MIRTAZAPINA 30 mg Film-Coated Tablets

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1. MIRTAZAPINA DOC 30 mg film-coated tablets
   1. What is MIRTAZAPINA DOC and what is it used for
   2. What you need to know before taking MIRTAZAPINA DOC
2. MIRTAZAPINA DOC may increase the effects of warfarin in the blood. Inform your doctor
   1. How to take MIRTAZAPINA DOC
   2. Possible side effects
   3. How to store MIRTAZAPINA DOC
   4. Package contents and other information

MIRTAZAPINA DOC 30 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What MIRTAZAPINA DOC is and what it is used for
• 2. What you need to know before you take MIRTAZAPINA DOC
• 3. How to take MIRTAZAPINA DOC
• 4. Possible side effects
• 5. How to store MIRTAZAPINA DOC
• 6. Contents of the pack and other information

1. What is MIRTAZAPINA DOC and what is it used for

MIRTAZAPINA DOC belongs to a group of medicines called antidepressants.
MIRTAZAPINA DOC is used to treat depressive disorders in adults.
It may take 1 or 2 weeks before MIRTAZAPINA DOC starts to work. You will begin
to feel better after 2-4 weeks. You should talk to your doctor if you do not feel
better or if you feel worse after 2-4 weeks. More information is provided in paragraph 3 “When can you
expect to feel better”.

2. What you need to know before taking MIRTAZAPINA DOC

Do not take MIRTAZAPINA DOC

• if you are allergicto mirtazapine or any of the other ingredients of this medicine (listed in section 6). In this case, you should tell your doctor as soon as possible before taking MIRTAZAPINA DOC.
• if you are taking or have recently taken (within the last 2 weeks) medicines called monoamine oxidase inhibitors (MAO-Is).

Warnings and precautions
Talk to your doctor or pharmacist before taking MIRTAZAPINA DOC.

Pay particular attention with MIRTAZAPINA DOC
Children and adolescents
Mirtazapine is generally not used in children and adolescents under the age of 18 because its effectiveness has not been demonstrated. It is important to know that in patients under the age of 18, this class of drugs is associated with an increased risk of undesirable effects, such as suicide attempts, suicidal thoughts and hostility (particularly aggression, argumentative behavior and anger). Despite this, your doctor may prescribe MIRTAZAPINA DOC to patients under 18 because they decide that this is in their best interest. If your doctor has prescribed MIRTAZAPINA DOC to a patient under the age of 18 and you would like clarification, please contact them directly. Immediately inform your doctor if any of the symptoms described above occur or worsen in patients under the age of 18 while undergoing therapy with MIRTAZAPINA DOC. It should also be noted that the effects on long-term safety of mirtazapine in this age group in terms of growth, maturation and cognitive and behavioral development have not yet been demonstrated.
Furthermore, a significant weight gain has been observed in this age group if treated with mirtazapine, more frequently than in adults.

Suicidal thoughts and worsening of depression
If you are depressed, you may sometimes think about harming yourself or taking your own life. These thoughts may increase immediately after starting treatment with antidepressants, as these medicines need time to work, usually about two weeks but sometimes longer.
You are more likely to have thoughts of this kind if:

• you have already thought about taking your own life or harming yourself in the past.
• if you are a young adult. Information from clinical studies has shown an increased risk of suicidal behavior in adults under 25 years of age with mental illness treated with antidepressants. → If at any time you find yourself thinking about taking your own life or harming yourself, contact your doctor or go to hospital immediately. It may be helpful to confide in a relative or friendthat you are suffering from depression and ask them to read this leaflet. You may ask them to let you know if they think your depression is getting worse, or if they are worried about changes in your behavior.

Pay particular attention with MIRTAZAPINA DOC also

• if you suffer from or have suffered from any of the conditions listed below. → If you have not already done so, tell your doctor about these conditions before taking MIRTAZAPINA DOC.
• seizures(epilepsy). If you start having seizures or if seizures become more frequent, stop taking MIRTAZAPINA DOC and contact your doctor immediately.
• liver diseases, including jaundice. If you develop jaundice, stop taking MIRTAZAPINA DOC and contact your doctor immediately.
• kidney diseases;
• heart diseaseor low blood pressure;
• schizophrenia. If psychotic symptoms, such as paranoid thoughts, become more frequent or severe, contact your doctor immediately.
• manic depression(alternating periods of euphoria/hyperactivity and depressed mood). If you start to feel euphoric or overexcited, stop taking MIRTAZAPINA DOC and contact your doctor immediately.
• diabetes(it may be necessary to adjust the dose of insulin or other anti-diabetic drugs).
• eye diseases, such as increased pressure in the eye (glaucoma).
• difficulty urinating, which may be caused by an enlarged prostate.
• some types of heart conditionsthat can change your heart rhythm, a recent heart attack, heart failure or taking certain medicines that can affect your heart rhythm.
• if you experience signs of infection, such as unexplained high fever, sore throat and ulcers in the mouth. → Stop taking MIRTAZAPINA DOC and contact your doctor immediately for a blood test.

In rare cases, these symptoms may be signs of a disorder of blood cell production in the bone marrow. Although rare, these symptoms are more common after 4-6 weeks of treatment.

• if you are elderly. You may be more sensitive to the side effects of antidepressants.

Other medicines and MIRTAZAPINA DOC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take MIRTAZAPINA DOCin combination with:

• monoamine oxidase inhibitors(MAO inhibitors). Also, do not take MIRTAZAPINA DOC within two weeks of stopping MAO inhibitors. Similarly, if you stop taking MIRTAZAPINA DOC, do not take MAO inhibitors within two weeks of stopping it. MAO inhibitors are, for example, moclobemide, tranylcypromine (both are antidepressants) and selegiline (used in Parkinson's disease).

Be careful whentaking MIRTAZAPINA DOC in combination with:

• antidepressants such as SSRIs, venlafaxine and L-tryptophan or triptans(used to treat migraine), tramadol(for pain relief), linezolid(an antibiotic), lithium(used to treat certain mental conditions), methylene blue(used to treat high levels of methemoglobin in the blood) and St. John's wort preparations(a herbal remedy for depression). Very rarely, mirtazapine, alone or in combination with these medicines, can lead to the so-called serotonin syndrome. Some of the symptoms of this syndrome are: unexplained fever, sweating, increased heart rate, diarrhea, muscle contractions (incontrollable), chills, hyperactive reflexes, restlessness, mood changes and loss of consciousness. If you experience a combination of these symptoms, tell your doctor immediately.
• the antidepressant called nefazodone, which can increase the amount of mirtazapine in your blood. Tell your doctor if you are using this medicine because it may require a reduction in the dose of MIRTAZAPINA DOC or, when the use of nefazodone is stopped, an increase in the dose of MIRTAZAPINA DOC.
• 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. If taken in combination with these medicines, mirtazapine may increase the drowsiness caused by these substances.
• medicines to treat infections;medicines for bacterial infections (such as erythromycin), medicines to treat fungal infections (such as ketoconazole) and medicines to treat HIV/AIDS (such as HIV protease inhibitors) and medicines to treat stomach ulcers (such as cimetidine). These medicines, in combination with mirtazapine, can increase the amount of mirtazapine in your blood. Tell your doctor if you are using these medicines. It may be necessary to reduce the dose of MIRTAZAPINA DOC or, when the use of these medicines is stopped, increase the dose of MIRTAZAPINA DOC again.
• medicines for epilepsy, such as carbamazepine and phenytoin;
• medicines for tuberculosis, such as rifampicin. These medicines, in combination with MIRTAZAPINA DOC, can decrease the amount of MIRTAZAPINA DOC in your blood. Tell your doctor if you are using these medicines.

It may be necessary to increase the dose of MIRTAZAPINA DOC or, when the use of these medicines is stopped, lower the dose of MIRTAZAPINA DOC again.

• medicines that prevent blood clotting, such as warfarin.

MIRTAZAPINA DOC may increase the effects of warfarin in the blood. Inform your doctor

if you are taking this medicine. If you are taking warfarin concurrently, your doctor
must closely monitor your blood.

• medicines that can affect heart rhythmsuch as some antibiotics and some antipsychotics.

MIRTAZAPINA DOC with alcohol
You may experience drowsiness if you consume alcoholic beverages while taking
MIRTAZAPINA DOC.
It is recommended not to consume alcoholic beverages.
MIRTAZAPINA DOC can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Limited experience regarding the administration of mirtazapine to pregnant women does not
indicate an increased risk. However, caution is advised when administering mirtazapine in
pregnancy.
If you use MIRTAZAPINA DOC up to or immediately before delivery, the newborn must be
carefully monitored for possible adverse effects.
Make sure that your midwife and/or doctor are informed that you are being treated with
MIRTAZAPINA DOC.
Medicines similar to this medicine (SSRIs), if taken during pregnancy, may increase the risk
of a serious condition in the baby called persistent pulmonary hypertension of the newborn
(PPHN) which causes rapid breathing in the newborn and a bluish skin tone. These symptoms
usually appear during the first 24 hours after the baby is born. Immediately inform
your midwife and/or doctor if your baby should present these
symptoms.

Driving and operating machinery
MIRTAZAPINA DOC may affect concentration or alertness. Make sure that your
abilities are not impaired before driving or operating machinery. If your doctor has prescribed
MIRTAZAPINA DOC to a patient under 18 years of age, make sure that concentration and
alertness are not impaired before entering traffic (e.g. cycling).

MIRTAZAPINA DOC tablets contains lactose.
This medicine contains lactose. If your doctor has told you that you suffer from an intolerance to some
sugars, consult him before taking this medicine.

3. How to take MIRTAZAPINA DOC

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

How much MIRTAZAPINA DOC to take
The recommended starting dose is 15 or 30 mg per day.Your doctor may advise you to increase the
dose after a few days to reach the appropriate amount (between 15 and 45 mg per day).
Normally the dose is the same for all ages. However, your doctor may adjust the dose if you are
elderly or if you have had a kidney or liver disease.

When to take MIRTAZAPINA DOC
→ Take MIRTAZAPINA DOC every day at the same time. It is best to take MIRTAZAPINA
DOC as a single dose before going to bed. In any case, your doctor may suggest dividing the
dose of MIRTAZAPINA DOC, once in the morning and once in the evening before going to bed. The
larger dose should be taken before bedtime.
Take the tablets orally. Swallow the prescribed dose of MIRTAZAPINA DOC without
chewing, with some water or juice.

When can you expect to feel better
Normally MIRTAZAPINA DOC takes 1-2 weeks to start working and after 2-4
weeks you may notice an improvement.
It is important that in the first few weeks of treatment you inform your doctor about the effects of
MIRTAZAPINA DOC:
→ 2-4 weeks after starting to take MIRTAZAPINA DOC, discuss with your doctor the
effects that the medicine has had on you.
If you continue to notice no improvement, your doctor may prescribe you a higher dose. In
this case, talk to your doctor again after another 2-4 weeks.
Normally you need to take MIRTAZAPINA DOC for 4-6 months after the disappearance of the
symptoms of depression.

If you take more MIRTAZAPINA DOC than you should
→ If you or someone else takes too much MIRTAZAPINA DOC, call your doctor immediately.
The most common signs of an overdose of MIRTAZAPINA DOC (without other medicines or alcohol)
are drowsiness, disorientation and increased heart rate. Symptoms of a possible
overdose may include changes in heart rhythm (fast, irregular heartbeat) and/or fainting, which may be symptoms of a life-threatening condition
known as Torsade de Pointes.

If you forget to take MIRTAZAPINA DOC
If you have to take the dose once a day

• Do not take a double dose to make up for a missed dose. Skip the dose and continue with the next dose at the usual time. If you have to take the dose twice a day
• if you forget the morning dose, simply take this dose together with the evening dose.
• if you forget the evening dose, you should not take it together with the morning dose afterwards; skip the dose and continue normally with the morning and evening dose.
• if you have forgotten to take both doses, you should not try to make up the missed dose. Skip both doses and continue the next day normally with the morning and evening dose.

If you stop taking MIRTAZAPINA DOC
→ You can only stop taking MIRTAZAPINA DOC after consulting your doctor.
If you stop taking it too soon, the depression may return. When you feel
better, talk to your doctor. Your doctor will decide when to stop treatment.
Do not suddenly stop taking MIRTAZAPINA DOC, even if the depression is
gone. If you suddenly stop MIRTAZAPINA DOC you may feel unwell, be dizzy, be agitated or anxious and have a headache. These symptoms can be avoided
by stopping treatment gradually. Your doctor will tell you how to reduce the dose gradually.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, MIRTAZAPINA DOC can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, stop taking MIRTAZAPINA DOC and tell your doctor immediately.
Uncommon(may affect up to 1 in 100 people):

• euphoria or emotional excitement (mania).

Rare(may affect up to 1 in 1000 people):

• yellowing of the eyes and skin, which may suggest liver problems (jaundice)

Not known(frequency cannot be estimated from available data):

• signs of an infection such as sudden, high fever and unexplained sore throat and mouth sores (agranulocytosis). In rare cases MIRTAZAPINA DOC may cause disorders in the production of blood cells (bone marrow depression). Some people become less resistant to infections because MIRTAZAPINA DOC can cause a temporary deficiency of white blood cells (granulocytopenia). In rare cases MIRTAZAPINA DOC can also cause a deficiency of red blood cells and white blood cells as well as platelets (aplastic anemia), a deficiency of platelets (thrombocytopenia) or an increase in the number of white blood cells (eosinophilia)
• seizure (convulsions)
• a combination of symptoms such as unexplained fever, sweating, increased heart rate, diarrhea, muscle contractions (involuntary), chills, overactive reflexes, agitation, change in mental status and increased salivation. In very rare cases these may be signs of serotonin syndrome
• self-harming thoughts or suicide
• severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other possible side effects that may occur with MIRTAZAPINA DOC are:
Very common(may affect more than 1 in 10 people) :

• increased appetite and body weight
• drowsiness
• headache
• dry mouth

Common(may affect up to 1 in 10 people) :

• constipation
• lethargy
• dizziness
• tremor
• nausea
• diarrhea
• vomiting
• rash or skin eruptions (exanthema)
• joint pain (arthralgia) or muscle pain (myalgia)
• back pain
• feeling lightheaded or fainting when getting up suddenly (orthostatic hypotension)
• swelling (usually in the ankles and feet) caused by fluid retention (edema)
• fatigue
• vivid dreams
• confusion
• anxiety
• sleep problems

Uncommon(may affect up to 1 in 100 people) :

• abnormal skin sensations, e.g. burning, prickling, itching or tingling (paresthesia)
• restless legs syndrome
• fainting (syncope)
• numbness of the mouth (oral hypoesthesia)
• low blood pressure
• nightmares
• agitation
• hallucinations
• need to move

Rare(may affect up to 1 in 1000 people) :

• muscle contractions (myoclonus)
• aggression
• abdominal pain and nausea; this may indicate inflammation of the pancreas (pancreatitis)

Not known(frequency cannot be estimated from available data) :

• abnormal sensation in the mouth (oral paresthesia)
• swelling of the mouth (oral edema)
• swelling throughout the body (generalized edema)
• localized swelling
• hyponatremia
• inappropriate secretion of antidiuretic hormone
• sleepwalking (somnambulism)
• severe skin reactions (bullous dermatitis, multiforme dermatitis)
• speech disorders

Other possible side effects with mirtazapine are:
increased levels of creatine kinase in the blood, difficulty urinating and muscle pain, stiffness and/or weakness and darkening or discoloration of the urine.

Additional side effects in children and adolescents
The following side effects have been observed frequently in clinical studies on children under 18 years of age: significant weight gain, hives and increased levels of triglycerides in the blood.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at:
www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store MIRTAZAPINA DOC

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 label and the carton after
“Exp.”. The expiry date refers to the last day of the month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MIRTAZAPINA DOC contains

• The active ingredient is mirtazapine. Each film-coated tablet contains 30 mg of mirtazapine
• The excipients are:

Core
lactose monohydrate
corn starch
hydroxypropylcellulose
anhydrous colloidal silicon dioxide
low substituted hypromellose
magnesium stearate

Coating:
hydroxypropylcellulose
hypromellose
titanium dioxide (E171)
yellow iron oxide (E172)
red iron oxide (E172)
black iron oxide (E172)

Description of the appearance of MIRTAZAPINA DOC and package contents
Film-coated tablets, biconvex, reddish-brown in colour, oval 14.0 x 6.0 mm, with
a fracture line and with “0” and “9” imprinted on one side and an “A” on the other side. The tablets
can be divided into two equal halves.
MIRTAZAPINA DOC 30 mg film-coated tablets are available in packs of 14, 20, 30,
50 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milan
Italy

Manufacturers
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Milpharm Limited
Ares, Odyssey Business Park,
West End Road,
South Ruislip HA4 6QD
United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Germany: MirtazapinAurobindo 30 mg Filmtabletten
Italy: MIRTAZAPINA DOC 30 mg film-coated tablets