Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
levothyroxine sodium, Quantity: 200 microgram
Accord Healthcare Pty Ltd
Tablet, uncoated
Excipient Ingredients: light magnesium oxide; sodium starch glycollate; sodium stearylfumarate; microcrystalline cellulose; allura red AC aluminium lake
Oral
200, 90
(S4) Prescription Only Medicine
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.
Visual Identification: Round, pink coloured, uncoated tablets, with a break line on both sides. Debossed with "P" and "11" 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
Registered
2022-07-25
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. Przeczytaj cały dokument
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 Przeczytaj cały dokument