OPTINATE 75 Milligram Film Coated Tablet

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

RISEDRONATE SODIUM

Διαθέσιμο από:

Warner Chilcott UK Limited

Φαρμακολογική κατηγορία (ATC):

M05BA07

INN (Διεθνής Όνομα):

RISEDRONATE SODIUM

Δοσολογία:

75 Milligram

Φαρμακοτεχνική μορφή:

Film Coated Tablet

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

Bisphosphonates

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2010-04-30

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OPTINATE 75 MG FILM-COATED TABLETS
risedronate sodium
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 Optinate is and what it is used for
2.
What you need to know before you take Optinate
3.
How to take Optinate
4.
Possible side effects
5.
How to store Optinate
6.
Contents of the pack and other information
1.
WHAT OPTINATE IS AND WHAT IT IS USED FOR
WHAT OPTINATE IS
Optinate belongs to a group of non-hormonal medicines called
bisphosphonates which 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 osteoporosis have no symptoms and you may not even
have known that you had it.
WHAT OPTINATE IS USED FOR
The treatment of osteoporosis in postmenopausal women.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE OPTINATE
DO NOT TAKE OPTINATE

If you are allergic to risedronate sodium or any of the other
ingredients of this medicine (listed
in section 6)

If your doctor has told you that you have a

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Optinate 75mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film
-
coated tablet contains 75 mg risedronate sodium (equivalent to 69.6 mg
risedronic acid).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film
-
coated tablet.
Oval pink 11.7 x 5.8 mm film
-
coated tablet engraved with RSN on one side and 75 mg on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of osteoporosis in postmenopausal women at increased risk of
fractures (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose in adults is one 75 mg tablet orally on two
consecutive days a month. The first tablet should be
taken on the same day each month, followed by the second tablet the
next day.
Method of administration
•
The absorption of risedronate sodium is affected by food and
polyvalent cations (see section 4.5), thus to ensure
adequate absorption patients should take Optinate 75 mg before
breakfast: at least 30 minutes before the first
food, other medicinal product or drink (other than plain water) of the
day. Plain water is the only drink that
should be taken with Optinate 75 mg tablet. Please note that some
mineral water may have a higher concentration
of calcium and therefore should not be used (see section 5.2).
•
Patients who miss a dose of Optinate 75 mg should be instructed to
take one Optinate 75 mg tablet the morning
after the day it is remembered, unless the time to the next month’s
scheduled doses are within 7 days. Patients
should then return to taking Optinate 75 mg tablet on two consecutive
days a month on the day the tablet is
normally taken.
• If the next month’s scheduled doses Optinate 75 mg are within 7
days, patients should wait until their next
month’s scheduled doses and then continue taking Optinate 75 mg on
two consecutive days each month as
originally scheduled.
• Three tablets should not be taken in the same week.
The tablet must be swall