MIRTAZAPINE SANDOZ 45 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Mirtazapine Sandoz 15 mg orodispersible tablets EFG

Mirtazapine Sandoz 30 mg orodispersible tablets EFG

Mirtazapine Sandoz 45 mg orodispersible tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.Keep this leaflet. You may need to read it again.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Mirtazapine Sandoz and what is it used for
2. What you need to know before you take Mirtazapine Sandoz
3. How to take Mirtazapine Sandoz
4. Possible side effects
5. Storage of Mirtazapine Sandoz
6. Contents of the pack and other information

1. What is Mirtazapine Sandoz and what is it used for

Mirtazapine Sandoz belongs to a group of medicines called antidepressants.

Mirtazapine is used for the treatment of depressive illnesses in adults.

It may take 1 to 2 weeks before mirtazapine starts to work. After 2 to 4 weeks you may start to feel better. You should consult your doctor if you do not feel better or if you feel worse after 2 to 4 weeks. For more information see section 3, “When can you expect to start feeling better”.

2. What you need to know before you take Mirtazapine Sandoz

Do not takeMirtazapine Sandoz:

• if you are allergicto mirtazapine or any of the other ingredients of this medicine (listed in section 6). In this case, talk to your doctor before taking Mirtazapine Sandoz,
• if you are taking or have taken in the last two weeks medicines called monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Mirtazapine Sandoz.

Tell your doctor before taking mirtazapine:

If you have ever developed severe skin rash, blistering of the skin, mouth sores, after taking mirtazapine.

Children and adolescents

Mirtazapine should not normally be used for the treatment of children and adolescents under 18 years. This is because the safety and effectiveness of mirtazapine in this age group have not been established. At the same time, you should know that in patients under 18 years, there is an increased risk of adverse effects such as suicide attempt, suicidal ideation, and hostility (mainly aggression, confrontation, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe mirtazapine to patients under 18 years when he decides what is best for the patient. If your doctor has prescribed mirtazapine to a patient under 18 years and you want to discuss this decision, please go back to your doctor. You should inform your doctor if any of the above symptoms appear or worsen in patients under 18 years when taking mirtazapine. Furthermore, the long-term effects on growth, maturation, and development of cognition and behavior of mirtazapine in this age group are not yet known. Additionally, a significant increase in weight has been observed more frequently in this age group when treated with mirtazapine, compared to adults.

Suicidal thoughts and worsening of your depression

If you are depressed, you may sometimes have thoughts of harming or killing yourself. These thoughts may be more frequent when you first start taking antidepressants, as these medicines take a few weeks to start working, usually around 2 weeks or sometimes longer.

You may be more likely to think this way if:

• you have previously had thoughts of self-harm or suicide,
• you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years with psychiatric disorders who were treated with antidepressants.

→If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital immediately.

It may be helpful to tell a relative or close friendthat you are depressed,and ask them to read this leaflet. You can ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behavior.

Also, be extra careful with mirtazapine:

• if you have or have ever had any of the following conditions:

→tell your doctor about these situations before taking mirtazapine, if you have not already:

• seizures(epilepsy). If seizures occur or your seizures become more frequent, stop taking mirtazapine and contact your doctor immediately,
• liver diseaseincluding jaundice. If jaundice occurs, stop taking mirtazapine and contact your doctor immediately,
• kidney disease,
• heart disease or low blood pressure,
• schizophrenia. If psychotic symptoms, such as paranoid thoughts, become more frequent or worsen, contact your doctor immediately,
• bipolar depression(alternating periods of excitement/hyperactivity and periods of depression). If you start to feel excited or over-stimulated, stop taking mirtazapine and contact your doctor immediately,
• diabetes(you may need to adjust your insulin or other antidiabetic medication dose),
• eye diseases, such as increased pressure in the eye (glaucoma),
• difficulty urinating, which may be due to an enlarged prostate,
• certain types of heart diseasethat can change your heart rhythm, recent heart attack, heart failure, or taking certain medications that can affect your heart rhythm.
• If signs of infection appear, such as unexplained high fever, sore throat, and mouth sores.

→Stop taking mirtazapine and contact your doctor immediately to have a blood test.

In rare cases, these symptoms can be signs of changes in blood cell production in the bone marrow. Although rare, these symptoms occur more frequently after 4 to 6 weeks of treatment,

• if you are an elderly person, you may be more sensitive to the adverse effects of antidepressant medicines.
• Severe skin reactions, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of mirtazapine. Stop taking mirtazapine and seek medical attention immediately if you notice any of the symptoms described in section 4 related to these severe skin reactions.
• If you have ever experienced severe skin reactions, do not restart treatment with mirtazapine.

Other medicines and Mirtazapine Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Mirtazapine Sandoz with:

• monoamine oxidase inhibitors (MAOIs). Also, do not take mirtazapine during the two weeks after you stop taking MAOIs. If you stop taking mirtazapine, do not take MAOIs during the following two weeks.

Examples of MAOIs are moclobemide, tranylcypromine (both are antidepressants), and selegiline (for Parkinson's disease).

Be careful ifyou take Mirtazapine Sandoz with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs),venlafaxine andL-tryptophan, or triptans(used for migraine), tramadol(a pain reliever), linezolid(an antibiotic), lithium(used to treat some psychiatric disorders), methylene blue(used to treat high levels of methemoglobin in the blood), and St. John's Wort-Hypericum perforatum(a herbal remedy for depression). In rare cases, mirtazapine alone or with these medicines may cause a condition called serotonin syndrome. Some symptoms of this syndrome are: unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), shivering, exaggerated reflexes, agitation, mood changes, and loss of consciousness. If you experience a combination of these symptoms, contact your doctor immediately,
• the antidepressant nefazodone. It may increase the amount of mirtazapine in your blood. Tell your doctor if you are taking this medicine. It may be necessary to decrease the dose of mirtazapine or increase it again when you stop taking nefazodone,
• medicines for anxiety or insomniasuch as benzodiazepines,
• medicines for schizophreniasuch as olanzapine,
• medicines for allergiessuch as cetirizine,
• medicines for severe painsuch as morphine,

When taken with these medicines, mirtazapine may increase the drowsiness caused by these medicines,

• medicines for infections, medicines for bacterial infections (such as erythromycin), medicines for fungal infections (such as ketoconazole), and medicines for HIV/AIDS (HIV protease inhibitors) and medicines for stomach ulcers(such as cimetidine).

If taken with mirtazapine, these medicines may increase the amount of mirtazapine in your blood. Tell your doctor if you are taking these medicines. It may be necessary to decrease the dose of mirtazapine or increase it again when you stop taking these medicines,

• medicines for epilepsysuch as carbamazepine and phenytoin,
• medicines for tuberculosissuch as rifampicin,

If taken with mirtazapine, these medicines may decrease the amount of mirtazapine in your blood. Tell your doctor if you are taking these medicines. It may be necessary to increase the dose of mirtazapine or decrease it again when you stop taking these medicines,

• medicines to prevent blood clottingsuch as warfarin.

Mirtazapine may increase the effects of warfarin on the blood. Tell your doctor if you are taking this medicine. In case of taking them together, it is recommended that your doctor perform blood tests,

• medicines that may affect your heart rhythmsuch as certain antibiotics and some antipsychotics.

Using Mirtazapine Sandoz with food and alcohol

You may feel drowsy if you drink alcohol while taking mirtazapine.

It is recommended not to drink any alcohol.

You can take mirtazapine with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Limited experience with the administration of mirtazapine to pregnant women does not indicate an increased risk. However, caution should be exercised when taking during pregnancy.

If you are treated with mirtazapine until, or just before, birth, your baby should be monitored for possible adverse reactions. When taken during pregnancy, similar medicines (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and appear blue. These symptoms usually start during the first 24 hours after the baby is born. If this happens to your baby, you should contact your midwife or doctor immediately.

Driving and using machines

Mirtazapine may affect your ability to concentrate or react. Make sure your abilities are not affected before driving or using machinery. If your doctor has prescribed mirtazapine for patients under 18 years, make sure their concentration and alertness are not affected before cycling (e.g., bicycles).

Mirtazapine Sandoz contains aspartame, benzyl alcohol, sulfites, and sodium:

Mirtazapine Sandoz 15 mg orodispersible tablets

This medicine contains 3 mg of aspartame in each orodispersible tablet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

This medicine contains 0.047 mg of benzyl alcohol in each orodispersible tablet. Benzyl alcohol may cause allergic reactions. Talk to your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause adverse effects (metabolic acidosis). Benzyl alcohol has been linked to the risk of serious effects, including respiratory problems ("gasping syndrome") in children.

Mirtazapine Sandoz 30 mg orodispersible tablets

This medicine contains 6 mg of aspartame in each orodispersible tablet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

This medicine contains 0.093 mg of benzyl alcohol in each orodispersible tablet. Benzyl alcohol may cause allergic reactions.

Talk to your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause adverse effects (metabolic acidosis). Benzyl alcohol has been linked to the risk of serious effects, including respiratory problems ("gasping syndrome") in children.

Mirtazapine Sandoz 45 mg orodispersible tablets

This medicine contains 9 mg of aspartame in each orodispersible tablet.

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

This medicine contains 0.14 mg of benzyl alcohol in each orodispersible tablet.

Benzyl alcohol may cause allergic reactions.

Talk to your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause adverse effects (metabolic acidosis). Benzyl alcohol has been linked to the risk of serious effects, including respiratory problems ("gasping syndrome") in children.

This medicine may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains small amounts of sulfites.

This medicine contains less than 23 mg of sodium (1mmol) per orodispersible tablet; this is, essentially “sodium-free”.

3. How to Take Mirtazapina Sandoz

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How Much to Take

The recommended initial dose is 15 or 30 mg per day.Your doctor may recommend increasing the dose after a few days to the amount that is best for you (between 15 and 45 mg per day). The dose is usually the same for all ages. However, if you are an elderly patient or if you have kidney or liver disease, your doctor may change the dose.

When to Take Mirtazapina Sandoz

→ Take mirtazapine at the same time every day.

It is best to take the dose of mirtazapine once before bedtime. However, your doctor may recommend that you divide your dose of mirtazapine in the morning and at night before bedtime. The highest dose should be taken before bedtime.

Take the orodispersible tablet as follows

The tablets are taken orally.

1. Do not crush the orodispersible tablet

In order to avoid crushing the orodispersible tablet, do not push against the blister pocket (Figure A).

Figure A

1. Separate a tablet from the blister

Each blister contains pockets with tablets, separated by perforations. Separate the pocket from the blister following the perforated lines (Figure 1).

Figure 1

1. Open the aluminum coating

Carefully open the aluminum coating, starting from the corner indicated by the arrow (Figures 2 and 3).

Figure 2

Figure 3

1. Remove the orodispersible tablet

Remove the orodispersible tablet with dry hands and place it on the tongue (Figure 4).

Figure 4

It disintegrates quickly and can be swallowed without water.

When You Can Expect to Feel Better

Normally, mirtazapine will start to take effect after 1 or 2 weeks, and after 2 to 4 weeks, you may start to feel better.

It is essential that, during the first few weeks of treatment, you talk to your doctor about the effects of mirtazapine:

→ between 2 and 4 weeks after starting to take mirtazapine, talk to your doctor about how this medication has affected you.

If you still do not feel better, your doctor may prescribe a higher dose. In that case, talk to your doctor again after another 2 to 4 weeks. You will usually need to take mirtazapine for 4 to 6 months until the symptoms of depression have disappeared.

If You Take More Mirtazapina Sandoz Than You Should

→ If you or someone has taken too much mirtazapine, consult a doctor immediately.

The most likely symptoms of a mirtazapine overdose (without other medications or alcohol) are drowsiness, disorientation, and palpitations. The symptoms of a possible overdose may include changes in heart rhythm (fast, irregular heartbeat) and/or fainting, which can be symptoms of a life-threatening condition known as Torsade de Pointes.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Mirtazapina Sandoz

If you have to take your dose once a day:

• do not take a double dose to make up for the missed dose. Take the next dose at the usual time.

If you have to take your dose twice a day:

If You Interrupt Treatment with Mirtazapina Sandoz

→ Stop taking mirtazapine only if you consult your doctor.

If you stop too soon, depression may reappear. When you feel better, talk to your doctor. Your doctor will decide when you can stop treatment.

Do not stop taking mirtazapine abruptly, even if depression has disappeared. If you stop taking mirtazapine abruptly, you may feel sick, dizzy, agitated, or anxious, and have headaches. These symptoms can be avoided by gradually stopping treatment. Your doctor will indicate how to gradually reduce the dose.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

If You Experience Any of the Following Serious Adverse Effects, Stop Taking Mirtazapine and Consult Your Doctor Immediately.

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

• feeling of exaggerated euphoria (mania).

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

• yellowing of the eyes or skin; may suggest liver function alterations (jaundice).

Frequency Not Known (cannot be estimated from available data):

• signs of infection such as high, unexplained, and sudden fever, sore throat, and sores in the mouth (agranulocytosis). In rare cases, mirtazapine may cause alterations in blood cell production (bone marrow depression). Some people may become less resistant to infections because mirtazapine can cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, mirtazapine may also decrease the number of red and white blood cells, as well as platelets (aplastic anemia), decrease in platelet count (thrombocytopenia), or an increase in white blood cell count (eosinophilia),
• epileptic seizure (convulsions),
• a combination of symptoms such as unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), chills, exaggerated reflexes, agitation, mood changes, loss of consciousness, and increased salivation. In very rare cases, these symptoms may be signs of a disorder called "serotonin syndrome",
• thoughts of self-harm or suicide,
• severe skin reactions,
• red patches on the torso, such as circumscribed or circular macules, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis),
• widespread erythema, elevated body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Other Possible Adverse Effects During Treatment Are:

Very Common (may affect more than 1 in 10 people):

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

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

• lethargy,
• dizziness,
• tremors or shakiness,
• nausea,
• diarrhea,
• vomiting,
• constipation,
• hives or skin rashes (exanthema),
• joint pain (arthralgia) or muscle pain (myalgia),
• back pain,
• feeling of dizziness or fainting when standing up suddenly (orthostatic hypotension),
• swelling (usually in the ankles or feet) due to fluid retention (edema),
• fatigue,
• vivid dreams,
• confusion,
• feeling of anxiety,
• difficulty sleeping,
• memory problems, which in most cases resolved when treatment was discontinued.

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

• strange sensation in the skin, for example, burning, itching, tingling, or numbness (paresthesias),
• restless legs,
• fainting (syncope),
• numbness in the mouth (oral hypoesthesia),
• low blood pressure,
• nightmares,
• feeling of agitation,
• hallucinations,
• need to move.

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

• muscle spasms or contractions (myoclonus),
• aggression,
• abdominal pain and nausea, which may suggest pancreatitis.

Frequency Not Known (cannot be estimated from available data):

• strange sensations in the mouth (oral paresthesia),
• swelling in the mouth (oral edema),
• swelling throughout the body (generalized edema),
• localized swelling,
• hyponatremia,
• inadequate secretion of antidiuretic hormone,
• severe skin reactions (bullous dermatitis, erythema multiforme),
• sleepwalking (somnambulism),
• speech disorders,
• increased creatine kinase levels in the blood,
• difficulty urinating (urinary retention),
• muscle pain, stiffness, and/or weakness, darkening or discoloration of urine (rhabdomyolysis),
• abnormal increase in prolactin levels in the blood (hyperprolactinemia, which includes symptoms of breast enlargement and/or milky discharge from the nipple).
• painful and prolonged erection of the penis

Additional Adverse Effects in Children and Adolescents

In children under 18 years of age, the following adverse effects have been frequently observed in clinical trials: significant weight gain, blisters, and significant increase in triglycerides.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Mirtazapina Sandoz

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on the blister after "EXP". The expiration date is the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect it from moisture.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Mirtazapina Sandoz

• The active ingredient is mirtazapine. Each orodispersible tablet contains 15 mg, 30 mg, or 45 mg of mirtazapine.
• The other components (excipients) are: mannitol (E 421), povidone K30, crospovidone, colloidal anhydrous silica, aspartame (E 951), calcium stearate, orange flavor (maltodextrin, natural and artificial flavors, dl-alpha-tocopherol, benzyl alcohol, sodium), peppermint flavor (maltodextrin, natural flavors, dextrin, sulfites).

Appearance of the Product and Package Contents

Orodispersible tablets: flat, round, white or almost white tablets with beveled edges and smooth on both sides.

Mirtazapina Sandoz 15 mg is presented in aluminum/aluminum blisters containing 6, 10, 18, 28, 30, 48, 84, 90, or 96 orodispersible tablets.

Mirtazapina Sandoz 30 mg and Mirtazapina Sandoz 45 mg are presented in aluminum/aluminum blisters containing 6, 18, 28, 30, 48, 84, 90, or 96 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Lek Pharmaceuticals d.d.

Verovskova 57,

1526 Ljubljana

Slovenia

or

Sandoz GmbH

Biochemiestrasse, 10

Kundl, Tirol

A-6250

Austria

This Medication is Authorized in the Member States of the European Economic Area with the Following Names:

Ireland: Mirap DisTab 15 mg Orodispersible Tablets

Mirap DisTab 30 mg Orodispersible Tablets

Mirap DisTab 45 mg Orodispersible Tablets

Netherlands: MIRTAZAPINE ORODISPERGEERB tablet 15 mg, orodispergeerbare tabletten 15 mg

MIRTAZAPINE ORODISPERGEERBARE TABLET 30 MG, orodispergeerbare tabletten

MIRTAZAPINE ORODISPERGEERBARE TABLET 45 MG, orodispergeerbare tabletten

Austria: Mirtazapin "Hexal" 30 mg – Schmelztabletten

Mirtazapin "Hexal" 45 mg – Schmelztabletten

Date of the Last Revision of this Leaflet:June 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/