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MIANSERIN 30MG TABLETS

Active substance(s): MIANSERIN HYDROCHLORIDE

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MIANSERIN
10 mg AND 30 mg
TABLETS

light-headedness or fainting
• have suicidal thoughts
• suffer from epilepsy or have
brain damage
• have a tumour of the adrenal
PACKAGE LEAFLET:
gland (phaeochromocytoma)
INFORMATION FOR THE USER
• have a withdrawal from alcohol
Read all of this leaflet carefully
or any anticonvulsive drugs.
before you start taking this
Other important information you
medicine.
should remember while taking
• Keep this leaflet. You may need
this medicine:
to read it again.
• You may not notice an
• If you have any further
improvement in your depression
questions, ask your doctor or
immediately. It may take 2-4
pharmacist.
weeks for Mianserin to have an
• This medicine has been
effect
prescribed for you. Do not pass • Tell your doctor or dentist you
it on to others. It may harm
are taking Mianserin if you are
them, even if their symptoms
to have surgery which requires
are the same as yours.
an anaesthetic. If you are given
• If any of the side effects get
an anaesthetic while you are
serious, or if you notice any side
taking Mianserin, the two drugs
effects not listed in this leaflet,
may make your blood pressure
please tell your doctor or
drop or alter your heart rate
pharmacist.
• You may have to have regular
blood tests during the first few
IN THIS LEAFLET:
months of your treatment to
1. What Mianserin is and what it is
monitor your liver and blood
used for
• If you see another doctor or visit
2. Before you take Mianserin
a hospital, remember to tell
3. How to take Mianserin
them what medicines you are
4. Possible side effects
already taking.
5. How to store Mianserin
6. Further information
Taking other medicines

1

DO NOT take Mianserin Tablets in

WHAT MIANSERIN IS AND combination with or if you have
WHAT IT IS USED FOR
taken within the last 14 days:

• Mianserin belongs to a group of • antidepressants known as
drugs known as antidepressants
MAOI’s e.g. moclobemide or
• Mianserin is used to treat
phenelzine.
depression.
Tell your doctor if you are due to
start taking moclobemide as it
BEFORE YOU TAKE
should not be started until at
MIANSERIN
least 1 week after stopping
Mianserin.
Do NOT take Mianserin if you:
• are allergic (hypersensitive) to
Talk to your doctor if you are
mianserin hydrochloride or any taking any of the following:
of the other ingredients of this
• antiepileptics e.g. phenytoin,
medicine
carbamazepine or barbiturates
• are taking monoamine oxidase
e.g. phenobarbital, primidone
inhibitors (MAOIs), or have
• drugs to stop your blood
stopped taking them during the
clotting e.g. warfarin
past 14 days
• drugs to lower your blood
• have severe liver problems
pressure e.g. bethanidine,
• suffer from mania (a mood
clonidine, diazoxide,
disorder characterised by high
hydralazine, guanethidine,
levels of excitement and activity)
nitroprusside or propranolol
• are under the age of 18 years
(your doctor may want to check
• have a hereditary problem of
your blood pressure more often
galactose intolerance, Lapp
if you are taking these medicines)
lactose deficiency or glucose
• antihistamines (for allergies and
malabsorption.
hayfever)
Take special care with Mianserin
• sublingual nitrates (tablets
Thoughts of suicide and
placed under the tongue to treat
worsening of your depression or
chest pain)
anxiety disorder
• apraclonidine or brimonidine (for
If you are depressed and/or have
glaucoma)
anxiety disorders you can
• sibutramine (for weight
sometimes have thoughts of
reduction)
harming or killing yourself. These
• artemether with lumefantrine
may be increased when first
(for malaria)
starting antidepressants, since
• antimuscarinic drugs
these medicines all take time to
• anxiolytic or sedative drugs e.g.
work, usually about two weeks but
diazepam
sometimes longer.
• hypnotic drugs (e.g. zopiclone)
You may be more likely to think
• antipsychotics (drugs used for
like this:
mental illness).
• if you have previously had
Please tell your doctor or
thoughts about killing or
pharmacist if you are taking or
harming yourself
have recently taken any other
• if you are a young adult.
medicines, including medicines
Information from clinical trials
obtained without a prescription.
has shown an increased risk of
suicidal behaviour in adults
Important information about some
aged less than 25 years with
of the ingredients of Mianserin
psychiatric conditions who were • Patients who are intolerant to
treated with an antidepressant.
lactose should note that
If you have thoughts of harming or
Mianserin Tablets contain a
killing yourself at any time, contact
small amount of lactose. If your
your doctor or go to a hospital
doctor has told you that you
straight away.
have an intolerance to some
You may find it helpful to tell a
sugars, contact your doctor
relative or close friend that you are
before taking this medicine.
depressed or have an anxiety
disorder, and ask them to read this Taking Mianserin with food and
leaflet. You might ask them to tell
drink
you if they think your depression
• DO NOT drink alcohol while you
or anxiety is getting worse, or if
are taking these tablets as it
they are worried about changes in
may increase the sedative
your behaviour.
effects of these tablets.

2

Tell your doctor before you start to
take this medicine if you:
• have recently had a heart attack
or have any other heart problems
• have diabetes
• have glaucoma (loss of vision
due to abnormally high pressure
in the eye)
• have problems with your
kidneys, liver or prostate gland
• are elderly you may experience
agitation, confusion, and a fall in
blood pressure on standing up
which causes dizziness,

Pregnancy and breast-feeding
• Mianserin is not recommended
if you are pregnant, planning
to become pregnant or are
breast-feeding. Ask your doctor
or pharmacist for advice
before taking this medicine.
Driving and using machines
• Mianserin may cause
drowsiness during the day. If
affected, DO NOT drive or
operate machinery.

3

HOW TO TAKE MIANSERIN

Always take Mianserin exactly as
your doctor has told you. You
should check with your doctor or
pharmacist if you are not sure. The
tablets should be swallowed whole
preferably with a glass of water.
The usual dose is:
• Adults:
Initially 30 - 40 mg a day either
in divided doses or as a single
dose at bedtime. Your doctor
may increase this gradually if
necessary. The maintenance
dose range is usually 30 mg to
90 mg a day.
• Elderly:
If you are elderly, your doctor
may give you a lower dose than
those mentioned above.
• Children and Adolescents
(below 18 years old):
Mianserin should not be used
for children and adolescents
under 18 years.
If you take more Mianserin than
you should
If you (or someone else) swallow a
lot of the tablets all together, or if
you think a child has swallowed
any of the tablets, contact your
nearest hospital casualty department
or your doctor immediately.
An overdose may cause nausea
(feeling sick), vomiting (being sick),
dry mouth, abnormally large or
small pupils, involuntary eye
movements, dizziness, lack of
coordination, difficulty moving,
drowsiness, convulsions (fits) or
coma. You may also experience
abnormally fast or slow heartbeats
and an increase or decrease in
blood pressure. Please take this
leaflet, any remaining tablets and
the container with you to the
hospital or doctor so that they
know which tablets were
consumed.
If you forget to take Mianserin
If you forget to take a dose at the
right time, take it as soon as you
remember. If it is almost time to
take the next dose, wait until then
and then carry on as before. DO
NOT take a double dose to make
up for a forgotten dose.
If you stop taking Mianserin
DO NOT stop taking Mianserin
without talking to your doctor first,
even if you feel better.
If you have any further questions on
the use of this product, ask your
doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Mianserin can
cause side effects, although not
everybody gets them.
If the following happens, stop
taking the tablets and tell your
doctor immediately or go to the
casualty department at your
nearest hospital:
• an allergic reaction (swelling of
the lips, face or neck leading to
severe difficulty in breathing;
skin rash or hives).
This is a very serious but rare side
effect. You may need urgent medical
attention or hospitalisation.










caused by a fall in blood
pressure when you stand up
from a sitting or lying position
oedema (water retention)
joint problems such as
polyarthropathy, arthralgia (joint
pain), arthritis
skin rash
sweating
shaking
psychiatric disorders such as
paranoid delusions
sexual problems
withdrawal symptoms in adults
and babies whose mothers
received similar drugs during
pregnancy.

The following side effects have
also been reported and occur more
in elderly patients:
• bone marrow depression (an
impairment in blood cell
production which can result in
anaemia and reduced ability to
fight infection and bruising or
bleeding)
• hyponatraemia (low blood levels
of sodium), which can cause
tiredness and confusion, muscle
twitching, fits or coma
• blood disorders including
leucopenia, agranulocytosis and
aplastic anaemia - reduction in
the number of red or white
blood cells, which causes
weakness, bruising or makes
infections more likely.
If any of the side effects get
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or
pharmacist.

5

HOW TO STORE
MIANSERIN

Keep out of the reach and sight of
children.
You should keep Mianserin Tablets
in a cool, dry place, away from
light. Keep them in the pack they
came in. Do not put them into
another container.
Do not use Mianserin after the
expiry date that is stated on the
outer packaging. The expiry date
refers to the last day of that
month.
Medicines should not be disposed
of via wastewater or household
waste. Ask your pharmacist how to
dispose of medicines no longer
required. These measures will help
to protect the environment.

6

FURTHER INFORMATION

What Mianserin Tablets contain:
• The active ingredient is
mianserin hydrochloride
• The other ingredients are
lactose, maize starch, povidone,
sodium starch glycolate,
magnesium stearate, colloidal
silicon dioxide, isopropyl
alcohol, opadry white Y-1-7000B,
titanium dioxide (E171), indigo
carmine (E132), purified water.
What Mianserin Tablets look like
and contents of the pack:
• Mianserin 10 mg Tablets are
white, biconvex, film-coated
tablets. They are marked ‘MSN
10’ on one side and twin triangle
logo on reverse
• Mianserin 30 mg Tablets are
white, biconvex, film-coated
tablets. They are marked ‘MSN
30’ on one side and twin triangle
logo on reverse.
• Mianserin Tablets are available
in pack sizes of 28, 50, 100, 250
and 500 tablets.
Not all pack sizes may be
marketed.

Mianserin can occasionally cause
serious side effects. These include:
• fits
• jaundice (your skin and whites
of your eyes may become
yellow)
• feeling elated or over-excited
• fever and a sore throat and
mouth.
Marketing Authorisation Holder
If you have any of these symptoms and Manufacturer
tell your doctor immediately.
Marketing Authorisation holder:
Teva UK Limited, Eastbourne,
The following side effects are brief, BN22 9AG.
mild and go away over time or if
Company responsible for
the dose is reduced. These include: manufacture:
• blurred vision
TEVA Pharmaceutical Works
• dry mouth
Private Limited Company, 4042
• constipation.
Debrecen, Pallagi ut 13, Hungary.
The following side effects have
This leaflet was last revised:
also been reported:
January 2012
• breast changes (breast
enlargement in men, tender
PL 00289/1228 & PL 00289/1229
nipples, milk production)
• liver problems
• dizziness and feeling faint,

39956-A

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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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