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MIRTAZAPINE 15MG TABLETS

Active substance(s): MIRTAZAPINE

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e-mail : prasad.pdp@gmail.com
Ph : +91-9845609386

Artwork No.

260113/1

Colours Used

Customer

Relon Chem

Balck

Description

Mitrazapine 15/30/45mg Pil

Keyline (not to print)

Market

UK

Language

English

Size

148 x 535 mm

Min. Font Size

9 pt

Page No.

1 of 2

Version No.

11

Date

24-08-17

Software

Illustrator 10

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Production

PACKAGE LEAFLET: INFORMATION FOR THE USER

Mirtazapine 15mg, 30mg and 45mg Film-coated Tablets
(Mirtazapine)
Read all of this leaflet carefully before you start taking this medicine.
!
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. Do NOT pass it on to others. It may harm them, even if their symptoms
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.
In this leaflet:
1. What Mirtazapine is and what it is used for
2. Before you take Mirtazapine Film-coated Tablets
3. How to take Mirtazapine Film-coated Tablets
4. Possible side effects
5. How to store Mirtazapine Film-coated Tablets
6. Further information
1. WHAT MIRTAZAPINE IS AND WHAT IT IS USED
FOR

!
Stop taking Mirtazapine Tablets and consult your
doctor immediately for a blood test.

!
In rare cases these symptoms can be signs of

Mirtazapine Film-coated tablets contains active
substance mirtazapine.
Which is one of a group of medicines called
antidepressants.
Mirtazapine Tablets are used to treat depressive illness
in adults.
Mirtazapine Tablets will take 1 to 2 weeks before it starts
working. After 2 to 4 weeks you may start feeling better.
You must talk to your doctor if you do not feel better or if
you feel worse after 2 to 4 weeks.
More information is in section 3 heading "When can you
expect to start feeling better".

disturbances in blood cell production in the bone
marrow. While rare, these symptoms most
commonly appear after 4-6 weeks of treatment.
!
if you are an elderly person. You could be more
sensitive to the side-effects of antidepressants.
Other medicines and Mirtazapine tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

Do not take Mirtazapine Tablets in combination with:
!
monoamine oxidase inhibitors (MAO inhibitors).
Also, do not take Mirtazapine Tablets during the two
weeks after you have stopped taking MAO
2. BEFORE YOU TAKE MIRTAZAPINE FILMinhibitors. If you stop taking Mirtazapine Tablets, do
COATED TABLETS
not take MAO inhibitors during the next two weeks
either. Examples of MAO inhibitors are
Do not take Mirtazapine Tablets:
moclobemide, tranylcypromine (both are
!
If you are allergic (hypersensitive) to
antidepressants) and selegiline (used for
mirtazapine(listed in section 6). or any of the other
Parkinson’s disease).
ingredients of Mirtazapine Tablets. If so, you must
!
Take care when taking Mirtazapine Tablets in
talk to your doctor as soon as you can before taking
combination with:
Mirtazapine Tablets.
!
antidepressants such as SSRIs, venlafaxine
!
if you are taking or have recently taken (within the
and L-tryptophan or triptans (used to treat
last two weeks) medicines called monoamine
migraine), tramadol (a pain-killer), linezolid (an
oxidase inhibitors (MAO-Is).
antibiotic), lithium (used to treat some psychiatric
conditions), methylene blue (used to treat high
Warnings and precautions
levels of methemoglobin in the blood) and St.
Talk to your doctor or pharmacist before taking
Johns Wort – Hypericum perforatum
Mirtazapine Tablets
preparations (a herbal remedy for depression). In
very rare cases Mirtazapine Tablets alone or the
Children and adolescents
combination of Mirtazapine Tablets with these
Mirtazapine Tablets should normally not be used for
medicines, can lead to a so-called serotonin
children and adolescents under 18 years because
syndrome. Some of the symptoms of this
efficacy was not demonstrated. Also, you should know
syndrome are: inexplicable fever, sweating,
that patients under 18 have an increased risk of sideincreased heart rate, diarrhoea, (uncontrollable)
effects such as suicide attempt, suicidal thoughts and
muscle contractions, shivering, overactive
hostility (predominantly aggression, oppositional
reflexes, restlessness, mood changes and
behavior and anger) when they take this class of
unconsciousness. If you get a combination of
medicines. Despite this, your doctor may prescribe
these symptoms, talk to your doctor immediately.
Mirtazapine Tablets for patients under 18 because
!
the antidepressant nefazodone. It can increase
he/she decides that this is in their best interests. If your
the amount of mirtazapine in your blood. Inform your
doctor has prescribed Mirtazapine Tablets for a patient
doctor if you are using this medicine. It might be
under 18 and you want to discuss this, please go back to
necessary to lower the dose of Mirtazapine Tablets,
your doctor. You should inform your doctor if any of the
or when use of nefazodone is stopped, to increase
symptoms listed above develop or worsen when patients
the dose of Mirtazapine Tablets again.
under 18 are taking Mirtazapine Tablets. Also, the long!
medicines for anxiety or insomnia such as
term safety effects concerning growth, maturation and
benzodiazepines;
cognitive and behavioral development of Mirtazapine
Tablets in this age group have not yet been
!
medicines for schizophrenia such as olanzapine;
demonstrated.
!
medicines for allergies such as cetirizine;
!
medicines for severe pain such as morphine.
In addition, significant weight gain has been observed in
In combination with these medicines Mirtazapine
this age category more often when treated with
Tablets can increase the drowsiness caused by
Mirtazapine Tablets compared with adults.
these medicines.
!
medicines for infections; medicines for bacterial
Thoughts of suicide and worsening of your
infections (such as erythromycin), medicines for
depression
fungal infections (such as ketoconazole) and
If you are depressed you can sometimes have thoughts
medicines for HIV/AIDS (such as HIV-protease
of harming or killing yourself. These may be increased
inhibitors) and drugs for stomach ulcer (such as
when first starting antidepressants, since these
cimetidine). In combination with Mirtazapine Tablets
medicines all take time to work, usually about two weeks
these medicines can increase the amount of
but sometimes longer.
mirtazapine in your blood. Inform your doctor if you
You may be more likely to think like this:
are using these medicines. It might be necessary to
!
if you have previously had thoughts about killing or
lower the dose of Mirtazapine Tablets, or when
harming yourself.
these medicines are stopped, to increase the dose
!
if you are a young adult. Information from clinical
of Mirtazapine Tablets again.
trials has shown an increased risk of suicidal
!
medicines for epilepsy such as carbamazepine
behavior in adults aged less than 25 years with
and phenytoin;
psychiatric conditions who were treated with an
!
medicines for tuberculosis such as rifampicin.
antidepressant.
In combination with Mirtazapine Tablets these
!
If you have thoughts of harming or killing yourself at
medicines can reduce the amount of mirtazapine in
any time, contact your doctor or go to a hospital
your blood. Inform your doctor if you are using these
straight away.
medicines. It might be necessary to increase the
dose of Mirtazapine Tablets, or when these
You may find it helpful to tell a relative or close friend
medicines are stopped to lower the dose of
that you are depressed, and ask them to read this leaflet.
Mirtazapine Tablets again.
You might ask them to tell you if they think your
!
medicines to prevent blood clotting such as
depression is getting worse, or if they are worried about
warfarin. Mirtazapine Tablets can increase the
changes in your behavior.
effects of warfarin on the blood. Inform your doctor if
Also take special care with Mirtazapine Tablets
you are using this medicine. In case of combination
!
if you have, or have ever had one of the following
it is advised that a doctor monitors your blood
conditions.
carefully.
!
Tell your doctor about these conditions before
!
medicines that may affect the heart's rhythm such
taking Mirtazapine Tablets, if not done previously.
as certain antibiotics and some anti-psychotics.
!
seizures (epilepsy). If you develop seizures or your
seizures become more frequent, stop taking
Mirtazapine Tablets with food and alcohol
Mirtazapine Tablets and contact your doctor
You may get drowsy if you drink alcohol while you are
immediately;
taking Mirtazapine Tablets. You are advised not to drink
!
liver disease, including jaundice. If jaundice
any alcohol. You can take Mirtazapine Tablets with or
occurs, stop taking Mirtazapine Tablets and contact
without food.
your doctor immediately;
!
kidney disease;
Pregnancy and breast-feeding
!
heart disease, or low blood pressure;
If you are pregnant or breast-feeding, think you may be
!
schizophrenia. If psychotic symptoms, such as
pregnant or are planning to have a baby, ask your doctor
paranoid thoughts become more frequent or
or pharmacist for advice before taking this medicine.
severe, contact your doctor straightaway;
!
manic depression (alternating periods of feeling
Limited experience with mirtazapine administration to
elated/overactivity and depressed mood). If you
pregnant women does not indicate an increased risk.
start feeling elated or over-excited, stop taking
However, caution should be exercised when used during
Mirtazapine Tablets and contact your doctor
pregnancy.
immediately;
If you use Zispin SolTab until, or shortly before birth, your
!
diabetes (you may need to adjust your dose of
baby should be supervised for possible adverse effects.
insulin or other antidiabetic medicines);
When taken during pregnancy, similar drugs (SSRIs)
!
eye disease, such as increased pressure in the eye
may increase the risk of a serious condition in babies,
(glaucoma);
called persistent pulmonary hypertension of the
!
difficulty in passing water (urinating), which might
newborn (PPHN), making the baby breathe faster and
be caused by an enlarged prostate.
appear bluish. These symptoms usually begin during the
!
certain kinds of heart conditions that may change
first 24 hours after the baby is born. If this happens to
your heart rhythm, a recent heart attack, heart
your baby you should contact your midwife and/or doctor
failure, or take certain medicines that may affect the
immediately.
heart's rhythm.
!
if you develop signs of infection such as inexplicable
high fever, sore throat and mouth ulcers.

e-mail : prasad.pdp@gmail.com
Ph : +91-9845609386

Artwork No.

260113/1

Colours Used

Customer

Relon Chem

Balck

Description

Mitrazapine 15/30/45mg Pil

Keyline (not to print)

Market

UK

Language

English

Size

148 x 535 mm

Min. Font Size

9 pt

Page No.

2 of 2

Version No.

11

Date

24-08-17

Software

Illustrator 10

Packaging Development

Quality Assurance (QA)

Driving and using machines
Mirtazapine Tablets 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 Tablets for a patient under 18
years make sure the concentration and alertness is not
affected before participation in traffic (e.g. on bicycle).
Mirtazapine Tablets contain Lactose monohydrate
Mirtazapine Tablets contain lactose. If you have been
told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.
Mirtazapine 15mg tablets also contain sunset yellow
FCF (E-110) which can cause allergic reactions
including asthma.
3. HOW TO TAKE MIRTAZAPINE FILM-COATED
TABLETS
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
How much to take
The recommended 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 prescribe a lower
dose.

Quality Control (QC)

Production

Other side effects

Very common (may affect more than 1 in 10 people):
!
increase in appetite and weight gain
!
drowsiness or sleepiness
!
headache
!
dry mouth

Common (may affect up to 1 in 10 people):
!
lethargy
!
dizziness
!
shakiness or tremor
!
nausea
!
diarrhoea
!
vomiting
!
constipation
!
rash or skin eruptions (exanthema)
!
pain in your joints (arthralgia) or muscles (myalgia)
!
back pain
!
feeling dizzy or faint when you stand up suddenly
(orthostatic hypotension)
!
swelling (typically in ankles or feet) caused by fluid
retention (oedema)
!
tiredness
!
vivid dreams
!
confusion
!
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
When to take Mirtazapine Tablets
hypoaesthesia)
!
Take Mirtazapine Tablets at the same time each day.
!
low blood pressure
It is best to take Mirtazapine Tablets as a single dose
!
nightmares
before you go to bed. However your doctor may
!
feeling agitated
suggest you to split your dose of Mirtazapine Tablets
!
hallucinations
– once in the morning and once at night-time before
!
urge to move
you go to bed. The higher dose should be taken
before you go to bed. Take your tablets orally.
Rare (may affect up to 1 in 1,000 people):
Swallow your prescribed dose of Mirtazapine
!
muscle twitching or contractions (myoclonus)
Tablets without chewing, with some water or juice.
!
aggression
!
abdominal pain and nausea; this may suggest
When can you expect to start feeling better
inflammation of the pancreas (pancreatitis)
Usually Mirtazapine Tablets will start working after 1 to 2
weeks and after 2 to 4 weeks you may start to feel better.
Not known (frequency cannot be estimated from the
It is important that, during the first few weeks of the
available data):
treatment, you talk with your doctor about the effects of
!
abnormal sensations in the mouth (oral
Mirtazapine Tablets:
paraesthesia)
!
2 to 4 weeks after you have started taking
!
swelling in the mouth (mouth oedema)
Mirtazapine Tablets, talk to your doctor about how
!
swelling throughout the body (generalized oedema)
this medicine has affected you.
!
localized swelling
If you still don’t feel better, your doctor may prescribe a
!
hyponatraemia
higher dose. In that case, talk to your doctor again after
!
inappropriate anti-diuretic hormone secretion
another 2 to 4 weeks.
!
severe skin reactions (dermatitis bullous, erythema
Usually you will need to take Mirtazapine Tablets until
multiforme,)
your symptoms of depression have disappeared for 4 to
!
sleep walking (somnambulism)
6 months.
!
speech disorder
!
increased creatinine kinase blood levels
If you take more Mirtazapine Tablets than you should
!
If you or someone else have taken too much
!
difficulty in passing urine (urinary retention)
Mirtazapine Tablets, call a doctor straight away.
!
muscle pain, stiffness and/or weakness, darkening
The most likely signs of an overdose of Mirtazapine
or discolouration of the urine (rhabdomyolysis)
Tablets (without other medicines or alcohol) are
drowsiness, disorientation and increased heart rate.
Additional side effects in children and adolescents
The symptoms of a possible overdose may include
In children under 18 years the following adverse events
changes to your heart rhythm (fast, irregular heartbeat)
were observed commonly in clinical trials: significant
and/or fainting which could be symptoms of a lifeweight gain, hives and increased blood triglycerides.
threatening condition known as Torsade de Pointes.
Reporting of side effects
If you forget to take Mirtazapine Tablets
If you get any side effects, talk to your doctor or
If you are supposed to take your dose once a day
pharmacist. This includes any possible side effects not
!
If you have forgotten to take your dose of
listed in this leaflet. You can also report side effects
MirtazapineTablets, do not take the missed dose.
directly via the yellow card scheme website:
Just skip it. Take your next dose at the normal time.
www.mhra.gov.uk/yellowcard.
If you are supposed to take your dose twice a day
By reporting side effects you can help provide more
!
if you have forgotten to take your morning dose,
information on the safety of this medicine.
simply take it together with your evening dose.
!
if you have forgotten to take your evening dose, do
5. HOW TO STORE MIRTAZAPINE FILM-COATED
not take it with the next morning dose; just skip it and
TABLETS
continue with your normal morning and evening
doses.
Keep out of the sight and reach of children.
!
if you have forgotten to take both doses, do not
Do not use Mirtazapine Tablets after the expiry date
attempt to make up for the missed doses. Skip both
which is stated on the blister and carton after EXP:. The
doses and continue the next day with your normal
expiry date refers to the last day of that month.
morning and evening doses.
!
Store in the original package to protect from light
and moisture.
If you stop taking Mirtazapine Tablets
!
Do not store above 30°C
!
Only stop taking Mirtazapine Tablets in consultation
!
If your doctor tells you to stop taking this medicine,
with your doctor.
take any remaining medicine back to the pharmacist
If you stop too early, your depression might come back.
for safe disposal. Only keep this medicine if your
Once you are feeling better, talk to your doctor. Your
doctor tells you to.
doctor will decide when treatment can be stopped.
!
If your medicine become discoloured or show any
Do not suddenly stop taking Mirtazapine Tablets, even
other signs of deterioration, consult your pharmacist
when your depression has lifted. If you suddenly stop
who will tell you what to do.
taking Mirtazapine Tablets you may feel sick, dizzy,
Medicines should not be disposed of via wastewater or
agitated or anxious, and have headaches. These
household waste. Ask your pharmacist how to dispose of
symptoms can be avoided by stopping gradually. Your
medicines no longer required. These measures will help
doctor will tell you how to decrease the dose gradually. If
to protect the environment.
you have any further questions on the use of this
product, ask your doctor or pharmacist.
6. FURTHER INFORMATION
4. POSSIBLE SIDE EFFECTS

What Mirtazapine Tablets contain:
!
The active substance is mirtazapine. Each filmLike all medicines, mirtazapine can cause side effects,
coated tablet contains 15mg, 30mg or 45mg of
although not everybody gets them.
mirtazapine.
!
The other ingredients are lactose monohydrate,
Tell your doctor and stop taking mirtazapine
maize starch, hydroxypropylcellulose, silica
immediately if you notice any of the following
colloidal anhydrous, magnesium stearate,
serious side effects :
hypromellose, macrogol 8000 and titanium dioxide
(E171). The 15mg tablet also contains quinoline
Uncommon (may affect up to 1 in 100 people):
yellow (E104), sunset yellow FCF (E110) and yellow
!
feeling elated or emotionally 'high' (mania)
iron oxide (E172). The 30mg tablet also contains
yellow iron oxide (E172), red iron oxide (E172) and
Rare (may affect up to 1 in 1,000 people):
black iron oxide (E172).
!
yellow colouring of eyes or skin; this may
!
suggest disturbance in liver function (jaundice)
What Mirtazapine Tablets look like and contents of
the pack:
Not known (frequency cannot be estimated from the
Your medicine is in the form of film-coated tablets.
available data):
!
The 15mg tablets are yellow, oblong, biconvex
!
signs of infection such as sudden unexplainable
tablets with a score line on one side.
high fever, sore throat and mouth ulcers
!
The 30mg tablets are beige, oblong, biconvex
(agranulocytosis). In rare cases mirtazapine can
tablets with a score line on one side.
cause disturbances in the production of blood cells
!
The 45mg tablets are white, round, biconvex tablets.
(bone marrow depression). Some people become
less resistant to infection because mirtazapine can
Mirtazapine Tablets are available in blisters of:
cause a temporary shortage of white blood cells
15mg: 14, 28, 30, 56, 60, 70, 90 and 100 tablets.
(granulocytopenia). In rare cases mirtazapine can
30mg: 14, 20, 28, 30, 50, 56, 60, 70, 90, 100, 200 and
also cause a shortage of red and white blood cells,
500 tablets
as well as blood platelets (aplastic anemia), a
45mg: 14, 20, 28, 30, 50, 56, 70, 100, 200 and 500
shortage of blood platelets (thrombocytopenia) or
tablets.
an increase in the number of white blood cells
Not all pack sizes may be marketed.
(eosinophilia).
!
epileptic attack (convulsions)
Marketing Authorisation Holder & Manufacturer:
!
a combination of symptoms such as inexplicable
Relonchem Limited
fever, sweating, increased heart rate, diarrhoea,
Cheshire House, Gorsey Lane, Widnes, Cheshire,
(uncontrollable) muscle contractions, shivering,
WA8 0RP, UK
overactive reflexes, restlessness, mood changes,
unconsciousness and increased salivation. In very
This leaflet was last revised in August 2017.
rare cases these can be signs of serotonin
syndrome.
!
thoughts of harming or killing yourself
!
severe skin reactions (Stevens-Johnson Syndrome,
toxic epidermal necrolysis)

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