Arrow - Tolterodine 1

Երկիր: Նոր Զելանդիա

Լեզու: անգլերեն

Աղբյուրը: Medsafe (Medicines Safety Authority)

Ակտիվ բաղադրիչ:

Tolterodine tartrate 1mg equivalent to tolterodine 0.68 mg

Հասանելի է:

Teva Pharma (New Zealand) Limited

INN (Միջազգային անվանումը):

Tolterodine tartrate 1 mg (equivalent to tolterodine 0.68 mg)

Դոզան:

1 mg

Դեղագործական ձեւ:

Film coated tablet

Կազմը:

Active: Tolterodine tartrate 1mg equivalent to tolterodine 0.68 mg Excipient: Colloidal silicon dioxide Magnesium stearate Microcrystalline cellulose Opadry white 03F58763 Purified water   Sodium starch glycolate

Միավորները փաթեթում:

Blister pack, PVC/PVdC/Aluminium, 14 tablets

Դաս:

Prescription

Ռեկվիզորի տեսակը:

Prescription

Պատրաստված է:

Interquim, S.A.

Թերապեւտիկ ցուցումներ:

Arrow – Tolterodine 1 & Arrow Tolterodine 2 are indicated for the treatment of overactive bladder with symptoms of urinary urgency, frequency, and/or urge incontinence.

Ապրանքի ամփոփագիր:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Aluminium - 14 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVdC/Aluminium - 28 tablets -   - Blister pack, PVC/PVdC/Aluminium - 56 tablets - 36 months from date of manufacture stored at or below 25°C

Հաստատման ամսաթիվը:

2010-07-22

Տեղեկատվական թերթիկ

Arrow - Tolterodine 1 & Arrow - Tolterodine 2
Page 1 of 8
CONSUMER MEDICINE INFORMATION
ARROW – TOLTERODINE 1 & ARROW
TOLTERODINE 2
1 MG & 2 MG TABLETS
_Tolterodine L-Tartrate_
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Arrow - Tolterodine 1
&
Arrow - Tolterodine 2. It does not contain all the available
information and
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 this medicine against the benefits it is expected to have
for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT ARROW - TOLTERODINE 1 & ARROW - TOLTERODINE 2 IS
USED FOR
Arrow - Tolterodine 1 & Arrow - Tolterodine 2 is used to treat
symptoms of an
overactive bladder, for example, urinary frequency, urgency or
incontinence.
Arrow - Tolterodine 1 & Arrow - Tolterodine 2 belong to a group of
medicines
called antimuscarinics. 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, ASK YOUR DOCTOR
IF YOU
HAVE ANY QUESTIONS ABOUT WHY ARROW - TOLTERODINE 1 & ARROW -
TOLTERODINE 2 HAS BEEN PRESCRIBED FOR YOU.
This medicine is only available with a doctor’s prescription.
BEFORE
YOU
TAKE
ARROW
-
TOLTERODINE
1
&
ARROW
-
TOLTERODINE 2
Arrow - Tolterodine 1 & Arrow - Tolterodine 2
Page 2 of 8
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ARROW - TOLTERODINE 1 & ARROW - TOLTERODINE 2 IF:
1. YOU HAVE AN ALLERGIC REACTION TO:
•
tolterodine or any other antimuscarinic medicine,
•
any of the other ingredients listed at the end of this leaflet.
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 UNCONTROLLED HIGH PR

Ապրանքի հատկությունները

Version 1.0
Page
1
of
8
NEW ZEALAND DATA SHEET
1 NAME OF THE MEDICINE
Arrow – Tolterodine 1, 1 mg, film coated tablets
Arrow – Tolterodine 2, 2 mg, film coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg or 2 mg tolterodine tartrate
For the full list of excipients, see Section 6.
1 List of excipients.
3 PHARMACEUTICAL FORM
Tablets 1 mg: White to off white, round, biconvex, film coated
tablets, debossed with “S16” on one
side and plain on other side.
Tablets 2 mg: White to off white, round, biconvex, film coated
tablets, debossed with “S042” on one
side and plain on other side.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Arrow – Tolterodine 1 and Arrow - Tolterodine 2 are indicated for
the treatment of overactive bladder
with symptoms of urinary urgency, frequency, and/or urge incontinence.
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dose is 2 mg twice a day. In the case of troublesome
side-effects the dose may be
reduced from 2 mg to 1 mg twice a day.
The recommended dose is 1 mg twice a day for patients with impaired
renal function, impaired liver
function, or receiving concomitant ketoconazole or other potent CYP3A4
inhibitors.
After six months the need for further treatment should be considered.
Safety and effectiveness in children have not been established.
4.3
CONTRAINDICATIONS
Tolterodine is contraindicated in patients with:
•
known hypersensitivity to tolterodine or any other component of the
drug
•
urinary retention
•
uncontrolled narrow angle glaucoma
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Tolterodine should be used with caution in the following patients:
•
at risk for urinary retention
•
at risk for decreased gastrointestinal motility
•
with impaired renal function. The recommended total daily dose is 2 mg
(see
Section 4.2 Dose
and method of administration, and Section 5.2 Pharmacokinetic
properties – Specific Patient
Groups)
•
with impaired hepatic function. The recommended total daily dose is 2
mg (see Section 4.2 Do