Mirtagen

Package Leaflet: Information for the User

Mirtagen, 15 mg, orodispersible tablets

Mirtagen, 30 mg, orodispersible tablets

Mirtagen, 45 mg, orodispersible tablets

Mirtazapine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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 you are allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6),
• if you 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 your doctor before starting treatment:

If you have 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 such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms have been reported. If you notice any of the symptoms described in section 4 regarding severe skin reactions, you should stop taking the medicine and seek medical attention immediately. If you have ever had severe skin reactions, do 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 the case of patients under 18 years of age taking medicines of this class, they are at 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 he considers it to be in their best interest. If the doctor has prescribed Mirtagen to a patient under 18 years of age and the patient wishes to discuss this, they should consult their doctor again. In the event of the development or worsening of the above symptoms in patients under 18 years of age taking Mirtagen, the attending physician should be informed. Additionally, the long-term impact of Mirtagen on the safety of growth, maturation, and cognitive and behavioral development in this age group has not been demonstrated. Furthermore, significant weight gain 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.

• 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. In the event of suicidal thoughts or suicidal attempts, seek medical attention immediately.

Talking to someone close, such as a family member or friend, may be helpful.The patient may inform these individuals 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.

• seizures(epilepsy)
• liver disease, including jaundice
• kidney disease
• heart disease or a history of heart disease, including certain heart rhythm disorders that may cause changes in heart rhythm, recent heart attack, 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

Inform your doctor:

• in the event 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. Do not start taking Mirtagen within two weeks of stopping MAOIs. Examples of MAOIs include moclobemide, tranylcypromine (antidepressants), and selegiline (used in the treatment of Parkinson's disease).

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription, especially:

• other antidepressant medicines 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 levels of methemoglobin in the blood), and Hypericum perforatum(herbal preparations used to treat depression). In very rare cases, patients taking only Mirtagen or in combination 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, and loss of consciousness. Seek medical attention immediately if you experience several of these symptoms at the same time.
• 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); antidepressant medicines(such as nefazodone) and medicines used to treat stomach ulcers (such as cimetidine). In combination with Mirtagen, these medicines may increase mirtazapine levels in the blood. Inform your doctor about taking these medicines. It may be necessary to reduce the dose of Mirtagen, and after stopping treatment with these medicines, increase the dose of Mirtagen.

Medicines that decrease mirtazapine levels 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 Mirtagen levels in the blood. Inform your doctor about taking these medicines. It may be necessary to increase the dose of Mirtagen, and after stopping treatment with these medicines, decrease the dose of Mirtagen.
• warfarin, a medicine that prevents blood clots. Mirtagen may increase the effect of warfarin. Inform your 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 used during pregnancy. If you become pregnant or plan to become pregnant while taking Mirtagen, consult your doctor about whether you 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. Ensure that the midwife and (or) doctor are aware that you 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 cyanosis. Symptoms usually start within 24 hours of birth. If these symptoms occur in the child, seek medical attention immediately. Ask your doctor if you can breastfeed while taking Mirtagen. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Mirtagen may reduce alertness and ability to concentrate. Before driving or operating machinery, ensure that your ability to concentrate and alertness have not been 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 orodispersible 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

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Dosage

The recommended initial dose is 15 or 30 mg per day.After a few days of treatment, your doctor may recommend increasing the dose to the most suitable for you (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 once a day, at the same time every day. Mirtagen is best taken in a single dose, before bedtime. However, your doctor may recommend taking the medicine in two divided doses – one dose in the morning and one in the evening before bedtime. The larger dose should be taken before bedtime.

Information about taking orodispersible tablets:

Tablets should be taken orally.

1. Do not crush the orodispersible tablet

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

Figure A.

2. Separate the blister

Each blister contains pockets with tablets, separated by a perforated line. Separate 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 orodispersible tablet

Remove the orodispersible 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 you expect an improvement in your condition

Mirtagen usually starts working after 1 to 2 weeks, and after 2 to 4 weeks, your condition will start to improve. It is essential to discuss the effects of Mirtagen with your doctor during the first few weeks of treatment. After 2 to 4 weeks from the start of Mirtagen treatment, discuss your progress with your doctor. In the case of an inadequate clinical response, the doctor may increase the dose. After another 2-4 weeks, discuss your progress with your 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").

Overdose of Mirtagen

If you or someone else has taken a larger dose of Mirtagen than recommended, seek medical attention immediately. The most common symptoms of Mirtagen overdose (without other medicines or alcohol) are drowsiness, disorientation, changes in heart rhythm (increased heart rate, irregular heart rhythm), and (or) fainting. These may be symptoms of life-threatening ventricular arrhythmias known as "torsades de pointes".

Missed dose of Mirtagen

In the event of forgetting to take a dose that is taken once a day, do not take the missed dose of Mirtagen. Take the next dose at the usual time the next day. Do not take a double dose to make up for the missed tablet. In the event of forgetting to take a dose that is taken twice a day, if you forget to take the morning dose, take it with the evening dose. If you forget to take the evening dose, do not take it with the morning dose; skip it and continue treatment with the usual morning and evening doses. If you forget to take both doses, do not try to make them up; skip them. The next day, continue treatment with the usual morning and evening doses.

Stopping treatment with Mirtagen

Stop taking Mirtagen only after consulting your doctor. Do not stop taking the medicine too early, as it may cause the disease to recur. If you experience an improvement, discuss it with your doctor. The doctor will inform you when you 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 you how to gradually reduce the dose. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following symptoms, stop taking Mirtagen and contact your 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 spots, often with blisters in the center; skin peeling; ulcers of the mucous membranes of the mouth, throat, nose, eyes, and genitals. This type of severe skin rash 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, and 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 pain, 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
• intense 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)
• 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 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 saliva production
• sleepwalking
• difficulty speaking
• increased prolactin levels in the blood (hyperprolactinemia, including symptoms such as breast enlargement and (or) milk secretion 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 involving children under 18 years of age: hives and increased triglyceride levels in the blood.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mirtagen

Keep this medicine out of the 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 stated. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. Ask your 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 15 mg orodispersible tablet contains 15 mg of mirtazapine. Each 30 mg orodispersible tablet contains 30 mg of mirtazapine. Each 45 mg orodispersible tablet contains 45 mg of mirtazapine.
• The 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 orodispersible tablets. Mirtagen 15 mg orodispersible tablets are round, white, marked with the letter "A" on one side and "36" on the other. Mirtagen 30 mg orodispersible tablets are round, white, marked with the letter "A" on one side and "37" on the other. Mirtagen 45 mg orodispersible tablets are round, white, marked with the letter "A" on one side and "38" on the other. Mirtagen is available in blister packs containing 6, 12, 18, 30, 48, 60, 90, 96, or 100 orodispersible 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, Ireland, Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Hungary