MIRTAZAPINE SANDOZ 30 mg FILM-COATED TABLETS

2. What you need to know before you take Mirtazapine Sandoz Pharmaceutical

DO NOT TAKE OR CONSULT YOUR DOCTOR BEFORE TAKING Mirtazapine Sandoz Pharmaceutical

• if you are allergicto 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,
• • if you are taking or have taken recently (in the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs),
  • if you have ever suffered from a severe skin rash or skin peeling, blisters or sores in the mouth after taking mirtazapine or other medicines.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Mirtazapine Sandoz Pharmaceutical.

Children and adolescents

Mirtazapine should not normally be used in the treatment of children and adolescents under 18 years because it has not been shown to be effective. At the same time, you should know that in patients under 18 years there is a greater risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritation) when taking this class of medicines. Nevertheless, the doctor may prescribe mirtazapine to patients under 18 years when he decides what is most convenient for the patient. If the doctor has prescribed mirtazapine to a patient under 18 years and you want to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen in patients under 18 years who are taking mirtazapine. Additionally, the long-term safety effects related to growth, maturity, and development of knowledge and behavior of mirtazapine in this age group are not yet known. Additionally, a significant weight gain has been observed in this age group more often 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 could get worse when you first start taking antidepressants, as these medicines take normally two weeks or sometimes more to work.

You may be more likely to think this way:

• if you have previously had thoughts of suicide or self-harm,
• if you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years with psychiatric disorders and who were being treated with an antidepressant.

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

It may be helpful to tell a relative or close friendthat you are depressed, and ask them to read this leaflet. You can ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behavior.

Also, be especially careful with mirtazapine:

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

→ Inform your doctor about these situations before taking Mirtazapine Sandoz Pharmaceutical, if you have not already:

• 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 appears, stop taking mirtazapine and contact your doctor immediately,
• kidney disease,
• heart diseaseor 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 excitement/hyperactivity and periods of depression). If you start to feel excited or overexcited, stop taking mirtazapine and contact your doctor immediately,
• diabetes(you may need to adjust your insulin or other antidiabetic medication dose),
• eye diseases, such as increased pressure in the eye (glaucoma),
• difficulty urinating, which may be due to an enlarged prostate,
• certain cases of heart conditionsthat can change your heart rhythm, a recent heart attack, heart failure, or taking certain medications that can affect heart rhythm,
• • if signs of infection appear, such as unexplained high fever, sore throat, and mouth sores,

→ Stop taking mirtazapine and contact your doctor immediately to have a blood test.

In rare cases, these symptoms can be signs of alterations in blood cell production in the bone marrow. Although rare, these symptoms usually appear 4-6 weeks after treatment.

• if you are an elderly patient, you may be more sensitive to the adverse effects of antidepressant medicines
• Severe skin reactions have been reported with the use of mirtazapine, including Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Discontinue use and seek medical attention immediately if you notice any of the symptoms described in section 4 related to these severe skin reactions.
• If you have ever suffered from severe skin reactions, you should not restart treatment with mirtazapine.

Taking Mirtazapine Sandoz Pharmaceutical with other medicines

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

DO NOT TAKE Mirtazapine Sandoz Pharmaceuticalwith:

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

BE CAREFULif you take Mirtazapine Sandoz Pharmaceutical 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 some psychiatric disorders), methylthioninium chloride (used to treat high levels of methemoglobin in the blood) and St. John's Wort –Hypericum perforatum(a medicinal plant for depression). In rare cases, mirtazapine alone or with these medicines can cause a condition called serotonin syndrome. Some of the symptoms of this syndrome are: unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), shivering, 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 can increase the amount of mirtazapine in the blood. Inform your doctor if you are taking this medicine. It may be necessary to decrease the dose of mirtazapine, or increase it again when stopping nefazodone.
• medicines for anxiety or insomniasuch as benzodiazepines;
• medicines for schizophreniasuch as olanzapine;
• medicines for allergiessuch as cetirizine;
• medicines for severe painsuch as morphine.

In combination with these medicines, mirtazapine can 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 with mirtazapine, these medicines can increase the amount of mirtazapine in the blood. Inform your doctor if you are taking these medicines. It may be necessary to decrease the dose of mirtazapine, or increase it again when stopping these medicines,

• medicines for epilepsysuch as carbamazepine and phenytoin;
• medicines for tuberculosissuch as rifampicin;

If taken with mirtazapine, these medicines can 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 clottingsuch as warfarin.

Mirtazapine can increase the effects of warfarin in the blood. Inform your doctor if you are taking this medicine. In case of taking them together, it is recommended that the doctor perform blood tests.

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

Taking Mirtazapine Sandoz Pharmaceutical 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 can 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. The limited experience of administering 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 until, 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 disease in babies, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and acquire a bluish tone. These symptoms usually start during the first 24 hours after birth. If this happens to your child, you should contact your midwife and/or doctor immediately.

Driving and using machines

Mirtazapine Sandoz Pharmaceutical may affect your concentration or alertness. Make sure your abilities are not affected before driving or using machinery. If your doctor has prescribed mirtazapine to a patient under 18 years, make sure that concentration and alertness are not affected before circulating (e.g., by bicycle).

Mirtazapine Sandoz Pharmaceutical contains lactose and orange yellow S (E110)

This medicine contains lactose. If your doctor has told 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 orange yellow S (E110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Mirtazapine Sandoz Pharmaceutical

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much to take

The recommended initial 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 an elderly patient or have kidney or liver disease, your doctor may change the dose.

When to take it

→ Take Mirtazapine Sandoz Pharmaceutical at the same time every day. It is best to take the dose of Mirtazapine Sandoz Pharmaceutical once before bedtime. However, your doctor may recommend that you divide your dose of Mirtazapine Sandoz Pharmaceutical in the morning and before bedtime. The highest dose should be taken before bedtime.

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

The tablets can be divided into equal doses.

When you can expect to feel better

Normally, Mirtazapine Sandoz Pharmaceutical will start to work after 1 or 2 weeks, and after 2 to 4 weeks, you may start to feel better.

It is important that during the first few weeks of treatment, you talk to your doctor about the effects of mirtazapine:

→ between 2 and 4 weeks after starting to take Mirtazapine Sandoz Pharmaceutical, 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, talk to your doctor again after another 2-4 weeks.

Normally, you will need to take Mirtazapine Sandoz Pharmaceutical until the symptoms of depression have disappeared for 4-6 months.

If you take more Mirtazapine Sandoz Pharmaceutical than you should

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

The most likely symptoms of an overdose of Mirtazapine Sandoz Pharmaceutical (without other medicines or alcohol) are drowsiness, disorientation, and palpitations. The symptoms of a possible overdose may include changes in your heart rhythm (fast, irregular heartbeat) and/or fainting, which could be symptoms of a potentially life-threatening disease known as Torsade de Pointes.

If you forget to take Mirtazapine Sandoz Pharmaceutical

If you have to take your dose once a day

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

If you have to take your dose twice a day

• If you have forgotten the morning dose, simply take it with the evening dose.
• If you have forgotten the evening dose, do not take it the next morning, skip it and continue treatment with your normal dose in the morning and evening.
• If you have forgotten both doses, do not try to make them up. Skip both doses and the next day continue with your normal dose in the morning and evening.

If you stop taking Mirtazapine Sandoz Pharmaceutical:

→ Stop taking Mirtazapine Sandoz Pharmaceutical only if you consult your doctor.

If you stop too soon, depression may come back. 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 abruptly, you may feel sick, dizzy, agitated, or anxious, and have headaches. These symptoms can be avoided by gradually stopping treatment. Your doctor will tell you how to gradually decrease the dose.

If you have any other 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 all people suffer from 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):

• yellowish discoloration of the eyes or skin; may suggest liver function alterations (jaundice).

Frequency Not Known(frequency cannot be estimated from available data):

• signs of infection such as high, unexplained, and sudden fever, sore throat, and sores in the mouth (agranulocytosis). In rare cases, mirtazapine may cause alterations in blood cell production (bone marrow depression). Some people become less resistant to infections because mirtazapine can 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 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 salivation. In very rare cases, these symptoms may be signs of a disorder called "serotonin syndrome".
• thoughts of self-harm or suicide.
• red patches on the torso, such as circumscribed or circular macules, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin erythemas 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,
• sleepiness,
• headache,
• dry mouth.

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

• lethargy,
• dizziness,
• agitation or tremor,
• nausea,
• diarrhea,
• vomiting,
• constipation,
• urticaria or skin eruptions (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 were resolved when treatment was discontinued.

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

• strange sensation in the skin, such as burning, pinching, tingling, or numbness (paresthesia),
• involuntary movements of the legs,
• fainting (syncope),
• numbness of the mouth (oral hyposthesia),
• low tension,
• 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 and nausea, which may suggest pancreatitis, causing intense pain in the abdomen and back.

Frequency Not Known(frequency cannot be estimated from available data):

• • abnormal sensations in the mouth (oral paresthesia),
  • swelling in the mouth (oral edema),
  • generalized swelling (generalized edema),
  • localized swelling,
  • hyponatremia,
  • inadequate secretion of antidiuretic hormone,
  • severe 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),
• abnormally high levels of prolactin hormone in the blood (and related symptoms such as milky secretion and swelling of breast tissue in men).

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 triglycerides in the blood.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Mirtazapine Sandoz Pharmaceutical

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Mirtazapine Sandoz Pharmaceutical

• The active ingredient is mirtazapine.

Each tablet contains 30 mg of mirtazapine.

• The other components are:

Tablet core:

Lactose monohydrate

Cornstarch

Hydroxypropylcellulose

Colloidal silicon dioxide

Magnesium stearate

Tablet coating:

Hypromellose

Macrogol 8000

Titanium dioxide (E 171)

Yellow iron oxide (E 172)

Red iron oxide (E 172)

Black iron oxide (E 172)

Product Appearance and Package Contents:

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

The film-coated tablets are packaged in white/opaque PVC/PVDC/aluminum blisters inserted into a cardboard box.

Package sizes:

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

Not all package 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

Salutas Pharma GmbH

Otto-von-Guericke-Allee, 1

39179 Barleben

Germany

This medicine is authorized in the member states of the European Economic Area under the following names:

Finland: Mirtazapin Hexal

Austria: Mirtazapin Hexal 30 mg - Filmtabletten

Germany: Mirtazapin HEXAL® 30 mg Filmtabletten

Norway: Mirtazapin Hexal 30 mg filmdrasjerte tabletter

Sweden: Mirtazapin Hexal

Date of the Last Revision of this Prospectus:December 2020

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