Surmontil 10mg tablets

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:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030100; GTIN: 5035906013163 5035906012340

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE USER
SURMONTIL
® 10MG TABLETS
(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.
The name of your medicine is Surmontil 10mg
Tablets but will be referred to as Surmontil
throughout this leaflet. Please note that this
leaflet also contains information about other
strength Surmontil 25mg Tablets.
IN THIS LEAFLET:
1. What Surmontil is and what it is used for
2. Before you take Surmontil
3. How to take Surmontil
4. Possible side effects
5. How to store Surmontil
6. Further information
1. WHAT SURMONTIL IS AND WHAT IT IS USED
FOR
Your tablets contain a medicine called
trimipramine. This belongs to a group of
medicines called antidepressants.
Surmontil 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 SURMONTIL
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 (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
X
You have had a heart attack
X
You have had any other heart problems
including slow or uneven heartbeat
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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Surmontil 10mg Tablets
or
Trimipramine 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 14mg of trimipramine maleate equivalent to 10mg
of
trimipramine.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Surmontil 10mg Tablets
White to pale yellow, circular, biconvex, film coated tablet, one face
impressed ‘SURMONTIL’ just inside the perimeter around a centrally
impressed ‘10’, scoreline on reverse.
Trimipramine 10mg Tablets
White to pale yellow, circular, biconvex, film coated tablet, embossed
‘TM’
above ‘10’ on one side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to
divide the dose.
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