Prospecto: information for the patient

Mirtazapina Sandoz Farmacéutica 15 mg film-coated tablets EFG

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

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

Contentsof the prospectus:

1. What Mirtazapina Sandoz Farmacéutica is and for what it is used
2. What you need to know before starting to take Mirtazapina Sandoz Farmacéutica
3. How to take Mirtazapina Sandoz Farmacéutica
4. Possible adverse effects
5. Storage of Mirtazapina Sandoz Farmacéutica
6. Contents of the package and additional information

Mirtazapina belongs to a group of medicines calledantidepressants.

Mirtazapina is used to treat depression 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 improve after 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 starting to take Mirtazapina Sandoz Farmacéutica

• if you areallergicto mirtazapina or to any of the other components of this medication (listed in section 6). In that case, consult your doctor as soon as possible before taking mirtazapina,
• • 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 sores in the mouth after taking mirtazapina or other medications.

Warnings and precautions

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

Children and adolescents

Mirtazapina should not be used normally in the treatment of children and adolescents under 18 years because its efficacy has not been demonstrated. At the same time, it should be known that in patients under 18 years there is a higher risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medication. Despite this, the doctor may prescribe mirtazapina to patients under 18 years when they decide what is best for the patient. If the doctor has prescribed mirtazapina to a patient under 18 years 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 who are taking mirtazapina. In addition, the long-term safety effects related to growth, maturation, and development of mirtazapina in this age group are still unknown. Furthermore, a significant increase in weight has been observed in this age group more often than in adults treated with mirtazapina.

Suicidal thoughts and worsening of depression

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

You may be more prone to thinking this way:

→ 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 friend that 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:

→ Inform your doctor about these situations before taking Mirtazapina Sandoz Farmacéutica, if you have not already done so:

• seizures(epilepsy). If you develop seizures or your seizures are 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 diseasesorlow blood pressure,
• schizophrenia. If psychotic symptoms, such as paranoid thoughts, are more frequent or severe, contact your doctor immediately,
• bipolar depression(periods of excitement/hyperactivity and periods of depression alternate). If you start feeling animated or overexcited, 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 could be due to an enlarged prostate,
• certain cases of heart conditionsthat may change your heart rhythm, a recent heart attack, heart failure, or taking certain medications that may affect your heart rhythm,
• • if you develop 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 alterations in blood cell production in the bone marrow. Although rare, these symptoms appear at 4-6 weeks of treatment.

• if you are an elderly patient, 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 reactions 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, you should not restart treatment with mirtazapina.

Other medications and Mirtazapina Sandoz Farmacéutica

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

Be carefulif you take Mirtazapina Sandoz Farmacéutica with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, and L-tryptophan or triptans(used for migraines),tramadol(for pain),linezolid(an antibiotic),lithium(used to treat certain psychiatric disorders),methylene blue(used to treat high levels of methemoglobin in the blood)and preparations based on St. John's Wort –Hypericum perforatum(medicinal plant for depression). In rare cases, mirtazapina alone or with these medications may cause the so-called serotonin syndrome. Some of the symptoms of this syndrome 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 the blood. Inform your doctor if you are taking this medication. You may need to reduce the dose of mirtazapina, or increase it again when you stop taking 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 the blood. Inform your doctor if you are taking these medications. You may need to reduce the dose of mirtazapina, or increase it again when you stop taking 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 the blood. Inform your doctor if you are taking these medications. You may need to increase the dose of mirtazapina, or reduce it again when you stop taking these medications.

• blood thinnerssuch as warfarin.

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

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

Taking Mirtazapina Sandoz Farmacéutica 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 if you think you may be pregnant, consult your doctor or pharmacist before using any medication. The limited experience of administering mirtazapina to pregnant women does not indicate an increased risk of congenital malformations. However, you should be careful if you use it during pregnancy.

If you use mirtazapina until, or shortly before delivery, your baby should be monitored to detect any possible adverse reactions.

When taken during pregnancy, similar medications (SSRIs) may increase the risk of a serious condition in newborns, called persistent pulmonary hypertension (PPHN), which makes the baby breathe faster and acquire a bluish tone. These symptoms usually begin within the first 24 hours after birth. If this happens to your child, you should contact your midwife and/or doctor immediately.

Driving and using machines

Mirtazapina Sandoz Farmacéutica may affect your concentration or alertness. Make sure your faculties are not affected before driving or using machinery. If your doctor has prescribed mirtazapina to a patient under 18 years, make sure concentration and alertness are not affected before driving (for example, on a bicycle).

Mirtazapina Sandoz Farmacéutica contains lactose and sunset yellow FCF (E110)

This medication contains lactose. If your doctor has told you that you have a intolerance to certain sugars, consult with them before taking this medication.

This medication may cause allergic reactions because it contains sunset yellow FCF (E110). It may cause asthma, especially in patients allergic to aspirin.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication should be taken exactly as directed 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 have a kidney or liver disease, your doctor may change the dose.

When to take it

→ Take Mirtazapina Sandoz Farmacéutica at the same time every day. It is better to take the dose of Mirtazapina Sandoz Farmacéutica all at once before going to bed. However, your doctor may recommend that you divide your dose of Mirtazapina Sandoz Farmacéutica into morning and evening doses before going to bed. The highest dose should be taken before going to bed.

The tablets are taken orally. Take the prescribed dose of Mirtazapina Sandoz Farmacéutica without chewing, with water or juice.

The tablets can be divided into equal doses.

When to expect to feel better

Normally, Mirtazapina Sandoz Farmacéutica 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 weeks of treatment, you talk to your doctor about the effects of mirtazapina:

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

If you are still not feeling better, your doctor may prescribe a higher dose. In that case, talk to your doctor again after another 2-4 weeks.

Normally, you will need to take Mirtazapina Sandoz Farmacéutica until the symptoms of depression have disappeared for 4-6 months.

If you take more Mirtazapina Sandoz Farmacéutica than you should

If you have taken more mirtazapina than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

The most likely symptoms of an overdose of Mirtazapina Sandoz Farmacéutica (without other medications or alcohol) are drowsiness, disorientation, and palpitations. The symptoms of a possible overdose may include changes in your heart rhythm (rapid or irregular heartbeat) and/or dizziness, which could be symptoms of a potentially life-threatening condition known as Torsade de Pointes.

If you forgot to take Mirtazapina Sandoz Farmacéutica

If you have to take your doseonce a day

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

If you have to take your dosetwice a day

• If you forgot the morning dose, simply take it with the evening dose.
• If you forgot the evening dose,do not take it the next morning, skip it and continue treatment with your usual morning and evening doses.
• If you forgot both dosesdo not try to recover them. Skip both doses and the next day continue with the usual morning and evening doses.

If you interrupt treatment with Mirtazapina Sandoz Farmacéutica:

→ Stop taking Mirtazapina Sandoz Farmacéutica 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 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 product, 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 mirtazapina and inform your doctor immediately.

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

• exaggerated feeling of euphoria (mania).

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

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

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

• signs of infection such as high fever, sudden and inexplicable, sore throat, and mouth sores (agranulocytosis). In rare cases, mirtazapina may cause alterations in blood cell production (bone marrow depression). Some people become less resistant to infections because mirtazapina may cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, mirtazapina may also cause a decrease in red and white blood cells and platelets (aplastic anemia), a decrease in platelets (thrombocytopenia), or an increase in white blood cells in the blood (eosinophilia).
• seizure (convulsions).
• a combination of symptoms such as inexplicable 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 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 serious side effects during treatment are:

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

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

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

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

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

• • abnormal sensations in the mouth (oral paresthesia),
  • swelling in the mouth (buccal edema),
  • swelling throughout the body (generalized edema),
  • localized swelling,
  • low sodium levels (hyponatremia),
  • inadequate secretion of antidiuretic hormone,
  • severe 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, dark or discolored urine (rhabdomyolysis),
• abnormally high levels of prolactin hormone in the blood (and related symptoms such as milk secretion and breast swelling in men).

Additional side effects in children and adolescents:

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed 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 blister after CAD/EXP. The expiration date is the last day of the month indicated.

This medicationdoes not require special storage conditions.

Medicines should not be thrown down the drain or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointof 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.

Mirtazapina Sandoz Pharmaceutical Composition

• The active ingredient is mirtazapine.

Each tablet contains 15 mg of mirtazapine.

• The other components are:

Tablet core:

Lactose monohydrate

Maize starch

Hydroxypropylcellulose

Colloidal silicon dioxide

Magnesium stearate

Tablet coating:

Hypromellose

Macrogol 8000

Titanium dioxide (E 171)

Yellow iron oxide (E 172)

Quinoline yellow (E 104)

Yellow-orange S (E 110)

Product appearance and packaging contents:

Yellow-coated, round, biconvex tablets with a notch on one side.

The yellow-coated tablets are packaged in white/opaque PVC/PVDC/aluminum blisters inserted into cardboard packaging.

Packaging sizes:

6, 10, 14, 18, 20, 28, 30, 48, 50, 56, 60, 70, 90, 96, 100, 30x1, 50x1, 100x1 coated tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Pharmaceutical, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee, 1

39179 Barleben

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria:Mirtazapin Hexal 15 mg – Filmtabletten

Germany:Mirtazapin HEXAL® 15 mg Filmtabletten

Finland:Mirtazapin Hexal 15 mg tabletti, kalvopäällysteinen

Last review date of this leaflet:November 2022

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