Package Insert: Information for the Patient

Mirtazapina Normon 45 mg Film-Coated Tablets EFG

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

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

1. What is Mirtazapina Normon 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 adverse effects

5. Storage of Mirtazapina Normon

6. Contents of the package and additional information

Mirtazapina Normon belongs to a group of medicines calledantidepressants.

Mirtazapina is used to treat depression in adults.

It takes 1 to 2 weeks for this medicine to start working. 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"How to take Mirtazapina Normon".

Do not take Mirtazapina Normon

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

Inform your doctor before taking Mirtazapina Normon:

If you have ever had a severe skin rash or skin peeling, blisters or sores in the mouth after taking mirtazapina.

Children and adolescents

Mirtazapina should not be used normally in the treatment of children and adolescents under 18 years because its efficacy has not been demonstrated. At the same time, it should be known 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 type of medication.

However, the doctor may prescribe mirtazapina to patients under 18 years when they decide what is best for the patient. If the 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 listed above in patients under 18 years taking mirtazapina appear or worsen.

Additionally, the long-term effects on safety related to growth, maturation, and development of mirtazapina in this age group are still unknown.

It has also been observed with greater frequency a considerable weight gain 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 of suicide.

This could worsen when you first start taking antidepressants, as these medications take time to become effective, usually two weeks or more.

You may be more prone to thinking this way if:

• 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 with psychiatric disorders and who are being treated with 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 worsening, or if they are concerned about changes in your behavior.

Also, be particularly careful with mirtazapina:

• If you have or have had at any time one of the following conditions:

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

• 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 elated or overexcited, stop taking mirtazapina and contact your doctor immediately.
• Diabetes(you may need to adjust your insulin dose or other diabetes medications).
• Eye diseases, such as increased eye pressure (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 you have signs of infection such as high fever, sore throat, and mouth sores.

• Stop taking mirtazapina and contact your doctor immediately to have 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.
• 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. 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 had severe skin reactions, you should not restart treatment with mirtazapina.

Other medications and Mirtazapina Normon

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

Do not take Mirtazapina Normonwith:

• Monamine 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 are moclobemida, tranilcipromina (both are antidepressants), and selegilina (for Parkinson's disease).

Be careful ifyou take mirtazapina with:

• Antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxina, 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 preparations(Hypericum perforatum, a 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 nefazodone. 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 nefazodone.
• Medications for anxiety or insomniasuch as benzodiazepines.

Medications for schizophreniasuch as olanzapina.

Medications for allergiessuch as cetirizina.

Medications for intense painsuch as morphine.

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

• 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) andmedications for stomach ulcers(such as cimetidine).

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.

• Medications for epilepsysuch as carbamazepine and phenytoin;

Medications for tuberculosissuch as rifampicin.

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.

• Medications to prevent blood clottingsuch as warfarin.

Mirtazapina may increase the effects of warfarin in the 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 heart rhythm,such as certain antibiotics and some antipsychotics.

Taking Mirtazapina Normon with food 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, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

The limited experience of administering mirtazapina 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.

Medications similar to this (SSRIs) taken during pregnancy may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN) in the baby, which makes the baby 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.

Driving and operating machinery

Mirtazapina may affect your concentration or alertness. Make sure your faculties are not impaired before driving or operating machinery. If your doctor has prescribed mirtazapina to a patient under 18 years, make sure concentration and alertness are not affected before driving (for example, on a bicycle).

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 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). 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 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 prescribed mirtazapine dose without

masticating, with water or juice.

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 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 Mirtazapina Normon than you should

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

The most likely symptoms of a mirtazapine overdose (without other medications or alcohol) aredrowsiness, disorientation, and palpitations.The symptoms of a possible overdose may include changes in your heart rhythm (fast or irregular heartbeat) and/or dizziness, 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Mirtazapina Normon

If you have to take your doseonce a day

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

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 the treatment with Mirtazapina Normon

• Stop taking mirtazapine only if you consult your doctor.

If you stop 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 this medication, ask your doctor or pharmacist.

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

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

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

• Exaggerated feeling of euphoria (mania).

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

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

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

• Signs of infection such as sudden and unexplained high fever and chills, sore throat, and mouth sores (agranulocytosis). In rare cases, mirtazapine may cause abnormalities 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 white blood cells in the blood (eosinophilia).
• Seizure (convulsion).
• A 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 condition called "serotonin syndrome."
• Thoughts of self-harm or suicide.
• Severe skin reactions:
• Red patches on the trunk, often with blisters in the center, skin peeling, mouth sores, throat sores, genital sores, and eye sores. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized erythema, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other possible side 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.
• Diarrhea.
• Vomiting.
• Constipation.
• Hives 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.

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

• Strange sensation in the skin, such as burning, pinching, tingling, or numbness (paresthesia).
• Restless leg syndrome during sleep.
• Fainting (syncope).
• Reduced sensation in the mouth (hypoaesthesia oral).
• Low blood pressure.
• Nightmares.
• Agitation.
• Hallucinations.
• Inability to remain still.

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

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

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

• Abnormal sensations in the mouth (paresthesia oral).
• Swelling in the mouth (buccal edema).
• Swelling throughout the body (generalized edema).
• Localized swelling.
• Low sodium levels in the blood (hyponatremia).
• Inadequate secretion of antidiuretic hormone.
• Severe skin reactions (dermatitis bullous, erythema multiforme).
• Sleepwalking (somnambulism).
• Speech problems.
• Increased levels of creatine kinase in the blood.
• Difficulty urinating (urinary retention).
• Muscle pain, stiffness, and/or weakness, dark or discolored urine (rhabdomyolysis).
• Increased levels of prolactin hormone in the blood (hyperprolactinemia, which includes symptoms of breast enlargement and/or nipple discharge).
• Prolonged and painful erection of the penis.

Other side effects in children and adolescents

In children under 18 years, the following side effects were frequently observed in clinical trials: significant weight gain, hives, and increased triglycerides in the blood.

Reporting 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 Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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.

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 SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medications you no longer need. By doing so, you will help protect the environment.

Composition of Mirtazapina Normon

• The active ingredient is mirtazapine.

Mirtazapina Normon 45 mg film-coated tablets contain 45 mg of mirtazapine (as mirtazapine hemihydrate) per tablet.

• The other components are:

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

Coating material: hypromellose, titanium dioxide (E-171), talc, and macrogol.

Appearance of the product and contents of the packaging

Mirtazapina Normon are film-coated tablets.

The tablets are white or almost white, round, biconvex, marked with “M45” on one face and smooth on the other with a diameter of 10.2 mm ± 10%.

Mirtazapina Normon 45 mg film-coated tablets are packaged in aluminum/PVC blisters of white opaque color.

The following packaging sizes are available: 30 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: January 2024

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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/89258/P_89258.html