Package Insert: Information for the Patient

Mirtazapina Flas Normogen 45 mg Bucodispersable Tablets EFG

Mirtazapina

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may 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 package insert. See section 4.

6. Contents of the pack and additional information

Mirtazapina Flas Normogen belongs to a group of medicines calledantidepressants.

Mirtazapina Flas Normogen is used to treat depression in adults.

It may take one to two weeks before Mirtazapina Flas Normogen starts to take effect. After 2 to 4 weeks, you may begin 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 takeMirtazapina Flas Normogen

• 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 Flas Normogen.
• If you are taking or have taken recently (in the last two weeks) medications calledmonoamine oxidase inhibitors (MAOIs).
• If you have ever had a severe skin rash or skin peeling, blisters, or mouth sores after taking mirtazapina or other medications.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Mirtazapina Flas Normogen.

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 suicidal attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medication. Nevertheless, the doctor may prescribe mirtazapina to a patient under 18 years when they decide it is the most convenient 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 in patients under 18 years taking mirtazapina appear or worsen. Furthermore, the long-term safety effects related to growth, maturity, and development of mirtazapina in this age group are still unknown. It has also been observed that there is a considerable weight gain in this age group when treated with mirtazapina, compared to adults.

Suicidal ideas and worsening of depression

If you are depressed, you may sometimes have ideas 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 have a normal effect.

You may be more prone to thinking this way:

• If you have previously had suicidal thoughts or self-harm.
• If you are a young adult. The information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years with psychiatric disorders and being treated with an antidepressant.
• If you have ideas 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 FlasNormogen:

• If youhave or have had any of the following conditions;

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

−seizures(epilepsy). If seizures occur or your seizures are more frequent, stop taking Mirtazapina FlasNormogenand contact your doctor immediately;

−liver diseases, including jaundice. If jaundice appears, stop taking Mirtazapina FlasNormogenand contact your doctor immediately;

− kidney diseases;

−heart disease or low blood pressure;

−schizophrenia. If psychotic symptoms, such as paranoid thoughts, are more frequent or severe, contact your doctor immediately;

−bipolar depression(periods ofmania/hyperactivity and periods of depression). If you start feeling animated or overexcited, stop taking Mirtazapina FlasNormogenand 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 signs of infection such as high fever, sore throat, and mouth sores;

- Stop taking Mirtazapina FlasNormogenand contact your doctor immediately to perform a blood test.

• In rare cases, these symptoms may be signs of bone marrow production disorders. Although rare, these symptoms appear at 4-6 weeks of treatment.

• If you are an older 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 and Mirtazapina Flas Normogen

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

Do not take Mirtazapina Flas Normogenwith:

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

Examples of MAOIs are moclobemida, tranilcipromina (both are antidepressants), and selegilina (for Parkinson's disease).

Be careful ifyou take Mirtazapina FlasNormogenwith:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs),venlafaxina, and L-triptófano or triptans(used for migraines),tramadol(for pain),linezolid(an antibiotic),litio(used to treat some psychiatric disorders),azul de metileno(used to treat high metahemoglobin levels in the blood) andHypericum perforatum(medicinal plant for depression). In rare cases, Mirtazapina Flas Normogen 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 nefazodona. It may increase the amount of Mirtazapina Flas Normogen in the blood. Inform your doctor if you are taking this medication. You may need to reduce the dose of Mirtazapina Flas Normogen, or increase it again when stopping nefazodona.
• anxiety or insomnia medicationssuch as benzodiazepines.
• schizophrenia medicationssuch as olanzapina.
• allergy medicationssuch as cetirizina.
• intense pain medicationssuch as morphine.

Mirtazapina Flas Normogen may increase the drowsiness caused by these medications when taken together.

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

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

• epilepsy medicationssuch as carbamazepina and fenitoína;
• tuberculosis medicationssuch as rifampicina.

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

• blood clotting medicationssuch as warfarina.

MirtazapinaFlasNormogenmay increase the effects of warfarina on the blood. Inform your doctor if you are taking this medication. In case of taking them together, it is recommended that the doctor perform blood tests.

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

Taking Mirtazapina FlasNormogen with food and alcohol

You may feel drowsy if you drink alcohol while taking Mirtazapina Flas Normogen. It is recommended not to drink any alcohol. You can take Mirtazapina Flas Normogen with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become 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, you should be careful if you use it during pregnancy. If you use Mirtazapina Flas Normogen until, or shortly before delivery, your baby will be examined to detect any possible adverse effects.

Antidepressants similar to Mirtazapina Flas Normogen (SSRIs) may increase the risk of a serious condition called persistent pulmonary hypertension in newborns (PPHN) in babies, making them breathe faster and appear blue. These symptoms usually start within the first 24 hours after birth. If this happens to your baby, you should consult your midwife and/or doctor immediately.

Consult your doctor if you can breastfeed while taking Mirtazapina Flas Normogen.

Driving and using machines

During treatment with Mirtazapina Flas Normogen, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how Mirtazapina Flas Normogen affects you.

Mirtazapina Flas Normogen contains glucose and aspartamo

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

This medication contains 6 mg of aspartamo in each tablet.

Aspartamo 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.

Follow exactly the administration instructions of this medication 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 mg 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 mg and 45 mg per day). Normally, the dose is the same for all ages. However, if you are an older person or have a kidney or liver disease, your doctor may change the dose.

When to take it

→Take Mirtazapina FlasNormogenat the same time every day.

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

Take the buccal tablet in the following way

1. The tablets are taken orally. To avoid the buccal tablet from crushing, press the tablet carefully through the blister foil.
2. Take the buccal tablet with dry hands and place it on the tongue.

The buccal tablet will dissolve quickly and can be swallowed without water.

When to expect to feel better

Normally, Mirtazapina Flas Normogen will start to take effect after 1 or 2 weeks and after2 to4 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 FlasNormogen:

→ between 2 and 4 weeks after starting to take Mirtazapina FlasNormogen, 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 2-4 weeks.

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

If you take more Mirtazapina Flas Normogen than you should

→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.

The most likely symptoms of an overdose of Mirtazapina Flas Normogen (without other medications or alcohol) aredrowsiness, 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 Flas Normogen

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 with your usual doses in the morning and evening.
• If you forgot both doses, do not try to recover them. Skip both doses and the next day continue with the usual dose in the morning and evening.

If you interrupt the treatment with Mirtazapina Flas Normogen

Stop taking Mirtazapina FlasNormogenonly if you consult with 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 FlasNormogenabruptly, even when depression has disappeared. If you stop taking Mirtazapina FlasNormogenabruptly, 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 immediately inform your doctor.

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

• exaggerated feeling of euphoria (mania).

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

• yellow discoloration of the eyes or skin; may indicate liver function abnormalities (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 bone marrow depression. Some people become less resistant to infections because mirtazapine may cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, mirtazapine may also cause a decrease in red and white blood cells 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 unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), chills, exaggerated reflexes, agitation, mood changes, loss of consciousness, and increased saliva production. In very rare cases, these symptoms may be signs of a condition called "serotonin syndrome",
• thoughts of self-harm or suicide,
• severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• red patches on the trunk, such as circumscribed or circular macules, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• generalized erythema, elevated body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other possible side effects with mirtazapine are:

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

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

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

• lethargy,
• dizziness,
• tremor,
• nausea,
• diarrhea,
• vomiting,
• constipation,
• urticaria or skin rash (exanthema),
• joint or muscle pain (arthralgia or myalgia),
• back pain,
• dizziness or fainting when standing up quickly (orthostatic hypotension),
• swelling (usually in ankles or feet) due to fluid retention (edema),
• fatigue,
• vivid dreams,
• confusion,
• anxiety,
• difficulty sleeping.
• Memory problems, which in most cases resolved when treatment was discontinued.

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

• strange sensation in the skin, for example, burning, pinching, tingling, or numbness (paresthesia),
• involuntary movements of leg agitation during sleep,
• fainting (syncope),
• sensation of numbness of the mouth (hypoaesthesia oral),
• low blood pressure,
• nightmares,
• agitation,
• hallucinations,
• inability to remain still.

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

• tics or muscle contractions (myoclonus),
• aggression,
• abdominal pain, nausea; this may indicate pancreatitis.

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

• abnormal sensations in the mouth (paresthesia oral),
• 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 (dermatitis bullous, erythema multiforme),
• sleepwalking (somnambulism),
• speech problems,
• increased levels of creatine kinase in the blood,
• difficulty urinating (urinary retention),
• muscle pain, stiffness, and/or weakness, darkening or discoloration of urine (rhabdomyolysis).

Other side effects in children and adolescents

In children under 18 years, the following side effects were frequently observed in clinical trials: a significant weight gain, urticaria, and increased triglycerides in the blood.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for the 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 box and the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

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

Composition ofMirtazapina Flas Normogen

• The active ingredient is mirtazapine.
• Each buccal dispersible tablet contains 45 mg of mirtazapine (as mirtazapine hemihydrate).
• The other components are: mannitol, cornstarch, microcrystalline cellulose, crospovidone, aspartame, orange essence (contains glucose in maltodextrin from corn) and vegetable magnesium stearate.

Appearance of the product and contents of the packaging

White, round, flat, bisected, and marked with “45” on one side buccal dispersible tablet.

Packaging size: 30 tablets in a pre-cut single-dose blister.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Last review date of this leaflet: September 2020

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

You can access detailed and updated information on this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/84117/P_84117.html