Leaflet: information for the user

Mirtazapina NORMON 30 mg film-coated tablets EFG

Read this 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, consult 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 leaflet.

1. What Mirtazapina NORMON is and for what it is used

2. What you need to know before starting to take Mirtazapina NORMON

3. How to take Mirtazapina NORMON

4. Possible side effects

5. Storage of Mirtazapina NORMON

6. Contents of the pack and additional information

Mirtazapina NORMON belongs to a group of medicines calledantidepressants.

Mirtazapina is used to treat depression.

Do not take - or consult your doctor before starting to take Mirtazapina NORMON

• if you areallergicto mirtazapina or any of the other components of 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).
• if you have ever had a severe skin rash or skin peeling, blisters or sores in the mouth after taking mirtazapina or other medications.

Warnings and precautions

Consult your doctor before starting to take Mirtazapina NORMON.

Children and adolescents

Mirtazapina NORMON should not be used normally in the treatment of children and adolescents under 18 years of age. At the same time, you should know that in patients under 18 years of age, there is a higher risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medication.

However, the doctor may prescribe Mirtazapina NORMON to patients under 18 years of age when they decide it is best for the patient. If the doctor has prescribed Mirtazapina NORMON to a patient under 18 years of age and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed above in patients under 18 years of age taking Mirtazapina NORMON appear or worsen.

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 more to take effect.

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. The information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders and who are being treated with an antidepressant.
• Severe skin reactions, such as Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (NET), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of mirtazapina. Stop using it immediately and seek medical attention 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, do not restart treatment with mirtazapina.

• if you have thoughts of harming yourself or committing 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.

Also, be especially careful with Mirtazapina NORMON:

• if you have or have had any of the following conditions:

• Inform your doctor about these situations before taking Mirtazapina NORMON, if you have not already:

• seizures(epilepsy). If seizures occur or your seizures are more frequent, stop taking Mirtazapina and contact your doctor immediately;
• liver disease, including jaundice. If jaundice appears, stop taking mirtazapina and contact your doctor immediately;
• kidney disease;
• heart diseaseorlow blood pressure;
• schizophrenia. If psychotic symptoms, such as paranoid thoughts, are more frequent or severe, contact your doctor immediately;
• bipolar depression(alternating periods of excitement/hyperactivity and periods of depression). If you start to feel animated or overexcited, stop taking mirtazapina and contact your doctor immediately;
• diabetes(you may need to adjust your insulin dose or other antidiabetic medications);
• eye diseases, such as increased eye pressure (glaucoma);
• difficulty urinating, which may be due to an enlarged prostate;

• if you have signs of infection such as high fever, sore throat, and mouth sores

• Stop taking Mirtazapina NORMON and contact your doctor immediately to perform a blood test.

In rare cases, these symptoms may be signs of bone marrow production disorders. Although rare, these symptoms appear 4-6 weeks after treatment.

• if you are an older person. You may be more sensitive to the adverse effects of antidepressant medications.

Taking Mirtazapina NORMON with other medications

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

Do not take MirtazapinaNORMON 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 either.

Examples of MAOIs are moclobemida, tranilcipromina (both are antidepressants), and selegilina (for Parkinson's disease).

Be careful ifyou take Mirtazapina NORMON with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxina, and L-tryptophan or triptans(used for migraines),tramadol(for pain),linezolid(an antibiotic),lithium(used to treat some psychiatric disorders), and herbal preparations based on St. John's Wort –Hypericum perforatum(medicinal plant for depression). In rare cases, mirtazapina alone or with these medications, may cause the so-called serotonin syndrome. Some of the 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 nefazodona. It 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 nefazodona.
• anxiety or insomnia medicationssuch as benzodiazepines.

schizophrenia medicationssuch as olanzapina.

allergy medicationssuch as cetirizina.

intense pain medicationssuch as morphine.

Mirtazapina may increase the drowsiness caused by these medications when taken together.

• infection medications:antibiotics for bacterial infections (such as erythromycin), antifungals (such as ketoconazole), and HIV/AIDS medications (protease inhibitors).

If taken together 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.

• epilepsy medicationssuch as carbamazepina and fenitoína;

tuberculosis medicationssuch as rifampicina.

If taken together 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.

• blood clotting medicationssuch as warfarina.

Mirtazapina may increase the effects of warfarina in the blood. Inform your doctor if you are taking this medication. In cases where they are taken together, it is recommended that the doctor perform blood tests.

Taking Mirtazapina NORMON with food, drinks, 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 before using this medication.

The limited experience of administering Mirtazapina NORMON to pregnant women does not indicate an increased risk. However, you should be careful 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.

Antidepressants similar to Mirtazapina NORMON (SSRIs) may increase the risk of a serious condition called persistent pulmonary hypertension in newborns (PPHN) in babies. This condition causes the baby to 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.

Consult your doctor if you can breastfeed while taking Mirtazapina NORMON.

Driving and operating machines

Mirtazapina NORMON may affect your concentration or alertness. . During treatment with Mirtazapina NORMON, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how Mirtazapina NORMON affects you.

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 usual 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 Mirtazapina NORMON at the same time every day.

It is better to take the mirtazapina dose all at once before going to bed. However, your doctor may recommend that you divide your mirtazapina dose into the morning and evening before going to bed. The highest dose should be taken before going to bed.

The tablets are taken orally. Take the prescribed dose of Mirtazapina NORMON without

chewing, with water or juice.

When to expect to feel better

Mirtazapina NORMON usually starts 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 weeks of treatment, you talk to your doctor about the effects of mirtazapina:

• between 2 and 4 weeks after starting to take mirtazapina, 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.

You will usually need to take mirtazapina until the symptoms of depression have disappeared for 4-6 months.

If you take more Mirtazapina NORMON than you should

• If you or someone takes too much Mirtazapina NORMON, consult a doctor immediately.

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

The most likely symptoms of a mirtazapina overdose (without other medications or alcohol) aredrowsiness, disorientation, and palpitations.

If you forgot to take Mirtazapina NORMON

If you have to take your doseonce a day

• If you forget to take your mirtazapina dose, do not take a double dose to make up for the missed dose. Skip it and take the usual dose the next day.

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 catch up. Skip both doses and the next day continue with the usual dose in the morning and evening.

If you interrupt treatment with Mirtazapina NORMON

• Stop taking mirtazapina only if you consult your doctor.

If you stop taking it 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 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 questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Mirtazapina NORMON may cause side effects, although not everyone will experience them.

Some side effects are more likely than others. The possible side effects of mirtazapina are listed below and can be divided into:

• Very common:affect more than 1 in 10 patients
• Common:affect between 1 and 10 in 100 patients
• Uncommon:affect between 1 and 10 in 1,000 patients
• Rare:affectbetween 1 and 10 in 10,000 patients
• Very rare:affect less than 1 in 10,000 patients
• Not known:cannot be estimated from available data

Very common:

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

Common:

• Drowsiness.
• Dizziness.
• Tremor.
• Nausea.
• Diarrhea.
• Vomiting.
• Urticaria or skin rash (exanthema).
• Joint or muscle 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, which in most cases resolved when treatment was discontinued.

In children under 18 years, the following adverse reactions were frequently observed in clinical trials: a significant weight gain, urticaria, and an increase in triglycerides in the blood.

Uncommon:

• Exaggerated feeling of euphoria (mania).

• Stop taking mirtazapina and consult your doctor immediately.

• Strange sensation in the skin, for example, 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.
• Hallucinations.
• Inability to remain still.

Rare:

• Yellowing of the eyes or skin; may indicate liver function abnormalities (jaundice).

• Stop taking mirtazapina and consult your doctor immediately.

• Tics or muscle contractions (myoclonus).
• Pancreatitis.

Not known:

• Signs of infection such as sudden and unexplained high fever, sore throat, and mouth sores (agranulocytosis).

• Stop taking mirtazapina and consult your doctor immediately for a blood test.

In rare cases, mirtazapina may cause alterations in blood cell production (bone marrow depression). Some people become less resistant to infections because mirtazapina may cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, mirtazapina 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 (convulsions).

• Stop taking mirtazapina and consult your doctor immediately.

• Combination of symptoms such as unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. In very rare cases, these symptoms may be signs of a condition called "serotonin syndrome."

• Stop taking mirtazapina and consult your doctor immediately.

• Thoughts of self-harm or suicide.

• Stop taking mirtazapina and consult your doctor immediately.

• Abnormal sensations in the mouth (paresthesia oral).
• Swelling in the mouth (buccal edema).
• Hyponatremia.
• Inadequate secretion of antidiuretic hormone.
• Severe skin reactions (Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme, toxic epidermal necrolysis).
• Red patches on the trunk, often with circular or circumscribed macules, and sometimes with blisters in the center, skin detachment, mouth ulcers, throat, genital, and eye ulcers. These severe skin reactions 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).

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

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 after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Store in the original packaging to protect it from light and moisture.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and the

medications you no longer need at the Pharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of the packaging and the medications you no longer need. This will help protect the environment.

Composition of Mirtazapina NORMON

• The active ingredient is mirtazapine.

Mirtazapina NORMON 30 mg film-coated tablets contain 30 mg of mirtazapine per tablet.

• The other components (excipients) are:

Tablet core: microcrystalline cellulose, pregelatinized maize starch, colloidal silica, magnesium stearate.

Tablet coating: hypromellose, titanium dioxide (E-171), talc, and macrogol 6000.

Appearance of the product and contents of the packaging

Mirtazapina NORMON are film-coated tablets.

The tablets are white or almost white, round, biconvex, with printing M30 and scored.

The tablet can be divided into two equal halves.

Mirtazapina NORMON 30 mg film-coated tablets are packaged in blisters.

The following packaging sizes are available: 30 and 56 tablets.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last review of this leaflet: September 2020

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 /

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67015/P_67015.html