Trimipramine 10mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Trimipramine maleate

Предлага се от:

DE Pharmaceuticals

АТС код:

N06AA06

INN (Международно Name):

Trimipramine maleate

дозиране:

10mg

Лекарствена форма:

Oral tablet

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 04030100

Листовка

TRIMIPRAMINE 10MG TABLETS
PATIENT INFORMATION LEAFLET
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.
Your medicine is called Trimipramine 10mg Tablets but will be referred
to as
Trimipramine Tablets throughout this leaflet. Please note that the
leaflet also
contains information about other strength of the medicine Trimipramine
25mg Tablets.
IN THIS LEAFLET:
What Trimipramine Tablets are and what they are used for
Before you take Trimipramine Tablets
How to take Trimipramine Tablets
Possible side effects
How to store Trimipramine Tablets
Further information
WHAT TRIMIPRAMINE TABLETS ARE AND WHAT THEY ARE
USED FOR
Your tablets contain a medicine called trimipramine. This belongs to a
group
of medicines called antidepressants.
Trimipramine 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).
BEFORE YOU TAKE TRIMIPRAMINE TABLETS
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:
X You are allergic (hypersensitive) to trimipramine or any of the
other
ingredients of Trimipramine 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
X You have had a heart attack
X You have had any other heart problems including slow or uneven heart
beat
X You have severe liver problems
X You have mania (signs include very high mood, energy and unusual
behaviour)
X You are breast-feeding
Do not take this medicine if this applies to you. If you are not sure,
talk to

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Trimipramine 10mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Trimpramine 10mg tablets contain Trimipramine Maleate 13.948 mg
equivalent to 10mg trimipramine per tablet.
Excipient(s) with known effect: Lactose Monohydrate
For the 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 the active substance 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 suic