Levothyroxine 50 micrograms/5 ml Oral Solution

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Levothyroxine sodium

Доступна с:

JensonR+ (Ireland) Limited

код АТС:

H03AA; H03AA01

ИНН (Международная Имя):

Levothyroxine sodium

дозировка:

50 Micrograms/5ml

Фармацевтическая форма:

Oral solution

Тип рецепта:

Product subject to prescription which may be renewed (B)

Терапевтические области:

Thyroid hormones; levothyroxine sodium

Статус Авторизация:

Not marketed

Дата Авторизация:

2018-06-29

тонкая брошюра

2
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOTHYROXINE 25 MICROGRAMS /5ML ORAL SOLUTION
LEVOTHYROXINE 50 MICROGRAM/5ML ORAL SOLUTION
LEVOTHYROXINE 100 MICROGRAMS/5ML ORAL SOLUTION
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 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.
WHAT IS IN THIS LEAFLET
1.
What Levothyroxine Oral Solution is and what it is used for
2.
What you need to know before you take Levothyroxine Oral Solution
3.
How to take Levothyroxine Oral Solution
4.
Possible side effects
5.
How to store Levothyroxine Oral Solution
6.
Contents of the pack and other information
1.
WHAT LEVOTHYROXINE ORAL SOLUTION IS AND WHAT IT IS USED FOR
Levothyroxine Oral Solution is used to treat hypothyroidism, a
condition in which the thyroid gland is
underactive and so does not make enough thyroxine for the body's
needs.
Levothyroxine Oral Solution is also used to treat thyroid cancer and
diffuse non-toxic goitre or
Hashimoto's thyroiditis, conditions in which the thyroid gland becomes
enlarged causing a swelling in
the front of the neck.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVOTHYROXINE ORAL SOLUTION
DO NOT TAKE LEVOTHYROXINE ORAL SOLUTION IF:
-
you are allergic (hypersensitive) to levothyroxine or any of the other
ingredients of this
medicine (listed in section 6)
-
you suffer from adrenal insufficiency and you do not have adequate
corticosteroid cover
-
you have a heart attack (acute myocardial infarction), inflammation of
the heart muscle (acute
myocarditis) or acute inflammation of all layers of the heart (acute
pancarditis)
-
you are pregnant d

Характеристики продукта

Health Products Regulatory Authority
13 April 2021
CRN00C772
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levothyroxine 50 micrograms/5 ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of Levothyroxine 50 micrograms/5 ml Oral Solution contains
10 micrograms levothyroxine sodium.
Each 5 ml of oral solution contains 50 micrograms levothyroxine sodium
Excipients with known effect:
Sodium methyl parahydroxybenzoate (E219): 14.58 mg per 5 ml dose.
Sodium propyl parahydroxybenzoate (E217): 2.915 mg per 5 ml dose.
Glycerol (E422): 3,780 mg per 5 ml dose.
This medicinal product contains 0.945 mmol (or 21.74 mg) sodium per 5
ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution
A clear, colourless to pale yellow liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Levothyroxine Oral Solution is indicated for:
i) hypothyroidism (congenital or acquired)
ii) diffuse non toxic goitre
iii) goitre associated with Hashimoto's thyroiditis
iv) Suppression therapy in thyroid carcinoma
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The treatment of any thyroid disorder should be determined on an
individual basis, taking account of clinical response,
biochemical tests and regular monitoring.
The individual daily dose should be determined on the basis of
laboratory tests and clinical examinations. As a number of
patients show elevated concentrations of T
4
and fT
4
, basal serum concentration of thyroid-stimulating hormone provides a
more reliable basis for following treatment course.
Patients switching from the oral solution to the tablet form or from
the tablet form to the oral solution should be monitored
closely.
Levothyroxine is best taken as a single dose on an empty stomach,
usually before breakfast.
Hypothyroidism (congenital or acquired)
Adults, children over 12 years
Initial dose: ​
50 - 100 micrograms daily before breakfast. ​
Usual maintenance dose:
​100 - 200 micrograms daily.
Health Products Regulatory Authority
13