ACTONEL ONCE A WEEK 35 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

RISEDRONATE SODIUM

Available from:

Warner Chilcott UK Limited

ATC code:

M05BA07

INN (International Name):

RISEDRONATE SODIUM

Dosage:

35 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Bisphosphonates

Authorization status:

Authorised

Authorization date:

2010-04-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE
PATIENT
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 Once a Week is and what it is
used for
2. What you need to know before you take Actonel
Once a Week
3. How to take Actonel Once a Week
4. Possible side effects
5. How to store Actonel Once a Week
6. Contents of the pack and other information
1.
WHAT ACTONEL ONCE A WEEK IS AND
WHAT IT IS USED FOR
WHAT ACTONEL ONCE A WEEK IS
Actonel 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 ACTONEL ONCE A WEEK IS USED FOR
Treatment of osteoporosis in postmenopausal
women, even if osteoporosis is severe. It reduces the
risk of spinal and hip fra

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actonel 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: Each film-coated tablet contains 126.0 mg
lactose monohydrate (equivalent to 119.7 mg
lactose).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Oval light-orange 11.7 x 5.8 mm film-coated tablet with RSN on one
side and 35 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 (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.
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, thus to
ensure adequate absorption patients should take Actonel Once A
Week 35 mg:
-
Before breakfast: At least 30 minutes before the first food, other
medicinal product or drin