MIRTAZAPINE NORMON 45 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Mirtazapine Normon 45 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Mirtazapine Normon belongs to a group of medicines called antidepressants.

Mirtazapine is used to treat depression in adults.

It may take 1 to 2 weeks before you start to feel better. After 2 to 4 weeks you may start to feel better. You should see your doctor if you do not feel better or if you feel worse after 2 to 4 weeks.

For more information, see section 3 "How to take Mirtazapine Normon".

2. What you need to know before you take Mirtazapine Normon

Do not take Mirtazapine Normon

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

Warnings and precautions

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

Tell your doctor before taking Mirtazapine Normon:

If you have ever suffered from severe skin rash or peeling of the skin, 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 it has not been shown to be effective. 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 suicidal attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this type of medicine.

However, your doctor may prescribe mirtazapine to patients under 18 years of age when they decide what is best for the patient. If your 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 above symptoms appear or worsen in patients under 18 years of age who are taking mirtazapine. Additionally, the long-term safety effects of mirtazapine on growth, maturity, and development of knowledge and behavior in this age group are not yet known.

It has also been observed that there is a significant increase in weight in this age group when treated with mirtazapine, 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 take 2 weeks or sometimes longer to start working.

You may be more likely to think this way if:

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

• If you have thoughts of self-harm or suicide at any time, contact 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 leaflet. You can ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behavior.

Also, be especially careful with mirtazapine:

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

• Tell 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 diseaseor 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 the rhythm of your heart, a recent heart attack, heart failure, or taking certain medications that can affect heart rhythm.

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

• Stop taking mirtazapine and contact your doctor immediately for 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 medicines.
• 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). Stop using it 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 medicines and Mirtazapine Normon

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

Do not take Mirtazapine Normonwith:

• 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 during the following two weeks.

Examples of MAOIs are moclobemide, tranylcypromine (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 migraine), tramadol(for pain), linezolid(an antibiotic), lithium(used to treat some 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 very rare cases, mirtazapine alone or with these medicines may cause a condition called serotonin syndrome. Some of the 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, contact your doctor immediately.
• The antidepressant nefazodone. It may increase the amount of mirtazapine in the blood. Inform your doctor if you are taking this medicine. It may be necessary to decrease the dose of mirtazapine or increase it again when stopping nefazodone.
• Medicines for anxiety or insomniasuch as benzodiazepines.

Medicines for schizophreniasuch as olanzapine.

Medicines for allergiessuch as cetirizine.

Medicines for severe painsuch as morphine.

In combination with these medicines, mirtazapine may increase the drowsiness caused by these medicines.

• Medicines for infections:medicines for bacterial infections (such as erythromycin), medicines for fungal infections (such as ketoconazole), and medicines for HIV/AIDS (HIV protease inhibitors) and medicines for stomach ulcers(such as cimetidine).

If taken 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 decrease the dose of mirtazapine or increase it again when stopping these medicines.

• Medicines for epilepsysuch as carbamazepine and phenytoin;

Medicines for tuberculosissuch as rifampicin.

If taken with mirtazapine, these medicines may decrease 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 decrease it again when stopping these medicines.

• Medicines to prevent blood clottingsuch as warfarin.

Mirtazapine may increase the effects of warfarin on the blood. Inform your doctor if you are taking this medicine. In case of taking them together, it is recommended that your doctor perform blood tests.

• Medicines that can affect heart rhythm, such as certain antibiotics and some antipsychotics.

Taking Mirtazapine Normon 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 medicine.

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

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

When taken during pregnancy, similar medicines (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 turn blue. These symptoms usually start within the first 24 hours after birth. If this happens to your baby, you should immediately consult your midwife and/or doctor.

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).

3. How to take Mirtazapine Normon

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If in 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 it

• 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 you can 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 medicine 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 Normon than you should

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

The most likely symptoms of a mirtazapine overdose (without other medicines or alcohol) are drowsiness, disorientation, and palpitations.The symptoms of a possible overdose may include changes in the rhythm of your heart (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 Toxicological Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Mirtazapine Normon

If you have 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 have 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 Normon

• Stop taking mirtazapine only 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 medicine, 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 high, unexplained, 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 white blood cells in the blood (eosinophilia).
• Epileptic 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, like circumscribed or circular macules, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin erythemas 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 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 were 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 prolactin hormone levels 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 patients 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 prospectus. 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 Normon

Keep this medicine out of sight and reach of children.

Do not use this medicine 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.

Medicines should not be thrown away 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 Normon

• The active ingredient is mirtazapine.

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

• The other components are:

Core of the tablet: 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 Package Contents

Mirtazapine Normon is a film-coated tablet.

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

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

The following package sizes are available: 30 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the Last Revision of this Prospectus: January 2024

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//

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/89258/P_89258.html