Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
ropinirole hydrochloride, Quantity: 0.57 mg (Equivalent: ropinirole, Qty 0.5 mg)
Arrotex Pharmaceuticals Pty Ltd
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; croscarmellose sodium; magnesium stearate; titanium dioxide; hypromellose; indigo carmine; iron oxide yellow; iron oxide red; laureth-8
Oral
28 tablets, 84 tablets
(S4) Prescription Only Medicine
REPREVE is indicated for the treatment of primary restless legs syndrome, including the reduction of associated periodic limb movement and episodes of nocturnal arousal.
Visual Identification: Pale yellow, pentagonal film-coated, 'Tiltab' tablets with bevelled edges and a raised pentagonal flattened tilt feature offset on each face. Debossed 'SB' on one side and '4891' on the other.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2004-10-05
REPREVE ® 1 REPREVE ® _Ropinirole (as hydrochloride) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you use REPREVE tablets. This leaflet answers some common questions about REPREVE tablets. 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 risks and benefits. Your doctor has weighed the expected benefits of you taking REPREVE tablets against the risks this medicine could 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 IS REPREVE USED FOR? The name of your medicine is REPREVE; it is also known as ropinirole. REPREVE 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 a naturally occurring body chemical: dopamine. REPREVE belongs to a group of medicines called non-ergoline, dopamine agonists. REPREVE 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. Your doctor may have prescribed REPREVE for another reason. REPREVE tablets are not addictive. BEFORE YOU TAKE REPREVE _DO NOT TAKE IF: _ You must not take REPREVE if: • you have ever had an allergic reaction to ropinirole or any of the ingredients listed toward the end of this leaflet. (See "Ingredients") • you are pregnant or intend to become pregnant • you are breastfeeding or wish to breastfeed • the expir Läs hela dokumentet
1 AUSTRALIAN PRODUCT INFORMATION REPREVE ® (ROPINIROLE HYDROCHLORIDE) TABLETS 1 NAME OF THE MEDICINE Ropinirole hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Repreve tablets come in four strengths and contain either 0.25 mg, 0.5 mg, 1 mg or 2 mg of ropinirole (as hydrochloride). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM _REPREVE 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). _REPREVE 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)._ _ _REPREVE 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). _REPREVE 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 a response can be anticipated after one Läs hela dokumentet