Trimipramine 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Trimipramine maleate

Available from:

DE Pharmaceuticals

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

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SURMONTIL
® 25MG 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.
§
Surmontil Tablets are also available in 10mg strength.
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
The name of your medicine is Surmontil 25mg Tablets (called
Surmontil Tablets in this leaflet). 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, swallowing
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 heartbeat
§
You have severe liver problems
§
You have mania (signs include very high mood, energy
and unusual behaviour)
§
You are breastfeeding
Do not take this medicine if this applies to you. If you are not
sure, talk to your doctor or pharm

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Trimipramine 25 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 34.9mg of trimipramine maleate, equivalent to
25mg of
trimipramine.
Excipient with known effect: each 25 mg 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, embossed
‘TM’ above
‘’25’ on one side, reverse side plain.
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
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
treatment,