Eltroxin 100micrograms/5ml oral solution

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Levothyroxine sodium anhydrous

Sẵn có từ:

Advanz Pharma

Mã ATC:

H03AA01

INN (Tên quốc tế):

Levothyroxine sodium anhydrous

Liều dùng:

20microgram/1ml

Dạng dược phẩm:

Oral solution

Tuyến hành chính:

Oral

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 06020100; GTIN: 5021691019787

Tờ rơi thông tin

WHAT IS IN THIS LEAFLET
1. What Eltroxin Oral Solution is and what it is used for
2. What you need to know before you take Eltroxin
Oral Solution
3. How to take Eltroxin Oral Solution
4. Possible side effects
5. How to store Eltroxin Oral Solution
6. Contents of the pack and other information
1. WHAT ELTROXIN ORAL SOLUTION IS AND
WHAT IT IS USED FOR
Eltroxin Oral Solution contains levothyroxine which 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.
Eltroxin Oral Solution is also used to treat thyroid
ca
ncer 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 ELTROXIN ORAL SOLUTION
DO NOT TAKE ELTROXIN 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
are pregnant do not take this medicine in
combination with medicines to treat hyperthyroidism
(see the section on Pregnancy and breast-feeding).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Eltroxin Oral solution:
If you have heart disease, problems with your
circulation or high blood pressure
If you are suffering from an overactive thyroid gland
(hyperthyroidism), an underactive adrenal g
land,
diabetes, or have had an underactive thyroid gland
for some time.
OTHER MEDICINES AND ELTROXIN ORAL SOLUTION
Please tell your doctor or pharmacist if you are taking,
have recently taken or might use any other medicines.
Levothyroxine can interfere with the action of some
other drugs and some drugs can have an effect on
Levothyroxine. In particular tell your doctor or
pharmacist

Đặc tính sản phẩm

OBJECT 1
ELTROXIN 100MICROGRAMS PER 5ML ORAL SOLUTION
Summary of Product Characteristics Updated 04-Sep-2013 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Eltroxin 100micrograms per 5ml Oral Solution
2. Qualitative and quantitative composition
Each 5ml of oral solution contains 100micrograms Levothyroxine Sodium
Excipients with known effect:
Sodium methyl hydroxybenzoate (E219): 9mg per 5ml dose.
Glycerol: 3,780mg per 5ml dose.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral Solution
Clear colourless liquid.
4. Clinical particulars
4.1 Therapeutic indications
Eltroxin 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
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 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 maintenance dose established.
Diffuse non toxic goitre or goitre associa