Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
milnacipran hydrochloride
Pierre Fabre Australia Pty Ltd
Milnacipran hydrochloride
Registered
CONSUMER MEDICINE INFORMATION Version: A02-090818 1 Supercedes: A01-1111 JONCIA ® 25, 50, 100 MG CAPSULES _Milnacipran hydrochloride _ _ _ _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Joncia ® . It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking Joncia ® against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT JONCIA ® IS USED FOR Joncia ® is used to manage fibromyalgia. Fibromyalgia is a health problem involving muscle and joint pain, tenderness, tiredness, sleep problems and a number of symptoms such as morning stiffness, mood disturbances and cognition problems. Joncia ® is a kind of medicine called a serotonin-noradrenaline reuptake inhibitor which has the ability to increase the levels of the biochemicals, serotonin and noradrenaline thereby improving the problems experienced with fibromyalgia syndrome. Your doctor may have prescribed Joncia ® for another purpose. Ask your doctor if you have any questions about why Joncia ® has been prescribed for you. This medicine is available only on a doctor’s prescription. BEFORE YOU TAKE JONCIA ® _WHEN YOU MUST NOT _ _TAKE IT _ YOU MUST NOT TAKE JONCIA ® IF YOU ARE TAKING MEDICINE TO TREAT DEPRESSION. Joncia ® is not used to treat depression, but it acts like medicines that are used to treat depression (antidepressants) and other psychiatric disorders. If you are taking medicine to treat another psychiatric disorder you should discuss this with your doctor before you take Joncia ® . If you take Joncia ® with medicines to treat depression, the potentially life-threatening condition of serotonin syndrome may occur. Serotonin syndrome may include agitation, hallucinations, coma, changes in blood pressure, fast he Soma hati kamili
Version: A03-201219 Page 1 of 21 Supersedes: A02-090818 AUSTRALIAN PRODUCT INFORMATION – JONCIA ® (MILNACIPRAN HYDROCHLORIDE) HARD CAPSULE 1 NAME OF THE MEDICINE milnacipran hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The milnacipran hydrochloride drug product is presented in an immediate-release hard capsule containing 25, 50 and 100 mg of milnacipran hydrochloride. For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM 25 mg hard capsule: yellow cap with “PFM” imprinted in black, white body with “25” imprinted in black. 50 mg hard capsule: orange cap with “PFM” imprinted in black, white body with “50” imprinted in black. 100 mg hard capsule: orange cap with “PFM” imprinted in black, yellow body with “100” imprinted in black. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Management of fibromyalgia. 4.2 DOSE AND METHOD OF ADMINISTRATION JONCIA ® capsules are for oral use. The recommended dose is 100 mg per day in two divided doses (morning and evening, preferably during meals). Based on efficacy and tolerability dosing may be titrated according to the following schedule: Day 1 – Day 2: 25 mg once daily (in the evening). Version: A03-201219 Page 2 of 21 Supersedes: A02-090818 Day 3 – Day 7: 50 mg daily in two divided doses (25 mg morning and 25 mg evening). After Day 7: 100 mg daily in two divided doses (50 mg morning and 50 mg evening). Based on individual patient response, the dose may be increased to 200 mg/day (100 mg twice daily). Doses above 200 mg/day have not been studied. After an initial 12 week period patients should be assessed and those with little or no benefit should discontinue treatment. In patients with apparent benefit, consideration should be given to periodically reassessing the need for ongoing treatment. JONCIA ® should be tapered and not abruptly discontinued after extended use (see Section 4.4 Special warnings and precautions for use: Discontinuation of treatment). USE IN PATIENTS WITH RENAL INSUFFICIENC Soma hati kamili