Trimipramine 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Trimipramine maleate

Available from:

Alliance Healthcare (Distribution) Ltd

ATC code:

N06AA06

INN (International Name):

Trimipramine maleate

Dosage:

25mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030100

Patient Information leaflet

1
Revision date: 29.09.2015
Leaflet Reference: SURM25
PACKAGE LEAFLET: INFORMATION FOR THE USER
SURMONTIL
® 25MG TABLETS
(trimipramine maleate)
Although your medicine is called Surmontil
®
25mg Tablets, it will be
called Surmontil
®
Tablets throughout this leaflet.
Surmontil
®
is also available as Surmontil
®
10mg Tablets.
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
®
Tablets are and what they are used for.
2.
Before you take Surmontil
®
Tablets
3.
How to take Surmontil
®
Tablets
4.
Possible side effects
5.
How to store Surmontil
®
Tablets
6.
Further Information
1. WHAT SURMONTIL
® TABLETS ARE AND WHAT THEY ARE USED FOR
Your tablets contain a medicine called trimipramine. 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. 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, 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-

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Trimipramine 25mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Trimpramine 25mg tablets contain Trimipramine Maleate 34.87mg
equivalent to
25mg trimipramine per tablet.
Excipient(s) with known effect: Lactose Monohydrate
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Trimipramine 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
Posology
_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.
Paediatric population: Not recommended.
Method of administration
Oral
4.3
CONTRAINDICATIONS
Hypersensitivity to trimipramine maleate or to any of the excipients
listed in
Section 6.1
Recent myocardial infarction.
Any degree of heart block or other cardiac arrhythmias.
Mania.
Severe liver disease.
During breast feeding.
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
treatment,
patients
should
be
closely
monitored
until
such
improvement occurs. It is general clinical experience that the risk of
suicide