ACTONEL PLUS CA & D

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

RISEDRONATE SODIUM ; CALCIUM CARBONATE; COLECALCIFEROL

Disponible desde:

Warner Chilcott UK Limited

Código ATC:

M05BB04

Designación común internacional (DCI):

RISEDRONATE SODIUM ; CALCIUM CARBONATE; COLECALCIFEROL

Dosis:

35 + 1000/880 IU Milligram

formulario farmacéutico:

Granules Effervescent

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

risedronic acid, calcium and colecalciferol, sequential

Estado de Autorización:

Marketed

Fecha de autorización:

2007-10-12

Información para el usuario

V319G
CRN2172432
29
th
February 2016
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACTONEL
® PLUS CA & D
35 mg film-coated tablets
+ 1000 mg / 880 IU effervescent granules
Risedronate sodium + calcium / colecalciferol
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 Plus Ca & D is and what it is used for
2.
What you need to know before you take Actonel Plus Ca & D
3.
How to take Actonel Plus Ca & D
4.
Possible side effects
5.
How to store Actonel Plus Ca & D
6.
Contents of the pack and other information
1.
WHAT ACTONEL PLUS CA & D IS AND WHAT IT IS USED FOR
WHAT ACTONEL PLUS CA & D IS
A combination medicine packed as weekly units each containing 1 tablet
of Actonel and 6 sachets of
calcium/vitamin D
3
.
⃝
_Actonel tablets _
Actonel 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 ha

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actonel Plus Ca & D 35mg film-coated tablets + 1000mg/880 IU
Effervescent Granules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film
-
coated tablet contains 35 mg risedronate sodium, (equivalent to 32.5
mg risedronic acid).
Each sachet of effervescent granules contains 1000 mg calcium (as 2500
mg calcium carbonate) and 22 micrograms
(880 IU) colecalciferol (vitamin D ).
Excipients with known effect:
Each film
-
coated tablet contains 126.0 mg of lactose monohydrate (equivalent to
119.7 mg lactose).
Each sachet of effervescent granules contains potassium (163 mg),
sucrose (3.6 mg), soya
-
bean oil (0.7 mg) and
sorbitol (100 mg).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
_Film-coated tablet._
Oval, light-orange, film-coated tablet with RSN on one side and 35 mg
on the other.
_Effervescent granules_
White effervescent granules.
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).
Actonel Plus Ca & D is only intended for use in assessed patients for
whom the amount of calcium and vitamin D
included is considered to provide adequate supplementation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
A weekly unit of Actonel Plus Ca & D consists of 1 Actonel 35 mg film
-
coated tablet and 6 calcium/vitamin D
sachets in a box.
Posology
The recommended dose in adults is 1 Actonel 35 mg tablet on the first
day followed on the next day by 1
calcium/vitamin D sachet daily for 6 days. This 7
-
day sequence is then repeated each week starting with Actonel
35 mg tablet.
Special populations
Elderly
No dose adjustment is necessary since bioavailability, distribution
and elimination were similar in elderly (>60 years of
age) compared to younger subjects. This has also been shown in the
very elderly, 75 years old and above in
postmenopausal population.