MIRTAZAPINE ALTER 15 mg FILM-COATED TABLETS

2. What you need to know before taking Mirtazapine Alter

Do not take Mirtazapine Alter

• if you are allergicto mirtazapine or any of the other ingredients of this medication (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 (in the last two weeks) medications called monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Consult your doctor or pharmacist before starting to take mirtazapine.

Tell your doctor before taking Mirtazapine Alter.

If you have ever suffered from a severe skin rash or skin peeling, 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, as it has not been shown to be effective. At the same time, you should be aware that in patients under 18 years of age, there is a greater risk of side effects such as suicidal attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this type of medication. Nevertheless, the doctor may prescribe mirtazapine to patients under 18 years of age when they decide it is most convenient for the patient. If the 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 symptoms mentioned above appear or worsen in patients under 18 years of age who are taking mirtazapine. Additionally, the long-term safety effects related to growth, maturity, and development of knowledge and behavior of mirtazapine in this age group are not yet known. It has also been observed that this age group experiences a significant increase in weight 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 committing suicide. This could get worse when you start taking antidepressants for the first time, as these medications usually take two weeks or sometimes longer to take effect.

You may be more likely to think this way if:

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

• If you have thoughts of harming yourself or committing suicide at any time, consult 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 package 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:

• 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 the heart rhythm
• • if you experience signs of infection such as unexplained high fever, sore throat, and mouth sores

• Stop taking mirtazapine and contact your doctor immediately to have a blood test. In rare cases, these symptoms can be signs of alterations 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 side effects of antidepressant medications.
  • Severe 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 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, you should not restart treatment with mirtazapine.

Taking mirtazapine with other medications

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

Do not take Mirtazapine Alterwith:

• 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, tranilcipromine (both are antidepressants), and selegiline (for Parkinson's disease).

Be careful ifyou take Mirtazapine Alter with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, and L-tryptophan or triptans(used to treat migraines), 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 medications can 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, consult your doctor immediately.
• the antidepressant nefazodone. It can increase the amount of mirtazapine in the blood. Inform your doctor if you are taking this medication. It may be necessary to decrease the dose of mirtazapine or increase it again when stopping nefazodone.
• medications for anxiety or insomniasuch as benzodiazepines.

medications for schizophreniasuch as olanzapine.

medications for allergiessuch as cetirizine.

medications for severe painsuch as morphine.

In combination with these medications, mirtazapine can increase the drowsiness caused by these medications.

• 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) and medications for stomach ulcers (such as cimetidine).

If taken with mirtazapine, these medications can increase the amount of mirtazapine in the blood. Inform your doctor if you are taking these medications. It may be necessary to decrease the dose of mirtazapine or increase it again when stopping these medications.

• medications for epilepsysuch as carbamazepine and phenytoin;
• medications for tuberculosissuch as rifampicin.

If taken with mirtazapine, these medications can decrease the amount of mirtazapine in the blood. Inform your doctor if you are taking these medications. It may be necessary to increase the dose of mirtazapine or decrease it again when stopping these medications.

• medications to prevent blood clottingsuch as warfarin. Mirtazapine can increase the effects of warfarin on the blood. Inform your doctor if you are taking this medication. In case of taking them together, it is recommended that the doctor perform blood tests.
• medications that can affect heart rhythm, such as certain antibiotics and

some antipsychotics.

Taking Mirtazapine Alter 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 any medication.

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 child will be examined for possible adverse effects. Taken during pregnancy, similar medications (SSRIs) can increase the risk of a serious disease called persistent pulmonary hypertension in newborns (PPHN) in babies, which makes the baby breathe faster and acquire a bluish tone. These symptoms usually start during the first 24 hours after birth. If this happens to your child, you should consult your midwife and/or doctor.

Driving and using machines

This medication can 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).

Mirtazapine Alter tablets contain lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Mirtazapine Alter

Follow the administration instructions of this medication indicated by your doctor or pharmacist exactly. 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). 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 Alter 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 Alter without chewing, with water or juice.

When can you expect to feel better

Normally, Mirtazapine Alter 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 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 medication has affected you.

If you still do not feel better, your doctor may prescribe a higher dose. In this 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 Alter than you should

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

The most likely symptoms of a mirtazapine overdose (without other medications 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.

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

If you forget to take Mirtazapine Alter

If you need to take your dose once a day

• if you forget to take your dose of mirtazapine, do not take the missed dose. Skip it and take your usual dose the next day.

If you need 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 normal 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 normal dose in the morning and evening.

If you stop taking Mirtazapine Alter

• 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 sick, dizzy, agitated, or anxious and have headaches. These symptoms can be avoided by gradually stopping treatment. Your doctor will indicate how to gradually decrease the dose.

If you have any other questions about the use of this medication, 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 unexplained high and sudden fever, sore throat, and sores in the mouth (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, 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 eruptions 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 resolved when treatment was discontinued.

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

• strange sensation in the skin, such as burning, pricking, tingling, or numbness (paresthesia).

• involuntary leg movements during sleep.
• fainting (syncope).
• numbness sensation in the mouth (oral hypoesthesia).
• low tension.
• nightmares.
• agitation.
• hallucinations.
• inability to remain still.

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

• twitches 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)
• swelling in the mouth (oral edema)
• swelling throughout the body (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 individuals 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 is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Mirtazapine Alter

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

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

Do not use this medicine after the expiration date that appears on the package after "CAD". The expiration date is the last day of the month indicated.

Medicines should not be thrown away through drains or into the trash. Deposit the packages and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Mirtazapine Alter:

• The active ingredient is mirtazapine

Mirtazapine Alter 15 mg film-coated tablets contain 15 mg of mirtazapine per tablet.

• The other components are:

Tablet core: pregelatinized starch (from corn), hydroxypropylcellulose, magnesium stearate, anhydrous colloidal silica, lactose monohydrate.

Coating: hypromellose, glycerol triacetate, titanium dioxide (E-171).

Appearance of the Product and Package Contents:

Mirtazapine Alter 15 mg are film-coated tablets.

The tablets are round, lenticular, white, and have a score line on one side.

The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

They are presented in blisters, in packages of 30 or 60 tablets.

Other Presentations

Mirtazapine Alter 30 mg film-coated tablets EFG

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer:

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036 Madrid

Spain

or

Laboratorios Alter, S.A.

C/ Zeus, 6

Polígono Industrial R2

28880 Meco (Madrid)

Spain

This prospectus was revised in:October 2023

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/