Dosulepin Viatris

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Dosulepin hydrochloride 75mg; Dosulepin hydrochloride 75mg; Dosulepin hydrochloride 75mg

Available from:

Viatris Limited

INN (International Name):

Dosulepin hydrochloride 75 mg

Dosage:

75 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Dosulepin hydrochloride 75mg Excipient: Carnauba wax Clear film coat 5544 + colour film coat 5553 Lactose monohydrate Magnesium stearate Maize starch Povidone Purified talc Sodium starch glycolate Active: Dosulepin hydrochloride 75mg Excipient: Carnauba wax Diethyl phthalate Ethanol Hypromellose Lactose monohydrate Magnesium stearate Maize starch Opaspray red K-1F-4972 Povidone Purified talc Purified water Sodium starch glycolate Active: Dosulepin hydrochloride 75mg Excipient: Opadry Red OY-B-25005 Lactose monohydrate Magnesium stearate Maize starch Povidone Purified talc Sodium starch glycolate

Units in package:

Blister pack, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Dipharma Francis Srl

Therapeutic indications:

Depression of any aetiology and the anxiety frequently associated with depressive illness.

Product summary:

Package - Contents - Shelf Life: Blister pack, Al/PVC/PVdC - 30 tablets - 36 months from date of manufacture stored at or below 30°C. (The product manufactured at Alphapharm Pty Ltd) - Blister pack, - 100 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1989-09-22

Patient Information leaflet

NEW ZEALAND CONSUMER MEDICINE INFORMATION
DOSULEPIN VIATRIS
_DOSULEPIN (DOTHIEPIN) 75MG TABLETS_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Dosulepin Viatris.
It does not contain all the
information available on this
medicine. 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 Dosulepin
Viatris against the benefits they
expect it will have for you.
If you have any concerns about
using this medicine, ask your doctor
or pharmacist.
Keep this leaflet. You may want to
read it again.
WHAT DOSULEPIN
VIATRIS IS USED FOR
AND HOW IT WORKS
Your Dosulepin Viatris tablets
contain dosulepin hydrochloride. It
belongs to a group of medicines
known as tricyclic antidepressants
(TCAs).
Dosulepin Viatris is used to treat
depression and the anxiety
associated with depression.
Depression may affect your whole
body and may 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, often waking up
early, loss of sex drive, lack of
energy and feeling guilty over
nothing.
Your doctor may, however,
prescribe Dosulepin Viatris for
another reason. Ask your doctor if
you have any questions about why
Dosulepin Viatris has been
prescribed for you.
DOSULEPIN VIATRIS IS NOT
RECOMMENDED FOR USE IN CHILDREN
12 YEARS OF AGE AND UNDER.
DOSULEPIN VIATRIS IS NOT
RECOMMENDED FOR USE IN
ADOLESCENTS (13-18 YEARS OF AGE)
FOR THE TREATMENT OF DEPRESSION,
UNLESS UNDER THE SUPERVISION OF A
SPECIALIST.
Dosulepin Viatris is available on
prescription from your doctor.
BEFORE YOU TAKE
DOSULEPIN VIATRIS
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE DOSULEPIN VIATRIS IF:
•
you are allergic to
dosulepin, other tricyclic
antidepressants or any
other ingredients listed at
the end of this leaflet
•
you have liver problems
•
you are taking a medicine
called a monoamine
oxidase inhibitor (MAOI) or
have been taking a MAOI

Summary of Product characteristics

Page 1 of 11
NEW ZEALAND DATA SHEET
DOSULEPIN VIATRIS
1. PRODUCT NAME
DOSULEPIN VIATRIS, 75 mg film-coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each DOSULEPIN VIATRIS 75 mg film-coated tablet contains 75 mg of
dosulepin (dothiepin)
hydrochloride.
Excipient with known effect: sulfites, soya bean products and lactose
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
DOSULEPIN VIATRIS 75 mg tablets: 8.5 mm, normal, convex, red,
film-coated tablet debossed
“DT/75” on one side and “α” on the other.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Depression of any aetiology and the anxiety frequently associated with
depressive illness.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSE
_ADULTS_
75 mg daily in divided doses or as a single dose at night increasing
to 150 mg daily. In certain
circumstances, e.g. in hospital use, dosages up to 225 mg daily have
been used.
ELDERLY
50-75 mg daily initially. Half the normal adult dose may be sufficient
to produce a satisfactory clinical
response.
_ADOLESCENTS_
Not recommended for use in adolescent patients 13-18 years of age for
the treatment of depression,
unless under the supervision of a specialist.
_4.3_
_CONTRAINDICATIONS_

Dosulepin is contraindicated for the treatment of depression in
patients 12 years of age and
under.

Dosulepin is contraindicated for the treatment of nocturnal enuresis.

Epilepsy; seizure thresholds may be lowered by the medicine.
Page 2 of 11

Tricyclic antidepressants should not be used concomitantly or within
14 days of treatment with
MAOIs since the combination may cause cerebral excitation followed by
coma and dangerous
hyperthermia.

Acute recovery phase following myocardial infarction; tricyclic
antidepressants may produce
conduction defects and arrhythmias.

Hepatic failure.

Hypersensitivity to dosulepin or to any of the excipients listed in
section 6.1.
_4.4_
_SPECIAL WARNINGS AND PRECAUTIONS FOR USE_
Due to its toxicity in overdose, dosulepin should only be used in