MIRTAZAPINE MABO 45 mg FILM-COATED TABLETS

Introduction

Package Leaflet:information for the patient

Mirtazapine MABO 45 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication,as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Mirtazapine MABO and what is it used for
2. What you need to know before taking Mirtazapine MABO
3. How to take Mirtazapine MABO
4. Possible side effects
5. Storage of Mirtazapine MABO
6. Contents of the pack and further information

1. What is Mirtazapine MABO and what is it used for

Mirtazapine MABO contains the active substance mirtazapine and belongs to the group of medicines called antidepressants.

Mirtazapine is used to treat depression in adults.

It may take 1 to 2 weeks before mirtazapine starts to work. 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 can you expect to feel better".

2. What you need to know before taking Mirtazapine MABO

Do not take Mirtazapine MABO

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take mirtazapine.

Tell your doctor before taking Mirtazapine MABO:

If you have ever suffered from a severe skin rash or skin peeling, blisters, or sores in the mouth after taking mirtazapine.

Children and adolescents

Mirtazapine should not normally be used 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 be aware that in patients under 18 years of age, there is a greater risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this type of medication. Nevertheless, the doctor may prescribe this medication to patients under 18 years of age when they decide it is most convenient for the patient. If the doctor has prescribed mirtazapine to a patient under 18 years of age and you want to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen in patients under 18 years of age who are taking this medication. Additionally, the long-term safety effects related to growth, maturity, and development of knowledge and behavior of mirtazapine in this age group are still unknown. It has also been observed that this age group experiences a significant increase in weight when treated with this medication, 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 sometimes more to work.

You may be more likely to think this way if:

• If you have previously had suicidal thoughts or thoughts of harming yourself.
• If you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders 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 a hospital immediately.

It may be helpful to tell a relative or close friendthat you are depressed and ask them to read this package 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.

Also, be especially careful with mirtazapine

• If you have or have ever had any of the following conditions:

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

• seizures(epilepsy). If seizures occur or your seizures become more frequent, stop taking mirtazapine and contact your doctor immediately;
• liver disease, including jaundice. If jaundice occurs, stop taking mirtazapine and contact your doctor immediately;
• kidney disease;
• heart disease or low blood pressure;
• schizophrenia. If psychotic symptoms, such as paranoid thoughts, become more frequent or severe, contact your doctor immediately;
• bipolar depression(alternating periods of excitement/hyperactivity and periods of depression). If you start to feel excited or overexcited, stop taking mirtazapine and contact your doctor immediately;
• diabetes(you may need to adjust your insulin or other antidiabetic medication dose);
• eye diseases, such as increased pressure in the eye (glaucoma);
• difficulty urinating, which may be due to an enlarged prostate;
• certain 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 signs of infection appear, such as unexplained high fever, sore throat, and mouth sores.

→ Stop taking mirtazapine and contact your doctor immediately to have a blood test.

In rare cases, these symptoms can be signs of changes in blood cell production in the bone marrow. Although rare, these symptoms usually appear 4-6 weeks after treatment.

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

• Severe skin reactions have been reported with the use of mirtazapine, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). 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 suffered from severe skin reactions, do not restart treatment with mirtazapine.

Other medications and Mirtazapine MABO

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

Do not takemirtazapine with:

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

Examples of MAOIs are moclobemide, tranilcipromine (both are antidepressants), and selegiline (for Parkinson's disease).

Be careful ifyou take mirtazapine with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, and L-tryptophan or triptans(used to treat 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(a medicinal plant for depression). In rare cases, mirtazapine 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 (involuntary), 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 mirtazapine in your blood. Inform your doctor if you are taking this medication. Your doctor may need to decrease the dose of mirtazapine or increase it again when you stop taking nefazodone.
• medications for anxiety or insomniasuch as benzodiazepines.
• medications for schizophreniasuch as olanzapine.
• medications for allergiessuch as cetirizine.
• medications for severe painsuch as morphine.

When combined with these medications, mirtazapine 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 inhibitors) and medications for stomach ulcers (such as cimetidine). If taken with mirtazapine, these medications may increase the amount of mirtazapine in your blood. Inform your doctor if you are taking these medications. Your doctor may need to decrease the dose of mirtazapine or increase it again when you stop taking these medications.

• medications for epilepsysuch as carbamazepine and phenytoin.
• medications for tuberculosissuch as rifampicin.

If taken with mirtazapine, these medications may decrease the amount of mirtazapine in your blood. Inform your doctor if you are taking these medications. Your doctor may need to increase the dose of mirtazapine or decrease it again when you stop taking these medications.

• medications to prevent blood clottingsuch as warfarin.

Mirtazapine may increase the effects of warfarin on your 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 can affect your heart rhythm, such as certain antibiotics and some antipsychotics.

Taking Mirtazapine MABO with food and alcohol

You may feel drowsy if you drink alcohol while being treated with mirtazapine.

It is recommended not to drink any alcohol.

You can take mirtazapine with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Limited experience with the administration of mirtazapine to pregnant women does not indicate an increased risk. However, caution should be exercised when using it during pregnancy.

If you use mirtazapine until or shortly before delivery, your child will be examined for possible adverse effects.

Taken during pregnancy, similar medications (SSRIs) may increase the risk of a serious disease called persistent pulmonary hypertension in newborns (PPHN) in babies, 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 child, you should consult your midwife and/or doctor immediately.

Driving and using machines

Mirtazapine may affect your concentration or alertness. Make sure your abilities are not affected before driving or using machinery. If your doctor has prescribed mirtazapine to a patient under 18 years of age, make sure that concentration and alertness are not affected before circulating (e.g., by bicycle).

Mirtazapine MABO contains lactose

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

3. How to take Mirtazapine MABO

Follow the administration instructions of this medication exactly 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 your dose after a few days to the amount that is best for you (between 15 and 45 mg per day). The dose is usually the same for all ages. However, if you are an elderly person or have kidney or liver disease, your doctor may change the dose.

When to take Mirtazapine MABO

Take mirtazapine at the same time every day.

It is best to take the dose of mirtazapine once before bedtime. However, your doctor may recommend that you divide your dose of mirtazapine into morning and bedtime. The highest dose should be taken before bedtime.

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

When can you expect to feel better

Normally, mirtazapine will start to work after 1 or 2 weeks, and after 2 to 4 weeks, you may start to feel better.

It is essential that during the first few 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 MABO than you should

→ If you or someone else 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.The symptoms of a possible overdose may include changes in your heart rhythm (fast, irregular heartbeat) and/or fainting, 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 call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Mirtazapine MABO

If you need to take your dose once a day

• Do not take a double dose to make up for forgotten doses. Take the next dose at the usual time.

If you need to take your dose twice a day

• If you have forgotten the morning dose, simply take it with the evening dose.
• If you have forgotten 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 have forgotten both doses, do not try to make them up. Skip both doses and the next day continue with your usual dose in the morning and evening.

If you stop taking Mirtazapine MABO

→ Only stop taking mirtazapine if you consult your doctor.

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

Do not stop taking mirtazapine abruptly, even if depression has disappeared. If you stop taking mirtazapine abruptly, you may feel unwell, dizzy, agitated, or anxious and have headaches. These symptoms can be avoided by gradually stopping treatment. Your doctor will tell you how to gradually decrease the dose.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you experience any of the following serious adverse effects, stop taking mirtazapine and inform your doctor immediately.

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

• Feeling of exaggerated euphoria (mania).

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

• Yellowing of the eyes or skin; may suggest liver function alterations (jaundice).

Frequency Not Known(cannot be estimated from available data):

• Signs of infection such as unexplained high and sudden fever, sore throat, and mouth ulcers (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 the number of white blood cells in the blood (eosinophilia).
• Seizure (convulsions).
• 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 disorder called "serotonin syndrome".
• Thoughts of self-harm or suicide.
• Severe skin reactions:

• Red patches on the torso, such as circumscribed or circular macules, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. 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 Adverse Effects with Mirtazapine Are:

Very Common(may affect more than 1 in 10 patients):

• Increased appetite and weight gain.
• Somnolence.
• Headache.
• Dry mouth.

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

• Lethargy.
• Dizziness.
• Tremor.
• Nausea.
• Diarrhea.
• Vomiting.
• Constipation.
• Urticaria or skin eruptions (exanthema).
• Joint pain (arthralgia) or muscle pain (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 patients):

• Strange sensation in the skin, such as burning, pinching, tingling, or numbness (paresthesia).
• Involuntary leg movements during sleep.
• Fainting (syncope).
• Oral numbness (oral hypoesthesia).
• Low tension.
• Nightmares.
• Agitation.
• Hallucinations.
• Inability to remain still.

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

• Tics or muscle contractions (myoclonus).
• Aggression.
• Abdominal pain, nausea; this may indicate pancreas inflammation (pancreatitis).

Frequency Not Known(cannot be estimated from available data):

• Abnormal sensations in the mouth (oral paresthesia).
• Mouth swelling (oral edema).
• Generalized swelling (generalized edema).
• Localized swelling.
• Hyponatremia.
• Inadequate secretion of antidiuretic hormone.
• Severe skin reactions (bullous dermatitis, erythema multiforme).
• Sleepwalking (somnambulism).
• Speech problems.
• Increased creatine kinase levels in the blood.
• Difficulty urinating (urinary retention).
• Muscle pain, stiffness, and/or weakness, darkening or discoloration of urine (rhabdomyolysis).
• Increased levels of prolactin hormone in the blood (hyperprolactinemia, including symptoms of breast enlargement and/or milky discharge from the nipple).
• Painful and prolonged erection of the penis.

Other Adverse Effects in Children and Adolescents

In individuals under 18 years of age, the following adverse effects were frequently observed in clinical trials: significant weight gain, urticaria, and increased triglycerides in the blood.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Mirtazapine MABO

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date that appears on the box and on the blister pack after "CAD". The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Mirtazapine MABO

The active ingredient is mirtazapine.

Mirtazapine MABO 45 mg film-coated tablets contain 45 mg of mirtazapine per film-coated tablet.

The other components (excipients) are:

• Core of the tablet: lactose monohydrate, corn starch, anhydrous colloidal silica, hydroxypropylcellulose, and magnesium stearate.
• Coating material: hypromellose, macrogol, and titanium dioxide (E171).

Appearance of the Product and Package Contents

White, oval, biconvex film-coated tablets, marked with "M7" on one side. Dimensions 14.10 x 7.60 mm.

The following package sizes are available for the 45 mg film-coated tablets: 30 tablets in white opaque PVDC-Aluminum blister packs.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

MABO-FARMA S.A.

Vía de los Poblados 3,

Edificio 6, 28033, Madrid,

Spain.

Manufacturer:

EMONA BIOPHARMA RAZVOJ PROIZVODNJA IN PRODAJA D.O.O.

Dunajska cesta 156

1000 Ljubljana,

Slovenia

Date of the Last Revision of this Leaflet: January 2025

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