Mirtazapine Sandoz 30 mg orodispersible tablets EFG

Package leaflet: Information for the user

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 the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Mirtazapine Sandoz belongs to a group of medicines called antidepressants.

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

It takes 1 to 2 weeks before mirtazapine starts to take effect. After 2 to 4 weeks, you may begin to feel better. You should consult your doctor if your condition worsens or if you do not improve after 2 to 4 weeks. For more information, see section 3, “When can you expect to feel better?”

2. What you need to know before taking Mirtazapine Sandoz

Do not take Mirtazapine Sandoz:

• if you are allergic to mirtazapine or to any of the other ingredients of this medicine (listed in section 6). In this case, consult your doctor as soon as possible before taking Mirtazapine Sandoz,
• if you are taking or have recently taken (within the last two weeks) medicines known as monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Mirtazapine Sandoz.

Tell your doctor before taking mirtazapine:

If you have ever developed a severe skin rash or peeling skin, blisters and/or mouth sores after taking mirtazapine.

Children and adolescents

Mirtazapine is not normally used in the treatment of children and adolescents under 18 years of age, as its efficacy has not been demonstrated. Also, you should be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe mirtazapine to patients under 18 years of age if they decide it is the most appropriate treatment for the patient. If your doctor has prescribed mirtazapine to a patient under 18 years of age and you wish to discuss this decision, please contact your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen in patients under 18 years of age while taking mirtazapine. In addition, the long-term effects on growth, maturation, and cognitive and behavioural development of mirtazapine in this age group are not yet fully known. Furthermore, a significant weight gain has been observed more frequently in this age group when treated with mirtazapine, compared to adults.

Suicidal thoughts and worsening of depression

If you are depressed, you may sometimes have thoughts of harming yourself or of suicide. This may worsen when you first start taking antidepressants, as these medicines take longer to take effect, usually two weeks or sometimes more.

You may be more likely to have such thoughts if:

• you have previously had suicidal thoughts or thoughts of self-harm,
• you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age being treated with antidepressants.

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

It may be helpful to tell a family member or close friend that you are depressed and ask them to read this leaflet. You may ask them to inform you if they believe your depression is worsening, or if they are concerned about changes in your behaviour.

Also, take special care with mirtazapine:

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

→Inform your doctor about these conditions before taking mirtazapine, if you have not already done so:

• seizures (epilepsy). If seizures occur or your seizures become more frequent, stop taking mirtazapine and contact your doctor immediately,
• liver disease, including 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 (periods of elevated mood/hyperactivity alternate with periods of depression). If you start feeling elated or over-excited, stop taking mirtazapine and contact your doctor immediately,
• diabetes (you may need to adjust your insulin dose or other antidiabetic medicines),
• eye disorders, such as increased pressure in the eye (glaucoma),
• difficulty in urinating, which may be due to an enlarged prostate,
• certain types of heart disease that may alter your heart rhythm, a recent heart attack, heart failure, or if you are taking certain medicines that may affect your heart rhythm.
• If signs of infection appear, such as unexplained high fever, sore throat, and mouth ulcers.

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

Rarely, these symptoms may indicate disturbances 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 elderly, you may be more sensitive to the adverse effects of antidepressant medicines.
• Serious skin reactions have been reported with the use of mirtazapine, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Discontinue use and seek immediate medical attention if you notice any of the symptoms described in section 4 related to these serious skin reactions.

If you have previously experienced serious skin reactions, mirtazapine treatment should not be restarted.

Other medicines and Mirtazapine Sandoz

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

Do not take Mirtazapine Sandoz together with:

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

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

Be careful if you take Mirtazapine Sandoz together with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine and L-tryptophan, or triptans (used for migraine), tramadol (a painkiller), linezolid (an antibiotic), lithium (used to treat certain psychiatric disorders), methylene blue (used to treat high levels of methaemoglobin in the blood), and preparations based on St. John's wort (Hypericum perforatum) (a herbal remedy for depression). In very rare cases, mirtazapine alone or in combination with these medicines may lead to a condition known as serotonin syndrome. Some of the symptoms of this syndrome are: unexplained fever, sweating, palpitations, diarrhoea, uncontrollable muscle contractions, chills, 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 the blood. Inform your doctor if you are taking this medicine. It may be necessary to reduce the dose of mirtazapine or increase it again when stopping nefazodone,
• medicines for anxiety or insomnia, such as benzodiazepines,
• medicines for schizophrenia, such as olanzapine,
• medicines for allergies, such as cetirizine,
• medicines for severe pain, such as morphine.

In combination with these medicines, mirtazapine may increase the drowsiness caused by them.

• 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 together with mirtazapine, these medicines may increase the amount of mirtazapine in the blood. Inform your doctor if you are taking these medicines. It may be necessary to reduce the dose of mirtazapine, or increase it again when stopping these medicines.

• medicines for epilepsy, such as carbamazepine and phenytoin,
• medicines for tuberculosis, such as rifampicin.

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

• medicines to prevent blood clotting, such as warfarin.

Mirtazapine may enhance the effects of warfarin in the blood. Inform your doctor if you are taking this medicine. If taken together, it is recommended that your doctor perform regular blood tests.

• medicines that may affect heart rhythm, such as certain antibiotics and some antipsychotics.

Use of 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 may take mirtazapine with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Limited experience with administering mirtazapine to pregnant women does not indicate an increased risk. However, caution should be exercised if taken during pregnancy.

If you are being treated with mirtazapine up to or just before birth, your baby should be monitored for possible adverse reactions. Medicines similar to mirtazapine (SSRIs) taken during pregnancy may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife or doctor immediately.

Driving and use of machines

Mirtazapine may affect your ability to concentrate or your level of alertness. Make sure your abilities are not impaired before driving or operating machinery. If your doctor has prescribed mirtazapine for patients under 18 years of age, ensure that concentration and alertness are not affected before engaging in activities such as cycling.

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

Mirtazapine Sandoz 15 mg orodispersible tablets

This medicine contains 3 mg of aspartame in each orodispersible tablet. Aspartame contains 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 properly eliminate it.

This medicine contains 0.047 mg of benzyl alcohol in each orodispersible tablet. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breastfeeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems ("gasping syndrome") in children.

Mirtazapine Sandoz 30 mg orodispersible tablets

This medicine contains 6 mg of aspartame in each orodispersible tablet. Aspartame contains 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 properly eliminate it.

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

Consult your doctor or pharmacist if you are pregnant or breastfeeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems ("gasping syndrome") in children.

Mirtazapine Sandoz 45 mg orodispersible tablets

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

Aspartame contains 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 properly eliminate it.

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

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems ("gasping syndrome") in children.

This medicine may rarely cause serious allergic reactions and bronchospasm (sudden sensation of suffocation) because it contains small amounts of sulphites.

This medicine contains less than 23 mg of sodium (1 mmol) per orodispersible tablet; therefore, it is essentially "sodium-free".

3. How to take Mirtazapine Sandoz

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

How much to take

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

When to take Mirtazapine Sandoz

→ Take mirtazapine at the same time each day.

It is best to take the dose of mirtazapine as a single dose before bedtime. However, your doctor may recommend that you divide your dose, taking part in the morning and part at night before bedtime. The larger dose should be taken before bedtime.

How to take the orodispersible tablet

The tablets are taken by mouth.

1. Do not crush the orodispersible tablet

To avoid crushing the orodispersible tablet, do not push against the tablet cavity (Figure A).

Figure A

1. Detach a tablet from the blister pack

Each blister contains tablet cavities separated by perforations. Detach the cavity from the blister along the perforated lines (Figure 1).

Figure 1

1. Open the aluminium foil

Carefully open the aluminium foil starting at the corner indicated by the arrow (Figures 2 and 3).

Figure 2

Figure 3

1. Remove the orodispersible tablet

With dry hands, remove the orodispersible tablet and place it on the tongue (Figure 4).

Figure 4

It disintegrates rapidly and can be swallowed without water.

When to expect improvement

Mirtazapine usually starts to take effect after 1 or 2 weeks, and after 2 to 4 weeks you may begin to feel better.

It is important that during the first weeks of treatment you speak with your doctor about how mirtazapine is affecting you:

→ 2 to 4 weeks after starting mirtazapine, talk to your doctor about how this medicine has affected you.

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

If you take more Mirtazapine Sandoz than you should

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

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

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone number: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Mirtazapine Sandoz

If you are taking your dose once daily:

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

If you are taking your dose twice daily:

• if you forget the morning dose, simply take it together with the evening dose,
• if you forget the evening dose, do not take it together with the next morning dose; skip it and continue with your normal morning and evening doses,
• if you forget both doses, do not take a double dose to make up for the missed doses. Skip both doses and the next day continue with your normal morning and evening doses.

If you stop taking Mirtazapine Sandoz

→ Stop taking mirtazapine only after consulting your doctor.

If you stop too early, depression may return. When you start feeling better, talk to your doctor. Your doctor will decide when you can stop treatment.

Do not stop taking mirtazapine abruptly, even if depression has resolved. If you stop mirtazapine suddenly, you may feel unwell, dizzy, agitated or anxious, and may experience headaches. These symptoms can be avoided by stopping treatment gradually. Your doctor will advise you on how to reduce the dose gradually.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience any of the following serious adverse effects, stop taking mirtazapine and contact 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 dysfunction (jaundice).

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

• signs of infection such as sudden unexplained fever, sore throat, and mouth ulcers (agranulocytosis). In rare cases, mirtazapine may cause disturbances in blood cell production (bone marrow depression). 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 reduce the number of red and white blood cells as well as platelets (aplastic anaemia), a decrease in the number of platelets (thrombocytopenia), or an increase in the number of white blood cells (eosinophilia),
• epileptic seizure (convulsions),
• a combination of symptoms such as unexplained fever, sweating, palpitations, diarrhoea, 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 harming yourself or of suicide,
• serious skin reactions,
• red patches on the trunk, often as circumscribed or circular spots, frequently with blisters in the centre, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis),
• widespread red rash, high body temperature, and enlarged lymph nodes (DRESS syndrome 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 shivering,
• nausea,
• diarrhoea,
• vomiting,
• constipation,
• hives or skin rash (exanthema),
• joint pain (arthralgia) or muscle pain (myalgia),
• back pain,
• feeling dizzy or faint upon standing suddenly (orthostatic hypotension),
• swelling (usually in the ankles or feet) due to fluid retention (oedema),
• fatigue,
• vivid dreams,
• confusion,
• feeling anxious,
• difficulty sleeping,
• memory problems, which in most cases resolved when treatment was stopped.

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

• unusual skin sensations such as burning, stinging, tingling, or pins and needles (paraesthesiae),
• restless legs,
• fainting (syncope),
• numbness sensations in the mouth (oral hypoesthesia),
• low blood pressure,
• nightmares,
• feeling of restlessness,
• hallucinations,
• urge 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 inflammation of the pancreas (pancreatitis).

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

• unusual sensations in the mouth (oral paraesthesia),
• swelling in the mouth (oral oedema),
• swelling throughout the body (generalised oedema),
• localized swelling,
• hyponatraemia,
• inappropriate antidiuretic hormone secretion,
• serious skin reactions (bullous dermatitis, erythema multiforme),
• sleepwalking (somnambulism),
• speech disorders,
• increased levels of creatine kinase in the blood,
• difficulty urinating (urinary retention),
• muscle pain, stiffness and/or weakness, darkening or discoloration of urine (rhabdomyolysis),
• abnormally increased levels of prolactin in the blood (hyperprolactinaemia, including symptoms such as breast enlargement and/or milky nipple discharge),
• painful and prolonged penile erection.

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 of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mirtazapine Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Package contents and other information

Composition of Mirtazapine Sandoz

• The active substance 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 flavour (maltodextrin, natural and artificial flavours, dl-alpha-tocopherol, benzyl alcohol, sodium), mint flavour (maltodextrin, natural flavours, dextrin, sulphites).

Nature of the product and package contents

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

Mirtazapine Sandoz 15 mg is available in aluminium/aluminium blisters containing 6, 10, 18, 28, 30, 48, 84, 90 or 96 orodispersible tablets.

Mirtazapine Sandoz 30 mg and Mirtazapine Sandoz 45 mg are available in aluminium/aluminium blisters containing 6, 18, 28, 30, 48, 84, 90 or 96 orodispersible tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area under 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 most recent revision of this leaflet: August 2025

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