MIRTAZAPINA 30 mg Фильм-Coated Таблетки

Содержание инструкции

1. Mirtazapina Zentiva 30 mg film-coated tablets
   1. What is Mirtazapina Zentiva and what it is used for
   2. What you need to know before taking Mirtazapina Zentiva
   3. How to take Mirtazapina Zentiva
   4. Possible side effects
   5. How to store Mirtazapina Zentiva
   6. Contents of the pack and other information

Mirtazapina Zentiva 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 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. See section 4.

Contents of this leaflet:

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

1. What is Mirtazapina Zentiva and what it is used for

Mirtazapina Zentiva belongs to a group of medicines called antidepressants.
Mirtazapina Zentiva is used to treat depressive disorders in adults.
Mirtazapina Zentiva will take 1 to 2 weeks to start working. After a period of between
2 and 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 between 2 and 4 weeks. More information is provided in section 3, under
“When you can expect to feel better”.

2. What you need to know before taking Mirtazapina Zentiva

Do not take Mirtazapina Zentiva

• if you are allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6).
• 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 Zentiva

Children and adolescents
Mirtazapina Zentiva is generally not used in children and adolescents under the age of 18 years because efficacy has not been demonstrated. Furthermore, it should be known that in patients under the age of 18 years, this class of drugs is associated with an increased risk of undesirable effects, such as suicide attempt, suicidal thoughts and hostility (particularly aggression, argumentative behaviour and anger). However, a doctor may decide to prescribe Mirtazapina Zentiva to patients under the age of 18 years if they consider it to be in their best interests. If the doctor has prescribed Mirtazapina Zentiva to a patient under the age of 18 years 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 years while taking Mirtazapina Zentiva. In addition, the effects on long-term safety of Mirtazapina Zentiva in this age group in terms of growth, maturation and cognitive and behavioural development have not yet been demonstrated. Furthermore, a significant weight gain has been observed more frequently in this age group when treated with mirtazapine compared to 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 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 illnesses treated with antidepressants. If at any time you find yourself thinking about killing yourself or harming yourself, contact your doctor or go tohospital immediately.It may be helpful to tell a relative or friendsthat you are depressed 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 behaviour. Be particularly careful with Mirtazapina Zentiva also
• if you suffer from or have suffered from any of the conditions listed below. Talk to your doctor about these conditions before taking Mirtazapina Zentiva, if you have not already done so.
• seizures(epilepsy). If you start having seizures or if seizures become more frequent, stop taking Mirtazapina Zentiva and contact your doctor immediately;
• liver diseases, including jaundice. If you develop jaundice, stop taking Mirtazapina Zentiva 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 Zentiva 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;
• some types of heart conditionsthat can change the heart rhythm, a recent heart attack, heart failure, or taking some 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 Zentiva 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 undesirable effects of antidepressants.

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

Do not take Mirtazapina Zentivain combination with:

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

Be careful whentaking Mirtazapina Zentiva 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 some mental illnesses), methylene blue(used to treat high levels of methemoglobin in the blood) and St John's Wort -Hypericum perforatum(a herbal medicine for depression). Very rarely, Mirtazapina Zentiva, 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 (incontrollable), tremor, overactive reflexes, restlessness, changes in mood 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 Zentiva in the blood. Tell your doctor if you are using this medicine because it may require a reduction in the dose of Mirtazapina Zentiva or, when the use of nefazodone is stopped, an increase in the dose of Mirtazapina Zentiva.
• 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. When given in combination with these medicines, Mirtazapina Zentiva can increase the drowsiness caused by these medicines.
• 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 treating stomach ulcers(such as cimetidine). These medicines, in combination with Mirtazapina Zentiva, can increase the amount of Mirtazapina Zentiva in the blood. Tell your doctor if you are using these medicines. It may be necessary to reduce the dose of Mirtazapina Zentiva or, when the use of these medicines is stopped, increase the dose of Mirtazapina Zentiva again.
• medicines for epilepsy, such as carbamazepine and phenytoin;
• medicines for tuberculosis, such as rifampicin. These medicines, in combination with Mirtazapina Zentiva, can decrease the amount of Mirtazapina Zentiva in the blood. Tell your doctor if you are using these medicines. It may be necessary to increase the dose of Mirtazapina Zentiva or, when the use of these medicines is stopped, lower the dose of Mirtazapina Zentiva again.
• medicines that prevent blood clotting, such as warfarin. Mirtazapina Zentiva can increase the effects of warfarin on the blood. Tell your doctor if you are

using this medicine. In case of concomitant use, the doctor must keep the blood under close
control.

• medicines that can affect the heart rhythm, such as some antibiotics and some antipsychotics.

Taking Mirtazapina Zentiva with food, drink and alcohol
You may feel sleepy if you drink alcohol while taking Mirtazapina Zentiva.
It is best not to drink alcohol.
Mirtazapina Zentiva can be taken with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Limited experience with the administration of Mirtazapina Zentiva to pregnant women does not indicate an
increased risk. However, caution should be exercised when administering Mirtazapina Zentiva during pregnancy.
If you use Mirtazapina Zentiva up to, or immediately before, delivery, the newborn must be carefully
monitored for possible undesirable effects.
When similar medicines (SSRIs) taken during pregnancy can increase the risk of a serious
condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), which makes the
baby breathe faster and makes it look bluish. These symptoms usually start within the first 24 hours
after the baby is born. If this happens to your baby, you need to contact the midwife and/or doctor
immediately.

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

Mirtazapina Zentiva contains lactose
Mirtazapina Zentiva film-coated tablets 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 Zentiva

Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your doctor or
pharmacist.
Take the tablets orally. Swallow the prescribed dose of Mirtazapina Zentiva without chewing, with a
little water or fruit juice.

How much to take
The recommended starting dose is 15(equivalent to half a tablet of Mirtazapina Zentiva) 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 –
half a tablet - and 45 mg – one and a half tablets of Mirtazapina Zentiva - per day). Usually 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 Zentiva
→ Take Mirtazapina Zentiva every day at the same time. It is best to take Mirtazapina Zentiva as a single
dose before going to bed. In any case, your doctor may suggest dividing the dose of Mirtazapina Zentiva
once in the morning and once in the evening before going to bed. The highest dose should be taken before
bedtime.

When you can expect to feel better
Usually Mirtazapina Zentiva 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 Zentiva:
→ 2-4 weeks after starting to take Mirtazapina Zentiva, 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 Zentiva for 4-6 months after the disappearance of the symptoms of
depression.

If you take more Mirtazapina Zentiva than you should
If you or someone else takes too much Mirtazapina Zentiva, call your doctor immediately.
The most likely signs of an overdose of Mirtazapina Zentiva (without other medicines or alcohol) are drowsiness,
disorientation and increased heart rate. The symptoms of a possible overdose may
include changes to your heart rhythm (fast, irregular heartbeat) and/or fainting which
could be the symptoms of a life-threatening condition known as torsades de pointes.

If you forget to take Mirtazapina Zentiva
If you have to take the dose once a day:

• Do not take a double dose to make up for a missed dose. Take 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 the next day; 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 Zentiva
You can only stop taking Mirtazapina Zentiva 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 the treatment.
Do not suddenly stop taking Mirtazapina Zentiva, even if the depression has disappeared. If
you suddenly stop taking Mirtazapina Zentiva 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 doubts about 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 mirtazapina and tell your doctor immediately.
Uncommon(may affect up to 1 in 100 people):

• feeling of 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).

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

• signs of infection such as a sudden and unexplained high fever, sore throat and mouth ulcers (agranulocytosis). In rare cases mirtazapina can cause disorders of blood cell production (bone marrow depression). Some people become less resistant to infections because mirtazapina can cause a temporary deficiency of white blood cells (granulocytopenia). In rare cases mirtazapina 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), chills, overactive reflexes, restlessness, mood changes and loss of consciousness. In very rare cases 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 of mirtazapina are:
Very common(may affect more than 1 in 10 people):

• increased appetite and body weight
• drowsiness or sleepiness
• headache
• dry mouth.

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

• lethargy
• dizziness
• instability or tremors
• nausea
• diarrhea
• vomiting
• constipation
• rash or skin eruptions (exanthema)
• joint pain (arthralgia) or muscle pain (myalgia)
• back pain
• feeling faint or lightheaded 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)
• feeling of numbness in the mouth (oral hypoesthesia)
• low blood pressure
• nightmares
• feeling agitated
• hallucinations
• need to move.

Rare(may affect up to 1 in 1,000):

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

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

• abnormal sensations 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
• severe skin reactions (bullous dermatitis, erythema multiforme)
• sleepwalking
• speech disorder
• increased salivation.
• increased levels of creatine kinase in the blood
• difficulty in urination
• muscle pain, stiffness and/or weakness and dark or discolored urine.

Additional side effects in children and adolescents
In children under 18 years of age, the following side effects have been commonly observed in clinical studies: significant increase in body weight, hives 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 Zentiva

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/blister. 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. Contents of the pack and other information

What contains Mirtazapina Zentiva
The active ingredient is mirtazapine.
Mirtazapina Zentiva contains 30 mg of mirtazapine per film-coated tablet.
The other components are:
Tablet core: lactose monohydrate, corn starch, hydroxypropylcellulose, anhydrous colloidal silica,
magnesium stearate (Ph. Eur.).
Tablet coating: hypromellose, macrogol 8000, titanium dioxide (E171), yellow iron oxide (E172),
red iron oxide (E172) and black iron oxide (E 172).

Description of the appearance of Mirtazapina Zentiva and contents of the pack
Mirtazapina Zentiva are film-coated tablets,
oblong, biconvex, beige in color, with a fracture line on one side. The tablet can be divided into two
equal doses.
Mirtazapina Zentiva 30 mg film-coated tablets are packaged in blisters.
The following blister packs are available: 14, 20, 28, 30, 50, 56, 60, 70, 90, 100, 200 and 500 tablets
film-coated (not all pack sizes may be marketed).

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Zentiva Italia S.r.l. – Viale Bodio n. 37/b – 20158 Milan

Manufacturer:
Saneca Pharmaceuticals a.s.
Nitrianska 100
920 27 Hlohovec
Slovak Republic

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Italy: Mirtazapina Zentiva
Portugal: Mirtazapina Zentiva 15 mg tablets
Mirtazapina Zentiva 30 mg tablets
Mirtazapina Zentiva 45 mg tablets
Spain: Mirtazapina Zentiva 15 mg film-coated tablets EFG
Mirtazapina Zentiva 30 mg film-coated tablets EFG