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Elidel® Cream Pimecrolimus 1 % w/w Consumer Medicine Information

What is in this leaflet Keep this leaflet with the This medicine is only available with medicine. a doctor's prescription. This leaflet answers some common You may need to read it again. Before you use Elidel questions about Elidel cream. cream It does not contain all the available information. It does not take the When you must not use it place of talking to your doctor or What Elidel cream is pharmacist. used for Do not use Elidel cream if you have ever had an allergic reaction The information in this leaflet was Elidel cream is used to treat the to pimecrolimus (the active last updated on the date listed on the early of ingredient), macrolactams (drugs final page. More recent information eczema (also called atopic similar to pimecrolimus) or to any on the medicine may be available. dermatitis), such as itching, redness of the other ingredients listed at You should ensure that you speak and tiny bumps or thickening of the the end of this leaflet. to your pharmacist or doctor to skin. It is suitable for infants of 3 Some of the symptoms of an obtain the most up to date months or older, children, teenagers allergic reaction to a medicine may information on the medicine. and adults. include shortness of breath, Those updates may contain Elidel can be used to treat repeated wheezing or difficulty breathing; important information about the episodes of eczema. Treatment is swelling of the face, , tongue or medicine and its use of which you started as soon as the first other parts of the body; , itching should be aware. symptoms of eczema appear, to or on the skin. All medicines have risks and prevent these from progressing to Do not use Elidel cream if you are benefits. Your doctor has weighed more severe symptoms that may having light therapy (called the risks to you or your child of require the use of a steroid cream. phototherapy) for your skin using Elidel cream against the However, if a steroid cream is condition. benefits they expect it will provide. required to treat an episode of Do not use this medicine after the This leaflet has mostly been written eczema, Elidel cream should be expiry date printed on the pack or for patients who are using Elidel on stopped and restarted to treat any if the packaging is torn or shows themselves, but, as Elidel can be remaining symptoms after the signs of tampering. used in children as young as 3 steroid cream has been stopped. In that case, return it to your months, the same advice and Elidel cream is a steroid-free pharmacist. precautions need to be exercised medicine that treats of when parents and carers are using the skin. It works in specific cells in Before you start to use it Elidel on children who have been the skin that cause inflammation prescribed the product. There are and the characteristic redness and If you want more information, additional instructions when using itching of eczema. discuss this with your doctor. Elidel in infants up to 2 years and Ask your doctor if you have any Some laboratory animals given these are explained separately in the questions about why this medicine large doses of pimecrolimus by leaflet. has been prescribed. mouth for long periods of time If you have any concerns about developed . Your doctor may have prescribed it this medicine, ask your doctor or Pimecrolimus is absorbed in small for another purpose. pharmacist. amounts through the skin of humans. A very small number of

1 people who have used Elidel have Tell your doctor if you are breast-  if your skin is infected, check developed skin or feeding. with your doctor before using , but a link that Elidel Although the amount of Elidel. Your doctor may ask you caused these has not been pimecrolimus that is absorbed into to use another medicine to clear shown. The number of cases your blood stream is very low, it is the first. reported is small, and so far is lower not known if it passes into the breast  on your breasts while you are than the average in the general milk and could affect your baby. breast-feeding. population. Although it cannot be Your doctor can discuss with you excluded, it is unlikely that people  if you have had a vaccination the benefits and risks involved with recently, do not apply the cream using Elidel cream have an using this medicine while you are to the site of vaccination until increased chance of getting these breast-feeding. conditions. It is important that reddening of the skin and/or swelling disappears. Elidel should only be used as Taking other medicines directed by your doctor. Only apply If you accidentally applied the it to the places your doctor has said Tell your doctor if you are taking cream to any of these areas, wipe it should go. Use it only for as long any other medicines, including it off and rinse well with clean as directed. medicines that you buy without a water. prescription from a pharmacy, Tell your doctor if you have any supermarket or health food shop. How to use it of the following medical problems/ conditions: Although it is unlikely that other To prevent the early symptoms of medicines and Elidel will interfere  you have had skin cancers eczema from progressing to more with each other, you should always removed or you have changes in severe symptoms, apply the cream make sure your doctor knows what your skin (called pre-malignant twice daily, for instance once in medicines you are taking, especially or pre-cancerous changes) that the morning and once in the any other creams or ointments you may develop into skin cancer evening. are using on your skin.  you have swelling of the lymph Apply the cream as follows: If you have not told your doctor nodes - the bean-shaped organs about any of these things, tell 1. Wash and dry your hands. found in the underarm, groin, him/her before you start using 2. Open the tube. The first time neck, chest and abdomen that act this medicine. you use the tube you will need as filters for the lymph fluid as it to break the seal using the spike circulates through the body in the top of the cap.  you have an infection of the skin 3. Squeeze cream onto your finger.  generalised erythroderma (a skin How to use Elidel 4. Apply a thin layer of cream and disorder characterised by cream completely cover the affected reddening and scaling of most of skin. the skin) Follow all directions given to you 5. Rub in gently and completely.  Netherton syndrome (a rare by your doctor and pharmacist hereditary disorder) carefully. 6. Replace the cap on the tube.  weakened (for These instructions may differ from 7. Wash your hands after applying example as a result of medical the information contained in this the cream. conditions such as HIV, leaflet. Do not cover the skin being treated diabetes, cancer, or from taking If you do not understand the with occlusive dressings. However, medicines that suppress instructions on the label, ask your you can wear normal clothing. immunity). doctor or pharmacist for help. Tell your doctor if you are Using other skin products pregnant or planning to become Areas of skin to avoid together with Elidel pregnant. Do not use the cream: Elidel cream is often used at the There is not enough information to  inside your nose, eyes or mouth. same time as other skin products, recommend the use of this medicine Do not swallow it. such as emollients (moisturisers) during pregnancy. Your doctor can and sunscreens.  on areas of the skin affected by discuss with you the risks and active viral infection such as If you are going to apply another benefits involved. cold sores or chicken pox. product to your skin (such as a

2 moisturiser or sunscreen) in If you have too much Avoid exposure to the sun of skin addition to Elidel cream, wait (Overdose) areas treated with Elidel cream. until the first one is completely Do not use a sunlamp or tanning If you accidentally apply more absorbed into your skin without table. When you are outdoors, cream to your skin than you were any residue before you apply the wear protective clothing and use next one. told to, just wipe it off. It will not at least a 15+ low-irritant harm you. If you want to use a moisturiser, sunscreen. you can apply it after using Elidel If you or anyone else swallows If the signs and symptoms of your some of the cream, immediately cream. eczema seem to be getting worse, telephone your doctor or Poisons tell your doctor. If you are going to be outside, Information Centre on 13 11 26 wear protective clothing and use (Australia) or the National If you are about to be started on at least a 15+ low-irritant Poisons Centre on 0800 764 766 any new medicine or given a sunscreen. (New Zealand) for advice, or go to vaccination, remind your doctor Accident and Emergency at your and pharmacist that you are using How long to use it nearest hospital, even if there are Elidel cream. For each episode of eczema, begin no signs of discomfort or Tell any other doctor or using Elidel as soon as you notice poisoning. pharmacist who treats you that the first signs and symptoms and you are using Elidel cream. until the end of redness when you should stop treatment. Continue Things you must not do using the cream for as long as While you are using Do not give this medicine to your doctor tells you to. Elidel cream anyone else, even if their In infants up to 2 years of age: symptoms seem to be the same as treatment of each episode of eczema Things you must do yours. should usually last no more than 3 If you become pregnant while you Do not use it to treat any other weeks. are using this medicine, tell your complaints unless your doctor Older children, teenagers and doctor. tells you to. adults: treatment can generally Your doctor can discuss with you continue of each episode of eczema the risks of using it while you are for up to 6 weeks, if necessary, to pregnant. clear up their signs and symptoms. Side effects If you develop lumps anywhere in If signs and symptoms come back, your body, or develop any moles, you should start treatment again. Tell your doctor or pharmacist as or you notice changes in existing soon as possible if you do not feel If there is no improvement after 6 moles, tell your doctor. well while you are using Elidel weeks of treatment or your cream. condition worsens, tell your doctor. If you think you may have All medicines can have side effects. developed a or Sometimes they are serious, most of In that case it may be necessary to notice painful sores anywhere on the time they are not. You may need stop using the cream while your your body while you are using medical treatment if you get some doctor re-evaluates your condition. Elidel cream, see your doctor of the side effects. Do not use this medicine right away. Do not be alarmed by this list of continuously for long periods If you experience facial flushing possible side effects. You may not without interruption. or skin irritation when you drink experience any of them. Ask your alcohol during treatment with doctor or pharmacist to answer If you forget to use it Elidel cream, tell your doctor. any questions you may have. If you forget to apply the cream, Rarely, facial flushing or skin If you notice any of the following apply it as soon as possible and irritation (e.g. rash, burning, itching symptoms on the skin where you then continue your normal or swelling) can occur in people have applied the cream and you routine. who drink alcohol while they are are worried about them, tell your using Elidel cream. doctor:

3  a temporary feeling of warmth Tell your doctor if you notice tube with a screw cap. Tubes of 5 and/or burning anything else that is making you g, 15 g and 30 g are available in  irritation, itching or reddening feel unwell, even if it is not on this Australia and New Zealand. list.  rash, , feeling of prickling, Ingredients dryness, flaking, swelling Other side effects not listed here or not yet known may happen in some Each gram of Elidel 1% cream  (inflammation of the people. contains 10 mg of the active hair follicles, sometimes causing ingredient, pimecrolimus. Elidel pustules) cream also contains the following  around the lips, nose or inactive ingredients: chin (cold sores) After using Elidel  benzyl alcohol  blisters, cracks, pain or swelling cream  cetyl alcohol around the groin ()  citric acid  painful, red skin rash or - Storage like sores ()  mono- and di-glycerides  Store the tube of cream in the  clusters of itchy or painful outer carton. Make sure the cap  oleyl alcohol blisters around the face or neck is tightly closed.  propylene glycol (eczema herpecticum)  Store it in a cool dry place  sodium cetostearyl sulfate  any other signs or symptoms below 25°C (room temperature).  sodium hydroxide that are different from your  Once you have opened the tube  stearyl alcohol usual symptoms of eczema. of cream, you should use it for These may be signs of a skin no more than 12 weeks.  medium chain triglycerides infection.  Do not store this medicine or  purified water.  a new spot, or mole or a any other medicine in the change to an existing one bathroom or near a sink. Sponsor  a change of skin colour.  Do not leave it in the car or on Tell your doctor if you notice a window sills. Mylan Health Pty Ltd swelling of your lymph nodes while Heat and dampness can destroy Level 1, 30 The Bond using Elidel. Lymph nodes are the some medicines. Elidel cream will 30-34 Hickson Road bean-shaped organs found in the keep well if it is cool and dry. underarm, groin, neck, chest and Millers Point NSW 2000 Keep the medicine where young abdomen that act as filters for the www.mylan.com.au lymph fluid as it circulates through children cannot reach it. Phone: 1800 314 527 the body. A locked cupboard at least one-and- If any of the above symptoms are a-half metres above the ground is a severe, tell your doctor good place to store medicines. Mylan New Zealand Ltd, immediately. PO Box 11183, Disposal Most of these symptoms happen Ellerslie, If you no longer need the cream early in treatment, are not usually Auckland severe and do not last long. or it has passed its expiry date, return any unused medicine to If any of the following happen, your pharmacist. stop taking Elidel and tell your This leaflet was prepared in May doctor immediately, or go to 2018. Accident and Emergency at your nearest hospital: Product description Australian Registration Number:  sudden signs of allergy such as AUST R 93680. rash, itching or hives on the What it looks like skin, swelling of the face, lips, Elidel_cmi\May18/00 tongue or other parts of the Elidel cream is a whitish, odourless, body, shortness of breath, non-staining and easily spreadable wheezing or trouble breathing. cream packaged in an aluminium

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