Risedronate Sodium Accord Once A Week 35 mg film-coated tablets

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Risedronate sodium

থেকে পাওয়া:

Accord Healthcare Ireland Ltd.

এটিসি কোড:

M05BA; M05BA07

INN (আন্তর্জাতিক নাম):

Risedronate sodium

ডোজ:

35 milligram(s)

ফার্মাসিউটিকাল ফর্ম:

Film-coated tablet

থেরাপিউটিক এলাকা:

Bisphosphonates; risedronic acid

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

2018-07-06

তথ্য লিফলেট

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RISEDRONATE SODIUM ACCORD ONCE A WEEK 35MG 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.

The full name of this medicine is Risedronate Sodium Accord Once a
Week 35 mg
film-coated tablets but within this leaflet it will be referred to as
Risedronate Sodium
Accord Once a Week.
WHAT IS IN THIS LEAFLET
1. What Risedronate Sodium Accord Once a Week is and what it is used
for
2. What you need to know before you take Risedronate Sodium Accord
Once a Week
3. How to take Risedronate Sodium Accord Once a Week
4. Possible side effects
5. How to store Risedronate Sodium Accord Once a Week
6. Contents of the pack and other information
1. WHAT RISEDRONATE SODIUM ACCORD ONCE A WEEK IS AND WHAT IT IS USED
FOR
Risedronate Sodium Accord Once a Week 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

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
03 March 2023
CRN00DG61
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Risedronate Sodium Accord Once A Week 35 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 35 mg risedronate sodium (equivalent
to 32.5 mg risedronic acid).
Excipient with known effect: Each film-coated tablet contains 126.0 mg
lactose monohydrate (equivalent to 119.7 mg lactose).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Light orange coloured, oval shaped, biconvex film-coated tablets
engraved with "RS1" on one side and plain on the other".
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.
Special populations
_Elderly_
No dosage adjustment is necessary since bioavailability, distribution
and elimination were similar in elderly (>60 years of age)
compared to younger subjects.
This has also been shown in the very elderly, 75 years old and above
postmenopausal population.
_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 (see
section 5.1).
Method of administration
The absorption of risedronate sodium is affected by food, thus to
ensure adequate absorption patients should take
Rised