Dosulepin Hydrochloride Azure 75 mg Coated Tablets

国: マルタ

言語: 英語

ソース: Medicines Authority

から入手可能:

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

ATCコード:

N06AA16

INN（国際名）:

DOSULEPIN HYDROCHLORIDE 75 mg

医薬品形態:

TABLET

構図:

DOSULEPIN HYDROCHLORIDE 75 mg

処方タイプ:

POM

治療領域:

PSYCHOANALEPTICS

製品概要:

Licence number in the source country: NOT APPLICAPABLE

認証ステータス:

Withdrawn

承認日:

2023-02-24

情報リーフレット

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DOSULEPIN HYDROCHLORIDE AZURE 75 MG COATED TABLETS
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 Azure 75 mg
Coated Tablets (called
Dosulepin in this leaflet). The active ingredient in Dosulepin
Hydrochloride is dosulepin.
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 tr

製品の特徴

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dosulepin Hydrochloride Azure 75 mg Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 75 mg of dosulepin hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White circular, convex sugar-coated tablets plain on both sides.
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.
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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 depression; the subject should be monitored closely during
this period. The anxiolytic
effect may be observed within a few days o