LUMIN 20 Mianserin Hydrochloride 20mg tablet

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

mianserin hydrochloride, Quantity: 20 mg

Tilgængelig fra:

Alphapharm Pty Ltd

Lægemiddelform:

Tablet, film coated

Sammensætning:

Excipient Ingredients: pregelatinised maize starch; Carnauba Wax; colloidal anhydrous silica; microcrystalline cellulose; calcium hydrogen phosphate; magnesium stearate; titanium dioxide; hypromellose; macrogol 400

Indgivelsesvej:

Oral

Enheder i pakken:

50

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

For the treatment of major depression.

Produkt oversigt:

Visual Identification: 7mm normal convex white film coated tablet marked MI 20 on one side, G on the reverse.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisation status:

Registered

Autorisation dato:

1996-05-20

Indlægsseddel

LUMIN
_mianserin (hydrochloride)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Lumin.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Lumin against the
benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT LUMIN IS USED
FOR
Lumin is used to treat depression.
Lumin is an antidepressant, which
works by acting on chemicals in your
brain called amines. These amines
are involved in controlling mood.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY LUMIN HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Lumin for another reason.
Lumin is not approved for use in
children and adolescents below 18
years of age for the treatment of
depression or other mental disorders.
The safe use and effectiveness of
Lumin in treating these disorders, for
this age group, has not been
established.
Lumin is available only with a
doctor's prescription.
BEFORE YOU TAKE LUMIN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE LUMIN IF YOU ARE
ALLERGIC TO:
•
medicines containing mianserin
hydrochloride (e.g. Tolvon)
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include skin rash,
itching or hives, swelling of the face,
lips, mouth, throat or other parts of
the body, shortness of breath,
wheezing or troubled breathing.
CHECK WITH YOUR DOCTOR OR
PHARMACIST IF YOU ARE NOT SURE
ABOUT ANY OF THE ABOVE.
DO NOT TAKE LUMIN IF YOU:
•
suffer from mania, a mental
condition characterised by
episodes of overactivity, elation
or irritability.
•
have severe liver disease
DO NOT TAKE LUMIN IF YOU ARE
TAKING ANOTHER MEDICINE FOR
DEPRESSION CALLED A MONOAMINE
OXIDASE INHIBITOR (MAOI), OR HAVE
BEEN TAKING AN MAOI WITHIN THE
LAST 14 DAYS. IF YO

Produktets egenskaber

AUSTRALIAN PRODUCT INFORMATION
LUMIN
_Mianserin hydrochloride tablets _
1
NAME OF THE MEDICINE
Mianserin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mianserin belongs to the tetracyclic series of antidepressant
compounds, the piperazinoazepines. These are
chemically different from the common tricyclic antidepressants.
Each Lumin 10 tablet contains 10 mg of mianserin hydrochloride and
each Lumin 20 tablet contains 20 mg
of mianserin hydrochloride as the active ingredient.
Lumin also contains trace amounts of sulfites.
For the full list of excipients, see Section
6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
LUMIN 10:
10 mg tablet: white, film coated, normal convex, marked MI 10 on one
side, G on reverse
LUMIN 20:
20 mg tablet: white, film coated, normal convex, marked MI 20 on one
side, G on reverse
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of major depression.
4.2
DOSE AND METHOD OF ADMINISTRATION
Lumin tablets should be taken orally between meals, preferably with a
little fluid, and swallowed without
chewing.
USE IN CHILDREN AND ADOLESCENTS (< 18 YEARS OF AGE)
Lumin should not be used in children and adolescents under the age of
18 years (see section
4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE
)
.
ADULTS
The initial dosage of Lumin should be judged individually. It is
recommended that treatment begin with a
daily dose of 30 mg given in three divided doses or as a single
bedtime dose and be adjusted weekly in the
light of the clinical response. The effective daily dose for adult
patients usually lies between 30 mg and 90
mg (average 60 mg) in divided doses or as a single bedtime dose. A
maximum daily dose of 120 mg should
not be exceeded. It is often advantageous to maintain antidepressant
treatment for several months after initial
clinical improvement has occurred.
ELDERLY
Initially, not more than 30 mg daily and increased slowly under close
supervision. A reduced dose may also
be required for maintenance, as hepatic, renal or cardiovascular
function may be impaired.
Pha