País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
levothyroxine sodium, Quantity: 0.2 mg
Southern Cross Pharma Pty Ltd
Tablet, uncoated
Excipient Ingredients: maize starch; Gelatin; croscarmellose sodium; magnesium stearate; lactose monohydrate
Oral
200 tablets
(S4) Prescription Only Medicine
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.
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
Registered
2022-12-23
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 Llegiu el document complet
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 Llegiu el document complet