Prothiaden 75mg Coated Tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Dosulepin hydrochloride

Dostępny od:

Teofarma S.R.L.

Kod ATC:

N06AA; N06AA16

INN (International Nazwa):

Dosulepin hydrochloride

Dawkowanie:

75 milligram(s)

Forma farmaceutyczna:

Coated tablet

Typ recepty:

Product subject to prescription which may not be renewed (A)

Dziedzina terapeutyczna:

Non-selective monoamine reuptake inhibitors; dosulepin

Status autoryzacji:

Marketed

Data autoryzacji:

1977-01-12

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE USER
PROTHIADEN
75 MG COATED
T
A
BLET
S
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 questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their signs 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 Prothiaden Coated Tablets are and what they are used for
2. What you need to know before you take Prothiaden
3. How to take Prothiaden
4. Possible side effects
5. How to store Prothiaden
6. Contents of the pack and other information
1. WHAT PROTHIADEN IS AND WHAT IT IS USED FOR
The name of your medicine is Prothiaden 75mg Coated Tablets (called
Prothiaden in this leaflet). The
active ingredient in Prothiaden is dosulepin hydrochloride. Prothiaden
belongs to a group of medicines
called tricyclic antidepressants.
PROTHIADEN 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 PROTHIADEN
DO NOT TAKE PROTHIADEN COATED TABLETS IF
-
You are allergic to dosulepin, ponceau 4R (E124), sunset yellow (E110)
or any of the other
ingredients in this medicine (see Section 6).
-
You have the eye condition known as glaucoma
-
You are pregnant or planning to become pregnant, or are breast
feeding.
-
You have an irregular heartbeat, recent heart attack or any other
heart problem.
-
You have severe liver problems.
-
You suffer from periods of exaggerated behaviour (mania).
-
You are a child or adolescent under the age of 18 years.
-
You are taking any of the following medicines:
-
A mono-amine oxidase inhibitor (MAOI), used to treat depression.
-
You sh

Charakterystyka produktu

Health Products Regulatory Authority
27 March 2024
CRN00F5DX
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prothiaden 75mg Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 75 mg dosulepin hydrochloride.
Excipients with known effect:
glucose 3.6 mg per coated tablet, sunset yellow (E110), ponceau 4R
(E124), sucrose, sodium benzoate (E211)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet.
A red, biconvex, sugar-coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prothiaden is indicated for the management of depression and
associated anxiety.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration
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.
Paediatric population: not recommended.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Prothiaden is contra-indicated following recent myocardial infarction,
and in patients with any degree of heart block or other
cardiac arrhythmias. It is also contra-indicated 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 sub