Alendronic acid/Colecalciferol Rowex 70 mg/2 800 IU tablets

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Alendronate sodium trihydrate; Colecalciferol

متاح من:

Rowex Ltd

ATC رمز:

M05BB03

INN (الاسم الدولي):

Alendronate sodium trihydrate; Colecalciferol

الشكل الصيدلاني:

Tablet

المجال العلاجي:

alendronic acid and colecalciferol

الوضع إذن:

Not marketed

تاريخ الترخيص:

2023-03-31

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALENDRONIC ACID/COLECALCIFEROL ROWEX 70 MG/2800 IU TABLETS
ALENDRONIC ACID/COLECALCIFEROL ROWEX 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. 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 before taking this medicine.
WHAT IS IN THIS LEAFLET
1.
What Alendronic acid/Colecalciferol Rowex is and what it is used for
2.
What you need to know before you take Alendronic acid/Colecalciferol
Rowex
3.
How to take Alendronic acid/Colecalciferol Rowex
4.
Possible side effects
5.
How to store Alendronic acid/Colecalciferol Rowex
6.
Contents of the pack and other information
1.
WHAT ALENDRONIC ACID/COLECALCIFEROL ROWEX IS AND WHAT IT IS USED FOR
WHAT IS ALENDRONIC ACID/COLECALCIFEROL ROWEX?
Alendronic acid/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 sunli

خصائص المنتج

Health Products Regulatory Authority
19 April 2023
CRN00DJ47
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alendronic acid/Colecalciferol Rowex 70 mg/2 800 IU tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 70 mg of alendronic acid (as sodium trihydrate)
and 70 microgram (2800 IU) colecalciferol (vitamin D
3
).
Excipients with known effect:
Each tablet contains 87.1 mg lactose and 13.75 mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Oblong-shaped, white to off-white, biconvex tablet, mottled, engraved
with '2800' on one side, 12.3 mm in length and 6.5 mm
in width.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Alendronic acid/Colecalciferol Rowex is indicated for the treatment of
postmenopausal osteoporosis in women at risk of
vitamin D insufficiency. It 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 Alendronic
acid/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, Alendronic
acid/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 Alendronic acid/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). Additional supplementation
with vitamin D should be considered on an individual basis taking into
account any vitamin D intake from vitamins and dietary
supplements.
The equivalence