Label: Information for the Patient

Mirtazapina Viatris Pharmaceuticals 30 mg Film-Coated Tablets EFG

Read this label carefully before taking this medicine, as it contains important information for you.

-Keep this label. You may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should 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 label. See section 4.

6.Contents of the pack and additional information

Mirtazapina Viatris Pharmaceuticals belongs to a group of medicines called antidepressants.

Mirtazapina Viatris Pharmaceuticals is used to treat depression.

Do not take Mirtazapina Viatris Pharmaceuticals

• If you are allergic to mirtazapina or any of the other ingredients in this medication (listed in section 6).
• If you are taking or have taken recently (in the last two weeks) medications called monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Do not take mirtazapina or consult your doctor before taking it:

If you have ever developed a severe skin rash or peeling of the skin, or if you have formed blisters or ulcers in your mouth after taking mirtazapina or other medications. With the use of mirtazapina, severe skin reactions have been reported, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop taking the medication and seek medical advice immediately if you experience any of the symptoms described in section 4 related to these severe skin reactions. If you have ever developed a severe skin reaction, you should not restart treatment with mirtazapina.

Children and adolescents under 18 years

Mirtazapina should not be used normally in the treatment of children and adolescents under 18 years. Also, 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 class of medications. Although this is the case, your doctor may prescribe mirtazapina to patients under 18 years when they decide it is best 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, maturity, and development of mirtazapina in this age group are not yet known. Furthermore, a significant weight gain has been observed more frequently 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 suicide. This could worsen when you start taking antidepressants for the first time, as these medications take time to become effective, 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 with psychiatric disorders and taking an antidepressant.

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 your depression is getting worse, or if they are concerned about changes in your behavior.

Consult your doctor or pharmacist before taking 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:

• Seizures(epilepsy).
• Liver diseases, such as jaundice.
• Kidney diseases.
• Heart diseasesorcertain heart diseasesthat may change your heart rhythm, a recent heart attack, heart failure, or if you are taking certain medications that may affect your heart rhythm.
• Low blood pressure.
• Schizophrenia.
• Bipolar disorders(alternating periods of excitement/hyperactivity and periods of depression).
• Diabetes(you may need to adjust your insulin dose or other diabetes medications).
• Eye diseases, such as increased pressure in the eye (glaucoma).
• Difficulty urinating, which may be due to an enlarged prostate.

During treatment

• If you experience signs of infection such as high fever, sore throat, and mouth sores. In rare cases, these symptoms may be signs of alterations in blood cell production in the bone marrow. Although rare, these symptoms occur mainly at 4-6 weeks of treatment.
• If you are an elderly person, you may be more sensitive to the adverse effects of antidepressant medications.

Other medications and Mirtazapina Viatris Pharmaceuticals

Do not take Mirtazapina Viatris Pharmaceuticals with:

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 include moclobemide, tranylcypromine (both are antidepressants), and selegiline (for Parkinson's disease).

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications, especially any of the following:

• Antidepressants such as selective serotonin reuptake inhibitors (SSRIs)such as citalopram, venlafaxine, and L-tryptophan or triptanssuch as sumatriptan(used for migraines),tramadol(for pain),linezolid(an antibiotic),lithium(used to treat certain psychiatric disorders),methylene blue(used to treat certain types of blood poisoning)andSt. John's Wort(a medicinal plant for depression). In rare cases, mirtazapina alone or with these medications may cause a condition called 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, 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.
• Medications for anxiety or insomniasuch as benzodiazepinessuch as diazepamor clordiazepoxide.
• Medications for schizophreniasuch as olanzapine.
• Medications for allergiessuch as cetirizine.
• Medications for intense painsuch as morphine.

In combination with these medications, mirtazapina may increase the drowsiness caused by these medications.

• Medications for infections: medications for bacterial infections (such as erythromycin), medications for fungal infections (such as ketoconazole), and medications for HIV/AIDS (HIV protease inhibitorssuch as ritonavir, nelfinavir).
• Cimetidine, a medication for stomach ulcers.

In combination with mirtazapina, these medications may increase the levels of mirtazapina in the blood. Inform your doctor if you are taking any of these medications. You may need to reduce the dose of mirtazapina, or increase it again when you stop taking these medications.

• Carbamazepine and phenytoin,medications for epilepsy.
• Medications for tuberculosissuch 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.

• Warfarin, medications to prevent blood clotting.

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 monitor your blood.

• Medications that may affect heart rhythmsuch as some antibiotics and some antipsychotics.

Mirtazapina Viatris Pharmaceuticals withalcohol

You may feel drowsy if you drink alcohol while taking mirtazapina.

It is recommended not to drink any alcohol.

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 taking this medication.

Pregnancy

The limited experience of administering mirtazapina to pregnant women does not indicate an increased risk of congenital malformations. However, caution should be exercised if used during pregnancy. If you take mirtazapina until shortly before delivery, your baby should be monitored to detect any possible adverse effects.

Make sure your midwife and/or doctor know that you are taking mirtazapina. Similar medications (SSRIs), taken during pregnancy, may increase the risk of a serious condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear blue. These symptoms usually start within the first 24 hours after the baby is born. If this occurs, contact your midwife and/or doctor immediately.

Breastfeeding

Mirtazapina passes into breast milk in small amounts. There is a potential risk of an effect on the baby. Therefore, you should consult your doctor, who will decide whether to interrupt breastfeeding or interrupt mirtazapina treatment.

Driving and operating machinery

Mirtazapina may affect your concentration or alertness. Make sure your faculties are not impaired before driving or operating machinery.

Mirtazapina Viatris Pharmaceuticals contains lactose

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have doubts.

How much to take

Adults:

The initial recommended dose is 15 mg or 30 mg once a 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 recommended 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.

The groove is only for breaking the tablet if it is difficult to swallow it whole.

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 are still not feeling 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.

Use in children and adolescents under 18 years:

Mirtazapine should not be used in children and adolescents under 18 years, (see section 2, “Children and adolescents under 18 years”).

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 tablet without chewing, with water or juice.

If you take more Mirtazapina Viatris Pharmaceuticals than you should

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

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

The most likely symptoms of a mirtazapine overdose (without other medications or alcohol) are drowsiness, disorientation, changes in heart rhythm (rapid and irregular heartbeat) and/or fainting, which may be symptoms of a potentially fatal condition known as Torsades de pointes.

If you forgot to take Mirtazapina Viatris Pharmaceuticals

If you have to take your doseonce a day

• If you forget to take your mirtazapine dose, do not take the missed dose. Skip it and take the usual dose the next day.

Do not take a double dose to make up for the missed doses.

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 Viatris Pharmaceuticals

Stop taking mirtazapine after consulting your doctor.

If you stop taking 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 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 thismedication, ask your doctor or pharmacist.

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

In some cases, side effects are not caused by the medicine, but are symptoms of the disease.

If you experience any of the following side effects, stop taking mirtazapine and consult your doctor or go to the nearest hospital:

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

• Pancreatitis.This can cause moderate to severe stomach pain that radiates to the back..
• Yellowing of the skin or eyes,which may indicate liver function abnormalities (jaundice)..

Unknown frequency(cannot be estimated from available data)

• Severe allergic reactions such as rash, itching, or skin eruptions, facial swelling, lip, tongue, or other body part swelling, shortness of breath, wheezing, or difficulty breathing.
• Symptoms of infection such as sudden high fever, sore throat, and mouth sores (agranulocytosis). Mirtazapine can cause changes in blood cell production (bone marrow depression). Some people become less resistant to infections because mirtazapine can cause a temporary decrease in white blood cells (granulocytopenia). Mirtazapine can also cause a decrease in red and white blood cells in the blood that can cause pale skin, fatigue, shortness of breath, and dark-colored urine, and platelets in the blood (aplastic anemia), a decrease in platelets with easy bruising and bleeding (thrombocytopenia) or an increase in white blood cells in the blood (eosinophilia).
• Low sodium levels in the blood that can make you feel weak and confused with muscle pain. This may be due to an inappropriate secretion of DHA, a hormone that the body produces, causing water retention and blood dilution, reducing the amount of sodium.
• Thoughts of self-harm or suicide (see section 2 "Suicidal thoughts and worsening depression").
• Seizures (convulsions).
• A combination of symptoms such as unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. These may be symptoms of "serotonin syndrome".
• Symptoms of severe skin reaction or disease that may include rash, skin redness, fever, sore throat, and fatigue that may be followed by ulcers, skin peeling, and other lesions, usually around the mouth and lips (Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous dermatitis, or erythema multiforme).
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Muscle rupture, which causes muscle pain, sensitivity, stiffness, and/or weakness, and darkening or discoloration of urine (rhabdomyolysis).
• Difficulty urinating or emptying the bladder.

Other possible side effects:

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 eruptions (exanthema).
• Muscle or joint 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 that resolve when the medication is stopped.

Uncommon(may affect up to 1 in 100 patients)

• Exaggerated feeling of euphoria (mania).

Stop taking mirtazapine and consult your doctor immediately.

• Strange sensation in the skin, such as burning, pinching, tingling, or numbness (paresthesia).
• Involuntary movements of leg agitation during sleep.
• Fainting (syncope).
• Feeling of numbness in the mouth (hypoaesthesia oral).
• Low blood pressure.
• Nightmares.
• Agitation.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Inabilityto remain still.

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

• Tics or muscle contractions (myoclonus).
• Aggressive behavior.
• Increased liver enzymes, detected in a blood test.

Unknown frequency(cannot be estimated from available data)

• Abnormal sensations in the mouth (paresthesia oral).
• Swelling in the mouth (buccal edema).
• Low sodium levels in the blood, detected in a blood test.
• Increased levels of creatine kinase in the blood, detected in a blood test.
• Difficulty speaking.
• Increased salivation.
• Somnambulism.
• Increased levels of prolactin hormone in the blood (hyperprolactinemia, which includes symptoms such as enlarged breasts or milk secretion from the nipple).
• Prolonged and painful erection of the penis.

Other side effects in children and adolescents

In clinical trials with children under 18 years old, the following side effects were frequently observed: 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 Pharmacovigilance of Medicines for Human Use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Store in theoriginal packaging.

Do not dispose of medications through drains or trash. Dispose of containers and unused medications at the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment..

Composition of Mirtazapina Viatris Pharmaceuticals

The active ingredient is mirtazapina. Each tabletcontains 30 mg of mirtazapina.

The other components (excipients) are: anhydrous lactose (see section 2 “Mirtazapina Viatris Pharmaceuticals contains lactose”), cornstarch, anhydrous colloidal silica, low-substituted hydroxypropyl cellulose, and magnesium stearate. The coating includes: titanium dioxide (E-171), macrogol 4000, monohydrate lactose (see section 2 “Mirtazapina Viatris Pharmaceuticals contains lactose”), red iron oxide (E-172), yellow iron oxide (E-172), black iron oxide (E-172), and hypromellose.

Appearance of the product and contents of the package

Mirtazapina tablets are film-coated, circular, ocre-colored tablets, marked with the code ‘MR/30’ on one face and ‘G’ on the other.

Mirtazapina is available in blisters of 10, 14, 20, 28, 30, 50, 100, 250, and 500 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible Manufacturer

McDermott Laboratories t/aGerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

Or

Mylan B.V.

Krijgsman 20

1186 DM Amstelveen

Netherlands

Or

Mylan Hungary Kft

H-2900 Komárom

Mylan utca 1

Hungary

For more information about this medication, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

GermanyMirtazapin dura 30 mg Filmtabletten

BelgiumMirtazapine Mylan 30 mg filmomhulde tabletten

SpainMirtazapina Viatris Pharmaceuticals30 mg film-coated tablets

GreeceMIRTAZAPINE/MYLAN F.C. TAB 30 mg/TAB

NetherlandsMirtazapine Mylan 30 mg filmomhulde tabletten

IrelandZismirt 30 mg Film Coated Tablets

ItalyMirtazapina Mylan Generics 30 mg

PortugalMirtazapina Mylan 30 mg Comprimidos Revestidos

United KingdomMirtazapine 30 mg Tablets

Last review date of this leaflet:March 2023

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/