ACTONEL ONCE A WEEK 35 Milligram Tablets Gastro-Resistant

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

RISEDRONATE SODIUM

Pieejams no:

Warner Chilcott UK Limited

ATĶ kods:

M05BA07

SNN (starptautisko nepatentēto nosaukumu):

RISEDRONATE SODIUM

Deva:

35 Milligram

Zāļu forma:

Tablets Gastro-Resistant

Receptes veids:

Product subject to prescription which may be renewed (B)

Ārstniecības joma:

Bisphosphonates

Autorizācija statuss:

Authorised

Autorizācija datums:

2016-12-16

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACTONEL ONCE A WEEK 35 MG GASTRO
‐
RESISTANT 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 Actonel is and what it is used for
2.
What you need to know before you take Actonel
3.
How to take Actonel
4.
Possible side effects
5.
How to store Actonel
6.
Contents of the pack and other information
1.
WHAT ACTONEL IS AND WHAT IT IS USED FOR
WHAT ACTONEL IS
Actonel 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.
Osteoporosis can also occur in men due to a number of causes including
ageing and/or a low level of
the male hormone, testosterone.
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 ACTONEL IS USED FOR
Treatment of osteoporosis in postmenopausal women, even if
osteoporosis is severe. It reduces the risk
of spinal and hip fractures.
2.
WHAT YOU NEED TO

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actonel Once a Week 35 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 35 mg risedronate sodium
(equivalent to 32.5 mg risedronic acid).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
Oval, yellow, gastro-resistant tablet with “EC 35” engraved on one
side.
The dimensions of the tablet are as follows: width 13.05 mm, length
5.94 mm.
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 Optinate Septimum 35 mg
gastro-resistant tablet orally once a week. The tablet
should be taken on the same day each week.
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
risedronate on an individual
patient basis, particularly after 5 or more years of use.
Special populations
_Elderly_
Of the patients receiving risedronate 35 mg gastro-resistant tablets
in postmenopausal osteoporosis studies, 59% were
65 and over, while 13 % were 75 and over.
No overall differences in safety and effectiveness were observed
between
these patients and younger patients.
_Patients with renal impairment_
No dosage adjustment is required for those patients with mild to
moderate renal impairment. The use of risedronate
sodium is contraindicated in patients with severe renal impairment
(creatinine clearance lower than 30 ml/min) (see
sections 4.3 and 5.2).
_Paediatric population_
Risedronate sodium is not recommended for use in children below age 18
due to insufficient data on safety and efficacy
(also see section 5.1).
Method of administration
Optinate Septimum 35 mg gastro-resistant tablets should be taken
orally in the morning immediate