MIRTAZAPINA 15 mg Orodispersible Tablet

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1. MIRTAZAPINA DOC Generici 15 mg orodispersible tablets, 30 mg orodispersible tablets, 45 mg orodispersible tablets
   1. WHAT IS MIRTAZAPINA DOC Generici AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING MIRTAZAPINA DOC Generici
2. MIRTAZAPINA DOC Generici may increase the effects of warfarin in the blood. Inform your
   1. HOW TO TAKE MIRTAZAPINA DOC Generici
   2. Do not break the orally disintegrating tablet
   3. Detach a tablet indentation
   4. Lift the cover sheet
   5. Remove the orodispersible tablet
   6. POSSIBLE SIDE EFFECTS
   7. HOW TO STORE MIRTAZAPINA DOC Generici
   8. CONTENT OF THE PACK AND OTHER INFORMATION

MIRTAZAPINA DOC Generici 15 mg orodispersible tablets, 30 mg orodispersible tablets, 45 mg orodispersible 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 their symptoms are the same as yours, as it could 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 Generici is and what it is used for
• 2. What you need to know before you take MIRTAZAPINA DOC Generici
• 3. How to take MIRTAZAPINA DOC Generici
• 4. Possible side effects
• 5. How to store MIRTAZAPINA DOC Generici
• 6. Contents of the pack and other information

1. WHAT IS MIRTAZAPINA DOC Generici AND WHAT IT IS USED FOR

MIRTAZAPINA DOC Generici belongs to a group of medicines called antidepressants.
MIRTAZAPINA DOC Generici is used to treat depressive disorders in adults.
MIRTAZAPINA DOC Generici will take 1 to 2 weeks to start working. After
2-4 weeks you may start to feel better. Contact your doctor if you do not feel better or if you feel
worse after 2-4 weeks. More information is provided in section 3 “When you can
expect to feel better”.

2. WHAT YOU NEED TO KNOW BEFORE TAKING MIRTAZAPINA DOC Generici

Do not take MIRTAZAPINA DOC Generici
 if you are allergic to mirtazapine or any of the other ingredients of this medicine
(listed in section 6). In this case, you should talk to your doctor as soon as possible before
taking MIRTAZAPINA DOC Generici.
 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 taking this medicine.

Pay particular attention with MIRTAZAPINA DOC Generici
Children and adolescents under 18 years of age
MIRTAZAPINA DOC Generici is generally not recommended for use in children and adolescents
under 18 years of age as its efficacy has not been demonstrated. It should also be known that
patients under 18 years of age who take this class of medicines have an increased risk of adverse
effects, such as suicide attempts, suicidal thoughts and hostility (particularly aggression, argumentative
behaviour and anger). Despite this, the doctor may prescribe MIRTAZAPINA DOC Generici to patients
under 18 years of age if they believe it is in their best interest. If the doctor has prescribed
MIRTAZAPINA DOC Generici to a patient under 18 years of age and you want to discuss this, see your
doctor. You should inform the doctor if any of the symptoms reported above occur or worsen when
patients under 18 years of age take MIRTAZAPINA DOC Generici.
Furthermore, the long-term safety effects of MIRTAZAPINA DOC Generici in this age group in terms
of growth, maturation and cognitive and behavioural development have not yet been demonstrated.
In addition, 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 committing suicide. 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 thought about committing suicide or harming yourself in the past.
 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 psychiatric illnesses treated with antidepressants.
 If at any time you find yourself thinking about committing suicide or harming yourself, contact your
doctor or go to hospital immediately.
It may help to tell a relative or friendthat you are depressed and ask them to read this leaflet. You
can ask them to watch out for any worsening of your depression or any changes in your behaviour.
Pay particular attention with MIRTAZAPINA DOC Generici also
 if you suffer or have suffered in the past from any of the conditions listed below.
 If you have not already done so, tell your doctor about these conditions before taking
MIRTAZAPINA DOC Generici.

• seizures(epilepsy). If you start to have seizures or if seizures become more frequent, stop taking MIRTAZAPINA DOC Generici and contact your doctor immediately.
• liver disease, including jaundice. If you develop jaundice, stop taking MIRTAZAPINA DOC Generici 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 immediately.
• manic depression (periods of alternating euphoria/hyperactivity and depressed mood). If you start to feel euphoric or overexcited, stop taking MIRTAZAPINA DOC Generici and contact your doctor immediately.
• diabetes (it may be necessary to adjust the dose of insulin or other antidiabetic medicines).
• eye diseases, such as increased pressure in the eye (glaucoma).
• difficulty urinating, which may be caused by an enlarged prostate.  If you experience signs of infection, such as unexplained high fever, sore throat and ulcers in the mouth.  Stop taking MIRTAZAPINA DOC Genericiand 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 Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Do not take MIRTAZAPINA DOC Genericiin combination with:

• monoamine oxidase inhibitors(MAO inhibitors). Also, do not take MIRTAZAPINA DOC Generici within two weeks of stopping MAO inhibitors. Similarly, if you stop taking MIRTAZAPINA DOC Generici, 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 DOC Generici in combination with:
 antidepressants such as SSRIs, venlafaxine and L-tryptophan or triptans(used to treat
migraine), tramadol(a painkiller), linezolid(an antibiotic), lithium(used to treat
certain psychiatric conditions) and St John's wort preparations(a herbal medicinal product for
depression). Very rarely, MIRTAZAPINA DOC Generici, 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
DOC Generici in the blood. Tell your doctor if you are using this medicine as this may
require a reduction in the dose of MIRTAZAPINA DOC Generici or, when the use of
nefazodone is stopped, an increase in the dose of MIRTAZAPINA DOC Generici.
 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 DOC Generici 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 DOC Generici, can increase the
amount of MIRTAZAPINA DOC Generici in the blood. Tell your doctor if you are using
these medicines. It may be necessary to reduce the dose of MIRTAZAPINA DOC Generici
or, when the use of these medicines is stopped, increase the dose of MIRTAZAPINA DOC
Generici again.
 medicines for epilepsy, such as carbamazepine and phenytoin;

medicines for tuberculosis, such as rifampicin.
These medicines, in combination with MIRTAZAPINA DOC Generici, can decrease the
amount of MIRTAZAPINA DOC Generici in the blood. Tell your doctor if you are using
these medicines. It may be necessary to increase the dose of MIRTAZAPINA DOC
Generici or, when the use of these medicines is stopped, lower the dose of MIRTAZAPINA DOC
Generici again.
 medicines that prevent blood clotting, such as warfarin.

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

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

MIRTAZAPINA DOC Generici with food, drinks and alcohol
You may experience drowsiness if you consume alcoholic beverages while taking
MIRTAZAPINA DOC Generici. It is best to avoid alcoholic beverages.
MIRTAZAPINA DOC Generici can be taken with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Limited experience regarding the administration of MIRTAZAPINA DOC Generici to pregnant
women does not indicate an increased risk. However, caution is required when administering
MIRTAZAPINA DOC Generici during pregnancy.
If you use MIRTAZAPINA DOC Generici until delivery 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 Generici.
Medicines similar to this one (SSRIs), if taken during pregnancy, can increase the risk of a
serious condition in children called persistent pulmonary hypertension of the newborn
(PPHN) which causes rapid breathing in the newborn and a bluish skin tone. These symptoms
usually appear within the first 24 hours after birth. Immediately inform your midwife and/or
doctor if this should happen to your baby.

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

MIRTAZAPINA DOC Generici orodispersible tablets contains aspartame, a source of
phenylalanine. It may be harmful for people with phenylketonuria.

3. HOW TO TAKE MIRTAZAPINA DOC Generici

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

How much MIRTAZAPINA DOC Generici to take
The recommended initial dose is 15 or 30 mg per day.The 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, the doctor may adjust the dose if you are
elderly or if you have had a kidney or liver disease.

When to take MIRTAZAPINA DOC Generici
 Take MIRTAZAPINA DOC Generici every day at the same time.
It is best to take MIRTAZAPINA DOC Generici as a single dose before going to bed. In any
case, the doctor may suggest dividing the dose of MIRTAZAPINA DOC Generici, once in the
morning and once in the evening before going to bed. The higher 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 indentation on the blister (figure A).

Fig. A.

2. Detach a tablet indentation

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

Fig. 1.

3. Lift the cover sheet

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

Fig. 2. 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).

Fig. 4.
It will disintegrate rapidly and can be swallowed without water.

When you can expect to feel better
Normally MIRTAZAPINA DOC Generici takes 1-2 weeks to start working and after 2-
4 weeks you may notice an improvement.
It is important that during the first weeks of treatment you inform your doctor about the effects of
MIRTAZAPINA DOC Generici:
 2-4 weeks after starting to take MIRTAZAPINA DOC Generici, 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, talk to your doctor again after another 2-4 weeks. Normally you need to
take MIRTAZAPINA DOC Generici for 4-6 months after the disappearance of the symptoms of
depression.

If you take more MIRTAZAPINA DOC Generici than you should
 If you or someone else takes too much MIRTAZAPINA DOC Generici, call your doctor
immediately.
The most common signs of an overdose of MIRTAZAPINA DOC Generici (without other medicines or
alcohol) are drowsiness, confusion and increased heart rate.

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

• Do not take a double dose to make up for a missed dose. Skip the dose and 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, 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 Generici
 You can only stop taking MIRTAZAPINA DOC Generici 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 Generici, even if the
depression has disappeared. If you suddenly stop MIRTAZAPINA DOC Generici you
may feel unwell, dizzy, 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 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 everyone will experience them.

If you experience any of the following serious side effects, stop taking
MIRTAZAPINA DOC Generici and inform 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; this may indicate liver function disorders (jaundice).

Not known(frequency cannot be estimated based on available data):

• signs of infection such as sudden and unexplained high fever, sore throat and stomatitis (agranulocytosis). In rare cases MIRTAZAPINA DOC Generici may cause a disorder of blood cell production (bone marrow depression). Some people become less resistant to infections because MIRTAZAPINA DOC Generici can cause a temporary deficiency of white blood cells (granulocytopenia). In rare cases MIRTAZAPINA DOC Generici can also cause a deficiency of white and red blood cells, and 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), tremor, hyperactive reflexes, fatigue, mood changes, loss of consciousness and increased salivation. Very rarely these may be symptoms of serotonin syndrome.
• thinking about harming yourself or taking your own 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
• drowsiness
• headache
• dry mouth

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

• lethargy
• dizziness
• tremors
• nausea
• diarrhea
• vomiting
• rash or skin eruptions (exanthema)
• joint pain (arthralgia) or muscle pain (myalgia)
• back pain
• feeling dizzy 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, tingling, itching or pins and needles (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 1000 people):

• muscle contraction (myoclonus)
• aggression
• pancreatitis

Not known(frequency cannot be estimated based on available data):

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

Additional side effects in children and adolescents
Commonly, the following adverse events have been observed in children under the age of 18 in clinical
studies: significant weight gain, urticaria and increased triglycerides in the
blood.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at:
http://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 Generici

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 package and on the blister after
EXP. The expiry date refers to the last day of that 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. CONTENT OF THE PACK AND OTHER INFORMATION

What MIRTAZAPINA DOC Generici contains

• The active ingredient is mirtazapine. MIRTAZAPINA DOC Generici 15 mg orodispersible tablets contains 15 mg of mirtazapine per orodispersible tablet. MIRTAZAPINA DOC Generici 30 mg orodispersible tablets contains 30 mg of mirtazapine per orodispersible tablet. MIRTAZAPINA DOC Generici 45 mg orodispersible tablets contains 45 mg of mirtazapine per orodispersible tablet.
• The other ingredients are crospovidone (type B), mannitol (E421), microcrystalline cellulose, aspartame (E951), anhydrous colloidal silica, magnesium stearate, strawberry-guarana flavour [maltodextrin, propylene glycol artificial flavourings, acetic acid] and peppermint flavour [artificial flavourings, corn starch].

Description of the appearance of MIRTAZAPINA DOC Generici and content of the pack
MIRTAZAPINA DOC Generici are orodispersible tablets.
MIRTAZAPINA DOC Generici 15 mg orodispersible tablets:
White orodispersible tablets, round in shape (diameter 6.5 mm), with a raised circular edge, and with the number “36” engraved on one side and the letter ‘A’ on the opposite side.
MIRTAZAPINA DOC Generici 30 mg orodispersible tablets:
White orodispersible tablets, round in shape (diameter 8.0 mm), with a raised circular edge, and with the number “37” engraved on one side and the letter ‘A’ on the opposite side.
MIRTAZAPINA DOC Generici 45 mg orodispersible tablets:
White orodispersible tablets, round in shape (diameter 9.5 mm), with a raised circular edge, and with the number “38” engraved on one side and the letter ‘A’ on the opposite side.
MIRTAZAPINA DOC Generici orodispersible tablets are available in perforated blister packs made of polyamide/ aluminium/ PVC/ paper/ polyester/ aluminium Unit Dose containing 6, 18, 30, 48, 90 and 96 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici Srl
Via Turati 40
20121 Milan – Italy

Manufacturer
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
or
Pfizer Services Company BVBA
Hoge Wei 10
B-1930 Zaventem
Belgium
or
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta
or
LABORATORIOS CINFA, S.A.
Ctra. Olaz-Chipi 10, Pol. Ind. Areta
31620 Huarte-Pamplona (Navarre)
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Belgium: Mirtazapine Apotex 15 mg/ 30 mg/ 45 mg orodispergeerbare tabletten
Mirtazapine Apotex 15 mg/ 30 mg/ 45 mg comprimés orodispersible
Mirtazapine Apotex 15 mg/ 30 mg/ 45 mg Schmeltztabletten
Bulgaria: Mirtazapine Aurobindo 15 mg/ 30 mg/ 45 mg тaблетки, диспергираща ce в
ycтaтa
Cyprus: Mirtazapin Aurobindo 15 mg/ 30 mg/ 45 mg δισκία διασπειρόμενο στο οτόμα
Denmark: Mirtazapin “Aurobindo”
Estonia: Mirtazapin Aurobindo 15 mg/ 30 mg/ 45 mg suus dispergeeruvad tabletid
Finland: Mirtazapin Aurobindo 15 mg/ 30 mg/ 45 mg tabletti, suussa hajoava
Mirtazapin Aurobindo 15 mg/ 30 mg/ 45 mg munsönderfallande tabletter
France: MIRTAZAPINE AUROBINDO 15 mg/ 30 mg/ 45 mg, comprimés
orodispersible
Germany: Mirtazapin Aurobindo 15 mg/ 30 mg/ 45 mg Schmelztabletten
Greece: mirtazaFer Aurobindo 15 mg/ 30 mg/ 45 mg δισκία διασπειρόμενο στο οτόμα
Hungary: Mirtazapine Aurobindo 15 mg/ 30 mg/ 45 mg szájban diszpergálódó tabletta
Ireland: Mirtazapine Aurobindo 15 mg/ 30 mg/ 45 mg orodispersible tablets
Italy: MIRTAZAPINA DOC Generici 15 mg/ 30 mg/ 45 mg compresse orodispersibili
Latvia: Mirtazapin Aurobindo 15 mg/ 30 mg/ 45 mg mutē disperģējamās tabletes
Lithuania: Mirtazapin Aurobindo 15 mg/ 30 mg/ 45 mg burnoje disperguojamosios tabletės
Mirtazapin Aurobindo 15 mg/ 30 mg/ 45 mg orodispersible tablets
Netherlands: Mirtazapine Aurobindo 15mg/30mg/45mg orodispergeerbare tabletten
Poland: Mirtazapine Aurobindo
Portugal: Mirtazapina Aurobindo
Romania: Mirtazapin Aurobindo 15 mg/ 30 mg/ 45 mg comprimate orodispersabile
Spain: MIRTAZAPINA FLAS CINFA 15 mg/ 30 mg/ 45 mg comprimidos
bucodispersables
Sweden: Mirtazapin Aurobindo 15 mg/ 30 mg/ 45 mg munsönderfallande tabletter
United Kingdom: Mirtazapine 15 mg/ 30 mg/ 45 mg orodispersible tablets

This leaflet was last updated on