Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
HYDROCORTISONE
Vitamode Sdn.bhd
HYDROCORTISONE
3 x 10 Tablets
RENATA LIMITED
RENSON TABLET Hydrocortisone (10mg and 20mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _Renson_ is used for 2. How _Renson _ works 3. Before you use _Renson_ 4. How to use _Renson_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Renson_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _RENSON _IS USED FOR _Renson _ is used: - to treat low hydrocortisone levels caused by diseases of the adrenal gland (such as Addison’s disease, adrenocortical insufficiency); - in the treatment of hypopituitarism (a condition in which the pituitary gland does not produce normal amounts of some or all of its hormones); - to treat congenital adrenal hyperplasia which affects your body’s natural production of steroids; - in conditions where systemic (oral or injectable) glucocorticoid therapy is needed Your doctor will tell you for which disease or symptom (s)he has prescribed _Renson_ for you. HOW _RENSON_ WORKS Hydrocortisone or cortisol is a natural glucocorticoid (corticosteroid hormone). It acts by binding to steroid receptors in the cytoplasm. It acts mainly by reducing the local inflammation reaction. It e.g. alleviates inflammation symptoms and eliminates allergic symptoms. BEFORE YOU USE _RENSON _ _ _ Some medicines may increase the effects of _Renson_ and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV such as cobicistat). _- When you must not use it _ Do not use _Renson_ tablet if: • you are allergic to hydrocortisone or any of the other ingredients in this medicine. • you have thrush, Candida or any other fungal infection. • you have any other infection. • you have been vaccinated recently or are going to have any vaccinations. _ _ _Pregnancy and lactation _ If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor wi Read the complete document
RENSON 10MG TABLET (HYDROCORTISONE 10 MG TABLETS) RENSON 20MG TABLET (HYDROCORTISONE 20 MG TABLETS) NAME AND STRENGTH OF ACTIVE SUBSTANCE(S): RENSON 10MG TABLET Name of Active Substance(s): Hydrocortisone BP/Ph. Eur. Strength of Active Substance(s): 10 mg Hydrocortisone BP/Ph. Eur. RENSON 20MG TABLET Name of Active Substance(s): Hydrocortisone BP/Ph. Eur. Strength of Active Substance(s): 20 mg Hydrocortisone BP/Ph. Eur. PRODUCT DESCRIPTION: RENSON 10MG TABLET 8 x 5.25 mm, white, oval, flat, bevelled with imprinted “H” on one side and plain on the other side. RENSON 20MG TABLET 10.9 x 7.1 mm, white, oval, flat, bevelled single breakline on one side and imprinted “H” on the other side. Breakline is to break the tablet in half if needed. PHARMACODYNAMICS Hydrocortisone or cortisol is a natural glucocorticoid (corticosteroid hormone). It acts by binding to steroid receptors in the cytoplasm. It acts mainly by reducing the local inflammation reaction. It e.g. alleviates inflammation symptoms and eliminates allergic symptoms. PHARMACOKINETICS Hydrocortisone is absorbed rapidly and completely from the alimentary tract. Because of first-pass metabolism, its bioavailability varies between 25% and 90%. In plasma, the peak concentration of hydrocortisone is reached in 1-2 hours after dosing. It is bound to plasma transcortin and albumin. At low concentrations, 10% of hydrocortisone is free; at higher concentrations, the binding capacity of transcortin is saturated and the proportion of free drug can increase to 40-50%. Its volume of distribution is 0.4-0.7 l/kg. The pharmacological half life of hydrocortisone averages 1.5 hours, but the half life of biological effect is considerably longer, approx. 10 hours. Hydrocortisone penetrates the placenta and is excreted in small amounts in breast milk. The elimination of hydrocortisone may be prolonged in liver diseases and shortened in thyrotoxicosis. INDICATION Adrenocortical insufficiency (Addison’s disease), diminution of anterior pituitary function (hypopituitarism), Read the complete document