BONAPENYA ONCE A WEEK 35 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

RISEDRONATE SODIUM

Available from:

Pharmathen S.A.

ATC code:

M05BA07

INN (International Name):

RISEDRONATE SODIUM

Dosage:

35 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Bisphosphonates

Authorization status:

Authorised

Authorization date:

2010-11-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BONAPENYA 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 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 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 BONAPENYA IS USED FOR
The treatment of osteoporosis
in postmenopausal women, even if osteoporosis is 

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bonapenya 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: 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.
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 g