Surmontil 50mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Trimipramine maleate

Available from:

Sigma Pharmaceuticals Plc

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

Patient Information leaflet

SURMONTIL 50MG CAPSULES
PATIENT INFORMATION LEAFLET
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.
Your medicine is called Surmontil 50mg Capsules, throughout this
leaflet it
will be referred to as Surmontil Capsules.
IN THIS LEAFLET:
What Surmontil Capsules are and what they are used for
Before you take Surmontil Capsules
How to take Surmontil Capsules
Possible side effects
How to store Surmontil Capsules
Further information
WHAT SURMONTIL CAPSULES ARE AND WHAT THEY ARE
USED FOR
Your Capsules contain a medicine called trimipramine. 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).
BEFORE YOU TAKE SURMONTIL CAPSULES
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:
X 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, swelling
or
breathing problems, swelling of your lips, face, throat or tongue
X You have had a heart attack
X you have had any other heart problems including slow or uneven heart
beat
X You have severe liver problems
X You have mania (signs include very high mood, energy and unusual
behaviour)
X 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 Surmontil Capsules.
TAKE SPECIAL CARE WITH SURMONTIL CAPSULES
THOUGHTS OF SUICIDE AND WORSEN

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