MIRTAZAPINE AUROVITAS SPAIN 30 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Mirtazapine Aurovitas Spain 30 mg Orodispersible 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 symptoms are the same as yours.
• If you experience 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 Package Leaflet

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

1. What is Mirtazapine Aurovitas Spain and what is it used for

Mirtazapine Aurovitas Spain belongs to a group of medicines called antidepressants.

Mirtazapine is used to treat depression in adults.

It may take 1 to 2 weeks before mirtazapine starts to work. 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 can you expect to feel better".

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

Do not take or consult your doctor before taking Mirtazapine Aurovitas Spain

• if you are allergic to the active substance 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.
• if you are taking or have recently taken (in the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).
• if you have ever suffered from a severe skin rash or skin peeling, blisters or sores in the mouth after taking mirtazapine or other medicines.

Be cautious with Mirtazapine Aurovitas Spain

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. Stop taking 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 had severe skin reactions, do not restart treatment with mirtazapine.

Warnings and precautions

Consult your doctor or pharmacist before taking Mirtazapine Aurovitas Spain.

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

Children and adolescents

Mirtazapine should not normally be used 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 they decide what 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 above symptoms appear or worsen in patients under 18 years who are taking mirtazapine. Additionally, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of mirtazapine in this age group are not yet known. It has also been observed that a significant weight gain is more frequent 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 time to work, usually 2 weeks or sometimes longer.

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. Clinical trial data have shown an increased risk of suicidal behavior in young adults (less than 25 years) with psychiatric disorders who are being treated with antidepressants.

→ If you have thoughts of harming yourself or of 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 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 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 disease, or low blood pressure;
• schizophrenia. If psychotic symptoms, such as paranoid thoughts, become more frequent or worsen, contact your doctor immediately;
• manic 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 medicine 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 your heart rhythm, a recent heart attack, heart failure, or taking certain medicines that can affect your heart rhythm.

• if signs of infection appear, such as high fever, sore throat, and mouth sores.

→ Stop taking mirtazapineand contact your doctor immediately to have a blood test. Although rare, these symptoms can be signs of changes in blood cell production in the bone marrow. These symptoms usually appear within 4-6 weeks of treatment.

• if you are an elderly person, you may be more sensitive to the adverse effects of antidepressant medicines.

Other medicines and Mirtazapine Aurovitas Spain

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

Do not take Mirtazapine Aurovitas Spainwith:

• 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 cautious ifyou take Mirtazapine Aurovitas Spain with:

• antidepressants such asselective serotonin reuptake inhibitors (SSRIs), venlafaxine, andL-tryptophan or triptans(used for 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 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.
• medicines for anxiety or insomniasuch as benzodiazepines;
• medicines for schizophreniasuch as olanzapine;
• medicines for allergiessuch as cetirizine;
• medicines for severe painsuch as morphine.

When taken 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), HIV/AIDS medicines (HIV protease inhibitors), and medicines for stomach ulcers(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 performs blood tests.

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

Some medicines can increase the side effects of mirtazapine and sometimes can cause very serious reactions. Do not take any other medicine while taking mirtazapine without consulting your doctor first, especially:

• medicines containing buprenorphine. These medicines can interact with mirtazapine, and you may experience symptoms such as involuntary and rhythmic muscle contractions, including the muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Contact your doctor when you experience these symptoms.

Taking Mirtazapine Aurovitas Spain with food, drinks, 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

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

When taken during pregnancy, similar medicines (SSRIs) may increase the risk of a serious condition in the baby, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and appear blue. These symptoms usually start within the first 24 hours after the baby is born. If this happens to your baby, you should contact your midwife or doctor immediately.

Driving and using machines

Mirtazapine Aurovitas Spain may affect your ability to concentrate or react. 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 their concentration and alertness are not affected before cycling (for example).

Mirtazapine Aurovitas Spain contains aspartame

This medicine contains 6 mg of aspartame in each orodispersible tablet.

Aspartame is a source of phenylalanine, which may be harmful in people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

3. How to take Mirtazapina Aurovitas Spain

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

How much to take

The recommended initial dose is 15 mg 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). Normally, the dose is the same for all ages. However, if you are an elderly person or if you have kidney or liver disease, your doctor may change the dose.

When to take Mirtazapina Aurovitas Spain

→ Take Mirtazapina Aurovitas Spain 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 at night before bedtime. The highest dose should be taken before bedtime.

Take the orodispersible tablet as follows:

The tablets are taken orally.

1. Do not crush the orodispersible tablet

To avoid crushing the orodispersible tablet, do not press the blister (Figure A).

Fig. A

1. Separate a blister

Each blister pack contains six blisters, which are separated by perforations. Separate a blister following the perforated lines (Figure 1).

Fig. 1

1. Remove the foil

Carefully remove the foil, starting from the corner marked with an arrow (Figures 2 and 3).

Fig. 2

Fig. 3

1. Remove the orodispersible tablet

Remove the orodispersible tablet with dry hands and place it on the tongue (Figure 4).

Fig. 4

It will dissolve quickly and can be swallowed without water.

When you can 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 moreMirtazapinaAurovitas Spainthan 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) are drowsiness, disorientation, and palpitations. The symptoms of a possible overdose may include changes in your heart rate (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 go to the nearest hospital. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeMirtazapinaAurovitas Spain

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 night dose.
• If you have forgotten the night dose, do not take it the next morning; skip it and continue with your normal doses in the morning and at night.
• 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 at night.

If you interrupt treatment withMirtazapinaAurovitas Spain

→ Stop taking mirtazapine 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 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 doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people suffer from them.

If you experience any of the following adverse effects, stop takingMirtazapina Aurovitas Spainand inform your doctor immediately.

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

• feeling of exaggerated 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 high, unexplained, and sudden fever, sore throat, and sores in the mouth (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, Mirtazapina Aurovitas Spain can 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, and 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.
• severe skin reactions (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• 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 redness, 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
• drowsiness
• headache
• dry mouth

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

• lethargy
• dizziness
• tremors 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
• sleeping difficulties
• memory problems, which in most cases were 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)
• restless legs
• 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):

• twitches or muscle contractions (myoclonus)
• aggression

• abdominal pain and nausea; this may indicate 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 in the blood
• difficulty urinating (urinary retention)
• muscle pain, stiffness, and/or weakness, darkening or discoloration of urine (rhabdomyolysis)
• increased prolactin levels in the blood (hyperprolactinemia, including symptoms such as breast enlargement and/or milky discharge from the nipple)
• painful and prolonged erection of the penis.

Other adverse effects in children and adolescents

In children under 18 years of age, the following adverse effects have been frequently observed in clinical trials: significant weight gain, urticaria, and increased triglycerides in the blood.

Reporting of 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: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Mirtazapina Aurovitas Spain

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on the blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

6. Package contents and additional information

Composition of Mirtazapina Aurovitas Spain

• The active ingredient is mirtazapine.

Mirtazapina Aurovitas Spain 30 mg orodispersible tablets contain 30 mg of mirtazapine per tablet.

• The other components are: crospovidone (type B), mannitol, microcrystalline cellulose, aspartame, anhydrous colloidal silica, magnesium stearate, strawberry guarana flavor [maltodextrin, propylene glycol, artificial flavors, acetic acid] and peppermint flavor [artificial flavors, cornstarch].

Appearance of the product and package contents

Orodispersible tablet.

Mirtazapina Aurovitas Spain 30 mg orodispersible tablets:

White, round, orodispersible tablets with a circular edge in relief, marked with "37" on one side and "A" on the other side.

Perforated blister pack divisible into individual doses: polyamide/aluminum/PVC/paper/polyester.

Package sizes:

30 mg: 30 orodispersible tablets

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer

APL Swift Services (Malta) Limited

HF26, Half Far Industrial Estate, Hal Far,

Birzebbuggia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medication is authorized in the member states of the European Economic Area with the following names:

Czech Republic Mirtazapine Aurovitas

Malta Mirtazapine Aurobindo 30 mg orodispersible tablets

Poland Mirtazapine Aurovitas

Spain Mirtazapina Aurovitas Spain 30 mg orodispersible tablets EFG

Portugal Mirtazapina Aurovitas

Date of the last revision of this prospectus:September 2021

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