Levothyroxine

Země: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktivní složka:

Levothyroxine sodium 0.1mg (anhydrous)

Dostupné s:

Boucher & Muir (NZ) Ltd t/a Mercury Pharma (NZ)

INN (Mezinárodní Name):

Levothyroxine sodium 0.1 mg (anhydrous)

Dávkování:

0.1 mg

Léková forma:

Tablet

Složení:

Active: Levothyroxine sodium 0.1mg (anhydrous) Excipient: Acacia Lactose monohydrate Magnesium stearate Maize starch Sodium citrate

Jednotky v balení:

Blister pack, PVC/PVdC-aluminium, 28 tablets

Třída:

Prescription

Druh předpisu:

Prescription

Výrobce:

Peptido GmbH

Terapeutické indikace:

Levothyroxine is indicated for the treatment of hypothyroidism. This product should only be prescribed to patients already taking this product who are known to be intolerant to all other levothyroxine containing products. This product may also be prescribed to patients already taking this product who are not known to be intolerant to all other levothyroxine containing products, but for whom changing to another levothyroxine containing product is not clinically appropriate.

Přehled produktů:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC-aluminium - 28 tablets - 24 months from date of manufacture stored at or below 25°C protect from light

Datum autorizace:

2008-09-11

Informace pro uživatele

CMI Levothyroxine Tablets
1
CONSUMER MEDICINE INFORMATION
LEVOTHYROXINE
_LEVOTHYROXINE TABLETS 50 MICROGRAMS AND 100 MICROGRAMS _
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
LEVOTHYROXINE TABLETS.
This leaflet answers some common questions about Levothyroxine
tablets. It does not
contain all of the available information. It does not take the place
of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
expected benefits of
you taking Levothyroxine tablets against the risks this medicine could
have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again.
WHAT LEVOTHYROXINE TABLETS ARE USED FOR
Levothyroxine tablets contain the active ingredient levothyroxine.
Levothyroxine belongs
to a small group of medicines called thyroid hormones, which work by
replacing the
body's low levels of thyroxine.
Levothyroxine tablets are used to treat hypothyroidism, a disease in
which the thyroid
gland is underactive and does not produce enough thyroxine, a hormone,
which is
important for controlling your metabolism. Symptoms of hypothyroidism
include
tiredness, muscle weakness, cramps, feeling the cold, a slow heart
rate, dry and flaky
skin, hair loss, a deep husky voice and weight gain.
Levothyroxine tablets are also used to treat children born with
hypothyroidism
(congenital), those who develop hypothyroidism in the first year of
life (neonatal) and
children who have hypothyroidism as part of juvenile myxoedema, a
condition in which
the amount of thyroxine produced by the body is low.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY LEVOTHYROXINE
TABLETS HAVE
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed Levothyroxine tablets for another
reason.
This medicine is available only with a doctor's prescription.
CMI Levothyroxine Tablets
2
BEFORE YOU TAKE LEVOTHYROXINE TABLETS
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE LEVOTHYROXI

Charakteristika produktu

1
LEVOTHYROXINE
LEVOTHYROXINE TABLETS 50 MICROGRAMS AND 100 MICROGRAMS
Page
1
of
12
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
LEVOTHYROXINE
50 microgram and 100 microgram tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levothyroxine sodium (anhydrous) 50 microgram and 100 microgram.
Each tablet contains 50 micrograms (0.05 mg) or 100 micrograms (0.1
mg) anhydrous
levothyroxine sodium, which is the monosodium salt of the levorotary
isomer of
thyroxine.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Levothyroxine 50 microgram (0.05 mg) tablets are white, uncoated,
biconvex tablets,
engraved on one face with “LT” and “50” on the other.
Levothyroxine 100 microgram (0.1 mg) tablets are white, uncoated,
biconvex tablets,
engraved on one face with “LT” and “100” on the other.
The tablets must be swallowed whole. Do not halve the tablets. Dose
equivalence when
the tablet is divided has not been established.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levothyroxine is indicated for the treatment of hypothyroidism.
This product should only be prescribed to patients already taking this
product who are
known to be intolerant to all other levothyroxine containing products.
This product may also be prescribed to patients already taking this
product who are not
known to be intolerant to all other levothyroxine containing products,
but for whom
changing to another levothyroxine containing product is not clinically
appropriate.
2
LEVOTHYROXINE
LEVOTHYROXINE TABLETS 50 MICROGRAMS AND 100 MICROGRAMS
Page
2
of
12
4.2
DOSE AND METHOD OF ADMINISTRATION
Thyroxine has a narrow therapeutic index. Appropriate thyroxine dosage
is based upon
clinical assessment and laboratory monitoring of thyroid function
tests. During the initial
titration period, careful dosage titration and monitoring is necessary
to avoid the
consequences of under- or over-treatment. The symptoms of excessive
thyroxine dosage
are the same as many features of endogenous thyrotoxicosis.
A pre-therapy ECG is valuable, as chan