Mianserin Tablets BP 10mg film coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MIANSERIN HYDROCHLORIDE

Available from:

Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC code:

N06AX03

INN (International Name):

MIANSERIN HYDROCHLORIDE 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

MIANSERIN HYDROCHLORIDE 10 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Withdrawn

Authorization date:

2006-11-02

Patient Information leaflet

PATIENT INFORMATION LEAFLET
MIANSERIN TABLETS BP
KEEP ALL MEDICATION OUT OF THE REACH AND SIGHT OF CHILDREN
BEFORE YOU TAKE YOUR MEDICINE PLEASE READ THIS LEAFLET CAREFULLY
This leaflet contains a summary of the information about your
medicine, Mianserin Tablets BP.
YOUR MEDICINE
Your medicine is in the form of a tablet. There are three different
strengths of Mianserin Tablets BP
available. Each tablet contains either 10 mg marked MI10, 20 mg marked
MI20, or 30 mg marked
MI30 of the active ingredient Mianserin Hydrochloride. Each tablet
also contains maize starch, silicon
dioxide, calcium hydrogen phosphate, microcrystalline cellulose,
magnesium stearate,
hydroxypropylmethyl-cellulose, ethylcellulose (20 mg and 30 mg
strengths only), diethyl phthalate,
hydroxypropyl cellulose, titanium dioxide and carnauba wax. Mianserin
Tablets BP are available in
blister packs of 28. Your pharmacist will dispense the number of
tablets prescribed by your doctor.
Product Licence Holder: Mylan Ireland Limited, Unit 35/36, Grange
Parade, Baldoyle Industrial
Estate, Dublin 13, Ireland
Manufacturer:
Generics [UK] Limited, Station Close, Potters Bar, Hertforsdshire,
United Kingdom.
WHY DO YOU NEED TO TAKE YOUR MEDICINE?
Your tablets contain Mianserin, which belongs to a group of medicines
called the tetracyclic
ANTIDEPRESSANTS. Your doctor will prescribe Mianserin to help relieve
the symptoms of
depression. The exact way in which Mianserin works to relieve the
symptoms of depression is not
known.
WHAT SHOULD YOU DO BEFORE TAKING YOUR MEDICINE?
YOU MUST TELL YOUR DOCTOR BEFORE TAKING YOUR MEDICINE IF:
•
you are pregnant, intend to become pregnant or are breast feeding
•
you have been or are being treated for any mental illness including
mania
•
you suffer from liver disease
•
you are taking or have recently stopped taking another medicine to
treat depression
particularly if it is a monoamine oxidase inhibitor (MAOI)
•
you are recovering from a recent heart attack or a condition called
'heart block'
•
you suffer from epileps

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Mianserin Tablets BP 10 mg.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg Mianserin Hydrochloride.
3.
PHARMACEUTICAL FORM
Film coated tablet.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Mianserin Tablets are indicated for symptoms of depressive illness.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
The tablets should be swallowed whole without chewing.
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.
_Adults_
: Treatment should usually commence with 30 mg or 40 mg mianserin per
day for the
first few days. The effective dosage usually lies between 30 mg and 90
mg.
_Elderly_
: Not more than 30 mg a day initially. The dose should be slowly
increased under
close supervision. 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 the elderly
patient; in addition a lower
than normal maintenance dose may be sufficient to produce a
satisfactory clinical response.
Page 2 of 7
_Children_
: Mianserin should not be used in the treatment of children and
adolescents under
the age of 18 years (See section 4.4 Special warnings and precautions
for use).
4.3
CONTRA-INDICATIONS
Mania. Severe liver disease.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Use in children & adolescents under 18 years of age:
Mianserin should not be used in the treatment of children and
adolescents under the age of
18 years. Suicide-related behaviours (suicide attempts and suicidal
thoughts) and hostility
(predominantly aggression, oppositional behaviour and anger) were more
frequently
observed i