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MIRTAZAPINE 30MG FILM-COATED TABLETS

Active substance: MIRTAZAPINE

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Patient Information Leaflet
MIRTAZAPINE 30mg FILM-COATED TABLETS
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 further questions, please ask your doctor or your pharmacist.
This medicine has been prescribed for you personally and you should not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
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. Storing mirtazapine.
6. More information.
1. WHAT MIRTAZAPINE IS AND WHAT IT IS USED FOR?
Mirtazapine is one of a group of medicines called antidepressants. Depression is linked to a shortage of
substances which carry messages in the brain (including serotonin and noradrenaline). Mirtazapine
helps to relieve the shortage if these ‘brain messages’. Common signs of depression include feelings of
worthlessness or deep sadness; difficulty with everyday tasks; sleeping too much or not being able to
sleep; felling anxious; and changes in appetite.
It may take 2 to 4 weeks before you start to feel better and sleep better. It is important to take
mirtazapine every day and not to stop taking it unless your doctor tells you to. If you do, your symptoms
may come back.
2. BEFORE YOU TAKE MIRTAZAPINE
Do not take mirtazapine:
• if you are allergic to mirtazapine or any of the other ingredients of Mirtazapine 30mg Film-Coated
Tablets.
• 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:
If you have or have used:
- epilepsy (seizures or fits). If you develop seizures or your seizures become more frequent, stop taking
mirtazapine and contact your doctor immediately
- liver disease (including jaundice) or kidney disease. If jaundice occurs, stop taking mirtazapine and
contact your doctor immediately.
- heart disease
- low blood pressure
- difficulty in passing water (urinating), which may be caused by an enlarged prostate
- eye disease, such as glaucoma
- diabetes (you may need to adjust your dose of insulin or other
antidiabetic medicines)
- 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
- 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.
Alcohol:
You may get drowsy if you drink alcohol while you are taking mirtazapine. It is therefore advisable to
avoid drinking any alcohol.
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 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 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.
Use in children and adolescents under 18 years of age:
Mirtazapine Film-Coated 30mg Tablets should normally not be used for children and adolescents under
18 years. Patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal
thoughts and hostility (predominantly aggression, defiant behaviour and anger) when they take this
class of medicines. In addition, significant weight gain has been observed in this age category more
often when treated with mirtazapine compared with adults. Despite this, your doctor may prescribe
Mirtazapine 30mg Film-Coated Tablets for patients under 18 because he/she decides that this is in their
best interests. If your doctor has prescribed Mirtazapine 30mg Film-Coated Tablets 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 Mirtazapine 30mg Film-Coated Tablets. The long-term safety effects concerning
growth, maturation and cognitive and behavioural development of Mirtazapine Film-Coated 30mg
Tablets in this age group have not yet been demonstrated.
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. Ask your doctor whether you can breast-feed,
while taking mirtazapine.
Make sure your midwife and/or doctor know you are on mirtazapine. When taking during pregnancy,
similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary
hypertension of the new born (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:
Antidepressants can affect your concentration or judgement. When you first start taking mirtazapine,
make sure your abilities are not affected before you drive or operate machinery.
Taking other medicines:
Other antidepressants:
You should not take Mirtazapine Film-Coated Tablets if you are taking other antidepressants known as
Monoamine Oxidase Inhibitors (MAOIs), or in the two weeks after they have been stopped. If you stop
taking mirtazapine, do not take MAOIs during the next two weeks either.
Examples of MAOIs are moclobemide, tranylcypromine (both are antidepressants) and selegiline (used
for Parkinson’s disease).
Drugs for anxiety or insomnia: Mirtazapine can increase the drowsiness caused by benzodiazepines.
Take care when taking any of the following medicines:
- 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. Johns 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.
- drugs for infection, such as erythromycin, medicines for fungal infections (such as ketoconazole) and
medicines for HIV/AIDS (such as HIV protease 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.
- drugs for epilepsy such as carbamazepine and phenytoin
- drugs for indigestion or stomach ulcers
- drugs to prevent clotting e.g. 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.
- 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 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.
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Mirtazapine 30mg Tablets - 28 Tabs
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Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines,
even those not prescribed.
Important information about some of the ingredients of mirtazapine:
Mirtazapine tablets contain lactose. If you have been told by your doctor that you have an intolerance
for some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE MIRTAZAPINE
The usual starting dose is 15mg, taken preferably in the evening. Your doctor may advise you to
increase your dose after a few days to the amount that will be best for you. Usually mirtazapine will start
working after 1 to 2 weeks and after 2 to 4 weeks you may start to feel better. After 2 to 4 weeks, talk to
your doctor about the effect the treatment has had. If you still don’t feel well, your doctor may prescribe
a higher dose. After another 2 to 4 weeks talk to your doctor again. If you have the impression that the
effect of mirtazapine is too strong or too week, talk to your doctor or pharmacist.
Your doctor will probably advise you to take mirtazapine as a single dose before you go to bed, as it
may help you to sleep. However, your doctor may suggest you split your dose - for example one tablet
in the morning, and another in the evening before you go to bed. The higher dose should be taken
before you go to bed. The tablets should be swallowed whole without chewing and with plenty of fluid.
Mirtazapine Film-Coated Tablets are not recommended for use in children or adolescents (under the
age of 18).
Mirtazapine Film-Coated Tablets can be taken by elderly patients, any dose changes will be done under
close supervision by your doctor. Patients with kidney or liver problems may be given a lower dose of
Mirtazapine.
Overdose: If you take more mirtazapine than you should:
Call a doctor straight away or go immediately to the nearest casualty department, taking the remaining
tablets with you. The most likely signs of overdose are drowsiness, disorientation and increased heart
rate.
If you forget to take mirtazapine:
Do not take a double dose to make up for forgotten individual doses. Just skip that dose and take your
next one at the normal time.
Effects when treatment with mirtazapine is stopped:
Do not suddenly stop taking mirtazapine even if your depression has lifted. If you stop suddenly, you
may feel sick, anxious or agitated and have headaches. It is possible that some of your symptoms may
come back. Once you are feeling better, talk to your doctor who will tell you how to reduce the dose
gradually. This will usually be about 4 to 6 months after you start feeling better.
4. POSSIBLE SIDE EFFECTS
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 divided 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
If you experience any of the following events you should tell your doctor
immediately, as your medication may need to be discontinued.
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 muscle (myalgia)
- back pain
- feeling dizzy or faint when you stand up suddenly (orthostatic hypotension)
- swelling (typical in ankles or feet caused by fluid retention (oedema)
- tiredness
- vivid dreams
- confusion
- feeling anxious
- sleeping problems
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
Rare:
- muscle twitching or contractions (myoclonus)
- pancreatitis
Not known:
- signs of infection such as sudden inexplicable 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)
- low sodium levels (hyponatraemia)
- yellow colouring of skin or eyes (jaundice)
- 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. STORING MIRTAZAPINE
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
Do not store above 25°C.
Store in the original package.
Keep the blister in the outer carton.
If your doctor tells you to stop treatment, return any left over to the pharmacist.
6. MORE INFORMATION
Mirtazapine 30mg Film-Coated Tablets are reddish brown, biconvex capsule-shaped, film-coated tablets
with a score line between 0 and 9 on one side and 'W' debossed on the other side.
Each film-coated tablet contains 30mg of the active substance mirtazapine.
The other ingredients are lactose monohydrate, hydroxypropylcellulose, maize starch, colloidal
anhydrous silica, low-substituted hydroxypropyl cellulose, magnesium stearate, purified water, opadry
brown (hydroxypropyl cellulose), hypromellose, titanium dioxide (E171), iron oxide yellow (E172), iron
oxide red and iron oxide black.
The tablets are supplied in blister packs of 28 film-coated tablets.
Who makes your medicine
Marketing Authorisation Holder: Wockhardt UK Limited, Ash Road North, Wrexham, LL13 9UF, UK.
Manufactured by: CP Pharmaceuticals Limited, Ash Road North, Wrexham, LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800
198 5000 (UK Only)
Please be ready to give the following information:
Product name
Reference number
Mirtazapine 30mg Film-Coated Tablets
29831/0142
This is a service provided by the Royal National Institute of Blind People.
This leaflet was revised: 07/2013
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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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