Surmontil 50mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Trimipramine maleate

Available from:

Sanofi

ATC code:

N06AA06

INN (International Name):

Trimipramine maleate

Dosage:

50mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030100; GTIN: 5035906015624

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRIMIPRAMINE 50MG CAPSULES
(trimipramine maleate)
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 Trimipramine is and what it is used for
2.
Before you take Trimipramine
3.
How to take Trimipramine
4.
Possible side effects
5.
How to store Trimipramine
6.
Further information
1.
WHAT TRIMIPRAMINE IS AND WHAT IT IS USED
FOR
The name of your medicine is Trimipramine 50mg Capsules
but will be referred to as Trimipramine in this leaflet.
Your capsules contain a medicine called trimipramine. This
belongs to a group of medicines called antidepressants.
Trimipramine 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.
BEFORE YOU TAKE TRIMIPRAMINE
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:

You are allergic (hypersensitive) to trimipramine or any
of the other ingredients of Trimipramine (listed in
section 6 Further information). Signs of an allergic
reaction include: a rash, swelling or breathing problems,
swelling of your lips, face, throat or tongue

You have had a heart attack

You have had any other heart problems including slow
or uneven heart beat

You have severe liver problems

You have mania (signs include very high mood, energy
and unusual behaviour)

You are breast-feeding.
Do not take this medicine if this applies to you. If you are not
sure, talk to your doctor or pharmacist before taking
Trimipramine.
TAKE SPECIAL CARE WITH TRIMIPRAMINE
THOUGHT

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Surmontil 50mg Capsules
Trimipramine 50mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 69.75mg of Trimipramine Maleate, equivalent to
50mg
Trimipramine.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule
Opaque hard gelatine capsules, the body white, the cap green. Both the
body
and the cap are printed longitudinally “SU50” in black.
The capsules contain an off white or slightly cream powder or plug of
powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Surmontil has a potent antidepressant action similar to that of other
tricyclic
antidepressants. It also possesses 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
Adults
For depression 50-75 mg/day initially increasing to 150-300 mg/day in
divided
doses or one dose at night. The maintenance dose is 75-150 mg/day.
Elderly
10-25 mg three times a day initially. The initial dose should be
increased with
caution under close supervision. Half the normal maintenance dose may
be
sufficient to produce a satisfactory clinical response.
Children
Not recommended.
Route of administration is oral.
4.3
CONTRAINDICATIONS
•
Recent myocardial infarction
•
Any degree of heart block or other cardiac arrhythmias
•
Mania
•
Severe liver disease
•
During breast feeding
•
Hypersensitivity to trimipramine maleate or to any of the excipients
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
SUICIDE/SUICIDAL THOUGHTS OR CLINICAL WORSENING
Depression is associated with an increased risk of suicidal thoughts,
self harm
and
suicide
(suicide-related
events).
This
risk
persists
until
significant
remission occurs. As improvement may not occur during the first few
weeks
or
more
of
trea