BONAPENYA 30 Milligram Film Coated Tablet

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

RISEDRONATE SODIUM

可用日期:

Pharmathen S.A.

ATC代码:

M05BA07

INN（国际名称）:

RISEDRONATE SODIUM

剂量:

30 Milligram

药物剂型:

Film Coated Tablet

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

Bisphosphonates

授权状态:

Authorised

授权日期:

2010-11-26

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
BONAPENYA 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 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.

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. Bonapenya changes the bone 
remodeling process back to normal, returning the 
strength to the bone structure. 
WHAT BONAPENYA IS USED FOR 
Treatment of Paget´s disease of the bone (osteitis 
deformans).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE 
BONAPENYA

DO NOT TAKE BONAPENYA 
- 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 lo

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bonapenya 30mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30 mg risedronate sodium (equivalent to 27.8 mg risedronic acid).
Excipient: 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, 4.5 mm in thickness and embossed with “30” on
one side.
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.
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 evening: Risedronate should be taken at least 2 hours after the last food, medicinal product or drink (other
than plain water) of the day. Risedronate should be taken at least 30 minutes before going to bed.
If a