Takfa Ointment (Tacrolimus 0.03%)

INTRODUCTION

TAKFA contains Tacrolimus which belongs to the group of medicines called immunosuppressants. It is used to treat moderate to severe atopic dermatitis (eczema) in adults and in children (2 years of age and older), who are not adequately responsive for conventional therapies like topical corticosteroids. It can also be used as a maintenance therapy, for the prevention of flares and prolongation of flare-free intervals in patients having a high frequency of disease exacerbations (4 or more times/year) who had an initial response up to 6 weeks of treatment.

Atopic dermatitis is an auto-immune skin disease, in which your skin becomes inflamed, red and itchy. Tacrolimus alters this abnormal immune function and relieves your skin from inflammation and itching. The most common side effects of applying this medicine are itching and burning sensation on the skin. This side effects are mild-moderate and generally disappears within 1 week of therapy.

Avoid consumption of alcohol while using this medicine, because drinking alcohol might cause your face or skin to become flushed. Limit your exposure to sun and UV light, because immunosuppressants could increase the risk of skin cancer. Always wear loose fitting clothes and sunscreen that protects your skin from sun. This medicine is not recommended for use in children younger than 2 years of age. Consult your doctor before using.

USES OF TAKFA

Treats and prevents moderate to severe atopic dermatitis (eczema) in adults and in children aged 2 years and above

HOW TAKFA WORKS

Tacrolimus binds to an intracellular protein called FK binding protein-12. The tacrolimus-FK binding protein-12 complex inhibits the activity of calcineurin (a calcium-dependent phosphatase transmitting chemical), which in turn, reduces the activity of T-lymphocytes in the immune system. As a result, the T-cells fail to release their cytokines that cause inflammation, redness and itching.

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DIRECTIONS FOR USE

Apply this medicine as directed by your physician. It is for external use only. Apply a thin layer of the medicine to affected areas of your skin. It can be used on your face, neck, elbows and knees. Do not cover the treated skin with bandages. Wash your hands after application. Avoid contact of this medicine with eyes, ears, nose or mouth, if happens wipe it or rinse it thoroughly with water. Continue to use this medicine, as long as your doctor tells you to do so, to obtain better results.

SIDE EFFECTS OF TAKFA

COMMON
Itching and burning sensation on the skin
Skin tingling, rash, redness or pain
Increased skin sensitivity
Local skin infection (infected hair follicles, generalized herpes simplex infections)

HOW TO MANAGE SIDE EFFECTS

Skin tingling, rash, redness or pain:

Avoid hot water showers since it can irritate the skin. Pat dry your skin after bath. Do not rub/scratch the infected area and avoid using perfumed soaps or deodorants. Excessive sun exposure should be avoided.

WARNING & PRECAUTIONS

PREGNANCY
TAKFA should be used with caution in pregnant women. Consult your doctor before taking this medicine.

BREASTFEEDING
TAKFA should be used with caution in breastfeeding women. Consult your doctor before taking this medicine.

ALCOHOL
Avoid consumption of alcohol while using this medicine, because drinking alcohol might cause your face or skin to become flushed.

LIVER
TAKFA should be used with caution in patients with severe liver disease. Consult your doctor for advice.

ALLERGY
Do not apply this medicine if you are allergic (hypersensitive) to tacrolimus, sirolimus, or to any macrolide-antibiotics.

OTHERS

Before applying this medicine, inform your doctor if you:

Have any skin malignancies, a weak immune system, an inherited skin barrier disease (e.g. Netherton’s syndrome, lamellar ichthyosis, generalised erythroderma), swollen lymph nodes or infected lesions