Surmontil 50mg hard Capsules

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Trimipramine maleate

Tilgængelig fra:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC-kode:

N06AA; N06AA06

INN (International Name):

Trimipramine maleate

Dosering:

50 milligram(s)

Lægemiddelform:

Capsule, hard

Recept type:

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

Terapeutisk område:

Non-selective monoamine reuptake inhibitors; trimipramine

Autorisation status:

Not marketed

Autorisation dato:

1978-04-01

Indlægsseddel

PACKAGE LEAFLET:
INFORMATION FOR THE USER
SURMONTIL 50MG
HARD CAPSULES
Trimipramine (as maleate)
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
• 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. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Surmontil Capsules are and what they are used for
2. What you need to know before you take Surmontil Capsules
3. How to take Surmontil Capsules
4. Possible side effects
5. How to store Surmontil Capsules
6. Contents of the pack and other information
1. WHAT SURMONTIL CAPSULES ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Surmontil 50mg Hard Capsules (called
Surmontil Capsules in
this leaflet). Surmontil Capsules contain a medicine called
trimipramine (as maleate). This
belongs to a group of medicines called antidepressants. Surmontil
Capsules can be used to
treat depression. They are especially useful for treating depression
in people who also have
problems sleeping, stress (anxiety) or feel irritable and restless
(agitation).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SURMONTIL CAPSULES
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:

You are allergic (hypersensitive) to trimipramine or any of the other
ingredients of
Surmontil Capsules (listed in Section 6 Further information). Signs of
an allergic
reaction include: a rash, swallowing or breathing problems, swelling
of your lips, face,
throat, or tongue

You are hypersensitive to other tricyclic antidepressants

You have recently had a heart attack You have any other heart problems
including
slow or uneven heartbeat

You have severe liver problems

In cases of urinary disorde

Produktets egenskaber

Health Products Regulatory Authority
20 February 2023
CRN00C7K9
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Surmontil 50mg hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Trimipramine Maleate equivalent to 50 mg of
Trimipramine.
Excipients: each capsule contains soya lecithin (trace amounts)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule
Opaque, size 1 hard capsules with a white body and green cap that
contains an off-white or slightly cream powder. "SU50" is
printed in black longitudinally on both ends."
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Surmontil is indicated in the treatment of depressive illness,
especially where sleep disturbance, anxiety, or agitation are
presenting symptoms. Sleep disturbance is controlled within 24 hours
and true antidepressant action follows within 7 to 10
days.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The route of administration is oral.
Recommended Dosage:
Depression:
_Adults:_
The usual daily dose is 50 - 100 mg daily as a single dose, 2 hours
before retiring.
In more severe depression, dosage should be increased gradually until
the optimum therapeutic response is achieved (usually
150 - 300 mg daily) then reduced after 4-6 weeks to a maintenance
level of 75 - 150 mg daily.
_Elderly:_
Initially, a low dosage is recommended, generally half the minimum
recommended dose (see Pharmacokinetic Data).
Increasing dosage, if required, must take place gradually under
clinical supervision: the side effects of imipramines may have
serious consequences in elderly patients (falls, confusion).
_Paediatric Population:_
Surmontil should not be used in the treatment of children or
adolescents under the age of 18 years (see section 4.4 and 4.8).
_Patients with hepatic or renal insufficiency:_
In patients with hepatic and renal insufficiency a lower dosage is
recommended (see section 5.2).
4.3 CONTRAINDICATIONS
Trimipramine must not be used in the following cases:

hypersensitivity t