Actonel Once a Week 35 mg film-coated tablets

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Risedronate sodium

Dostupné s:

IMED Healthcare Ltd.

ATC kód:

M05BA07

INN (Mezinárodní Name):

Risedronate sodium

Dávkování:

35 milligram(s)

Léková forma:

Film-coated tablet

Druh předpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

risedronic acid

Stav Autorizace:

Authorised

Datum autorizace:

2009-07-03

Informace pro uživatele

PACKAGE LEAFLET:
INFORMATION FOR THE USER
ACTONEL® ONCE A WEEK 35MG FILM-COATED
TABLETS
RISEDRONATE SODIUM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Actonel® Once a Week is and what it is used for
2. 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. Further 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
The treatment of osteoporosis
• in postmenopausal women, even if osteoporosis is severe.
It reduces the risk of spinal and hip fractures.
• in men.
2. BEFORE YOU TAKE

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actonel Once a Week 35mg 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: Each film-coated tablet contains Lactose
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from the UK and Italy:_
Oval light-orange film-coated tablet with ‘RSN’ on one side and
‘35mg’ 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.
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 drink (other than plain
water) of the day.
Patients should be instructed that if a dose is missed, one Actonel
Once-a-Week 35 mg 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.
The tablet must be swallowed whole and not sucked or chewed. To aid
delivery of the tablet to the stomach Actonel
Once-a-Week 35 mg is to be taken while in an upright position with a
glass of plain water (
120 ml). Patients should
not lie down for 30 minutes after taking the tablet (see section 4.4).
Supplemental calcium and vitamin D should be considered if the dietary
intake is inadequate.
The optimal duration