What is Protopic used for?

• Moderate to severe eczema (atopic dermatitis).
• Protopic ointment is used for the short-term relief of eczema flare-ups, and as intermittent treatment in the long-term management of eczema.
• Protopic ointment is used when topical corticosteroids have not been effective, or when they shouldn't be used, for example in people who have experienced unacceptable side effects related to topical steroids.
• Protopic 0.03% is suitable for children aged two years and over.
• Protopic 0.1% is suitable for adults aged 16 years and over.

How does Protopic work?

• Protopic ointment contains the active ingredient tacrolimus, which is a type of medicine called a topical immunomodulator. It is used to decrease skin inflammation in eczema.
• It's not fully understood how tacrolimus works in eczema, but it has been shown to suppress inflammatory reactions in the skin.
• Severe eczema is thought to be partly caused by immune cells in the skin over-reacting to a stimulus and causing inflammation. Applying tacrolimus to the eczema suppresses these reactions in the skin, and improvement of the eczema is generally seen within a week of starting treatment.

How do I use Protopic?

• The ointment should be applied thinly, to affected areas of skin only, twice a day. Adults aged 16 and over should continue twice daily application until the eczema clears up. For children aged 2 to 16, application should be reduced to once a day after three weeks. Most people's eczema tends to improve within one week of starting treatment. If there's no improvement in the skin after two weeks treatment, or if the skin gets worse, you should see your doctor.
• Don't apply the ointment to infected areas of eczema.
• Take care to avoid getting the ointment in the eyes, and inside the mouth or nose. If it does come into contact with these areas it should be thoroughly wiped off and/or rinsed off with water.
• Wash your hands thoroughly after applying Protopic, unless the hands are the area being treated.
• Don't cover the treated area with airtight dressings such as bandages or other dressings, including infants' nappies, as these will increase the absorption of the medicine into the body and may increase the risk of side effects.
• You should use Protopic in this way whenever you get the first signs of a flare-up of eczema (redness and itching of the skin).
• If you have frequent flare-ups of your eczema (four or more times a year), and your eczema usually gets better within six weeks of treating it with Protopic, your doctor may suggest using Protopic on a regular basis to help prevent flare-ups. To do this, you apply the ointment to the areas usually affected by the eczema, once a day on two days each week (eg Monday and Thursday). Between applications there should be two to three days without Protopic treatment. If a flare-up does occur, you should then apply the ointment twice daily again until it is controlled.
• Continuous long-term use of the ointment should be avoided. The safety of regular maintenance treatment hasn't been studied beyond 12 months, so your doctor will want to review your skin after this time to decide if you should still use Protopic to prevent flare-ups.

What should I know before using Protopic?

• The ointment may cause a burning sensation, itching or a feeling of warmth where you've applied it. These reactions are usually mild and short-lived. Consult your doctor if you experience a more severe reaction after applying Protopic.
• You should avoid drinking alcohol while using Protopic because this may cause facial flushing or skin irritation.
• Don't apply moisturisers to the same area of skin within two hours of applying Proptopic.
• There may be an increased risk of skin infections in people using Protopic. If you think your skin has become infected during treatment you should consult your doctor, as you may need to stop using Protopic until the infection has cleared. You should also consult your doctor if your lymph glands become swollen during treatment.
• There may be a slightly increased risk of skin cancer associated with immunosuppressant medicines like tacrolimus. To help minimise any risk you should protect your skin from sunlight with clothing, or by using a suncream with an SPF of at least 15, even on a bright but cloudy day. Don't use sunbeds or sunlamps and don't have light treatment, such as PUVA or other UV light treatment, while using Proptopic.

Who shouldn't use Protopic?

• People who are allergic to macrolide-type antibiotics, eg erythromycin, clarithromycin.
• People with infected eczema or dermatitis.
• People with an underactive immune system, for example due to a condition present from birth, certain diseases, or treatment with certain medicines (eg immunosuppressants, chemotherapy).
• People with genetic skin defects such as Netherton's syndrome, or people with intense widespread reddening of the skin (erythroderma), or Graft Versus Host Disease affeecting the skin, where there may be increased absorption of the medicine into the bloodstream.
• Proptopic should not be applied to areas of skin affected by cancerous or potentially cancerous growths.
• Protopic 0.03% should not be used in children under two years of age.
• Protopic 0.1% should not be used in children under 16 years of age.

Don't use Protopic if you are allergic to any of its ingredients. Check the ingredients listed in the leaflet that comes with the ointment if you know you have specific allergies.

Who might need extra monitoring while using Protopic?

• People with liver failure.
• People with swollen lymph glands.
• Can I use Protopic while pregnant or breastfeeding?
• The safety of Protopic for use during pregnancy has not been established. It should not be used by pregnant women unless considered essential by your doctor. Ask your doctor for further information and advice.
• When taken by mouth or injection, tacrolimus passes into breast milk. Although it's less likely that tacrolimus applied to the skin will pass into breast milk in significant amounts, breastfeeding during treatment with Protopic ointment is not recommended. Ask your doctor for further advice.

What are the possible side effects of Protopic?

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects known to be associated with Protopic ointment. Just because a side effect is stated here doesn't mean that all people using this medicine will experience that or any side effect.

Very common (affect more than 1 in 10 people)

• Burning sensation at application site.
• Itching at the application site.

Common (affect between 1 in 10 and 1 in 100 people)

• Sensation of warmth, pins and needles, or pain at the application site.
• Redness, rash or irritation at the application site.
• Herpes simplex infections, such as cold sores, eczema herpeticum.
• Infection and inflammation of the hair follicles (folliculitis).
• Itching.
• Increased skin sensitivity, especially to hot and cold.
• Facial flushing or skin irritation after drinking alcohol.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Swollen lymph glands (consult your doctor if you experience this).
• Acne.
• Application site infections, such as impetigo, were noted to occur more frequently in adults and children using Protopic ointment twice weekly as maintenance treatment.
• Rare cases of malignancies, including lymphomas and skin cancers, have been reported in people using Protopic ointment since it has been on the market. Whether these malignancies were related to treatment with Protopic has not yet been confirmed from the evidence that is currently available.
• If you want any more information about the possible side effects of Protopic you should talk to your doctor or pharmacist, or read the leaflet that comes with the medicine. 

Can I use Protopic with other medicines?

There have not been any formal studies into the effect of this medicine on other medicines and vice versa. Make sure your doctor or pharmacist know what medicines you're already using, including herbal medicines and those bought without a prescription, before you start treatment with Protopic. Likewise, ask your doctor or pharmacist before starting any new medicines while you're using Protopic, to check that the combination is safe.

• This medicine should not be used in combination with immunosuppressive medicines such as azathioprine or ciclosporin.
• You should not receive light treatment such as PUVA or other UV light treatment while using Protopic.
• Don't apply moisturisers to the same area of skin within two hours of applying Proptopic.

There is a possibility that the following medicines may prevent the breakdown of tacrolimus that is absorbed into the bloodstream. These medicines should be used with caution in people using Protopic ointment, especially in people with widespread eczema who are using the ointment on large areas of skin:

• diltiazem
• erythromycin
• itraconazole
• ketoconazole

References:

https://www.fda.gov/downloads/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm107848.pdf

https://www.netdoctor.co.uk/medicines/skin-hair/a8353/protopic-ointment-tacrolimus/

https://www.webmd.com/drugs/2/drug-20335/protopic-topical/details

https://www.medicines.org.uk/emc/product/1608/smpc

http://www.protopic.com

https://www.ema.europa.eu/en/medicines/human/EPAR/protopic