Dosulepin Hydrochloride 25 mg Hard Capsules

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Azure Pharmaceuticals Ltd 12 Hamilton Drive, The Rock Road, Blackrock, Co. Louth A91 T997, Ireland

ATC code:

N06AA16

INN (International Name):

DOSULEPIN HYDROCHLORIDE 25 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

DOSULEPIN HYDROCHLORIDE 25 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Withdrawn

Authorization date:

2022-08-11

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DOSULEPIN HYDROCHLORIDE 25 MG HARD CAPSULES
dosulepin hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their sign of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Dosulepin is and what it is used for
2.
What you need to know before you take Dosulepin
3.
How to take Dosulepin
4.
Possible side effects
5.
How to store Dosulepin
6.
Contents of the pack and other information
1. WHAT DOSULEPIN IS AND WHAT IT IS USED FOR
The name of your medicine is Dosulepin Hydrochloride 25 mg Hard
Capsules (called Dosulepin in this
leaflet). The active ingredient in Dosulepin is dosulepin
hydrochloride. Dosulepin belongs to a group of
medicines called antidepressants.
Dosulepin is used to treat depression and can also help reduce
feelings of anxiety. Please ask your doctor
or pharmacist if you need more information.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOSULEPIN
DO NOT TAKE DOSULEPIN:
•
If you are allergic to dosulepin hydrochloride or any of the other
ingredients of this medicine
(listed in section 6).
•
If you have the eye condition known as glaucoma.
•
If you are pregnant or planning to become pregnant, or are breast
feeding.
•
If you have an irregular heartbeat, recent heart attack or any other
heart problem.
•
If you have severe liver problems.
•
If you suffer from periods of exaggerated behaviour (mania).
•
If you are a child or adolescent under the age of 18 years.
•
If you are taking any of the following medicines:
•
A mono-amine oxidase inhibitor (MAOI), used to treat depression. You
shou

Summary of Product characteristics

Page
1
of
6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dosulepin Hydrochloride 25 mg Hard Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 25 mg of dosulepin hydrochloride.
Excipient(s) with known effect
Lactose monohydrate 109.40 mg per capsule.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
Hard gelatin capsule size “4” with brown opaque body and
reddish-brown opaque cap containing
white to off white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dosulepin is indicated for the management of depression and associated
anxiety.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults:_
The usual total daily dose is 75 mg to 150 mg in divided doses or as a
single night-time dose.
Treatment should be initiated at the lower dose. In certain
circumstances,
_e.g. _
in hospital use, dosages
up to 225 mg daily have been used.
Suggested regimens: 25 or 50 mg three times daily or, alternatively,
75 or 150 mg as a single dose at
night. Should the regimen of 150 mg as a single night-time dose be
adopted, it is better to give a
smaller dose for the first few days.
_Elderly:_
50 to 75 mg daily initially. As with any antidepressant, the initial
dose should be increased
with caution under close supervision. Half the normal adult dose may
be sufficient to produce a
satisfactory clinical response.
_Children:_
Not recommended.
Method of administration
For oral administration.
Page
2
of
6
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Dosulepin is contraindicated following recent myocardial infarction,
and in patients with any degree
of heart block or other cardiac arrhythmias. It is also
contraindicated in mania, severe liver disease,
narrow angle glaucoma or other causes of increased intraocular
pressure.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
It may be two to four weeks from the start of treatment before there
is an improvement in the patient's
depr