Active substance of Protopic tacrolimus monohydrate, is an immunomodulator.
Protopic 0,03% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids and in children (2 years or more) who fail to respond adequately bshtoprietite therapies such as topical corticosteroids.
If after treatment of attack, up to 6 weeks, moderate to severe atopic dermatitis is cleared or almost cleared and if in you are experiencing frequent flares (ie 4 or more per year), it is possible to prevent the recurrence of attacks or to extend the time without relapses using Protopic 0,03% ointment twice weekly.
In atopic dermatitis, an over-reaction of the skin's immune system causes skin inflammation (itchiness, redness, dryness). Protopic alters the abnormal immune response and relieves the skin inflammation and itching.
2. BEFORE YOU USE PROTOPIC
Do not use Protopic:
If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Protopic or to macrolide antibiotics (eg. Azithromycin, clarithromycin, erythromycin).
Take special care with Protopic
Tell your doctor if:
have liver failure;
have any skin malignancies (tumors) or if you have a weakened immune system (immuno-compromised) whatever the cause;
have an inherited skin disease as Neterton syndrome, lamellar ichthyosis (hard scaly skin due to a thickening of the outer layer of skin) or if you suffer from generalized erythroderma (inflammatory reddening and scaling of the entire skin);
skin reaction sickness "graft versus host" (immune response of the skin, which is a common complication in patients undergoing bone marrow transplantation);
You have swollen lymph nodes at initiation of treatment. If during treatment with Protopic your lymph nodes are enlarged, consult your doctor;
You have infected lesions. Do not apply the ointment to infected lesions;
notice change the appearance of your skin, please inform your doctor.
Please note that:
Protopic ointment is not approved for children under 2 years of age. It should therefore 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 in young children, is not established;
The safety of using Protopic for a long time is not known. Very few people who have used Protopic ointment have had malignancies (eg., Skin or lymphoma). However, it is proven that there is a relationship to treatment with Protopic ointment;
You should avoid prolonged exposure of the skin to natural 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. Furthermore, ask your doctor about other suitable methods for protection from the sun. If you are prescribed light therapy, inform your doctor that you are using Protopic, since no concomitant use Protopic and light therapy;
If your doctor tells you to use Protopic twice weekly to keep your atopic dermatitis cleared, he should check your condition at least 12 months, even if it is under control. In children, maintenance treatment should be suspended after 12 months to assess whether there is a need for continued treatment.
Acceptance or use of other medicines or cosmetics
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
You may use moisturizing creams and lotions during treatment with Protopic, but they must be administered at least 2 hours after Protopic.
Protopic use concomitantly with other products applied on the skin or oral corticosteroids (eg. Cortisone) or medicines that affect the immune system has not been studied.
Using Protopic with food and drink
While using Protopic, drinking alcohol can cause reddening of the skin or the face and a feeling of warmth.
Pregnancy and lactation
Do not use Protopic, if you are pregnant or breast-feeding.
Ask your doctor or pharmacist before taking any medicine.
3. HOW TO USE PROTOPIC
Always use Protopic exactly as your doctor tells you. If you're not sure, ask your doctor or pharmacist.
Apply a thin layer of Protopic on the affected areas of your skin;
Protopic can be used on most parts of the body including the face, neck and folds of the elbows and knees;
Avoid using the ointment inside your nose, mouth or eyes. If the ointment gets on any of these areas should be thoroughly wiped off and / or rinsed with water;
Do not cover the treated skin with bandages or wraps;
Wash your hands after applying Protopic, unless your hands are to be treated;
Before applying Protopic after a bath or shower, be sure your skin is completely dry.
Children (2 years and older)
Apply Protopic 0,03% ointment twice daily for a maximum of three weeks, once in the morning and once at night. Afterwards the ointment should be used once a day on each affected region of the skin until the eczema.
Adults (16 years and older)
For adults (16 years and older) offers two concentrations of Protopic (Protopic 0,03% and Protopic 0,1% ointment). Your doctor will decide which one is best for you.
Typically, treatment starts with Protopic 0,1% ointment twice a day, once in the morning and once in the evening, until the eczema has cleared. Depending on the response of your eczema your doctor will decide whether to reduce the frequency of administration or continue with a lower concentration Protopic 0,03% ointment.
Each affected region of your skin until the eczema has gone away. Improvement is usually seen within one week. If after 2 weeks there is no improvement, you should see your doctor about other possible treatments.
When your atopic dermatitis has cleared or almost cleared, your doctor may tell you to use Protopic ointment twice weekly (Protopic 0,03% for children and Protopic 0,1% for adults). Protopic ointment should be applied once a day twice weekly (eg Monday and Thursday) to areas of your body commonly affected by atopic dermatitis. There should be 2-3 days without Protopic treatment between applications.
If symptoms reappear you should use Protopic twice daily as described above and to save an appointment with your doctor.
If you accidentally swallow some ointment
If you accidentally swallow the ointment should immediately consult your doctor. Do not try to induce vomiting.
If you forget to use Protopic
If you forget to apply the ointment at the scheduled time, do it as soon as you remember and then continue as before.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Protopic can cause side effects, although not everybody gets them.
Very common (probably affecting more than 1 in 10):
burning sensation and itching.
Generally these symptoms are mild to moderate and go away within one week of using Protopic.
Common (probably affecting up to 1 to 10):
feeling of warmth;
increased skin sensitivity (especially to hot and cold);
pricking the skin;
limited skin infections, regardless of the specific causative agent, including but not limited to: inflammatory or infected hair follicle, herpes simplex, generalized infection caused by herpes simplex virus, generalized infection with herpes simplex virus (a virus which causes herpes simplex);
flushing or skin irritation after drinking alcohol is frequently observed.
Uncommon (likely to affect less than 1 in 100):
Following twice-weekly treatment in children and adults has been reported infections at the injection site. In children, impetigo, superficial bacterial skin infection, which usually leads to blistering of the skin or wounds.
Rosacea (facial redness), rosacea-like dermatitis and swelling at the injection site have been reported during postmarketing experience.
Since commercial availability a very small number of people used Protopic ointment have had malignancies (eg, lymphoma, including cutaneous lymphoma and other skin tumors). Link with Protopic ointment treatment has not been confirmed or refuted on the available evidence so far.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE PROTOPIC
Keep out of reach of children.
Do not use Protopic after the expiry date stated on the tube and carton after "EXP". The expiry date refers to the last day of that month.
Do not store above 25 ° C.
Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Protopic contains
The active ingredient is tacrolimus monohydrate.
One gram of Protopic 0,03% ointment contains 0,3 mg of tacrolimus (as tacrolimus monohydrate).
The other ingredients are white soft paraffin, liquid paraffin, propylene carbonate, white beeswax and hard paraffin.
What Protopic looks like and contents of the pack
Protopic is a white to pale yellow ointment. Available in tubes containing 10, 30 or 60 g of ointment.
Not all pack sizes may be marketed.
Protopic is available in two strengths (Protopic 0,03% and Protopic 0,1% ointment).