MIRTAZAPINA 15 mg Таблетка

Содержание инструкции

1. Mirtazapina Almus 15 mg orodispersible tablets
   1. What is Mirtazapina Almus and what is it used for
   2. What you need to know before taking Mirtazapina Almus
   3. How to take Mirtazapina Almus
   4. How to store Mirtazapina Almus
   5. Contents of the pack and other information

Mirtazapina Almus 15 mg orodispersible tablets

Mirtazapina Almus 30 mg orodispersible tablets
Generic medicine

Read this leaflet carefully before 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, pharmacist, or nurse.
• 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 any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Mirtazapina Almus belongs to a group of medicines called antidepressants.
Mirtazapina Almus is used to treat depressive disorders.
Mirtazapina Almus 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. More information is
provided in paragraph 3, under “When can you expect to feel better”.

2. What you need to know before taking Mirtazapina Almus

Do not take Mirtazapina Almus

• if you are allergic to 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 Almus.
• 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, pharmacist or nurse before taking Mirtazapina Almus.
Tell your doctor before taking Mirtazapina Almus:

• if you have had a severe skin rash or skin exfoliation, blisters and/or mouth ulcers after taking Mirtazapina Almus or other medicines.

Children and adolescents
Mirtazapina Almus is generally not used in children and adolescents under the age of
18 years. It is important to know that in patients under 18 years of age, this class of drugs is associated
with an increased risk of undesirable effects, such as suicide attempts, suicidal thoughts and hostility (in
particular aggression, argumentative behaviour and anger). However, a doctor may decide to
prescribe Mirtazapina Almus to patients under 18 years of age if they consider it to be in their
best interests. If your doctor has prescribed Mirtazapina Almus to a patient under 18 years of age and
you would like clarification, please contact them directly. Immediately tell your
doctor if any of the symptoms described above occur or worsen in patients under 18
years of age while taking Mirtazapina Almus.
It should also be noted that the long-term safety effects of Mirtazapina Almus 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
more often 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, generally 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.
• 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 committing suicide 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 behaviour.

Also, talk to your doctor, pharmacist or nurse before taking Mirtazapina Almus
and pay particular attention with Mirtazapina Almus if you suffer or have suffered in the past from any of
the conditions listed below.

→If you haven't already, tell your doctor about these conditions before taking Mirtazapina
Almus.

• seizures(epilepsy). If you start having seizures or if seizures become more frequent, stop taking Mirtazapina Almus and contact your doctor immediately.
• liver diseases, including jaundice. If you develop jaundice, stop taking Mirtazapina Almus 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(periods of euphoria/hyperactivity and depressed mood). If you start to feel euphoric or overexcited, stop taking Mirtazapina Almus 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 conditions,that can change the heart rhythm, a recent heart attack, heart failure or taking certain medicines that can affect the heart rhythm.
• if you develop signs of infection, such as unexplained high fever, sore throat and ulcers in the mouth. →Stop taking Mirtazapina Almus 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.
• Serious skin reactions have been reported with the use of Mirtazapina Almus, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop using it and seek immediate medical attention if you observe any of the symptoms described in section 4 in relation to these serious skin reactions. If you have had serious skin reactions in the past, treatment with Mirtazapina Almus should not be restarted.

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

Do not take Mirtazapina Almusin combination with:

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

Be careful whentaking Mirtazapina Almus 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 methemoglobin in the blood) and St John's wort preparations(a herbal remedy for depression). Very rarely, Mirtazapina Almus, 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 (involuntary), 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 Almus in the blood. Tell your doctor if you are using this medicine because it may require a reduction in the dose of Mirtazapina Almus or, when the use of nefazodone is stopped, an increase in the dose of Mirtazapina Almus.
• 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 Almus can 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), medicines to treat HIV/AIDS

(such as HIV protease inhibitors) and medicines for stomach ulcers(such as cimetidine).
These medicines, in combination with Mirtazapina Almus, can increase the amount of
Mirtazapina Almus in the blood. Tell your doctor if you are using these medicines. It may
be necessary to reduce the dose of Mirtazapina Almus or, when the use of these medicines is
stopped, to increase the dose of Mirtazapina Almus again.

• medicines for epilepsy, such as carbamazepine and phenytoin; medicines for tuberculosis, such as rifampicin. These medicines, in combination with Mirtazapina Almus, can decrease the amount of Mirtazapina Almus in the blood. Tell your doctor if you are using these medicines. It may be necessary to increase the dose of Mirtazapina Almus or, when the use of these medicines is stopped, to lower the dose of Mirtazapina Almus again.
• medicines that prevent blood clotting, such as warfarin. Mirtazapina Almus can increase the effects of warfarin on the blood. Tell your doctor if you are using this medicine. If taking warfarin concomitantly, your doctor must keep your blood under close control.
• medicines that can affect the heart rhythmsuch as some antibiotics and some antipsychotics.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are 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 Almus to pregnant women does not
indicate an increased risk. However, caution is advised when administering Mirtazapina Almus in
pregnancy.
If you use Mirtazapina Almus up to or immediately before delivery, the newborn must be
carefully monitored for possible adverse effects.
Make sure your midwife and/or doctor knows that you are taking Mirtazapina Almus.
When taken during pregnancy, similar medicines (SSRIs) can increase the risk of a
serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN),
inducing faster breathing and a bluish appearance in the baby. These symptoms usually
begin within the first 24 hours after the baby's birth. If this happens to your baby, you must
contact your midwife and/or doctor immediately.

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

Mirtazapina Almus contains aspartame
This medicine contains 6 mg of aspartame per 15 mg orodispersible tablet and 12
mg of aspartame per 30 mg orodispersible tablet. Aspartame is a source of
phenylalanine. It may be harmful to you if you suffer from phenylketonuria, a rare genetic disease that causes
phenylalanine to build up because the body cannot break it down properly.

3. How to take Mirtazapina Almus

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

How much Mirtazapina Almus 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 Almus
→Take Mirtazapina Almus every day at the same time.
It is best to take Mirtazapina Almus as a single dose before going to bed. In any case, your doctor
may suggest dividing the dose of Mirtazapina Almus, 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 press on the tablet’s imprint on the blister (Figure 1).

Figure 1

• 2. Separate each cell from the strip(figure 2).

Figure 2

• 3. Carefully lift the cover sheet, startingfrom the corner indicated by the arrow (figures 3 and 4).

Figure 3

Figure 4

• 4. Remove the tablet from its compartment with dry hands and place it on your tongue (Figure 5). It will disintegrate rapidly and can be swallowed without water.

Figure 5
When you can expect to feel better
Normally Mirtazapina Almus 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
Almus:
2-4 weeks after starting to take Mirtazapina Almus, 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 Almus for 4-6 months after the disappearance of the symptoms of depression.

If you take more Mirtazapina Almus than you should
If you or someone else takes too much Mirtazapina Almus, call your doctor immediately.
The most common signs of an overdose of Mirtazapina Almus (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 Almus
If you need 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 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 for the missed dose. Skip both doses and continue the next day normally with the morning and evening dose.

If you stop taking Mirtazapina Almus
You can only stop taking Mirtazapina Almus 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 Almus, even if the depression is
gone. If you suddenly stop Mirtazapina Almus 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 using Mirtazapina Almus, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone
experiences them.

Stop taking Mirtazapina Almus and consult your doctor immediately if you experience one
of the following serious side effects:
Very common(may affect up to 1 in 10 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 on the basis of available data):

• Signs of infection such as a sudden and unexplained high fever, sore throat and mouth ulcers (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, involuntary muscle contractions, tremors, hyperactive reflexes, fatigue, mood changes and loss of consciousness. Very rarely these may be symptoms of serotonin syndrome.
• Thoughts of harming yourself or taking your own life - consult your doctor immediately or go to hospital.
• Reddish patches on the trunk, i.e. target-shaped or circular macules, often with central blisters, skin exfoliation, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

In addition, the following side effects have been reported:

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
• constipation
• 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
• memory problems, which in most cases resolved with discontinuation of treatment In children under 18 years of age, the following adverse events are commonly observed in clinical studies:
• weight gain
• urticaria
• increased triglycerides in the blood

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

• abnormal sensations on the skin, e.g. burning, tingling, itching or prickling (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 people):

• muscle contraction (myoclonus)
• feeling of aggressiveness
• abdominal pain and nausea, this may indicate inflammation of the pancreas (pancreatitis). Not known(frequency cannot be assessed on the basis of available data):
• abnormal sensation in the mouth (oral paresthesia)
• swelling of the mouth (oral edema)
• generalized swelling (generalized edema)
• localized swelling
• hyponatremia
• inappropriate secretion of antidiuretic hormone
• severe skin reactions (bullous dermatitis, erythema multiforme)
• increased salivation
• difficulty speaking (dysarthria)
• sleepwalking
• difficulty urinating
• muscle pain, stiffness and/or weakness, dark or unusual urine color (rhabdomyolysis)
• alteration of enzymes in the blood (detected in blood tests)

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Mirtazapina Almus

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, on the container of
tablets and on the blister after EXP. The expiry date refers to the last day of the month.
Storage conditions (blister): store in the original packaging to protect the
medicine from moisture and light.
Storage conditions (container of tablets): store in the original container of the
tablets and keep it tightly closed to protect the medicine from moisture and light.
Do not dispose of any medicine in the 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 Almus contains

• The active ingredient is mirtazapine. Each orodispersible tablet of Mirtazapina Almus contains 15 mg or 30 mg of mirtazapine.
• The other excipients are: mannitol, microcrystalline cellulose, heavy magnesium carbonate, hydroxypropylcellulose, crospovidone, anhydrous colloidal silica, L-Methionine, microcrystalline cellulose and guarana gum, aspartame (E951), orange flavour, magnesium stearate.

Description of the appearance of Mirtazapina Almus tablets and contents of the pack
Orodispersible tablets.
15 mg tablets: white to off-white round tablets, 8 mm in diameter, biconvex, uncoated
marked with “M1”.
30 mg tablets: white to off-white round tablets, 10 mm in diameter, biconvex, uncoated
marked with “M2”.
15 mg:
Blister packs of 6, 18, 30, 48, 90, 96 and 180 (hospital packs 18 x 10) tablets
Blister packs with easy opening, separable into single doses, packs of 6, 18, 30, 48, 90, 96 and 180
(hospital packs 18 x 10) tablets.
Container: 50, 100 tablets (desiccant included).
30 mg:
Blister packs of 6, 18, 30, 48, 90, 96 and 180 (hospital packs 18 x 10) tablets
Blister packs with easy opening, separable into single doses, packs of 6, 18, 30, 48, 90, 96 and 180
(hospital packs 18 x 10) tablets.
Container: 50, 100 tablets (desiccant included).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Almus S.r.l.
Via Cesarea, 11/10 – 16121 Genova

Production and batch release
Actavis hf.
Reykjavíkurvergur 76-78
220 Hafnarfjordur
Iceland
Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Italy: Mirtazapina Almus 15 mg orodispersible tablets
Mirtazapina Almus 30 mg orodispersible tablets