Alendronate - 1 A Pharma plus Colecalciferol Tablets 70mg, 5600IU

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

ALENDRONIC ACID, COLECALCIFEROL

Διαθέσιμο από:

1 A Pharma GmbH Keltenring 1+3, 82041 Oberhaching, Germany

Φαρμακολογική κατηγορία (ATC):

M05BB03

INN (Διεθνής Όνομα):

ALENDRONIC ACID 70 mg COLECALCIFEROL 140 µg

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

ALENDRONIC ACID 70 mg COLECALCIFEROL 140 µg

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

DRUGS FOR TREATMENT OF BONE DISEASES

Καθεστώς αδειοδότησης:

Withdrawn

Ημερομηνία της άδειας:

2016-07-13

Φύλλο οδηγιών χρήσης

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALENDRONATE - 1 A PHARMA PLUS COLECALCIFEROL 70 MILLIGRAMS/5600 IU
TABLET
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 - 1 A Pharma plus Colecalciferol ”, before taking this
medicine.
WHAT IS IN THIS LEAFLET:
1.
What Alendronate - 1 A Pharma plus Colecalciferol is and what it is
used for
2.
What you need to know before you take Alendronate - 1 A Pharma plus
Colecalciferol
3.
How to take Alendronate - 1 A Pharma plus Colecalciferol
4.
Possible side effects
5
How to store Alendronate - 1 A Pharma plus Colecalciferol
6.
Contents of the pack and other information
1. WHAT ALENDRONATE - 1 A PHARMA PLUS COLECALCIFEROL IS AND WHAT IT IS
USED FOR
WHAT IS ALENDRONATE - 1 A PHARMA PLUS COLECALCIFEROL ?
Alendronate - 1 A Pharma plus Colecalciferol is a tablet containing
the two active substances,
alendronic acid (commonly called alendronate) and colecalciferol known
as vitamin D3.
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

Αρχείο Π.Χ.Π.

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Alendronate - 1 A Pharma plus Colecalciferol 70mg/5600 IU tablet_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
tablet
contains
70
mg
of
alendronic
acid
(as
sodium
alendronate
trihydrate)
and
140 microgram colecalciferol (equivalent to 5600 IU vitamin D3)
Excipient(s) with known effect: sucrose (9.8 mg)
For the full list of excipients, see section 6.1_ _
3.
PHARMACEUTICAL FORM
Tablet_ _
White to almost white, oval tablet debossed with 714 on one side
Approximately 12.6 x 6.6 x 5.2mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Alendronate - 1 A Pharma plus Colecalciferol 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 - 1 A Pharma plus Colecalciferol 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
- 1 A Pharma plus
Colecalciferol 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
- 1 A Pharma plus
Colecalciferol 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 - 1 A Pharma plus Colecalciferol on an individual
patient basis, particularly
after 5 or more years of use.
Page 2 of 13
Patients should receive supplemental calcium if intake from diet is
inadequate (see section 4.4). The
equivalence of intake of 5600 IU of vitamin D3 weekly in Alendronate -
1 A Pharma plus
Colecalciferol to daily dosing of vitamin D 8