Risedronate Bluefish Once a Week 35 mg film-coated tablets

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Risedronate sodium hemipentahydrate

থেকে পাওয়া:

Bluefish Pharmaceuticals AB

এটিসি কোড:

M05BA; M05BA07

INN (আন্তর্জাতিক নাম):

Risedronate sodium hemipentahydrate

ডোজ:

35 milligram(s)

ফার্মাসিউটিকাল ফর্ম:

Film-coated tablet

প্রেসক্রিপশন টাইপ:

Product subject to prescription which may be renewed (B)

থেরাপিউটিক এলাকা:

Bisphosphonates; risedronic acid

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

2011-03-21

তথ্য লিফলেট

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RISEDRONATE BLUEFISH ONCE A WEEK 35 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 or
nurse.
-
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 or
nurse. This includes any possible
side effects not listed in this leaflet, See sectiom 4.
WHAT IS IN THIS LEAFLET
:
1.
What Risedronate Bluefish is and what it is used for
2.
What you need to know before you take Risedronate Bluefish
3.
How to take Risedronate Bluefish
4.
Possible side effects
5.
How to store Risedronate Bluefish
6.
Contents of the pack and other information
1.
WHAT RISEDRONATE BLUEFISH IS AND WHAT IT IS USED FOR
WHAT RISEDRONATE BLUEFISH IS
Risedronate Bluefish 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 RISEDRONATE BLUEFISH
IS USED FOR
Risedronate Bluefish is use

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
25 June 2020
CRN009P70
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Risedronate Bluefish Once a Week 35 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 35 mg risedronate sodium which is
equivalent to 32.5 mg risedronic acid.
Excipient(s) with known effect: 1.9 mg lactose in each tablet
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White round biconvex film-coated tabletwith diameter of 11.2 mm, 5.0
mm in thickness and embossed with “35” on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of postmenopausal osteoporosis, to reduce the risk of
vertebral fractures. Treatment of established postmenopausal
osteoporosis, to reduce the risk of hip fractures (see section 5.1).
Treatment of osteoporosis in men at high risk of fractures. (see
section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose in adults is one 35 mg tablet orally once a week.
The tablet should be taken on the same day each
week. The absorption of risedronate sodium is affected by food, thus
to ensure adequate absorption patients should take
Risedronate:
- Before breakfast: At least 30 minutes before the first food, other
medicinal product or drink (other than plain water) of the
day.
Patients should be instructed that if a dose is missed, one
Risedronate 35 mg tablet should be taken on the day that the tablet
is remembered. Patients should then return to taking one tablet once a
week on the day the tablet is normally taken. Two
tablets should not be taken on the same day.
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 sodium on an individual
patient basis, particularly after 5 or more years of use.
Supplemental calcium and vitamin D should be considered if the dietary
i