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MIRTAZAPINE 45MG ORODISPERSIBLE TABLET

Active substance(s): MIRTAZAPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Mirtazapine 15 mg orodispersible tablets
Mirtazapine 30 mg orodispersible tablets
Mirtazapine 45 mg orodispersible tablets
(Mirtazapine)
Read all of this leaflet carefully before you start using 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 any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What mirtazapine is and what it is used for
2. Before you take mirtazapine
3. How to take mirtazapine
4. Possible side effects
5. How to store Mirtazapine tablets
6. Further information
1. WHAT MIRTAZAPINE IS AND WHAT IT IS USED FOR
Mirtazapine is one of a group of medicines called antidepressants. Mirtazapine is used to
treat depressive illness.
2. BEFORE YOU TAKE MIRTAZAPINE
Do not take Mirtazapine
• if you are allergic (hypersensitive) to mirtazapine or any of the other ingredients of
Mirtazapine tablets. If so, you must talk to your doctor as soon as you can before
taking mirtazapine.
• if you are taking or have recently taken (within the last two weeks) medicines called
monoamine oxidase inhibitors (MAO-Is).
Take special care with Mirtazapine
Use in children and adolescents under 18 years of age
Mirtazapine should normally not be used for children and adolescents under 18 years
because efficacy was not demonstrated. 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. Also, the long-term safety effects concerning growth, maturation
and cognitive and behavioural development of mirtazapine in this age group have not yet
been demonstrated. In addition, significant weight gain has been observed in this age
category more often when treated with Mirtazapine compared with adults.
Thoughts of suicide and worsening of your depression:
If you are depressed 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 adults aged less than 25 years with psychiatric conditions who
were treated with an antidepressant.
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, and
ask them to read this leaflet. You might ask them to tell you if they think your depression
is getting worse, or if they are worried about changes in your behaviour.
Also take special care with mirtazapine
• if you have, or have ever had one of the following conditions.
→ Tell your doctor about these conditions before taking mirtazapine, if not done
previously.
seizures (epilepsy). If you develop seizures or your seizures become more
frequent, stop taking mirtazapine and contact your doctor immediately;
liver disease, including jaundice. If jaundice occurs, stop taking mirtazapine and
contact your doctor immediately;
kidney disease;
heart disease, or low blood pressure;
schizophrenia. If psychotic symptoms, such as paranoid thoughts become
more frequent or severe, contact your doctor straight away;
manic depression (alternating periods of feeling elated/overactivity and
depressed mood). If you start feeling elated or over-excited, stop taking
mirtazapine and contact your doctor immediately;
diabetes (you may need to adjust your dose of insulin or other antidiabetic
medicines);
eye disease, such as increased pressure in the eye (glaucoma);
difficulty in passing water (urinating), which might be caused by an enlarged
prostate.
• if you develop signs of infection such as inexplicable high fever, sore throat and
mouth ulcers.
→ Stop taking mirtazapine and consult your doctor immediately for a blood test. In
rare cases these symptoms can be signs of 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.
Taking other medicines
Tell your doctor or pharmacist if you are taking (or plan to take) any of the medicines in
the following list.
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Do not take mirtazapine in combination with:
• monoamine oxidase inhibitors (MAO inhibitors). Also, do not take mirtazapine
during the two weeks after you have stopped taking MAO inhibitors. If you stop taking
mirtazapine, do not take MAO inhibitors during the next two weeks either. Examples
of MAO inhibitors are moclobemide, tranylcypromine (both are antidepressants) and
selegiline (used for Parkinson’s disease).

Take care when taking mirtazapine in combination with:
• antidepressants such as SSRIs, venlafaxine and L-tryptophan, or triptans (used
to treat migraine), tramadol (a pain-killer), linezolid (an antibiotic), lithium (used to
treat some psychiatric conditions) 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, overactive 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 HIVprotease inhibitors).
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 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 as warfarin.
Mirtazapine can increase the effects of warfarin on the blood. Inform your doctor if
you are using this medicine. In case of combination it is advised that a doctor
monitors your blood carefully.
Taking mirtazapine with food and drink
You may get drowsy if you drink alcohol while taking mirtazapine.
You are advised not to drink any alcohol.
You can take mirtazapine with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any 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 are taking mirtazapine and you become pregnant or you plan to get pregnant, ask
your doctor whether you may continue taking mirtazapine. If you use mirtazapine until, or
shortly before birth, your baby should be supervised for possible adverse effects.
Make sure your midwife and/or doctor knows you are on Mirtazapine. 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.
Ask your doctor whether you can breast-feed, while taking mirtazapine.
Driving and using machines
Mirtazapine can affect your concentration or alertness. Make sure these abilities are not
affected before you drive or operate machinery.
Important information about some of the ingredients of Mirtazapine tablets
Mirtazapine tablets contains aspartame, a source of phenylalanine. May be harmful for
people with phenylketonuria.
3. HOW TO TAKE MIRTAZAPINE
Always take mirtazapine exactly as your doctor or pharmacist tells you to. You should
check with your doctor or pharmacist if you are not sure.
How much to take
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.
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 to 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.
Take the orodispersible tablet as follows:
The tablets should be taken orally. The tablet will rapidly disintegrate and can be
swallowed without water
1. Do not crush the orodispersible tablet
In order to prevent crushing the orodispersible tablet, do not push against the tablet
pocket (Figure A).
Figure A

2. Tear off one tablet pocket
Each strip contains six tablet pockets, which are separated by perforations. Tear off one
tablet pocket along the dotted lines (Figure 1).
Figure 1

3. Peel off the lid
Carefully peel off the lidding foil, starting in the corner indicated by the arrow (Figures 2
and 3).

Figure 2

Figure 3

4. Take out the orodispersible tablet
Take out the orodispersible tablet with dry hands and place it on the tongue (Figure 4).
Figure 4

It will rapidly disintegrate and can be swallowed without water..
When can you expect to start feeling better
Usually mirtazapine will start working after 1 to 2 weeks and after 2 to 4 weeks you may
start to feel better.
It is important that, during the first few weeks of the treatment, you talk with your doctor
about the effects of mirtazapine:
→ 2 to 4 weeks after you have started taking mirtazapine, talk to your doctor about how
this medicine has affected you.
If you still don’t feel better, your doctor may prescribe a higher dose. In that case, talk to
your doctor again after another 2 to 4 weeks. Usually you will need to take mirtazapine
until your symptoms of depression have disappeared for 4 to 6 months.
If you take more mirtazapine than you should
If you or someone else have taken too much mirtazapine, call a doctor straight away.
The most likely signs of an overdose of mirtazapine (without other medicines or alcohol)
are drowsiness, disorientation and increased heart rate.
If you forget to take Mirtazapine
If you are supposed to take your dose once a day
• If you have forgotten to take your dose of mirtazapine, do not take the missed dose.
Just skip it. Take your next dose at the normal time.
If you are supposed to take your dose twice a day
• If you have forgotten to take your morning dose, simply take it together with your
evening dose.
• If you have forgotten to take your evening dose, do not take it with the next morning
dose; just skip it and continue with your normal morning and evening doses.
• If you have forgotten to take both doses, do not attempt to make up for the missed
doses. Skip both doses and continue the next day with your normal morning and
evening doses.
If you stop taking mirtazapine
→ Only stop taking mirtazapine in consultation with your doctor.
If you stop too early, your depression might come back. Once you are feeling better, talk
to your doctor. Your doctor will decide when treatment can be stopped. Do not suddenly
stop taking mirtazapine, even when your depression has lifted.
If you suddenly stop taking mirtazapine you may feel sick, dizzy, agitated or anxious, and
have headaches. These symptoms can be avoided by stopping gradually. Your doctor will
tell you how to decrease the dose gradually.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

Rare:
• yellow colouring of eyes or skin; this may suggest disturbance in liver function (jaundice)
→ Stop taking mirtazapine and tell your doctor straight away.
• muscle twitching or contractions (myoclonus)
• pancreatitis which can cause a severe dull pain around the top of your stomach which
may move along your back sometimes with feeling and being sick, diarrhea, loss of
appetite, high temperature and tenderness of the abdomen (stomach)
Not known:
• signs of infection such as sudden unexplainable high fever, sore throat and mouth
ulcers (agranulocytosis)
→ Stop taking mirtazapine and contact your doctor straight away for a blood test.
In rare cases mirtazapine can cause disturbances in the production of blood cells (bone
marrow depression). Some people become less resistant to infection because mirtazapine can cause a temporary shortage of white blood cells (granulocytopenia). In rare
cases mirtazapine can also cause a shortage of red and white blood cells, as well as
blood platelets (aplastic anemia), a shortage of blood platelets (thrombocytopenia) or an
increase in the number of white blood cells (eosinophilia).
• epileptic attack (convulsions)
→ Stop taking mirtazapine and tell your doctor straight away.
• a combination of symptoms such as inexplicable fever, sweating, increased heart
rate, diarrhoea, (uncontrollable) muscle contractions, shivering, overactive reflexes,
restlessness, mood changes and unconsciousness. In very rare cases these can be
signs of serotonin syndrome.
→ Stop taking mirtazapine and tell your doctor straight away.
• thoughts of harming or killing yourself
→ Contact your doctor or go to a hospital straight away.
• abnormal sensations in the mouth (oral paraesthesia)
• swelling in the mouth (mouth oedema)
• hyponatraemia
• inappropriate anti-diuretic hormone secretion
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE MIRTAZAPINE TABLETS
Keep out of sight and reach of children.
Do not use Mirtazapine tablets after the expiry date which is stated on the carton 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.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose off medicines no longer required. These measures
will help to protect the environment.
6. FURTHER INFORMATION
What Mirtazapine contains
• The active substance is mirtazapine. Each orodispersible tablet contains 15 mg, 30 mg
or 45 mg mirtazapine.
• The other ingredients are crospovidone (type B), mannitol (E421), Cellulose, micro
crystalline, aspartame (E951), silica colloidal anhydrous, magnesium stearate,
strawberry guarana flavor [maltodextrin, propylene glycol, artificial flavours, acetic
acid] and peppermint flavor [artificial flavours, corn starch].

4. POSSIBLE SIDE EFFECTS

What Mirtazapine look like and contents of the pack

Like all medicines, mirtazapine can cause side effects, although not everybody gets
these side effects.
Some side effects are more likely to occur than others. The possible side effects of
mirtazapine are listed below and can be devided as:
• Very common:
affects more than 1 user in 10
• Common:
affects 1 to 10 users in 100
• Uncommon:
affects 1 to 10 users in 1,000
• Rare:
affects 1 to 10 users in 10,000
• Very rare:
affects less than 1 user in 10,000
• Not known:
cannot be estimated from the available data

Orodispersible tablet.

Very common:
• increase in appetite and weight gain
• drowsiness or sleepiness
• headache
• dry mouth
Common:
• lethargy
• dizziness
• shakiness or tremor
• nausea
• diarrhoea
• vomiting
• 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

Mirtazapine 15 mg orodispersible tablets:
White, round orodispersible tablets debossed with “36”on one side and ‘A’ on the other
side with an embossed circular edge.
Mirtazapine 30 mg orodispersible tablets:
White, round orodispersible tablets debossed with “37” on one side and ‘A’ on the other
side with an embossed circular edge.
Mirtazapine 45 mg orodispersible tablets:
White, round orodispersible tablets debossed with “38” on one side and ‘A’ on the other
side with an embossed circular edge.
Mirtazapine orodispersible tablets are available in Polyamide/ aluminium/ PVC/ paper/
polyster/ aluminum perforated unit dose blister packs of 6, 18, 30, 48, 90 and 96 tablets.
Not all pack sizes may be marketed.
15mg: PL 21880/0107
30mg: PL 21880/0108
45mg: PL 21880/0109
This leaflet was last updated in July 2013.

In children under 18 years the following adverse events were observed commonly in
clinical trials: significant weight gain, hives and increased blood triglycerides.
Uncommon:
• feeling elated or emotionally ‘high’ (mania)
→ Stop taking mirtazapine and tell your doctor straight away.
• 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

Marketing Authorisation Holder and Manufacturer
MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK
E-mail : info@medreich.co.uk

XXXXXXX

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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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