Tofranil

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Imipramine hydrochloride 25mg

Available from:

AFT Pharmaceuticals Ltd

INN (International Name):

Imipramine hydrochloride 25 mg

Dosage:

25 mg

Pharmaceutical form:

Coated tablet

Composition:

Active: Imipramine hydrochloride 25mg Excipient: Carnauba wax Colloidal silicon dioxide Copovidone Glycerol Hypromellose Dispersive Red Isopropyl alcohol Lactose monohydrate Macrogol 8000 Magnesium stearate Maize starch Microcrystalline cellulose Povidone Purified talc     Purified water Stearic acid Sucrose Titanium dioxide  

Units in package:

Blister pack, PVC/PE/PVDC-Al, 50 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Plantex Ltd

Therapeutic indications:

All forms of depression, including endogenous, organic and psychogenic forms, and depression associated with personality disorders or chronic alcoholism.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC-Al - 50 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2000-12-18

Patient Information leaflet

NEW ZEALAND CONSUMER MEDICINE INFORMATION
TOFRANIL
IMIPRAMINE HYDROCHLORIDE 10 MG AND 25 MG COATED TABLETS
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.
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 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
feelings of guilt.
Tofranil belongs to a group of medicines called tricyclic
antidepressants.
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.
TOFRANIL IS NOT RECOMMENDED FOR USE IN CHILDREN 12 YEARS OF AGE AND
UNDER.
TOFRANIL IS NOT RECOMMENDED FOR USE IN ADOLESCENTS (13-18 YEARS OF
AGE) FOR THE
TREATMENT OF DEPRESSION, UNLESS UNDER THE SUPERVISION OF A SPECIALIST.
This medicine is only available with a doctor's prescription.
BEFORE YOU TAKE TOFRANIL
_WHEN YOU MUST NOT TAKE IT_
_ _
DO NOT TAKE TOFRANIL IF YOU HAVE EVER HAD AN ALLERGIC REACTION AFTER
TAKING:
•
imipramine (the active ingredient in Tofranil)
•
any of the other ingredients listed at the end of this leaflet
•
any other tricyclic antidepressant
Some of the symptoms of an allergic reaction may include shor

Summary of Product characteristics

TOFRANIL
IMIPRAMINE HYDROCHLORIDE 10 MG AND 25 MG COATED TABLETS
Page 1 of 18
DATA SHEET
1
TOFRANIL (10 MG AND 25 MG COATED TABLET)
TOFRANIL
10 mg and 25mg coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of imipramine hydrochloride
Each tablet contains 25 mg of imipramine hydrochloride
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tofranil 10 mg tablets are convex, reddish brown, sugar coated,
triangular tablets.
Tofranil 25 mg tablets are biconvex, reddish brown, sugar coated,
round tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
All forms of depression, including endogenous, organic and psychogenic
forms, and
depression associated with personality disorders or chronic
alcoholism.
4.2
DOSE AND METHOD OF ADMINISTRATION
The dosage and method of administration should be adapted to the
individual patient's
condition. The aim is to achieve an optimum effect while keeping doses
as low as possible
and
increasing them
cautiously,
particularly in elderly patients or
adolescents, who
generally show a stronger response to Tofranil than patients of the
intermediate age group.
TOFRANIL
IMIPRAMINE HYDROCHLORIDE 10 MG AND 25 MG COATED TABLETS
Page 2 of 18
_ADULTS_
_ _
_DEPRESSION AND DEPRESSIVE SYNDROMES_
Outpatients: Start treatment with 25 mg 1-3 times daily. Raise the
daily dosage gradually
to 150-200 mg. This dosage should be reached by the end of the first
week and maintained
to this dose until a clear improvement is seen. The maintenance dose,
which must be
individually determined by cautiously reducing the dosage, is usually
50-100 mg daily.
Hospitalised patients: Start treatment with 25 mg 3 times daily. Raise
the dosage by 25
mg daily until a dose of 200 mg has been reached, and keep to this
dose until the patient's
condition has improved. In severe cases the dose may be increased to
100 mg 3 times
daily. Once a clear improvement has set in, the maintenance dose
should be determined
according to the patient's individual requirements (generally