LEVOTHOX levothyroxine sodium 50 microgram tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levothyroxine sodium, Quantity: 50 microgram

Available from:

Accord Healthcare Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: sodium starch glycollate; sodium stearylfumarate; microcrystalline cellulose; light magnesium oxide

Administration route:

Oral

Units in package:

90, 200

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: Round, white coloured, uncoated tablets, with a break line on both sides. Debossed with "P" and "2" on one side and plain on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2022-07-25

Patient Information leaflet

LEVOTHOX CMI v1 07.22
1
LEVOTHOX
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about taking this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING LEVOTHOX?
LEVOTHOX contains the active ingredient Levothyroxine sodium. LEVOTHOX
is used to treat thyroid hormone deficiency also
known as Hypothyroidism and TSH-responsive tumours of the thyroid.
For more information, see Section 1. Why am I taking LEVOTHOX? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE LEVOTHOX?
Do not take if you have ever had an allergic reaction to LEVOTHOX 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 take
LEVOTHOX? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with LEVOTHOX 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 LEVOTHOX?
•
Your doctor will calculate the right dose for you
More instructions can be found in Section 4. How do I take LEVOTHOX?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING LEVOTHOX?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
LEVOTHOX.
•
Do not switch or interchange with other brands unless advised by your
doctor.
•
Use it exactly as directed or as your doctor has prescribed
THINGS YOU
SHOULD NOT DO
•
Do not stop taking this medicine suddenly
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools where
alertness is required, until you know
how LEVOTHOX affects you.
DRINKING
ALCOHOL
•
Tell your doctor if you drink alcohol
LOOKING AFTER
YOUR MEDICINE
•
Store the medicine in a cool dry place where the temperature stays
below 25 °C. Protect from light.
For more information, see Section 5.

Summary of Product characteristics

LEVOTHOX - Product Information v 1 June 22
Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION – LEVOTHOX (LEVOTHYROXINE
SODIUM) TABLETS
LEVOTHOX is bioequivalent to ELTROXIN.
LEVOTHOX is not bioequivalent on a same-dose basis with
EUTROXSIG/OROXINE. If a decision is
made to switch a patient from EUTROXSIG/OROXINE to LEVOTHOX, 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 LEVOTHOX and
EUTROXSIG/OROXINE unless
a decision has been made to switch products, and there is a plan for
monitoring TSH levels and
review of dose.
1
NAME OF THE MEDICINE
Levothyroxine sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each LEVOTHOX tablet contains levothyroxine sodium.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Oral Tablets
LEVOTHOX 25 microgram: Round, orange coloured, uncoated tablets, with
a break line on both
sides. Debossed with "P" and "1" on one side and plain on the other
side.
LEVOTHOX 50 microgram: Round, white coloured, uncoated tablets, with a
break line on both sides.
Debossed with "P" and "2" on one side and plain on the other side.
LEVOTHOX 75 microgram: Round, violet coloured, uncoated tablets, with
a break line on both sides.
Debossed with "P" and "3" on one side and plain on the other side.
LEVOTHOX 88 microgram: Round, olive coloured, uncoated tablets, with a
break line on both sides.
Debossed with "P" and "4" on one side and plain on the other side.
LEVOTHOX 100 microgram: Round shaped, yellow coloured, uncoated
tablets, with a break line on
both sides. Debossed with "P" and "14" on one side and plain on the
other side.
LEVOTHOX 112 microgram: Round, rose coloured, uncoated tablets, with a
break line on both sides.
Debossed with "P" and "6" on one side and plain on the other side.
LEVOTHOX 125 microgram: Round, brown coloured, uncoated tablets, with
a break line on both
sides. Debossed with "P" and "7" on one side and plain on the othe