Leaflet: information for the user

Mirtazapina Aristo 15 mg film-coated tablets

Read this leaflet carefully before you start taking this medicine, as 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 pass it on to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3.How to take Mirtazapina Aristo

4.Possible side effects

5Storage of Mirtazapina Aristo

6.Contents of the pack and additional information

Mirtazapina Aristo 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 Mirtazapina Aristo

• if you are allergic to mirtazapina or any of the other ingredients of this medication (listed in section 6). In that case, consult your doctor as soon as possible before taking Mirtazapina Aristo.
• if you are taking or have taken in the last two weeks monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Mirtazapina Aristo:

• if you are taking buprenorphine. The use of this medication with mirtazapina may cause serotonin syndrome, a potentially fatal disease (see "Other medications and Mirtazapina Aristo").

Inform your doctor before taking Mirtazapina Aristo:

If you have ever had a severe skin rash or skin peeling, blisters or sores in the mouth after taking mirtazapina.

Children and adolescents

Mirtazapina Aristo 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. However, the doctor may prescribe mirtazapina to patients 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 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. It has also been observed that there is a significant 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 usually take two weeks or more to have a normal effect.

You may be more prone to thinking this way if:

• if you have previously had suicidal thoughts or self-harm.to yourself.
• 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 who are being treated with 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 themto 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 MirtazapinaAristo,if you have not already done so

• seizures(epilepsy). If 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 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 feeling 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 could 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 have signs of infection such as high fever, sore throat, and mouth sores

→ Stop taking Mirtazapina Aristo 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 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 Aristo

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

Do not take Mirtazapina Aristowith:

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

Be careful ifyou take Mirtazapina Aristo with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, and L-tryptophan or triptans(used to treat migraines),tramadolorbuprenorphine(for pain),linezolid(an antibiotic),lithium(used to treat some 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: involuntary rhythmic muscle contractions, including the muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor if you experience these symptoms: unexplained fever, sweating, palpitations, diarrhea, involuntary muscle contractions (uncontrollable), chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. If you present 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 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:infection medications (such as erythromycin), fungal infection medications (such as ketoconazole), and HIV/AIDS medications (HIV protease inhibitors).
  If taken together 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 ofmirtazapina, or increase it again when stopping these medications.

• epilepsy medicationssuch as carbamazepine and phenytoin;
• tuberculosis medicationssuch as rifampicin.

If taken together withmirtazapina, 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 ofmirtazapina, or reduce it again when stopping these medications.

• blood thinnerssuch as warfarin.
  Mirtazapinamay 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 Aristo 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, 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 until, or shortly before delivery, your baby will be examined to detect any possible adverse effects.

Antidepressants similar to mirtazapina (SSRIs) taken during pregnancy may increase the risk of a serious disease called persistent pulmonary hypertension in the newborn (PPHN) in the baby, which makes the baby breathe faster and acquire a bluish tone. 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.

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

Important information about some of the components of Mirtazapina Aristo

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

This medication may cause allergic reactions because it contains yellow-orange S (E-110) dye.

It may cause asthma, especially in patients allergic to aspirin.

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 or 30mg per day.Your doctor may recommend increasing the dose after a few days to the amount that is best for you (between 15 and 45mg 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 it

→ Take mirtazapine 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.

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

When to expect to feel better

Normally, mirtazapine 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 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 Aristo 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) 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 Torsades de pointes.

You can also consult the Toxicological Information Service. Phone 91 562 04 20.

If you forgot to take Mirtazapina Aristo

→ If you have to take yourdoseonce 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 Aristo

→ Stop taking mirtazapine 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 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 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.

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(cannot be estimated from available data):

• signs of infection such as unexplained and sudden high fever, sore throat, and mouth sores (agranulocytosis). In rare cases, mirtazapine may cause changes 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 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:
• red patches on the trunk, often with blisters in the center, skin peeling, mouth sores, throat sores, nasal 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 swollen 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, such as burning, pinching, tingling, or numbness (paresthesia)
• involuntary leg movements during sleep
• fainting (syncope)
• 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, dark or discolored urine (rhabdomyolysis)
• increased levels of prolactin hormone in the blood (hyperprolactinemia, which includes symptoms of breast enlargement and/or nipple discharge)
• painful and prolonged erection of the penis

Other side effects in children and adolescents

In patients under 18 years, the following side effects were frequently observed in clinical trials: a significant increase in weight, 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 Pharmacovigilance of Medicinal Products 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.

Store in the original packaging to protect it from light and moisture

No special storage conditions are required.

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 Pointof the pharmacy. In case of doubtask 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 Mirtazapina Aristo

• The active ingredient is mirtazapine.

MirtazapinaAristo15 mg film-coated tablets contain 15mg of mirtazapine per tablet.

• The other components are:

Tablet core:Maize starch, colloidal silicon dioxide, magnesium stearate, hydroxypropylcellulose, lactose monohydrate.

Tablet coating: Yellow-orange S (E-110), titanium dioxide (E-171), hydroxypropylmethylcellulose, yellow iron oxide (E-172), polyethylene glycol 8000 and yellow-orange quinoline (E-104).

Appearance of the product and content of the packaging

Mirtazapina Aristo are film-coated tablets.

The tablets are yellow, round, biconvex, and scored on one face.

The tablet can be divided into two equal halves.

Mirtazapina Aristo 15 mgfilm-coated tabletsare packaged in blisters.

The following packaging sizes are available: 30 and 60 tablets.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid - Spain

Responsible manufacturer:

Laboratorios Medicamentos Internacionales (Medinsa)

C/ Solana nº 26

28850 - Torrejón de Ardoz, Madrid

Date of the last review of this leaflet:July 2023

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