Optinate Once a Week 35mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Risedronate sodium

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

M05BA; M05BA07

INN (International Name):

Risedronate sodium

Dosage:

35 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Bisphosphonates; risedronic acid

Authorization status:

Not marketed

Authorization date:

2009-12-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OPTINATE 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 Optinate Once a Week is and what it is used for
2.
What you need to know before you take Optinate Once a Week
3.
How to take Optinate Once a Week
4.
Possible side effects
5.
How to store Optinate Once a Week
6.
Contents of the pack and other information
1.
WHAT OPTINATE ONCE A WEEK IS AND WHAT IT IS USED FOR
WHAT OPTINATE ONCE A WEEK IS
Optinate 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 OPTINATE ONCE A WEEK IS USED FOR
Treatment of osteoporosis in postmenopausal wome

Summary of Product characteristics

Health Products Regulatory Authority
31 January 2020
CRN009DL7
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Optinate Once a Week 35mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film‑coated tablet contains 35 mg risedronate sodium
(equivalent to 32.5 mg risedronic acid).
Excipients with known effect:
Each film‑coated tablet contains 126.0 mg lactose monohydrate
(equivalent to 119.7 mg lactose).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film‑coated tablet.
Oval light‑orange 11.7 x 5.8 mm film‑coated tablet with RSN on one
side and 35 mg on the other.
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 Optinate
Once a Week 35 mg:
• 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 Optinate
Once a Week 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 Optinate Once a
Week 35 mg is to be taken while in an upright position with a glass of
plain water (>120 ml).Patients should not lie down for 30
minutes after taking the tablet (see se