Risedronate sodium ADAMED PHARMA Once a week 35 mg film-coated tablets

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Risedronate sodium

から入手可能:

Zaklad Farmaceutyczny Adamed Pharma S.A.

ATCコード:

M05BA; M05BA07

INN（国際名）:

Risedronate sodium

投薬量:

35 milligram(s)

医薬品形態:

Film-coated tablet

処方タイプ:

Product subject to prescription which may be renewed (B)

治療領域:

Bisphosphonates; risedronic acid

認証ステータス:

Not marketed

承認日:

2010-11-05

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE USER
RISEDRONATE SODIUM ADAMED PHARMA ONCE A WEEK 35 MG FILM-COATED TABLETS
, 35 MG
FILM-COATED TABLETS
_Risedronate sodium _
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have any questions, ask your doctor or pharmacist
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
•
symptoms are the same as yours.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Risedronate sodium ADAMED PHARMA Once a week 35 mg film-coated
tablets is
and what it is used for
2.
Before you take Risedronate sodium ADAMED PHARMA Once a week 35 mg
film-
coated tablets
3.
How to take Risedronate sodium ADAMED PHARMA Once a week 35 mg
film-coated
tablets
4.
Possible side effects
5.
How to store Risedronate sodium ADAMED PHARMA Once a week 35 mg
film-coated
tablets
6.
Further information
1. WHAT RISEDRONATE SODIUM ADAMED PHARMA ONCE A WEEK 35 MG
FILM-COATED TABLETS IS AND WHAT IT IS USED FOR
Risedronate sodium ADAMED PHARMA Once a week 35 mg film-coated tablets
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 an

製品の特徴

Health Products Regulatory Authority
26 March 2021
CRN00C4RH
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Risedronate sodium ADAMED PHARMA 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: lactose monohydrate.
Each film-coated tablet contains 133.58 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Film-coated, biconvex, pale orange coloured round tablet.
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 sodium ADAMED PHARMA Once a week 35 mg film-coated
tablets:
° 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 sodium ADAMED PHARMA Once a week 35 mg
film-coated tablets 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 tablet must be swallowed whole and not sucked or chewed. To aid
delivery of the tablet to the stomach Risedronate
sodium ADAMED PHARMA Once a week 35 mg film-coated tablets is to be
taken while in an upright position with a glass of
plain water (>120 ml). Patie