Country: যুক্তরাজ্য
ভাষা: ইংরেজি
সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrocortisone
Shire Pharmaceuticals Ltd
H02AB09
Hydrocortisone
20mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06030200; GTIN: 5060147020168
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PLENADREN 5 MG MODIFIED-RELEASE TABLETS PLENADREN 20 MG MODIFIED-RELEASE TABLETS Hydrocortisone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Plenadren is and what it is used for 2. What you need to know before you take Plenadren 3. How to take Plenadren 4. Possible side effects 5. How to store Plenadren 6. Contents of the pack and other information 1. WHAT PLENADREN IS AND WHAT IT IS USED FOR Plenadren contains a substance called hydrocortisone (sometimes called cortisol). Hydrocortisone is a glucocorticoid. It belongs to a group of medicines called corticosteroids. Glucocorticoids occur naturally in the body, and help to maintain your general health and well-being. Plenadren is used in adults to treat a condition known as adrenal insufficiency, or cortisol deficiency. Adrenal insufficiency occurs when your adrenal glands (just above your kidneys) do not produce enough of the hormone cortisol. Patients suffering from long-term (chronic) adrenal insufficiency need a replacement therapy to survive. Plenadren replaces the natural cortisol that is missing in adrenal insufficiency. The medicine delivers hydrocortisone to your body throughout the day. The cortisol levels in your blood increase rapidly to a maximum level, about 1 hour after taking the tablet in the morning, and then gradually decrease over the day with no or almost no cortisol level in the blood in the late evening and night when the levels should be low. 2. WHAT YOU NEED TO KNOW BEFO সম্পূর্ণ নথি পড়ুন
OBJECT 1 PLENADREN 5 MG MODIFIED RELEASE TABLETS Summary of Product Characteristics Updated 14-Jun-2018 | Shire Pharmaceuticals Limited 1. Name of the medicinal product Plenadren 5 mg modified-release tablets Plenadren 20 mg modified-release tablets 2. Qualitative and quantitative composition Plenadren 5 mg modified-release tablets Each modified-release tablet contains hydrocortisone 5 mg. Plenadren 20 mg modified-release tablets Each modified-release tablet contains hydrocortisone 20 mg. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Modified-release tablet. Plenadren 5 mg modified-release tablets The tablets are round (diameter 8 mm), convex and pink. Plenadren 20 mg modified-release tablets The tablets are round (diameter 8 mm), convex and white. 4. Clinical particulars 4.1 Therapeutic indications Treatment of adrenal insufficiency in adults. 4.2 Posology and method of administration Posology Plenadren is given as maintenance therapy. Oral replacement doses must be individualised according to the clinical response. A common maintenance dose is 20 – 30 mg per day, given once daily in the morning. In patients with some remaining endogenous cortisol production a lower dose may be sufficient. 40 mg is the highest maintenance dose studied. The lowest possible maintenance dosage should be used. In situations when the body is exposed to excessive physical and/or mental stress, patients may need additional substitution of immediate release hydrocortisone tablets especially in the afternoon/evening, see also section 'Use in intercurrent illness' where other ways of temporarily increasing the dose of hydrocortisone is described. _Changing from conventional oral glucocorticoid treatment to Plenadren _ When changing patients from conventional oral hydrocortisone replacement therapy given three times daily to Plenadren, an identical total daily dose may be given. Due to a lower bioavailability of the daily dose of Plenadren compared to that of conventional hydrocortisone tablets given three time সম্পূর্ণ নথি পড়ুন