Mianserin 10mg tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Mianserin hydrochloride

Beschikbaar vanaf:

Viatris UK Healthcare Ltd

ATC-code:

N06AX03

INN (Algemene Internationale Benaming):

Mianserin hydrochloride

Dosering:

10mg

farmaceutische vorm:

Oral tablet

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 04030100; GTIN: 5016695390697

Bijsluiter

PAGE 1 OF 7
PACKAGE LEAFLET
PAGE 2 OF 7
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
Mianserin 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 or any of the other ingredients of this
medicine (listed in section 6)

suffer from severe liver disease

have been or are being treated for mania (feeling over-excited with
unusual behaviour)

are breast-feeding (refer to the 'Pregnancy and breast-feeding'
section of this leaflet)

are also taking the following medicines used to treat depression:

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
before you take a MAOI

a selective reversi

Productkenmerken

OBJECT 1
MIANSERIN 10 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 27-Sep-2017 | Generics UK
T/A Mylan
1. Name of the medicinal product
Mianserin 10 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains 10 mg mianserin hydrochloride.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Film-coated tablet.
Round, white film-coated convex tablet marked “MI 10” on one side
and “G” on reverse.
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
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 in the elderly patient suggest a
longer half-life and slower
metabolic clearance. This information implies that a single night time
dose of mianserin should be
preferable to the divided dose in older people; in addition a lower
than normal maintenance dose may be
sufficient to produce a satisfactory clinical response.
_Paediatric population_
Mianserin should not be used in the treatment of children and
adolescents under the age of 18 years (see
section 4.4).
Method of a