Trimipramine 50mg capsules

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Trimipramine maleate

Tillgänglig från:

Alliance Healthcare (Distribution) Ltd

ATC-kod:

N06AA06

INN (International namn):

Trimipramine maleate

Dos:

50mg

Läkemedelsform:

Oral capsule

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 04030100

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRIMIPRAMINE 50MG CAPSULES
(trimipramine maleate)
Your medicine is known by the above name, but will be referred to as
Trimipramine Capsules throughout this leaflet
This medicine is also available in another strength.
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 Capsules are and what they are used for.
2.
Before you take Trimipramine Capsules
3.
How to take Trimipramine Capsules
4.
Possible side effects
5.
How to store Trimipramine Capsules
6.
Further Information
1. WHAT TRIMIPRAMINE CAPSULES ARE AND WHAT THEY ARE
USED FOR
Your Capsules contain a medicine called trimipramine. This belongs to
a
group of medicines called antidepressants.
Trimipramine 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).
2. BEFORE YOU TAKE TRIMIPRAMINE CAPSULES
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:

You are allergic (hypersensitive) to trimipramine or any of the other
ingredients of Trimipramine 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

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. I

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Trimpramine 50mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Trimipramine Maleate 69.74mg equivalent to 50mg trimipramine per
capsule.
Excipient(s) with known effect: Lactose Monohydrate
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Capsule, hard
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
may increase in the early stages