Risedronate Sandoz

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Risedronate sodium hemipentahydrate 40.2mg equivalent to risedronate sodium 35 mg and = risedronic acid 32.5 mg

Available from:

Sandoz New Zealand Limited

INN (International Name):

Risedronate sodium hemipentahydrate 40.2 mg (= risedronate sodium 35 mg and = risedronic acid 32.5 mg)

Dosage:

35 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Risedronate sodium hemipentahydrate 40.2mg equivalent to risedronate sodium 35 mg and = risedronic acid 32.5 mg Excipient: Crospovidone Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry orange 03B32322

Units in package:

Blister pack, PVC/Al, 4 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Chr Olesen Synthesis A/S

Therapeutic indications:

· Treatment of osteoporosis · Treatment of glucocorticoid-induced osteoporosis · Treatment of postmenopausal osteoporosis

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Al - 4 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2012-11-08

Patient Information leaflet

Risedronate Sandoz®
1
RISEDRONATE SANDOZ®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING RISEDRONATE SANDOZ?
Risedronate Sandoz contains the active ingredient risedronate sodium.
Risedronate Sandoz is used to treat bone disease and
belongs to a group of medicines called bisphosphonates. For more
information, see Section 1. Why am I using Risedronate
Sandoz? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE RISEDRONATE SANDOZ?
Do not use if you have ever had an allergic reaction to risedronate
sodium or any of the ingredients listed at the end of the
CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS,
TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO
BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see
Section 2. What should I know before I use Risedronate
Sandoz? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Risedronate Sandoz and affect how it
works. A list of these medicines is in Section 3. What
if I am taking other medicines? in the full CMI.
4.
HOW DO I USE RISEDRONATE SANDOZ?
•
For osteoporosis, the usual dose is one 35mg tablet each week.
•
Take your Risedronate Sandoz tablet while sitting or standing upright.
•
Swallow your Risedronate Sandoz tablet whole with a glass of plain
water (at least 120mL). Do not chew, cut , crush or
suck the tablet.
•
Risedronate Sandoz should be taken in the morning either with or
without food. More instructions can be found in Section
4. How do I use Risedronate Sandoz? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING RISEDRONATE SANDOZ?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist and pharmacist who are treating you that
you are taking Risedronate
Sandoz.
•
If you require a dental procedure tell your dentist that you are
taking Risedronate Sandoz. Invasive
dental procedures should be avoided where possible.
•
If you develop a toothach

Summary of Product characteristics

230320-Risedronate Sandoz-ds
Page 1 of 22
NEW ZEALAND DATA SHEET
RISEDRONATE SANDOZ (RISEDRONATE SODIUM) FILM-COATED TABLETS
1.
PRODUCT NAME
Risedronate sodium
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Risedronate Sandoz 35 mg film-coated tablet contains 35 mg
risedronate sodium
equivalent to 32.5 mg risedronic acid.
Risedronate sodium is a fine, white to off white, odourless,
crystalline powder. It is soluble in
water and in aqueous solutions and essentially insoluble in common
organic solvents.
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Risedronate Sandoz 35 mg
_ - _
orange, oval, biconvex film-coated tablets marked 35 on one side
and containing 35 mg risedronate sodium.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Treatment of Osteoporosis.
Prevention of Glucocorticoid-induced Osteoporosis.
Treatment of Postmenopausal Osteoporosis.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
The recommended dose is 35 mg once a week, taken on the same day each
week.
METHOD OF ADMINISTRATION
Risedronate Sandoz must only be taken with plain water. Plain water is
the only drink that
should be taken with Risedronate Sandoz tablets. Please note that some
mineral waters or
water from regional areas may have a higher concentration of calcium
and therefore should
not be used.
Risedronate Sandoz must be taken 30 minutes before the first food or
drink other than water.
To facilitate delivery to the stomach, Risedronate Sandoz should be
taken in an upright
position and the patient should avoid lying down for 30 minutes.
Patients should not chew or suck on the tablet because of the
potential for oropharyngeal
irritation.
DOSAGE ADJUSTMENT IN:

renal impairment
No dose adjustment is necessary in patients with mild to moderate
renal insufficiency
(creatinine clearance 30 to 60 mL/minute). Risedronate Sandoz is not
recommended in patients
230320-Risedronate Sandoz-ds
Page 2 of 22
with severe renal impairment (creatinine clearance < 30 mL/minute) due
to limited clinical
data.

Children
Ri