How does it work?

This medicine contains the active ingredient pimecrolimus, which is a type of medicine called a skin-selective inflammatory cytokine inhibitor. It is used to decrease skin inflammation in eczema. Pimecrolimus is absorbed into the skin, where it works by blocking the production of inflammatory chemicals called cytokines. These are produced by white blood cells in the skin as part of the body's immune response to allergy or irritation, and are part of a cascade of events in the skin that results in the irritated area becoming inflamed - red, swollen and itchy. As pimecrolimus stops the white blood cells in the skin from producing cytokines, it reduces inflammation in the skin. Pimecrolimus cream is used to reduce the inflammation of the skin seen in eczema (atopic dermatitis). This relieves the symptoms of this condition, such as redness and itching. Pimecrolimus is used for the short-term relief of eczema symptoms, and as intermittent treatment in the long-term management of eczema. The cream should be applied at the first signs of a flare-up of eczema (redness and itching of the skin), as this can help prevent progression to more severe flare-ups.

What is it used for?

Mild to moderate eczema (atopic dermatitis) in adults and children aged two years and over

Warning!

This preparation is for external use only.

You should not cover the area being treated with airtight dressings such as bandages or other dressings, including nappies, as these will enhance the absorption of the medicine into the body and may increase the risk of adverse effects.

Wash your hands thoroughly after applying this medicine, unless the hands are the area being treated.

This medicine is not recommended for children under two years of age.

You should not receive light treatment, such as PUVA, or other UV light treatment, while using this medicine. You should also avoid using sun beds, and minimise exposure of your skin to sunlight by using sunscreens, wearing appropriate clothing to protect the skin when outside, and minimising time spent in the sun.

There may be an increased risk of skin infections such as severe herpes simplex infection (eczema herpeticum) in people using this medicine. If your skin becomes infected during treatment you should consult your doctor, as you may need to stop using this medicine until the infection has cleared.

The use of this medicine has not been studied in people with a weakened immune system (immunocompromised), skin malignancies (tumours), intense widespread reddening of the skin (erythroderma), or Netherton's syndrome, and so is not currently recommended for people with these conditions. Consult your doctor before using this medicine if you have any of these conditions.

Avoid contact of this medicine with the eyes, and areas of skin lining the body cavities (mucous membranes), eg inside the mouth and nose. If this medicine does accidentally come into contact with these areas it should be thoroughly wiped off and/or rinsed off with water.

This cream may cause skin reactions at the site of application, such as a feeling of warmth and/or a burning sensation. These reactions are usually mild and short-lived. Consult your doctor if you experience a more severe reaction after applying this cream.

The affected area(s) of skin should be treated with this medicine as directed, until the symptoms clear. If there is no improvement in your skin after six weeks treatment, or if your skin gets worse, you should consult your doctor.

This medicine should not be used for longer than 12 weeks after opening the tube. Dispose of any unused medicine carefully, preferably by returning it to your pharmacist. You may find it helpful to write the date of opening on the packet.

Not to be used in

Allergy to macrolactam compounds such as tacrolimus, sirolimus or ciclosporin

Areas of skin affected by viral infections, such as cold sores (herpes simplex) or chicken pox (herpes zoster)

Infected eczema or dermatitis

Pregnancy

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

The safety of this medicine during pregnancy has not been established, therefore it should not be used by pregnant women. Consult your doctor.

It is not known if this medicine passes into breast milk. This is unlikely however, because only minimal amounts of the medicine are absorbed into the body. Mothers who are breastfeeding may use this medicine, but only on the advice of a doctor, and if so should not apply the medicine to the breasts to prevent the nursing infant ingesting the medicine.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Inflammation of the hair follicles (folliculitis)

Worsening of symptoms

Herpes simplex infections such as cold sores

Burning sensation at application site

Redness, itching or irritation at application site

Skin infections

Rash, pain, pins and needles, swelling, dryness, or shedding of surface skin at application site

Boils (furuncles)

The side effects listed above may not include all of the side effects reported by the drug's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

There have not been any systematic studies into the effect of this medicine on other medicines, and vice versa. This medicine is minimally absorbed into the rest of the body and so is unlikely to interact with medicines taken by mouth or injection, however, you should tell your doctor or pharmacist what medicines you are using, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Likewise, check with your doctor or pharmacist before starting any new medicines while you are using this medicine. There is a possibility that vaccines may be less effective in people with widespread dermatitis who are using this medicine. The manufacturer states that this is unlikely because this medicine is only absorbed minimally into the rest of the body, however, as this has not been studied, it is recommended that people who are using this medicine on widespread areas of skin should have any necessary vaccines during a treatment free interval. This medicine should not be used at the same time as corticosteroid creams or ointments, other anti-inflammatory medicines applied to the skin, or immunosuppressive medicines such as azathioprine or ciclosporin, as these combinations have not yet been studied. Light treatment with PUVA, UVA or UVB should also be avoided while using this medicine. Moisturisers may be used with this cream - if you do use moisturisers they should be applied immediately after applying this cream.

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