Actonel Combi 35mg + 500mg film-coated tablets

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Calcium carbonate; Risedronate sodium

Mevcut itibaren:

Teva NI Limited

ATC kodu:

M05BB; M05BB04

INN (International Adı):

Calcium carbonate; Risedronate sodium

Doz:

35/500 milligram(s)

Farmasötik formu:

Film-coated tablet

Reçete türü:

Product subject to prescription which may be renewed (B)

Terapötik alanı:

Bisphosphonates, combinations; risedronic acid, calcium and colecalciferol, sequential

Yetkilendirme durumu:

Marketed

Yetkilendirme tarihi:

2005-03-18

Bilgilendirme broşürü

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Actonel Combi 35 mg + 500 mg film-coated tablets
risedronate sodium + 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.

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 Combi is and what it is used for
2.
What you need to know before you take Actonel Combi
3.
How to take Actonel Combi
4.
Possible side effects
5.
How to store Actonel Combi
6.
Contents of the pack and other information
1.
WHAT ACTONEL COMBI IS AND WHAT IT IS USED FOR
WHAT ACTONEL COMBI IS
A combination medicine packed as weekly units each containing 1 tablet
of Actonel (light-orange
tablet) and 6 tablets of calcium (blue tablets).
⃝
_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 have no symptoms and you may not
even have known that
you had it.

_Calcium tablets _
The t

Ürün özellikleri

Health Products Regulatory Authority
11 October 2018
CRN008J0R
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actonel Combi 35mg + 500mg film-coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Light-orange tablets:
Each film-coated tablet contains 35 mg risedronate sodium, which is
equivalent to
32.5 mg risedronic acid.
Blue tablets:
Each film-coated tablet contains 1250 mg calcium carbonate, which is
equivalent to
500 mg elemental calcium.
Excipient with known effect:
Each light-orange film-coated tablet contains 126.0 mg lactose
monohydrate
(equivalent to 119.7 mg lactose).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Risedronate sodium tablet_:
Oval, light-orange, film-coated tablet with RSN on one side and 35 mg
on the other.
_Calcium carbonate tablet_:
Capsule-shaped, blue, film-coated tablet with NE 2 on both sides.
Health Products Regulatory Authority
11 October 2018
CRN008J0R
Page 2 of 16
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Actonel Combi is a two component therapy consisting of 7 tablets in a
blister, 1 Actonel
35 mg film‑coated tablet (light‑orange tablet) and 6 calcium 500
mg film‑coated tablets
(blue tablets). Actonel Combi 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 be considered if the dietary
intake is inadequate.
Posology
The recommended dose in adults is 1 Actonel 35 mg tablet on the first
day followed
beginning on the next day by 1 calcium 500 mg tablet daily for 6 days.
This 7 day sequence
is then repeated each week.
Special populations
_Elderly_
Since the target population is postmenopausal women, a specific dosage
instruction for the
elderl