RISEDRONATE/CALCIUM MYLAN

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

CALCIUM ; RISEDRONATE SODIUM

Verfügbar ab:

McDermott Laboratories Ltd t/a Gerard Laboratories

ATC-Code:

M05BB02

INN (Internationale Bezeichnung):

CALCIUM ; RISEDRONATE SODIUM

Dosierung:

35/500 Milligram

Darreichungsform:

Film Coated Tablet

Verschreibungstyp:

Product subject to prescription which may be renewed (B)

Therapiebereich:

risedronic acid and calcium, sequential

Berechtigungsstatus:

Not Marketed

Berechtigungsdatum:

2012-10-26

Gebrauchsinformation

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RISEDRONATE/CALCIUM MYLAN 35 MG / 500 MG FILM-COATED TABLETS
(RISEDRONATE SODIUM AND CALCIUM)
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 or
nurse.
-
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 or
nurse. This includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Risedronate/Calcium Mylan is and what it is used for
2.
What you need to know before you take Risedronate/Calcium Mylan
3.
How to take Risedronate/Calcium Mylan
4.
Possible side effects
5.
How to store Risedronate/Calcium Mylan
6.
Contents of the pack and other information
1.
WHAT RISEDRONATE/CALCIUM MYLAN IS AND WHAT IT IS USED FOR
A combination medicine packed as weekly units each containing 1 tablet
of Risedronate Sodium (light
orange tablet) and 6 tablets of Calcium (light lavender tablets).
RISEDRONATE SODIUM TABLETS
Risedronate Sodium tablets contain risedronate sodium which belongs to
a group of non-hormonal medicines
called bisphosphonates. These medicines 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.
Postmenopausal osteoporosis is a condition occurring in women after
the menopause where the bones
become weaker, more fragile and more likely to break after a fall or
strain. The spine, hip and wrist are the
most likely bones to break, although this can happen to any bone in
your body. Osteoporosis–related
fractures can also cause back pain, height loss and a curved back.
Many patients with osteoporosis have no
symptoms and yo

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Risedronate/Calcium Mylan 35mg/500mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Risedronate/Calcium Mylan is a co-package product containing
risedronate sodium film-coated tablets, 35 mg for once
weekly dosing and calcium carbonate film-coated tablets for daily
dosing for the remaining 6 days of the week.
Each light orange film-coated tablet contains 35 mg of risedronate
sodium equivalent to 32.5 mg risedronic acid.
Each light lavender film-coated tablet contains 1250 mg calcium
carbonate equivalent to 500 mg of calcium.
Excipients with known effect:
Also contains Allura red (E129) and polydextrose (contains glucose and
sorbitol).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Risedronate Sodium:
Light orange film-coated, round, biconvex, bevelled edge tablet
debossed with ‘M’ on one side of the tablet and ‘714’
on the other side.
Calcium:
A light lavender, clear film-coated, modified oval, biconvex, bevelled
edge tablet debossed with ‘M CC5’ on one side
of the tablet and blank on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of postmenopausal osteoporosis, to reduce the risk of
vertebral fractures.
Treatment of established postmenopausal osteoporosis, to reduce the
risk of hip fractures (see section 5.1).
Risedronate/Calcium Mylan is only intended for use in assessed
patients for whom the amount of calcium included is
considered to provide adequate supplementation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
Risedronate/Calcium Mylan is a two component therapy consisting of 7
tablets in a blister,
1 Risedronate Sodium 35
mg
film-coated
tablet
(light-orange
tablet)
and
6
Calcium 500
mg
film-coated
tablets
(light
lavender
tablets). Risedronate/Calcium Mylan is intended for patients for whom
the amount of calcium included is considered to
provide adequate supplementation,
based on individual
assessment.
Supplemental
vitamin D should b