Leaflet: information for the user

Mirtazapina Aurovitas 15 mg film-coated tablets EFG

mirtazapina

Read this leaflet carefully before you start to take 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, and you must 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.

Mirtazapina belongs to a group of medicines calledantidepressants.

Mirtazapina is used to treat depression in adults.

It takes 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 Aurovitas

• 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 Aurovitas.
• if you are taking or have taken recently (in the last two weeks) medications called monoamine oxidase inhibitors (MAOs).
• if you have ever had a severe skin rash or skin peeling, blisters or mouth sores after taking mirtazapina or other medications.

Be especially careful with mirtazapina:

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.

Warnings and precautions

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

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").

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 type of medication. However, your doctor may prescribe mirtazapina to patients under 18 years of age when they decide it is the best option 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 on safety related to growth, maturation, and development of mirtazapina in this age group are not yet known. It has also been observed that there is a significant increase in weight 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. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders and taking an antidepressant.

→ 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 are more frequent,stop takingmirtazapina and contact your doctor immediately;
• liver diseases, including jaundice. If jaundice appears, stop taking

mirtazapina and contact your doctor immediately;

• kidney diseases;
• heart diseaseorlow blood pressure;
• schizophrenia. If psychotic symptoms, such as paranoid thoughts, are more frequent or severe, contact your doctor immediately;
• bipolar depression(alternating periods of euphoria/hyperactivity and periods of depression). If you start to feel euphoric 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);
• urinary difficulties, 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 attack your heart rhythm.

• if you experience 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 4-6 weeks after treatment.

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

Other medications and Mirtazapina Aurovitas

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

Do not take Mirtazapina Aurovitaswith:

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

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

Be careful ifyou take Mirtazapina Aurovitas with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, and L-tryptophan or triptans(used for migraines),tramadol(for pain),medications containing buprenorphine(used in opioid dependence treatment programs),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 Wortpreparations (Hypericum perforatum, a medicinal plant for depression). In rare cases, mirtazapina alone or with these medications may cause serotonin syndrome. Some 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:antibiotics for bacterial infections (such as erythromycin), antifungals (such as ketoconazole), and HIV/AIDS medications (protease inhibitors) andulcer 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 Aurovitas 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, you should be careful if you use it during pregnancy.

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

If you are taking mirtazapina and become pregnant or want to become pregnant, make sure your midwife and/or doctor know that you are taking mirtazapina and consult your doctor if you can continue taking mirtazapina. If you use mirtazapina until, or shortly before delivery, your child will be examined to detect possible adverse effects.

Make sure your midwife or doctor knows that you are taking mirtazapina. Taken during pregnancy, similar medications (SSRIs) may increase the risk of a serious disease called persistent pulmonary hypertension in the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start within the first 24 hours after birth. If this happens to your child, you should consult your midwife and/or doctor immediately.

Consult your doctor if you can breastfeed while taking mirtazapina.

Driving and using machines

Mirtazapina 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 of age, make sure concentration and alertness are not affected before driving (for example, on a bicycle).

Mirtazapina Aurovitas contains lactose monohydrate

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

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 recommended initial 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 older person or if you have a kidney or liver disease, your doctor may change the dose.

When to take Mirtazapina Aurovitas

→ 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 the morning and evening before going to bed. The highest dose should be taken before going to bed.

The tablets are taken orally. Take the prescribed mirtazapina dose without chewing, with water or juice.

When to expect to feel better

Normally, mirtazapina 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, 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 until the depression symptoms have disappeared for 4-6 months.

If you take moreMirtazapina Aurovitasthan you should

→ If you or someone takes too muchmirtazapina, consult a doctor immediately.

The most likely symptoms of a mirtazapina overdose (without other medications or alcohol) are drowsiness, 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 Torsade de pointes.

You can also consult the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Mirtazapina Aurovitas

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 as usual.

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 Aurovitas

→ Stop takingmirtazapinaonly 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 takingmirtazapinaabruptly, even when depression has disappeared. If you stop takingmirtazapinaabruptly, 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 mirtazapine and inform 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 inexplicable fever, sore throat, and mouth sores (agranulocytosis). In rare cases, mirtazapine may cause alterations in blood cell production (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 (convulsion),
• 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 saliva production. 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 detachment, 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, 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 people)

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

Common(may affect up to 1 in 10 people)

• lethargy,
• dizziness,
• agitation or 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.

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

• strange sensation in the skin, such as burning, pinching, tingling, or numbness (paresthesia),
• involuntary movements of leg agitation during sleep,
• fainting (syncope),
• sensation of numbness in 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, 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),
• generalized swelling,
• localized swelling,
• hyponatremia,
• inadequate secretion of antidiuretic hormone,
• severe skin reactions (dermatitis bullosa, erythema multiforme),
• sleepwalking (somnambulism),
• speech problems,
• increased levels of creatine kinase,
• urination problems (urinary retention),
• muscle pain, stiffness, and/or weakness, dark or discolored urine (rhabdomyolysis),
• increased levels of prolactin hormone in the blood (hyperprolactinemia, which includes symptoms of breast enlargement and/orbreast milk secretion).
• prolonged and painful 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: 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 to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:http://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.

This medication does not require special storage conditions.

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

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. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Mirtazapina Aurovitas Composition

• The active ingredient is mirtazapina.

Each tablet contains 15 mg of mirtazapina.

• The other components are:

Core:Lactose monohydrate, cornstarch, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, magnesium stearate (E470b), anhydrous colloidal silica.

Coating:Hydroxypropylcellulose, hypromellose (E464), titanium dioxide (E171), and yellow iron oxide (E172).

Product appearance and packaging contents

Coated tablet.

Coated tablets, capsule-shaped, biconvex, yellow in color, engraved on one side with the numbers “1” and “5” on either side of the groove and with “MI” on the other side.

The tablet can be divided into two equal halves.

Mirtazapina Aurovitas 15 mg tablets are available in PVC/PVDC/Aluminum blister packs and PEAD bottles.

Packaging sizes:

Blister pack:10, 14, 20, 28, 30, 50, 56, 60, and 100 coated tablets.

PEAD bottles: 30, 50, 56, 60, 100, 250, and 500 coated tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the Member States of the European Economic Area with the following names:

SpainMirtazapina Aurovitas15 mgcoated tablets EFG

FranceMirtazapine Arrow Génériques15 mg coated tablet

NetherlandsMirtazapine Aurobindo15 mg,film-coated tablets

PortugalMirtazapina Aurobindo

Last review date of thisleaflet: July 2023

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