FIORINAL® DENTAL capsules
Paracetamol, Codeine Phosphate and Doxylamine Succinate
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Fiorinal Dental.
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, dentist or pharmacist has weighed the risks of you taking Fiorinal Dental against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor, dentist or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What Fiorinal Dental is used for
Fiorinal Dental contains the active ingredients paracetamol, codeine phosphate and doxylamine succinate.
Paracetamol is an analgesic which 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 pain relief than any of these drugs alone and avoids the side effects associated with large doses of these components.
About 8% of people are poor metabolisers of codeine; poor metabolisers are likely to obtain reduced pain relief with codeine compared with other people who are not poor metabolisers.
Fiorinal Dental is used to provide temporary relief from the symptoms of pain associated with surgical and dental procedures, toothache and neuralgia.
Your doctor or pharmacist may have recommended Fiorinal Dental for another reason. Ask your doctor or pharmacist if you have any questions about why Fiorinal Dental has been recommended for you.
Before you take Fiorinal Dental
When you must not take it
Do not take Fiorinal Dental if you have an allergy to Fiorinal Dental or any of the ingredients listed at the end of this leaflet.
Do not take Fiorinal Dental if you have an allergy to an opiod analgesic such as morphine or pethidine, or to another antihistamine.
Symptoms of an allergic reaction to Fiorinal Dental 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 Fiorinal Dental if you regularly drink large amounts of alcohol.
Your liver may be more susceptible to damage from the paracetamol in Fiorinal Dental.
Do not take Fiorinal Dental if you have any of the following conditions:
- Severe breathing difficulties;
- Diarrhoea associated with bacteria or poisons;
- Chronic constipation;
- Enlarged prostate;
- Stomach ulcer;
- A blockage in your bladder or gut;
Fiorinal Dental may make your condition worse, or you may be more likely to get side effects.
Do not take Fiorinal Dental if you take medicines known as monoamine oxidase inhibitors (MAOIs). You may be more likely to get side effects.
Do not give Fiorinal Dental to a child under 12 years of age. The safety and effectiveness of Fiorinal Dental in children under 12 years of age have not been established.
Do not take Fiorinal Dental after the expiry date (EXP) printed on the pack. If you take this medicine after the expiry date has passed, it may not work as well.
Do not take Fiorinal Dental if the packaging is torn or shows signs of tampering, or the tablets or capsules do not look quite right.
If you are not sure whether you should start taking Fiorinal Dental, talk to your doctor or pharmacist.
Before you start to take it
Tell your doctor or pharmacist if you have allergies to:
- any other medicines
- any other substances, such as foods, preservatives or dyes
Tell your doctor or pharmacist if you are pregnant or intend to become pregnant. Your doctor or pharmacist will discuss the possible risks and benefits of using Fiorinal Dental during pregnancy.
Tell your doctor or pharmacist if you are breast-feeding or plan to breast-feed. Like most medicines, Fiorinal Dental is not recommended while you are breast-feeding. If there is a need to consider Fiorinal Dental while you are breast-feeding, your doctor or pharmacist will discuss with you the benefits and risks of taking it.
Tell your doctor or pharmacist if you have or have had any medical conditions, especially the following:
- problems with breathing
- kidney or liver problems
- problems urinating
- prostate problems
- stomach or bowel problems
- thyroid problems
- low blood pressure
- myasthenia gravis
- recent surgery
Tell your doctor or pharmacist if you are a heavy drinker or have a history of drug abuse.
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking Fiorinal Dental.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Fiorinal Dental may interfere with each other. These include:
- sleeping tablets, sedatives, or other medicines that make you sleepy
- some drugs to lower blood pressure
- some antidepressants
- some anti-coagulants (medicines to thin your blood)
- medicines used to control fits
- other analgesics (medicines to relieve pain)
- drugs that affect your stomach or bowel
These medicines may be affected by Fiorinal Dental, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist will advise you.
Your doctor and pharmacist may have more information on medicines to be careful with or avoid while taking Fiorinal Dental.
How to take Fiorinal Dental
How much to take
Adults and children 12 years and over: Take 1-2 capsules every 4-6 hours as necessary to relieve pain.
Do not take more than 8 capsules in 24 hours.
Do not give to children under 12 years of age.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
How to take it
Swallow Fiorinal Dental capsules with a glass of water.
When to take it
It does not matter if you take Fiorinal Dental before or after food.
How long to take it
Fiorinal Dental is for minor and temporary ailments and should be used strictly as directed. Prolonged use without medical supervision may be harmful. Codeine may be habit-forming if taken frequently and over a long period of time.
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 as required.
Do not take a double dose to make up for the dose that you missed.
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.
If you take too much (overdose)
Immediately telephone your doctor or pharmacist or the Poisons Information Centre (telephone 13 11 26 in Australia or 0800 764 766 in New Zealand), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much Fiorinal Dental. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you take too much Fiorinal Dental, you may feel drowsy, sick in the stomach, or restless.
While you are using Fiorinal Dental
Things you must do
Tell any other doctors, dentists, and pharmacists who are treating you that you are taking Fiorinal Dental.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking Fiorinal Dental.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking Fiorinal Dental.
If you become pregnant while taking Fiorinal Dental, tell your doctor or pharmacist.
Things you must not do
Do not give Fiorinal Dental to anyone else, even if they have the same condition as you.
Do not take Fiorinal Dental to treat any other complaints unless your doctor or pharmacist tells you to.
Do not drink alcohol.
Things to be careful of
Be careful driving or operating machinery until you know how Fiorinal Dental affects you.
Fiorinal Dental may cause dizziness, tiredness, or drowsiness in some people. Make sure you know how you react to Fiorinal Dental before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or sleepy. If this occurs do not drive.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Fiorinal Dental.
Fiorinal Dental helps most people with mild or moderate pain, 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 treatment if you get some of the side effects. If you are over 65 years of age you may have an increased chance of getting side effects.
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:
- skin rashes
- dry mouth
- loss or increase of appetite, weight loss
- depression or anxiety
- dizziness or hallucinations
- nausea, vomiting or stomach pains
- blurred vision
- problems urinating
- increased heart rate
Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
After using Fiorinal Dental
Keep your capsules in the pack until it is time to take them. If you take the capsules out of the pack they will not keep well.
Keep your capsules in a cool dry place where the temperature stays below 30°C.
Do not store Fiorinal Dental or any other medicine in the bathroom or near a sink.
Do not leave it in the car on hot days 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.
Return any unused medicines, or medicines that have passed their expiry date to your pharmacist for disposal.
What it looks like
Fiorinal Dental Capsules are available in packs of 20. They are half dark blue and half grey marked “Fiorinal Dental”.
- paracetamol 500 mg
- codeine phosphate 10 mg
- doxylamine succinate 2 mg
- Silica – colloidal anhydrous
- Talc – purified
- Magnesium stearate
- Titanium dioxide
- Brilliant blue FCF
- Iron oxide black
Fiorinal Dental does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
Fiorinal Dental is supplied in Australia by:
Novartis Consumer Health
Australasia Pty Ltd
327-333 Police Road,
Mulgrave VIC 3170
Australian Registration Number:
AUST R 13356
This leaflet was prepared in September 2008.
Published by MIMS November 2011