Product Information for the Patient

Mirtazapina Alter 30 mg Film-Coated Tablets EFG

Read this entire product information carefully before starting to take this medicine, because it contains important information for you.

• Keep this product information, as you may need to read it again.

• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone and should not be given 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 product information. See section 4.

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

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

3. How to take Mirtazapina Alter

4. Possible side effects

5. Storage of Mirtazapina Alter

6. Contents of the pack and additional information

Mirtazapina belongs to a group of medicines calledantidepressants.

Mirtazapina is used to treat depression in adults.

It takes 1 to 2 weeks for mirtazapina 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 “When you can expect to feel better”.

Do not take Mirtazapina Alter

Warnings and precautions

Consult your doctor or pharmacist before starting to take mirtazapina.

Inform your doctor before taking Mirtazapina:

If you have ever had a severe skin rash or peeling of the skin, 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 of age because its efficacy has not been demonstrated. At the same time, it should be known that in patients under 18 years of age 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 class of medications. Nevertheless, the doctor may prescribe mirtazapina to patients under 18 years of age when they decide that it is the most appropriate for the patient. If the doctor has prescribed mirtazapina 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 appear or worsen in patients under 18 years of age who are taking mirtazapina. In addition, the long-term safety effects 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 suicide. This could worsen when you start taking antidepressants for the first time, as these medications usually take two weeks or more to have a normal effect.

You may be more prone to thinking this way if:

• 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 especially careful with mirtazapina

• 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 diseases, including jaundice. If jaundice occurs, stop taking mirtazapina and contact your doctor immediately;
• kidney diseases;
• 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 euphoria/hyperactivity and periods of depression). If you start to feel euphoric 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;specific types of heart diseasethat may change your heart rhythm, a

recent heart attack, heart failure, or taking certain medications that may

affect your heart rhythm.

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

• infection signs, such as unexplained high fever, sore throat, and mouth sores

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

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

Taking Mirtazapina Alter 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 Mirtazapina Alterwith:

Examples of MAOIs include moclobemide, tranylcypromine (both are antidepressants), and selegiline (for Parkinson's disease).

Be careful ifyou take Mirtazapina Alter with:

schizophrenia medicationssuch as olanzapine.

allergy medicationssuch as cetirizine.

intense pain medicationssuch as morphine.

In combination with these medications, mirtazapina may increase the drowsiness caused by these medications.

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.

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 warfarin. Mirtazapina may increase the effects of warfarin in the blood. Inform your doctor if you are taking this medication. In the case of taking them together, it is recommended that your doctor perform blood tests.
• medications that may affect heart rhythm, such as certain antibiotics and some antipsychotics.

Taking Mirtazapina Alter 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 mirtazapinauntil, or shortly before delivery, your child will be examined to detect any possible adverse effects. Takenduring pregnancy, similar medications (SSRIs), may increase the risk of a serious disease called persistent pulmonary hypertension in the newborn (PPHN),which makes the baby breathe faster and acquire a bluish tone. These symptoms usually begin within the first 24 hours after birth. If thishappens to your child, you should consult your midwife and/or doctor immediately.

Driving and using machines

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

Mirtazapina Alter tablets contain lactose

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor again.orpharmacist.

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 Mirtazapina Alter 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 Alter without chewing, with water or juice.

When to expect to feel better

Mirtazapina usually starts 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 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.

Normally, you will need to take mirtazapina until the symptoms of depression have disappeared for 4-6 months.

If you take more Mirtazapina Alter than you should

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

The most likely symptoms of a mirtazapina overdose (without other medications or alcohol) are drowsiness, disorientation, and palpitations.Symptoms of a possible overdose may include changes in your heart rhythm (rapid or irregular heartbeat) and/or dizziness, which could be symptoms of a potentially life-threatening condition known as Torsades de pointes.

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

If you forgot to take Mirtazapina Alter

If you have to take your doseonce a day

If you have to take your dosetwice a day

If you interrupt the treatment with Mirtazapina Alter

• Stop taking mirtazapina only if you consult your doctor.

If you stop 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 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 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.

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

• exaggerated feeling of euphoria (mania).

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

• yellow discoloration of the eyes or skin, which 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 sore throat, 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, and 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):

Common(may affect up to 1 in 10 patients):

• difficulty sleeping.
• memory problems, which in most cases resolved when treatment was discontinued.

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

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

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

• swelling throughout the body (generalized edema)
• localized swelling
• • hyponatremia.
• inadequate secretion of antidiuretic hormone.
• severe skin reactions (dermatitis bullosa, erythema multiforme)

• sleepwalking (somnambulism)
• speech problem
• 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)
• painful and prolonged 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: a significant weight gain, urticaria, and increased triglycerides in the blood.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.

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

Keep out of the sight and reach of children.

No special storage conditions are required.

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

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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Mirtazapina Alter:

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

Tablet core: pregelatinized cornstarch,hydroxypropylcellulose, magnesium stearate, anhydrous colloidal silica, lactose monohydrate.

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

Appearance of the product and content of the packaging:

Mirtazapina Alter 30 mg are film-coated tablets.

The tablets are round, biconvex, white in color, and have a notch on one of their faces.

The notch is only for splitting and facilitating swallowing, but not for dividing into equal doses.

It is presented in blisters, in packs of 30 or 56 tablets.

Other presentations

Mirtazapina Alter 15 mg film-coated tablets EFG

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Responsible for manufacturing:

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

This leaflet has been reviewed in:October 2023

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