SAMSCA tolvaptan 15 mg tablet blister pack

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

tolvaptan, Quantity: 15 mg

Tersedia dari:

Otsuka Australia Pharmaceutical Pty Ltd

INN (Nama Internasional):

Tolvaptan

Bentuk farmasi:

Tablet

Komposisi:

Excipient Ingredients: hyprolose; magnesium stearate; microcrystalline cellulose; indigo carmine aluminium lake; lactose monohydrate; maize starch

Rute administrasi :

Oral

Unit dalam paket:

30 tablets per blister per pack, 10 tablets per blister per pack

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

SAMSCA is indicated for the treatment of clinically significant hypervolemic or euvolemic hyponatremia (serum sodium less than 125 mmol/L, or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction) including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH).

Ringkasan produk:

Visual Identification: blue triangular tablets debossed with 'OTSUKA' and '15' on one side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status otorisasi:

Licence status A

Tanggal Otorisasi:

2012-04-05

Selebaran informasi

SAMSCA
®
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A
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®
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 SAMSCA?
SAMSCA contains the active ingredient tolvaptan. SAMSCA is used to
treat hyponatraemia in adults, including patients who have
conditions such as heart failure, and “syndrome of inappropriate
antidiuretic hormone secretion” (SIADH).
For more information, see Section 1. Why am I using SAMSCA? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE SAMSCA?
Do not use if you have ever had an allergic reaction to SAMSCA 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 take
SAMSCA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with SAMSCA 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 TAKE SAMSCA?
•
Take SAMSCA once a day with or without food
•
The dose can be from 15 mg to 60 mg once a day
More instructions can be found in Section 4. How do I take SAMSCA? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING SAMSCA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
SAMSCA
•
Make sure you have access to water and continue to drink when thirsty
THINGS YOU
SHOULD NOT DO
•
Do not stop taking SAMSCA or lower the dose unless you notice side
effects requiring urgent medical
attention or if your doctor tells you to do so
•
Do not use SAMSCA to treat any complaint other than that directed by
your doctor
•
Do not give SAMSCA to someone else even if their symptoms are the same
DRIVING
OR USING
MACHINES
•
SAMSCA may occasionally make you feel dizzy or weak or you may faint
for a short period
DRINKING
ALCOH

Karakteristik produk

Page 1 of 18
AUSTRALIAN PRODUCT INFORMATION
SAMSCA
® (TOLVAPTAN) TABLETS
1
NAME OF THE MEDICINE
Tolvaptan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SAMSCA tablets for oral use contain 15 mg or 30 mg of tolvaptan.
Excipients with known effect: sugars as lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
SAMSCA is supplied as 15 mg and 30 mg tolvaptan tablets.
The 15 mg tablet is blue, triangular, shallow-convex, debossed with
“OTSUKA” and “15” on
one side.
The 30 mg tablet is blue, round, shallow-convex, debossed with
“OTSUKA” and “30” on one
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SAMSCA is indicated for the treatment of clinically significant
hypervolemic or euvolemic
hyponatremia (serum sodium less than 125 mmol/L, or less marked
hyponatremia that is
symptomatic and has resisted correction with fluid restriction)
including patients with heart
failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH).
IMPORTANT LIMITATIONS
Patients requiring intervention to raise serum sodium urgently to
prevent or to treat serious
neurological symptoms should not be treated with SAMSCA. It has not
been established that
raising serum sodium with SAMSCA provides a symptomatic benefit to
patients.
4.2
DOSE AND METHOD OF ADMINISTRATION
Due to the need for a dose titration phase with close monitoring of
serum sodium and volume
status,
TREATMENT WITH SAMSCA SHOULD BE INITIATED AND RE-INITIATED IN
HOSPITAL.
Treatment with SAMSCA should be initiated at a dose of 15 mg, orally,
once daily. The dose
may be increased to a maximum of 60 mg once daily as tolerated to
achieve the desired level
Page 2 of 18
of serum sodium. Increase from the starting dose should be done
incrementally (first to 30 mg
and then to 60 mg if required) at intervals ≥ 24 hours. During
titration, patients should be
monitored for serum sodium and volume status.
For patients with an appropriate increase in serum sodium, the
underlying disease and serum
sodium levels should be