Protopy
tacrolimus
Tacrolimus monohydrate
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
What Protopy is and what it is used for
longer authorised
Before you use Protopy
How to use Protopy
Possible side effects
How to store Protopy
Further information
The active substance of Protopy, tacrolimus monohydrate, is an immunomodulating agent.
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Protopy 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 of age and older) who failed to respond adequately to conventional therapies such as topical corticosteroids. In atopic dermatitis, an over-reaction of the skin’s immune system causes skin inflammation (itchiness, redness, dryness). Protopy alters the abnormal immune response and relieves the skin inflammation and the itch.
Medicinal product
If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Protopy or to macrolide antibiotics (e.g. azithromycin, clarithromycin, erythromycin).
Protopy ointment is not approved for children younger than 2 years of age. Therefore it should not be used in this age group. Please consult your doctor.
The effect of treatment with Protopy on the developing immune system in children, especially the young, has not been established.
The safety of using Protopy for a long time is not known. A very small number of people who have used Protopy ointment have had malignancies (for example, skin or lymphoma). However, a link to Protopy ointment treatment has not been shown.
If you have infected lesions. Do not apply the ointment to infected lesions.
If you have liver failure. Talk to your doctor before using Protopy.
Also speak to your doctor before using Protopy 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 or if you suffer from generalised erythroderma (inflammatory reddening and scaling of the entire skin). Talk to your doctor before using Protopy.
You should inform your doctor if you have swollen lymph nodes at initiation of treatment. If your lymph nodes become swollen during treatment with Protopy, consult your doctor.
Before receiving a vaccination tell your doctor that you are using Protopy. Vaccinations should not be given during treatment and for a certain time after treatment with Protopy. For live attenuated vaccinations (e.g. measles, mumps, rubella or oral polio) the waiting time is 28 days, for inactivated vaccines (e.g. tetanus, diphtheria, pertussis or influenza) 14 days.
Avoid exposing the skin to long periods of sunlight or artificial sunlight such as tanning beds. If you spend time outdoors after applying Protopy, 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 Protopy as it is not recommended to use Protopy and light therapy at the same time.
Avoid contact with the eyes or mucous membranes (inside of your nose or mouth).
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 moisturising creams and lotions during treatment with Protopy but these products should not be used within two hours of applying Protopy.
The use of Protopy 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.
Before receiving a vaccination tell your doctor that you are using Protopy (see Section “Take special care with Protopy”).
Medicinal product no longer authorised
While using Protopy, drinking alcohol may cause the skin or face to become flushed or red and feel hot.
Don’t use Protopy if you are pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Always use Protopy exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Apply Protopy as a thin layer to affected areas of your skin.
Protopy may be used on most parts of the body, including the face and neck and in the creases of your elbows and knees.
Avoid using the ointment inside your nose or mouth or in your eyes. If the ointment gets on any of these areas, it should be thoroughly wiped off and/or rinsed off with water.
Do not cover the skin being treated with bandages or wraps.
Wash your hands after applying Protopy unless your hands are also being treated. Before applying Protopy after a bath or shower, be sure your skin is completely dry.
Children (2 years of age and older)
Apply Protopy twice a day for up to three weeks, once in the morning and once in the evening. Afterwards the ointment should be used once a day on each affected region of the skin until the eczema has gone away.
Adults (16 years of age and older)
Two strengths of Protopy (Protopy 0.03% and Protopy 0.1% ointment) are available for adult patients. Your doctor will decide which strength is best for you. Usually, treatment is started with Protopy 0.1% ointment twice a day, once in the morning and once in the evening, until the eczema has cleared. If symptoms reappear, treatment with Protopy 0.1% twice a day should be restarted. Depending on the response of your eczema your doctor will decide if the frequency of application can be reduced or the lower strength, Protopy 0.03% ointment, can be used.
Treat each affected region of your skin until the eczema has gone away. Improvement is usually seen within one week. If you do not see any improvement after two weeks, see your doctor about other possible treatments. Treatment with Protopy may be repeated if symptoms reappear.
If you accidentally swallow the ointment, consult your doctor or pharmacist as soon as possible. Do not try to induce vomiting.
If you forget to apply the ointment at the scheduled time, do it as soon as you remember and then continue as before.
Medicinal product no longer authorised
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Protopy can cause side effects, although not everybody gets them.
Approximately half of the patients who use Protopy have some type of skin irritation where they have applied the ointment. Burning sensation and itching are very common (> 10%). These symptoms are usually mild to moderate and generally go away within one week of using Protopy. Other common
(> 1%) side effects are redness, feeling of warmth, pain, increased skin sensitivity (especially to hot and cold), skin tingling, rash, folliculitis (inflamed or infected hair follicles) and herpes viral infections
(e.g. cold sores, generalised herpes simplex infections). Facial flushing or skin irritation after drinking alcohol is also common. Acne is an uncommon side effect. Rosacea and rosacea-like dermatitis have also been reported.
Since commercial availability a very small number of people who have used Protopy ointment have
had malignancies (for example, skin or lymphoma). However, a link to Protopy ointment treatment has not been confirmed or refuted on the available evidence so far.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not use Protopy after the expiry date which is stated on the tube and carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25ºC.
Medicinal product no longer authorised
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.
The active substance is tacrolimus monohydrate.
One gram of Protopy 0.03% ointment contains 0.3 mg tacrolimus (as tacrolimus monohydrate).
The other ingredients are white soft paraffin, liquid paraffin, propylene carbonate, white beeswax and hard paraffin.
Protopy is a white to slightly yellowish ointment. It is supplied in tubes containing 10, 30 or 60 grams of ointment. Not all pack sizes may be marketed. Protopy is available in two strengths (Protopy 0.03% and Protopy 0.1% ointment).
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Medicinal product no longer authorised
B-1070 Brüssel/Bruxelles Tél/Tel: +32 (0)2 5580737
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