Ridate Plus Ca & D 35 mg Film-Coated Tablets + 1000 mg/880 IU Effervescent Tablets

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Calcium carbonate; Cholecalciferol; Risedronate sodium

Доступна с:

Rowex Ltd

код АТС:

M05BB; M05BB04

ИНН (Международная Имя):

Calcium carbonate; Cholecalciferol; Risedronate sodium

дозировка:

35 milligram(s)

Фармацевтическая форма:

Effervescent tablet + film-coated tablet

Тип рецепта:

Product subject to prescription which may be renewed (B)

Терапевтические области:

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

Статус Авторизация:

Not marketed

Дата Авторизация:

2012-03-30

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RIDATE PLUS CA & D 35 MG FILM-COATED TABLETS
+ 1000 MG / 880 IU EFFERVESCENT TABLETS
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 Ridate Plus Ca & D is and what it is used for
2.
What you need to know before you take Ridate Plus Ca & D
3.
How to take Ridate Plus Ca & D
4.
Possible side effects
5.
How to store Ridate Plus Ca & D
6.
Contents of the pack and other information
1. WHAT RIDATE PLUS CA & D IS AND WHAT IT IS USED FOR
Ridate Plus Ca & D is used to
TREAT OSTEOPOROSIS,
even if severe
,
in women after menopause who also
need daily calcium and vitamin D
3
supplementation. This combination medicine reduces the risk of
spinal and hip fractures.
A
)
RISEDRONATE
tablets contains 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 oste

Характеристики продукта

Health Products Regulatory Authority
08 March 2021
CRN009ZJ5
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ridate Plus Ca & D 35 mg Film-Coated Tablets + 1000 mg/880 IU
Effervescent Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 35 mg of risedronate sodium
(equivalent to 32.5 mg risedronic acid).
Each effervescent tablet contains 2500 mg of calcium carbonate
(equivalent to 1000 mg calcium) and 22 micrograms (880 IU)
colecalciferol (vitamin D3).
Excipients with known effect
Each film-coated tablet contains 114 mg of lactose.
Each effervescent tablet contains 376.62 mg of lactose, 4.18 mmol
(96.12 mg) of sodium,3.68 mg of sucrose, 0.73 mg of soya
oil, and less than 10 ppm sulphites (part of orange juice flavour).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
_Film-coated tablet._
Oval biconvex orange film-coated tablet, encoded 35 on one side.
_Effervescent tablets._
Cylindrical, white or off-white coloured biplanar effervescent tablets
with bevel-edges on both sides.
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).
Ridate Plus Ca & D 35 mg Film-Coated Tablets + 1000 mg/880 IU
Effervescent Tablets is only intended for use in assessed
patients for whom the amount of calcium and vitamin D3 included is
considered to provide adequate supplementation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Ridate Plus is a weekly therapy of 1 Risedronate 35 mg film-coated
tablet and 6 calcium/vitamin D3 effervescent tablets.
RISEDRONATE
Posology
The recommended dose in adults is 1 Risedronate 35 mg tablet on the
first day followed on the next day by 1 calcium/vitamin
D3 effervescent tablet daily for 6 days. This 7-day sequence is then
repeated each week starting with Risedronate 35 mg tablet.
Method of administration
The Risedronate 35 mg film-co