Prothiaden 25 mg Hard Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dothiepine hydrochloride

Available from:

Teofarma S.R.L.

ATC code:

N06AA; N06AA16

INN (International Name):

Dothiepine hydrochloride

Dosage:

25mg milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

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

Therapeutic area:

Non-selective monoamine reuptake inhibitors; dosulepin

Authorization status:

Marketed

Authorization date:

1977-01-12

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PROTHIADEN
25 MG HARD
CA
P
SU
LE
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 or are not sure about anything, ask your
doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it onto others.
It may harm them, even if their
symptoms are the same as yours.
- If you get any of the 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 Hard Capsules 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 HARD CAPSULES ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Prothiaden 25mg Hard Capsules (called
Prothiaden in this leaflet). The
active ingredient in Prothiaden is dosulepin hydrochloride. Prothiaden
belongs to a group of medicines called
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 CAPSULES IF
-
You are allergic to dosulepin or any of the other ingredients in this
medicine (see Section 6).
-
Prothiaden Capsules contains soya oil (see section 6). If you are
allergic to peanut or soya, do not use
this medicinal product.
-
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 age of 18 years.
-
You are

Summary of Product characteristics

Health Products Regulatory Authority
12 August 2020
CRN009SHY
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prothiaden 25 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 25 mg dosulepin hydrochloride.
Excipients with known effect:
Lactose monohydrate 106 mg per hard capsule; soya lecithin.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
A red/brown hard gelatin capsule containing a white to off-white
powder. The identifying code “P25” is printed on the capsule.
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 50mg 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.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Contains soya lecithin. If you are allergic to peanut or soya, do not
use this medicinal product.
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.
Health Products Regulatory Authority
12 Au