol), e.g. some cough syrups
cough suppressants or antitussives
Medicines used to treat alcohol and/or opioid dependence (e.g. naltrexone or buprenorphine)
Antihistamines (medicines used to treat allergies
medicines used to treat depression
medicines used to treat mental illness
monoamine oxidase inhibitors (medicines used to treat depression) taken within the last 10 days
salicylates or non-steroidal anti-inflammatory drugs (NSAIDS), such as aspirin or ibuprofen
other pain relievers
diflunisal, an anti-inflammatory medicine
anticholinergics (medicines used to relieve stomach cramps or spasms, to prevent travel sickness, or to treat Parkinson's disease)
medicines which thin the blood, such as warfarin
medicines used to relax muscles
medicines to treat epilepsy
chloramphenicol, a medicine used to treat ear and eye infections
flucloxacillin, rifampicin or zidovudine, medicines used to treat infections
medicines used to lower high blood pressure
medicines used to treat diarrhoea, including kaolin, pectin and loperamide
metoclopramide, a medicine used to treat nausea and vomiting
colestyramine, a medicine used to treat high blood cholesterol, and/or other conditions
chelating resin.
These medicines may be affected by Codapane Forte or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist may have more information on medicines to be careful with or avoid while taking Codapane Forte.
How to take Codapane Forte
Always follow the directions given to you by your doctor or pharmacist.
These directions may differ from the information contained in this leaflet.
If you do not understand the directions on the box, ask your doctor or pharmacist for help.
How much to take
Adults:
The usual dose of Codapane Forte is 1 to 2 tablets.
This dosage may be repeated every 4 to 6 hours if needed.
Do not take more than 8 tablets in 24 hours.
If Codapane Forte is not adequately relieving your pain, do not increase the dose. Please see your doctor.
Codapane Forte is not recommended for children under 12 years.
How to take it
Swallow Codapane Forte with a glass of water.
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, and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your pharmacist or doctor.
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 Forte. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you take too much Codapane Forte, you may have stomach pain and feel nauseous, sweaty, light headed, dizzy or drowsy, or have difficulty breathing.
While you are taking Codapane Forte
Things you must do
Tell all of the doctors, dentists, and pharmacists who are treating you that you are taking Codapane Forte.
If you are about to start taking any new medicine tell your doctor and pharmacist that you are taking Codapane Forte.
Tell your doctor if you become pregnant while taking Codapane Forte.
If you are about to have any blood test, tell your doctor that you are taking this medicine.
It may interfere with the results of some tests.
Things you must not do
Do not give Codapane Forte to anyone else, even if they have the same condition as you.
Do not use Codapane Forte to treat any other complaints unless your doctor tells you to.
Do not take alcoholic drinks.
Combining Codapane Forte and alcohol can make you drowsier.
Things to be careful of
Depending on your body's individual ability to break down codeine, you may experience signs of overdose even when you take Codapane Forte as recommended by your doctor. If symptoms such as blurred vision, dizziness, sleepiness, abdominal pain, or circulatory problems occur, contact your doctor immediately.
Codapane Forte may cause dizziness or drowsiness in some people, especially after the first dose.
If you are affected, do not drive a car, operate machinery or do anything else that could be dangerous if you are dizzy or drowsy.
Children should not ride bikes if affected and should be supervised to avoid potential harm.
Do not drink alcohol.
Drinking alcohol increases the likelihood of becoming drowsy.
Codapane Forte may be addictive if taken in high doses for extended periods of time.
Ask your doctor or pharmacist if you are concerned about this.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Codapane Forte.
Like other medicines, Codapane Forte can cause some side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.
If you are over 65 years of age you may have an increased chance of getting side effects.
Do not be alarmed by the following list of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
constipation
nausea (feeling sick)
vomiting
Stomach pain
dizziness, light-headedness
drowsiness
skin rashes
sweating.
These are the more common side effects of Codapane Forte. They are usually mild.
Tell your doctor as soon as possible if you notice any of the following:
Shortness of breath
fever, sore throat or mouth ulcers
bleeding or bruising more easily than normal
Unusual or extreme mood swings
Dizziness, light-headedness
Flushing of the face
Painful red areas with blisters and peeling layers of skin which may be accompanied by fever and/or chills
Severe blisters and bleeding in the lips, eyes, mouth, nose and genitals
Hepatitis (symptoms include loss of appetite, itching, yellowing of the skin and eyes, light coloured bowel motions, dark coloured urine).
difficulty passing urine
The above list includes serious side effects that may require medical attention. These side effects are rare.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.
Some people may get other side effects that are not listed above.
If you are taking Codapane Forte regularly, you may also need to take laxatives to prevent constipation.
Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.
After taking Codapane Forte
Storage
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the box and blister pack they will not keep well.
Keep Codapane Forte tablets in a cool dry place where the temperature stays below 25°C.
Do not store Codapane Forte 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 it 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 tells you to stop taking Codapane Forte or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
Product description
What it looks like
Codapane Forte tablets are white, oblong, convex tablets with "PC/F" ("PC" over breakline over "F") on one side and "α" on the other.
They are available in packs of 20s.
Ingredients
The active ingredients in Codapane Forte tablets are paracetamol (present as "Compap L") and codeine phosphate hemihydrate. Each tablet contains 500 mg paracetamol and 30 mg codeine phosphate hemihydrate.
The tablets also contain the following inactive ingredients:
crospovidone
colloidal anhydrous silica
sodium lauryl sulfate
stearic acid
magnesium stearate
Codapane Forte tablets contain maize starch.
They do not contain lactose or sugar.
