0.03% ointment
tacrolimus monohydrate
WHAT PROTOPIC IS AND WHAT IT IS USED FOR
The active substance in Protopic, tacrolimus monohydrate, is an immunomodulatory agent.
Protopic 0.03% ointment is used to treat moderate to severe atopic dermatitis ( eczema ) in adults who have not had enough effect or can not tolerate conventional treatment such as topical corticosteroids and in children (2 years and older) who have not had enough effect of conventional treatment such as topical corticosteroids are.
When moderate to severe atopic dermatitis is completely or almost healed, after up to 6 weeks of treatment for an eczema outbreak, and if you usually have eczema outbreaks frequently (4 times a year or more), it may be possible to prevent the recurrence of eczema outbreaks or that extend the time when you have no outbreak, by using Protopic 0.03% ointment twice a week.
In atopic dermatitis, an overreaction of the skin’s immune system causes inflammation of the skin ( itching, redness, dryness). Protopic alters the abnormal immune response and relieves inflammation and itching of the skin.
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 (eg azithromycin, clarithromycin, erythromycin).
Warnings and cautions
Talk to your doctor before using Protopic:
- If you have liver failure.
- If you have any form of skin cancer ( tumors ) or if you have a weakened immune system (immune deficiency), for whatever reason.
- If you have a hereditary skin barrier disease such as Netherton’s syndrome, lamellar ichthyosis (skin that scales heavily, due to the thickening of the outer layer of skin), or if you have general erythroderma (red, inflamed, flaky skin on the whole body).
- If you have cutaneous Graft versus Host disease (an immune reaction in the skin that is a common complication in patients who have had a bone marrow transplant)
- If you have swollen lymph nodes at the beginning of treatment. If your lymph nodes swell during treatment with Protopic, consult your doctor.
- If you have infected eczema. Do not use the ointment on infected eczema.
- If you notice any change in the appearance of your skin, consult your doctor.
- Based on the results of long-term studies and experience, no association between treatment with Protopic ointment and the development of malignancy has been confirmed, but no definitive conclusions can be drawn.
- Avoid exposing the skin to sunlight for extended periods and artificial sunlight such as tanning beds. If you spend a lot of time outdoors after using Protopic, you should wear sunscreen and wear loose-fitting clothing that protects your skin from sunlight. Ask your doctor for advice on other suitable ways to protect yourself from the sun. If you have been prescribed light therapy, tell your doctor that you are using Protopic, as concomitant treatment with Protopic, and light therapy is not recommended.
- If your doctor prescribes treatment with Protopic twice a week, to keep eczema away, your condition should be evaluated by a doctor at least once a year, even if the disease is under control. For children, a break must be made in the maintenance treatment after 12 months, to be able to assess whether further treatment is needed.
- It is recommended to use the Protopic ointment with the lowest possible strength and the lowest frequency for the shortest possible time. This decision should be based on your doctor’s assessment of how your eczema responds to the Protopic ointment.
Children
- Protopic ointment is not approved for the treatment of children under 2 years. The ointment should therefore not be used on this age group. Consult your doctor.
- The effect of treatment with Protopic on a developing immune system in children, especially young children, have not been studied.
Other medicines, cosmetics, and Protopic
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You can use emollient creams and skin lotions during treatment with Protopic, but these products should not be used within two hours before and after using Protopic.
The use of Protopic with other topical medicinal products or with concomitant treatment with oral corticosteroids (eg cortisone ) or medicines affecting the immune system has not been studied.
Protopic with food and alcohol
When using Protopic, alcohol consumption can cause swelling or redness and a feeling of warmth in the skin or face.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Protopic contains butylhydroxytoluene (E321)
Protopic contains butylhydroxytoluene (E321) which may cause local skin reactions (eg contact dermatitis) or be irritating to eyes and mucous membranes.
HOW TO USE PROTOPIC
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
- Apply a thin layer of Protopic on the affected skin areas.
- Protopic can be used on most body parts, including the face and neck and in the elbow and knee creases.
- Avoid using the ointment on the inside of the nose or mouth or in the eyes. If the ointment comes in contact with any of these areas, wipe it off thoroughly and/or rinse with water.
- Do not cover skin areas treated with the ointment with a bandage or similar.
- Wash your hands after using Protopic, unless your hands are also treated.
- Before using Protopic after showering or bathing, the skin should be completely dry.
Children (2 years and older)
Use Protopic 0.03% ointment twice daily for up to three weeks, once in the morning and once in the evening. Thereafter, the ointment is applied once daily on the affected skin areas until the eczema is gone.
Adults (16 years and older)
For adult patients (16 years and older) there are two strengths of Protopic (Protopic 0.03% and Protopic 0.1% ointment). Your doctor will decide which strength is best for you.
Treatment is usually started with Protopic 0.1% ointment twice daily, once in the morning and once in the evening until eczema has healed. Depending on the effect on your eczema, your doctor will decide if you can use the ointment less often or if the lower strength, Protopic 0.03% ointment, can be used.
Treat any affected skin area until the eczema is gone. Improvement usually occurs within a week. If you do not notice any improvement within two weeks, talk to your doctor about other possible treatments.
Your doctor may prescribe you to use Protopic ointment twice a week, when the eczema is completely or almost healed (Protopic 0.03% for children and Protopic 0.1% for adults). The Protopic ointment should then be used once a day two days a week (eg Monday and Thursday) on the skin areas where you usually get eczema. It should take 2-3 days without Protopic treatment between each treatment session.
If symptoms recur, you should use Protopic twice daily, as described above, and consult your doctor to review treatment.
If you happen to swallow ointment
If you accidentally swallow the ointment, talk to your doctor or pharmacist as soon as possible. Do not try to induce vomiting.
If you forget to use Protopic
If you forget to apply the ointment at the time you should do it, 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.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people):
- burning sensation and itching
These symptoms are usually mild to moderate and usually go away within a week of starting treatment.
Common (may affect up to 1 in 10 people):
- redness
- feeling of warmth
- pain
- increased sensitivity of the skin (especially to heat and cold)
- creeps in the skin
- rash
- local skin reactions regardless of cause; a reaction can be inflamed or infected hair follicles
- herpes virus infections (eg cold sores, generalized herpes simplex infections )
- redness of the face or skin irritation after consuming alcohol
Uncommon (may affect less than 1 in 100 people):
- acne
After treatment twice a week, infection at the treatment site has been reported in children and adults. Impetigo, a superficial bacterial skin infection that normally causes blisters or sores on the skin, has been reported in children.
Rosacea ( redness of the face), rosacea-like skin inflammation, lentigo (flat brown spots on the skin), edema (fluid accumulation) at the site where the ointment has been used, and herpes infection of the eye have been reported after the product was introduced to the market.
HOW TO STORE PROTOPIC
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the tube and the carton after “EXP”. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
CONTENTS OF THE PACKAGING AND OTHER INFORMATION
Content declaration
- The active substance is tacrolimus monohydrate. 1 g Protopic 0.03% ointment contains 0.3 mg tacrolimus (as tacrolimus monohydrate).
- The other ingredients are white petrolatum, liquid paraffin, propylene carbonate, white beeswax, solid paraffin, butylhydroxytoluene (E321), and all -rac -α-tocopherol.
What the medicine looks like and the contents of the pack
Protopic is a white to slightly yellowish ointment. It is provided in tubes containing 10, 30, or 60 grams of ointment. Not all pack sizes may be marketed. Protopic is available in two strengths (Protopic 0.03% and Protopic 0.1% ointment).
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
LEO Pharma A / S, Industriparken 55, 2750 Ballerup, Denmark.
Manufacturer:
Astellas Ireland Co. Ltd., Killorglin, County Kerry, Ireland.
LEO Laboratories Ltd. 285 Cashel Road, Crumlin, Dublin 12, Ireland
Contact the representative of the marketing authorization holder to find out more about this medicine:
LEO Pharma AB
Tel: +46 40 3522 00