Mirtazapine Aurovitas 30 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Mirtazapine Aurovitas 30 mg film-coated tablets EFG

mirtazapine

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 may 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.

Leaflet contents

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

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

Mirtazapine belongs to a group of medicines called antidepressants.

Mirtazapine is used to treat depression in adults.

It takes 1 to 2 weeks before mirtazapine 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 can you expect to start feeling better?”

2. What you need to know before taking Mirtazapine Aurovitas

Do not take or consult your doctor before starting Mirtazapine Aurovitas

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

Take special care with mirtazapine:

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 using 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 ever had serious skin reactions, restarting treatment with mirtazapine should not be considered.

Warnings and precautions

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

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”).

Children and adolescents

Mirtazapine should not normally be used in the treatment of children and adolescents under 18 years of age because 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 thoughts, and hostility (mainly aggression, confrontational 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 most appropriate 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 return to your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen in patients under 18 years of age who are taking mirtazapine. In addition, the long-term effects on safety related to growth, maturation, and cognitive and behavioral development with mirtazapine in this age group are still unknown. A considerable 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 thoughts or thoughts of harming yourself.
• 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 an antidepressant.

→ If at any time you have thoughts of harming yourself or of suicide, consult your doctor or go to a hospital immediately.

It may be helpful to tell a close relative 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 getting worse 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 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 severe, contact your doctor immediately;

• bipolar depression (periods of mania/hyperactivity alternate with periods of depression). If you start feeling elated or overexcited, stop taking mirtazapine and contact your doctor immediately;

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

• eye diseases, 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 such as unexplained high fever, sore throat, and mouth ulcers appear.

→ 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 typically appear 4–6 weeks after starting treatment.

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

Other medicines and Mirtazapine Aurovitas

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

Do not take Mirtazapine Aurovitas together with:

• 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 for the next two weeks.

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

Be cautious if you take Mirtazapine Aurovitas together 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 certain psychiatric disorders), methylene blue (used to treat high levels of methemoglobin in the blood), and St. John’s wort – Hypericum perforatum (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, consult 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 used in combination with these medicines, mirtazapine may increase the drowsiness caused by them.

• medicines for infections: medicines for bacterial infections (such as erythromycin), medicines for fungal infections (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 decrease 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, your doctor may recommend regular blood monitoring.

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

If you use mirtazapine up to or shortly before delivery, your baby will be monitored for possible adverse effects.

If you are taking mirtazapine and become pregnant or wish to become pregnant, ensure that your midwife and/or doctor know that you are taking mirtazapine, and consult your doctor about whether you can continue taking mirtazapine. If you use mirtazapine up to or shortly before delivery, your baby will be monitored for possible adverse effects.

Ensure that your midwife or doctor knows you are taking mirtazapine. Medicines similar to mirtazapine (SSRIs) taken during pregnancy may increase the risk in newborns of a serious condition called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and develop a bluish tint. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, consult your midwife and/or doctor immediately.

Consult your doctor about whether you can breastfeed while taking mirtazapine.

Driving and using machines

Mirtazapine may affect your concentration or 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 cycling or similar activities.

Mirtazapine Aurovitas contains lactose monohydrate

If your doctor has informed you that you have an intolerance to certain sugars, consult them before taking this medicine.

3. How to take Mirtazapine Aurovitas

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

How much to take

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

When to take Mirtazapine Aurovitas

→ Take mirtazapine at the same time each day.

It is best to take the dose of mirtazapine as a single dose before going to bed. However, your doctor may recommend that you split your dose of mirtazapine, taking part in the morning and part before going to bed. The higher dose should be taken before going to bed.

The tablets are taken orally. Take the prescribed dose of mirtazapine without chewing, with water or juice.

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 start to feel better.

It is important that during the first weeks of treatment you speak with your doctor about the effects of mirtazapine:

→ 2 to 4 weeks after starting 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, speak again with your doctor after another 2–4 weeks. Normally, you will need to continue taking mirtazapine until depressive symptoms 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 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, irregular heartbeat) and/or fainting, which could be signs of a potentially life-threatening condition known as Torsade de pointes.

You may also contact the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Mirtazapine Aurovitas

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 as usual.

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 catch up. Skip both doses and the next day continue with your normal morning and evening doses.

If you stop taking Mirtazapine Aurovitas

→ 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 disappeared. If you stop taking mirtazapine suddenly, you may feel unwell, dizzy, agitated, or anxious and may have headaches. These symptoms can be avoided by stopping treatment gradually. Your doctor will advise you on how to reduce the dose gradually.

If you have any further 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 everyone will experience 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 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 dysfunction (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 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, mirtazapine 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),
• a combination of symptoms such as unexplained fever, sweating, palpitations, diarrhoea, involuntary muscle contractions, chills, exaggerated reflexes, agitation, mood changes, loss of consciousness, and increased salivation. In very rare cases, these symptoms may be signs of a disorder called "serotonin syndrome",
• thoughts of harming yourself or of suicide,
• red patches on the trunk, appearing as circumscribed or circular macules, often with blisters in the centre, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes 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 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,
• restlessness or tremor,
• nausea,
• diarrhoea,
• vomiting,
• constipation,
• hives or skin rashes (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 discontinued.

Uncommon (may affect up to 1 in 100 people)

• abnormal skin sensations such as burning, pricking, tingling, or numbness (paraesthesia),
• involuntary leg movements during sleep,
• fainting (syncope),
• numbness sensation 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)

• tics or muscle contractions (myoclonus),
• aggression,
• abdominal pain, 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,
• severe skin reactions (bullous dermatitis, erythema multiforme),
• sleepwalking (somnambulism),
• speech problems,
• increased levels of creatine kinase,
• problems urinating (urinary retention),
• muscle pain, stiffness and/or weakness, darkening or discoloration 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 individuals under 18 years of age, the following adverse effects were 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mirtazapine Aurovitas

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the outer carton and on the blister pack after “EXP”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to a pharmacy’s SIGRE collection point. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Mirtazapine Aurovitas

• The active substance is mirtazapine.

Each tablet contains 30 mg of mirtazapine.

• The other components are:

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

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

Nature of the product and contents of the pack

Film-coated tablet.

Film-coated, capsule-shaped, biconvex tablets, reddish-brown in colour, marked on one side with the numbers “3” and “0” on either side of the indentation and with “MI” on the other side.

The tablet can be divided into two equal halves.

Mirtazapine Aurovitas 30 mg tablets are available in PVC/PVDC/Aluminium blister packs and in HDPE bottles.

Pack sizes:

Blister packs: 10, 14, 20, 28, 30, 50, 56, 60, 100, 250 and 500 film-coated tablets.

HDPE bottles: 30, 50, 56, 60, 100, 250 and 500 film-coated tablets.

Only certain pack 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 medicinal product is authorised in the European Economic Area Member States under the following names:

Spain: Mirtazapine Aurovitas 30 mg film-coated tablets EFG

Netherlands: Mirtazapine Aurobindo 30 mg, filmomhulde tabletten

Portugal: Mirtazapina Aurobindo

Date of the most recent revision of this leaflet: July 2023

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