Optinate Plus Ca & D 35 mg film-coated tablets + 1000 mg/880 IU Effervescent Granules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Colecalciferol concentrate (oily form) [vitamin d3]; Calcium carbonate; Risedronate sodium

Available from:

Theramex Ireland Limited

ATC code:

M05BB; M05BB04

INN (International Name):

Colecalciferol concentrate (oily form) [vitamin d3]; Calcium carbonate; Risedronate sodium

Dosage:

35 mg & 1000 mgu/880  international unit(s)

Pharmaceutical form:

Effervescent granules + film-coated tablet

Therapeutic area:

Bisphosphonates, combinations; risedronic acid, calcium and colecalciferol, sequential

Authorization status:

Not marketed

Authorization date:

2011-07-08

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NORSED COMBI D
35 mg + 1000 mg / 880 IU film-coated tablets + effervescent granules
Risedronate sodium + calcium / colecalciferol
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 Norsed Combi D is and what it is used for
2.
What you need to know before you take Norsed Combi D
3.
How to take Norsed Combi D
4.
Possible side effects
5.
How to store Norsed Combi D
6.
Contents of the pack and other information
1.
WHAT NORSED COMBI D IS AND WHAT IT IS USED FOR
WHAT NORSED COMBI D IS
A combination medicine packed as weekly units each containing 1 tablet
of Norsed and 6 sachets of
calcium/vitamin D
3
.
⃝
_Norsed tablets _
Norsed tablets contain risedronate sodium which belongs to a group of
non-hormonal medicines called
bisphosphonates. These medicines 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.
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

Summary of Product characteristics

Health Products Regulatory Authority
26 November 2019
CRN008J74
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Optinate Plus Ca & D 35 mg film-coated tablets + 1000 mg/880 IU
Effervescent Granules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 35 mg risedronate sodium, (equivalent
to 32.5 mg risedronic acid).
Each sachet of effervescent granules contains 1000mg calcium (as 2500
mg calcium carbonate) and 22 micrograms (880 IU)
colecalciferol (vitamin D3).
Excipients:
Each film-coated tablet contains 126.0 mg of lactose monohydrate
(equivalent to 119.7 mg lactose).
Each sachet of effervescent granules contains potassium (163 mg),
sucrose (3.6 mg), soya-bean oil (0.7 mg) and sorbitol (100
mg).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
_Film-coated tablet._
Oval, light-orange, film-coated tablet with RSN on one side and 35 mg
on the other.
_Effervescent granules_
White effervescent granules.
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).
Optinate Plus Ca & D is only intended for use in assessed patients for
whom the amount of calcium and vitamin D
3
included is
considered to provide adequate supplementation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
A weekly unit of Optinate Plus Ca & D consists of 1 Optinate 35 mg
film‑coated tablet and 6 calcium/vitamin D 3 sachets in a
box.
Posology
The recommended dose in adults is 1 Optinate 35 mg tablet on the first
day followed on the next day by 1 calcium/vitamin D 3
sachet daily for 6 days. This 7‑day sequence is then repeated each
week starting with Optinate 35 mg tablet.
Method of administration
_Optinate 35 mg (light‑orange tablet):_
The Optinate 35 mg tablet should be taken orally on the same day each
week.
The absorption of risedronate sodium is affected by food, thus to
ensure a