LEVOXINE levothyroxine sodium 100 micrograms tablet bottle

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

levothyroxine sodium, Quantity: 0.1 mg

Tilgjengelig fra:

Sun Pharma ANZ Pty Ltd

Legemiddelform:

Tablet

Sammensetning:

Excipient Ingredients: magnesium stearate; hyprolose; pregelatinised starch; microcrystalline cellulose; sunset yellow FCF aluminium lake; quinoline yellow aluminium lake

Administreringsrute:

Oral

Enheter i pakken:

200

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Levothyroxine sodium is indicated for the management of demonstrated thyroid hormone deficiency.,Levothyroxine sodium is also used to suppress thyrotropin (TSH) for the management of TSH-responsive tumours of the thyroid.

Produkt oppsummering:

Visual Identification: Yellow coloured, round shaped, flat faced beveled edge, tab debossed with A & 9 on either side of break line on one side & plain on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Autorisasjon status:

Registered

Autorisasjon dato:

2021-07-29

Informasjon til brukeren

LEVOXINE v1.1
1
LEVOXINE
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING LEVOXINE?
LEVOXINE contains the active ingredient levothyroxine sodium. LEVOXINE
is used to treat thyroid hormone deficiency also
known as Hypothyroidism and TSH‐responsive tumours (certain tumours
of the thyroid gland) of the thyroid.
For more information, see Section 1. Why am I using LEVOXINE? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE LEVOXINE?
Do not use if you have ever had an allergic reaction to LEVOXINE or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
LEVOXINE? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with LEVOXINE and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I TAKE LEVOXINE?
•
The usual starting dose for adults is 50 to 100 micrograms daily. The
dose may be increased over time. The average adult
maintenance dose is 100 to 200 micrograms. Lower doses are used in the
elderly and children. Your doctor will calculate
the dose required for you.
More instructions can be found in Section 4. How do I use LEVOXINE? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LEVOXINE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
LEVOXINE.
•
Immediately stop taking LEVOXINE if a skin rash or other allergic
reaction occurs.
THINGS YOU
SHOULD NOT DO
•
Do not give this medicine to anyone else, even if his or her symptoms
seem similar to yours.
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how LEVOXINE affects you.
•
Do not drive or ope

Preparatomtale

LEVOXINE is also used to suppress thyrotropin (TSH) for the management
of TSH-
responsive tumours of the thyroid.
LEVOXINE PI v1.0
1
AUSTRALIAN PRODUCT INFORMATION – LEVOXINE
(LEVOTHYROXINE SODIUM) TABLETS
1
NAME OF THE MEDICINE
Levothyroxine sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LEVOXINE tablets are available in four strengths and contain
levothyroxine sodium 50, 75,
100 or 200 micrograms as the active ingredient.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
50 MICROGRAM:
White to off white, round shaped, flat faced beveled edge tablets
debossed
with ‘A’ and ‘6’ on either side of break line on one side and
plain on the other.
75 MICROGRAM
: Violet coloured, round shaped, flat faced beveled edge tablets
debossed with
'A' and '7' on either side of break line on one side and plain on the
other.
100 MICROGRAM
: Yellow coloured, round shaped, flat faced beveled edge tablets
debossed
with 'A' and '9' on either side of break line on one side and plain on
the other.
200 MICROGRAM
: Pink coloured, round shaped, flat faced beveled edge tablets
debossed with
'B' and '6' on either side of break line on one side and plain on the
other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
LEVOXINE is indicated for the management of demonstrated thyroid
hormone deficiency.
WARNING:
LEVOXINE is not bioequivalent on a same-dose basis with ELTROXIN. If a
decision is made to switch a patient from ELTROXIN to LEVOXINE, then
prescribers should
have a plan for monitoring TSH. Prescribers should be aware that dose
adjustment may be
required.
Prescribers should tell their patients not to interchange LEVOXINE and
ELTROXIN unless a
decision has been made to switch products, and there is a plan for
monitoring TSH levels and
review of dose.
LEVOXINE PI v1.0
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
Thyroxine is best taken as a single daily dose first thing in the
morning. It should be taken with
water and on an empty stomach, and at least 30 minutes and preferably
60 minutes before the
intake