Eltroxin 100microgram tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Levothyroxine sodium anhydrous

Dostępny od:

Advanz Pharma

Kod ATC:

H03AA01

INN (International Nazwa):

Levothyroxine sodium anhydrous

Dawkowanie:

100microgram

Forma farmaceutyczna:

Oral tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 06020100; GTIN: 5021691110064

Ulotka dla pacjenta

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 (

Charakterystyka produktu

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