Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Risedronate sodium
Warner Chilcott UK Ltd
M05BA07
Risedronate sodium
30mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06060200; GTIN: 04015600005177
Risedronic Acid (Actonel) 30mg PIL - UK (Warner Chilcott) item no: AAAI5654 print proof no: 02 origination date: 01-12-2015 originated by: NM revision date: 02-12-2015 revised by: NM dimensions: 210 x 320 pharmacode: colours/plates: approved for print/date Non Printing Colours 1. Black 2. 3. 4. 5. 6. 1. 2. 3. date sent: 01-12-2015 supplier: Warner Chilcott approved: 02-12-2015 min pt size: 9 pts TECHNICAL APPROVAL PACKAGE LEAFLET: INFORMATION FOR THE PATIENT READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Actonel is and what it is used for 2. What you need to know before you take Actonel 3. How to take Actonel 4. Possible side effects 5. How to store Actonel 6. Contents of the pack and other information 1. WHAT ACTONEL IS AND WHAT IT IS USED FOR WHAT ACTONEL IS Actonel belongs to a group of non-hormonal medicines called bisphosphonates which are used to treat bone diseases. It works directly on your bones to make them stronger and therefore less likely to break. Bone is a living tissue. Old bone is constantly removed from your skeleton and replaced with new bone. Paget’s disease occurs when this process, called remodeling, happens too quickly and in a disordered way. The new bone that is produced is weaker than normal and the affected bones may become enlarged, painful and may fracture. Actonel changes the bone remodeling process back to normal, returning the strength to the bone structure. WHAT ACTONEL IS USED FOR Treatment of Paget’s disease of the bone (osteitis deformans). 2. WHA Prečítajte si celý dokument
OBJECT 1 ACTONEL 30 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 03-Mar-2016 | Warner Chilcott UK Limited (a subsidiary of Actavis PLC) 1. Name of the medicinal product Actonel 30 mg film-coated tablets. 2. Qualitative and quantitative composition Each film-coated tablet contains 30 mg risedronate sodium (equivalent to 27.8 mg risedronic acid). Excipient with known effect Each film-coated tablet contains 131.0 mg lactose monohydrate (equivalent to 124.45 mg lactose). For a full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablets. Oval white film-coated tablet with RSN on one side and 30 mg on the other. 4. Clinical particulars 4.1 Therapeutic indications Treatment of Paget's disease of the bone. 4.2 Posology and method of administration POSOLOGY The recommended daily dose in adults is one 30 mg tablet orally for 2 months. If re-treatment is considered necessary (at least two months post-treatment), a new treatment with the same dose and duration of therapy could be given. SPECIAL POPULATIONS _Elderly: _ No dosage adjustment is necessary since bioavailability, distribution and elimination were similar in elderly (>60 years of age) compared to younger subjects. _Renal Impairment: _ No dosage adjustment is required for those patients with mild to moderate renal impairment. The use of risedronate sodium is contraindicated in patients with severe renal impairment (creatinine clearance lower than 30 ml/min) (see sections 4.3 and 5.2). _Paediatric population: _ Risedronate sodium is not recommended for use in children below age 18 due to insufficient data on safety and efficacy (also see section 5.1). METHOD OF ADMINISTRATION The absorption of Actonel is affected by food, thus to ensure adequate absorption patients should take Actonel: • Before breakfast: At least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day. In the particular instance that before breakfast dosing is not practical, Actonel can be taken between me Prečítajte si celý dokument