Actonel Once a week 35mg film-coated Tablets

Country: Malta

Bahasa: Inggeris

Sumber: Medicines Authority

Bahan aktif:

RISEDRONATE SODIUM

Boleh didapati daripada:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Kod ATC:

M05BA07

INN (Nama Antarabangsa):

RISEDRONATE SODIUM 35 mg

Borang farmaseutikal:

FILM-COATED TABLET

Komposisi:

RISEDRONATE SODIUM 35 mg

Jenis preskripsi:

POM

Kawasan terapeutik:

DRUGS FOR TREATMENT OF BONE DISEASES

Status kebenaran:

Withdrawn

Tarikh kebenaran:

2005-11-21

Risalah maklumat

Risedronic acid 35 mg Film-coated tablets, PIL, Malta
item no: AAAJ8151
print proof no: 4
origination date: 22.05.17
originated by: KM
revision date: 24.07.2017
revised by: KM
dimensions: 190 x 600
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1.
2.
3.
date sent: 22.05.17
supplier: Dupnitsa
approved:
min pt size: 10pt
TECHNICAL APPROVAL
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

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Page 1 of 17
SUMMARY OF THE 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). Excipients 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 (also see section 5.1).
Page 2 of 17
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