Actonel Plus Ca & D 35mg film-coated tablets + 1000mg/880 IU effervescent granules

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Risedronate sodium; Calcium carbonate; Colecalciferol

Disponibil de la:

Theramex Ireland Limited

Codul ATC:

M05BB; M05BB04

INN (nume internaţional):

Risedronate sodium; Calcium carbonate; Colecalciferol

Dozare:

35 mg + 1000 mg/880  international unit(s)

Forma farmaceutică:

Effervescent granules + film-coated tablet

Zonă Terapeutică:

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

Statutul autorizaţiei:

Marketed

Data de autorizare:

2007-10-12

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACTONEL® PLUS CA & D 35MG + 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 Actonel Plus Ca & D is and what it is used for
2. What you need to know before you take Actonel Plus Ca & D
3. How to take Actonel Plus Ca & D
4. Possible side effects
5. How to store Actonel Plus Ca & D
6. Contents of the pack and other information
1. WHAT ACTONEL PLUS CA & D IS AND WHAT IT IS USED FOR
WHAT ACTONEL PLUS CA & D IS
A combination medicine containing tablets of Actonel and sachets of
calcium/ vitamin D
3
.
⃝ _Actonel tablets _
Actonel 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 have
known that you had it.
_Calc

Caracteristicilor produsului

Health Products Regulatory Authority
12 May 2022
CRN00CX7K
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actonel Plus Ca & D 35mg film-coated tablets + 1000mg/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 1000 mg calcium as 2500
mg calcium carbonate and 22 micrograms (880 IU)
colecalciferol (vitamin D3).
Excipients with known effect:
Each film-coated tablet contains 126.0 mg of lactose monohydrate
equivalent to 119.7 mg lactose.
Each sachet of effervescent granules contains 163 mg potassium, 1.7 mg
sucrose, and 1.1 mg sorbitol.
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).
Actonel Plus Ca & D is only intended for use in assessed patients for
whom the amount of calcium and vitamin D3
included is considered to provide adequate supplementation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Actonel Plus Ca & D is a combination product consisting of Actonel
35mg film-coated tablet or tablets and calcium/vitamin D3
sachets in a box.
Posology
The recommended dose in adults is 1 Actonel 35 mg tablet on the first
day followed on the next day by 1 calcium/vitamin
D3 sachet daily for 6 days. This 7-day sequence is then repeated each
week starting with Actonel 35 mg tablet.
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. This has also been shown in the very
elderly, 75 year