Levothyroxine 100 micrograms/5ml Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levothyroxine sodium

Available from:

Wockhardt UK Limited

ATC code:

H03AA; H03AA01

INN (International Name):

Levothyroxine sodium

Dosage:

100 Micrograms/5ml

Pharmaceutical form:

Oral solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Thyroid hormones; levothyroxine sodium

Authorization status:

Not marketed

Authorization date:

2016-04-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Levothyroxine 25micrograms/5ml, 50micrograms /5ml, and 100micrograms
/5ml
Oral Solution
Levothyroxine sodium
(referred to as Levothyroxine Oral Solution in the remainder of this
leaflet)
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 of the side effects, talk to your doctor, pharmacist or
nurse.
This includes any possible side effects not listed in this leaflet.
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 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
pan

Summary of Product characteristics

Health Products Regulatory Authority
29 June 2020
CRN009KWT
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levothyroxine 100 micrograms/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of oral solution contains 100micrograms levothyroxine sodium.
Excipients with known effect:
Sodium methyl parahydroxybenzoate 10.3 mg/5ml
Sodium propyl parahydroxybenzoate 1.12 mg/5ml
Propylene glycol 150 mg/5ml
Maltitol 3,350 mg/5ml
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
• Hypothyroidism (congenital or acquired)
• Diffuse non toxic goitre
• Goitre associated with Hashimoto’s thyroiditis
• Suppression therapy in thyroid carcinoma
Levothyroxine 100 micrograms/5ml oral solution in this formulation is
not suitable for children under the age of five years due
to the excipient content (see section 4.4). Alternative formulations
of levothyroxine 100 micrograms/5ml oral solution exist,
with a different excipient content, that are more suitable for the
paediatric population under five years of age.
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 T4 and fT4, 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 mai