Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Levothyroxine sodium
Mercury Pharmaceuticals Ltd
H03AA; H03AA01
Levothyroxine sodium
25 microgram(s)
Tablet
Product subject to prescription which may be renewed (B)
Thyroid hormones; levothyroxine sodium
Marketed
2004-07-02
PACKAGE LEAFLET: INFORMATION FOR THE USER ELTROXIN™ 25, 50, 100 MICROGRAMS TABLETS LEVOTHYROXINE SODIUM 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, pharmacist or nurse. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4 • Thyroxine is a hormone produced by the thyroid gland. Levothyroxine is used to replace thyroxine in people whose thyroid gland does not work properly. You will usually need to take this medicine for the rest of your life and must not stop taking it, or change the dose, without speaking to your doctor first. • This medicine can affect the way other medicines work (See Section 2 ‘Taking other medicines’). If you take medicines to control diabetes or warfarin to prevent blood clots, the dose may need to be adjusted by your doctor when you start taking Eltroxin tablets. • You will start off taking a low dose of this medicine (See Section 3 ‘How to take’). Your doctor will then increase the dose gradually at 3 – 4 week intervals until your thyroxine levels are corrected. This will help to reduce the chance of side effects. • You will need regular blood tests whilst you are taking this medicine. • These tablets can be taken by both adults and children. If you are giving this medicine to your child make sure you know how many and when to give the tablets (See Section 3 ‘How to take’) and what side effects to look out for (See Section 4 ‘Possible side effects’). WHAT IS IN THIS LEAFLET 1. What Eltroxin Tablets are and what they are used for 2. What you need to know before you take Eltroxin Tablets 3. How to take Eltroxin Tablets 4. Possible side eff Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eltroxin 25 microgram Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 micrograms levothyroxine sodium anhydrous. Excipients with known effect: Lactose 30.49mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White uncoated biconvex tablets engraved on one face “FW41” and a score line on the other. The scoreline is to allow breaking for ease of swallowing. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Recommended clinical indications: Control of hypothyroidism, congenital hypothyroidism in infants, acquired hypothyroidism in children and juvenile myxoedema. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology A pre-therapy ECG is valuable because ECG changes due to hypothyroidism may be confused with ECG evidence of cardiac ischemia. If too rapid an increase in metabolism is produced (causing diarrhoea, nervousness, rapid pulse, insomnia, tremors, and sometimes anginal pain where there is latent cardiac ischemia) dosage must be reduced, or withheld, for a day or two, and then re-started at a lower dose level. Initial monitoring and dose adjustments. It is especially necessary when starting Eltroxin to establish a maintenance dose. The timing of this blood test depends on patients symptoms. If their symptoms have improved after starting Eltroxin, patients should have their TSH level measured at around 6 weeks after starting Eltroxin. If a patient still has symptoms 2-3 weeks after starting Eltroxin, they will need a TSH level taken earlier. _Adults (under 50 years age):_ Initially 50 to 100 micrograms daily (2 to 4 tablets daily), preferably taken before breakfast or the first meal of the day. Adjust at three to four week intervals by 50 micrograms until normal metabolism is steadily maintained. The final daily dose may be up to 100 to 200 micrograms. In younger patients and in the absence of heart disease, a serum thyroxine (T4) level of approximately 70 to 160 nanomoles per litre, or Прочитать полный документ