BONAPENYA 5 Milligram Film Coated Tablet

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

RISEDRONATE SODIUM

Mevcut itibaren:

Pharmathen S.A.

ATC kodu:

M05BA07

INN (International Adı):

RISEDRONATE SODIUM

Doz:

5 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:

2010-11-26

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER
BONAPENYA 5 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 or nurse.This includes any possible side 
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET: 
1. What Bonapenya is and what it is used for
2. What you need to know before you take Bonapenya 
3. How to take Bonapenya 
4. Possible side effects
5. How to store Bonapenya 
6. Contents of the pack and other information
1. WHAT BONAPENYA IS AND WHAT IT IS USED FOR

WHAT BONAPENYA IS
Bonapenya 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 is more likely to occur in women who 
have reached the menopause early and also in patients 
treated long-term with steroids. 
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 BONAPENYA IS USED FOR
The treatment of osteoporosis
in POSTMENOPAUSAL WOMEN
The prevention of ost

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bonapenya 5mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg risedronate sodium (equivalent to 4.64 mg risedronic acid).
Excipient: 0.57 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 6.1 mm and 2.6 mm in thickness.
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. Prevention of osteoporosis in postmenopausal women
with increased risk of osteoporosis (see section 5.1). To maintain or increase bone mass in postmenopausal women
undergoing long-term (more than 3 months), systemic corticosteroid treatment at doses
7.5mg/day prednisone or
equivalent.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The recommended daily dose in adults is one 5 mg tablet orally.
METHOD OF ADMINISTRATION
The absorption of Risedronate 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.
In the particular instance that before breakfast dosing is not practical, Risedronate can be taken
between meals or in the evening at the same time everyday, with strict adherence to the following instructions, to
ensure Risedronate is taken on an empty stomach:
•
Between meals: Risedronate should be taken at least 2 hours before and at least 2 hours after any food, medicinal
product or drink (other than plain water).
•
In the eveni