Alendronate/Colecalciferol Teva 70 mg/2800 IU tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Vitamin d3; Alendronic acid

제공처:

Teva Pharma B.V.

ATC 코드:

M05BB; M05BB03

INN (국제 이름):

Vitamin d3; Alendronic acid

복용량:

70 mg/2800 international unit(s)

약제 형태:

Tablet

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 영역:

Bisphosphonates, combinations; alendronic acid and colecalciferol

승인 상태:

Marketed

승인 날짜:

2014-04-16

환자 정보 전단

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALENDRONATE/COLECALCIFEROL TEVA 70 MG/2800 IU TABLETS
ALENDRONATE/COLECALCIFEROL TEVA 70 MG/5600 IU TABLETS
alendronic acid/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 or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
-
It is particularly important to understand the information in section
3. How to take
Alendronate/Colecalciferol Teva, before taking this medicine.
WHAT IS IN THIS LEAFLET
1.
What
Alendronate/Colecalciferol Teva is and what it is used for
2.
What you need to know before you take Alendronate/Colecalciferol Teva
3.
How to take Alendronate/Colecalciferol Teva
4.
Possible side effects
5.
How to store Alendronate/Colecalciferol Teva
6.
Contents of the pack and other information
1.
WHAT ALENDRONATE/COLECALCIFEROL TEVA IS AND WHAT IT IS USED FOR
WHAT IS ALENDRONATE/COLECALCIFEROL TEVA?
Alendronate/Colecalciferol Teva is a tablet containing the two active
substances, alendronic acid (as
alendronate sodium monohydrate) and colecalciferol (known as vitamin D
3
).
WHAT IS ALENDRONATE/COLECALCIFEROL TEVA USED FOR?
Your doctor has prescribed Alendronate/Colecalciferol Teva to treat
your osteoporosis and because you are
at risk of vitamin D insufficiency. Alendronate/Colecalciferol Teva
reduces the risk of spine and hip
fractures in women after menopause.
WHAT IS ALENDRONIC ACID?
Alendronic acid belongs to a group of non-hormonal medicines called
bisphosphonates.
Alendronic acid prevents bone loss (osteoporosis), and helps to
rebuild bone. It reduces the risk of spine and
hip fractures.

제품 특성 요약

Health Products Regulatory Authority
03 December 2020
CRN009XPT
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alendronate/Colecalciferol Teva 70 mg/2800 IU tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 70 mg alendronic acid as alendronate sodium
monohydrate, and 2800 IU (70 micrograms) colecalciferol
(vitamin D
3
).
Excipient with known effect: Each tablet contains 5.6 mg sucrose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to off white, capsule shaped tablet, approximately 12.7mm x
6.4mm, debossed with “A70” on one side and “2800” on the
other side of the tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Alendronate/Colecalciferol Teva is indicated for the treatment of
postmenopausal osteoporosis in women at risk of vitamin D
insufficiency. Alendronate/Colecalciferol Teva reduces the risk of
vertebral and hip fractures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one Alendronate/Colecalciferol Teva tablet
once weekly.
Patients should be instructed that if they miss a dose of
Alendronate/Colecalciferol Teva they should take one tablet on the
morning after they remember. They should not take two tablets on the
same day but should return to taking one tablet once a
week, as originally scheduled on their chosen day.
Due to the nature of the disease process in osteoporosis,
Alendronate/Colecalciferol Teva is intended for long-term use. The
optimal duration of bisphosphonate treatment for osteoporosis has not
been established. The need for continued treatment
should be re-evaluated periodically based on the benefits and
potential risks of Alendronate/Colecalciferol Teva on an
individual patient basis, particularly after 5 or more years of use.
Patients should receive supplemental calcium if intake from diet is
inadequate (see section 4.4). Additional supplementation
with vitamin D should be considered on an individual basis taking into
account any vitamin D intake from vit