DETRUSITOL tolterodine tartrate 2mg tablet blister pack

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

tolterodine tartrate, Quantity: 2 mg

थमां उपलब्ध:

Viatris Pty Ltd

फार्मास्यूटिकल फॉर्म:

Tablet, film coated

रचना:

Excipient Ingredients: stearic acid; calcium hydrogen phosphate dihydrate; microcrystalline cellulose; colloidal anhydrous silica; sodium starch glycollate; titanium dioxide; hypromellose; magnesium stearate

प्रशासन का मार्ग:

Oral

पैकेज में यूनिट:

28 Tablets, 56 Tablets, 140 Tablets, 14 Tablets

प्रिस्क्रिप्शन प्रकार:

(S4) Prescription Only Medicine

चिकित्सीय संकेत:

DETRUSITOL is indicated for the treatment of patients with overactive bladder with symptoms of urinary frequency, urgency or incontinence or any combination of these symptoms.

उत्पाद समीक्षा:

Visual Identification: white round biconvex film-coated tablet engraved with arcs above and below the letters DT; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2004-12-15

सूचना पत्रक

DETRUSITOL
®
_tolterodine tartrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DETRUSITOL. 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 taking
DETRUSITOL against the benefits it
is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
Read this leaflet carefully before you
start DETRUSITOL.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT DETRUSITOL IS
USED FOR
DETRUSITOL is used to treat
symptoms of an overactive bladder,
for example urinary frequency,
urgency or incontinence.
DETRUSITOL belongs to a group of
medicines called antispasmodics. It
helps to control the release of urine
by reducing spasm, and relaxing the
smooth muscle of the bladder wall. It
also increases the storage volume of
the bladder, and can act on the brain
to delay the desire to urinate.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
DETRUSITOL HAS BEEN
PRESCRIBED FOR YOU.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
DETRUSITOL
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE DETRUSITOL IF:
1.
you have an allergy to
•
tolterodine
•
any of the ingredients listed at the
end of this leaflet
•
any other similar medicines
Some of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathing; swelling of the face, lips,
tongue or other parts of the body;
rash, itching or hives on the skin.
2.
you are unable to pass urine
3.
you have a blocked gastro-
intestinal tract or other gastro-
intestinal disorders (ulcerative
colitis, toxic megacolon)
4.
you have uncontrolled high
pressure in the eye (narrow angle
glaucoma)
5.
you have a disease of the muscles
causing drooping eyelids, double
vision, difficulty in speaking and
swallowing and sometimes
muscle we

उत्पाद विशेषताएं

Version: ujpdetrt10821
Supersedes: pfpdetrt11219
Page 1 of 16
AUSTRALIAN PRODUCT
INFORMATION –
DETRUSITOL
® (TOLTERODINE TARTRATE)
1.
NAME OF THE MEDICINE
tolterodine tartrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DETRUSITOL
tablets
contain
the
active
substance
tolterodine
tartrate,
a
competitive
muscarinic receptor antagonist.
DETRUSITOL Tablets 1 mg, contain 1 mg of tolterodine tartrate as the
active ingredient.
DETRUSITOL Tablets 2 mg, contain 2 mg of tolterodine tartrate as the
active ingredient.
3.
PHARMACEUTICAL FORM
Tablet, film coated
The 1 mg tablet is white, round, biconvex, film-coated, engraved with
arcs above and below
the letters “TO”.
The 2 mg tablet is white, round, biconvex film-coated, engraved with
arcs above and below the
letters “DT”.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DETRUSITOL is indicated for the treatment of patients with overactive
bladder with
symptoms of urinary frequency, urgency or incontinence or any
combination of these
symptoms.
4.2 DOSE AND METHOD OF ADMINISTRATION
The recommended oral dose for tolterodine tablets is 2 mg twice daily.
The dose may be
lowered to 1 mg twice daily based on individual response and
tolerability. For patients with
significantly reduced hepatic function or severely impaired renal
function (GFR

30 mL/min),
the recommended dose is 1 mg twice daily (See Section 4.4 Special
warnings and precautions
for use).
Concomitant administration with potent CYP3A4 inhibitors is not
recommended (See Section
4.5 Interactions with other medicines and other forms of interactions
-
Cytochrome P450 3A4
inhibitors).
Version: ujpdetrt10821
Supersedes: pfpdetrt11219
Page 2 of 16
After 6 months the need for further treatment should be considered.
4.3 CONTRAINDICATIONS
DETRUSITOL
is
contraindicated
in
patients
with
urinary
retention;
gastric
retention;
uncontrolled narrow angle glaucoma; myasthenia gravis; severe
ulcerative colitis; toxic
megacolon.
DETRUSITOL
is
also
contraindicated
in
patients
who
have
demonstrated
hypersensitivity to the