Tacrolimus monohydrate 0.1% ointment What Tacrolimus ointment is used for: Tacrolimus monohydrate, is an immunomodulating agent. Tacrolimus ointment is used to treat moderate to severe atopic dermatitis 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 Tacrolimus ointment twice weekly. In atopic dermatitis, an over-reaction of the skin’s immune system causes skin inflammation (itchiness, redness, dryness). Tacrolimus alters the abnormal immune response and relieves the skin inflammation and the itch. Do not use Tacrolimus ointment: If you are allergic to tacrolimus or any of the other ingredients of this medicine or to macrolide antibiotics Warnings and precautions: Talk to your doctor before using Tacrolimus ointment: If you have liver failure. If you have skin diseases. If you have any skin malignancies. if you have a weakened immune system. If you have swollen lymph nodes at initiation of treatment. Possible side effects: Like all medicines, this medicine can cause side effects, although not everybody gets them. These side effects include: burning sensation and itching 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, generalized herpes simplex infections facial flushing or skin irritation after drinking alcohol is also common 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), edema at the application site and herpes eye infections have been reported during post-marketing experience. Other medicines and Tacrolimus ointment: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. You may use moisturizing creams and lotions during treatment with Tacrolimus ointment but these products should not be used within two hours of applying Tacrolimus ointment. The use of Tacrolimus ointment 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. How to use Tacrolimus ointment: Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Apply Tacrolimus ointment as a thin layer to affected areas of your skin. Tacrolimus ointment 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 Tacrolimus ointment unless your hands are also being treated. Before applying Tacrolimus ointment after a bath or shower, be sure your skin is completely dry. Adults (16 years of age and older) Two strengths of Tacrolimus ointment (Tacrolimus ointment 0.03% and Tacrolimus ointment 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 Tacrolimus 0.1% ointment twice a day, once in the morning and Once in the evening, until 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, Tacrolimus ointment 0.03% ointment, can be used. Treat each affected region of your skin until 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 Tacrolimus ointment twice weekly once your atopic dermatitis has cleared or almost cleared (Tacrolimus ointment 0.03% for children and Tacrolimus Ointment 0.1% for adults). Tacrolimus 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 Tacrolimus ointment treatment between applications. How to store Tacrolimus 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° 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.