Actonel 5mg tablets

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Risedronate sodium

Dostupné s:

Accord-UK Ltd

ATC kód:

M05BA07

INN (Mezinárodní Name):

Risedronate sodium

Dávkování:

5mg

Léková forma:

Oral tablet

Podání:

Oral

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 06060200; GTIN: 05052667000195

Informace pro uživatele

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACTONEL® 5MG 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 name of your medicine is Actonel 5mg film-coated tablets but will
be
referred to as Actonel throughout the remainder of this leaflet.
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.
Osteoporosis is more likely to occur in women who have reached the
menopause early and also in patients treated long-term with steroids.
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 ost

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Risedronate Sodium Accord 5 mg film-coated tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg risedronate sodium (equivalent
to 4.64
mg risedronic acid).
Excipient: Each film-coated tablet contains lactose.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Oval yellow film-coated tablet with RSN on one side and 5 mg 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. Prevention of osteoporosis in
postmenopausal women
with increased risk of osteoporosis (see 5.1).
To maintain or increase bone mass in postmenopausal women undergoing
long-term (more than 3 months), systemic corticosteroid treatment at
doses
≥
7.5mg/day prednisone or equivalent.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended daily dose in adults is one 5 mg tablet orally.
Special population
_ _
_Elderly: _No dosage adjustment is necessary since bioavailability,
distribution and elimination
were similar in elderly (>60 years of age) compared to younger
subjects.
_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 (also see section 5.1).
Method of administration
The absorption of risedronate sodium is affected by food, thus to
ensure adequate absorption
patients should take Risedronate Sodium Accord 5 mg film-coated
tablets:
•
Before breakfast: At least 30 minutes before the first food, other
medicinal product or
drink (other than plain wate