Mianserin Tablet, film coated 30mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MIANSERIN HYDROCHLORIDE

Available from:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC code:

N06AX03

INN (International Name):

MIANSERIN HYDROCHLORIDE 30 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

MIANSERIN HYDROCHLORIDE 30 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Authorised

Authorization date:

2007-04-05

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MIANSERIN 10 MG FILM-COATED TABLETS
MIANSERIN 30 MG FILM-COATED TABLETS
Mianserin hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
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 only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Mianserin is and what it is used for
2.
What you need to know before you take Mianserin
3.
How to take Mianserin
4.
Possible side effects
5.
How to store Mianserin
6.
Contents of the pack and other information
1.
WHAT MIANSERIN IS AND WHAT IT IS USED FOR
Mianserin belongs to a group of medicines called tetra-cyclic
antidepressants. Mianserin
is believed to work by increasing the levels of two naturally
occurring chemicals within
the brain, noradrenaline and 5 hydroxytryptamine (also called
serotonin). Your doctor
will prescribe Minaserin to help relieve the symptoms of depression.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIANSERIN
DO NOT TAKE MIANSERIN
•
if you are allergic to mianserin hydrochloride or any of the other
ingredients of this
medicine (listed in section 6).
•
if you suffer from severe liver disease.
•
if you have been or are being treated for mania (feeling over-excited
with unusual
behavior).
•
if you are breast-feeding (refer to the ‘Pregnancy and
breast-feeding’ section of this
leaflet).
•
if you are also taking the following medicines used to treat
depression:
o
a monoamine oxidase inhibitor (MAOI). You should not take mianserin at
the same time or within 2 weeks of taking an MAOI. If you have taken
mianserin, you should wait 1-2 weeks befo

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Mianserin 10 mg film-coated tablets
Mianserin 30 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mianserin 10 mg film-coated tablets:
Each film-coated tablet contains 10 mg mianserin hydrochloride.
Mianserin 30 mg film-coated tablets:
Each film-coated tablet contains 30 mg mianserin hydrochloride.
Excipient(s) with known effect
Each Mianserin 10 mg film-coated tablet contains 62,5 mg lactose.
Each Mianserin 30 mg film-coated tablet contains 98,2 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Mianserin 10 mg film-coated tablets:
White, round, film-coated tablets.
Mianserin 30 mg film-coated tablets:
White, round, scored, film-coated tablets.
The tablet can be divided into equal doses using a pill cutter.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mianserin tablets are indicated for symptoms of depressive illness.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The daily dose can be taken either in divided doses or as a single
dose at night (due to the
favourable effect on sleep). It is often advantageous to maintain
antidepressant treatment for
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several months after clinical improvement has occurred. In order to
ensure an optimal
antidepressant effect the dosage of mianserin should not be reduced.
_ _
_Adults _
Treatment should usually commence with 30 mg or 40 mg mianserin per
day increasing
gradually as necessary. The effective dosage usually lies between 30
mg and 90 mg. Divided
doses of up to 200 mg are well tolerated.
_Older people _
The use of mianserin is restricted to patients over 65 who:
•
do not respond to other antidepressant drugs
•
have glaucoma
•
have prostatic hypertrophy
Not more than 30 mg a day initially. A lower than normal maintenance
dose may be sufficient
to produce a satisfactory clinical response.
Pharmacokinetic studies of mianserin