TOFRANIL 25 imipramine hydrochloride 25mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

imipramine hydrochloride, Quantity: 25 mg

Available from:

Amdipharm Mercury Australia Pty Ltd

Pharmaceutical form:

Tablet, sugar coated

Composition:

Excipient Ingredients: titanium dioxide; microcrystalline cellulose; colloidal anhydrous silica; sucrose; magnesium stearate; stearic acid; lactose monohydrate; hypromellose; maize starch; glycerol; povidone; iron oxide red; macrogol 8000; Carnauba Wax; purified talc; copovidone

Administration route:

Oral

Units in package:

50

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Major depression. Nocturnal enuresis (from the age of 5 years onwards and provided the possibility of organic causes has first been excluded).

Product summary:

Visual Identification: Reddish-brown, round, biconvex, sugar-coated tablets; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1997-09-16

Patient Information leaflet

TOFRANIL
®
_10 MG AND 25 MG TABLETS_
_Imipramine hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tofranil. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you or your child taking
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 need to read it again.
WHAT TOFRANIL IS USED
FOR
Tofranil is used to treat:
1.
Depression that is longer lasting
and/or more severe than the "low
moods" that everyone has from
time to time due to the stress of
everyday life. It is thought to be
caused by a chemical imbalance
in parts of the brain. This
imbalance affects your whole
body and can cause emotional
and physical symptoms such as
feeling low in spirit, loss of
interest in activities, being unable
to enjoy life, poor appetite or
overeating, disturbed sleep, loss
of sex drive, lack of energy and
feeling guilty over nothing.
2.
Bed-wetting in people from the
age of 5 years onwards if there is
no physical cause for the problem
(i.e. there is nothing wrong with
the bladder itself).
Tofranil belongs to a group of
medicines called tricyclic
antidepressants (TCAs).
Tofranil corrects this chemical
imbalance and may help relieve the
symptoms of depression.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
This me

Summary of Product characteristics

TOFRANIL
®
1
AUSTRALIAN PRODUCT INFORMATION
TOFRANIL
®
IMIPRAMINE HYDROCHLORIDE
TABLET
1
NAME OF THE MEDICINE
Imipramine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tofranil 10 tablets contain 10 mg imipramine hydrochloride.
Tofranil 25 tablets contain 25 mg imipramine hydrochloride.
Excipients with known effect: Lactose monohydrate, Sucrose
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Tofranil 10: The tablets are red-brown, triangular-shaped, convex,
sugar-coated tablets
printed “FT” on one side in white ink.
Tofranil 25: The tablets are reddish-brown, round, biconvex,
sugar-coated tablets printed
“CZ” on one side in white ink.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Major depression.
•
Nocturnal enuresis (from the age of 5 years onwards and provided the
possibility of
organic causes has first been excluded).
4.2 DOSE AND METHOD OF ADMINISTRATION
GENERAL
The dosage should be determined individually and adapted to the
patient's condition. In
principle, every effort must be made to achieve an optimum effect
while keeping the dose as
low as possible and increasing the dosage cautiously, particularly
when treating elderly
patients, who generally show a more marked response to Tofranil than
patients belonging to
intermediate age groups.
TOFRANIL
®
2
During treatment with Tofranil patients must be kept under close
surveillance with respect
to the efficacy and tolerability of the medication.
MAJOR DEPRESSION
Treatment in ambulatory patients:
Initiate treatment with 25 mg up to three times daily. Raise the daily
dosage stepwise to
150 to 200 mg. This dosage should be reached by the end of the first
week and adhered to
until a clear-cut improvement has occurred. The subsequent maintenance
dose, which must
be individually determined by cautiously reducing the dosage, usually
amounts to 50 to
100 mg daily.
Treatment in hospitalised patients:
Initiate treatment with 25 mg three times a day. Raise the daily
dosage stepwise by 25 mg,
until