Paracetamol, Pseudoephedrine hydrochloride, Codeine phosphate
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Codral Original Cold & Flu Tablets.
It does not contain all the available information. It does not take the place of talking to your pharmacist or doctor.
All medicines have risks and benefits. Your pharmacist or doctor has weighed the risks of you taking Codral Original Cold & Flu against the benefits they expect it will 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 Codral Original Cold & Flu is used for
Codral Original Cold & Flu tablets provide temporary relief from the symptoms of runny nose, nasal congestion, headache, body aches and pains and fever.
Paracetamol works to stop the pain messages from getting through to the brain. It also acts in the brain to reduce fever.
Pseudoephedrine belongs to a group of medicines called sympathomimetic decongestants. It works by reducing congestion in the upper respiratory tract, including the nose, nasal passages and sinuses, and making it easier to breathe.
Codeine phosphate belongs to a group of medicines called analgesics. It is an opioid analgesic and it acts by blocking pain and your emotional response to pain.
Ask your pharmacist or doctor if you have any questions about this medicine.
Your pharmacist or doctor may have given it for another reason.
This medicine is only available from your pharmacist.
Before you take Codral Original Cold & Flu
When you must not take it
Do not take Codral Original Cold & Flu if you have an allergy to:
any medicine containing paracetamol
any medicine containing pseudoephedrine
any medicine containing codeine
any of the ingredients listed at the end of this leaflet.
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 this medicine if you have:
very high blood pressure
severe coronary artery disease (heart disease caused by poor blood flow or narrowing of the blood vessels of the heart)
taken monoamine oxidase inhibitors, medicines used to treat depression, in the last 14 days.
Do not use this medicine if you are an ultra-rapid metaboliser of codeine.
Do not take this medicine if you have or have had any of the following medical conditions:
acute breathing difficulties such as bronchitis, unstable asthma or emphysema
chronic constipation
diarrhoea caused by antibiotics or poisoning.
Do not take codeine if you have alcohol dependence.
Do not take this medicine if you are pregnant or plan to become pregnant.
It may affect your developing baby if you take it during pregnancy. Your pharmacist or doctor will discuss the benefits and possible risks of taking the medicine during pregnancy.
Do not take codeine during labour, especially if the baby is premature.
The medicine may produce withdrawal effects in the newborn baby.
Do not take this medicine if you are breastfeeding or plan to breastfeed.
It passes into the breast milk and there is a possibility that the baby may be affected.
Do not take this medicine after the expiry date (EXP) 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 pharmacist or doctor.
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:
low blood pressure
high blood pressure
underactive thyroid gland
overactive thyroid gland
thyroid disease
diabetes
heart disease and poor blood flow in the blood vessels of the heart
glaucoma (high pressure in the eyes)
prostate problems
liver or kidney disease
difficulty breathing, wheezing, chronic cough, asthma or other chronic breathing conditions (particularly if aged between 12 and 18 years)
pulmonary oedema
a history of drug dependence, including alcohol dependence
recent surgery on the stomach or intestines
obstructive bowel disorder
head injury
epilepsy.
Tell your pharmacist or doctor if you take sedatives (medicines used to help you relax or sleep).
Tell you pharmacist of doctor if you are pregnant or plan to become pregnant.
Your pharmacist or doctor will discuss the benefits and possible risks of taking the medicine during pregnancy.
If you have not told your pharmacist or doctor about any of the above, tell him/her before you start taking Codral Original Cold & Flu.
Taking other medicines
Tell your pharmacist or 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 Codral Original Cold & Flu may interfere with each other.
These include:
warfarin, a medicine used to prevent blood clots
medicines used to treat heart conditions
medicines used to treat high blood pressure
quinidine, a medicine used to treat abnormal or irregular heart beat
metoclopramide, a medicine used to treat nausea and vomiting
medicines for diarrhoea, such as kaolin, pectin and loperamide
medicines used to relieve stomach cramps or spasms, to prevent travel sickness and to treat Parkinson's disease
medicines used to treat urinary tract infections and bladder problems
medicines used to treat epilepsy or fits
medicines used to treat depression
medicines used to help you relax, sleep or relieve anxiety, such as barbiturates and sedatives
monoamine oxidase inhibitors, medicines used to treat depression, taken within the last 14 days
phenothiazines and antipsychotic agents, medicines used to treat mental disorders.
medicines used to treat behavioural disorders
other opioid analgesics used to treat pain
chloramphenicol, an antibiotic used to treat ear and eye infections
phenylephrine, a medicine used to treat congestion
appetite suppressants
alcohol.
These medicines may be affected by Codral Original Cold & Flu or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your pharmacist or doctor will have more information on medicines to be careful with or avoid while taking this medicine.
How to take Codral Original Cold & Flu
Follow all directions given to you by your pharmacist or doctor carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the pack, ask your pharmacist or doctor for help.
How much to take
The recommended dose of Codral Original Cold & Flu, for adults and children over 12 years, is 2 tablets 3 to 4 times a day.
Do not use this medicine for children under 12 years of age.
Do not take more than the recommended dose.
If you are over 65 years of age, talk to you pharmacist or doctor about how much to take.
If you are over 65 years of age you may have an increased chance of getting side effects.
How to take it
Swallow tablets whole with a glass of water.
How long to take it
As Codral Original Cold & Flu contains paracetamol, take only for a few days at a time in adults or for 48 hours in children unless your doctor tells you to take it for longer.
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, you may take a dose as soon as you remember if you think you need it.
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 go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Codral Original Cold & Flu. Do this even if there are no signs of discomfort or poisoning.
While you are using Codral Original Cold & Flu
Things you must do
Talk to your pharmacist or doctor if your symptoms do not improve, worsen, or if new symptoms appear.
Your pharmacist or doctor will assess your condition and decide if you should continue to take the medicine.
Things you must not do
Do not take for more than a few days at a time unless your doctor tells you to.
Prolonged use of codeine may produce tolerance, and physical and psychological dependence.
Do not drink alcohol while taking Codral Original Day & Night Cold & Flu.
The sedative effects of alcohol may be increased.
Drinking large quantities of alcohol while taking this medicine may also increase the risk of liver side effects.
Do not take Codral Original Cold & Flu to treat any other complaints unless your pharmacist or doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Do not take more than the recommended dose unless your pharmacist or doctor tells you to.
Things to be careful of
Be careful driving or operating machinery until you know how Codral Original Cold & Flu affects you.
This medicine may cause drowsiness in some people. If this happens, do not drive or operate machinery.
Do not take high doses of the medicine for long periods of time unless your doctor tells you to.
Codeine may be habit forming.
Side effects
Tell your pharmacist or doctor as soon as possible if you do not feel well while you are taking Codral Original Cold & Flu.
This medicine helps most people with cold and flu symptoms, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your pharmacist or doctor to answer any questions you may have.
Tell your pharmacist or doctor if you notice any of the following and they worry you:
nausea or dyspepsia
abdominal pain
diarrhoea
pain when passing urine
vomiting
constipation
headache
drowsiness or sleepiness
dizziness
difficulty sleeping
nervousness
excitability
euphoria
restlessness
feeling jittery
fear or anxiety
rapid or irregular heart beat
tremor
hallucinations.
The above list includes the more common side effects of your medicine. They are usually mild.
Children and people over 65 years of age may have an increased chance of getting side effects.
Tell your doctor as soon as possible if you notice any of the following:
shallow breathing or shortness of breath
unusual or extreme mood swings
dizziness, light-headedness
flushing of the face
fast heart beat
difficult or painful urination
seizures (fits).
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 pharmacist or doctor immediately or go to Accident and Emergency at your nearest hospital:
urine retention
extreme sleepiness
confusion
shortness of breath
shallow breathing
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.
Tell your pharmacist or doctor if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
After using Codral Original Cold & Flu
Storage
Keep your medicine in the original pack until it is time to take.
Keep your medicine in a cool dry place where the temperature stays below 25°C.
Do not store Codral Original Cold & Flu 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 your 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
Ask your pharmacist what to do with any medicine that is left over, or if the expiry date has passed.
Product description
What it looks like
Codral Original Cold & Flu are round, white, bevelled, biconvex, uncoated tablets. They are scored and branded 'K7F' on the upper face and plain on the bottom face.
Codral Original Cold & Flu tablets are available in blister packs of 24 tablets.
Ingredients
Codral Original Cold & Flu tablets contain 500 mg of paracetamol, 30 mg of pseudoephedrine hydrochloride and 6 mg of codeine phosphate as the active ingredients.
Codral Original Cold & Flu tablets also contain the following inactive ingredients:
microcrystalline cellulose
hydroxypropylcellulose
lactose
magnesium stearate
sodium starch glycollate
pregelatinised wheat starch
stearic acid.
This medicine does not contain sucrose, tartrazine or any other azo dyes.
