ACTONEL ONCE-A-MONTH risedronate sodium 150 mg tablet blister pack

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

risedronate sodium, Quantity: 150 mg

Inapatikana kutoka:

Theramex Australia Pty Ltd

INN (Jina la Kimataifa):

Risedronate sodium

Dawa fomu:

Tablet, film coated

Tungo:

Excipient Ingredients: macrogol 8000; microcrystalline cellulose; hyprolose; colloidal anhydrous silica; hypromellose; crospovidone; indigo carmine; titanium dioxide; magnesium stearate; macrogol 400

Njia ya uendeshaji:

Oral

Vitengo katika mfuko:

2 tablets per carton, 1 tablet per carton, 4 tablets per carton, 3 tablets per carton

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

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

Bidhaa muhtasari:

Visual Identification: Light blue oval shaped film-coated tablet with "RSN" engraved on one side and "150 mg" on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 60 Months; Container Temperature: Store below 25 degrees Celsius

Idhini hali ya:

Licence status A

Idhini ya tarehe:

2009-03-04

Taarifa za kipeperushi

ACTONEL
®
A
C
T
O
N
E
L
®
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 ACTONEL?
Actonel contains the active ingredient risedronate sodium. Actonel 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 Actonel? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ACTONEL
Do not use if you have ever had an allergic reaction to Actonel 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 Actonel? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Actonel 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 ACTONEL?
For osteoporosis, the usual dose is one 5mg tablet each day or one
150mg tablet once a month. For Paget's disease of the bone,
the usual dose is one 30 mg tablet each day for 2 months. More
instructions can be found in Section 4. How do I use Actonel? in the
full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ACTONEL?
THINGS YOU SHOULD DO
•
Tell any doctors, dentists and pharmacists who are treating you that
you are taking Actonel.
•
If you require a dental procedure tell your dentist that you are
taking Actonel. Invasive dental
procedures should be avoided where possible.
•
If you become pregnant while taking Actonel tell your doctor or
pharmacist.
•
If you are about to be started on any new medicine, tell your doctor,
dentist or pharmacist that
you are taking Actonel.
THINGS YOU SHOULD NOT
DO
•
Do not stop using this medicine without checking with your doctor or
pharmacist.
•
Do not lie down for 30 minutes after taking Acton

Tabia za bidhaa

ACTONEL
®
(Risedronate sodium)
Theramex Australia Pty Ltd
Version 1.1
1
AUSTRALIAN PRODUCT INFORMATION – ACTONEL
® AND
ACTONEL
® ONCE-A-MONTH (RISEDRONATE SODIUM) FILM-
COATED TABLETS
1
NAME OF THE MEDICINE
Risedronate sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Actonel tablet contains the equivalent of 5 or 30 mg of
risedronate sodium.
Each Actonel Once-a-Month tablet contains the equivalent of 150 mg of
risedronate sodium.
Excipients with known effect:
•
Sugars as lactose (5 or 30 mg tablets only)
For the full list of excipients, see Section 6.1 - List of Excipients.
3
PHARMACEUTICAL FORM
Film-coated tablet
Actonel 5 mg tablets: oval, yellow film-coated tablets with RSN
embossed on one side and 5 mg
on the other side.
Actonel 30 mg tablets: oval, white film-coated tablets with RSN
embossed on one side and
30 mg on the other side.
Actonel 150 mg Once-a-Month tablets: oval, light-blue film-coated
tablets with RSN engraved
on one side and 150 mg on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Actonel 5 mg and 150 mg Tablets
•
Treatment of osteoporosis
•
Treatment of glucocorticoid-induced osteoporosis
•
Preservation of bone mineral density in patients on long term
corticosteroid therapy
Actonel 30 mg Tablet
•
Treatment of Paget’s disease of bone
ACTONEL
®
(Risedronate sodium)
Theramex Australia Pty Ltd
Version 1.1
2
4.2
DOSE AND METHOD OF ADMINISTRATION
Actonel must only be taken with plain water.
Plain water is the only drink that should be taken with Actonel
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.
Actonel must be taken 30 minutes before the first food or drink other
than water. To facilitate
delivery to the stomach, Actonel 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.
OSTEOPOROSIS:
_Actonel 5 mg _
The r