Trimipramine 50mg capsules

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Trimipramine maleate

Tilgjengelig fra:

CST Pharma Ltd

ATC-kode:

N06AA06

INN (International Name):

Trimipramine maleate

Dosering :

50mg

Legemiddelform:

Oral capsule

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 04030100; GTIN: 5055946805122

Informasjon til brukeren

TRIMIPRAMINE 50MG CAPSULES
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING 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 get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
THE LEAFLET CONTAINS INFORMATION ON:
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
The name of your medicine is Trimipramine 50mg
Capsules (called trimipramine throughout this leaflet).
Trimipramine belongs to a group of medicines called
antidepressants and can be used to treat depression. In
particular it is used to treat depression in people who
also have the following symptoms
- problems sleeping, anxiety or are feeling irritable and
restless (agitation).
2. BEFORE YOU TAKE TRIMIPRAMINE CAPSULES
DO NOT TAKE TRIMIPRAMINE AND TELL YOUR DOCTOR IF YOU:
•
are allergic (hypersensitive) to trimipramine maleate
or any of the other ingredients of the capsules (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
•
have had a heart attack
•
have any other heart problems including slow or
uneven heart beat
•
have severe liver problems
•
have mania (signs include very high mood, energy
and unusual behaviour)
•
are pregnant or breast-feeding.
Do not take trimipramine if the above apply to you. If you
are not sure, talk to your doctor or pharmacist.
TAKE SPECIAL CARE AND CHECK WITH YOUR DOCTOR OR
PHARMACIST BEFORE YOU TAKE TRIMIPRAMINE I

Preparatomtale

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