MIRTAGEN 45 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Mirtagen, 15 mg, orally disintegrating tablets
3. Mirtagen, 30 mg, orally disintegrating tablets
4. Mirtagen, 45 mg, orally disintegrating tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
5. What is Mirtagen and what is it used for
6. Important information before taking Mirtagen
   1. When not to take Mirtagen:
   2. Warnings and precautions
   3. When not to take Mirtagen or consult a doctor before starting treatment:
   4. Children and adolescents
   5. Suicidal thoughts and worsening of depression
   6. Elderly patients
   7. During treatment
   8. Mirtagen and other medicines
   9. Mirtagen and alcohol
   10. Pregnancy and breastfeeding
   11. Driving and using machines
   12. Mirtagen contains aspartame
7. How to take Mirtagen
   1. Dosage
   2. When to take Mirtagen
   3. Information about taking orally disintegrating tablets:
8. Do not crush the orally disintegrating tablet
9. Tear off the tablet blister
10. Tear off the foil
11. Remove the orally disintegrating tablet
    1. When can improvement in well-being be expected
    2. Use in children and adolescents under 18 years of age
    3. Taking a higher dose of Mirtagen than recommended
    4. Missing a dose of Mirtagen
    5. Stopping treatment with Mirtagen
12. Possible side effects
    1. If any of the following symptoms occur, stop taking Mirtagen and contact a doctor or go to the emergency room immediately:
    3. Other side effects:
    4. Additional side effects in children and adolescents
    5. Reporting side effects
13. How to store Mirtagen
14. Package contents and other information
    1. What Mirtagen contains
    2. What Mirtagen looks like and contents of the pack
    3. Marketing authorization holder:
    4. Manufacturer:
    5. Viatris Healthcare Sp. z o.o.
    6. This medicine is authorized in the Member States of the European Economic Area under the following names:
    7. Date of last revision of the leaflet: 03/2024

Leaflet accompanying the packaging: information for the user

Mirtagen, 15 mg, orally disintegrating tablets

Mirtagen, 30 mg, orally disintegrating tablets

Mirtagen, 45 mg, orally disintegrating tablets

Mirtazapine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Mirtagen and what is it used for
• 2. Important information before taking Mirtagen
• 3. How to take Mirtagen
• 4. Possible side effects
• 5. How to store Mirtagen
• 6. Package contents and other information

1. What is Mirtagen and what is it used for

Mirtagen belongs to a group of medicines called antidepressants.
Mirtagen is used to treat depression in adults.

2. Important information before taking Mirtagen

When not to take Mirtagen:

• if the patient is allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6),
• if the patient is currently taking or has taken in the last two weeks monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

When not to take Mirtagen or consult a doctor before starting treatment:

If the patient has ever experienced symptoms such as severe skin rash or skin peeling, blisters, and (or) ulcers of the mucous membranes of the mouth after taking Mirtagen or other medicines.
During treatment with Mirtagen, severe skin reactions have been reported, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms. If any of the symptoms described in section 4 regarding severe skin reactions occur, treatment with Mirtagen should be discontinued and medical attention should be sought immediately. If the patient has ever experienced severe skin reactions, they should not restart treatment with Mirtagen.

Children and adolescents

Mirtagen should not be used in children and adolescents under 18 years of age, as its efficacy has not been established. It should also be noted that in patients under 18 years of age, taking medicines of this class, there is an increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and anger). Nevertheless, the doctor may prescribe Mirtagen to patients under 18 years of age if they consider it to be in their best interest. If the doctor has prescribed Mirtagen to a patient under 18 years of age and the patient wants to discuss it, they should consult their doctor again. If the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Mirtagen, the treating physician should be informed. Additionally, the long-term effects of Mirtagen on safety regarding growth, maturation, and cognitive and behavioral development in this age group have not been established. Furthermore, a significant increase in body weight has been more frequently observed in patients treated with mirtazapine in this age group compared to adults.

Suicidal thoughts and worsening of depression

Patients with depression may sometimes have thoughts of self-harm or suicidal thoughts. Such thoughts may worsen when antidepressant medicines are first taken, as these medicines take time to work, usually about 2 weeks, or sometimes longer.
The patient may be particularly at risk:

• If the patient has previously had thoughts of self-harm or suicide.
• If the patient is a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years of age with mental disorders treated with antidepressants. If thoughts of self-harm or suicidal thoughts occur, the patient should contact their doctor or go to the hospital immediately.

It may be helpful to talk to someone close, such as a family member or friend.The patient may inform these people about their depression and ask them to read this leaflet so that they can tell the patient if they notice a worsening of their condition or unusual changes in behavior.
Before starting treatment with Mirtagen, the patient should discuss the following conditions with their doctor or pharmacist:

• seizures(epilepsy)
• liver disease, including jaundice
• kidney disease
• heart disease or a family history of heart disease, including certain heart rhythm disorders that may cause changes in heart rhythm, recent myocardial infarction, heart failure, or the use of certain medications that may cause heart rhythm disorders
• low blood pressure
• schizophrenia
• bipolar affective disorder(alternating periods of elevated mood and depression)
• diabetes(may require a change in insulin or other hypoglycemic medication dosage)
• eye diseases, such as increased intraocular pressure (glaucoma)
• difficulty urinating, which may be caused by an enlarged prostate.

Elderly patients

• if the patient is elderly. The patient may be more sensitive to the side effects of antidepressant medicines.

During treatment

The patient should inform their doctor:

• in case of symptoms of infection, such as high fever, sore throat, and mouth ulcers. In rare cases, these symptoms may be a sign of

blood disorders. Although rare, these symptoms usually occur within 4-6 weeks of treatment.

Mirtagen and other medicines

Do not take Mirtagen with:

• monoamine oxidase inhibitors (MAOIs)or within two weeks of stopping their use. Mirtagen should not be started until two weeks after stopping MAOIs. Examples of MAOIs are moclobemide, tranylcypromine (antidepressants), and selegiline (used to treat Parkinson's disease).

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those available without a prescription, especially:

• other antidepressants like SSRIs(e.g., citalopram), venlafaxine, L-tryptophan, or triptans(used to treat migraines), tramadol(a pain reliever), linezolid(an antibiotic), lithium salts(used to treat certain psychiatric disorders), methylene blue(used to treat high methemoglobin levels in the blood), and products containing St. John's Wort (Hypericum perforatum)(herbal products used to treat depression). In very rare cases, when taking only Mirtagen or in combination with these medicines, serotonin syndrome may occur. Some of its symptoms include fever, sweating, increased heart rate, diarrhea, (uncontrolled) muscle spasms, chills, increased reflexes, anxiety, mood changes, and loss of consciousness. If several of these symptoms occur at the same time, the patient should contact their doctor immediately.
• medicines used to treat anxiety and insomnia, such as benzodiazepines, e.g., diazepam, chlordiazepoxide.
• medicines used to treat schizophrenia, such as olanzapine.
• medicines used to treat allergies, such as cetirizine.
• medicines used to treat severe pain, such as morphine. Mirtagen in combination with these medicines may increase the sedation caused by these medicines.

Medicines that increase mirtazapine levels in the blood:

• medicines used to treat infections; antibacterial medicines (such as erythromycin), antifungal medicines (such as ketoconazole), medicines used to treat HIV and AIDS (such as HIV protease inhibitors, e.g., ritonavir, nelfinavir); antidepressants(such as nefazodone) and medicines used to treat stomach ulcers (such as cimetidine). When combined with Mirtagen, these medicines may increase mirtazapine levels in the blood. The patient should inform their doctor about taking these medicines. It may be necessary to reduce the dose of Mirtagen, and after stopping treatment with these medicines, the dose of Mirtagen may need to be increased.

Medicines that decrease mirtazapine levels in the blood:

• carbamazepine and phenytoin, medicines used to treat epilepsy; rifampicin, a medicine used to treat tuberculosis. When combined with Mirtagen, these medicines may decrease Mirtagen levels in the blood. The patient should inform their doctor about taking these medicines. It may be necessary to increase the dose of Mirtagen, and after stopping treatment with these medicines, the dose of Mirtagen may need to be decreased.
• warfarin, a medicine that prevents blood clots. Mirtagen may increase the effect of warfarin. The patient should inform their doctor about taking these medicines. When treating with Mirtagen, it is recommended to monitor blood tests.

Mirtagen and alcohol

When drinking alcohol while taking this medicine, drowsiness may occur.
It is best to avoid drinking alcohol while taking Mirtagen .

Pregnancy and breastfeeding

Limited experience with the use of Mirtagen in pregnant women does not indicate an increased risk. However, caution should be exercised when using during pregnancy.
If the patient becomes pregnant or plans to become pregnant while taking Mirtagen, they should ask their doctor if they can continue taking the medicine. If Mirtagen is taken during pregnancy or shortly before delivery, it is recommended to monitor the newborn for possible side effects.
The patient should ensure that their midwife and (or) doctor are aware that they are taking Mirtagen.
The use of similar medicines (SSRIs) during pregnancy may increase the risk of a serious condition in children, called persistent pulmonary hypertension of the newborn (PPHN), causing rapid breathing and bluish discoloration. Symptoms usually start within 24 hours of birth. If the child experiences these symptoms, the patient should contact their midwife or doctor immediately.
The patient should ask their doctor if they can breastfeed while taking Mirtagen.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Mirtagen may reduce alertness and concentration. Before driving or operating machinery, the patient should make sure that their concentration and alertness are not impaired.

Mirtagen contains aspartame

This medicine contains 3 mg, 6 mg, or 9 mg of aspartame in each 15 mg, 30 mg, and 45 mg orally disintegrating tablet, respectively. Aspartame is a source of phenylalanine.
It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper elimination.

3. How to take Mirtagen

This medicine should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

Dosage

The recommended initial dose is 15 or 30 mg per day.After a few days of treatment, the doctor may recommend increasing the dose to the most suitable for the patient (from 15 to 45 mg per day).
The recommended dose is usually the same for all age groups. However, in elderly patients or those with kidney and liver disease, the doctor may recommend a different dose.

When to take Mirtagen

Mirtagen should be taken every day at the same time.
Mirtagen is best taken in a single dose, before bedtime. The doctor may, however, recommend taking the medicine in two divided doses – one dose in the morning and the other in the evening before bedtime. The larger dose should be taken before bedtime.

Information about taking orally disintegrating tablets:

Tablets should be taken orally.

1. Do not crush the orally disintegrating tablet

To avoid crushing the orally disintegrating tablet, do not press on the blister containing the tablet (Figure A).

Figure A.

2. Tear off the tablet blister

Each blister contains tablet blisters separated by a perforated line.
Tear off one blister along the perforated line (Figure 1).

Figure 1.

3. Tear off the foil

Carefully tear off the covering foil, starting from the corner (Figure 2).

Figure 2.

4. Remove the orally disintegrating tablet

Remove the orally disintegrating tablet with dry hands and place it on the tongue.
(Figure 3).

Figure 3.
The tablet dissolves quickly and can be swallowed without water.

When can improvement in well-being be expected

Mirtagen usually starts working after 1 to 2 weeks, and after 2 to 4 weeks, the patient's well-being will start to improve.
It is essential to discuss the effects of Mirtagen with the doctor during the first weeks of treatment.
After 2 to 4 weeks of taking Mirtagen, the patient should discuss their progress with the doctor.
If there is no adequate clinical response, the doctor may increase the dose. After another 2-4 weeks, the patient should discuss their progress with the doctor again. Treatment should be continued until the symptoms have completely resolved, which usually takes 4 to 6 months.

Use in children and adolescents under 18 years of age

Mirtagen should not be used in children and adolescents under 18 years of age (see section 2 "Children and adolescents").

Taking a higher dose of Mirtagen than recommended

If the patient or someone else has taken a higher dose of Mirtagen than recommended, they should contact their doctor immediately.
The most common symptoms of Mirtagen overdose (without other medicines or alcohol) are drowsiness, disorientation, changes in heart rhythm (accelerated heart rate, irregular heart rhythm), and (or) fainting. These may be symptoms of life-threatening ventricular arrhythmias, known as "torsades de pointes".

Missing a dose of Mirtagen

In case of forgetting to take a dose that is supposed to be taken once a day
Do not take the missed dose of Mirtagen; skip it.
Take the next dose the next day at the usual time.
Do not take a double dose to make up for the missed tablet.
In case of forgetting to take a dose that is supposed to be taken twice a day
If the patient forgets to take the morning dose, they should take it together with the evening dose.
If the patient forgets to take the evening dose, they should not take it together with the morning dose; skip it and continue treatment with the usual morning and evening doses.
If the patient forgets to take both doses, they should not try to make them up; skip them. The next day, they should continue treatment with the usual morning and evening doses.

Stopping treatment with Mirtagen

The patient should only stop taking Mirtagen after consulting their doctor.
The patient should not stop taking Mirtagen too early, as this may cause the illness to recur. If an improvement occurs, the patient should discuss it with their doctor. The doctor will inform them when they can stop treatment. Suddenly stopping treatment with Mirtagen may cause nausea, dizziness, agitation, or anxiety, headache. These symptoms can be avoided by gradually stopping the medicine. The doctor will inform the patient how to gradually reduce the dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

If any of the following symptoms occur, stop taking Mirtagen and contact a doctor or go to the emergency room immediately:

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

• Pancreatitis, causing moderate to severe abdominal pain radiating to the back.

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

• seizures (convulsions)
• yellowing of the skin or eyes, which may indicate liver function disorders (jaundice)
• a combination of symptoms such as unexplained fever, sweating, increased heart rate, diarrhea, (uncontrolled) muscle spasms, chills, increased reflexes, anxiety, mood changes, and loss of consciousness. In very rare cases, these may be symptoms of serotonin syndrome
• thoughts of self-harm or suicide or suicide attempts
• red skin lesions on the torso in the form of target-like spots or round patches, often with blisters in the center; skin peeling; ulcers of the mucous membranes of the mouth, throat, nose, eyes, and genitals. Such 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)
• infection symptoms such as sudden high fever, sore throat, and mouth ulcers (agranulocytosis). Mirtazapine may cause blood disorders (bone marrow suppression). Some people become more susceptible to infections because mirtazapine may cause a temporary decrease in the number of white blood cells (granulocytopenia). In rare cases, mirtazapine may also cause a decrease in the number of red and white blood cells, as well as platelets (aplastic anemia), a decrease in the number of platelets (thrombocytopenia), or an increase in the number of white blood cells (eosinophilia),
• muscle tissue breakdown, causing muscle pain, tenderness, stiffness, and (or) weakness, as well as dark urine (rhabdomyolysis)
• difficulty urinating or emptying the bladder
• lower than normal sodium levels in the blood, which may cause feelings of weakness and disorientation with muscle pain. This may be due to the improper secretion of antidiuretic hormone, which causes water retention in the body and dilution of the blood, reducing the amount of sodium.

Other side effects:

Very common(may affect more than 1 in 10 people):

• increased appetite or weight gain
• drowsiness
• headache
• dry mouth

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

• lethargy
• dizziness
• seizures or tremors
• nausea
• diarrhea
• vomiting
• constipation
• rash or skin eruptions
• joint or muscle pain
• back pain
• dizziness or fainting when changing body position quickly, e.g., when standing up (orthostatic hypotension)
• swelling (usually of the ankles or feet) due to fluid accumulation (edema)
• fatigue
• vivid dreams
• disorientation
• feeling anxious
• sleep problems
• memory problems, which in most cases disappeared after stopping treatment

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

• feeling excited or agitated (mania)
• unusual skin sensations, e.g., burning, tingling, or numbness (paresthesia)
• restless legs syndrome
• fainting
• unusual sensations in the mouth (oral hypoesthesia)
• low blood pressure
• nightmares
• agitation
• seeing, feeling, or hearing things that do not exist (hallucinations)
• urge to move

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

• muscle twitching or spasms (clonic muscle spasms)
• aggressive behavior
• increased liver enzyme activity in blood tests

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

• unusual sensations in the mouth, e.g., burning, tingling, or numbness (oral paresthesia)
• swelling of the mouth
• low sodium levels in the blood (hyponatremia) visible in blood tests
• increased creatine kinase activity in the blood, visible in blood tests
• increased salivation
• sleepwalking
• speech difficulties
• increased prolactin levels in the blood (hyperprolactinemia, including symptoms such as breast enlargement and (or) milky discharge from the nipple)
• prolonged, painful erection of the penis

Additional side effects in children and adolescents

The following side effects were commonly observed in clinical trials with children under 18 years of age: hives and increased triglyceride levels in the blood.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: 22 49 21 301
fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Mirtagen

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Mirtagen contains

• The active substance of Mirtagen is mirtazapine. Each 15 mg, 30 mg, and 45 mg orally disintegrating tablet of Mirtagen contains 15 mg, 30 mg, and 45 mg of mirtazapine, respectively.
• Other ingredients are: crospovidone, mannitol (E421), microcrystalline cellulose, aspartame (E951) (see section 2 "Mirtagen contains aspartame"), strawberry-guarana flavor, peppermint flavor, colloidal anhydrous silica, and magnesium stearate.

What Mirtagen looks like and contents of the pack

Mirtagen is an orally disintegrating tablet.
Mirtagen 15 mg, 30 mg, and 45 mg orally disintegrating tablets are round, white, and marked with the letter "A" on one side and "36", "37", and "38" on the other side, respectively.
Mirtagen is available in blister packs containing 6, 12, 18, 30, 48, 60, 90, 96, or 100 orally disintegrating tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland

Manufacturer:

McDermott Laboratories t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Irlandia
Mylan Hungary Kft
H-2900 Komárom
Mylan utca 1
Węgry
To obtain more detailed information on this medicine, the patient should contact the representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

Tel: +48 22 546 64 00

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic
Mirtazapin Viatris
Denmark
Mirtazapin Viatris 15 mg, 30 mg & 45 mg smeltetabletter
Italy
Mirtazapina Mylan Generics Italia 30 mg & 45 mg compresse orodispersibili
Poland
Mirtagen 15 mg, 30 mg, 45 mg
Portugal
Mirtazapina Mylan 15 mg, 30 mg & 45 mg comprimindo orodispersive
Spain
Mirtazapina FLAS MYLAN 15 mg & 30 mg comprimidos bucodispersables
Netherlands
Mirtazapine SmeltTab Viatris 15 mg, 30 mg & 45 mg orodispergeerbare tablet
United Kingdom
Mirtazapine 15 mg, 30 mg & 45 mg orodispersible tablets
(Northern Ireland)

Date of last revision of the leaflet: 03/2024