Mirtagen

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Mirtagen(Mirtazapine SmeltTab Mylan 15 mg)

15 mg, orally disintegrating tablets Mirtazapinum

Mirtagen and Mirtazapine SmeltTab Mylan 15 mg are different trade names for the same medicine.

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 you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. 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. Contents of the pack 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 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 who are taking medicines of this type, there is an increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of 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 this, they should consult their doctor again. If the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Mirtagen, the doctor should be informed. Additionally, the long-term effects of Mirtagen on safety related to growth, maturation, and cognitive and behavioral development in this age group have not been established. Significant weight gain has been observed more frequently in patients treated with mirtazapine in this age group compared to adults.

Suicidal thoughts and worsening of depression and anxiety

Patients with depression may sometimes have thoughts of self-harm or suicidal thoughts. These thoughts may worsen when antidepressant medicines are first taken, as these medicines take time to work, usually around 2 weeks or 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. If thoughts of self-harm or suicide occur, the patient should contact their doctor or go to the hospital immediately.

Talking to someone close to the family or a 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 conditions with their doctor or pharmacist if they occur or have occurred:

• 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 can cause changes in heart rhythm, recent myocardial infarction, heart failure, or the use of certain medicines that can cause changes in heart rhythm
• low blood pressure
• schizophrenia
• bipolar affective disorder(alternating periods of elevated mood and excitement and depression)
• diabetes(may require a change in insulin or other hypoglycemic medication dosage)
• 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 they are 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 contractions, chills, increased reflexes, anxiety, mood changes, loss of consciousness. The patient should contact their doctor immediately 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). In combination 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 .In combination 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 clots. Mirtagen may increase 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.
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 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 severe 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. If the described symptoms occur in the child, the patient should contact the 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 ability to concentrate and alertness have not been impaired.

Mirtagen contains aspartame (E 951)

This medicine contains 3 mg of aspartame (E 951) per orally disintegrating tablet.
Aspartame (E 951) 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.
Mirtagen is available in the following strengths: 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).
Usually, the 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 bedtime. However, the doctor may recommend taking the medicine in two divided doses – one in the morning and one in the evening before bedtime. The higher 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 pack that contains 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

Carefully remove 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 from the start of Mirtagen treatment, 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 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").

Take more than the recommended dose of Mirtagen

If the patient or someone else has taken more than the recommended dose of Mirtagen, they should contact their doctor immediately.
The most common signs 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".

Miss 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; they should skip it.
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; they should skip it and continue treatment by 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 skip them. The next day, they should continue treatment by taking the usual morning and evening doses.

Stop taking 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 this with their doctor. The doctor will inform them when they can stop treatment. Suddenly stopping 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.
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, the patient should stop taking Mirtagen and immediately contact their doctor or go to the emergency room:

Very 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 contractions, 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 spots, often with blisters in the central part; skin peeling; 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 more susceptible 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 feelings of weakness and be mistaken for muscle pain. This may be due to the inappropriate 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 position quickly, e.g., when getting 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 hypoesthesia)
• low blood pressure
• nightmares
• agitation
• seeing, feeling, or hearing things that do not exist (hallucinations)
• urgent need to move.

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

• muscle twitching or contractions (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 secretion 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 or pharmacist. 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 given month.
There are no special precautions for storing the medicinal product.
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. Contents of the pack and other information

What Mirtagen contains

• The active substance of Mirtagen is mirtazapine. Each orally disintegrating tablet contains 15 mg of mirtazapine.
• The other ingredients are: crospovidone, mannitol (E 421), microcrystalline cellulose, aspartame (E 951) (see section 2 "Mirtagen contains aspartame (E 951)"), strawberry-guarana flavor, peppermint flavor, anhydrous colloidal silica, and magnesium stearate.

What Mirtagen looks like and what the pack contains

Mirtagen is an orally disintegrating tablet.
The orally disintegrating tablets are round, white, marked with the letter "A" on one side and "36" on the other side.
Mirtagen is available in packs containing 30 or 96 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
Irlandia
Mylan Hungary Kft.
Mylan utca 1
H-2900 Komarom
Węgry

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Netherlands marketing authorization number: RVG 34052
Parallel import authorization number: 123/24

Date of leaflet approval: 20.03.2024

[Information about the trademark]