Trimipramine 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Trimipramine maleate

Available from:

CST Pharma 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; GTIN: 5055946803210 5055946804705

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 Tablets are and what they
are used for
2.
Before you take Trimipramine Tablets
3.
How to take Trimipramine Tablets
4.
Possible side effects
5.
How to store Trimipramine Tablets
6.
Further information
1. WHAT TRIMIPRAMINE TABLETS ARE
AND WHAT THEY ARE USED FOR
The name of your medicine is Trimipramine 10mg
or 25mg Tablets (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
TABLETS
DO NOT TAKE TRIMIPRAMINE AND TELL YOUR DOCTOR
IF YOU:
•
are allergic (hypersensitive) to trimipramine
maleate or any of the other ingredients of the
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
•
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 IF YOU:
•
are elderly
•
have an enlarged prostate g

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