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MIANSERIN 30MG FILM-COATED TABLETS

Active substance(s): MIANSERIN HYDROCHLORIDE

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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

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 monoamine oxidase
inhibitor (MAO-A inhibitor) such as
moclobemide. You should not start taking
mianserin within 1 week of taking an
MAO-A inhibitor.

TBC
1211122

Warnings and precautions
Talk to your doctor or pharmacist before
taking mianserin if you:
• have ever had an epileptic seizure (a fit), or
are at risk of having one due to any of the
following reasons:
* head injury
* taking or stopping medicines for mental
health conditions (which can make you feel
very sleepy or may possibly cause fitting as a
side effect)
* stopping medicines that control seizures
(fits), or you are
* reducing the amount of alcohol you are
drinking
• have a heart disorder such as cardiovascular
insufficiency (when the heart cannot pump
enough blood around the body). In this
case your doctor may monitor your heart
function
• are recovering from a recent heart attack
(myocardial infarction) or suffer from a
condition known as heart block, or have an
abnormal heart rhythm
• suffer from manic depressive illness
• are pregnant (refer to the 'Pregnancy and
breast-feeding' section of this leaflet)
• suffer from a tumour in your adrenal gland
(phaeochromocytoma)
• are diabetic, as your diabetic medicine may
need to be adjusted
• have kidney or other liver problems
• have, or have had in the past:
* raised pressure in the eye (in particular an eye
condition called narrow-angle glaucoma)
* urinary retention (difficulty passing urine)
or symptoms of obstruction of the neck
of the bladder (e.g. due to an enlarged
prostate gland).
Blood tests
This medicine may affect your blood or the
way your liver works. You will need regular
blood tests – usually every 4 weeks during the
first 3 months of treatment. Tell your doctor
straight away if you develop a fever, sore
throat, sore mouth or any other signs of an
infection.

If you have thoughts of harming or killing
yourself at any time, contact your doctor or
go to a hospital straight away.
You may find it helpful to tell a relative or
close friend that you are depressed or have
an anxiety disorder, and ask them to read this
leaflet. You might ask them to tell you if they
think your depression or anxiety is getting
worse, or if they are worried about changes in
your behaviour.
Children and adolescents
Mianserin should not normally be used by
children and adolescents under 18 years. Also,
you should know that patients under 18 have
an increased risk of side effects such as suicide
attempt, suicidal thoughts and hostility
(predominantly aggression, oppositional
behaviour and anger) when they take this
class of medicines.
Despite this, your doctor may prescribe
mianserin for patients under 18 because he or
she decides that this is in their best interests.
If your doctor has prescribed mianserin for a
patient under 18 and you want to discuss this,
please go back to your doctor. You should
inform your doctor if any of the symptoms
listed above develop or worsen when patients
under 18 are taking mianserin. Also, the
long-term safety effects concerning growth,
maturation and cognitive and behavioural
development of mianserin in this age group
have not yet been demonstrated.
Other medicines and Mianserin
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, including medicines obtained
without a prescription, or the following:
• medicines that affect the way your blood
clots, e.g. warfarin and other 'coumarins'
(blood thinning medicines)
• medicines for depression particularly
MAOIs e.g. tranylcypromine, phenelzine
and selective reversible monoamine
oxidase inhibitors (MAO-A inhibitors) e.g.
moclobemide (see 'Do not take' above)
medicines to help you sleep, feel less
anxious, or for mental health conditions
• any medicine for epilepsy such as phenytoin,
carbamazepine, phenobarbital and primidone
• diazoxide, hydralazine, nitroprusside or any
other medicine used to treat high blood
pressure
• medicines for chest pain (angina) which are
dissolved under the tongue
• medicines for allergy (antihistamines – in
some cases these may also be given to help
you sleep, such as diphenhydramine)
• artemether with lumefantrine, used to treat
malaria
• atomoxetine, used in the treatment attention
deficit hyperactivity disorder (ADHD)
• apraclonidine or brimonidine, eye drops
used to treat glaucoma (raised pressure in
the eyes), or eye drops to dilute the pupil
(such as atropine)
• sibutramine, used to help weight loss
• medicines known as 'anti-muscarinics'. These
may be used to treat lung problems (such
as tiotropium, ipratropium), bowel spasms
(such as dicycloverine, hyoscine), Parkinson's
disease (such as procyclidine), or problems
with urinating (such as bethanechol)
Surgery
If you are going to be given a general
anaesthetic for an operation or a local
anaesthetic for a small operation or dental
procedure let your anaesthetist or dentist
know that you are taking this medicine.
Mianserin with alcohol
Do not drink alcohol whilst taking this
medicine. Alcohol can make the feeling of
drowsiness worse.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to have
a baby, ask your doctor or pharmacist for
advice before taking this medicine.
There is limited information on the use of
Mianserin during pregnancy and therefore
you should not take Mianserin if you are
pregnant, think you may be pregnant or are
trying to become pregnant. If taken during
pregnancy, there is a risk of withdrawal

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1211122

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.

Thoughts of suicide and worsening of your
depression or anxiety disorder
If you are depressed and/or have anxiety
disorders you can sometimes have thoughts
of harming or killing yourself. These may be
increased when first starting antidepressants,
since these medicines all take time to work,
usually about two weeks but sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts about
killing or harming yourself.
• If you are a young adult. Information from
clinical trials has shown an increased risk of
suicidal behaviour in young adults (less than
25 years old) with psychiatric conditions who
were treated with an antidepressant.

symptoms in the baby after birth, such as
irritability.
Mianserin may reach your baby through the
breast milk. Therefore, do not take Mianserin
if you are breast-feeding.
Driving and using machines
Do not drive or operate machinery because
this medicine may make you feel drowsy and
can cause blurred vision. Alcohol can make
the feeling of drowsiness worse.
3. How to take Mianserin
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
The tablets should be swallowed whole with a
drink of water. Do not chew them.
Duration of treatment
You should take your tablets for as long as
your doctor says. Remember that you may
need to take Mianserin for 2 to 4 weeks before
you begin to feel better (see also section 2). So
do not stop taking this medicine just because
you do think that it is not working. You may
need to take these tablets for a long time.
Your dose will be adjusted so that it is right for
you and helps control the symptoms of your
illness.
The recommended dose is:
Adults
The recommended starting dose is 30 mg or
40 mg per day, increasing gradually, normally
up to a maximum of 90 mg per day. Your dose
may be taken as a single dose at bedtime
(which may help you sleep) or split into 2 or
3 doses taken throughout the day.
Older people
The recommended starting dose is 30 mg per
day. Your doctor may carefully increase this as
needed, to a maximum dose which may be
lower than that recommended for younger
patients. It is recommended that your dose is
taken as a single dose at bedtime.
Use in children and adolescents
Mianserin is not recommended in children
and adolescents (see also section 2).
If you take more Mianserin than you should
Contact your doctor or nearest hospital
emergency department immediately. Take
the container and any remaining tablets with
you.
You may have the following symptoms: you
may feel or be sick, have a dry mouth, closed
or wide open pupils, rapid uncontrollable
movements of the eye, feel dizzy, drowsy,
shaky or unsteady or experience convulsions
(fits) or fall into a coma. In addition, you may
notice a slow or fast heartbeat, have low or
raised blood pressure (these may make you
feel faint), or experience changes in the heart
rhythm which could cause the heart to stop.
If you forget to take Mianserin
Take the next dose as soon as you remember
unless it is almost time for your next dose.
Do not take a double dose to make up for a
forgotten dose.
If you stop taking Mianserin
Speak to your doctor first before stopping
this medicine. Your doctor will tell you how
to gradually reduce your medication. This
will help avoid unwanted side effects such
as sweating, shaking, being sick, feeling sick,
aggression, anxiety, or experiencing blurred
vision or hallucinations (seeing or hearing
things that are not real).
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
If you begin to experience any of the
following side effects stop taking Mianserin
and contact your doctor immediately:
• Sore throat, mouth ulcers, cold sores,
or other infections, inflammation of the
mouth lining, fever, feeling tired, weak or
pale. These may be signs of changes in the
numbers of certain blood cells which may
indicate a problem with the bone marrow
(where these cells are produced, more
common in elderly patients)
• Thoughts of harming or killing yourself, or
behaviours consistent with trying to harm or
kill yourself
• Fits (convulsions)
• Yellowing of the skin or whites of the eyes
• A feeling of elated mood which may mean
that you make unusual decisions or may
not consider other people. Your speech
may be fast and animated, sex drive may be
increased, and you may be very persistent or
irritable

Other possible side effects include:
• Feeling very elated or over-excited, which
can rapidly change to irritability. Speech may
be very rapid and incoherent and unusual
behaviour which may be extravagant,
overbearing or violent may occur
• Feelings or beliefs which are not consistent
with reality, which may include thoughts
that other people are trying to harm you
• Interference with sexual function in adults
• Breast enlargement in men
• Nipple tenderness
• Production of breast milk (in men, or in
women who are not expecting to produce
milk)
• Disturbances of liver function, or low levels
of sodium in the blood (these may show
up in blood tests, more common in elderly
patients)
• Joint pain and swollen joints
• Dizziness, light-headedness or fainting on
standing up (these may be a sign of low
blood pressure).
• Fluid retention
• Skin rash
• Sweating
• Shaking
If you stop taking the medicine, you may
get withdrawal symptoms such as sweating,
shaking, being sick, feeling sick, aggression,
anxiety, or experience blurred vision or
hallucinations (seeing or hearing things that
are not real)
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
You can also report side effects directly
via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this
medicine.
5. How to store Mainserin
Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry
date, which is stated on the pack after 'EXP'.
The expiry date refers to the last day of that
month.
Store below 25°C. Store in the original
package in order to protect from moisture
and light.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help to
protect the environment.
6. Contents of the pack and other
information
What Mianserin contains
The active substance is mianserin
hydrochloride. Each 10 mg film-coated tablet
contains 10 mg mianserin hydrochloride.
Each 30 mg film-coated tablet contains 30 mg
mianserin hydrochloride.
The other ingredients are: maize starch,
pregelatinised, silica, colloidal anhydrous,
cellulose, microcrystalline, calcium hydrogen
phosphate and magnesium stearate. The film
coating of the tablets contains titanium oxide
(E171), hypromellose, macrogol 400 and talc.
What Mianserin looks like and contents of
the pack
Mianserin film-coated tablets are white filmcoated tablets. 10 mg film-coated tablets are
embossed with 'MI 10' on one side and 'G' on
the other side. 30 mg film-coated tablets are
embossed with 'MI 30' on one side and 'G' on
the other side.
The tablets are available in plastic containers
(which may also contain an optional plastic
spacer at the top of the pack) or blister packs
of 28, 30, 56, 60, 84, 90, 100, 112, 250, 500 or
1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, UK
Manufacturers
Generics [UK] Limited, Potters Bar,
Hertfordshire, EN6 1TL, UK
Gerard Laboratories, 35/36 Baldoyle Industrial
Estate, Grange Road, Dublin 13, Ireland

This leaflet was last revised in 12/2013

321246

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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