Risedronate Sodium Actavis once weekly 35mg Film-Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Risedronate sodium

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

M05BA; M05BA07

INN (International Name):

Risedronate sodium

Dosage:

35 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Bisphosphonates; risedronic acid

Authorization status:

Not marketed

Authorization date:

2010-10-01

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RISEDRONATE SODIUM ACTAVIS ONE WEEKLY 35 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 Risedronate Sodium Actavis once weekly is and what it is used for
2.
What you need to know before you take Risedronate Sodium Actavis once
weekly
3.
How to take Risedronate Sodium Actavis once weekly
4.
Possible side effects
5.
How to store Risedronate Sodium Actavis once weekly
6.
Contents of the pack and other information
1.
WHAT RISEDRONATE SODIUM ACTAVIS ONCE WEEKLY IS AND WHAT IT IS USED FOR
WHAT RISEDRONATE SODIUM ACTAVIS ONCE WEEKLY IS
Risedronate Sodium Actavis once weekly 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 osteopor

Summary of Product characteristics

Health Products Regulatory Authority
06 December 2019
CRN009GWW
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Risedronate Sodium Actavis once weekly 35mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film‑coated tablet contains 35 mg risedronate sodium
(amorphous), equivalent to 32.48 mg risedronic acid.
Excipients with known effect: Each film‑coated tablet contains
153.18 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film‑coated tablet.
Orange 9.0 mm round, film‑coated tablet.
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).
Risedronate Sodium once weekly 35 mg is indicated in adults.
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.
The absorption of risedronate sodium is affected by food, thus to
ensure adequate absorption, patients should take
Risedronate Sodium once weekly 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
Risedronate Sodium once weekly 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 Risedronate
Sodium once weekly 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