Package Leaflet: Information for the User

Mirtazapina Tarbis 45 mg Film-Coated Tablets

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package 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 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 package leaflet. See section 4.

This medicationcontains the active ingredient mirtazapina.

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 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 Mirtazapina Tarbis

Warnings and precautions

Consult your doctor or pharmacist before starting to take mirtazapina.

Inform your doctor before taking Mirtazapina Tarbis:

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

Severe skin reactions, such as Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of mirtazapina. Stop using it 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.

Suicidal thoughts and worsening of depression

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

You may be more prone to thinking this way if:

→ If you have thoughts of harming yourself or 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 yourdepression is getting worse, or if they are concerned about changes in your behavior.

Also, be especially careful with Mirtazapina Tarbis

• Inform your doctor about these situations before taking mirtazapina, if you have not already done so

• convulsions (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 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 of excitement/hyperactivity alternate with periods of depression). If you start to feel excited or overexcited, stop taking mirtazapina and contact your doctor immediately;
• diabetes (you may need to adjust your insulin dose or other diabetes medications);
• eye diseases, such as increased eye pressure (glaucoma);
• difficulty urinating, which may be due to an enlarged prostate;
• certain types of heart disease that can change your heart rhythm, a recent heart attack, heart failure, or taking certain medications that can affect 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 have a blood test. In rare cases, these symptoms can be signs of bone marrow problems. Although rare, these symptoms appear 4-6 weeks after treatment.
• • if you are an older person. You may be more sensitive to the side effects of antidepressant medications.

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. However, you should know that in patients under 18 years, 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. Nevertheless, your doctor may prescribe mirtazapina to patients under 18 years when they decide it is the best option for the patient. If your 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 described above in patients under 18 years taking mirtazapina appear or worsen. Additionally, 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 increase in weight in this age group when treated with mirtazapina, compared to adults.

Other medications and Mirtazapina Tarbis

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

Do not take Mirtazapina Tarbis with:

Be careful if you take Mirtazapina Tarbis with:

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.

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.

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

Taking mirtazapina 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 cautious 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. Taken during pregnancy, similar medications (SSRIs) may increase the risk of a severe disease called persistent pulmonary hypertension of the newborn (PPHN) in babies, which makes them breathe faster and turn 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.

Driving and operating machinery

Mirtazapina may affect your concentration oralertness. Make sure your faculties are not affected before driving or operating 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 Tarbis contains lactose

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

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

Form of administration

Mirtazapine is for oral use.

Take your tablets without chewing, with a little water or juice.

You can take mirtazapine with or without food.

When to expect to feel better

Normally, mirtazapine 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 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 mirtazapine 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 fainting, 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

If you have to take your dose once a day

If you have to take your dosetwice a day

If you interrupt the treatment with mirtazapina

→ Stop taking mirtazapine only if you consult your doctor.

If you stop it 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 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.

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

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

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 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, 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):

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(cannot be estimated from available data):

Other side effects

In children and adolescents, 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, pharmacist, or nurse, 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 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 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 ofthrough drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need.This will help protect the environment.

Composition of Mirtazapina Tarbis

The active ingredient is mirtazapine.

Eachfilm-coated tabletcontains 45 mg of mirtazapine.

The other components are:

Tablet core:

Lactose monohydrate, cornstarch,hypromellose, anhydrous colloidal silica, magnesium stearate.

Film coating of the tablet: Hypromellose (E464), macrogol 8000, titanium dioxide(E171).

Appearance of the product and content of the container

Mirtazapina Tarbis 45 mg film-coated tablets EFG

Film-coated tablets, biconvex, white in color, oval in shape, with the inscription “MH” engraved on one face and “45” on the other.

Blister pack containing 20, 30, 50, 60, 100, and 500 film-coated tablets.

HDPE bottle containing 250 film-coated tablets.

Only some container sizes may be commercially marketed.

Marketing authorization holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

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

Germany: Mirtazapin Amarox 45 mg Filmtabletten

Italy: Mirtazapina Amarox 45 mg compresse rivestite con film

Netherlands: Mirtazapine Amarox 45 mg filmomhulde tabletten

Spain: Mirtazapina Tarbis 45 mg film-coated tablets EFG

Last review date of this leaflet: November 2023

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