Risontel Once a week 35mg film-coated tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Risedronate sodium

זמין מ:

Clonmel Healthcare Ltd

קוד ATC:

M05BA; M05BA07

INN (שם בינלאומי):

Risedronate sodium

כמות:

35 milligram(s)

טופס פרצבטיות:

Film-coated tablet

סוג מרשם:

Product subject to prescription which may be renewed (B)

איזור תרפויטי:

Bisphosphonates; risedronic acid

מצב אישור:

Marketed

תאריך אישור:

2010-10-08

עלון מידע

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
RISONTEL ONCE A WEEK 35MG 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 Risontel Once a Week is and what it is used for
2.
What you need to know before you take Risontel Once a Week
3.
How to take Risontel Once a Week
4.
Possible side effects
5.
How to store Risontel Once a Week
6.
Contents of the pack and other information
1.
WHAT RISONTEL ONCE A WEEK IS AND WHAT IT IS USED FOR
WHAT RISONTEL ONCE A WEEK IS
Risontel 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 RISONTEL ONCE A WEEK IS USED FOR
The treatment of osteoporosis in postmenopausal wo

מאפייני מוצר

Health Products Regulatory Authority
12 February 2021
CRN009VGK
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Risontel 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(s) with known effect: 1.9 mg lactose in each tablet.
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White round biconvex film-coated tabletwith 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.
Method of administration
The absorption of risedronate sodium is affected by food, thus to
ensure adequate absorption patients should take
Risedronate:

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 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 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 sho