Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Levothyroxine sodium
Mercury Pharma Group Ltd
H03AA; H03AA01
Levothyroxine sodium
50 microgram(s)
Tablet
Product subject to prescription which may be renewed (B)
Thyroid hormones; levothyroxine sodium
Marketed
1995-09-18
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 Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eltroxin 50 microgram Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 micrograms anhydrous levothyroxine sodium. Excipient with known effect: Lactose monohydrate 31.879 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Each white tablet is scored on one side and is engraved with ‘Eltroxin 50’ on the other side. The scoreline is to allow breaking for ease of swallowing and not to divide into equal doses. 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 ischaemia. 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 ischaemia) 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, 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 microgram. In younger patients and in the absence of heart disease, a serum thyroxine (T4) level of approximately 70 Đọc toàn bộ tài liệu