MIRTAZAPINA 30 mg Tabletka

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1. Mirtazapina Teva Italia 30 mg orodispersible tablets
   1. What is Mirtazapina Teva Italia and what it is used for
   2. What you need to know before taking Mirtazapina Teva Italia MIRTAZAPINA TEVA
   3. How to take Mirtazapina Teva Italia
   4. Do not break the orally disintegrating tablet
   5. Detach a tablet indentation
   6. Lift the cover sheet
   7. Remove the orodispersible tablet
   8. Possible side effects
   9. How to store Mirtazapina Teva Italia
   10. Contents of the pack and other information

Mirtazapina Teva Italia 30 mg orodispersible tablets

Generic medicine

Read this leaflet carefully before using 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. Never give it to others. Even if their symptoms are the same as yours, it may be dangerous for other people to use this medicine.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Mirtazapina Teva Italia and what it is used for

Mirtazapina Teva Italia belongs to a group of medicines called antidepressants.
Mirtazapina Teva Italia is used to treat depressive disorders in adults.
Mirtazapina Teva Italia will take 1 to 2 weeks before it starts to work. After a
period of 2 to 4 weeks you may start to feel better. You should contact your doctor if you do not
feel better or if you feel worse after a period of 2 to 4 weeks. Further
information is provided in paragraph 3, under “When to expect to feel better”.

2. What you need to know before taking Mirtazapina Teva Italia MIRTAZAPINA TEVA

Do not take Mirtazapina Teva Italia

• if you are allergicto mirtazapine or any of the other ingredients of Mirtazapina Teva (listed in section 6). In this case, you should talk to your doctor as soon as possible before taking Mirtazapina Teva Italia
• if you are taking or have recently taken (within the last 2 weeks) medicines called monoamine oxidase inhibitors (MAOIs)

Warnings and precautions
Talk to your doctor or pharmacist before using Mirtazapina Teva Italia

Children and adolescentsMirtazapina Teva Italia is generally not recommended for use in children and
adolescents under the age of 18 years as its efficacy has not been demonstrated. It should be
known that in patients under the age of 18 years this class of drugs is associated with an increased risk of
adverse effects, such as suicide attempts, suicidal thoughts and hostility (particularly
aggression, argumentative behaviour and anger). Nevertheless, a doctor may decide to prescribe
Mirtazapina Teva Italia to patients under the age of 18 years if they consider it to be in their interest. If
your doctor has prescribed Mirtazapina Teva Italia to a patient under the age of 18 years and you
would like clarification, please contact him directly. Immediately inform your doctor if any of the
symptoms described above occur or worsen in patients under the age of 18 years who are undergoing
therapy with Mirtazapina Teva Italia. It should also be noted that the effects on long-term safety of
Mirtazapina Teva Italia in this age group in terms of growth, maturation and
cognitive and behavioural development have not yet been demonstrated. In addition, a significant increase in weight has been observed more frequently in this age group compared to adults when
treated with mirtazapine.

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

• you have thought about killing yourself or harming yourself in the past.
• if you are a young adult. Information from clinical studies has shown an increased risk of suicidal behaviour in adults under 25 years of age with mental illness treated with antidepressants. → If at any time you find yourself thinking about killing yourself or harming yourself, contact your doctor or go to hospital immediately.

It may be helpful to tell a relative or friendthat you are suffering from depression and ask them to
read this leaflet. You may ask them to inform you if they think your depression is getting worse, or if they are worried about changes in your behaviour.

Take particular care with Mirtazapina Teva Italia also

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

Do not take Mirtazapina Teva Italiain combination with:

• monoamine oxidase inhibitors (MAO inhibitors). Also, do not take Mirtazapina Teva Italia within two weeks of stopping MAO inhibitors. Similarly, if you stop taking Mirtazapina Teva Italia, do not take MAO inhibitors within two weeks of stopping it. MAO inhibitors include, for example, moclobemide, tranylcypromine (both are antidepressants) and selegiline (used in Parkinson's disease). Be careful whentaking Mirtazapina Teva Italia 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 illnesses) methylene blue(used to treat high levels of methaemoglobin in the blood) and St John's wort preparations(a herbal remedy for depression). Very rarely, Mirtazapina Teva Italia, 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, diarrhoea, muscle contractions (uncontrollable), tremor, overactive 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 Mirtazapina Teva Italia in the blood. Tell your doctor if you are using this medicine as it may require a reduction in the dose of Mirtazapina Teva Italia or, when the use of nefazodone is stopped, an increase in the dose of Mirtazapina Teva Italia.
• 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, Mirtazapina Teva Italia can increase the drowsiness caused by these substances.
• medicines for treating infections;medicines for bacterial infections (such as erythromycin), medicines for treating fungal infections (such as ketoconazole) and medicines for treating HIV/AIDS (such as HIV protease inhibitors) and medicines for stomach ulcers (such as cimetidine). These medicines, in combination with Mirtazapina Teva Italia, can increase the amount of Mirtazapina Teva Italia in the blood. Tell your doctor if you are using these medicines. It may be necessary to reduce the dose of Mirtazapina Teva Italia or, when the use of these medicines is stopped, to increase the dose of Mirtazapina Teva Italia again.
• medicines for epilepsy, such as carbamazepine and phenytoin; medicines for tuberculosis, such as rifampicin. These medicines, in combination with Mirtazapina Teva Italia, can decrease the amount of Mirtazapina Teva Italia in the blood. Tell your doctor if you are using these medicines. It may be necessary to increase the dose of Mirtazapina Teva Italia or, when the use of these medicines is stopped, to lower the dose of Mirtazapina Teva Italia again.
• medicines that prevent blood clotting, such as warfarin. Mirtazapina Teva Italia can increase the effects of warfarin on the blood. Tell your doctor if you are using this medicine. If you are taking warfarin at the same time, your doctor must monitor your blood closely.
• medicines that can affect the heart rhythmsuch as some antibiotics and some antipsychotics.

Mirtazapina Teva Italia with food and alcohol
You may feel drowsy if you drink alcohol while taking Mirtazapina
Teva Italia.
It is best not to drink alcohol.
Mirtazapina Teva Italia can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Limited experience with the administration of Mirtazapina Teva Italia to pregnant women does not indicate an increased risk. However, caution is advised when administering
Mirtazapina Teva Italia during pregnancy.
If you use Mirtazapina Teva Italia until or immediately before delivery, the newborn must be
carefully monitored for possible adverse effects.
Mirtazapina TevaWhen taken during pregnancy, similar drugs (SSRIs) can increase
the risk of a serious disorder in babies, called persistent pulmonary hypertension of the newborn
(PPHN), causing the baby to breathe faster and turn bluish. These
symptoms usually appear within the first 24 hours of the baby's birth. If this
happens to your baby, you should contact your midwife and/or doctor immediately.

Driving and using machines
Mirtazapina Teva Italia can affect concentration or alertness. Make sure your
abilities are not impaired before driving or using machines. If your doctor has prescribed
Mirtazapina Teva Italia to a patient under the age of 18 years, make sure that concentration and
alertness are not impaired before travelling on the road (e.g. by bicycle).

Mirtazapina Teva Italia orodispersible tablets contains aspartame, a source of
phenylalanine.
Mirtazapina Teva Italia orodispersible tablets contains aspartame, a source of phenylalanine. It may
be harmful for people with phenylketonuria.

3. How to take Mirtazapina Teva Italia

Always take Mirtazapina Teva, this medicine, following exactly the instructions of your
doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

How much Mirtazapina Teva Italia to take
The recommended initial 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 Teva Italia
→ Take Mirtazapina Teva Italia every day at the same time.
It is best to take Mirtazapina Teva Italia as a single dose before going to bed. In any case, your
doctor may suggest dividing the dose of Mirtazapina Teva Italia, once in the morning and once
in the evening before going to bed. The highest dose should be taken before bedtime.

Take the orally disintegrating tablet as indicated below:
Take the tablets orally.

1. Do not break the orally disintegrating tablet

To prevent the orally disintegrating tablet from breaking, do not press on the tablet’s indentation on the
blister (figure A).

2. Detach a tablet indentation

Fig. A.
Each blister contains 6 tablets (indentations), which are separated by perforated lines. Detach one
portion by tearing along the perforated lines (figure 1).

3. Lift the cover sheet

Carefully lift the cover sheet, starting from the corner indicated by the arrow (figures 2 and 3).

Fig. 3.

4. Remove the orodispersible tablet

The orodispersible tablet must be removed from its compartment with dry hands and placed on the tongue.
(Figure 4).

It will disintegrate rapidly and can be swallowed without water.

When you can expect to feel better
Normally Mirtazapina Teva Italia 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 Teva
Italia:
→ 2-4 weeks after starting to take Mirtazapina Teva Italia, discuss with your doctor the effects
that the medicine has had on you.
If you continue to notice no improvement, your doctor may prescribe a higher dose. In this
case, speak to your doctor again after another 2-4 weeks. Normally you need to take
Mirtazapina Teva Italia for 4-6 months after the disappearance of the symptoms of depression.

If you take more Mirtazapina Teva Italia than you should
→ If you or someone else takes too much Mirtazapina Teva Italia, call your doctor immediately.
The most common signs of an overdose of Mirtazapina Teva Italia (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 Teva Italia
If you need to take the dose once a day

• Do not take a double dose to make up for a missed dose of Mirtazapina Teva. Take the next dose at the usual time. If you need 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, do not take it together with the morning dose the next day; skip the dose and continue normally with the morning and evening dose.
• if you have forgotten to take both doses, do 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 Teva Italia
→ You can only stop taking Mirtazapina Teva Italia 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 Teva Italia, even if the depression has
disappeared. If you suddenly stop Mirtazapina Teva Italia you may feel unwell, dizzy, agitated or anxious and have a headache. These symptoms can be avoided by stopping the
treatment gradually. Your doctor will tell you how to reduce the dose gradually.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects, stop taking
mirtazapine 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 1,000):

• yellowing of the eyes or skin; this may indicate problems with liver function (jaundice)

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

• signs of infection such as a sudden and unexplained high fever, sore throat and ulcers in the mouth (agranulocytosis). In rare cases mirtazapine can cause disorders of blood cell production (bone marrow depression). Some people become less resistant to infections because mirtazapine can cause a temporary deficiency of white blood cells (granulocytopenia). In rare cases mirtazapine can also cause a deficiency of red blood cells and white blood cells, and platelets (aplastic anemia), a deficiency of platelets (thrombocytopenia) or an increase in the number of white blood cells (eosinophilia).
• seizures (convulsions)
• a combination of symptoms such as unexplained fever, sweating, increased heart rate, diarrhea, muscle contractions (involuntary), tremor, hyperactive reflexes, agitation, mood changes, loss of consciousness and increased salivation. Very rarely these may be symptoms of serotonin syndrome
• thinking about harming yourself or ending your life
• severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• ) Other possible side effects with mirtazapine are:

Very common(may affect more than 1 in 10 people):
increased appetite and body weight
confusion or drowsiness
headache
dry mouth

Common(may affect up to 1 in 10 people):
lethargy
dizziness
tremors
nausea
diarrhea
vomiting
constipation
skin rash or skin eruption
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) :
Mirtazapina Teva abnormal skin sensations, e.g. burning, prickling, itching or tingling
(paresthesia)
restless legs syndrome
fainting (syncope)
feeling of numbness in the mouth (oral hypoesthesia)
low blood pressure
nightmares
agitation
hallucinations
need to move

Rare(may affect up to 1 in 1,000 ):
muscle contraction (myoclonus)
aggression
abdominal pain and nausea; this may indicate inflammation of the pancreas
(pancreatitis)

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

• abnormal sensation in the mouth (oral paresthesia)
• swelling of the mouth (edema of the mouth)
• swelling throughout the body (generalized edema)
• localized swelling
• hyponatremia
• inappropriate secretion of antidiuretic hormone
• severe skin reactions (bullous dermatitis, erythema multiforme,)
• sleepwalking
• speech disorder
• pain, stiffness and/or weakness of muscles and darkening or discoloration of urine (rhabdomyolysis)
• difficulty in urination (urinary retention)
• increased blood levels of creatine kinase Additional side effects in children and adolescentsIn children under the age of 18, the following side effects were commonly observed in clinical studies: significant weight gain, urticaria and increased triglycerides in the blood.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 Teva Italia

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 pack and blister. The
expiry date refers to the last day of the month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Mirtazapina Teva Italia contains
The active ingredient is mirtazapine.
Each orally disintegrating tablet contains 30 mg of mirtazapine.
The other ingredients are: crospovidone (Type B), mannitol (E 421), microcrystalline cellulose (E 460),
aspartame (E 951), anhydrous colloidal silica, magnesium stearate (E 572), strawberry flavour [artificial flavours,
maltodextrin, triethyl citrate and propylene glycol], and peppermint flavour [artificial flavours, corn starch]

Description of the appearance of Mirtazapina Teva Italia and contents of the pack
Orally disintegrating tablets.
Mirtazapina Teva Italia 30 mg orally disintegrating tablets:
White, rounded tablets with the inscription “37” on one side and ‘A’ on the other, with raised circular edges.
Mirtazapina Teva Italia orally disintegrating tablets is available in packs of 6, 10, 18, 20, 30, 48, 50,
60, 90, 96, 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva Italia S.r.l. Piazzale Luigi Cadorna, 4 20123 Milan
Manufacturer responsible for batch release
Teva Operation Poland SP.z o.o. Ul. Mogilska 80 31-546 Krakow, Poland
Merckle GmbH – Ludwig-Merckle Strasse, 3 – 89143 Blaubeuren (Germany)

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Germany: Mirtazapin-ratiopharm 30 mg Schmelztabletten
Italy: Mirtazapina Teva Italia 30 mg orally disintegrating tablets
Lithuania: Mirtazapin-ratiopharm 30 mg burnoje disperguojamosios tabletės
Luxembourg: Mirtazapin-ratiopharm 30 mg Schmelztabletten
Netherlands: Mirtazapine ratiopharm dispergeerbaar 30 mg, orodispergeerbare tabletten
Portugal: Mirtazapina Teva
Spain: Mirtazapina Flas ratiopharm 30 mg comprimidos bucodispersables EFG
United Kingdom: Mirtazapine 30 mg orodispersible tablets