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 Clobex 500mcg/mL clobetasol propionate

Consumer Medicine Information

What is in this leaflet Before you use 18 years unless directed by the child’s doctor. CLOBEX SHAMPOO This leaflet answers some common Growth retardation may be questions about CLOBEX When you must not use it observed in children in case of SHAMPOO. It does not contain all systemic of topical the available information. Do not use CLOBEX SHAMPOO corticosteroids.

if: It does not take the place of talking Before you start to use it to your doctor or pharmacist. 1. you have ever had an allergic

reaction to : You must tell your doctor if: All medicines have risks and  medicines containing benefits. Your doctor has weighed clobetasol propionate 1. you are allergic to any other the risks of you taking CLOBEX  any of the ingredients listed medicines or other substances SHAMPOO against the benefits such as foods, dyes or this medicine is expected to have at the end of this leaflet preservatives. for you. 2. you have areas affected by bacterial, mycobacterial or 2. you are pregnant or plan to If you have any concerns about become pregnant taking this medicine, ask your viral skin (such as cold sores, shingles or doctor or pharmacist. Your doctor will discuss the risks chicken pox) and benefits of using CLOBEX Keep this leaflet with the SHAMPOO when pregnant. medicine. You may need to read it 3. you have skin areas affected by fungal or parasitic skin again. 3. you are breast-feeding or plan infections (such as thrush, tinea or ringworm) to breast-feed What CLOBEX SHAMPOO is used for 4. you have skin areas affected Your doctor will discuss the risks by specific skin diseases and benefits of using CLOBEX

(such as skin tuberculosis or SHAMPOO when breast-feeding. CLOBEX SHAMPOO is used as a skin disease caused by lues) topical treatment for moderate to If you have not told your doctor severe scalp in adults. 5. you have skin areas with about any of the above, tell them

ulcerous wounds before you start using CLOBEX It belongs to a group of medicines SHAMPOO. called corticosteroids. If you are not sure whether you

should be using CLOBEX Using other medicines CLOBEX SHAMPOO is used on SHAMPOO, talk to your doctor. the scalp to relieve the redness, Tell your doctor if you are using swelling, itching and discomfort of Do not use CLOBEX SHAMPOO creams, ointments or or scalp psoriasis. if the packaging is torn or shows taking any other medicines. This

signs of tampering. includes any that you buy Your doctor, however, may have without a prescription from a prescribed CLOBEX SHAMPOO for Do not use CLOBEX SHAMPOO pharmacy, supermarket or health another purpose. after the expiry date (EXP) food shop.

printed on the box or bottle has Ask your doctor if you have any passed. Some medicines may affect the questions about why CLOBEX The expiry date refers to the last day way others work. Your doctor or SHAMPOO has been prescribed of that month. If you use this pharmacist will be able to tell you for you. medicine after the expiry date it what to do when taking/using

may not work (as well). CLOBEX SHAMPOO with other There is no evidence that CLOBEX medicines. SHAMPOO is addictive. Do not use CLOBEX SHAMPOO CLOBEX SHAMPOO is available on children under 2 years. You only with a doctor's prescription. How to use CLOBEX should not use CLOBEX

SHAMPOO on children aged 2 to SHAMPOO

CLOBEX SHAMPOO (500mcg/mL clobetasol propionate) Ver3 1 [Type text]

Things you must do Follow all directions given to you How long to use it by your doctor and pharmacist Tell all doctors and pharmacists carefully. They may differ from the Your doctor will tell you how long to who are treating you that you are information contained in this leaflet. use CLOBEX SHAMPOO. It should using CLOBEX SHAMPOO. not be used continuously for more If you do not understand the than 4 weeks. If you feel that CLOBEX instructions on the box, ask your SHAMPOO is not helping your doctor or pharmacist for help. Do not use CLOBEX SHAMPOO condition, tell your doctor (or for longer than your doctor tells pharmacist). CLOBEX SHAMPOO is for topical you. use on the scalp only. Tell your doctor if, for any If you use CLOBEX SHAMPOO for reason, you have not used How to use longer than your doctor tells you, CLOBEX SHAMPOO exactly as the chance of side effects may prescribed. CLOBEX SHAMPOO should be increase. Prolonged and/or applied directly to a dry scalp once intensive treatment with CLOBEX Otherwise, your doctor may think daily taking care to cover and SHAMPOO may cause that it was not effective and change massage into all lesions. suppression of the immune your treatment unnecessarily. response, opportunistic infections Using the measuring cup included, and other skin conditions. If you become pregnant while measure out 7.5mL which is using CLOBEX SHAMPOO, tell sufficient to cover the scalp. This is If you are not sure how long to your doctor. the maximum amount to be used use CLOBEX SHAMPOO, talk to per day. your doctor. If you are or want to start breastfeeding, tell your doctor. CLOBEX SHAMPOO should be If you forget to use it left without covering for 15 minutes Things you must not do before rinsing. If it is almost time for your next dose, skip the dose you missed Do not use CLOBEX SHAMPOO As with any topical , and use your next dose when in or near the eyes and . wash hands carefully after you are meant to. Otherwise, use application. it as soon as you remember, and Do not give CLOBEX SHAMPOO then go back to using your to anyone else, even if they have After 15 minutes, the product must medicine as you would normally. the same symptoms as yours. be rinsed with water and / or can be washed by using an additional Do not use a double dose to Do not use CLOBEX SHAMPOO amount of regular shampoo if make up for the dose that you to treat other complaints unless needed to facilitate washing. Then, missed. your doctor tells you to. hair can be dried as usual. If you have trouble remembering to Things to be careful of In order to avoid hair colour use your medicine, ask your changes in hair that has been dyed, pharmacist for some hints. Do not use large amounts of CLOBEX SHAMPOO should be CLOBEX SHAMPOO for a long thoroughly rinsed. If you swallow it time.

Avoid contact with the eyes. If you Immediately telephone your Avoid contact with the eyes. If the accidentally get CLOBEX doctor or Poisons Information shampoo accidentally comes in SHAMPOO in your eyes, rinse out Centre (telephone 13 11 26), or go contact with the eyes, rinse out the the eyes with water immediately. to casualty at your nearest eyes with water immediately. hospital, if you think that you or It is important to use CLOBEX anyone else may have swallowed Tell your doctor if experience blurred SHAMPOO exactly as your doctor CLOBEX SHAMPOO. Do this vision or other visual disturbances has told you. If you use it less often even if there are no signs of after using CLOBEX SHAMPOO. than you should, it may not work as discomfort or poisoning. You well and your skin problem may not may need urgent medical If you use large amounts for a improve. Using it more often than attention. Keep these telephone long time, the chance of you should may not improve your numbers handy. absorption through the skin and skin problem any faster and may the chance of side effects cause or increase side effects. increases. While you are using Use CLOBEX SHAMPOO at the Ask your doctor if you are same time every day. CLOBEX SHAMPOO concerned about the length of time

CLOBEX SHAMPOO (500mcg/mL clobetasol propionate) Ver3 2 [Type text]

you have been using CLOBEX  hypercortisolism (Cushing’s closures which contain 8 or 16 SHAMPOO. syndrome) days’ worth of treatment,  adrenal suppression respectively. The HDPE bottle of Side effects  blurred vision 30mL is fitted with polypropylene Some people may get other side screw closure which contains 4

effects while using CLOBEX days’ worth of treatment. Not all Tell your doctor or pharmacist as SHAMPOO. pack sizes may be marketed. soon as possible if you do not feel well while you are using Do not be alarmed by this list of Ingredients CLOBEX SHAMPOO. possible side effects. You may not

experience any of them. CLOBEX SHAMPOO contains the All medicines can have side effects. active ingredient clobetasol Sometimes they are serious, most propionate 500mcg/mL. of the time they are not. You may After using CLOBEX need medical treatment if you get SHAMPOO 1 millilitre of CLOBEX SHAMPOO some of the side effects. contains 500micrograms of

Storage clobetasol propionate. Ask your doctor or pharmacist to answer any questions you may Store in the original bottle. CLOBEX SHAMPOO also contains have. the following excipients:

Keep CLOBEX SHAMPOO in a ethanol, coco-betaine, sodium The more common side effects of laureth sulfate, polyquaternium-10, CLOBEX SHAMPOO (occur in less cool, dry place where the temperature stays below 25°C. sodium citrate, citric acid, purified than 1 in 10 patients) include: water.  skin burning sensation Do not store it, or any other medicine, in a bathroom or near a  /inflammation of hair sink. Do not leave them in the car Sponsor/distributor follicles or on window sills.

Galderma Australia Pty Ltd Tell your doctor if you notice any Heat and dampness can destroy Suite 4, 13B Narabang Way of these and they worry you. Belrose NSW 2085 some medicines. Ph. 1800 800 765 The uncommon side effects of Keep CLOBEX SHAMPOO where CLOBEX SHAMPOO (occur in less children cannot reach it. In New Zealand by: than 1 in 100 patients) include: A locked cupboard at least one-and- Healthcare Logistics’  local signs of skin irritation a-half metres above the ground is a 58 Richard Pearce Drive  itching of the skin good place to store medicines. Airport Oaks  hives Auckland  small red or purple clusters Disposal Telephone 0800 174 104 on the skin  skin becoming fragile and Discard 4 weeks after first Made in France prone to tears and opening. ulcerations Australian Registration Number:  skin discomfort If your doctor tells you to stop AUST R 188346  pain of skin using CLOBEX SHAMPOO, or it  fluid retention under the skin has passed its expiry date, ask ® Registered Trademark (oedema) your pharmacist what to do with  aggravation of psoriasis any left over. This leaflet was prepared on  hair loss causing spot Medicines should not be disposed July 2018 baldness of via wastewater or household  dry skin waste.  eye stinging / burning  eye irritation Product description  ocular tight sensation

 headache What it looks like  stretch marks

 rash CLOBEX SHAMPOO is a viscous, Post-marketing adverse event translucent colourless to pale reports have also included yellow shampoo with  erythema (redness) alcoholic odour.  rash CLOBEX SHAMPOO is packaged  allergic contact dermatitis in high density polyethylene  glaucoma (HDPE) bottles of 60mL or 125mL  hypersensitivity fitted with polypropylene snap

CLOBEX SHAMPOO (500mcg/mL clobetasol propionate) Ver3 3