Surmontil 25mg film-coated Tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Trimipramine

Dostupné z:

Neuraxpharm Ireland Limited

ATC kód:

N06AA; N06AA06

INN (Medzinárodný Name):

Trimipramine

Forma lieku:

Film-coated tablet

Terapeutické oblasti:

Non-selective monoamine reuptake inhibitors; trimipramine

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

1978-04-01

Príbalový leták

SURMONTIL 25MG
FILM-COATED TABLETS
_Trimipramine _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
IS THIS LEAFLET HARD TO SEE OR READ? PHONE [phone]
FOR HELP 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 only. 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.
IN THIS LEAFLET:
1. What Surmontil Tablets are and whatthey are used for
2. What you need to know before you take
Surmontil Tablets
3. How to take Surmontil Tablets
4. Possible side effects
5. How to store Surmontil Tablets
6. Contents of the pack and other information
1. WHAT SURMONTIL TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Surmontil 25mg Film-coated Tablets
(called Surmontil Tablets
in this leaflet). Surmontil Tablets contain a medicine called
trimipramine (as maleate). This
belongs to a group of
medicines called antidepressants. Surmontil Tablets 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 TABLETS DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:
• You are allergic (hypersensitive) to trimipramine or any of the
other ingredients of Surmontil
Tablets (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
• if you have recently had a heart attack
• You have any other heart problems including slow or uneven heart
beat
• You have severe liver problems
•

Súhrn charakteristických

Health Products Regulatory Authority
03 October 2023
CRN00D8TF
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Surmontil 25mg film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Trimipramine Maleate equivalent to 25 mg of
Trimipramine.
Excipients: each tablet contains 4.32 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to pale yellow, circular, biconvex, film-coated tablet, one face
impressed “SURMONTIL” just inside the perimeter around
a centrally impressed ‘25’, reverse face plain.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Surmontil has a potent antidepressant action similar to that of other
tricyclic antidepressants. It also possesses a pronounced
sedative action. It is therefore 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