Product Details

Protopic 0.1% Ointment Product Information

What you need to know before you use Protopic®
Do not use Protopic
• If you are allergic to tacrolimus or any of the other ingredients of this medicine (listed in section
6) or to macrolide antibiotics (e.g. azithromycin, clarithromycin, erythromycin).
Warnings and precautions
Talk to your doctor before using Protopic:
• If you have liver failure.
• If you have any skin malignancies (tumours) or if you have a weakened immune system
(immuno-compromised) whatever the cause.
• If you have an inherited skin barrier disease such as Netherton’s syndrome, lamellar
ichthyosis (extensive scaling of the skin due to a thickening of the outer layer of the skin), or if
you suffer from generalised erythroderma (inflammatory reddening and scaling of the entire
skin).
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• If you have a cutaneous Graft Versus Host Disease (an immune reaction of the skin which is a
common complication in patients who have undergone a bone marrow transplant).
• If you have swollen lymph nodes at initiation of treatment. If your lymph nodes become
swollen during treatment with Protopic, consult your doctor
• If you have infected lesions. Do not apply the ointment to infected lesions.
• If you notice any change to the appearance of your skin, please inform your physician.
• Based on the results of long term studies and experience, a link between Protopic ointment
treatment and the development of malignancies has not been confirmed, but definitive
conclusions cannot be drawn.
• Avoid exposing the skin to long periods of sunlight or artificial sunlight such as tanning beds. If
you spend time outdoors after applying Protopic, use a sunscreen and wear loose fitting clothing
that protects the skin from the sun. In addition, ask your doctor for advice on other appropriate
sun protection methods. If you are prescribed light therapy, inform your doctor that you are
using Protopic as it is not recommended to use Protopic and light therapy at the same time.
• If your doctor tells you to use Protopic twice weekly to keep your atopic dermatitis cleared,
your condition should be reviewed by your doctor at least every 12 months, even if it remains
under control. In children, maintenance treatment should be suspended after 12 months, to
assess whether the need for continued treatment still exists.
• It is recommended to use Protopic ointment at the lowest possible strength, at the lowest
frequency and for the shortest possible duration necessary. This decision should be based on
your doctor’s assessment of how your eczema responds to Protopic ointment
Children
• Protopic 0.1 % ointment is not approved for children younger than 16 years of age.
Therefore it should not be used in this age group. Please consult your doctor.
• The effect of treatment with Protopic on the developing immune system in children, especially
the young, has not been established.
Other medicines, cosmetics and Protopic
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
You may use moisturising creams and lotions during treatment with Protopic but these products
should not be used within two hours of applying Protopic.
The use of Protopic at the same time as other preparations to be used on the skin or while taking oral
corticosteroids (e.g. cortisone) or medicines which affect the immune system has not been studied.
Protopic with alcohol
While using Protopic, drinking alcohol may cause the skin or face to become flushed or red and feel
hot.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before using this medicine.
Protopic contains butylhydroxytoluene (E321)
Protopic contains butylhydroxytoluene (E321), which may cause local skin reactions (e.g. contact
dermatitis), or irritation to the eyes and mucous membranes.