Mirtagen

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Mirtagen (Mirtazapine SmeltTab Mylan 45 mg)

45 mg, orally disintegrating tablets

Mirtazapine
Mirtagen and Mirtazapine SmeltTab Mylan 45 mg are different trade names for the same drug.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 they are currently taking or have 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 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 such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms have been reported.
If any of the symptoms described in section 4 regarding severe skin reactions occur, treatment with Mirtagen should be discontinued and a doctor should be consulted immediately.
If the patient has ever had severe skin reactions, they should not be re-treated 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 the case of patients under 18 years of age taking this type of medicine, there is an increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger).
However, the doctor may prescribe Mirtagen to patients under 18 years of age if it is 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.
In the event of development or worsening of the above symptoms in patients under 18 years of age taking Mirtagen, the doctor should be informed.
Additionally, the long-term impact of Mirtagen on safety regarding growth, maturation, and cognitive and behavioral development in this age group has not been demonstrated yet.
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 and anxiety disorders

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 act slowly, usually within 2 weeks, and sometimes longer.
This may happen:

• 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 antidepressant medicines.

In case of suicidal thoughts or suicidal attempts, the patient should immediately contact their doctor or go to the hospital.
Talking to someone close, such as a family member or friend, may be helpful.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 diseases with their doctor or pharmacist if they have or have had them:

• seizures(epilepsy)
• liver disease, including jaundice
• kidney disease
• heart disease or a history of heart disease in the family, including certain heart rhythm disorders that may cause a change in heart rhythm, recent myocardial infarction, heart failure, or the use of certain medicines that may cause a disturbance in heart rhythm
• low blood pressure
• schizophrenia
• bipolar affective disorder(alternating periods of elevated mood and excitement, and depression)
• diabetes(the dose of insulin or other hypoglycemic medicines may need to be adjusted)
• eye disease, such as increased intraocular pressure (glaucoma)
• difficulty urinating, which may be due to prostate enlargement.

Elderly patients

• Elderly patients are often more sensitive, especially 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, 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

Mirtagen should not be taken at the same time as:

• 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 in the treatment of Parkinson's disease).

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription, especially:

• other antidepressant medicines such as 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), and Hypericum perforatum(herbal preparations used to treat depression). In very rare cases, patients taking only Mirtagen or in combination therapy with these medicines may experience serotonin syndrome. Some of its symptoms include fever, sweating, increased heart rate, diarrhea, (uncontrolled) muscle spasms, chills, increased reflexes, anxiety, mood changes, loss of consciousness. The patient should immediately contact their doctor if they experience several of these symptoms together.
• medicines used to treat anxiety and insomniasuch as benzodiazepines, e.g., diazepam, chlordiazepoxide.
• medicines used to treat schizophreniasuch as olanzapine.
• medicines used to treat allergiessuch as cetirizine.
• medicines used to treat severe painsuch as morphine. Mirtagen in combination with these medicines may increase the sedation caused by these medicines.

Medicines that increase the amount of mirtazapine 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); antidepressant medicines(such as nefazodone) and medicines used to treat stomach ulcers (such as cimetidine). When combined with Mirtagen, these medicines may increase the concentration of mirtazapine 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 the amount of mirtazapine 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 the concentration of Mirtagen 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 clotting. Mirtagen may enhance the effect of warfarin. The patient should inform their doctor about taking these medicines. In the case of combination treatment 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 it during pregnancy.
In case of pregnancy or planning to become pregnant while taking Mirtagen, the patient 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 the 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), which causes rapid breathing and bluish discoloration.
Symptoms usually start within 24 hours of birth.
In case of these symptoms in the child, the patient should immediately contact the midwife or doctor.
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 baby, 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 have not been impaired.

Mirtagen contains aspartame (E 951)

This medicine contains 9 mg of aspartame in each orally disintegrating tablet.
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 excretion.

3. How to take Mirtagen

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Mirtagen is available in the following doses: 15 mg, 30 mg, 45 mg.

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 usual recommended dose is used in patients of different ages. 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 going to bed. However, the doctor may recommend taking the medicine in two divided doses – one in the morning and one in the evening before going to bed. The higher dose should be taken before going to bed.

Information about taking orally disintegrating tablets:

The tablets should be taken orally.

1. Do not crush the orally disintegrating tablet

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

Figure A.

2. Remove the blister pack with the tablet

Each blister pack contains 6 pockets with tablets, separated by a perforated line.
The patient should bend the blister pack and remove one pocket along the perforated line (Figure 1).

Figure 1.

3. Remove the foil

The patient should carefully remove the covering foil, starting from the corner (Figure 2).

Figure 2.

4. Remove the orally disintegrating tablet

The patient should remove the orally disintegrating tablet with dry hands and place it on their tongue. (Figure 3).

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

When to expect improvement in well-being

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 from the start of Mirtagen treatment, the patient should discuss their progress with the doctor.
In case of insufficient 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 disappeared, 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 immediately contact their doctor.
The most common signs of Mirtagen overdose (without other medicines or alcohol) are drowsiness, disorientation, changes in heart rhythm (rapid heartbeat, irregular heartbeat), 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 taken once a day.
The patient should not take the missed dose of Mirtagen; it should be skipped.
The next dose should be taken the next day at the usual time.
The patient should not take a double dose to make up for the missed tablet.
In case of forgetting to take a dose that is 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; it should be skipped and the patient should continue treatment, taking the usual morning and evening doses.
If the patient forgets to take both doses, they should not try to make up for them; they should be skipped. The next day, the patient should continue treatment, taking 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 there is an improvement, 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, headaches. These symptoms can be avoided by gradually stopping the medicine.
The doctor will inform the patient how to gradually reduce the dose of Mirtagen.
In case of any further doubts about taking this medicine, the patient 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, the patient should stop taking Mirtagen and immediately consult their doctor or go to the emergency room:

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, 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 central part; peeling of the skin; ulcers of the mucous membranes of the mouth, throat, nose, eyes, and genitals. These types of 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, i.e., drug hypersensitivity syndrome);
• infection symptoms, such as sudden high fever, sore throat, mouth ulcers (agranulocytosis). Mirtazapine may cause blood disorders (bone marrow suppression). Some people may become less resistant to infections because mirtazapine may cause a temporary lack of white blood cells (granulocytopenia). In rare cases, mirtazapine may also cause a lack of red and white blood cells, as well as platelets (aplastic anemia), a lack of platelets (thrombocytopenia), or an increased 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 a feeling of weakness and be mistaken for muscle pain. This may be due to the improper excretion 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 position quickly, e.g., when standing up (orthostatic hypotension);
• swelling (usually of the ankles or feet) due to fluid accumulation (edema);
• fatigue;
• intensive dreams;
• confusion;
• feeling anxious;
• sleep problems.

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 hypoaesthesia);
• low blood pressure;
• nightmares;
• agitation;
• seeing, feeling, or hearing things that do not exist (hallucinations);
• an urgent need to move.

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

• muscle twitching or spasms (clonic muscle spasms);
• aggressive behavior;
• increased liver enzyme activity visible 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);
• mouth swelling;
• low sodium levels in the blood (hyponatremia) visible in blood tests;
• increased saliva production;
• sleepwalking;
• speech difficulties;
• increased prolactin levels in the blood (hyperprolactinemia, including symptoms such as breast enlargement and/or milk discharge from the nipple).

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, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 (22) 49 21 301
fax: + 48 (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Mirtagen

The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
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 orally disintegrating tablet contains 45 mg of mirtazapine.
• The other ingredients are: crospovidone, mannitol (E 421), microcrystalline cellulose, aspartame (E 951) (see section 2 "Mirtagen contains aspartame (E 951) and mannitol (E 421)"), strawberry-guarana flavor, peppermint flavor, anhydrous colloidal silica, and magnesium stearate.

What Mirtagen looks like and what the package contains

Round, white, marked with the letter 'A' on one side and '38' on the other.
Package sizes: 30 orally disintegrating tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Mylan Pharmaceuticals Ltd, Damastown Industrial Park, Mulhuddart, Dublin 15, Dublin, Ireland

Manufacturer:

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft., Mylan utca 1, H-2900 Komarom, Hungary

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Netherlands marketing authorization number: RVG 34054

Parallel import authorization number: 306/22

Leaflet approval date: 23.11.2023

[Information about the trademark.]