Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Risedronate sodium
A A H Pharmaceuticals Ltd
M05BA07
Risedronate sodium
30mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06060200; GTIN: 5025903009580
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 Risedronate is and what it is used for 2. What you need to know before you take Risedronate 3. How to take Risedronate 4. Possible side effects 5. How to store Risedronate 6. Contents of the pack and other information 1. WHAT RISEDRONATE IS AND WHAT IT IS USED FOR WHAT RISEDRONATE IS Risedronate 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. Risedronate changes the bone remodeling process back to normal, returning the strength to the bone structure. WHAT RISEDRONATE IS USED FOR Treatment of Paget´s disease of the bone (osteitis deformans). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RISEDRONATE DO NOT TAKE RISEDRONATE • if you are ALLERGIC to risedronate sodium or any of the other ingredients of this medicine (listed in section 6). • if your doctor has told you that you have a condition called HYPOCALCAEMIA (a low blood calcium level). • if you may be PREGNANT, are pregnant or are planning to become pregnant. • if you are BREAST-FEEDING. • if you have SEVERE Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Risedronate sodium 30 mg film-coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 30 mg risedronate sodium (amorphous), equivalent to 27.84 mg risedronic acid. Excipient: Each film-coated tablet contains 131.3 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White 8.5 mm round, biconvex, film-coated tablet. 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 18 years of age due to insufficient data on safety and efficacy (see also section 5.1). METHOD OF ADMINISTRATION The absorption of Risedronate sodium is affected by food, thus to ensure adequate absorption patients should take Risedronate sodium: • 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, Risedronate sodium can be taken between meals or in the evening at the same time everyday, with strict adherence to the following instructions, to ensure Risedronate sodium is ta Prečítajte si celý dokument