ACTONEL 75 Milligram Film Coated Tablet

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

RISEDRONATE SODIUM

Доступно од:

Warner Chilcott UK Limited

АТЦ код:

M05BA07

INN (Међународно име):

RISEDRONATE SODIUM

Дозирање:

75 Milligram

Фармацеутски облик:

Film Coated Tablet

Тип рецептора:

Product subject to prescription which may be renewed (B)

Терапеутска област:

Bisphosphonates

Статус ауторизације:

Authorised

Датум одобрења:

2010-04-30

Информативни летак

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACTONEL 75 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 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.
WHAT IS IN THIS LEAFLET
1.
What Actonel is and what it is used for
2.
What you need to know before you take Actonel
3.
How to take Actonel
4.
Possible side effects
5.
How to store Actonel
6.
Contents of the pack and other information
1.
WHAT ACTONEL IS AND WHAT IT IS USED FOR
WHAT ACTONEL IS
Actonel 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.
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 ACTONEL IS USED FOR
The treatment of osteoporosis in postmenopausal women.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACTONEL
DO NOT TAKE ACTONEL

If you are allergic to risedronate sodium or any of the other
ingredients of this medicine (listed
in section 6)

If your doctor has told you that you have a condition

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actonel 75 mg Film Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Film-coated tablet contains 75 mg risedronate sodium, (equivalent
to 69.6 mg risedronic acid).
For the list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Oval pink 11.7 x 5.8 mm film-coated tablet engraved with RSN on one
side and 75 mg on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of osteoporosis in postmenopausal women at increased risk of
fractures (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose in adults is one 75 mg tablet orally on two
consecutive days a month. The first tablet should be taken on
the same day each month, followed by the second tablet the next day.
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 and
polyvalent cations (see section 4.5), thus to ensure adequate
absorption patients should take Optinate 75 mg before breakfast: at
least 30 minutes before the first food, other medicinal
product or drink (other than plain water) of the day. Plain water is
the only drink that should be taken with Optinate 75 mg
tablet. Please note that some mineral water may have a higher
concentration of calcium and therefore s