RISEDRONATE SANDOZ risedronate sodium 35mg tablet blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

risedronate sodium, Quantity: 35 mg

Tilgjengelig fra:

Sandoz Pty Ltd

INN (International Name):

Risedronate sodium

Legemiddelform:

Tablet, film coated

Sammensetning:

Excipient Ingredients: magnesium stearate; crospovidone; lactose monohydrate; iron oxide yellow; macrogol 400; hypromellose; titanium dioxide; iron oxide red; microcrystalline cellulose

Administreringsrute:

Oral

Enheter i pakken:

4

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Treatment of osteoporosis. Treatment of glucocorticoid induced osteoporosis. Preservation of bone mineral density in patients on long-term corticosteroid therapy

Produkt oppsummering:

Visual Identification: orange, oval, biconvex film-coated tablet marked 35 on one side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

2010-01-27

Informasjon til brukeren

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

Preparatomtale

210622-risedronate-sandoz-pi
Page 1 of 23
AUSTRALIAN PRODUCT INFORMATION
RISEDRONATE SANDOZ
®
(RISEDRONATE SODIUM) FILM-COATED
TABLET
1
NAME OF THE MEDICINE
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.
_Excipient with known effect:_
Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Risedronate Sandoz is an orange, oval, biconvex film-coated tablet
marked 35 on one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
•
Treatment of osteoporosis
•
Treatment of glucocorticoid-induced osteoporosis
•
Preservation of bone mineral density in patients on long-term
corticosteroid therapy.
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.
210622-risedronate-sandoz-pi
Page 2 of 23
DOSAGE ADJUSTMENT IN:

renal impairment
No dose adjustment is necessary in patients with mild to moderate
renal insufficiency
(creatinine clearance 30 to 60 mL/min). Risedronate Sandoz is not
recommended in patients
with severe renal impairment (creatinine clearance < 30 mL/min) due to
limited clinical data.

men
The dosage is 35 mg/week.

hepatic impairment
Dose adjustments are unlikely to be ne