NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
CODRAL ORIGINAL COLD &FLU + COUGH DAY & NIGHT CAPSULES
Paracetamol, Pseudoephedrine hydrochloride, Dextromethorphan hydrobromide monohydrate, Chlorphenamine maleate
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Codral Original
Day & Night + Dry Cough Capsules. It does not contain all the available information. It does not take the place of talking to your pharmacist or doctor.
Day & Night + Dry Cough Capsules. 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 Day & Night + Dry Cough 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 Day & Night + Dry Cough is used for
Codral Original Day & Night + Dry Cough provides temporary relief of cold and flu symptoms.
The DAY capsules give temporary relief of headache, body aches and pains, blocked nose, fever and dry irritated coughs, without causing drowsiness.
The NIGHT capsules give temporary relief of headache, body aches and pains, blocked nose, fever, dry irritated coughs and runny nose.
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.
Dextromethorphan is a cough suppressant that acts on the cough centre in the brain to suppress a dry cough.
Chlorphenamine belongs to a group of medicines called ‘antihistamines’.Antihistamines help reduce allergic symptoms by preventing the effects of a substance called histamine. Histamine is produced by the body in response to foreign substances that the body is allergic to.
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 Day & Night + Dry Cough
When you must not take it
Do not take Codral Original Day & Night + Dry Cough if you have an allergy to:
any medicine containing paracetamol
any medicine containing pseudoephedrine
any medicine containing dextromethorphan
any medicine containing chlorphenamine or other antihistamines
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 are having an asthma attack.
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 take this medicine if you have or have had any of the following medical conditions:
glaucoma (high pressure in the eyes)
stomach or duodenal ulcer, or other stomach problems
prostate problems
bladder problems.
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 give this medicine to newborn or premature babies.
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 pharmacist or doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your pharmacist or doctor if you have or have had any of the following medical conditions:
liver or kidney disease
high blood pressure
overactive thyroid gland
diabetes
heart disease and poor blood flow in the blood vessels of the heart
glaucoma (high pressure in the eyes)
prostate problems
asthma
chronic obstructive airways disease
pneumonia
any other respiratory (breathing) conditions
epilepsy.
Tell your pharmacist or doctor if you take sedatives.
Tell your pharmacist or doctor if you have a chronic cough.
This medicine may make your cough worse.
Tell your pharmacist or doctor if you have a condition that produces large amounts of mucus.
This medicine may make your condition worse.
If you have not told your pharmacist or doctor about any of the above, tell him/her before you start taking Codral Original Day & Night + Cough.
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 Day & Night + Dry Cough may interfere with each other.These include:
warfarin, a medicine used to prevent blood clots
medicines used to treat high blood pressure
medicines used to treat heart conditions
quinidine and amiodarone, medicines used to treat abnormal or irregular heart beat
medicines used to treat depression, especially monoamine oxidase inhibitors and tricyclic antidepressants
medicines used to treat behavioural disorders
medicines used to help you relax, sleep or relieve anxiety, such as sedatives and hypnotics
medicines used to treat epilepsy or fits, including phenytoin
opioid analgesics, medicines used to treat pain
metoclopramide, a medicine used to control nausea and vomiting
medicines used to treat urinary tract infections and bladder problems
phenylephrine, a medicine used to treat congestion
chloramphenicol, an antibiotic used to treat ear and eye infections
appetite suppressants
alcohol
other products containing paracetamol.
These medicines may be affected by Codral Day & Night + Dry Cough 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 will have more information on these and other medicines to be careful with or avoid while taking this medicine.
How to take Codral Day & Night + Dry Cough
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 doses of Codral Day & Night + Dry Cough for adults and children over 12 years are:
DAY dosage: one or two green ‘Day’ capsules in the morning, at midday and in the afternoon, as required.
NIGHT dosage: one or two red ‘Night’ capsules at bedtime, as required.
Codral Original Day & Night + Dry Cough is not recommended 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.
You may have an increased chance of getting side effects.
How to take it
Swallow capsules whole with a glass of water.
When to take it
Take each dose at least 4 to 6 hours apart.
Do not exceed four doses in 24 hours.
How long to take it
As Codral Original Day & Night + Dry Cough contains paracetamol, take only for a few days at a time 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.
Your next dose should be taken in 4 to 6 hours if you think you need it.
If you are not sure what to do, ask your pharmacist or doctor.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, 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 Day & Night + Cough.Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are using Codral Original Day & Night + Dry Cough
Things you must do
Talk to your pharmacist or doctor if your symptoms do not improve.
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.
Do not drink alcohol (beer, wine or spirits) while taking this medicine.
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 more than the recommended dose unless your doctor tells you to.
Do not take this medicine 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.
Things to be careful of
Be careful driving or operating machinery until you know how Codral Original Day & Night + Dry Cough affects you.
This medicine may cause dizziness or sleepiness in some people. If this happens, do not drive or operate machinery.
Side effects
Tell your pharmacist or doctor as soon as possible if you do not feel well while you are taking Codral Day & Night + Dry Cough.
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
vomiting
stomach discomfort
constipation
drowsiness or sleepiness
dizziness
fatigue
difficulty sleeping
nervousness and irritability
dry mouth, nose and throat
excitability
restlessness
fear or anxiety
rapid heart beat
tremor
twitching or jerking muscles
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:
muscle spasms affecting the eyes, head, neck and body
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
excitation
extreme confusion
nervousness and anxiety
irritability
restlessness
severe nausea and vomiting
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
any sign of hypersensitivity.
The above list includes very serious side effects.You may need urgent medical attention or hospitalisation.These side effects are very rare for low doses of this medicine and when used for a short period of time.
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 Day & Night + Dry Cough
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 degrees C.
Do not store Codral Original Day & Night + Dry Cough 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 Day & Night + Dry Cough contain two types of capsules:
DAY capsules which are blue green/white opaque hard gelatin capsules with ‘Day’ printed in black.
NIGHT capsules which are reddish orange/white opaque hard gelatin capsules with ‘Night’ printed in black.
Codral Original Day & Night + Dry Cough capsules are available in blister packs of 24 capsules (18 DAY capsules and 6 NIGHT capsules).
Ingredients
The DAY capsules contain 500 mg of paracetamol, 30 mg of pseudoephedrine hydrochloride and 10 mg of dextromethorphan hydrobromide monohydrate as the active ingredients.
The DAY capsules also contain the following inactive ingredients:
allura red AC
brilliant blue FCF
gelatin
lactose
magnesium stearate
quinoline yellow
anhydrous colloidal silica
silicon dioxide
sodium lauryl sulfate
purified talc
titanium dioxide
Opacode Black A-10259.
The NIGHT capsules contain 500 mg of paracetamol, 2 mg of chlorphenamine maleate and 10 mg of dextromethorphan hydrobromide monohydrate as the active ingredients.
The NIGHT capsules also contain the following inactive ingredients:
allura red AC
brilliant blue FCF
gelatin
lactose
magnesium stearate
anhydrous colloidal silica
silicon dioxide
sodium lauryl sulfate
purified talc
titanium dioxide
Opacode Black A-10259.
This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.
Manufacturer
Codral Original Day & Night + Dry Cough is made in Australia by:
Johnson & Johnson Pacific
45 Jones Street
Ultimo NSW 2007
CODRAL is a registered trademark.
This leaflet was prepared in March 2019.
Australian Register Number:
AUST R 73421
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