Ülke: Malta
Dil: İngilizce
Kaynak: Medicines Authority
FLUDROCORTISONE ACETATE, LACTOSE MONOHYDRATE
Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
H02AA02
FLUDROCORTISONE ACETATE 0.1 mg LACTOSE MONOHYDRATE 93.4 mg
TABLET
FLUDROCORTISONE ACETATE 0.1 mg LACTOSE MONOHYDRATE 93.4 mg
POM
CORTICOSTEROIDS FOR SYSTEMIC USE
Withdrawn
2017-01-09
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FLUDROCORTISONE ACETATE 0.1 MG TABLETS 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. • FLUDROCORTISONE ACETATE 0.1 MG TABLET 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. • FLUDROCORTISONE ACETATE 0.1 MG TABLET CAN CAUSE SIDE EFFECTS IN SOME PEOPLE (read section 4 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 tablets, 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, 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. WHAT IS IN THIS LEAFLET 1. What Fludrocortisone Acetate is and what it is used for Belgenin tamamını okuyun
Page 1 of 9 1. NAME OF THE MEDICINAL PRODUCT Fludrocortisone Acetate 0.1 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.1 mg fludrocortisone acetate. Excipient(s) with known effect: Each tablet also contains 93.4 mg of lactose monohydrate For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White to off-white round tablet, marked with ‘FL 0.1’ on one side and a break-line on the other side. The break-line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenogenital syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: A daily dosage range of 0.05-0.3 mg Fludrocortisone Acetate tablets orally. Supplementary parenteral administration of sodium-retaining hormones is not necessary. When an enhanced glucocorticoid effect is desirable, cortisone or hydrocortisone by mouth should be given concomitantly with Fludrocortisone Acetate tablets. Elderly: No specific dosage recommendations (See 4.4 Precautions). Children: May be used adjusted to the age and weight of the child according to the severity of the condition. Caution should be used in the event of exposure to chickenpox, measles or other communicable diseases. (See 4.3 Contraindications). 4.3 CONTRAINDICATIONS Page 2 of 9 Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Systemic infections unless specific anti-infective therapy is employed. Because of its marked effect on sodium retention, the use of Fludrocortisone Acetate in the treatment of conditions other than those indicated, is not advised. Since Fludrocortisone Acetate is a potent mineralocorticoid both the dosage and salt intake should be carefully monitored to avoid the development of hypertension, oedema or weight gain. Periodic checking of serum electrolyte l Belgenin tamamını okuyun