Alendronate/Colecalciferol Rowex 70 mg/5600 IU tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Alendronic acid; Vitamin D3

Tilgjengelig fra:

Rowex Ltd

ATC-kode:

M05BB; M05BB03

INN (International Name):

Alendronic acid; Vitamin D3

Dosering :

70 mg/5600 international unit(s)

Legemiddelform:

Tablet

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Bisphosphonates, combinations; alendronic acid and colecalciferol

Autorisasjon status:

Marketed

Autorisasjon dato:

2016-09-16

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALENDRONATE / COLECALCIFEROL ROWEX 70MG / 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. 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 Rowex”, before taking this medicine.
WHAT IS IN THIS LEAFLET
1. What Alendronate / Colecalciferol Rowex is and what it is used for
2. What you need to know before you take Alendronate / Colecalciferol
Rowex
3. How to take Alendronate / Colecalciferol Rowex
4. Possible side effects
5
How to store Alendronate / Colecalciferol Rowex
6. Contents of the pack and other information
1. WHAT ALENDRONATE / COLECALCIFEROL ROWEX IS AND WHAT IT IS USED FOR
WHAT IS ALENDRONATE / COLECALCIFEROL ROWEX?
Alendronate / Colecalciferol Rowex is a tablet containing the two
active substances, alendronic acid
(commonly called alendronate) and colecalciferol known as vitamin D
3
.
WHAT IS ALENDRONATE?
Alendronate belongs to a group of non-hormonal medicines called
bisphosphonates. Alendronate
prevents the loss of bone that occurs in women after they have been
through the menopause, and helps
to rebuild bone. It reduces the risk of spine and hip fractures.
WHAT IS VITAMIN D?
Vitamin D is an essential nutrient, required for calcium absorption
and healthy bones. The body can
only absorb calcium properly from our food if it has enough vitamin D.
Very few foods contain
vitamin D. The main source is through exposure to summer sunlight,
which makes vitamin

Preparatomtale

Health Products Regulatory Authority
10 October 2019
CRN00911Z
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alendronate/Colecalciferol Rowex 70 mg/5600 IU tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 70 mg of alendronic acid (as sodium alendronate
trihydrate) and
140 micrograms colecalciferol (equivalent to 5600 IU vitamin D3).
Excipient with known effect:
Each tablet contains 9.8 mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_ _
White to almost white, oval, debossed with 714 on one side.
Approximately 12.6mm x 6.6mm x 5.2mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Alendronate / Colecalciferol Rowex is indicated for the treatment of
postmenopausal osteoporosis in women who are not
receiving vitamin D supplementation and are at risk of vitamin D
insufficiency. Alendronate / Colecalciferol Rowex reduces the
risk of vertebral and hip fractures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one tablet once weekly.
Patients should be instructed that if they miss a dose of Alendronate
/ Colecalciferol Rowex 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 Rowex 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 Rowex
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). The
equivalence of intake of 5,600 IU of vitamin D
3
weekly in Alendronate / Colecalciferol Rowex to daily dosing of
vitamin D 800 IU
h