Mianserin 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mianserin hydrochloride

Available from:

Actavis UK Ltd

ATC code:

N06AX03

INN (International Name):

Mianserin hydrochloride

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030100

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 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 reversible monoamin

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
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 administration
For oral use.
The tablets should be swallowed whole without chewing.
4.3
CONTRAI