Mirtazapine Sandoz 15 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Mirtazapine Sandoz 15 mg film-coated tablets EFG

Mirtazapine Sandoz 30 mg film-coated tablets EFG

Mirtazapine Sandoz 45 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 must 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.

Leaflet contents

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

1. What Mirtazapine Sandoz 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 you can expect to start feeling better".

2. What you need to know before taking Mirtazapine Sandoz

Do not take Mirtazapine Sandoz

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

Warnings and precautions

Talk to your doctor or pharmacist before starting mirtazapine.

Tell your doctor before taking Mirtazapine Sandoz:

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

Children and adolescents

Mirtazapine is not normally used to treat children and adolescents under 18 years of age because its effectiveness 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 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 contact your doctor again. 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 with mirtazapine in this age group are not yet known. 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 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 work.

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 behaviour 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 family member 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, be especially careful with mirtazapine

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

Tell 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 you develop jaundice, 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 insulin dose or other antidiabetic medicines);
  • eye diseases, 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 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 be signs of disturbances in blood cell production in the bone marrow. Although rare, these symptoms typically appear between 4 and 6 weeks after starting treatment.

• if you are an elderly patient. 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 experienced serious skin reactions, mirtazapine treatment should not be restarted.

Other medicines and Mirtazapine Sandoz

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

Do not take Mirtazapine Sandoz 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 two weeks afterwards.

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

Be careful if you take mirtazapine together with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine and L-tryptophan or triptans (used to treat migraine), buprenorphine (used to treat pain or opioid dependence), tramadol (for pain), linezolid (an antibiotic), lithium (used to treat certain psychiatric disorders), methylene blue (used to treat high levels of methaemoglobin 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, palpitations, diarrhoea, uncontrollable muscle twitching, 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.

When taken together 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) 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 enhance the effects of warfarin on the blood. Inform your doctor if you are taking this medicine. If taken together, your doctor is advised to monitor your blood regularly,

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

Taking Mirtazapine Sandoz 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.

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 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 a serious condition in newborns 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 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 riding (e.g. on a bicycle).

Mirtazapine Sandoz contains lactose

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

3. How to take Mirtazapine Sandoz

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). Normally, the dose is the same for all age groups. However, if you are elderly or if you have kidney or liver disease, your doctor may adjust the dose.

When to take Mirtazapine Sandoz

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

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

Mirtazapine Sandoz 15 mg film-coated tablets EFG and Mirtazapine Sandoz 30 mg film-coated tablets EFG:

The tablet can be divided into equal doses.

When you can expect to feel better

Mirtazapine usually starts to work after 1 or 2 weeks, and you may start to feel better after 2 to 4 weeks.

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 to your doctor again after another 2 or 4 weeks.

You will usually need to take mirtazapine until depressive symptoms have disappeared for 4 to 6 months.

If you take more Mirtazapine Sandoz than you should

If you or someone else takes too much mirtazapine, contact a doctor immediately, your pharmacist, or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and amount taken.

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.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and amount ingested.

If you forget to take Mirtazapine Sandoz

If you are supposed to take your dose once daily

• do not take a dose to make up for the missed dose. 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 make them up. Skip both doses and the next day continue with your normal morning and evening doses.

If you stop taking Mirtazapine Sandoz

Stop taking mirtazapine only after consulting 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 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 using 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 contact 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; this may indicate liver dysfunction (jaundice).

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

• signs of infection such as sudden unexplained 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 temporarily reduce white blood cells (granulocytopenia). In very rare cases, mirtazapine may also cause a reduction 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 saliva production. In very rare cases, these symptoms may indicate a disorder called "serotonin syndrome",
• thoughts of harming yourself or of suicide,
• serious skin reactions:
  • red patches on the trunk, as circumscribed or circular spots, often with blisters in the center, 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),
  • widespread 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,
• 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 the 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):

• unusual skin sensations such as burning, prickling, tingling, or numbness (paraesthesia),
• involuntary restless leg movements,
• fainting (syncope),
• numbness sensation in the mouth (oral hypoesthesia),
• low blood pressure,
• nightmares,
• restlessness,
• 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,
• serious skin reactions (bullous dermatitis, erythema multiforme),
• sleepwalking (somnambulism),
• 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),
• increased levels of prolactin hormone in the blood (hyperprolactinaemia, including symptoms such as breast enlargement and/or milky discharge from the nipples),
• painful and prolonged erection of the penis.

Other adverse effects in children and adolescents

In clinical trials, the following adverse effects were commonly observed in individuals under 18 years of age: 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 Sandoz

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

Do not use this medicine after the expiry date stated on the container, bottle, and blister pack after CAD/EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

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

6. Contents of the pack and other information

Composition of Mirtazapina Placasod

The active substance is mirtazapine.

Mirtazapina Placasod 15 mg film-coated tablets EFG

Each film-coated tablet contains 15 mg of mirtazapine.

Mirtazapina Placasod 30 mg film-coated tablets EFG

Each film-coated tablet contains 30 mg of mirtazapine.

Mirtazapina Placasod 45 mg film-coated tablets EFG

Each film-coated tablet contains 45 mg of mirtazapine.

The other components are:

Tablet core: lactose monohydrate, corn starch, hypromellose, anhydrous colloidal silica, magnesium stearate.

Coating: hypromellose (E 464), macrogol (E 1521), titanium dioxide (E 171).

Mirtazapina Placasod 15 mg film-coated tablets EFG

yellow iron oxide (E 172).

Mirtazapina Placasod 30 mg film-coated tablets EFG

yellow iron oxide (E 172), red iron oxide (E 172).

Appearance of the product and contents of the pack

Film-coated tablets.

Mirtazapina Placasod 15 mg film-coated tablets EFG

Yellow, oval-shaped, biconvex film-coated tablet, approximately 10 mm x 6 mm, with the inscription "MH" in relief on one side and "1" and "5" on the other, separated by a score line.

Mirtazapina Placasod 30 mg film-coated tablets EFG

Reddish-brown, oval-shaped, biconvex film-coated tablet, approximately 13 mm x 7 mm, with the inscription "MH" in relief on one side and "3" and "0" on the other, separated by a score line.

Mirtazapina Placasod 45 mg film-coated tablets EFG

White, oval-shaped, biconvex film-coated tablet, approximately 14 mm x 8 mm, with the inscription "MH" in relief on one side and "45" on the other.

Pack sizes:

Opaque white PVC/Al blisters: 20, 30, 60, 100, 105 film-coated tablets.

HDPE bottle with PP cap: 250 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Pharmadox Healthcare Ltd.,

KW20A Kordin Industrial Park

Paola, PLA 3000,

Malta

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179 Berleben, Saxony-Anhalt

Germany

or

Lek pharmaceuticals D.D

Verovškova Ulica 57,

Ljubljana, 1526

Slovenia

Date of the most recent revision of this leaflet: 02/2024.

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.