Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
teriflunomide
Sanofi-Aventis Australia Pty Ltd
Teriflunomide
Registered
Teriflunomide Sanofi ® 1 TERIFLUNOMIDE SANOFI® 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 TERIFLUNOMIDE SANOFI? Teriflunomide Sanofi contains the active ingredient teriflunomide. Teriflunomide Sanofi is used to treat relapsing forms of multiple sclerosis (MS). For more information, see Section 1. Why am I using Teriflunomide Sanofi? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE TERIFLUNOMIDE SANOFI? Do not use if you have ever had an allergic reaction to teriflunomide, leflunomide 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 Teriflunomide Sanofi? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Teriflunomide Sanofi 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 USE TERIFLUNOMIDE SANOFI? • Follow all directions given to you by your doctor and pharmacist carefully. The usual dose for this medicine is one 14 mg tablet per day. Swallow the tablet whole with a glass of water. More instructions can be found in Section 4. How do I use Teriflunomide Sanofi? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING TERIFLUNOMIDE SANOFI? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Teriflunomide Sanofi. • If you become pregnant while you are taking this medicine, stop taking it and tell your doctor or pharmacist immediately. THINGS YOU SHOULD NOT DO • Do not stop taking Teriflunomide Sanofi, or lower the dose, without checking with your doctor. DRIVING OR USING MACHINES • Be careful before you drive or use any machines or tools until you know how Teriflunomide San Læs hele dokumentet
. Teriflunomide Sanofi-ccdsv8-piv9-17sep20 Page 1 of 27 AUSTRALIAN PRODUCT INFORMATION – TERIFLUNOMIDE SANOFI (TERIFLUNOMIDE) 1 NAME OF THE MEDICINE Teriflunomide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Teriflunomide Sanofi tablet contains 14 mg teriflunomide. Excipient with known effect: lactose monohydrate For full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Teriflunomide is formulated as film-coated tablets for oral administration Teriflunomide Sanofi is available as pale blue to pastel blue, pentagonal film-coated tablets with “14” imprinted on one side and engraved with a logo on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Teriflunomide Sanofi is indicated for the treatment of patients with relapsing forms of Multiple Sclerosis to reduce the frequency of clinical relapses and to delay the progression of physical disability. 4.2 DOSE AND METHOD OF ADMINISTRATION The recommended dose of Teriflunomide Sanofi is 14mg orally once daily. Teriflunomide Sanofi can be taken with or without food. SPECIAL POPULATIONS _CHILDREN _ The safety and efficacy of Teriflunomide Sanofi in paediatric patients with MS below the age of 18 years has not yet been established. _ELDERLY _ Clinical studies of Teriflunomide Sanofi did not include patients over 65 years old. Teriflunomide Sanofi should be used with caution in patients aged over 65 years. . Teriflunomide Sanofi-ccdsv8-piv9-17sep20 Page 2 of 27 _HEPATIC IMPAIRMENT _ No dosage adjustment is necessary for patients with mild or moderate hepatic impairment. Teriflunomide is contraindicated in patients with severe hepatic impairment (see Section 4.4 Special Warnings and Precautions for use- Hepatic Impairment). _ _ _RENAL IMPAIRMENT _ No dosage adjustment is necessary for patients with severe renal impairment (see Section 4.4 Special Warnings and precautions for use – Renal impairment). _ _ _SWITCHING PATIENTS FROM OR TO OTHER DISEASE MODIFYING THERAPIES _ For recommendations related to switching patients from o Læs hele dokumentet