Risedronate Cipla
LAKEMEDELSVERKET
MEDICAL PRODUCTS AGENCY
Summary Public Assessment Report
Risedronate Cipla (risedronate)
SE/H/1369/01/DC
Postadress/Postal address: P.O. Box 26, SE-751 03 Uppsala, SWEDEN Besoksadress/Visiting address: Dag Hammarskjolds vag 42, Uppsala Telefon/Phone: +46 (0)18 17 46 00 Fax: +46 (0)18 54 85 66 Internet: www.lakemedelsverket.se E-mail: registrator@mpa.se
Summary Public Assessment Report
Risedronate Cipla (risedronate)
Film-coated tablet, 35 mg
This is a summary of the public assessment report (PAR) for Risedronate Cipla. It explains how Risedronate Cipla was assessed and its authorisation recommended as well as its conditions of use. It is not intended to provide practical advice on how to use Risedronate Cipla.
For practical information about using Risedronate Cipla, patients should read the package leaflet or contact their doctor or pharmacist.
What is Risedronate Cipla and what is it used for?
Risedronate Cipla is a ‘generic medicine’. This means that Risedronate Cipla is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Optinate Septimum.
Risedronate Cipla is used for treatment of osteoporosis in postmenopausal women, even if osteoporosis is severe. It reduces the risk of spinal and hip fractures.
Risedronate Cipla is used for treatment of osteporosis in men with high risk of fractures.
How does Risedronate Cipla work?
Risedronate Cipla 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.
How is Risedronate Cipla used?
The pharmaceutical form of Risedronate Cipla is film-coated tablet for oral use.
Please read section 3 of the package leaflet for detailed information on dosing recommendations, the route of administration, and the duration of treatment.
The medicine can only be obtained with a prescription.
What benefits of Risedronate Cipla have been shown in studies?
Because Risedronate Cipla is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Optinate Septimum. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
What are the possible side effects of Risedronate Cipla?
Because Risedronate Cipla is a generic medicine and is bioequivalent to the reference medicine, its benefits and possible side effects are taken as being the same as the reference medicine. For the full list of restrictions, see the package leaflet.
Why is Risedronate Cipla approved?
It was concluded that, in accordance with EU requirements, Risedronate Cipla has been shown to have comparable quality and to be bioequivalent to the reference medicine Optinate Septimum. Therefore, the Medical Products Agency in Sweden decided that, as for Optinate Septimum, the benefits are greater than its risks and recommended that it can be approved for use.
What measures are being taken to ensure the safe and effective use of Risedronate Cipla?
A risk management plan has been developed to ensure that Risedronate Cipla is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Risedronate Cipla, including the appropriate precautions to be followed by healthcare professionals and patients.
Known side effects are continuously monitored. Furthermore new safety signals reported by patients/healthcare professionals will be monitored/reviewed continuously as well.
Other information about Risedronate Cipla
The marketing authorisation for Risedronate Cipla was granted on 2014-12-17 in Sweden.
The full PAR for Risedronate Cipla can be found on the following website: http://mri.medagencies.org/Human/. For more information about treatment with Risedronate Cipla, please read the package leaflet or contact your doctor or pharmacist.
This summary was last updated in 2014-12.