Pajjiż: Ingilterra
Lingwa: Ingliż
Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dexamethasone
Accord-UK Ltd
H02AB02
Dexamethasone
2mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06030200
TEMPLATE DEXAMETHASONE 0.5 MG AND 2 MG TABLETS PATIENT INFORMATION LEAFLET THIS LEAFLET CONTAINS IMPORTANT INFORMATION ABOUT DEXAMETHASONE TABLETS. READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor or your 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. • 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 ‘Possible Side Effects’ section below). 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 ‘Possible Side Effects’ section below) • IF YOU TAKE IT FOR MORE THAN 3 WEEKS, YOU WILL GET A BLUE ‘STEROID CARD’: always keep it with you and show 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. IN THIS LEAFLET 1. WHAT DEXAMETHASONE TABLETS IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dexamethasone 2mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.0 mg dexamethasone. Contains lactose monohydrate (68.8mg per tablet); for a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Round white tablet, one side marked DX 2 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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. _1._ _ _ _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 pm 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. Twenty-four hour urine collections are made before, during and at the end of the test for determination of 17-hydroxycorticosteroids. 2. _Children_ 0.01-0.1mg/kg of body weight daily Dosage of glucocorticoids should be adjusted on the basis of the individual patient's response. 4.3 CONTRAINDICATIONS • Systemic infection unless specific antimicrobial therapy given. • Avoid live virus vaccines in those receiving immunosuppressive doses as the serum antibod Aqra d-dokument sħiħ