Ludiomil

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Maprotiline hydrochloride 75mg;  

Tilgjengelig fra:

AFT Pharmaceuticals Ltd

INN (International Name):

Maprotiline hydrochloride 75 mg

Dosering :

75 mg

Legemiddelform:

Film coated tablet

Sammensetning:

Active: Maprotiline hydrochloride 75mg   Excipient: Calcium phosphate Colloidal silicon dioxide Hypromellose Iron oxide red Iron oxide yellow Lactose monohydrate Magnesium stearate Maize starch Polysorbate 80 Purified talc   Stearic acid Titanium dioxide

Enheter i pakken:

Blister pack, PVC/PVdC, 20 tablets

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

Olon SpA

Indikasjoner:

Depression Endogenous and late-onset (involutional) depression. Psychogenic, reactive, and neurotic depression, exhaustion depression. Somatogenic depression Masked depression Menopausal depression Other depressive mood disorders characterised by anxiety, dysphoria, or irritability; apathetic states(especially in the elderly); psychosomatic and somatic symptoms with underlying depression and/or anxiety The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) and the International Statistical Classification of Diseases and Related Health Problems (ICD-10) are standard classifications of mental disorders used by mental health professionals and describe the above mentioned disorders as follows: Treatment of depressive episodes, recurrent depressive disorder or major depression.

Produkt oppsummering:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC - 20 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVdC - 30 tablets - 36 months from date of manufacture stored at or below 30°C

Autorisasjon dato:

1982-05-20

Informasjon til brukeren

LUDIOMIL
®
25MG & 75MG TABLETS
MAPROTILINE HYDROCHLORIDE
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start taking Ludiomil
®
.
This leaflet answers some common questions about Ludiomil
®
. It does not contain all
the available information. It does not take the place of talking to
your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking
Ludiomil
®
against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT LUDIOMIL
® IS USED FOR
Ludiomil
®
is used for the treatment of depressive illness.
Ludiomil
®
helps to relieve the symptoms of depression such as anxiety, sadness,
loss
of interest, difficulty in performing everyday tasks, nervousness and
feelings of failure
or guilt. It also improves physical symptoms caused by depression such
as lack of
energy, fatigue, poor sleep, dizziness, headache, indigestion and
pain.
Ludiomil
®
belongs to a group of medicines called tricyclic antidepressants.
These
medicines correct the chemical imbalance and help to relieve the
physical and
emotional symptoms of depression.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY LUDIOMIL
® HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it for another purpose.
LUDIOMIL
® IS NOT RECOMMENDED FOR USE IN CHILDREN 12 YEARS OF AGE AND UNDER.
LUDIOMIL
® IS NOT RECOMMENDED FOR USE IN ADOLESCENTS (13 -18 YEARS OF AGE) FOR
THE TREATMENT OF DEPRESSION, UNLESS UNDER THE SUPERVISION OF A
SPECIALIST.
This medicine is only available with a doctor's prescription.
BEFORE YOU TAKE LUDIOMIL
®
_WHEN YOU MUST NOT TAKE IT _
Do not take Ludiomil
®
if you have ever had an allergic reaction after taking:

maprotiline (the active ingredient in Ludiomil
®
)

any of the other ingredients listed at the end of this leaflet

any other tricyclic antidepressant.
Some of the symptoms of an allergic reaction

Preparatomtale

NEW ZEALAND DATA SHEET
Page 1 of 19
1 LUDIOMIL
Maprotiline hydrochloride 25 mg and 75 mg film coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets contain 25 mg or 75 mg of Maprotiline hydrochloride
3 PHARMACEUTICAL FORM
Ludiomil® 25 mg are round, grey-orange tablets with a white core,
diameter 6.1 mm, with
slightly convex faces and slightly bevelled edges. The tablets are
imprinted DP and a score on
one side. Each tablet contains 25 mg maprotiline hydrochloride.
Ludiomil® 75 mg are round, brown-red tablets with a white core,
diameter 8.1 mm, with
slightly convex faces and slightly bevelled edges. The tablets are
imprinted FS with score on
one side. Each tablet contains 75 mg maprotiline hydrochloride.
Do not halve the 75 mg tablets. Dose equivalence when the 75 mg tablet
is divided has not
been established. Tablets should be swallowed whole with sufficient
liquid.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
•
Depression
•
Endogenous and late-onset (involutional) depression.
•
Psychogenic, reactive, and neurotic depression, exhaustion depression.
•
Somatogenic depression.
•
Masked depression.
•
Menopausal depression.
•
OTHER DEPRESSIVE MOOD DISORDERS characterised by anxiety, dysphoria,
or irritability;
apathetic states (especially in the elderly); psychosomatic and
somatic symptoms with
underlying depression and/or anxiety.
The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR)
and the International
Statistical Classification of Diseases and Related Health Problems
(ICD-10) are standard
classifications of mental disorders used by mental health
professionals and describe the
above
mentioned
disorders
as
follows:
Treatment
of
depressive
episodes,
recurrent
depressive disorder or major depression.
4.2
Dose and method of administration
During treatment with Ludiomil® the patient should be kept under
medical surveillance.
NEW ZEALAND DATA SHEET
Page 2 of 19
The recommended dose range is between 75 and 150 mg daily. Depending
on the severity of
the symptoms, patient