Mirtazapine Sandoz Farmacéutica 15 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Mirtazapine Sandoz Farmacéutica 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 you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Mirtazapine Sandoz Farmacéutica 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 work. 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 Sandoz Farmacéutica

Do not take Mirtazapine Sandoz Farmacéutica

• 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,
  • 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 Sandoz Farmacéutica.

Tell your doctor before taking mirtazapine:

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

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 ideation and hostility (mainly aggression, confrontational behaviour 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 in the patient's best interest. 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 behavioural development of mirtazapine in this age group are still unknown. Furthermore, a significant weight gain has been observed more frequently in this age group than in adults treated with mirtazapine.

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 usually take two weeks or sometimes longer to take effect.

You may be more likely to have these thoughts:

• if you have previously had suicidal thoughts or thoughts of self-harm,
• if you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age who were treated with an antidepressant.

→ 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 close relative or friend that you are depressed and ask them to read this leaflet. You may ask them to let you know if they think your depression is getting worse, or if they are concerned about changes in your behaviour.

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 Sandoz Farmacéutica, if you have not already done so:

• seizures (epilepsy). If you develop seizures 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 elevated mood/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 eye pressure (glaucoma),
• difficulty urinating, which may be due to an enlarged prostate,
• certain heart conditions 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 sores 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 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 the use of mirtazapine. 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, treatment with mirtazapine should not be restarted.

Other medicines and Mirtazapine Sandoz Farmacéutica

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

Do not take Mirtazapine Sandoz Farmacéutica together with:

• monoamine oxidase inhibitors (MAO inhibitors). Also, do not take mirtazapine during the two weeks after stopping MAO inhibitors. If you stop taking mirtazapine, do not take MAO inhibitors for the following two weeks. Examples of MAO inhibitors are moclobemide, tranylcypromine (both are antidepressants) and selegiline (used for Parkinson's disease).

Be cautious if taking Mirtazapine Sandoz Farmacéutica together with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine and 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 methaemoglobin in 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 of the symptoms of this syndrome are: unexplained fever, sweating, palpitations, diarrhoea, 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. It 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.

In combination 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) and 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 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 reduce it again when stopping these medicines.

• medicines to prevent blood clotting such as warfarin.

Mirtazapine may increase the effects of warfarin on the blood. Inform your doctor if you are taking this medicine. If taken together, it is recommended that your doctor perform blood tests.

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

Taking Mirtazapine Sandoz Farmacéutica with food and alcohol

You may feel drowsy if you drink alcohol while taking 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 any medicine. Limited experience with the administration of mirtazapine to pregnant women does not indicate an increased risk of congenital malformations. However, caution should be exercised if used during pregnancy.

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

When taken during pregnancy, similar medicines (SSRIs) may increase the risk of a serious condition in newborns 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 child, contact your midwife and/or doctor immediately.

Driving and using machines

Mirtazapine Sandoz Farmacéutica may affect your concentration or level of alertness. Make sure your abilities are not affected 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 (for example) or engaging in similar activities.

Mirtazapine Sandoz Farmacéutica contains lactose and sunset yellow S (E110)

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 because it contains sunset yellow S (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Mirtazapine Sandoz Farmacéutica

Follow exactly the instructions for using this medicine as 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 daily. Your doctor may recommend increasing the dose after a few days to the amount that is best for you (between 15 and 45 mg daily). The dose is usually the same for all age groups. However, if you are an elderly patient or if you have kidney or liver disease, your doctor may adjust the dose.

When to take it

→ Take Mirtazapine Sandoz Farmacéutica at the same time each day. It is best to take the dose of Mirtazapine Sandoz Farmacéutica as a single dose before bedtime. However, your doctor may recommend dividing your dose, taking part in the morning and part at night before bedtime. The higher dose should be taken before bedtime.

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

The tablets may be divided into equal doses.

When you can expect to feel better

Mirtazapine Sandoz Farmacéutica 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 speak with your doctor about the effects of mirtazapine:

→ Between 2 and 4 weeks after starting Mirtazapine Sandoz Farmacéutica, 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 with your doctor again after another 2–4 weeks.

Usually, you will need to take Mirtazapine Sandoz Farmacéutica until depressive symptoms have disappeared for 4–6 months.

If you take more Mirtazapine Sandoz Farmacéutica than you should

If you have taken more mirtazapine than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 91 562 04 20, indicating the medicine and the amount taken.

The most likely symptoms of an overdose of Mirtazapine Sandoz Farmacéutica (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.

If you forget to take Mirtazapine Sandoz Farmacéutica

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 treatment 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 Sandoz Farmacéutica:

→ Stop taking Mirtazapine Sandoz Farmacéutica only if advised by your doctor.

Stopping too early may cause depression to 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 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 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 contact 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; may indicate liver dysfunction (jaundice).

Frequency not known (frequency 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 very 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, uncontrollable 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 suicide,
• severe skin reactions,
• red spots on the trunk, often as defined or circular macules, frequently 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 serious adverse effects during treatment are:

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,
• agitation or tremor,
• 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 discontinued.

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

• unusual skin sensations such as burning, prickling, tingling, or numbness (paraesthesia),
• involuntary restless leg movements,
• fainting (syncope),
• sensation of numbness in the mouth (oral hypoaesthesia),
• low blood pressure,
• nightmares,
• restlessness,
• hallucinations,
• inability to remain still.

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

• tics or muscle jerks (myoclonus),
• aggression,
• abdominal pain and nausea, which may suggest inflammation of the pancreas (pancreatitis), causing severe pain in the abdomen and back.

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

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

Additional 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 significant increase in 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 Sandoz Farmacéutica

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 blister after CAD/EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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 dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mirtazapine Sandoz Farmacéutica

• The active substance is mirtazapine.

Each tablet contains 15 mg of mirtazapine.

• The other components are:

Tablet core:

Monohydrate lactose

Corn starch

Hydroxypropylcellulose

Colloidal silicon dioxide

Magnesium stearate

Tablet coating:

Hypromellose

Macrogol 8000

Titanium dioxide (E 171)

Yellow iron oxide (E 172)

Quinoline yellow (E 104)

Orange yellow S (E 110)

Appearance of the product and contents of the pack:

Yellow, round, biconvex film-coated tablets with a score line on one side.

The film-coated tablets are packed in white/opaque PVC/PVDC/aluminum blisters inserted into cardboard packaging.

Pack sizes:

6, 10, 14, 18, 20, 28, 30, 48, 50, 56, 60, 70, 90, 96, 100, 30x1, 50x1, 100x1 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee, 1

39179 Barleben

Germany

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

Austria: Mirtazapin Hexal 15 mg – Filmtabletten

Germany: Mirtazapin HEXAL® 15 mg Filmtabletten

Finland: Mirtazapin Hexal 15 mg tabletti, kalvopäällysteinen

Date of the most recent revision of this leaflet: June 2025

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/).