Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
ropinirole hydrochloride, Quantity: 2.28 mg (Equivalent: ropinirole, Qty 2 mg)
Arrotex Pharmaceuticals Pty Ltd
Ropinirole hydrochloride
Tablet, film coated
Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black
Oral
28 tablets
(S4) Prescription Only Medicine
Treatment of primary restless legs syndrome, including the reduction of associated periodic limb movement and episodes of nocturnal arousal.
Visual Identification: Pink, pentagon shaped tablet with 'RI' over '2' on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2008-08-04
APPESE- Consumer Medicine Information Page 1 of 4 APPESE ropinirole (as hydrochloride) CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about APPESE. It does not contain all of 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 APPESE against the benefits they expect it will have for you. TALK TO YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE. Keep this leaflet with your medicine. You may need to read it again. WHAT APPESE IS USED FOR APPESE is used to treat restless legs syndrome. Restless legs syndrome is a condition in which a sense of uneasiness, restlessness, and itching often accompanied by twitching and pain is felt in the legs and sometimes arms when sitting or lying down, especially in bed at night. The only relief is walking or moving the affected limbs, which often leads to problems sleeping at night time. Restless legs syndrome is thought to be due to a deficiency in the body of dopamine, a naturally occurring body chemical. APPESE belongs to a group of medicines called non-ergoline, dopamine agonists. APPESE works by having a similar effect on the body as dopamine, therefore it makes up for the dopamine shortage in restless legs syndrome. This in turn relieves the discomfort and reduces the involuntary limb movements that disrupt night time sleep. APPESE is not recommended for use in children or adolescents (under the age of 18), as there have been no studies of its effects in this age group). This medicine is available only with a doctor's prescription. There is no evidence that it is addictive. BEFORE YOU TAKE IT WHEN YOU MUST NOT TAKE IT DO NOT TAKE APPESE IF YOU ARE ALLERGIC TO MEDICINES CONTAINING ROPINIROLE OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. DO NOT TAKE IT IF YOU ARE PREGNANT OR INTEND TO BECOME PREGNANT. It may affect your developing baby if you take it du Perskaitykite visą dokumentą
1 AUSTRALIAN PRODUCT INFORMATION APPESE (ROPINIROLE HYDROCHLORIDE) TABLETS 1 NAME OF THE MEDICINE Ropinirole hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Appese tablets come in four strengths and contain either 0.25 mg, 0.5 mg, 1 mg or 2 mg of ropinirole (as hydrochloride). Excipients of known effect: Lactose monohydrate For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM _APPESE 0.25*_ White to off-white, pentagon shaped tablet with ‘RI’ over ‘25’ on one side and plain on the other side. Each tablet contains 0.25mg ropinirole (as hydrochloride). _APPESE 0.5 _ Yellow, pentagon shaped tablet with ‘RI’ over ‘50’ on one side and plain on the other side. Each tablet contains 0.5mg ropinirole (as hydrochloride)._ _ _APPESE 1* _ Green, pentagon shaped tablet with ‘RI’ over ‘1’ on one side and plain on the other side. Each tablet contains 1mg ropinirole (as hydrochloride). _APPESE 2 _ Pink, pentagon shaped tablet with ‘RI’ over ‘2’ on one side and plain on the other side. Each tablet contains 2mg ropinirole (as hydrochloride). *Not currently marketed 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Treatment of primary restless legs syndrome, including the reduction of associated periodic limb movement and episodes of nocturnal arousal. 4.2 D OSE AND METHOD OF ADMINISTRATION Individual dose titration against efficacy and tolerability is recommended. Ropinirole should be taken once-daily before bedtime, however the dose can be taken up to three hours before retiring. _TREATMENT INITIATION (WEEK 1) _ The recommended initial dose is 0.25 mg once daily for two days. If this dose is well tolerated the dose may be increased to 0.5 mg once daily for the remainder of week 1. 2 _THERAPEUTIC REGIMEN (WEEK 2 ONWARDS) _ Following treatment initiation, the daily dose can be increased according to the regimen shown in Table 1 until optimal therapeutic response is achieved. Table 1 WEEK DOSE (MG)/ONCE DAILY 2 3 4 5 6 7 1 1.5 2 2.5 3 4 First signs of Perskaitykite visą dokumentą