ACTONEL ONCE A WEEK 35 Milligram Film Coated Tablet

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

RISEDRONATE SODIUM

Доступно од:

LTT Pharma Limited

INN (Међународно име):

RISEDRONATE SODIUM

Дозирање:

35 Milligram

Фармацеутски облик:

Film Coated Tablet

Тип рецептора:

Product subject to prescription which may be renewed (B)

Статус ауторизације:

Withdrawn

Датум одобрења:

2014-03-04

Информативни летак

CHILDREN AND ADOLESCENTS
Risedronate sodium is not recommended for use in children below
18 due to insufficient data on safety and efficacy.
OTHER MEDICINES AND ACTONEL ONCE A WEEK
Medicines containing one of the following lessen the effect
of Actonel Once
a Week if taken at the same time:
*
calcium
*
magnesium
*
aluminium (for example some indigestion mixtures)
*
iron.
Take these medicines at least 30 minutes after your Actonel Once a
Week
tablet.
Tell your doctor or pharmacist if you are taking, have recently taken
or might
take any other medicines. 
ACTONEL ONCE A WEEK WITH FOOD AND DRINK
It is very important that you do NOT take your Actonel Once a Week
tablet
with food or drinks (other than plain water) so that it can work
properly. 
In particular do not take this medicine at the same time as dairy
products
(such as milk) as they contain calcium (see section 2, “Other
medicines and
Actonel Once a Week”). Take food and drinks (other than plain
water) at
least 30 minutes after your Actonel Once a Week tablet.
PREGNANCY AND BREAST-FEEDING
Do NOT take Actonel Once a Week if you may be pregnant, are pregnant
or
planning to become pregnant (see section 2, “Do not take Actonel
Once a
Week”). The potential risk associated with the use of risedronate
sodium
(active substance in Actonel Once a Week) in pregnant women is
unknown.
Do NOT take Actonel Once a Week if you are breast-feeding (see
section 2,
“Do not take Actonel Once a Week”).
Actonel Once a Week should only be used to treat postmenopausal
women and men.
DRIVING AND USING MACHINES
Actonel Once a Week is not known to affect your ability to drive and
use
machines.
ACTONEL ONCE A WEEK CONTAINS A SMALL AMOUNT OF LACTOSE (see section
2, “Warnings and precautions”).
HOW TO TAKE ACTONEL ONCE A WEEK
Always take this medicine exactly as your doctor or pharmacist has
told you. 
Check with your doctor if you are not sure.
Recommended dose:
Take ONE Actonel Once a Week tablet (35 mg of risedronate sodium)
once
a week.
Choose one day

Карактеристике производа

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 35mg risedronate sodium (equivalent to 32.5mg 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