INFORMATION FOR CONSUMERS
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This leaflet answers some common questions about Elidel cream.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using Elidel cream against the benefits they expect it will give you.
If you have any concerns about this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
Elidel cream is used to treat the early signs and symptoms of eczema (also called atopic dermatitis), such as itching, redness and tiny bumps or thickening of the skin. It is suitable for infants of 3 months or older, children, teenagers and adults.
Elidel can be used to treat repeated episodes of eczema. Treatment is started as soon as the first symptoms of eczema appear, to prevent these from progressing to more severe symptoms that may require the use of a steroid cream.
However, if a steroid cream is required to treat an episode of eczema, Elidel cream can be used to treat any remaining symptoms after the steroid cream has been stopped.
Elidel cream is a steroid-free medicine that treats inflammation of the skin. It works in specific cells in the skin that cause inflammation and the characteristic redness and itching of eczema.
Elidel belongs to a group of medicines called topical calcineurin inhibitors
Do not use the cream:
If you have had a vaccination recently, do not apply the cream to the site of vaccination until reddening of the skin and/or swelling disappears.
To prevent the early symptoms of eczema from progressing to more severe symptoms, apply the cream twice daily, for instance once in the morning and once in the evening.
Apply the cream as follows:
If you wish, you can apply a moisturiser immediately after using Elidel cream. However, after a bath or shower, apply the moisturiser first before applying the cream.
For the intermittent long-term treatment of eczema, begin using Elidel as soon as you notice the first signs and symptoms, and continue using for up to 6 weeks. If you have not noticed any signs of improvement, Elidel should be stopped and you should consult your doctor.
Use in infants (3-23 months of age) should be limited to the smallest practicable body surface area and treatment should generally be limited to no more than 3 weeks.
If you forget to apply the cream, apply it as soon as possible and then continue your normal routine.
If you have too much (Overdose)
If you accidentally apply more cream to your skin than you were told to, just wipe it off. It will not harm you.
If you or anyone else swallows some of the cream, immediately telephone your doctor or the National Poisons Information Centre, Dunedin (0800 POISON or 0800 764 766) for advice, or go to the Accident and Emergency Department at your nearest hospital, even if there are no signs of discomfort or poisoning.
If you become pregnant while you are using this medicine, tell your doctor.
Your doctor can discuss with you the risks of using it while you are pregnant.
If you think you may have developed a skin infection while you are using Elidel cream, see your doctor right away.
If your skin is infected, your doctor will prescribe another medicine to treat the infection in addition to Elidel cream. If the infection does not go away, your doctor may ask you to stop using Elidel cream until the infection has been cleared up.
Avoid exposure to the sun of skin areas treated with Elidel cream. Do not use a sunlamp or tanning table. When you are outdoors, wear protective clothing and use at least a 15+ sunscreen. Wait until Elidel cream is completely absorbed into your skin without any residue before you apply the sunscreen.
Take special care if you have a skin disease called Netherton's syndrome or generalised erthroderma (inflammatory reddening of the entire skin). Your doctor will have told you if you have this.
Take special care if you have been told you have a weakend immune system
If the signs and symptoms of your eczema seem to be getting worse, tell your doctor.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using Elidel cream.
Tell any other doctor or pharmacist who treats you that you are using Elidel cream.
Do not give this medicine to anyone else, even if their symptoms seem to be the same as yours.
Do not use it to treat any other complaints unless your doctor tells you to.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Elidel cream.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
In rare instances, people may be allergic to Elidel 1% cream. This could cause swelling and pain, skin rashes or hives. In very rare cases, the allergic reactions can be severe with symptoms like sudden wheezing and chest pain or tightening, swelling of eyelids, face or lips.
If you experience any of these symptoms soon after using Elidel cream, stop using the cream and tell your doctor or pharmacist immediately.
Tell your doctor if you lumph nodes becom swollen during treatment with Elidel
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
If you notice any of the following symptoms on the skin where you have applied the cream and you are worried about them, tell your doctor:
In rare cases, patients have had cancer (e.g. skin or lymphoma) during
treatment with topical calcineurin inhibitors, including Elidel cream.
However a causal link has not been shown.
If any of the above symptoms are severe, tell your doctor immediately.
Most of these symptoms happen early in treatment, are not usually severe and do not last long.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.
Some people may get other side effects of Elidel cream.
Heat and dampness can destroy some medicines. Elidel cream will keep well if it is cool and dry.
Keep the medicine 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.
If you no longer need the cream or it has passed its expiry date, return any unused medicine to your pharmacist.
Elidel cream is a whitish, odourless, non-staining and easily spreadable cream packaged in an aluminium tube with a screw cap; in tubes of 15 grams.
Each gram of Elidel 1% cream contains 10 mg of the active ingredient, pimecrolimus.
Elidel cream also contains the following inactive ingredients:
Elidel cream is supplied in New Zealand by:
Novartis New Zealand Limited
Private Bag 65904
Mairangi Bay
Auckland
Building G, 5 Orbit Drive
Rosedale
Auckland 0632
Telephone 0800 652 422
® = Registered Trademark
This leaflet was prepared on 23 June 2009 based on the currently approved data sheet for Elidel