LEVOTHYROXINE LUP levothyroxine sodium 200 microgram un-coated tablet blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

levothyroxine sodium, Quantity: 0.2 mg

Beschikbaar vanaf:

Southern Cross Pharma Pty Ltd

farmaceutische vorm:

Tablet, uncoated

Samenstelling:

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

Toedieningsweg:

Oral

Eenheden in pakket:

200 tablets

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

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 samenvatting:

Visual Identification: Round and white tablets with debossed on one side with 200 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

Autorisatie-status:

Registered

Autorisatie datum:

2022-12-23

Bijsluiter

Levothyroxine Lup v1
1
LEVOTHYROXINE LUP
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 LEVOTHYROXINE LUP?
Levothyroxine Lup contains the active ingredient levothyroxine sodium.
Levothyroxine Lup 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 Levothyroxine Lup?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LEVOTHYROXINE LUP?
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
Levothyroxine Lup? 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 LEVOTHYROXINE LUP?
•
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
Levothyroxine Lup? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LEVOTHYROXINE LUP?
THINGS YOU
SHOULD DO
•
Remind any doctors, dentists and pharmacists treating you that you are
taking Levothyroxine Lup.
•
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 Levothyroxine Lup requires adjustment.
•
If you plan to have surgery, tell your doctor or dentist that you are
taking Levothyroxine Lup.
•
If you

Productkenmerken

Levothyroxine Lup v1
Page 1 of 12
(levothyroxine as sodium) tablet
AUSTRALIAN PRODUCT INFORMATION – LEVOTHYROXINE LUP
(LEVOTHYROXINE SODIUM) TABLETS
1
NAME OF THE MEDICINE
Levothyroxine sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LEVOTHYROXINE LUP 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
LEVOTHYROXINE LUP 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.
LEVOTHYROXINE LUP 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.
LEVOTHYROXINE LUP 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.
LEVOTHYROXINE LUP 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.
LEVOTHYROXINE LUP 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.
LEVOTHYROXINE LUP 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.
LEVOTHYROXINE LUP 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: LEVOTHYROXINE LUP is not bioequivalent on a same-dose basis
with ELTROXIN. If a
decision is made to switch a patient from ELTROXIN to LEVOTHYROXINE
LUP, 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 LEVOTHYROXINE LUP and ELTROXIN
unless a decision has
been made to