Mirtagen

Patient Information Leaflet: Information for the User

Warning!
Keep this leaflet. Information on the immediate packaging is in a foreign language.
Mirtagen (Mirtazapine SmeltTab Mylan), 15 mg, orodispersible tablets
Mirtazapinum
Mirtagen and Mirtazapine SmeltTab Mylan are different trade names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Table of Contents:

1. What Mirtagen is and what it is used for
2. What you need to know 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 Mirtagen is and what it is used for

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

2. Important information before using Mirtagen

When not to use 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 recently (within the last 2 weeks) taken medicines from the group of monoamine oxidase inhibitors (MAOIs).

Warnings and precautions
When not to use Mirtagen or consult a doctor before starting treatment:

If severe skin rash, skin peeling, skin blisters and/or erosions of the oral mucosa have ever occurred in the patient during treatment with Mirtagen or other medicines. Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with Mirtagen. If any of the symptoms described in section 4 relating to severe skin reactions occur, treatment should be discontinued immediately and the patient should seek medical advice without delay. Mirtagen should not be restarted in patients who have previously experienced severe skin reactions.

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 emphasized that patients under 18 years of age taking medicines from this group are at increased risk of experiencing adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behavior, and anger). Nevertheless, a doctor may prescribe Mirtagen to patients under 18 years of age if they consider it to be in the patient's best interest. If a doctor has prescribed Mirtagen to a patient under 18 years of age and the patient wishes to discuss this, they should contact their doctor again. If development or worsening of the above-mentioned symptoms occurs in patients under 18 years of age taking Mirtagen, the treating doctor should be informed. Furthermore, the long-term impact of Mirtagen on safety regarding growth, maturation, and cognitive and behavioral development in this age group has not yet been established. Additionally, 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
Patients with depression may sometimes have thoughts of self-harm or suicidal ideation. These thoughts may increase when antidepressant treatment is first initiated, as these medicines require time to take effect—usually about 2 weeks, sometimes longer.

The patient may be particularly at risk:

• if they have previously experienced thoughts of self-harm or suicide,
• if they are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders treated with antidepressants.

If thoughts of self-harm or suicidal thoughts occur, the patient should contact their doctor immediately or go to the hospital without delay.
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 they can alert the patient if they notice worsening of their condition or unusual changes in behavior.

Before starting treatment with Mirtagen, discuss with your doctor or pharmacist if any of the following conditions are present or have ever occurred:

• seizures (epilepsy),
• liver disease, including jaundice,
• kidney disease,
• heart disease or family history of heart disease, including certain types of heart disorders that may affect heart rhythm, recent heart attack, heart failure, or use of medicines that may cause heart rhythm disturbances,
• low blood pressure,
• schizophrenia,
• bipolar affective disorders (alternating periods of elevated mood and mania with depression),
• diabetes (a change in insulin or other antidiabetic medicine dosage may be necessary),
• eye disorders, such as increased intraocular pressure (glaucoma),
• difficulty urinating, which may be due to an enlarged prostate.

Elderly patients

• if the patient is elderly. Elderly patients may be more sensitive to the adverse effects of antidepressants.

During treatment
Inform your doctor:

• if symptoms of infection occur, such as high fever, sore throat, and mouth ulcers. In rare cases, these symptoms may indicate bone marrow suppression affecting blood cell production. Although rare, these symptoms most commonly occur 4–6 weeks after starting treatment.

Mirtagen and other medicines
Do not use Mirtagen together with:

• monoamine oxidase inhibitors (MAOIs) or within two weeks of stopping them. Mirtagen should not be started within two weeks of discontinuing 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 currently or recently taken, including those obtained without a prescription, and especially about:

• other antidepressants such as SSRIs (e.g. citalopram), venlafaxine, L-tryptophan, or triptans (used to treat migraine), tramadol (a painkiller), linezolid (an antibiotic), lithium salts (used in the treatment of certain psychiatric disorders), methylene blue (used to treat high levels of methemoglobin in the blood), and herbal preparations containing St. John’s wort Hypericum perforatum (herbal remedies used for depression). In very rare cases, serotonin syndrome may occur in patients taking only Mirtagen or in combination with these medicines. Some symptoms include fever, sweating, increased heart rate, diarrhea, involuntary muscle contractions, shivering, increased reflexes, restlessness, mood changes, and loss of consciousness. Contact your doctor immediately if several of these symptoms occur simultaneously.
• 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, when used in combination with these medicines, may increase drowsiness caused by them.

Medicines that increase mirtazapine blood levels:

• medicines used to treat infections; antibacterial agents (such as erythromycin), antifungal agents (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 used in combination with Mirtagen, these medicines may increase mirtazapine blood levels. Inform your doctor if you are taking any of these medicines. A reduction in the dose of Mirtagen may be necessary, and after stopping these medicines, the dose of Mirtagen may need to be increased.

Medicines that decrease mirtazapine blood levels:

• carbamazepine and phenytoin, medicines used to treat epilepsy; rifampicin, a medicine used to treat tuberculosis. When used in combination with Mirtagen, these medicines may reduce mirtazapine blood levels. Inform your doctor if you are taking any of these medicines. An increase in the dose of Mirtagen may be necessary, and after stopping these medicines, the dose of Mirtagen may need to be reduced.
• warfarin, a medicine used to prevent blood clots. Mirtagen may enhance the effect of warfarin. Inform your doctor if you are taking these medicines. When used in combination with Mirtagen, monitoring of blood parameters is recommended.

Mirtagen and alcohol
Drowsiness may occur when consuming alcohol during treatment with this medicine.
It is best to avoid 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 during pregnancy.
If pregnancy occurs or is planned while taking Mirtagen, consult your doctor whether to continue treatment. If Mirtagen is taken during pregnancy or shortly before delivery, newborns should be monitored for possible adverse effects.
Ensure that your midwife and/or doctor are aware that you are taking Mirtagen.
Use of similar medicines (SSRIs) during pregnancy may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing rapid breathing and cyanosis (bluish discoloration). Symptoms usually begin within 24 hours after birth. If these symptoms occur in the newborn, contact your midwife or doctor immediately.
Ask your doctor whether you can breastfeed while taking Mirtagen.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery
Mirtagen may reduce alertness and the ability to concentrate. Before driving or operating machinery, ensure that your concentration and alertness are not impaired.

Mirtagen contains aspartame (E 951) and mannitol (E 421)
This medicine contains 3 mg of aspartame in each orodispersible 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 improper excretion.
This medicine also contains mannitol. It may cause a mild laxative effect.

3. How to take Mirtagen

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Mirtagen is available in the following strengths: 15 mg, 30 mg, 45 mg.
Dosage
The recommended starting dose is 15 or 30 mg once daily. After a few days of treatment, your doctor may
recommend increasing the dose to the most appropriate level for the patient (from 15 to 45 mg daily).
The recommended dose is usually the same for all age groups. However, in elderly patients or in patients with
kidney or liver disease, your doctor may recommend a different dose.
When to take Mirtagen
Mirtagen should be taken every day at the same time.
Mirtagen is best taken as a single dose, before going to bed. However, your doctor may recommend taking the
medicine in two divided doses – one dose in the morning and another in the evening before going to bed. The
larger dose should be taken before going to bed.
Instructions for taking orally disintegrating tablets:
The tablets are to be taken by mouth.
1. Do not crush the orally disintegrating tablet
To avoid crushing the orally disintegrating tablet, do not press on the blister pocket containing the tablet (Figure A).

Figure A.
2. Detach the blister pocket containing the tablet
Each blister contains individual tablet pockets separated by a perforated line. Detach one pocket along the perforated line (Figure 1).

Figure 1.
3. Peel back the foil
Carefully peel back the foil covering, starting from the corner (Figure 2).

Figure 2.
4. Remove the orally disintegrating tablet
Remove the orally disintegrating tablet with a dry hand and place it on the tongue (Figure 3).

Figure 3.
The tablet will rapidly disintegrate and can be swallowed without water.
When to expect improvement in well-being
Mirtagen usually starts to work after 1 to 2 weeks, and your well-being will begin to improve after 2 to 4 weeks.
It is important to discuss the effects of Mirtagen with your doctor during the first weeks of treatment.
After 2 to 4 weeks of starting Mirtagen, you should discuss your treatment progress with your doctor.
If there is no adequate clinical response, your doctor may increase the dose. After another 2–4 weeks, you should again discuss your treatment progress with your doctor. Treatment should be continued until symptoms have completely resolved, which usually takes 4 to 6 months.
Use in children and adolescents under 18 years of age
Mirtagen must not be used in children and adolescents under 18 years of age (see section 2 “Children and adolescents”).
Taking more Mirtagen than recommended
If you or anyone else takes more Mirtagen than recommended, contact your doctor immediately.
The most common symptoms of overdose with Mirtagen (without other medicines or alcohol) are: drowsiness,
disorientation, changes in heart rhythm (increased heart rate, irregular heartbeat) and/or fainting. These may be symptoms of life-threatening ventricular arrhythmias known as "torsade de pointes".
If you forget to take Mirtagen
If you forget to take a dose of Mirtagen that is to be taken once daily:
Do not take the missed dose; simply skip it.
Take the next dose at the usual time the next day.
Do not take a double dose to make up for the missed tablet.
If you forget to take a dose of Mirtagen that is to be taken twice daily:
If you forget the morning dose, take it together with the evening dose.
If you forget the evening dose, do not take it together with the morning dose; skip it and continue taking your usual morning and evening doses.
If you forget both doses, do not try to make them up; skip them. Continue treatment the next day with your usual morning and evening doses.
Stopping Mirtagen
You should stop taking Mirtagen only after consulting your doctor.
Do not stop taking the medicine too early, as this may cause the illness to return. If you feel better, discuss this with your doctor. Your doctor will advise you when it is safe to stop treatment. Stopping Mirtagen suddenly may cause nausea, dizziness, agitation or anxiety, and headache. These symptoms can be avoided by gradually discontinuing the medicine. Your doctor will advise you how to gradually reduce the dose of Mirtagen.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the symptoms listed below occur, stop taking the medicine
Mirtagen and immediately contact a doctor or go to the emergency department of the nearest hospital:

Rare (may occur in up to 1 in 1,000 patients):

• inflammation of the pancreas causing moderate to severe abdominal pain radiating to the back.

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

• seizures (convulsions),
• yellowing of the skin or eyes, which may indicate liver dysfunction (jaundice),
• a combination of symptoms such as fever of unknown cause, sweating, increased heart rate, diarrhoea, involuntary muscle contractions, chills, muscle twitching, increased reflexes, restlessness, mood changes, loss of consciousness. In very rare cases, these may be signs of serotonin syndrome,
• thoughts of self-harm or suicide, or suicide attempts,
• red skin lesions on the trunk appearing as target-like spots or round patches, often with blisters in the center; skin peeling; mucosal ulceration of the mouth, throat, nose, eyes, and genital organs. 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),
• signs of infection such as sudden high fever, sore throat, mouth ulcers (agranulocytosis). Mirtazapine may cause disturbances in blood cell production (bone marrow suppression). Some people may become less resistant to infections because mirtazapine may cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, mirtazapine may also cause a reduction in red and white blood cells and platelets (aplastic anaemia), a decrease in platelets (thrombocytopenia), or an increase in white blood cells (eosinophilia),
• breakdown of muscle tissue causing muscle pain, tenderness, stiffness and/or weakness, and dark urine (rhabdomyolysis),
• difficulty in passing urine or emptying the bladder,
• lower than normal blood sodium levels, which may cause weakness, confusion, and muscle pain. This may result from inappropriate antidiuretic hormone secretion, leading to water retention in the body, dilution of the blood, and reduced sodium levels.

Other adverse reactions:
Very common (may affect more than 1 in 10 patients):

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

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

• lethargy,
• dizziness,
• convulsions or tremor,
• nausea,
• diarrhoea,
• vomiting,
• constipation,
• rash or skin eruptions,
• joint pain, muscle pain,
• back pain,
• dizziness or fainting upon sudden change in body position, e.g. when standing up (orthostatic hypotension),
• swelling (usually ankles or feet) due to fluid accumulation (oedema),
• fatigue,
• vivid dreams,
• disorientation,
• anxiety,
• sleep problems,
• memory problems, which in most cases resolved after discontinuation of treatment.

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

• feelings of excitement or agitation (mania),
• unusual skin sensations such as burning, stinging, or tingling (paraesthesia),
• restless legs syndrome,
• fainting,
• abnormal sensations in the mouth (oral paraesthesia),
• low blood pressure,
• nightmares,
• restlessness,
• seeing, feeling, or hearing things that are not real (hallucinations),
• an urgent need for movement.

Rare (may affect up to 1 in 1,000 patients):

• muscle twitching or cramps (clonic muscle convulsions),
• aggressive behaviour,
• increased liver enzyme activity visible in blood tests.

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

• abnormal sensations in the mouth, such as burning, stinging, or tingling (oral paraesthesia),
• swelling of the mouth,
• low blood sodium levels (hyponatraemia) visible in blood tests,
• increased blood creatine kinase activity, visible in blood tests,
• increased salivation,
• sleepwalking,
• difficulty speaking,
• increased blood levels of prolactin hormone (hyperprolactinaemia, including symptoms such as breast enlargement and/or milky nipple discharge),
• prolonged, painful penile erection.

Additional adverse reactions in children and adolescents
The following adverse reactions were commonly observed in clinical trials involving children under 18 years of age: urticaria and increased blood triglyceride levels.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Mirtagen

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines must not be disposed of via 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 Mirtagen contains

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

What Mirtagen looks like and contents of the pack
Mirtagen is an orodispersible tablet.
Mirtagen 15 mg orodispersible tablets are round, white tablets, marked with the letter "A" on one side and "36" on the other.
For Mirtagen 15 mg orodispersible tablets, the following pack sizes are available: 30 orodispersible tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in the Netherlands, 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
Poland

Repackaged by:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing Authorisation Number in the Netherlands, country of export: RVG 34052
Parallel Import Licence Number: 493/15

This medicinal product is authorised for sale in the European Economic Area under the following names:
Czech Republic: Mirtazapin Viatris
Denmark: Mirtazapin Viatris 15 mg smeltetabletter
Poland: Mirtagen
Portugal: Mirtazapina Mylan 15 mg comprimido orodispersivo
Spain: Mirtazapina FLAS MYLAN 15 mg comprimidos bucodispersables EFG
Netherlands: Mirtazapine SmeltTab Mylan 15 mg orodispergeerbare tablet
United Kingdom: Mirtazapine 15 mg orodispersible tablets
(Northern Ireland)