Package Insert: Information for the User

Mirtazapina Aurovitas Spain 15 mg Bucodispersable Tablets EFG

Read this 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.

MirtazapinaAurovitas Spain belongs to a group of medicines called antidepressants.

Mirtazapinais used to treat depression in adults.

It takes 1 to 2 weeks formirtazapinato start taking effect. 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 takeMirtazapinaAurovitas Spain

• if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).Consult your doctor as soon as possible before taking mirtazapina.
• if you are taking or have taken in the last two weeks any 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.

Take special care with Mirtazapina Aurovitas Spain

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. Stop using mirtazapina 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.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Mirtazapina Aurovitas Spain.

If you are taking medications that contain buprenorphine. The use of these medications with mirtazapina may cause serotonin syndrome, a potentially fatal disease (see Other medications and Mirtazapina Aurovitas Spain).

Children and adolescents

Mirtazapina should not be used normally in the treatment of children and adolescents under 18 years of age because its efficacy has not been demonstrated. At the same time, you should know that in patients under 18 years of age, there is a higher risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this class of medications. Despite this, your doctor may prescribe mirtazapina to patients under 18 years of age when they decide what is best for the patient. If your doctor has prescribed mirtazapina to a patient under 18 years of age and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms described above appear or worsen in patients under 18 years of age who are taking mirtazapina. In addition, the long-term effects related to safety and growth, maturity, and cognitive and behavioral development of mirtazapina in this age group are still unknown. It has also been observed more frequently a considerable weight gain in this age group when treated with mirtazapina, compared to adults.

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 take time to take effect, usually two weeks or more.

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 young adults under 25 years of age with psychiatric disorders and who are 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 family member 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, take special care 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 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 diseases, orlow blood pressure;
• schizophrenia. If psychotic symptoms, such as paranoid thoughts, become more frequent or worsen, contact your doctor immediately;
• bipolar depression(periods of excitement/hyperactivity alternate with periods of depression). If you start feeling excited 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;
• specific types of heart diseasethat can change your heart rhythm, a recent heart attack, heart failure, or taking certain medications that can affect your heart rhythm.

• if you have signs of infection, such as high fever, sore throat, and mouth sores.

→Stop taking mirtazapinaand contact your doctor immediatelyto perform a blood test. In rare cases, these symptoms may be signs of bone marrow production disorders. Although rare, these symptoms occur mainly 4-6 weeks after treatment.

• if you are an elderly person, you may be more sensitive to the adverse effects of antidepressant medications.

Other medications and Mirtazapina Aurovitas Spain

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

Do not take Mirtazapina Aurovitas Spainwith:

• 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 careful ifyou take Mirtazapina Aurovitas Spain with:

• antidepressants such asselective 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 St. John's Wort – Hypericum perforatum(herbal remedy for depression).In rare cases, mirtazapina alone or with these medications, may cause 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.

Mirtazapina may increase the drowsiness caused by these medications.

• infection medications;infection medications (such as erythromycin), fungal infection medications (such as ketoconazole), 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 on the blood. Inform your doctor if you are taking this medication. In case you take them together, your doctor may recommend blood tests.

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

Some medications may increase the side effects of mirtazapina and sometimes may cause very serious reactions. Do not take any other medication while taking mirtazapina without consulting your doctor, especially:

• medications that contain buprenorphine. These medications may interact with mirtazapina and you may experience symptoms such as involuntary and rhythmic muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38orC. Contact your doctor when you experience these symptoms.

Taking Mirtazapina Aurovitas Spain with food, drinks, 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, 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 cautious if you use it during pregnancy.

If you use mirtazapina until birth, or shortly before, your child will be examined to detect any possible adverse effects.

When taken during pregnancy, similar medications (SSRIs) may increase the risk of a serious condition in the baby, 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, you should consult your midwife or doctor immediately.

Driving and using machines

Mirtazapina Aurovitas Spain may affect your ability to concentrate or be alert. Make sure your faculties are not affected before driving or using machinery. If your doctor has prescribed mirtazapina to a patient under 18 years of age, make sure concentration and alertness are not affected before driving (for example, on a bicycle).

Mirtazapina Aurovitas Spain contains aspartame

This medication contains 3 mg of aspartame in each buccal dispersible tablet.

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

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

When to take Mirtazapina Aurovitas Spain

→Take Mirtazapina Aurovitas Spain at the same time every day.

It is better to take the mirtazapine dose all at once before going to bed. However, your doctor may recommend that you divide your mirtazapine 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 press the alveolus(Figure A).

Fig. A

1. Separate an alveolus

Each blister contains six alveoli, which are separated by perforations. Separate an alveolus following the perforated lines (Figure 1).

Fig. 1

1. Remove the film

Remove the film carefully, starting from the corner marked with an arrow (Figures 2 and 3).

Fig. 2

Fig. 3

1. Remove the buccal dispersible tablet

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

Fig. 4

It will disintegrate quickly and can be swallowed without water.

When to expect to feel better

Mirtazapine will usually start to work 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 mirtazapine:

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

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

If you take more Mirtazapina Aurovitas Spain than you should

If you or someone takes too much mirtazapine, consult a doctor immediately.

The most likely symptoms of a mirtazapine overdose (without other medications or alcohol) aredrowsiness, disorientation, and palpitations. 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 Torsades de Pointes.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to the nearest hospital. You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Mirtazapina Aurovitas Spain

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 treatment with Mirtazapina Aurovitas Spain

→Stop taking mirtazapinaonly if you consult your doctor.

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

Do not stop taking mirtazapine abruptly, even when depression has disappeared. If you stop taking mirtazapine abruptly, you may feel sick, dizzy, agitated, or anxious and have headaches.

These symptoms can be avoided by gradually stopping treatment. Your doctor will indicate how to gradually reduce the dose.

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

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

If you experience any of the following side effects, stop takingMirtazapina Aurovitas Spainand immediately inform your doctor.

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

• exaggerated feeling of euphoria (mania).

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

• 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 chills, sore throat, and mouth sores (agranulocytosis). In rare cases, mirtazapina may cause abnormalities 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 Aurovitas Spain 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 (convulsion).
• a combination of symptoms such as unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), chills, exaggerated reflexes, agitation, mood changes, and loss of consciousnessand 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 or toxic epidermal necrolysis).
• red patches on the trunk, often with blisters in the center, skin peeling, mouth sores, throat sores, genital sores, and eye sores. These severe skin reactions 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 with mirtazapina are:

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

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

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

• lethargy
• dizziness
• tremors or shaking
• 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.

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

• strange sensation in the skin, such as burning, pinching, tingling, or numbness (paresthesia)
• restless legs
• fainting (syncope)
• numbness of the mouth (hypoaesthesia oral)
• low blood pressure
• nightmares
• agitation
• hallucinations
• inability to remain still

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

• tics or muscle contractions (myoclonus)
• aggression

-abdominal pain and nausea; this may indicate pancreatitis(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 in the blood (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, dark or discolored urine (rhabdomyolysis)
• increased levels of prolactin hormone in the blood (hyperprolactinemia, including symptoms such as breast enlargement and/or nipple discharge)
• painful and prolonged erection of the penis.

Other side effects in children and adolescents

In children under 18 years, the following side effects were frequently observed in clinical trials: 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 the Spanish System for the Vigilance 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.

This medication does not require special storage conditions..

Medications should not be disposed of through drains or in the trash. Dispose of the packaging 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of MirtazapineAurovitas Spain

• The active ingredient is mirtazapine.

Mirtazapine Aurovitas Spain 15 mg buccal dispersible tablets contain 15 mg of mirtazapine per tablet.

• The other components are: crospovidone (type B), mannitol, microcrystalline cellulose, aspartame, anhydrous colloidal silica, magnesium stearate, strawberry guarana flavor [maltodextrin, propylene glycol, artificial flavors, acetic acid] and peppermint flavor [artificial flavors, cornstarch].

Appearance of the product and contents of the package

Buccal dispersible tablet.

Mirtazapine Aurovitas Spain 15 mg buccal dispersible tablets:

White, round, buccal dispersible tablets with a circular edge in relief, marked with "36" on one side and "A" on the other side.

Divided blister pack in individual doses: polyamide/Aluminum/PVC/Paper/Polyester.

Package sizes:

15mg:6 and 30 buccal dispersible tablets

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible manufacturer

APL Swift Services (Malta) Limited

HF26, Half Far Industrial Estate, Hal Far,

Birzebbuggia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

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

Republic of CzechiaMirtazapine Aurovitas

MaltaMirtazapine Aurobindo 15 mg orodispersible tablets

PolandMirtazapine Aurovitas

SpainMirtazapine Aurovitas Spain 15 mg buccal dispersible tablets EFG

PortugalMirtazapine Aurovitas

Last review date of this leaflet:September 2021

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