Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Levothyroxine sodium anhydrous
Advanz Pharma
H03AA01
Levothyroxine sodium anhydrous
100microgram
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06020100; GTIN: 5021691110064
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. Your medicine is called either Eltroxin 50 micrograms or 100 micrograms tablets depending on what your doctor has prescribed. It will be known as Eltroxin Tablets for ease hereafter. 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 EFFECTS 5. HOW TO STORE ELTROXIN TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT ELTROXIN TABLETS ARE AND WHAT THEY ARE USED FOR Thyroxine is a hormone which is produced naturally in the body by the thyroid gland. Levothyroxine is a synthetic version of this hormone. Thyroxine controls how much energy your body uses. When the thyroid gland does not produce enough thyroxine (a condition known as hypothyroidism), many of the body’s functions slow down. Some of the most common symptoms of hypothyroidism are: • tiredness • weight gain • feeling depressed Eltroxin tablets are used to replace the thyroxine that your thyroid gland cannot produce and prevent the symptoms of hypothyroidism. Before starting your treatment your doctor will carry out a blood test to work out how much levothyroxine you need. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ELTROXIN TABLETS DO NOT TAKE ELTROXIN TABLETS: • if you are allergic to levothyroxine or any of the other ingredients of this medicine (listed in section 6) • if you suffer from an overactive thyroid gland that produces too much thyroid hormone ( Les hele dokumentet
OBJECT 1 ELTROXIN 100MCG TABLETS Summary of Product Characteristics Updated 29-May-2018 | Concordia International - formerly AMCo 1. Name of the medicinal product Eltroxin 100mcg tablets Levothyroxine 100mcg tablets 2. Qualitative and quantitative composition Each tablet contains 100 micrograms Levothyroxine sodium anhydrous . Excipient with known effect Lactose 48.86mg per tablet For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet White, uncoated, biconvex tablets engraved on one face with “LT” and 100 on the other. 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 In younger patients, and in the absence of heart disease, a serum Levothyroxine (T4) level of 70 to 160 nanomols per litre, or a serum thyrotrophin level of less that 5 milli-units per litre should be targeted. 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. Adults: Initially 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 micrograms. Elderly: As for patients aged over 50 years. For patients over 50 years, initially, it is not advisable to exceed 50 micrograms daily. In this condition, the daily dose may be increased by 50 micrograms at intervals of every 3-4 weeks, until stable thyroxine levels are attained. The final daily dose may be up to 50 to 200 micrograms. Patien Les hele dokumentet