Protopic Ointment
(Tacrolimus)

What Protopic Ointment is and what it is used for

The active substance of Protopic, tacrolimus monohydrate, is an immunomodulating agent. 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 of age and older) who failed to respond adequately to conventional therapies such as topical corticosteroids Once moderate to severe atopic dermatitis is cleared or almost cleared after up to 6 weeks treatment of a flare, and if you are experiencing frequent flares (i.e. 4 or more per year), it may be possible to prevent flares coming back or prolong the time you are free from flares by 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 the itch.

How to take Protopic Ointment

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• Apply Protopic as a thin layer to affected areas of your skin.
• Protopic 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 Protopic unless your hands are also being treated.
• Before applying Protopic after a bath or shower, be sure your skin is completely dry. Children (2 years of age and older) Apply Protopic 0.03% ointment 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 Protopic (Protopic 0.03% and Protopic 0.1% ointment) are available for adult patients (16 years of age and older). Your doctor will decide which strength is best for you. Usually, treatment is started 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 if the frequency of application can be reduced or the lower strength, Protopic 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. You may be told by your doctor to use Protopic ointment twice weekly once your atopic dermatitis has cleared or almost cleared (Protopic 0.03% for children and Protopic 0.1% for adults). Protopic ointment should be applied once a day twice weekly (e.g. 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 outlined above and arrange to see your doctor to review your treatment. If you accidentally swallow some ointment 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 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 medicine, 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 generally go away within one week of using Protopic.

Common (may affect up to 1 in 10 people):
• redness
• feeling of warmth
• pain
• increased skin sensitivity (especially to hot and cold)
• skin tingling
• rash
• local skin infection regardless of specific cause including but not limited to: inflamed or infected hair follicles, cold sores, generalised herpes simplex infections
• facial flushing or skin irritation after drinking alcohol is also common

Uncommon (may affect fewer than 1 in 100 people):
• acne Following twice-weekly treatment application site infections have been reported in children and adults. Impetigo, a superficial bacterial skin infection that usually produces blisters or sores on skin, has been reported in children. Rosacea (facial redness), rosacea-like dermatitis, lentigo (presence of flat brown spots on the skin), oedema at the application site and herpes eye infections have been reported during post-marketing experience. Since commercial availability a very small number of people who have used Protopic ointment have had malignancies (for example lymphoma, including skin lymphoma, and other skin tumours). However, a link to Protopic ointment treatment has not been confirmed or refuted on the available evidence so far.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store Ireland HPRA Pharmacovigilance Earlsfort Terrace IRL
•Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie E-mail: [email protected]

How to Store Protopic Ointment

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 carton after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.