MIRTAGEN

Package leaflet: Information for the user

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

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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 to 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 with Mirtagen:
If, after using Mirtagen or other medicines, the patient has ever experienced symptoms such as severe skin rash, skin peeling, skin blisters and/or oral mucosal erosion. Severe skin reactions, including 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 medical advice sought without delay. Mirtagen should not be restarted in patients who have previously experienced severe skin reactions.

Children and adolescents
Mirtagen must 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 of this class 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 consult their doctor again. If the above-mentioned symptoms develop or worsen 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 such 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, contact a doctor immediately or go to a hospital without delay.

Talking to a close 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 health or unusual changes in behavior.

Before starting treatment with Mirtagen, discuss with a doctor or pharmacist if the patient has or has ever had any of the following conditions:

• Seizures (epilepsy)
• Liver diseases, including jaundice
• Kidney diseases
• Heart diseases or family history of heart disease, including certain heart rhythm disorders, recent heart attack, heart failure, or use of medicines that may cause heart rhythm disturbances
• Low blood pressure
• Schizophrenia
• Bipolar affective disorder (alternating periods of elevated mood and excitement with depression)
• Diabetes (a change in insulin or other antidiabetic medicine dosage may be necessary)
• Eye diseases, such as increased intraocular pressure (glaucoma)
• Difficulty urinating, which may be due to an enlarged prostate.

Elderly patients
Elderly patients are often more sensitive, particularly to the adverse effects of antidepressant medicines.

During treatment
Inform the doctor if signs of infection occur, such as high fever, sore throat, or 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 take Mirtagen together with:

• Monoamine oxidase inhibitors (MAOIs) or within two weeks of stopping them. 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 the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines, and particularly:

• 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 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 a 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 the 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 the doctor if taking these medicines. A dose reduction of Mirtagen may be necessary, and after stopping these medicines, the Mirtagen dose 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 Mirtagen blood levels. Inform the doctor if taking these medicines. An increase in the Mirtagen dose may be necessary, and after stopping these medicines, the Mirtagen dose may need to be reduced.
• Warfarin, a medicine used to prevent blood clots. Mirtagen may enhance the effect of warfarin. Inform the doctor if taking these medicines. Monitoring of blood parameters is recommended when Mirtagen is used concomitantly with warfarin.

Mirtagen and alcohol
Drinking alcohol while taking this medicine may cause drowsiness.
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 a doctor about whether to continue treatment. If Mirtagen is taken during pregnancy or shortly before delivery, newborns should be monitored for possible adverse effects.

Ensure that the midwife and/or doctor are aware that the patient is 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 the midwife or doctor immediately.

Ask the doctor whether breastfeeding is permitted while taking Mirtagen.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a 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 concentration and alertness are not impaired.

Mirtagen contains aspartame (E 951)
This medicine contains 3 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 impaired excretion.

3. How to use 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 those 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 daily dose, taken before going to bed. However, your doctor may
recommend taking the medicine in two divided doses – one in the morning and one in the evening before
going to bed. The larger dose should be taken before going to bed.
Instructions for taking orodispersible tablets:
The tablets are for oral use.
1. Do not crush the orodispersible tablet
To avoid crushing the orodispersible tablet, do not press on the blister pack containing the tablet (Figure A.).

Figure A.
2. Tear off the blister with the tablet
Each blister pack contains individual blisters separated by perforated lines.
Tear off one blister 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 orodispersible tablet
Remove the orodispersible tablet with a dry hand and place it on the 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 to work after 1 to 2 weeks, and after 2 to 4 weeks, well-being begins to improve.
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 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 review 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 prescribed, contact your doctor immediately.
The most common symptoms of Mirtagen overdose (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 the next day at the usual time.
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. The next day, continue treatment
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 improvement occurs,
discuss this with your doctor. Your doctor will advise when treatment may be stopped.
Suddenly stopping Mirtagen may cause nausea, dizziness, agitation or anxiety, and headache. These
symptoms can be avoided by gradually discontinuing the medicine. Your doctor will advise how to
gradually reduce the dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, 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 stomach pain radiating to the back.

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

• Seizures (fits)
• 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, (uncontrolled) muscle spasms, chills, 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
• Reddish skin lesions on the trunk appearing as target-like spots or round patches, often with blisters in the central area; 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 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 decrease in red and white blood cells as well as 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 passing urine or emptying the bladder
• Lower than normal sodium levels in the blood, which may cause weakness, confusion, and muscle pain. This may result from inappropriate antidiuretic hormone secretion, leading to water retention in the body and dilution of the blood, thereby reducing 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
• Tremors or shaking
• 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 of ankles or feet) due to fluid accumulation (oedema)
• Fatigue
• Vivid dreams
• Disorientation
• Feeling of anxiety
• Sleep problems
• Memory problems, which in most cases resolved after discontinuation of treatment

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

• Feeling of excitement or agitation (mania)
• Unusual skin sensations such as burning, stinging, or tingling (paraesthesia)
• Restless legs syndrome
• Fainting
• Unusual sensations in the mouth (oral paraesthesia)
• Low blood pressure
• Nightmares
• Agitation
• Seeing, feeling, or hearing things that do not exist (hallucinations)
• Urgent need for movement

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

• Muscle twitching or cramps (muscle clonic seizures)
• Aggressive behaviour
• Increased liver enzyme activity visible in blood tests

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

• Unusual sensations in the mouth such as burning, stinging, or tingling (oral paraesthesia)
• Swelling of the mouth
• Low sodium levels in the blood (hyponatraemia) detectable in blood tests
• Increased creatine kinase activity in blood, detectable 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 symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. 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.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Mirtagen

Keep this medicine out of the 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 instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in 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 of Mirtagen contains 15 mg of mirtazapine.
• The other ingredients are: crospovidone, mannitol, microcrystalline cellulose, aspartame (E 951) (see section 2 “Mirtagen contains aspartam (E 951)”), 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 tablets are round, white, marked with the letter “A” on one side and “36” on the other side.
Mirtagen is available in blister packs containing: 30 or 100 orodispersible tablets.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation 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.
H-2900 Komarom
Mylan utca 1, Hungary
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation number in the Netherlands, the country of export: RVG 34052
Parallel import authorisation number: 251/15
This medicinal product is authorised in the European Economic Area (EEA) Member States 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
EFG
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)