Mirtazapine Aurovitas Spain 45 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Mirtazapina Aurovitas Spain 45 mg orodispersible tablets EFG

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Mirtazapina is used to treat depression in adults.

It takes 1 to 2 weeks before mirtazapina starts to take effect. After 2 to 4 weeks, you may begin to feel better. You should consult your doctor if your condition worsens or if you do not improve after 2 to 4 weeks. For more information, see section 3, “When you can expect to start feeling better”.

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

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

• if you are allergic to the active substance or to any of the other components 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 (within the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).
• if you have ever experienced a severe skin rash, skin peeling, blisters, or mouth sores after taking mirtazapine or other medicines.

Take special care with Mirtazapine Aurovitas Spain

Serious 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 taking it and seek immediate medical attention if you notice any of the symptoms described in section 4 related to these serious skin reactions.

If you have previously experienced serious skin reactions, treatment with mirtazapine should not be restarted.

Warnings and precautions

Talk to your doctor or pharmacist before starting Mirtazapine Aurovitas Spain.

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

Children and adolescents

Mirtazapine should not normally be used to treat children and adolescents under 18 years of age, as its efficacy has not been demonstrated. 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 suicide attempts, suicidal ideation, and hostility (mainly aggression, confrontation behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe mirtazapine to patients under 18 years of age if they decide it is the most appropriate treatment for the patient. If your doctor has prescribed mirtazapine to a patient under 18 years of age and you wish to discuss this decision, please contact your doctor again. Inform your doctor if any of the symptoms listed above appear or worsen in patients under 18 years of age taking mirtazapine. In addition, the long-term effects on safety, growth, maturation, cognitive development, and behavior with mirtazapine in this age group are still unknown. A significant weight gain has also been observed more frequently 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 two weeks or sometimes longer.

You may be more likely to have such thoughts:

• If you have previously had suicidal or self-harming thoughts.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in psychiatric patients under 25 years of age treated with antidepressants.

→ If you ever have thoughts of harming yourself or of suicide, contact your doctor or go to a hospital immediately.

It may be helpful to tell a close family member or friend that you are depressed and ask them to read this leaflet. You may ask them to inform you if they think your depression is worsening or if they are concerned about changes in your behavior.

Also, take special care with mirtazapine:

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

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

• seizures (epilepsy). If seizures occur or 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 elevated mood/hyperactivity and depression). If you start feeling elated or overexcited, stop taking mirtazapine and contact your doctor immediately;

• diabetes (you may need to adjust your insulin dose or other antidiabetic medicines);

• eye disorders, such as increased pressure in the eye (glaucoma);

• difficulty urinating, which could be due to an enlarged prostate;

• certain types of heart disease that may alter your heart rhythm, a recent heart attack, heart failure, or use of certain medicines that may affect heart rhythm.

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

→ Stop taking mirtazapine and contact your doctor immediately for a blood test. Rarely, these symptoms may indicate disturbances in blood cell production in the bone marrow. Although rare, these symptoms mostly occur 4–6 weeks after starting treatment.

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

Other medicines and Mirtazapine Aurovitas Spain

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

Do not take Mirtazapine Aurovitas Spain together with:

• monoamine oxidase inhibitors (MAOIs). Also, do not take mirtazapine within two weeks after stopping MAOIs. If you stop taking mirtazapine, do not take MAOIs for at least the next two weeks.

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

Be cautious if you take Mirtazapine Aurovitas Spain together with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, L-tryptophan, or triptans (used for migraine), tramadol (for pain), linezolid (an antibiotic), lithium (used to treat certain 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 very rare cases, mirtazapine alone or in combination with these medicines may lead to a condition called serotonin syndrome. Some symptoms of this syndrome include: unexplained fever, sweating, rapid heartbeat, diarrhea, uncontrollable muscle contractions, 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. This may increase the amount of mirtazapine in the blood. Inform your doctor if you are taking this medicine. It may be necessary to reduce the dose of mirtazapine or increase it again after stopping nefazodone.
• medicines for anxiety or insomnia, such as benzodiazepines;
• medicines for schizophrenia, such as olanzapine;
• medicines for allergies, such as cetirizine;
• medicines for severe pain, such as morphine.

When taken together with these medicines, mirtazapine may increase the drowsiness caused by them.

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

If taken together 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 reduce the dose of mirtazapine or increase it again after stopping these medicines.

• medicines for epilepsy, such as carbamazepine and phenytoin;
• medicines for tuberculosis, such as rifampicin.

If taken together with mirtazapine, these medicines may reduce 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 reduce it again after stopping these medicines.

• medicines to prevent blood clotting, such as warfarin.

Mirtazapine may enhance the effects of warfarin in the blood. Inform your doctor if you are taking this medicine. If taken together, regular blood monitoring by your doctor is recommended.

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

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

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

Mirtazapine may be taken 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 mirtazapine use in pregnant women does not indicate an increased risk. However, caution should be exercised if used during pregnancy.

If you take 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 newborn called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear blue. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife or doctor immediately.

Driving and using machines

Mirtazapine Aurovitas Spain may affect your ability to concentrate or your level of alertness. Make sure your abilities are not impaired before driving or operating machinery. If your doctor has prescribed mirtazapine to a patient under 18 years of age, ensure that concentration and alertness are not affected before engaging in activities such as cycling.

Mirtazapine Aurovitas Spain contains aspartame

This medicine contains 9 mg of aspartame per orodispersible tablet.

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

3. How to take Mirtazapine Aurovitas Spain

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

How much to take

The recommended starting 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 elderly or have kidney or liver disease, your doctor may adjust the dose.

When to take Mirtazapine Aurovitas Spain

→ Take Mirtazapine Aurovitas Spain at the same time each day.

It is best to take the mirtazapine dose as a single dose before bedtime. However, your doctor may recommend splitting your mirtazapine dose, taking part in the morning and part at night before bedtime. The higher dose should be taken before bedtime.

Take the orodispersible tablet as follows:

The tablets are taken by mouth.

1. Do not crush the orodispersible tablet

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

Fig. A

1. Separate one blister

Each strip contains six blisters, separated by perforations. Separate one blister along the perforated lines (Fig. 1).

Fig. 1

1. Remove the foil

Carefully peel off the foil, starting at the corner marked with an arrow (Figs. 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 (Fig. 4).

Fig. 4

It will dissolve quickly and can be swallowed without water.

When you can expect to feel better

Mirtazapine usually starts to take effect after 1 or 2 weeks, and after 2 to 4 weeks you may begin to feel better. It is important that during the first weeks of treatment you talk to your doctor about the effects of mirtazapine:

Between 2 and 4 weeks after starting mirtazapine, discuss with your doctor how this medicine has affected you.

If you still do not feel better, your doctor may prescribe a higher dose. In that case, speak with your doctor again after another 2–4 weeks. You will usually need to continue taking mirtazapine until depressive symptoms have been absent for 4–6 months.

If you take more Mirtazapine Aurovitas Spain than you should

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

The most likely symptoms of an overdose of mirtazapine (without other medicines or alcohol) are drowsiness, confusion, and palpitations. Symptoms of a possible overdose may include changes in your heart rhythm (fast or irregular heartbeat) and/or fainting, which could be signs of a potentially life-threatening condition known as Torsades de Pointes.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or go to the nearest hospital. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Mirtazapine Aurovitas Spain

If you are supposed to take your dose once daily

• Do not take a double dose to make up for missed doses. Take the next dose at the usual time.

If you are supposed to take your dose twice daily

• If you forget the morning dose, simply take it together with the evening dose.
• If you forget the evening dose, do not take it the next morning; skip it and continue with your normal morning and evening doses.
• If you forget both doses, do not try to recover them. Skip both doses and the next day continue with your normal morning and evening doses.

If you stop taking Mirtazapine Aurovitas Spain

→ Stop taking mirtazapine only after consulting your doctor.

If you stop too early, depression may return. When you start feeling better, talk to your doctor. Your doctor will decide when you can stop treatment.

Do not stop taking mirtazapine abruptly, even if depression has resolved. If you stop taking mirtazapine suddenly, you may feel unwell, dizzy, agitated, or anxious, and may experience headaches.

These symptoms can be avoided by stopping treatment gradually. Your doctor will advise you on how to gradually reduce the dose.

If you have any further 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 everybody will experience them.

If you experience any of the following adverse effects, stop taking Mirtazapine Aurovitas Spain and 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 indicate liver problems (jaundice).

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

• signs of infection such as sudden unexplained fever, sore throat, and mouth ulcers (agranulocytosis). In rare cases, mirtazapine may cause disturbances 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, Mirtazapina Aurovitas Spain may also cause a decrease in red and white blood cells and platelets (aplastic anaemia), a decrease in platelets (thrombocytopenia), or an increase in the number of white blood cells in the blood (eosinophilia).
• epileptic seizure (convulsions).
• combination of symptoms such as unexplained fever, sweating, palpitations, diarrhoea, uncontrollable muscle contractions, 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 harming yourself or of suicide.
• serious skin reactions (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• red spots on the trunk, such as well-defined or circular macules, often with blisters in the centre, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread red rash, high body temperature, and enlarged lymph nodes (DRESS syndrome 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 shaking
• nausea
• diarrhoea
• vomiting
• constipation
• hives or skin rash (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 (oedema)
• fatigue
• vivid dreams
• confusion
• anxiety
• difficulty sleeping
• memory problems, which in most cases resolved when treatment was stopped.

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

• unusual skin sensations such as burning, prickling, tingling, or numbness (paraesthesia)
• restless legs
• fainting (syncope)
• numbness sensation in the mouth (oral hypoesthesia)
• low blood pressure
• nightmares
• agitation
• hallucinations
• inability to stay still

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

• tics or muscle contractions (myoclonus)

• aggression

• abdominal pain and nausea; this may indicate inflammation of the pancreas (pancreatitis)

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

• abnormal sensations in the mouth (oral paraesthesia)
• swelling in the mouth (oral oedema)
• swelling throughout the body (generalised oedema)
• localized swelling
• hyponatraemia
• inappropriate secretion of antidiuretic hormone
• serious skin reactions (bullous dermatitis, erythema multiforme)
• sleepwalking
• speech disorder
• increased levels of creatine kinase in the blood
• difficulty urinating (urinary retention)
• muscle pain, stiffness and/or weakness, darkening or discolouration of urine (rhabdomyolysis)
• increased levels of prolactin hormone in the blood (hyperprolactinaemia, including symptoms such as breast enlargement and/or milky discharge from the nipple)
• painful and prolonged penile erection.

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: considerable weight gain, urticaria, and increased blood triglyceride levels.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mirtazapine Aurovitas Spain

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their packaging to your pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mirtazapine Aurovitas Spain

• The active substance is mirtazapine.

Mirtazapine Aurovitas Spain 45 mg orodispersible tablets contain 45 mg of mirtazapine per tablet.

• The other components are: crospovidone (type B), mannitol, microcrystalline cellulose, aspartame, colloidal anhydrous silica, magnesium stearate, strawberry guarana flavour [maltodextrin, propylene glycol, artificial flavours, acetic acid] and mint flavour [artificial flavours, corn starch].

Nature of the product and contents of the container

Orodispersible tablet.

Mirtazapine Aurovitas Spain 45 mg orodispersible tablets:

White, round orodispersible tablets with a raised circular edge, marked with "38" on one side and "A" on the other.

Perforated blister pack allowing individual dose separation: polyamide/aluminum/PVC/paper/polyester.

Pack sizes:

45 mg: 30 orodispersible tablets

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 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

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Czech Republic Mirtazapine Aurovitas

Malta Mirtazapine Aurobindo 45 mg orodispersible tablets

Poland Mirtazapine Aurovitas

Spain Mirtazapina Aurovitas Spain 45 mg orodispersible tablets EFG

Portugal Mirtazapina Aurovitas

Date of the most recent revision of this leaflet: September 2021

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