NEW ZEALAND CONSUMER MEDICINE INFORMATION BETA Betamethasone valerate cream 0.1% w/w Betamethasone valerate ointment 0.1% w/w

 discoid lupus Some of the symptoms of an What is in this leaflet erythematosus (recurring allergic reaction may include: scaly rash) shortness of breath; wheezing or This leaflet answers some common  prickly heat skin reaction difficulty breathing; swelling of the questions about BETA Cream and  insect bite reactions face, lips, tongue or other parts of Ointment.  prurigo nodularis (an itching the body; rash, itching or hives on and thickening of the skin the skin. It does not contain all the available with lumps or nodules) information. It does not take the  contact sensitivity reactions Do not use BETA Cream or place of talking to your doctor or  an additional treatment for Ointment to treat any of the pharmacist. an intense widespread following skin problems as it reddening and inflammation could make them worse: All medicines have risks and of the skin,  infected skin (unless the benefits. Your doctor has weighed when milder topical corticosteroids infection is being treated the risks of you using BETA Cream cannot treat the skin condition with an anti-infective or Ointment against the benefits effectively. medicine at the same time) they expect it will have for you.  acne BETA Cream is usually used to  rosacea (a facial skin If you have any concerns about treat skin conditions on moist condition where the nose, taking this medicine, ask your surfaces; BETA Ointment is usually cheeks, chin, forehead or doctor or pharmacist. used to treat skin conditions on dry, entire face are unusually scaly skin. red, with or without tiny Keep this leaflet with the visible blood vessels, medicine. You may need to read it Ask your doctor if you have any bumps (papules) or pus- again. questions about why this filled bumps (pustules)) medicine has been prescribed for  rashes around the mouth you.  itchy skin which is not What BETA Cream Your doctor may have prescribed it inflamed or Ointment is used for another reason.  itching around the anus or genitals (penis or vagina). for This medicine is available only with a doctor’s prescription. If your doctor advises the use of Your BETA Cream or Ointment BETA Cream or Ointment to treat contains the active ingredient There is no evidence that BETA one of the above skin betamethasone valerate. It belongs Cream or Ointment is addictive. complications, it is important you to a group of medicines known as follow your doctor’s instructions topical corticosteroids. “Topical” carefully. means that they are applied onto Before you use the skin. Topical corticosteroids are Do not use BETA Cream or used to help reduce the BETA Cream or Ointment on a child under the inflammation that causes the Ointment age of 1 year. redness and itchiness in a variety of Safety and effectiveness in children conditions (they are not ‘anabolic’ younger than 1 year old have not steroids which are sometimes When you must not use been established. misused by athletes). it: Do not use this medicine after the BETA Cream or Ointment is useful Do not use BETA Cream or expiry date printed on the pack or in treating various inflamed Ointment if you have an allergy if the packaging is torn or shows conditions of the skin such as: to: signs of tampering. If it has expired or is damaged,  psoriasis  any medicine containing betamethasone valerate return it to your pharmacist for  severe forms of eczema disposal.  lichen planus (chronic itchy  any of the ingredients listed skin of unknown origin) at the end of this leaflet.

Page 1 of 4 If you are not sure whether you They may differ from the information your doctor has prescribed. If the should start using this medicine, contained in this leaflet. condition worsens or does not talk to your doctor. improve within two to four weeks, If you do not understand the talk to your doctor or pharmacist. Before you start to use instructions on the box ask your it: doctor or pharmacist for help. If you forget to use it Tell your doctor if you have How much to use If you forget to use BETA Cream or allergies to any other medicines, Ointment apply it as soon as you foods, preservatives or dyes. Use only enough BETA Cream or remember then continue as before. Ointment to cover the entire Tell your doctor if you are affected area once or twice a day. Do not apply extra BETA Cream or pregnant or plan to become Ointment to make up for a missed pregnant or are breast-feeding. It is important that you only apply dose. Your doctor can discuss with you BETA Cream or Ointment exactly the risks and benefits involved. as directed by your doctor. Do not If you are not sure what to do, use more than the recommended ask your doctor or pharmacist. If you do use BETA Cream or amount. Ointment when breast-feeding, do If you have trouble remembering to not use on your breast area so that Sometimes repeated short courses take your medicine, ask your the baby does not accidently get the of BETA CREAM or OINTMENT pharmacist for some hints. medicine in their mouth. may be used to control your skin condition. Your doctor may tell If you use too much If you have not told your doctor you to use a different amount. If (overdose) about any of the above, tell so, it is important you follow their him/her before you start using instructions carefully. Immediately telephone your BETA Cream or Ointment. doctor or the National Poisons How to use it Information Centre (0800 POISON Taking other medicines or 0800 764 766) for advice, or go Apply a thin layer once or twice to Accident and Emergency at Tell your doctor or pharmacist if daily and gently rub in, using only the nearest hospital, if you think you are taking any other enough to cover the entire affected that you or anyone else may have medicines, including any that you area. accidently swallowed BETA get without a prescription from Cream or Ointment; or if you or your pharmacy, supermarket or Wash your hands after use unless anyone else may have used too health food shop. treating the hands. much BETA Cream or Ointment. Some medicines and BETA Cream Do this even if there are no signs or Ointment may interfere with each If you are also using an emollient or of discomfort or poisoning. You other. These include: moisturising preparation, allow time may need urgent medical attention. for BETA Cream or Ointment to be  ritonavir (a medicine used absorbed after each application for the treatment of HIV) before applying the emollient. While you are using  itraconazole (a medicine for the treatment of fungal If your eczema flares up frequently, BETA Cream or infections). your doctor may suggest that you Ointment use a less frequent dose of BETA These medicines may be affected Cream or Ointment once your by BETA Cream or Ointment or may eczema is under control, to stop Things you must do affect how well it works. You may your eczema from coming back. need different amounts of your Tell your doctor if, for any reason, you have not used your medicines, or you may need to take When to use it different medicines. medicine exactly as directed. Use BETA Cream or Ointment at Otherwise, your doctor may think Your doctor and pharmacist have about the same time each day. that it was not working as it should more information on medicines to Using it at the same time each day and change your treatment be careful with or avoid while using will have the best effect. It will also unnecessarily. this medicine. help you remember when to use it. If you are about to be started on any new medicine, remind your How to use BETA How long to use it doctor and pharmacist that you BETA Cream or Ointment should be are using BETA Cream or Cream or Ointment used once or twice daily for no more Ointment. than four weeks at a time. Follow all directions given to you Tell any other doctors, dentists, by your doctor or pharmacist Do not use BETA Cream or and pharmacists who treat you carefully. Ointment for any longer than that you are using this medicine.

Page 2 of 4 If you are going to have any The above list includes very serious blood tests, tell your doctor that Side effects side effects. You may need urgent you are using BETA Cream or medical attention or hospitalisation. Ointment. Tell your doctor or pharmacist as soon as possible if you do not Use of BETA Cream or Ointment If you become pregnant while feel well while you are using for a long period of time, or use using this medicine, tell your BETA Cream or Ointment. under an airtight dressing, may doctor immediately. This medicine helps most people, cause the following symptoms: but it may have unwanted side  increased weight Things you must not do effects in a few people. All  moon face / rounding of the medicines can have side effects. face Do not use BETA Cream or Sometimes they are serious, most  obesity Ointment on children under 1 of the time they are not. You may  skin thinning, this may year of age. need medical attention if you get cause stretch marks some of the side effects. Do not use BETA Cream or  skin wrinkling Ointment to treat any other Do not be alarmed by the  skin dryness complaints unless your doctor following lists of side effects.  the appearance of blood tells you to. You may not experience any of vessels under the surface them. of your skin Do not give your medicine to  increased body hair anyone else, even if they have Ask your doctor or pharmacist to  hair loss / lack of hair the same condition as you. answer any questions you may growth / damaged looking have. hair. Do not stop using your medicine without checking with your Tell your doctor or pharmacist if Other very rare skin reactions doctor. you notice any of the following that may occur are: If you use BETA Cream or Ointment and they worry you: regularly make sure you talk to your  allergic reaction at the site doctor before you stop using it.  skin rash of application  hot burning sensation  worsening of condition Do not let BETA Cream or  itching.  irritation at the site of Ointment get into your eyes. application If the medicine does accidentally Tell your doctor as soon as  redness enter your eyes, rinse your eye(s) possible if you notice any of the  rash or hives thoroughly with water. Do not touch following:  skin infection your eyes until you have washed  if you have psoriasis you your hands.  thinning of the skin and may get raised bumps with appearance of stretch pus under the skin. This can marks Things to be careful of happen very rarely during or  changes to the colour of after treatment and is Take care when applying BETA your skin known as pustular Cream or Ointment to the eyelids  increase in hair growth psoriasis. to make sure it does not get into  appearance of blood your eye. vessels under the surface Tell your doctor or pharmacist if of your skin. you notice anything that is Take care when applying BETA  blurred vision. making you feel unwell. Cream or Ointment to the face Other side effects not listed above over a long period of time as it If any of the following happen, may also occur in some people. may cause skin thinning. tell your doctor immediately or go to Accident and Emergency at Some very rare side effects can If you have eczema around a leg your nearest hospital: only be found when your doctor ulcer, use of a topical does blood tests or a medical  if your skin condition gets corticosteroid may increase the examination: worse or your skin becomes risk of an allergic reaction or an swollen during treatment, infection around the ulcer.  decrease in the level of the you may be allergic to the hormone cortisol in your medicine, have an infection blood Only use an airtight dressing or need other treatment over this medicine if your doctor  increased levels of sugar in  wheezing, swelling of the your blood or urine has told you to. lips/mouth, difficulty in If you are applying BETA Cream or  high blood pressure breathing, hayfever, lumpy Ointment under an airtight dressing,  cloudy lens in the eye rash (hives) or fainting. make sure that the skin is cleansed (cataract) These could be a symptom before a fresh dressing is applied to  increased pressure in the of an allergic reaction. prevent infections. eye (glaucoma)

Page 3 of 4  a weakening of the bones  ceteareth 20 through gradual loss of  sodium phosphate mineral (osteoporosis). monobasic Additional tests may be  chlorocresol needed after your medical  sodium hydroxide examination to confirm if  purified water. you have this condition. BETA Ointment also contains: After using BETA  white soft paraffin  white beeswax Cream or Ointment  propylene glycol  stearyl alcohol. Storage BETA Cream and BETA Ointment Keep your BETA Cream or do not contain lanolin or parabens. Ointment in the tube until it is time to use it. If you want to know Keep your BETA cream or ointment in a cool dry place more where the temperature stays below 25°C. Should you have any questions regarding this product, please Do not store BETA Cream or contact your pharmacist or doctor. Ointment or any other medicine in the bathroom or near a sink. Do not Who supplies this leave it on a window sill or in the car. medicine Heat and dampness can destroy Distributed in New Zealand by: some medicines. Mylan New Zealand Ltd, Keep it where children cannot PO Box 11183, reach it. Ellerslie, A locked cupboard at least one-and- Auckland. a half metres above the ground is a good place to store medicines. Telephone: (09) 579 2792

Disposal Date of Information If your doctor tells you to stop 16 January 2019 (Based on using this medicine or the expiry datasheet dated 16 January 2019) date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like Both BETA Cream and Ointment are white in colour.

Ingredients BETA Cream and BETA Ointment each contain 0.1% w/w of betamethasone as the active ingredient.

BETA Cream also contains:  white soft paraffin  cetostearyl alcohol  liquid paraffin

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