General Core CMI For Use At QARG -Feb 2001

Core CMI for Paracetamol (text in italics is instructional for the CMI writer only) 30 November 2005  [Medicine name] (If you want to include phonetic spelling, the Second Edition of the Usability Guidelines suggests using the system outlined in the Webster’s International Dictionary).

Generic name

Consumer Medicine Information Date of Dispensing This Core leaflet covers both prescription and non-prescription products containing paracetamol, and therefore must be modified to suit the particular product being written about. Information in the CMI must be consistent with the product’s Product Information (PI).

When writing about consumers seeking advice from health professionals, the schedule of the product should be taken into consideration. Thus:  S4 products should direct consumers to seek advice from their doctor or pharmacist, and  S3 products should direct consumers to seek advice from their pharmacist or doctor.

What is in this leaflet Ask your pharmacist or doctor if the packaging is torn or shows signs you have any questions about this of tampering. This leaflet answers some common medicine. If it has expired or is damaged, return it questions about [Medicine name]. Your pharmacist or doctor may have to your pharmacist for disposal. It does not contain all the available given it for another reason. If you are not sure whether you information. It does not take the place Below are further statements that may should start taking this medicine, of talking to your pharmacist or doctor. be included in this section. talk to your pharmacist or doctor (or doctor or pharmacist). All medicines have risks and benefits. This medicine is not addictive. Your pharmacist or doctor has weighed the risks of you taking [Medicine It is only available from your Before you start to take it name] against the benefits they expect pharmacist. it will have for you. This medicine is only available on a Tell your pharmacist or doctor if prescription from your doctor. you have allergies to any other If you have any concerns about medicines, foods, preservatives or taking this medicine, ask your dyes. pharmacist or doctor. Tell your pharmacist or doctor if Keep this leaflet with the medicine. you have or have had any of the You may need to read it again. Before you take/give following medical conditions: [Medicine name]  liver or kidney disease Ask your pharmacist or doctor When you must not take it about taking paracetamol if you are What [Medicine name] pregnant or plan to become is used for Do not take [Medicine name] if you pregnant, or breastfeeding. have an allergy to: Paracetamol may be used during Paracetamol is used to (insert  any medicine containing pregnancy and if you are breastfeeding. indication as specified in the ARTG, or paracetamol If you have not told your pharmacist for a non-validated grandfathered  any of the ingredients listed at the or doctor about any of the above, tell product, as specified on the product end of this leaflet. him/her before you start taking label). Some of the symptoms of an allergic [Medicine name].  List multiple indications in dot reaction may include: points  shortness of breath Taking other medicines Paracetamol works to stop the pain  wheezing or difficulty breathing messages from getting through to the Tell your pharmacist or doctor if  swelling of the face, lips, tongue or brain. It also acts in the brain to reduce you are taking any other medicines, other parts of the body fever. including any that you get without a  rash, itching or hives on the skin prescription from your pharmacy, Do not take this medicine/it after the supermarket or health food shop. expiry date printed on the pack or if

[Medicine name] 1 Core CMI for Paracetamol (text in italics is instructional for the CMI writer only) 30 November 2005

Some medicines and paracetamol may Children: Things you must not do interfere with each other. These Only give paracetamol to children include: for up to 48 hours unless a doctor Children:  warfarin, a medicine used to has told you to give it longer. Do not give paracetamol for more prevent blood clots than 48 hours unless a doctor has told you to.  metoclopramide, a medicine used If you forget to take it to control nausea and vomiting Adults: If it is less than ‘x’ hours before your Do not take for more than a few days  medicines used to treat epilepsy or next dose, skip the dose you missed at a time unless your doctor tells you fits and take your next dose when you to.  chloramphenicol, an antibiotic used are meant to. to treat ear and eye infections Do not take more than the Otherwise, take it as soon as you recommended dose unless your  alcohol remember, and then go back to doctor tells you to. Your doctor and pharmacist will have taking your medicine as you would more information on these and other normally. Do not take [Medicine name] to treat medicines to be careful with or avoid any other complaints unless your Do not take a double dose to make while taking this medicine. pharmacist or doctor tells you to. up for the dose that you missed. This may increase the chance of you Do not give your medicine to anyone getting an unwanted side effect. else, even if they have the same condition as you. If you are not sure what to do, ask How to take [Medicine your pharmacist or doctor. name] Things to be careful of If you have trouble remembering to take your medicine, ask your Follow all directions given to you by Only drink small quantities of pharmacist for some hints. your pharmacist or doctor carefully. alcohol (beer, wine or spirits) while They may differ from the information taking paracetamol. contained in this leaflet. If you take too much Drinking large quantities of alcohol (overdose) while taking paracetamol may increase If you do not understand the the risk of liver side effects. instructions on the box/bottle, ask Immediately telephone your doctor your pharmacist or doctor for help. or the Poisons Information Centre (telephone 13 11 26) for advice, or go How much to take to Accident and Emergency at the nearest hospital, if you think that Side effects Include dosage ranges, usual doses for you or anyone else may have taken each indication or patient group etc too much [Medicine name]. Do this Tell your pharmacist or doctor as .as specified on the product label. even if there are no signs of soon as possible if you do not feel discomfort or poisoning. well while you are taking [Medicine Do not take more than the You may need urgent medical name]. recommended dose. attention. This medicine helps most people with (indication), but it may have unwanted How to take it side effects in a few people. All Include specific instructions as medicines can have side effects. specified on the product label. Sometimes they are serious, most of While you are using the time they are not. You may need [Medicine name] medical attention if you get some of When to take it the side effects. Include specific instructions as Do not be alarmed by the following specified on the product label. Things you must do lists of side effects. You may not Talk to your pharmacist or doctor if experience any of them. How long to take it your symptoms do not improve. Ask your pharmacist or doctor to Include specific instructions as Your pharmacist or doctor will assess answer any questions you may have. your condition and decide if you specified on the product label. Tell your pharmacist or doctor if should continue to take the medicine. Adults: you notice any of the following and they worry you: Only take paracetamol for a few  nausea or dyspepsia days at a time unless your doctor tells you to take it for longer.

[Medicine name] 2 Core CMI for Paracetamol (text in italics is instructional for the CMI writer only) 30 November 2005

If any of the following happen, tell Product description your pharmacist or doctor immediately or go to Accident and Emergency at your nearest hospital: What it looks like  shortness of breath  wheezing or difficulty breathing Include identifying details as  swelling of the face, lips, tongue or appropriate, such as dose form, colour other parts of the body and markings of tablets, colour and consistency of liquids, pack sizes, etc.  rash, itching or hives on the skin The above list includes very serious side effects. You may need urgent Ingredients medical attention or hospitalisation. [Medicine name] contains x mg of These side effects are very rare for low (generic name) as the active ingredient. doses of this medicine and when used for a short period of time. It also contains:  list excipients in dot points Tell your pharmacist or doctor if you notice anything that is making Where Australian Food Standard you feel unwell. codes exist, these could follow each Other side effects not listed above may Australian Approved name. also occur in some people. As appropriate, the CMI may include a negative list of ingredients. For example: This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes. After using [Medicine name] Manufacturer/Distributor/ Supplier Storage (use appropriate heading) Keep your medicine in the original pack until it is time to take. [Medicine name] is made/distributed/supplied in Australia Keep your medicine in a cool dry by: place where the temperature stays Include name and address of sponsor below x°C.  = Registered Trademark or Do not store [Medicine name] or any other medicine in the bathroom or  = Trademark (if appropriate) near a sink. Do not leave it on a This leaflet was prepared in window sill or in the car. month/year. Heat and dampness can destroy some Include AUST R number(s) medicines. You may want to include a document Keep it where children cannot reach code and/or a reference to the it. approved PI. 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.

[Medicine name] 3