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MIRTAZAPINE 30 MG TABLETS

Active substance(s): MIRTAZAPINE

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• feeling anxious
• sleeping problems
Uncommon (may affect up to 1 in 100
people):
• abnormal sensation in the skin e.g.
burning, stinging, tickling or tingling
(paraesthesia)
• restless legs
• fainting (syncope)
• sensations of numbness in the mouth
(oral hypoaesthesia)
• low blood pressure
• nightmares
• feeling agitated
• hallucinations
• urge to move

Not known (frequency cannot be
estimated from the available data):
• Erythema multiforme, a skin disease
characterised by itchy pink-red blotches
starting on your feet and hands
• blisters full of fluid (dermatitis bullous)
• abnormal sensations in the mouth (oral
paraesthesia)
• swelling in the mouth (mouth oedema)
• swelling throughout the body
(generalized oedema)
• localized swelling
• hyponatraemia
• inappropriate antidiuretic hormone
secretion
• difficulty passing urine
• distorted speech (dysarthria)
• increased salivation
• sleepwalking
• increase in certain enzyme levels in the
body
• muscle pain, tenderness, weakness and
swelling of the affected muscles
(rhabdomyolysis)
Additional side effects in children and
adolescents
In children under 18 years the following
adverse events were observed commonly
in clinical trials: significant weight gain,
hives and increased blood triglycerides.
Reporting of side effects:

information

depression is getting worse, or if they are
worried about changes in your behaviour.

Mirtazapine

What Mirtazapine contains

Also take special care with Mirtazapine
• if you have, or have ever had one of the
following conditions.
→ Tell your doctor about these conditions
Read all of this leaflet carefully before you
before taking Mirtazapine, if not done
start taking this medicine because it
previously.
contains important information for you.
- seizures (epilepsy). If you develop
• Keep this leaflet. You may need to read it
seizures or your seizures become more
again.
frequent, stop taking Mirtazapine and
• If you have any further questions, ask
contact your doctor immediately;
your doctor or pharmacist.
- liver disease, including jaundice. If
• This medicine has been prescribed for
jaundice occurs, stop taking Mirtazapine
you only. Do not pass it on to others. It
and contact your doctor immediately;
may harm them, even if their symptoms
- kidney disease;
are the same as yours.
- heart disease or low blood pressure;
• If you get any side effects, talk to your
- schizophrenia. If psychotic symptoms,
doctor or pharmacist. This includes any
such as paranoid thoughts become
possible side effects not listed in this
more frequent or severe, contact your
leaflet. See section 4.
doctor straight away;
What is in this leaflet:
- manic depression (alternating periods
1. What Mirtazapine is and what it is used
of feeling elated/over-activity and
for
depressed mood). If you start feeling
2. What you need to know before you take
elated or over-excited, stop taking
Mirtazapine
Mirtazapine and contact your doctor
3. How to take Mirtazapine
immediately;
4. Possible side effects
- diabetes (you may need to adjust your
5. How to store Mirtazapine
dose of insulin or other antidiabetic
6. Content of the pack and other
medicines);
information
- eye disease, such as increased
pressure in the eye (glaucoma);
1 What Mirtazapine is and what it
- difficulty in passing water (urinating),
is used for
which might be caused by an enlarged
prostate ;
• Mirtazapine is one of a group of
- certain kinds of heart conditions that
medicines called antidepressants.
may change your heart rhythm, a
• Mirtazapine is used to treat depressive
recent heart attack, heart failure, or
illness in adults.
take certain medicines that may affect
the heart’s rhythm.
What
you
need
to
know
before
2

if
you
develop signs of infection such as
you take Mirtazapine
inexplicable high fever, sore throat and
Do not take Mirtazapine
mouth ulcers.
• If you are allergic to mirtazapine or any
→ Stop taking Mirtazapine and consult
of the other ingredients of this medicine
your doctor immediately for a blood test.
(listed in section 6). If so, you must talk
In rare cases these symptoms can be
to your doctor as soon as you can before
signs of disturbances in blood cell
taking Mirtazapine.
production in the bone marrow. While
• If you are taking or have recently taken
rare, these symptoms most commonly
(within the last two weeks) medicines
appear after 4-6 weeks of treatment.
called monoamine oxidase inhibitors
• if you are an elderly person. You could be
(MAO-Is).
more sensitive to the side effects of
antidepressants.
Warnings and precautions
Children and adolescents
Talk to your doctor or pharmacist before
Mirtazapine should normally not be used
taking Mirtazapine
for children and adolescents under 18
Thoughts of suicide and worsening of your years because efficacy was not
demonstrated . Also , you should know
depression
that patients under 18 have increased risk
If you are depressed you can sometimes
of side effects such as suicide thoughts and
have thoughts of harming or killing
hostility (predominantly aggression,
yourself. These may be increased when
oppositional behaviour and anger) when
first starting antidepressants, since these
they take this class of medicines. Despite
medicines all take time to work, usually
this, your doctor may prescribe
about two weeks but sometimes longer.
Mirtazapine for patients under 18 because
You may be more likely to think like this:
he/she decides that this is in their best
• if you have previously had thoughts
interests. If your doctor has prescribed
about killing or harming yourself
Mirtazapine for a patient under 18 and you
• if you are a young adult. Information
want to discuss this, please go back to your
from clinical trials has shown an
doctor. You should inform your doctor if
increased risk of suicidal behaviour in
any of the symptoms listed above develop
adults aged less than 25 years with
or worsen when patients under 18 are
psychiatric conditions who were treated taking Mirtazapine. Also, the long-term
with an antidepressant.
safety effects concerning growth,
→If you have thoughts of harming or killing maturation and cognitive and behavioural
yourself at any time, contact your doctor or development of Mirtazapine in this age
go to a hospital straight away.
group have not yet been demonstrated. In
addition, significant weight gain has been
You may find it helpful to tell a relative or
observed in this age category more often
close friend that you are depressed, and
ask them to read this leaflet. You might ask when treated with Mirtazapine compared
with adults.
them to tell you if they think your
Package leaflet: Information
for the user

Film coated tablets
• The active substance is mirtazapine. Each
film-coated tablet contains 15mg/30
mg/45mg of Mirtazapine.
• The other ingredients present in the 15 mg,
30 mg and 45 mg of Mirtazapine tablets
are lactose monohydrate, maize starch,
povidone K-30, anhydrous colloidal silica,
magnesium stearate, hypromellose,
titanium dioxide (E171), macrogol 400,
macrogol 6000, 15 mg: yellow iron oxide
(E 172) and 45 mg: yellow iron oxide
(E 172) and red iron oxide (E172).
What Mirtazapine looks like and contents
of the pack
• The 15 mg tablets are yellow, round
tablets. One side of the tablet has a
scoreline with the marking “9” on one
side of the score line and the number “3”
on the other. The other side of the tablet
is marked with the number “7206”.The
tablet can be divided into equal doses.
• The 30 mg tablets are reddish brown,
round tablets. One side of the tablet has
a scoreline with the marking ”9” on one
side of the scoreline and the number ”3”
on the other. The other side of the tablet
is marked with the number ”7207”.The
tablet can be divided into equal doses.
• The 45 mg tablets are white to off-white,
round tablets, debossed with the number
“93” on one side of the tablet and
debossed with the number “7208” on the
other side.
• The 15 mg tablets are available in pack
sizes of 14, 20, 28, 30, 50, 56, 60, 70 and
100 tablets.
• The 30 mg tablets are available in pack
sizes of 14, 20, 28, 30, 50, 60, 100 and 200
(2 x 100) tablets.
• The 45 mg tablets are available in pack
sizes of 20, 28, 30, 50, 60, 100 and 200
tablets.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation holder and
company responsible for manufacture is:
TEVA UK Limited, Eastbourne, BN22 9AG.

If you get any side effects, talk to your
This leaflet was last revised in: March 2015.
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. PL 00289/0438
PL 00289/0439
You can also report side effects via the
PL 00289/0440
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 Mirtazapine
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 carton
packaging and blister after EXP. The expiry
date refers to the last day of that month.
This medicinal product does not require
any special storage conditions.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines
you no longer use. These measures will
help protect the environment.

Mirtazapine 15,
30 and 45 mg Tablets

88365-D
323 x 320

Peel Here To Open

Pharma code 318 (00111111)
First bar is 105mm from top edge.

Rare (may affect up to 1 in 1,000 people):
• muscle twitching or contractions
(myoclonus)
• aggression
• inflammation of the pancreas

6 Contents of the pack and other

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Other medicines and Mirtazapine

doctor if you are using these medicines.
It might be needed to increase the dose
of Mirtazapine, or when these medicines
are stopped to lower the dose of
Mirtazapine again.

medicines to prevent blood clotting such
Do not take Mirtazapine in combination
as warfarin.
with:
Mirtazapine can increase the effects of
• monoamine oxidase inhibitors (MAO
warfarin on the blood. Inform your
inhibitors). Also, do not take Mirtazapine
doctor
if you are using this medicine. In
during the two weeks after you have
case of combination it is advised that a
stopped taking MAO inhibitors. If you
doctor
monitors your blood carefully.
stop taking Mirtazapine, do not take MAO
• medicines that may affect the heart’s
inhibitors during the next two weeks
rhythm
such as certain antibiotics and
either.
some antipsychotics.
Examples of MAO inhibitors are
moclobemide, tranylcypromine (both are Mirtazapine with food, drink and alcohol
antidepressants) and selegiline (used for
Parkinson’s disease).
You may get drowsy if you drink alcohol
while you are taking Mirtazapine. You are
Take care when taking Mirtazapine in
advised not to drink any alcohol.
combination with:
• antidepressants such as SSRIs,
You can take Mirtazapine with or without
venlafaxine and L-tryptophan or triptans food.
(used to treat migraine), tramadol (a
Pregnancy and breast-feeding
painkiller), linezolid (an antibiotic),
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.









lithium (used to treat some psychiatric
conditions), methylene blue (used to
treat high levels of methemoglobin in the
blood) and St. John's Wort – Hypericum
perforatum preparations (a herbal
remedy for depression). In very rare
cases Mirtazapine alone or the
combination of Mirtazapine with these
medicines, can lead to a so-called
serotonin syndrome. Some of the
symptoms of this syndrome are
inexplicable fever, sweating, increased
heart rate, diarrhoea, (uncontrollable)
muscle contractions, shivering, over-active
reflexes, restlessness, mood changes and
unconsciousness. If you get a
combination of these symptoms, talk to
your doctor immediately.
the antidepressant nefazodone. It can
increase the amount of Mirtazapine in
your blood. Inform your doctor if you are
using this medicine. It might be needed
to lower the dose of Mirtazapine, or
when use of nefazodone is stopped, to
increase the dose of Mirtazapine again.
medicines for anxiety or insomnia such
as benzodiazepines;
medicines for schizophrenia such as
olanzapine;
medicines for allergies such as cetirizine;
medicines for severe pain such as
morphine.
In combination with these medicines
Mirtazapine can increase the drowsiness
caused by these medicines.
medicines for infections; medicines for
bacterial infections (such as
erythromycin, medicines for fungal
infections (such as ketoconazole) and
medicines for HIV/AIDS (such as HIV
protease inhibitors);
cimetidine (a medicine for certain
digestive disorders).
In combination with Mirtazapine these
medicines can increase the amount of
Mirtazapine in your blood. Inform your
doctor if you are using these medicines.
It might be needed to lower the dose of
Mirtazapine, or when these medicines
are stopped, to increase the dose of
Mirtazapine again.
medicines for epilepsy such as
carbamazepine and phenytoin;
medicines for tuberculosis such as
rifampicin.
In combination with Mirtazapine these
medicines can reduce the amount of
Mirtazapine in your blood. Inform your

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..
Limited experience with Mirtazapine
administration to pregnant women does
not indicate an increased risk. However,
caution should be exercised when used
during pregnancy. If you use Mirtazapine
until, or shortly before birth, your baby
should be supervised for possible adverse
effects.
When taken during pregnancy, similar
drugs (SSRIs) may increase the risk of a
serious condition in babies, called
persistent pulmonary hypertension of the
newborn (PPHN), making the baby breathe
faster and appear bluish. These symptoms
usually begin during the first 24 hours after
the baby is born. If this happens to your
baby you should contact your midwife
and/or doctor immediately.
Driving and using machines
Mirtazapine can affect your concentration
or alertness. Make sure these abilities are
not affected before you drive or operate
machinery. If your doctor has prescribed
Mirtazapine for a patient under 18 years
make sure the concentration and alertness
is not affected before participation in traffic
(e.g. on bicycle).
Mirtazapine contains lactose
Mirtazapine contains lactose. If you have
been told by your doctor that you have an
intolerance forsome sugars, contact your
doctor before taking this medicinal
product.

3

How to take Mirtazapine

Always take this medicine exactly as your
doctor or pharmacist has told you to. Check
with your doctor or pharmacist if you are
not sure.
The recommended dose is between 15mg
and 45mg.
The usual starting dose is 15 or 30 mg
every day. Your doctor may advise you to
increase your dose after a few days to the
amount that is best for you (between 15
and 45 mg per day). The dose is usually the
same for all ages. However, if you are an
elderly person or if you have renal or liver
disease, your doctor may adapt the dose.

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When to take Mirtazapine
→ Take Mirtazapine at the same time each
day. It is best to take Mirtazapine as a
single dose before you go to bed. However,
your doctor may suggest you split your
dose of Mirtazapine – once in the morning
and once at night-time before you go to
bed. The higher dose should be taken
before you go to bed.

If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

Take your tablets orally. Swallow your
prescribed dose of Mirtazapine without
chewing, with some water or juice.

If you experience any of the following
serious side effects, stop taking
mirtazapine and tell your doctor
immediately.

4 POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.

When can you expect to start feeling better
Usually Mirtazapine will start working after Uncommon (may affect up to 1 in 100
1 to 2 weeks and after 2 to 4 weeks you
people):
may start to feel better.
• feeling elated or emotionally ‘high’
(mania)
It is important that, during the first few
weeks of the treatment, you talk with your Rare (may affect up to 1 in 1,000 people):
doctor about the effects of Mirtazapine:
• yellow colouring of the eyes or skin; this
→ 2 to 4 weeks after you have started
may suggest disturbance in liver function
taking Mirtazapine, talk to your doctor
(jaundice)
about how this medicine has affected you.
If you still don’t feel better, your doctor may Not known (frequency cannot be estimated
prescribe a higher dose. In that case, talk to from the available data):
your doctor again after another 2 to 4 weeks. • signs of infection such as sudden
unexplainable high fever, sore throat and
mouth ulcers (agranulocytosis). In rare
Usually you will need to take Mirtazapine
cases mirtazapine can cause disturbances
until your symptoms of depression have
in the production of blood cells (bone
disappeared for 4 to 6 months.
marrow depression). Some people
If you take more Mirtazapine than you
become less resistant to infection
should
because mirtazapine can cause a
→ If you or someone else have taken too
temporary shortage of white blood cells
much Mirtazapine, call a doctor straight
(granulocytopenia). In rare cases
away. The most likely signs of an overdose
mirtazapine can also cause a shortage of
of Mirtazapine (without other medicines or
red and white blood cells, as well as blood
alcohol) are drowsiness, disorientation and
platelets (aplastic anaemia), a shortage of
increased heart rate. The symptoms of a
blood platelets (thrombocytopenia) or an
possible overdose may include changes to
increase in the number of white blood
your heart rhythm (fast, irregular heartbeat) cells (eosinophilia).
and/or fainting which could be symptoms
• epileptic attack (convulsions)
of a life-threatening condition known as
• a combination of symptoms such as
Torsade de Pointes.
inexplicable fever, sweating, increased
heart rate, diarrhoea, (uncontrollable)
If you forget to take Mirtazapine
muscle contractions, shivering,
If you are supposed to take your dose once
overactive reflexes, restlessness, mood
a day
changes, unconsciousness and increased
• Do not take double dose to make up for a
salivation. In very rare cases these can be
forgotten dose. Just skip it. Take your
signs of serotonin syndrome.
next dose at the normal time.
• thoughts of harming or killing yourself.
If you are supposed to take your dose
• severe skin reactions (Stevens-Johnson
twice a day
syndrome, toxic epidermal necrolysis)
• if you have forgotten to take your
Other possible side effects with
morning dose, simply take it together
mirtazapine are:
with your evening dose.
• if you have forgotten to take your
Very common (may affect more than 1 in
evening dose, do not take it with the next 10 people):
morning dose; just skip it and continue
• increase in appetite and weight gain
with your normal morning and evening
• drowsiness or sleepiness
doses.
• headache
• if you have forgotten to take both doses, • dry mouth
do not attempt to make up for the missed
doses. Skip both doses and continue the Common (may affect up to 1 in 10 people):
next day with your normal morning and • lethargy
evening doses.
• dizziness
• shakiness or tremor
If you stop taking Mirtazapine
• nausea
→ Only stop taking Mirtazapine in
• diarrhoea
consultation with your doctor.
• vomiting
If you stop too early, your depression
• constipation
might come back. Once you are feeling
• rash or skin eruptions (exanthema)
better, talk to your doctor. Your doctor will • pain in your joints (arthralgia) or muscles
decide when treatment can be stopped.
(myalgia)
• back pain
Do not suddenly stop taking Mirtazapine,
• feeling dizzy or faint when you stand up
even when your depression has lifted. If
suddenly (orthostatic hypotension)
you suddenly stop taking Mirtazapine you
• swelling (typically in ankles or feet)
may feel sick, dizzy, agitated or anxious,
caused by fluid retention (oedema)
and have headaches. These symptoms can
• tiredness
be avoided by stopping gradually. Your
• vivid dreams
doctor will tell you how to decrease the
• confusion
dose gradually.

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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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