Mirtazapine Aristo 15 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Mirtazapine Aristo 15 mg film-coated 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 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 Aristo is and what it is used for
2. What you need to know before taking Mirtazapine Aristo
3. How to take Mirtazapine Aristo
4. Possible adverse effects
5. Storage of Mirtazapine Aristo
6. Contents of the pack and other information

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

Mirtazapina Aristo 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 you can expect to start feeling better".

2. What you need to know before taking Mirtazapine Aristo

Do not take Mirtazapine Aristo

• if you are allergic to 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 Aristo.
• if you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Mirtazapine Aristo:

• if you are taking buprenorphine. Using this medicine together with mirtazapine may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Mirtazapine Aristo”).

Tell your doctor before taking Mirtazapine Aristo:

If you have ever experienced a severe skin rash or skin peeling, blisters, or mouth sores after taking mirtazapine.

Children and adolescents

Mirtazapine Aristo should not normally be used to treat children and adolescents under 18 years of age because its efficacy has not been demonstrated. Also, 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 described above appear or worsen in patients under 18 years of age taking mirtazapine. In addition, the long-term effects on safety related to growth, maturation, and cognitive and behavioral development of 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 committing suicide. This may worsen when you first start taking antidepressants, as these medicines usually take two weeks or sometimes longer to take effect.

You may be more likely to have such thoughts if:

• you have previously had suicidal thoughts or thoughts of self-harm.
• 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 committing suicide, consult 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 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 Aristo, 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 (alternating periods of elevated mood/hyperactivity and 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 insulin dose or other antidiabetic medicines);

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

• difficulty urinating, which may 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 occur such as unexplained high fever, sore throat, and mouth ulcers

→ Stop taking Mirtazapine Aristo and contact your doctor immediately for a blood test.

Rarely, these symptoms may be signs of disturbances in blood cell production in the bone marrow. Although rare, these symptoms typically appear 4–6 weeks after starting treatment.

• if you are elderly, you may be more sensitive to the adverse effects of antidepressant medicines.
• serious 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 mirtazapine use. Discontinue use 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, re-initiation of mirtazapine treatment should not be attempted.

Other medicines and Mirtazapine Aristo

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

Do not take Mirtazapine Aristo 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 following two weeks.

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

Be careful if you take Mirtazapine Aristo together with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, L-tryptophan, or triptans (used to treat migraine), tramadol or buprenorphine (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: involuntary rhythmic muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Contact your doctor if you experience these symptoms: unexplained fever, sweating, palpitations, diarrhea, uncontrollable muscle contractions, chills, exaggerated reflexes, agitation, mood changes, or 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 when 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), and medicines for HIV/AIDS (HIV protease inhibitors). 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 when 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 when 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, it is recommended that your doctor perform regular blood tests.
• medicines that may affect heart rhythm, such as certain antibiotics and some antipsychotics.

Taking Mirtazapine Aristo 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 take mirtazapine up to or shortly before delivery, your baby will be monitored for possible adverse effects.

Antidepressants similar to mirtazapine (SSRIs) taken during pregnancy may increase the risk of newborns developing a serious condition called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

Driving and use of machines

Mirtazapine may affect your concentration or 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.

Important information about some of the ingredients of Mirtazapine Aristo

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

This medicine may cause allergic reactions as it contains the colouring agent sunset yellow FCF (E-110).

It may trigger asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Mirtazapine Aristo

Follow exactly the instructions for using 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). 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 it

→ 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 divide your dose of

mirtazapine, taking part in the morning and part at night 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 talk to your doctor about the effects of mirtazapine.

→ Between 2 and 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 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 Aristo 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 Torsades de pointes.

You can also contact the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to take Mirtazapine Aristo

→ If you are supposed to take your dose once a day

• 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 a day

• 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 make them up. Skip both doses and the next day continue with your normal morning and evening doses.

If you stop taking Mirtazapine Aristo

→ Stop taking mirtazapine only if you have discussed it with your doctor.

If you stop too early, depression may return. 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 your depression has disappeared. If you stop taking mirtazapine suddenly, you may feel unwell, dizzy, restless, or anxious and may have headaches. These symptoms can be avoided by stopping treatment gradually. Your doctor will tell you how to reduce the dose gradually.

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 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 patients):

• feeling of exaggerated euphoria (mania).

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

• yellowing of the eyes or skin; this may indicate liver function abnormalities (jaundice).

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

• signs of infection such as unexplained and sudden high 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 very 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 the number of 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, 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 suicide.
• serious skin reactions:
• red patches on the trunk, such as well-defined or circular macules, often with blisters in the center, skin peeling, 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 include:

Very common (may affect more than 1 in 10 patients):

• increased appetite and weight gain
• drowsiness
• headache
• dry mouth

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

• lethargy
• dizziness
• tremor
• nausea
• diarrhea
• 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 (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 patients):

• unusual skin sensations such as burning, prickling, tingling, or numbness (paresthesia)
• involuntary leg movements during sleep (restless legs)
• 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 patients):

• 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 paresthesia)
• swelling in the mouth (oral edema)
• swelling throughout the body (generalized edema)
• localized swelling
• hyponatremia
• inappropriate antidiuretic hormone secretion
• serious skin reactions (bullous dermatitis, erythema multiforme)
• sleepwalking (somnambulism)
• speech disorder
• increased levels of creatine kinase in the blood
• difficulty urinating (urinary retention)
• muscle pain, stiffness and/or weakness, darkening or discoloration of urine (rhabdomyolysis)
• increased levels of prolactin hormone in the blood (hyperprolactinemia, including symptoms of breast enlargement and/or milky nipple discharge)
• painful and prolonged penile erection

Other adverse effects in children and adolescents

In patients 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, consult 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mirtazapine Aristo

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 expiration date refers to the last day of the month indicated.

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Package contents and other information

Composition of Mirtazapine Aristo

• The active substance is mirtazapine.

Mirtazapine Aristo 15 mg film-coated tablets contain 15 mg of mirtazapine per tablet.

• The other components are:

Tablet core: Corn starch, colloidal silicon dioxide, magnesium stearate, hydroxypropylcellulose, lactose monohydrate.

Tablet coating: Sunset yellow FCF (E-110), titanium dioxide (E-171), hypromellose, iron oxide yellow (E-172), polyethylene glycol 8000, and quinoline yellow (E-104).

Appearance of the product and contents of the pack

Mirtazapine Aristo are film-coated tablets.

The tablets are yellow, round, biconvex, and scored on one side.

The tablet can be divided into equal halves.

Mirtazapine Aristo 15 mg film-coated tablets are packed in blisters.

The following pack sizes are available: 30 and 60 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid - Spain

Manufacturer:

Laboratorios Medicamentos Internacionales (Medinsa)

C/ Solana nº 26

28850 - Torrejón de Ardoz, Madrid

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

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