Risedronate Pinewood 5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Risedronate sodium

Available from:

Pinewood Laboratories Ltd

ATC code:

M05BA; M05BA07

INN (International Name):

Risedronate sodium

Dosage:

5 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

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RISEDRONATE PINEWOOD 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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Risedronate Pinewood is and what it is used for
2.
What you need to know before you take Risedronate Pinewood
3.
How to take Risedronate Pinewood
4.
Possible side effects
5.
How to store Risedronate Pinewood
6.
Contents of the pack and other information
1.
WHAT RISEDRONATE PINEWOOD IS AND WHAT IT IS USED FOR
WHAT RISEDRONATE PINEWOOD IS
Risedronate Pinewood 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.
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 osteop

Summary of Product characteristics

Health Products Regulatory Authority
23 July 2019
CRN008R51
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Risedronate Pinewood 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg risedronate sodium (equivalent
to 4.64 mg risedronic acid).
Excipients with known effect
Each film-coated table contains 0.57 mg lactose.
Each film-coated tablet contains 0.016 mmol (0.38 mg) of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White round biconvex film-coated tabletwith 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.
_Special populations_
_ _
_Elderly_
No dose adjustment is necessary since bioavailability, distribution
and elimination were similar in elderly (>60 years of age)
compared to younger subjects.
_Renal impairment_
No dose adjustment is required for those patients with mild to
moderate renal impairment. The use of risedronate sodium is
contraindicated in patients with severe renal impairment (creatinine
clearance lower than 30 mL/min) (see sections 4.3 and 5.2).
_Paediatric population_
Risedronate sodium is not recommended for use in children below 18
years of age due to insufficient data on safety and
efficacy (see also section 5.1).
Method of administration
The absorption of risedronate sodium is affected by food, thus to
ensure adequate absorption patients