Mirtazapine Mabo 30 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Mirtazapine MABO 30 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because 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 give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects 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 start feeling 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 to take mirtazapine.

Tell your doctor before taking Mirtazapine MABO:

If you have ever experienced a severe skin rash or skin peeling, blisters, or mouth sores 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 know that in patients under 18 years of age there is an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behaviour, 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 the most appropriate treatment. 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 growth, maturation, and cognitive and behavioural 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 committing 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 behaviour in psychiatric patients under 25 years of age treated with an antidepressant.

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

It may be helpful to tell a close family member or friend that you are depressed and ask them to read this leaflet. You may ask them to let you know if they think your depression is getting worse, or if they are concerned about changes in your behaviour.

Also, take special care 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 could 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 your heart rhythm.

• If signs of infection occur, such as unexplained high fever, sore throat, or mouth ulcers.

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

In rare cases, these symptoms may be signs of 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 such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of mirtazapine. 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, re-initiation of treatment with mirtazapine is not recommended.

Other medicines and Mirtazapine MABO

Tell 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 at least two weeks afterwards.

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 known as serotonin syndrome. Some symptoms of this syndrome include: unexplained fever, sweating, rapid heartbeat, diarrhoea, uncontrollable muscle contractions, 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. This may increase the amount of mirtazapine in the 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 taken together 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).

If 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.

If 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 that prevent blood clotting such as warfarin.

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

• 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 taking mirtazapine. It is recommended not to consume 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Limited experience with the use of mirtazapine 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 examined 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 blue. 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 affected before cycling or engaging in similar activities.

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 administration instructions for 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 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). 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 mirtazapine dose as a single dose before bedtime. However, your doctor may recommend splitting your mirtazapine dose, taking part in the morning and the remainder before bedtime. The higher dose should be taken before bedtime.

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

The tablet may be divided into equal doses.

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 speak with your doctor about the effects of mirtazapine:

→ 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 with your doctor again after another 2–4 weeks.

Usually, you will need to take mirtazapine until depression symptoms 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 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 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 a day

• 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 a day

• 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

→ Stop taking mirtazapine only if advised by 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 gradually.

If you have any further questions about using 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 contact 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 skin or eyes; this may suggest 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 temporarily reduce white blood cells (granulocytopenia). In rare cases, mirtazapine may also cause a reduction 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).

• A combination of symptoms such as unexplained fever, sweating, palpitations, diarrhoea, uncontrollable muscle twitching, chills, overactive reflexes, agitation, mood changes, loss of consciousness, and increased saliva production. In very rare cases, these symptoms may indicate a disorder called "serotonin syndrome".

• Thoughts of harming yourself or of suicide.

• Serious skin reactions:

• Red patches on the trunk, often as well-defined or circular spots, sometimes with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious 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 rash (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 (oedema).
• Tiredness.
• Vivid dreams.
• Confusion.
• Anxiety.
• Difficulty sleeping.
• Memory problems, which in most cases resolved when treatment was stopped.

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

• Unusual skin sensations such as burning, prickling, tingling, or pins and needles (paraesthesia).
• Involuntary restless leg movements during sleep.
• Fainting (syncope).
• Numbness of 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 of the mouth (oral oedema).
• Swelling throughout the body (generalised oedema).
• Localised swelling.
• Hyponatraemia.
• 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 discolouration of urine (rhabdomyolysis).
• Increased levels of prolactin hormone in the blood (hyperprolactinaemia, including symptoms such as breast enlargement and/or milky nipple discharge).
• 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 on the blister after “EXP”. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. If in doubt, 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 30 mg film-coated tablets EFG contains 30 mg of mirtazapine per film-coated tablet.

The other components (excipients) are:

• Tablet core: monohydrate lactose, corn starch, colloidal anhydrous silica, hydroxypropylcellulose and magnesium stearate.
• Coating material: hypromellose, macrogol, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).

Appearance of the product and contents of the container

Brownish, oval, biconvex, film-coated tablets, scored on one side and smooth on the other, marked with “M” and a “6”, one on each side of the score line. Dimensions: 12.50 x 6.50 mm.

The tablet can be divided into equal doses.

The following pack sizes are available for the 30 mg film-coated tablets: 30 and 56 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,

Edificio 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 this summary: January 2025

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