ACTONEL 30 Milligram Film Coated Tablet

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

RISEDRONATE SODIUM

Mevcut itibaren:

Warner Chilcott UK Limited

ATC kodu:

M05BA07

INN (International Adı):

RISEDRONATE SODIUM

Doz:

30 Milligram

Farmasötik formu:

Film Coated Tablet

Reçete türü:

Product subject to prescription which may be renewed (B)

Terapötik alanı:

Bisphosphonates

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2010-04-30

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACTONEL 30 MG 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.
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.
Paget’s disease occurs when this process, called remodeling, happens
too quickly and in a disordered
way. The new bone that is produced is weaker than normal and the
affected bones may become
enlarged, painful and may fracture. Actonel changes the bone
remodeling process back to normal,
returning the strength to the bone structure.
WHAT ACTONEL IS USED FOR
Treatment of Paget’s disease of the bone (osteitis deformans).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACTONEL
DO NOT TAKE ACTONEL

If you are allergic to risedronate sodium or any of the other
ingredients of this medicine (listed
in section 6)

If your doctor has told you that you have a condition called
hypocalcaemia (a low blood calcium
level)

If you may be pregnant, are pregnant or planning to become pregnant

If

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actonel 30 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30 mg risedronate sodium (equivalent
to 27.8 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 tablets.
Oval white film-coated tablet with RSN on one side and 30 mg on the
other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of Paget’s disease of the bone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended daily dose in adults is one 30 mg tablet orally for 2
months. If re treatment is considered necessary
(at least two months post treatment), a new treatment with the same
dose and duration of therapy could be given.
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.
_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 Actonel is affected by food, thus to ensure adequate
absorption patients should take Actonel:
-
Before breakfast: At least 30 minutes before the first food, other
medicinal product or drink (other than plain
water) of the day.
In the particular instance that before breakfast dosing is not
practical, Actonel can be taken between meals or in the
evening at the same time everyday, with strict adherence to the
following instructions, to ensure Actonel is taken on an
empty stomach:
-
Between meals: Actonel should be taken at least 2 hours bef