APO-LEVOTHYROXINE levothyroxine sodium 75 microgram un-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levothyroxine sodium, Quantity: 0.075 mg

Available from:

Southern Cross Pharma Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: maize starch; Gelatin; croscarmellose sodium; magnesium stearate; lactose monohydrate

Administration route:

Oral

Units in package:

200 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Indicated for the management of demonstrated thyroid hormone deficiency. And also used to suppress thyrotropin (TSH) for the management of TSH-responsive tumours of the thyroid.

Product summary:

Visual Identification: Round and white tablets with debossed on one side with 75 and scored in the shape of + sign on the other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-12-23

Patient Information leaflet

APO-Levothyroxine v1
1
APO-LEVOTHYROXINE
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 APO-LEVOTHYROXINE?
APO-Levothyroxine contains the active ingredient levothyroxine sodium.
APO-Levothyroxine is used as replacement therapy in
the treatment of thyroid hormone deficiency (hypothyroidism) or for
treatment of TSH-responsive tumours.
For more information, see Section 1. Why am I using APO-Levothyroxine?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE APO-LEVOTHYROXINE?
Do not use if you have ever had an allergic reaction to levothyroxine
sodium 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
APO-Levothyroxine? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with levothyroxine sodium 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 APO-LEVOTHYROXINE?
•
Swallow your tablets whole with a glass of water first thing in the
morning on an empty stomach.
More instructions can be found in Section 4. How do I take
APO-Levothyroxine? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING APO-LEVOTHYROXINE?
THINGS YOU
SHOULD DO
•
Remind any doctors, dentists and pharmacists treating you that you are
taking APO-Levothyroxine.
•
Use it exactly as your doctor has prescribed. Discuss with your doctor
any problems during or after
taking the medicine.
•
Visit your doctor regularly and attend all of your blood tests, so
your doctor can check your progress
and see whether your dose of APO-Levothyroxine requires adjustment.
•
If you plan to have surgery, tell your doctor or dentist that you are
taking APO-Levothyroxine.
•
If you

Summary of Product characteristics

APO-Levothyroxine v1
Page 1 of 12
(levothyroxine as sodium) tablet
AUSTRALIAN PRODUCT INFORMATION – APO-LEVOTHYROXINE
(LEVOTHYROXINE SODIUM) TABLETS
1
NAME OF THE MEDICINE
Levothyroxine sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APO-LEVOTHYROXINE tablets are available in seven strengths and contain
levothyroxine sodium 25,
50, 75, 100
, 125, 150 or 200 micrograms as the active ingredient.
They also contain sugars as lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
APO-LEVOTHYROXINE 25 µg tablets are round white tablets with debossed
on one side with “25”
and scored in the shape of “+” sign on the other side.
APO-LEVOTHYROXINE 50 µg tablets are round white tablets with debossed
on one side with “50”
and scored in the shape of “+” sign on the other side.
APO-LEVOTHYROXINE 75 µg tablets are round white tablets with debossed
on one side with “75”
and scored in the shape of “+” sign on the other side.
APO-LEVOTHYROXINE 100 µg tablets are round white tablets with
debossed on one side with “100”
and scored in the shape of “+” sign on the other side.
APO-LEVOTHYROXINE 125 µg tablets are round white tablets with
debossed on one side with “125”
and scored in the shape of “+” sign on the other side.
APO-LEVOTHYROXINE 150 µg tablets are round white tablets with
debossed on one side with “150”
and scored in the shape of “+” sign on the other side.
APO-LEVOTHYROXINE 200 µg tablets are round white tablets with
debossed on one side with “200”
and scored in the shape of “+” sign on the other side.
WARNING: APO-LEVOTHYROXINE is not bioequivalent on a same-dose basis
with ELTROXIN. If
a decision is made to switch a patient from ELTROXIN to
APO-LEVOTHYROXINE, 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 APO-LEVOTHYROXINE and ELTROXIN
unless a decision has
been made to