Mirtazapine Mabo 45 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Mirtazapine MABO 45 mg film-coated tablets EFG

Read the entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

Mirtazapine is used to treat depression in adults.

It takes 1 to 2 weeks before mirtazapine starts to take effect. After 2 to 4 weeks, you may begin to feel better. You should consult your doctor if you worsen 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 medicine (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 (within the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Talk to your doctor or pharmacist before starting mirtazapine.

Tell your doctor before taking Mirtazapine MABO:

If you have ever experienced a severe skin rash or peeling of the skin, blisters, or mouth sores after taking mirtazapine.

Children and adolescents

Mirtazapine should not normally be used to treat children and adolescents under 18 years of age because its efficacy has not been demonstrated. Also, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe this medicine to patients under 18 years of age if they decide it is best for the patient. If your doctor has prescribed mirtazapine to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen in patients under 18 years of age who are taking this medicine. In addition, the long-term effects on safety related to growth, maturation, and cognitive and behavioral development of mirtazapine in this age group are still unknown. A considerable weight gain has also been observed more frequently in this age group when treated with this medicine, compared to adults.

Suicidal thoughts and worsening of depression

If you are depressed, you may sometimes have thoughts of harming yourself or of suicide. This may worsen when you first start taking antidepressants, as these medicines usually take two weeks or sometimes longer to become effective.

You may be more likely to have such thoughts if:

• You have previously had suicidal thoughts or thoughts of self-harm.
• You are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in psychiatric patients under 25 years of age treated with an antidepressant.

→ If at any time you have thoughts of harming yourself or of suicide, contact your doctor or go to a hospital immediately.

It may be helpful to tell a close relative or friend that you are depressed and ask them to read this leaflet. You may ask them to inform you if they think your depression is worsening 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 conditions 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 elevated mood/hyperactivity and periods of depression). If you start feeling elated or overexcited, stop taking mirtazapine and contact your doctor immediately;

• Diabetes (you may need to adjust your insulin dose or other antidiabetic medicines);

• Eye disorders, such as increased pressure in the eye (glaucoma);

• Difficulty urinating, which may be due to an enlarged prostate;

• Certain types of heart disease that may alter your heart rhythm, a recent heart attack, heart failure, or if you are taking certain medicines that may affect 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 for a blood test.

Rarely, these symptoms may indicate disturbances in blood cell production in the bone marrow. Although rare, these symptoms typically appear 4–6 weeks after starting treatment.

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

• Serious 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 immediate medical attention if you notice any of the symptoms described in section 4 related to these serious skin reactions.

If you have previously experienced serious skin reactions, treatment with mirtazapine should not be restarted.

Other medicines and Mirtazapine MABO

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

Do not take mirtazapine together with:

• Monoamine oxidase inhibitors (MAOIs). Also, do not take mirtazapine within two weeks after stopping MAOIs. If you stop taking mirtazapine, do not take MAOIs for the following two weeks.

Examples of MAOIs include moclobemide, tranylcypromine (both are antidepressants), and selegiline (used for Parkinson’s disease).

Be careful if you take mirtazapine together with:

• Antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, and L-tryptophan or triptans (used to treat migraine), 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 herbal remedy for depression). In very rare cases, mirtazapine alone or in combination with these medicines may lead to a condition called serotonin syndrome. Some symptoms of this syndrome include: unexplained fever, sweating, rapid heartbeat, diarrhea, uncontrollable muscle contractions, chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. If you experience a combination of these symptoms, contact your doctor immediately.
• The antidepressant nefazodone. This may increase the amount of mirtazapine in your blood. Inform your doctor if you are taking this medicine. It may be necessary to reduce the dose of mirtazapine, or increase it again when stopping nefazodone.
• Medicines for anxiety or insomnia such as benzodiazepines.
• Medicines for schizophrenia such as olanzapine.
• Medicines for allergies such as cetirizine.
• Medicines for severe pain such as morphine.

When used in combination with these medicines, mirtazapine may increase the drowsiness caused by them.

• Medicines for infections: medicines for bacterial infections (such as erythromycin), medicines for fungal infections (such as ketoconazole), medicines for HIV/AIDS (HIV protease inhibitors), and medicines for stomach ulcers (such as cimetidine). When taken together with mirtazapine, these medicines may increase the amount of mirtazapine in the blood. Inform your doctor if you are taking these medicines. It may be necessary to reduce the dose of mirtazapine, or increase it again when stopping these medicines.

• Medicines for epilepsy such as carbamazepine and phenytoin.

• Medicines for tuberculosis such as rifampicin.

When taken together with mirtazapine, these medicines may reduce the amount of mirtazapine in the blood. Inform your doctor if you are taking these medicines. It may be necessary to increase the dose of mirtazapine, or reduce it again when stopping these medicines.

• Medicines to prevent blood clotting such as warfarin.

Mirtazapine may enhance the effects of warfarin in the blood. Inform your doctor if you are taking this medicine. If taken together, your doctor may recommend regular blood monitoring.

• Medicines that may affect 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 may 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 medicine.

Limited experience with mirtazapine use in pregnant women does not indicate an increased risk. However, caution should be exercised if used during pregnancy.

If you take mirtazapine up to or shortly before delivery, your baby will be monitored for possible adverse effects.

Antidepressants similar to mirtazapine (SSRIs) taken during pregnancy may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

Driving and using machines

Mirtazapine may affect your concentration or level of alertness. Make sure your abilities are not impaired before driving or operating machinery. If your doctor has prescribed mirtazapine to a patient under 18 years of age, ensure that concentration and alertness are not impaired before engaging in activities such as cycling.

Mirtazapine MABO contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Mirtazapine MABO

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much to take

The recommended starting dose is 15 or 30 mg once daily. Your doctor may recommend increasing your dose after a few days to the amount that is best for you (between 15 and 45 mg daily). Usually, the dose is the same for all age groups. However, if you are elderly or have kidney or liver disease, your doctor may adjust the dose.

When to take Mirtazapine MABO

Take mirtazapine at the same time each day.

It is best to take the dose of mirtazapine as a single dose before going to bed. However, your doctor may recommend splitting your dose, taking part in the morning and part in the evening before bedtime. The higher dose should be taken at bedtime.

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

When you can expect to feel better

Mirtazapine usually starts to take effect after 1 or 2 weeks, and after 2 to 4 weeks you may begin to feel better.

It is important that during the first weeks of treatment you discuss the effects of mirtazapine with your doctor:

→ 2 to 4 weeks after starting mirtazapine, talk to your doctor about how this medicine has affected you.

If you still do not feel better, your doctor may prescribe a higher dose. In that case, speak to your doctor again after another 2–4 weeks.

You will usually need to continue taking mirtazapine until depressive symptoms have been absent 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 an overdose of mirtazapine (without other medicines or alcohol) are drowsiness, confusion, and palpitations. Symptoms of a possible overdose may include changes in your heart rhythm (fast, irregular heartbeat) and/or fainting, which could be signs of a potentially life-threatening condition known as Torsades de Pointes.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Mirtazapine MABO

If you are supposed to take your dose once daily

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

If you are supposed to take your dose twice daily

• If you forget the morning dose, simply take it together with the evening dose.
• If you forget the evening dose, do not take it the next morning; skip it and continue with your normal morning and evening doses.
• If you forget both doses, do not try to make them up. Skip both doses and the next day continue with your normal morning and evening doses.

If you stop taking Mirtazapine MABO

→ Only stop taking mirtazapine after consulting your doctor.

Stopping too early may cause depression to return. 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 resolved. If you stop mirtazapine suddenly, you may feel unwell, dizzy, agitated, or anxious, and may experience headaches. These symptoms can be avoided by stopping treatment gradually. Your doctor will advise you on how to reduce the dose step by step.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 indicate liver problems (jaundice).

Frequency not known (cannot be estimated from available data):

• Signs of infection such as sudden unexplained fever, sore throat, and mouth ulcers (agranulocytosis). In rare cases, mirtazapine may cause disturbances 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 very rare cases, mirtazapine may also cause a decrease in red and white blood cells and platelets (aplastic anaemia), a decrease in platelets (thrombocytopenia), or an increase in the number of white blood cells in the blood (eosinophilia).

• Epileptic seizure (convulsions).

• Combination of symptoms such as unexplained fever, sweating, palpitations, diarrhoea, uncontrollable muscle twitching, chills, exaggerated reflexes, restlessness, mood changes, loss of consciousness, and increased salivation. In very rare cases, these symptoms may be signs of a disorder called "serotonin syndrome".

• Thoughts of harming yourself or of suicide.

• Serious skin reactions:

• red patches on the trunk, such as circumscribed or circular spots, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes 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.
• Drowsiness.
• Headache.
• Dry mouth.

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

• Lethargy.
• Dizziness.
• Tremor.
• Nausea.
• Diarrhoea.
• Vomiting.
• Constipation.
• Hives or skin rashes (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.
• Sleep difficulties.
• Memory problems, which in most cases resolved when treatment was discontinued.

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

• Abnormal skin sensations such as burning, pricking, tingling, or numbness (paraesthesia).
• Involuntary restless leg movements during sleep.
• Fainting (syncope).
• Numbness sensation in the mouth (oral hypoesthesia).
• Low blood pressure.
• Nightmares.
• Agitation.
• Hallucinations.
• Inability to stay still.

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

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

Frequency not known (cannot be estimated from available data):

• Abnormal sensations in the mouth (oral paraesthesia).
• Swelling in the mouth (oral edema).
• Swelling throughout the body (generalized edema).
• Localized swelling.
• Hyponatremia.
• Inappropriate secretion of antidiuretic hormone.
• Serious skin reactions (bullous dermatitis, erythema multiforme).
• Sleepwalking (somnambulism).
• Speech disorder.
• Increased levels of creatine kinase 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 (hyperprolactinaemia, including symptoms such as breast enlargement and/or milky discharge from the nipple).
• Painful and prolonged penile erection.

Other adverse effects in children and adolescents

In patients under 18 years of age, the following adverse effects were frequently observed in clinical trials: considerable weight gain, urticaria, and increased blood triglyceride levels.

Reporting of adverse effects

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

5. Storage of Mirtazapine MABO

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mirtazapine MABO

The active substance is mirtazapine.

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

The other components (excipients) are:

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

Appearance of the product and contents of the pack

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

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Vía de los Poblados 3,

Building 6, 28033, Madrid,

Spain.

Manufacturer:

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

Dunajska cesta 156

1000 Ljubljana,

Slovenia

Date of latest revision of the package leaflet: January 2025

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