Risedronate Mylan Once a Week 35mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Risedronate sodium hemipentahydrate

Available from:

McDermott Laboratories Ltd t/a Gerard Laboratories

ATC code:

M05BA; M05BA07

INN (International Name):

Risedronate sodium hemipentahydrate

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:

2010-11-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
RISEDRONATE MYLAN ONCE A WEEK 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.
WHAT IS IN THIS LEAFLET:
1.
What Risedronate Mylan Once a Week is and what it is used for
2.
What you need to know before you take Risedronate Mylan Once a Week
3.
How to take Risedronate Mylan Once a Week
4.
Possible side effects
5.
How to store Risedronate Mylan Once a Week
6.
Contents of the pack and further information
1.
WHAT RISEDRONATE MYLAN ONCE A WEEK IS AND WHAT IT IS USED FOR
WHAT RISEDRONATE MYLAN ONCE A WEEK IS
Risedronate Mylan 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 RISEDRONATE MYLAN ONCE A WEEK I

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Risedronate Mylan Once a Week 35mg film-coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 35 mg risedronate sodium which is
equivalent to 32.5 mg risedronic acid.
Excipient with known effect: 1.9 mg lactose in each tablet
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White round biconvex film-coated tablet with diameter of 11.2 mm, 5.0
mm in thickness and embossed with “35” on
one side.
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. The absorption of risedronate sodium is affected by food,
thus to ensure adequate absorption patients
should take Risedronate Mylan Once a Week:
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 Mylan 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
Risedronate Mylan Once a Week is to be taken while in an upright
(standing or sitting) 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 inad