Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dexamethasone
Aspen Pharma Trading Ltd
H02AB02
Dexamethasone
2mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06030200; GTIN: 5013257001213 5013257000711 5013257000728
Package leaflet: Important information for the patient Dexamethasone 2mg Tablets Dexamethasone • Dexamethasone is a steroid medicine, prescribed for many different conditions including serious illnesses • You need to take it regularly to get the maximum benefit • Don’t stop taking this medicine without talking to your doctor-you may need to reduce the dose gradually • Dexamethasone can cause side effects in some people (read Section 4: Possible side effects). Some problems such as mood changes (feeling depressed, or ‘high’), or stomach problems can happen straight away. If you feel unwell, in any way, keep taking your medicine, but see your doctor straight away • Some side effects only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face (read Section 4 for more information) • If you take it for more than 3 weeks, in the UK, you will get a blue ‘steroid card’: always keep it with you and show it to any doctor or nurse treating you • Keep away from people who have chicken pox or shingles, if you have never had them. They could affect you severely. If you do come into contact with chicken pox or shingles, see your doctor straight away Now read the rest of this leaflet It includes other important information on the safe and effective use of this medicine that might be especially important for you. 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 Dexamethasone is and what it is used for 2. What you need to know before you take Dex Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dexamethasone Tablets BP 2.0mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.0mg dexamethasone PhEur. Excipient with known effect Each tablet contains approximately 116mg lactose monohydrate Ph.Eur. For the full list of excipients, see section 6.1 . 3 PHARMACEUTICAL FORM Tablet White, round and flat tablets with bevelled edges and a diameter of 6 mm, coded XC above, and 8 below on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indicated in a wide variety of disorders amenable to glucocorticoid therapy, as well as an adjunct in the control of cerebral oedema. Dexamthasone is indicated in the treatment of coronavirus disease 2019 (COVID-19) in adult and adolescent patients (aged 12 years and older with body weight at least 40 kg) who require supplemental oxygen therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology In general, glucocorticoid dosage depends on the severity of the condition and response of the patient. Under certain circumstances, for instance in stress and changed clinical picture, extra dosage adjustments may be necessary. If no favourable response is noted within a couple of days, glucocorticoid therapy should be discontinued. _Adults_ Usually, daily oral dosages of 0.5 - 10 mg are sufficient. In some patients higher dosages may be temporarily required to control the disease. Once the disease is under control the dosage should be reduced or tapered off to the lowest suitable level under continuous monitoring and observation of the patient. (SEE SECTION 4.4) For a short dexamethasone suppression test, 1mg dexamethasone is given at 11 p.m. and plasma cortisol measured the next morning. Patients who do not show a decrease in cortisol can be exposed to a longer test: 500 micrograms dexamethasone is given at 6 hourly intervals for 48 hours followed by 2mg every 6 hours for a further 48 hours. 24 hour-urine collections are made before, during and at the end of the test fo Lesen Sie das vollständige Dokument