Trimipramine 50mg capsules

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Trimipramine maleate

Tersedia dari:

DE Pharmaceuticals

Kode ATC:

N06AA06

INN (Nama Internasional):

Trimipramine maleate

Dosis:

50mg

Bentuk farmasi:

Oral capsule

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 04030100

Selebaran informasi

PACKAGE LEAFLET:
INFORMATION FOR THE USER
SURMONTIL™ 50MG CAPSULES/
TRIMIPRAMINE 50MG CAPSULES
(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.
Your medicine is available as any of the above names but will be
referred to as Surmontil Capsules throughout this leaflet.
IN THIS LEAFLET:
1.
What Surmontil Capsules are and what they are used for.
2.
Before you take Surmontil Capsules
3.
How to take Surmontil Capsules
4.
Possible side effects
5.
How to store Surmontil Capsules
6.
Further information
1.
WHAT SURMONTIL CAPSULES ARE AND WHAT THEY ARE USED FOR
Surmontil Capsules contain a medicine called trimipramine. This
belongs to a group of medicines called antidepressants.
Surmontil 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 CAPSULES
2.
BEFORE YOU TAKE SURMONTIL CAPSULES
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:
•
You are allergic (hypersensitive) to trimipramine or any of the
other ingredients of Surmontil 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. If you are not

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Trimipramine 50mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 69.75mg of Trimipramine Maleate, equivalent to
50mg
Trimipramine.
Excipients with known effect:
Each capsule contains 1.40 mg of sodium.
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Capsule
Hard gelatin capsules approximately 19.20 x 6.93 mm in size with white
opaque body
imprinted with “301” in black ink and green cap imprinted with
Glenmark logo “G”
in black ink, filled with white to pale yellow powder.
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
•
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 signifi