Risonate Once Weekly 35 mg Film-coated Tablets

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Risedronate sodium

Beszerezhető a:

Teva Pharma B.V.

ATC-kód:

M05BA; M05BA07

INN (nemzetközi neve):

Risedronate sodium

Adagolás:

35 milligram(s)

Gyógyszerészeti forma:

Film-coated tablet

Recept típusa:

Product subject to prescription which may be renewed (B)

Terápiás terület:

Bisphosphonates; risedronic acid

Engedélyezési státusz:

Marketed

Engedély dátuma:

2008-12-12

Betegtájékoztató

RISONATE ONCE WEEKLY 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.
• This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their sign 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.
1. What Risonate Once Weekly is and what it
is used for
2. What you need to know before you take
Risonate Once Weekly
3. How to take Risonate Once Weekly
4. Possible side effects
5. How to store Risonate Once Weekly
6. Contents of the pack and other information
WHAT RISONATE ONCE WEEKLY IS AND
WHAT IT IS USED FOR
WHAT RISONATE ONCE WEEKLY IS
Risonate Once Weekly 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 RISONATE ONCE WEEKLY IS USED FOR
The treatment of osteoporosis
• in postmenopausal women, even if
osteoporosis is severe. It reduces the risk
of spinal an

Termékjellemzők

Health Products Regulatory Authority
18 November 2020
CRN009ZH2
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Risonate Once Weekly 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).
Excipients with known effect:
Each Film-coated Tablet contains 140 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet.
Orange, round, Film-coated Tablet, debossed with “R35”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.
Patients should be instructed that if a dose is missed, one 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.
Supplemental calcium and vitamin D should be considered if the dietary
intake is inadequate.
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.
_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.