Levothyroxine 50 micrograms per 5 ml oral solution

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Levothyroxine sodium

Tilgængelig fra:

Mercury Pharmaceuticals Ltd

ATC-kode:

H03AA; H03AA01

INN (International Name):

Levothyroxine sodium

Dosering:

50 Micrograms/5ml

Lægemiddelform:

Infus/Pdr/Oral Soln

Recept type:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Thyroid hormones; levothyroxine sodium

Autorisation status:

Marketed

Autorisation dato:

2012-07-06

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOTHYROXINE 25 MICROGRAMS / 50 MICROGRAMS AND
100 MICROGRAMS PER 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, 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.
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 contains the active ingredient
levothyroxine sodium. It 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 to levothyroxine or any of the other
ingredients of this medicine (listed in
section 6)
• If you suffer from adrenal insufficiency and you do not have
adequate corticosteroid cover
• If you have a heart attack (acute myocardial infarction),
inflammation of the heart muscle
(acute myocarditis) or inflammation of the sac surrounding the heart
(acute pancarditis)
•
If
you

Produktets egenskaber

Health Products Regulatory Authority
12 October 2018
CRN008HGF
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levothyroxine 50 micrograms per 5 ml oral solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of oral solution contains 50 micrograms Levothyroxine Sodium
Excipients with known effect:
Sodium methyl hydroxybenzoate (E219): 9mg per 5ml dose.
Glycerol: 3,780mg per 5ml dose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution
Clear colourless 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
ADULTS
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 T4
and fT4, basal serum concentration of thyroid-stimulating hormone
provides a more
reliable basis for following treatment course.
Health Products Regulatory Authority
12 October 2018
CRN008HGF
Page 2 of 12
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.
The initial dose is adjusted by 25 to 50 microgram increments at 3 –
4 week intervals
until clinical response and measurements of plasma thyroxine and
thyroid stimulating hormone indicate that the thyroid deficiency is
corrected and a
maintenan