Core CMI for Topical Corticosteroids (Text in Italics Is Instructional)

March 1997 Core CMI for Topical Corticosteroids (text in italics is instructional)

Medicine Name (phonetic spelling if required)

Generic name

Consumer Medicine Information

Name Address Address

What is in this leaflet1 Before you use Medicine Name is a type of cortisone and belongs to the group Medicine Name Standard information as suggested of medicines called corticosteroids. in Usability Guidelines When you must not use it Medicine Name is used on the skin This leaflet answers some common to relieve the redness, swelling, Do not use Medicine Name if: questions about Medicine Name. itching and discomfort of many skin It does not contain all the available problems such as: 1. you have an allergy to: information.  psoriasis (a stubborn skin  Medicine Name or any of the It does not use the place of talking disorder with raised, rough, to your doctor (or pharmacist). ingredients in Medicine Name reddened areas covered with listed at the end of this leaflet dry, fine silvery scales) All medicines have risks and  other substances as per PI  eczema (an often itchy skin benefits2. Your doctor or condition with redness, swelling, pharmacist has weighed the risks 2. you have a viral skin infection oozing of fluid, crusting which of you using Medicine Name (such as cold sores, shingles may lead to scaling) against the benefits they expect it or chicken pox)  other types of dermatitis will have for you.  as per PI 3. a fungal skin infection (such Alternative: as thrush, tinea or ringworm) Non-approved uses: Your doctor or pharmacist has Others, as per PI weighed the risks of you using Your doctor or pharmacist may Medicine Name against the have prescribed or recommended Ask your doctor or pharmacist to benefits this medicine/it is expected Medicine Name for another be sure you do not have any of to have for you. purpose. Ask your doctor or these conditions. pharmacist if you have any If you have any concerns about questions about why Medicine Do not use Medicine Name just this medicine, ask your doctor or Name has been prescribed or before having a bath, shower or pharmacist. recommended for you. going swimming. If you do, you may reduce the Keep this leaflet with your Statement about addictive effectiveness of Medicine Name. medicine. You may need to read it properties: again. Tampering and expiry date Medicine Name is not addictive. warnings:

or Do not use Medicine Name if the packaging is torn or shows signs There is no evidence that Medicine of tampering. Name is addictive What Medicine Name is Do not use Medicine Name if the used for expiry date (EXP) printed on the If applicable: pack has passed. If you use this medicine after the 1 Depending on the length of your CMI, This medicine is available only with expiry date has passed, it may not consider using a table of contents (see a doctor’s prescription. work (as well). Usability Guidelines) 2 Consider reversing ‘risks’ and ‘benefits’ Medicine Name 1 March 1997 Core CMI for Topical Corticosteroids (text in italics is instructional)

If you are not sure whether you These medicines may be affected pharmacist has told you. If you use should start taking Medicine by Medicine Name, or may affect it less often than you should, it may Name, contact your doctor. how well it works. You may need not work as well and your skin If use in children a contraindication: to use different amounts of your problem may not improve. Using it medicine, or you may need to use more often than you should may Do not give Medicine Name to a different medicines. Your doctor not improve your skin problem any child under x years. will advise you. faster and may cause or increase The safety and effectiveness of side effects. Medicine Name in children have Your doctor and pharmacist may not been established. have more information on Use Medicine Name at the same medicines to be careful with or time every day. Before you start to use it avoid while taking Medicine Name. How long to use it Tell your doctor if: Alternative: Your doctor or pharmacist will tell 1. if you have any allergies to Some medicines may affect the you how long to use Medicine any other medicines or any way others work. Your doctor or Name. other substances, such as pharmacist will be able to tell you foods, preservatives or dyes. what to do when taking/using Do not use Medicine Name for Medicine Name with other longer than your doctor tells Pregnancy and breast-feeding: medicines. you. If you use Medicine Name for 2. if you are pregnant or intend How to use Medicine longer than your doctor or to become pregnant pharmacist tells you, the chance of Your doctor will discuss the risks Name side effects may increase. and benefits of using Medicine Name when pregnant. This information will be product If you are not sure how long to specific, consistent with the use Medicine Name, talk to your 3. if you are breast-feeding or approved PI. The following order doctor or pharmacist. intend to breast-feed of information is suggested, but will Your doctor will discuss the risks depend upon the particular product If you forget to take/use it and benefits of using Medicine and the amount of information. As per Usability Guidelines Name when breast-feeding. These subheadings and information are suggested but may If it is almost time for your next Do not apply Medicine Name to the not be necessary in all cases. dose, skip the dose you missed breasts before breast feeding. and use your next dose when How much to use you are meant to. Otherwise, 4. you have or have had any use it as soon as you remember, other medical conditions, Include dosage ranges, usual and then go back to using your including: doses for each indication or patient medicine as you would group, or a general statement that normally3.  as per PI the dose will depend on the patient and will be determined by the Do not use a double dose to If you have not told your doctor doctor. make up for the dose that you about any of the above, tell them missed. before you use any Medicine Follow all directions given to you Name. by your doctor and pharmacist If you have trouble remembering to carefully. use your medicine, ask your Using other medicines They/These directions may differ pharmacist for some hints. from the information contained in Tell your doctor or pharmacist if this leaflet. If you swallow it you are using other creams, ointments or lotions or taking If you do not understand the Immediately telephone your any medicine. This includes any instructions on the box/bottle, ask doctor or Poisons Information that you buy without a your doctor or pharmacist for help. Centre (telephone 13 11 26)4, or prescription from a pharmacy, go to casualty at your nearest supermarket or health food How to use it hospital, if you think that you or shop. anyone else may have swallowed Some medicines may interfere with Include how to apply, rub, massage Medicine Name. Do this even if

Medicine Name. These include: etc and frequency of application as 3 per PI. These two sentences are in reverse order from that recommended in the  list as per PI Usability Guidelines. It is important to use Medicine 4 Consider including the relevant New Name exactly as your doctor or Zealand telephone numbers here. Medicine Name 2 March 1997 Core CMI for Topical Corticosteroids (text in italics is instructional) there are no signs of discomfort Ask your doctor or pharmacist if  list as per PI or poisoning. You may need you are concerned about the urgent medical attention5. Keep length of time you have been These are serious side effects. these telephone numbers handy. using Medicine Name. You may need urgent medical attention. Serious side effects are If you swallow Medicine Name, you Do not use Medicine Name on rare. may feel ..... (list symptoms in PI) skin areas that rub together such as under the arm or in the groin If any of the following happen, While you are using area unless your doctor tells you stop taking Medicine Name and to. tell your doctor immediately or Medicine Name go to casualty at your nearest Side effects hospital: Things you must do  list as per PI Tell your doctor or pharmacist if Tell all doctors and pharmacists you do not feel well while you who are treating you that you are These are very serious side effects. are using Medicine Name. using Medicine Name. You may need urgent medical Medicine Name helps most people attention or hospitalisation. These with skin problems but it may have If you feel that Medicine Name is side effects are rare. unwanted side effects in a few not helping your condition, tell people. your doctor (or pharmacist). Other side effects not listed above may also occur in some All medicines can have side effects. Tell your doctor if, for any patients. Tell your doctor if you Sometimes they are serious, most reason, you have not used notice anything else that is of the time they are not. You may Medicine Name exactly as making you feel unwell. need medical treatment if you get prescribed. some of the side effects. Otherwise, your doctor may think or that it was not effective and change Alternative: your treatment unnecessarily. Some people may get other side effects while taking/using Check with your doctor or If you become pregnant while Medicine Name. pharmacist as soon as possible using Medicine Name, tell your if you have any problems while doctor. Ask your doctor or pharmacist if taking Medicine Name, even if you don’t understand anything in you do not think the problems this list. Things you must not do are connected with the medicine or are not listed in this leaflet. Do not be alarmed by this list of Do not use Medicine Name under Like other medicines, Medicine possible side effects. You may not dressings or on large areas of Name can cause some side effects. experience any of them. skin unless your doctor tells If they occur, most are likely to be you. minor and temporary. However, some may be serious and need Do not use Medicine Name in or medical attention. After using Medicine near the eyes. Name Do not give Medicine Name to Ask your doctor or pharmacist to anyone else, even if they have answer any questions you may This information will be product the same symptoms as yours. have. Do not use Medicine Name to specific. See general statements in Usability Guidelines, including: treat other complaints unless Tell your doctor if you notice any your doctor or pharmacist tells of the following and they worry you to. you: Storage Keep Medicine Name in a cool Things to be careful of  list as per PI dry place where the temperature Do not use large amounts of These side effects are usually mild. stays below xx°C. Do not store Medicine Name for a long time. Medicine Name or any other If you use large amounts for a long or medicine in the bathroom or near time, the chance of absorption a sink. Do not it in the car or on through the skin and the chance of These are the more common side window sills. side effects increases. effects of Medicine Name. Heat and dampness can destroy some medicines. Tell your doctor immediately if Do not refrigerate Medicine 5 The reference to casualty and urgent you notice any of the following: medical attention could be left out, Name. (if applicable) depending on the type of product. Medicine Name 3 March 1997 Core CMI for Topical Corticosteroids (text in italics is instructional)

Keep Medicine Name where young 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 using Medicine Name or it has passed its expiry date, ask your pharmacist what to do with any that is left over.

Product description

This information will be product specific. The Usability Guidelines suggest the information should be presented in the following order:

What it looks like

Ingredients

Where Australian Food Standard codes exist, these could follow each Australian Approved name.

Manufacturer / Distributor / Supplier

Include:  Name and address of sponsor  ARTG number  Date of preparation

The statements in this core document are optional. Some may not be appropriate for a given product. In order to achieve consistency, however, CMI writers are encouraged to use these statements and follow the Usability Guidelines wherever possible.

Medicine Name 4