Apo-Risedronate risedronate sodium 150 mg tablets blister pack

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

risedronate sodium hemipentahydrate, Quantity: 173.4 mg

थमां उपलब्ध:

Arrotex Pharmaceuticals Pty Ltd

INN (इंटरनेशनल नाम):

Risedronate sodium hemipentahydrate

फार्मास्यूटिकल फॉर्म:

Tablet, film coated

रचना:

Excipient Ingredients: hypromellose; magnesium stearate; crospovidone; titanium dioxide; hyprolose; colloidal anhydrous silica; macrogol 8000; lactose; monobasic sodium phosphate dihydrate; dibasic sodium phosphate; indigo carmine aluminium lake; monobasic sodium phosphate monohydrate

प्रशासन का मार्ग:

Oral

पैकेज में यूनिट:

3, 2, 4, 1

वर्ग:

Medicine Registered

प्रिस्क्रिप्शन प्रकार:

(S4) Prescription Only Medicine

चिकित्सीय संकेत:

The treatment of osteoporosis,The treatment of glucocorticoid-induced osteoporosis,The preservation of bone-mineral density in patients on long term corticosteroid therapy

उत्पाद समीक्षा:

Visual Identification: Blue, round, biconvex coated tablet. Engraved "APO" on one side, "RIS" over "150" on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2012-03-08

सूचना पत्रक

APO- RISEDRONATE TABLETS
1
APO- RISEDRONATE
TABLETS
_Risedronate sodium hemipentahydrate _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about risedronate. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Risedronate is used to treat
osteoporosis, including osteoporosis
caused by taking steroids. It is also
used to preserve bone mineral
density in patients on long term
steroid therapy.
_OSTEOPOROSIS _
Throughout life, old bone is broken
down and replaced with new bone.
After the age of 35, bone loss may
occur faster than your body can
replace it. Excessive bone loss causes
bones to become thinner and weaker,
and therefore more likely to break.
Osteoporosis is a disease that
gradually weakens bones. Early
osteoporosis may not show
symptoms. However, if left
untreated, it can result in broken
bones. Osteoporosis can also cause
back pain, height loss and a curved
back.
_HOW IT WORKS _
Risedronate works by slowing down
the process of old bone being
removed, which allows the bone-
forming cells time to rebuild normal
bone. This reverses the progression
of osteoporosis by creating stronger
bone which is less likely to fracture.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
There is not enough information to
recommend the use of risedronate in
children under the age of 18 years.
BEFORE YOU USE THIS
MEDICINE
_

उत्पाद विशेषताएं

1
AUSTRALIAN PRODUCT INFORMATION
APO-RISEDRONATE (RISEDRONATE SODIUM
HEMIPENTAHYDRATE) TABLETS
1
NAME OF THE MEDICINE
Risedronate sodium hemipentahydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 35, 75 or 150 mg risedronate sodium as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Contains sugars as Lactose
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
FILM COATED TABLETS:
35 MG TABLETS
Orange, round, biconvex coated tablets, engraved “APO” on one
side, “RIS” over “35” on the
other side.
75 MG TABLETS
Dark pink, round, biconvex coated tablet, engraved “APO” on one
side, “RIS” over “75” on the
other side.
150 MG TABLETS
Blue, round, biconvex coated tablet, engraved “APO” on one side,
“RIS” over “150” on the
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of osteoporosis
•
Treatment of glucocorticoid-induced osteoporosis.
•
Preservation of bone mineral density in patients on long-term
corticosteroid therapy.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
Risedronate tablets are intended for oral administration.
DOSAGE
Risedronate must only be taken with PLAIN WATER.
Plain water is the only drink that should be taken with risedronate
tablets. Note that some
mineral waters or water from regional areas may have a higher
concentration of calcium and
therefore should not be used.
Risedronate must be taken 30 minutes before the first food or drink
other than water.
To facilitate delivery to the stomach, risedronate should be taken
while the patient is in an
upright position and the patients should avoid lying down for 30
minutes.
Patients should not chew or suck the tablet because of the potential
for oropharyngeal irritation.
OSTEOPOROSIS
The recommended dose is either:
•
5 mg daily;
•
35 mg once-a-week, taken on the same day each week;
•
75 mg taken for two consecutive days on the same dates each month; or
•
150 mg taken once-a-month. The tablet should be taken on the same date
ea