MIRTAZAPINE AUROVITAS 15 mg FILM-COATED TABLETS

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

Do not take or consult your doctor before taking Mirtazapine Aurovitas

• if you are allergicto mirtazapine or any of the other ingredients of this medicine (listed in section 6). In this case, consult your doctor as soon as possible before taking Mirtazapine Aurovitas.
• if you are taking or have taken in the last two weeks medicines called monoamine oxidase inhibitors (MAOIs).
• if you have ever suffered from severe skin rash or skin peeling, blisters or sores in the mouth after taking mirtazapine or other medicines.

Be especially cautious with mirtazapine:

Severe skin reactions, including 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, do not restart treatment with mirtazapine.

Warnings and precautions

Consult your doctor or pharmacist before taking Mirtazapine Aurovitas.

If you are taking medicines containing buprenorphine. The use of these medicines with mirtazapine may cause serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Mirtazapine Aurovitas").

Children and adolescents

Mirtazapine 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, you should know that in patients under 18 years, there is a greater risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritation) when taking this class of medicines. Nevertheless, your doctor may prescribe mirtazapine to patients under 18 years when he decides it is most convenient for the patient. If your doctor has prescribed mirtazapine to a patient under 18 years and you wish 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 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 more frequently in this age group that there is 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 of suicide. This could worsen when you first start taking antidepressants, as these medicines take time to work, usually two weeks or sometimes more.

You may be more likely to think this way:

• if you have previously had thoughts of suicide or self-harm.
• if you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years with psychiatric disorders who are being treated with an antidepressant.

→ If you have thoughts of self-harm or 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 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 cautious with mirtazapine

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

→ Inform your doctor about these situations before taking mirtazapine, if you have not already done so.

• seizures(epilepsy). If seizures occur or your seizures are 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;

mirtazapine and contact your doctor immediately;

• kidney disease;
• heart diseaseor low 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 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 signs of infection appear, such as unexplained high fever, sore throat, and mouth sores.

→ Stop taking mirtazapine and contact your doctor immediately for a blood test. Although rare, 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.

Other medicines and Mirtazapine Aurovitas

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

Do not take Mirtazapine Aurovitaswith:

• monoamine oxidase inhibitors(MAOIs). Also, do not take mirtazapine during the two weeks after you stop taking 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 Aurovitas with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, and L-tryptophan or triptans(used for migraine), tramadol(for pain), medicines containing buprenorphine(used in opioid dependence treatment programs), 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 herbal remedy for depression. In rare cases, mirtazapine alone or with these medicines may cause serotonin syndrome. Some symptoms of this syndrome are: unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), shivering, 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 mirtazapine in your 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 you stop taking nefazodone.
• anxiety or insomnia medicinessuch as benzodiazepines.
• schizophrenia medicinessuch as olanzapine.
• allergy medicinessuch as cetirizine.
• strong pain medicinessuch as morphine.

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

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

If taken with mirtazapine, these medicines may increase the amount of mirtazapine in your 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 you stop taking 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 your 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 you stop taking these medicines.

• medicines to prevent blood clottingsuch as warfarin.

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

Taking Mirtazapine Aurovitas 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 child will be examined for possible adverse effects.

If you are taking mirtazapine and become pregnant or plan to become pregnant, make sure your midwife and/or doctor know that you are taking mirtazapine and consult your doctor if you can continue taking mirtazapine. If you use mirtazapine until or shortly before delivery, your child will be examined for possible adverse effects.

Make sure your midwife or doctor knows that you are taking mirtazapine. Taken during pregnancy, similar medicines (SSRIs) may increase the risk in babies of a serious disease called persistent pulmonary hypertension of the newborn (PPHN), 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 immediately.

Consult your doctor if you can breastfeed while taking mirtazapine.

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, make sure concentration and alertness are not affected before cycling (for example).

Mirtazapine Aurovitas contains lactose monohydrate

If your doctor has told you that you have an intolerance to some sugars, consult with him before taking this medicine.

3. How to take Mirtazapine Aurovitas

Follow exactly the administration instructions of this medicine 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 the 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 Mirtazapine Aurovitas

→ 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 in the morning and before 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 important 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. You will usually need to take mirtazapine until the symptoms of depression have disappeared for 4-6 months.

If you take more Mirtazapine Aurovitas than you should

→ If you or someone else takes too much mirtazapine, consult 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 Torsade de pointes.

You can also contact the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Mirtazapine Aurovitas

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 as usual.

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 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 Aurovitas

→ 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 indicate how to gradually decrease the dose.

If you have any other questions about the use of this product, 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 immediately inform your doctor:

Uncommon(may affect up to 1 in 100 people)

• exaggerated feeling of euphoria (mania).

Rare(may affect up to 1 in 1,000 people)

• 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 and sudden fever, sore throat, and mouth ulcers (agranulocytosis). In rare cases, mirtazapine can cause alterations in blood cell production (bone marrow depression),
• some people become less resistant to infections because mirtazapine can cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, mirtazapine can also cause a decrease in red and white blood cells and platelets (aplastic anemia), a decrease in platelets (thrombocytopenia), or an increase in the number of white blood cells in the blood (eosinophilia),
• epileptic seizure (convulsions),
• 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 can be signs of a disorder called "serotonin syndrome",
• thoughts of self-harm or suicide,
• red patches on the torso, such as circumscribed or circular macules, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions can 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 people)

• increased appetite and weight gain,
• sleepiness,
• headache,
• dry mouth.

Common(may affect up to 1 in 10 people)

• lethargy,
• dizziness,
• agitation or 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 people):

• strange sensation in the skin, such as burning, pinching, tingling, or numbness (paresthesia),
• involuntary movements of the legs during sleep,
• fainting (syncope),
• numbness in the mouth (oral hypoesthesia),
• low blood pressure,
• nightmares,
• agitation,
• hallucinations,
• inability to remain still.

Rare(may affect up to 1 in 1,000 people)

• twitching 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),
• 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,
• urination problems (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 it directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Mirtazapine Aurovitas

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date shown on the packaging and blister pack after "EXP". The expiration date is the last day of the month indicated.

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. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Mirtazapine Aurovitas

• The active ingredient is mirtazapine.

Each tablet contains 15 mg of mirtazapine.

• The other components are:

Core:Lactose monohydrate, cornstarch, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, magnesium stearate (E470b), anhydrous colloidal silica.

Coating:Hydroxypropylcellulose, hypromellose (E464), titanium dioxide (E171), and yellow iron oxide (E172).

Appearance of the Product and Package Contents

Coated tablet.

Coated tablets, capsule-shaped, biconvex, yellow in color, scored on one side with the numbers "1" and "5" on either side of the score line and with "MI" on the other side.

The tablet can be divided into two equal halves.

Mirtazapine Aurovitas 15 mg coated tablets are available in PVC/PVDC/Aluminum blister packs and PEAD bottles.

Package Sizes:

Blister pack: 10, 14, 20, 28, 30, 50, 56, 60, and 100 coated tablets.

PEAD bottles: 30, 50, 56, 60, 100, 250, and 500 coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000

Malta

This Medicine is Authorized in the Member States of the European Economic Area with the Following Names:

Spain Mirtazapine Aurovitas 15 mg coated tablets EFG

France Mirtazapine Arrow Generics 15 mg coated tablet

Netherlands Mirtazapine Aurobindo 15 mg, film-coated tablets

Portugal Mirtazapine Aurobindo

Date of the Last Revision of this Prospectus: July 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es