RISEDRONATE ONCE A WEEK

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

RISEDRONATE SODIUM

Доступно од:

McDermott Laboratories Ltd t/a Gerard Laboratories

АТЦ код:

M05BA07

INN (Међународно име):

RISEDRONATE SODIUM

Дозирање:

35 Milligram

Фармацеутски облик:

Film Coated Tablet

Тип рецептора:

Product subject to prescription which may be renewed (B)

Терапеутска област:

risedronic acid

Статус ауторизације:

Not Marketed

Датум одобрења:

2011-08-05

Информативни летак

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v1/May 2015
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170 x 480 mm
9 pt
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Risedronate Sodium 35 mg 4
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1. What Risedronate Once a Week is and
what it is used for
What Risedronate Once a Week is
Risedronate 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 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 Once a Week is used for
The treatment of osteoporosis:
• in postmenopausal women, even if osteoporosis
is severe.
It reduces the risk of spinal and hip fractures
• in men.
2. What you need to know before you take
Risedronate Once a Week
Do not take Risedronate Once a Week tablets
• If you are allergic to risedronate sodium or any
of the other ingredients of this

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Risedronate Once a week 35 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 35 mg of risedronate sodium
equivalent to 32.5 mg risedronic acid.
Excipients with known effect:
Also contains polydextrose (glucose and sorbitol).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Light orange film-coated tablet, round, biconvex, bevelled edge tablet
debossed with M on
one side of the tablet and 714 on the other 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.
_Method of administration_
Oral use.
The absorption of risedronate sodium is affected by food,
thus to ensure adequate absorption patients should take
Risedronate 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 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 tablet
must
be swallowed whole and not
sucked or
chewed.
To aid delivery of
the tablet
to the stomach
Risedronate is to be taken while in an upright position with a glass
of plain water (>120 ml).
Patients should not lie
down for 30 minutes after taking the tablet (see section 4.4).
Supplemental calcium and vitamin D should be considered if the dietary
intake is inadequat