Package Leaflet: Information for the Patient

Mirtazapina Sandoz 15 mg Buccodispersible Tablets EFG

Mirtazapina Sandoz 30 mg Buccodispersible Tablets EFG

Mirtazapina Sandoz 45 mg Buccodispersible Tablets EFG

Read this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Mirtazapina Sandoz

3.How to take Mirtazapina Sandoz

4.Possible side effects

5.Storage of Mirtazapina Sandoz

6.Contents of the pack and additional information

Mirtazapina Sandoz belongs to a group of medicines calledantidepressants.

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

It may take 1 to 2 weeks for mirtazapina to start working. After 2 to 4 weeks, you may start to feel better.You should consult your doctor if you get worse or do not improveafter 2 to 4 weeks. For more information, see section 3, “When you can expect to feel better”.

Do not take or consult your doctor before takingMirtazapina Sandoz:

• if you areallergicto mirtazapina or any of the other components of this medication (listed in section 6). In this case, consult your doctor as soon as possible before taking Mirtazapina Sandoz,
• if you are taking or have taken recently (in the last two weeks) medications called monoamine oxidase inhibitors (MAOIs),
• if you have ever had a severe skin rash or peeling of the skin, blisters, or mouth sores after taking mirtazapina or other medications.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Mirtazapina Sandoz.

Children and adolescents

Mirtazapina should not be used normally in the treatment of children and adolescents under 18 years old since its efficacy has not been demonstrated. At the same time, it should be known that in patients under 18 years old there is a higher risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medication. Nevertheless, your doctor may prescribe mirtazapina to patients under 18 years old when deciding what is best for the patient. If your doctor has prescribed mirtazapina to a patient under 18 years old and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen in patients under 18 years old when taking mirtazapina. Additionally, the long-term safety effects related to growth, maturity, and development of mirtazapina in this age group are still unknown. Furthermore, a significant weight gain has been observed more frequently in this age range when treated with mirtazapina, compared to adults.

Suicidal thoughts and worsening of your depression

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

You may be more prone to thinking this way if:

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

→if you have thoughts of harming yourself or committing suicide at any time, consult your doctor or go to the hospital immediately.

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

Also, be especially careful with mirtazapina:

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

→inform your doctor about these situations before taking mirtazapina, if you have not already done so:

• seizures(epilepsy). If seizures occur or your seizures become more frequent, stop taking mirtazapina and contact your doctor immediately,
• liver diseases, including jaundice. If jaundice appears, stop taking mirtazapina and contact your doctor immediately,
• kidney diseases,
• heart diseases 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 animation/hyperactivity and periods of depression alternate). If you start feeling animated or over-excited, stop taking mirtazapina and contact your doctor immediately,
• diabetes(you may need to adjust your insulin dose or other antidiabetic medications),
• eye diseases, such as increased eye pressure (glaucoma),
• difficulty urinating, which may be due to an enlarged prostate,
• certain types of heart diseasethat may change your heart rhythm, a recent heart attack, heart failure, or taking certain medications that may affect your heart rhythm.
• if you experience any signs of infection, such as high fever, sore throat, and mouth sores.

→stop taking mirtazapina and contact your doctor immediately to perform a blood test.

In rare cases, these symptoms may 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 medications.
• Severe skin reactions, such as Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (NET), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of mirtazapina. Discontinue use 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 had severe skin reactions, do not restart treatment with mirtazapina.

Other medications andMirtazapina Sandoz

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

Do not take Mirtazapina Sandoz with:

• monoamine oxidase inhibitors(MAOIs). Also, do not take mirtazapina during the two weeks after stopping MAOIs. If you stop taking mirtazapina, do not take MAOIs for the next two weeks.

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

Be careful if you take Mirtazapina Sandoz with:

• antidepressants such as selective serotonin reuptake inhibitors(SSRIs),venlafaxine, andL-tryptophan, or triptans(used for migraines),tramadol(a painkiller),linezolid(an antibiotic),lithium(used to treat certain psychiatric disorders),methylene blue(used to treat high levels of methemoglobin in the blood) andSt. John's Wort(a medicinal plant for depression). In rare cases, mirtazapina alone or with these medications may cause a condition called serotonin syndrome. Some symptoms of this condition are: unexplained fever, sweating, palpitations, diarrhea, muscle contractions (uncontrollable), chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. If you experience a combination of these symptoms, consult your doctor immediately,
• the antidepressant nefazodone. It may increase the amount of mirtazapina in your blood. Inform your doctor if you are taking this medication. You may need to reduce your mirtazapina dose or increase it again when stopping nefazodone,
• anxiety or insomnia medicationssuch as benzodiazepines,
• schizophrenia medicationssuch as olanzapine,
• allergy medicationssuch as cetirizine,
• intense pain medicationssuch as morphine,

In combination with these medications, mirtazapina may increase the drowsiness caused by these medications,

• infection medications, bacterial infection medications (such as erythromycin), fungal infection medications (such as ketoconazole), and HIV/AIDS medications (protease inhibitors) andstomach ulcer medications(such as cimetidine).

If taken with mirtazapina, these medications may increase the amount of mirtazapina in your blood. Inform your doctor if you are taking these medications. You may need to reduce your mirtazapina dose or increase it again when stopping these medications,

• epilepsy medicationssuch as carbamazepine and phenytoin,
• tuberculosis medicationssuch as rifampicin,

If taken with mirtazapina, these medications may reduce the amount of mirtazapina in your blood. Inform your doctor if you are taking these medications. You may need to increase your mirtazapina dose or reduce it again when stopping these medications,

• blood clotting medicationssuch as warfarin.

Mirtazapina may increase the effects of warfarin in your blood. Inform your doctor if you are taking this medication. In case of taking them together, your doctor may recommend blood tests,

• medicationsthat can affect heart rhythmsuch as certain antibiotics and some antipsychotics.

Use of Mirtazapina Sandoz with food and alcohol

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

It is recommended not to drink any alcohol.

You can take mirtazapina with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The limited experience of administering mirtazapina to pregnant women does not indicate an increased risk. However, caution should be exercised if taken during pregnancy.

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

Driving and using machines

Mirtazapina may affect your concentration or alertness. Make sure your faculties are not impaired before driving or using machinery. If your doctor has prescribed mirtazapina for patients under 18 years old, make sure concentration and alertness are not affected before driving (e.g., bicycles).

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

Mirtazapina Sandoz 15 mg buccal tablets

This medicationcontains 3 mg of aspartame in each buccal tablet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains 0.047 mg of benzyl alcohol in each buccal tablet. Benzyl alcohol may cause allergic reactions. Consult 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).

Mirtazapina Sandoz 30 mg buccal tablets

This medicationcontains 6 mg of aspartame in each buccal tablet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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

Consult 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).

Mirtazapina Sandoz 45 mg buccal tablets

This medicationcontains 9 mg of aspartame in each buccal tablet.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains 0.14 mg of benzyl alcohol in each buccal tablet.

Benzyl alcohol may cause allergic reactions.

Consult 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).

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

This medication contains less than 23 mg of sodium (1 mmol) per buccal tablet; it is essentially "sodium-free".

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

How much to take

The initial recommended 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). Normally, the dose is the same for all ages. However, if you are an elderly patient or if you have a renal or hepatic disease, your doctor may change the dose.

When to take Mirtazapina Sandoz

→ Take mirtazapina at the same time every day.

It is better to take the mirtazapina dose all at once before going to bed. However, your doctor may recommend that you divide your mirtazapina dose into morning and evening before going to bed. The highest dose should be taken before going to bed.

Take the buccal dispersible tablet in the following way

The tablets are taken orally.

1. Do not crush the buccal dispersible tablet

To avoid crushing the buccal dispersible tablet, do not push against the alveolus of the tablet (Figure A).

Figure A

2. Separate a tablet from the blister

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

Figure 1

3. Open the aluminum coating

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

Figure 2

Figure 3

4. Remove the buccal dispersible tablet

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

Figure 4

It rapidly disintegrates and can be swallowed without water.

When to expect to feel better

Mirtazapina usually starts to work after 1 or 2 weeks and after 2 to 4 weeks you may start to feel better.

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

→ between 2 and 4 weeks after starting to take mirtazapina, 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. Normally, you will need to take mirtazapina for between 4 and 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 mirtazapina, consult a doctor immediately.

The most likely symptoms of a mirtazapina overdose (without other medications or alcohol) aresleepiness, disorientation, and palpitations. The symptoms of a possible overdose may include changes in heart rhythm (rapid or irregular heart rhythm) and/or fainting, which may 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 Toxicological 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 doseonce a day:

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

If you have to take your dosetwice a day:

• if you have forgotten the morning dose, simply take it with the evening dose,
• if you have forgotten the evening dose, do not take it with the morning dose the next day; skip it and continue with your usual doses in the morning and evening,
• if you have forgotten both doses, do not take a double dose to compensate for the missed doses. Skip both doses and the next day continue with the usual dose in the morning and evening.

If you interrupt the treatment withMirtazapina Sandoz

→ Stop taking mirtazapina only if you consult your doctor.

If you stop taking mirtazapina 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 mirtazapina abruptly, even when depression has disappeared. If you stop taking mirtazapina 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.

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

If you experience any of the following serious side effects, stop taking mirtazapine and consult your doctor immediately.

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

• exaggerated feeling of euphoria (mania).

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

• yellowing of the eyes or skin, which may indicate liver dysfunction (jaundice).

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

• signs of infection such as sudden and unexplained high fever and sore throat, mouth sores (agranulocytosis). In rare cases, mirtazapine may cause changes 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 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),
• seizure (convulsion),
• 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. Invery rare cases, these symptoms may be signs of a condition called "serotonin syndrome",
• thoughts of self-harm or suicide,
• red patches on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat ulcers, nasal ulcers, genital ulcers, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis),
• generalized erythema, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other possible side 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,
• diarrhea,
• vomiting,
• constipation,
• urticaria or skin rash (exanthema),
• joint or muscle pain (arthralgia or myalgia),
• back pain,
• sensation 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,
• sensation 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, such as burning, itching, tingling, or prickling (paresthesias),
• restless legs,
• fainting (syncope),
• numbness in the mouth (hypoaesthesia oral),
• low blood pressure,
• nightmares,
• sensation 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 indicate pancreatitis.

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

• strange sensations in the mouth (paresthesia oral),
• swelling in the mouth (buccal edema),
• swelling throughout the body (generalized edema),
• localized swelling,
• hyponatremia,
• inadequate secretion of antidiuretic hormone,
• severe skin reactions (bullous dermatitis, erythema multiforme),
• 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),
• abnormal increase in prolactin levels in the blood (and related symptoms such as nipple discharge and breast tissue growth in men).

Other possible side effects with mirtazapine are:

Increased levels in the blood of creatinin-kinase, difficulty urinating, and muscle pain, torticollis and/or weakness, and darkening or discoloration of urine.

Additional side effects in children and adolescents

In children under 18 years, the following side effects were frequently observed in clinical trials: significant weight gain, blisters, and significant increase in triglycerides.

Reporting of side effects

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

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

Do not use this medication after the expiration date that appears on the packaging and in the blister pack after “CAD”. The expiration date is the last day of the month indicated.

Do not store above30°C.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofMirtazapina Sandoz

• The active ingredient is mirtazapine. Each buccal dispersible tablet contains 15 mg, 30 mg or 45 mg of mirtazapine.
• The other components (excipients) are:mannitol(E 421), povidone K30, crospovidone, anhydrous colloidal 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 contents of the package

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

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

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

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 medicine 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 review of this leaflet:December 2020

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/