MIRTAZAPINE STADA 30 mg FILM-COATED TABLETS

2. What you need to know before starting to take Mirtazapine STADA

DO NOT take Mirtazapine STADA

• if you are allergic to mirtazapine or any of the other components of this medication (listed in section 6). In this case, consult your doctor as soon as possible before taking Mirtazapine STADA.
• if you are taking or have recently taken (in the last two weeks) medications called monoamine oxidase inhibitors (MAOIs).

DO NOT TAKE - OR CONSULT YOUR DOCTOR BEFORE STARTING TO TAKE MIRTAZAPINE:

• If you have ever suffered from a severe skin rash or skin peeling, blisters, or sores in the mouth after taking mirtazapine or other medications.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Mirtazapine STADA.

Children and adolescents.

Mirtazapine STADA should not normally be used in the treatment of children and adolescents under 18 years of age, as its efficacy has not been demonstrated. At the same time, you should be aware that in patients under 18 years of age, 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 medications. Nevertheless, the doctor may prescribe Mirtazapine STADA to patients under 18 years of age when they decide it is most convenient for the patient. If the doctor has prescribed Mirtazapine STADA to a patient under 18 years of age and you want to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen in patients under 18 years of age who are taking Mirtazapine STADA. Additionally, the long-term safety effects related to growth, maturity, and development of knowledge and behavior of Mirtazapine STADA in this age group are still unknown. Furthermore, significant weight gain has been observed more frequently in patients in this age category treated with Mirtazapine STADA compared to adults treated.

Suicidal ideas and worsening of depression

If you are depressed, you may sometimes have ideas of harming yourself or committing suicide. This could worsen when you start taking antidepressants for the first time, as these medications usually take two weeks or sometimes more to take effect. You may be more prone to thinking this way if:

• you have previously had suicidal thoughts or thoughts of harming yourself.

• you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders and who were being treated with an antidepressant.

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

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

Also, be especially careful with Mirtazapine STADA

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

Tell your doctor about these situations before taking Mirtazapine STADA, if you have not already done so.

• seizures(epilepsy). If seizures occur or your seizures become more frequent, stop taking Mirtazapine STADA and contact your doctor immediately;

• liver disease, including jaundice. If jaundice occurs, stop taking Mirtazapine STADA 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 STADA 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;

• if signs of infection appear, such as high unexplained fever, sore throat, and mouth sores

→Stop taking Mirtazapine STADA and contact your doctor immediately to have a blood test done.

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 begins.

• if you are an elderly person. You may be more sensitive to the adverse effects of antidepressant medications.
• Severe 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 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, do not restart treatment with mirtazapine.

Other medications and Mirtazapine STADA

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

DO NOT takeMirtazapine STADA with:

• monoamine oxidase inhibitors(MAOIs). Also, do not take Mirtazapine STADA during the two weeks after stopping MAOIs. If you stop taking Mirtazapine STADA, do not take MAOIs for the next two weeks. Examples of MAOIs are moclobemide, tranilcipromine (both are antidepressants), and selegiline (for Parkinson's disease).

Be carefulif you take Mirtazapine STADA with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, and L-tryptophan or triptans(used for migraines), tramadol(for pain), linezolid(an antibiotic), lithium(used to treat some psychiatric disorders), and St. John's Wort – Hypericum perforatum(a medicinal plant for depression). In very rare cases, Mirtazapine STADA alone or with these medications may cause a condition called serotonin syndrome. Some symptoms of this syndrome are: unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. If you experience a combination of these symptoms, consult your doctor immediately, as treatment should be discontinued and supportive symptomatic treatment initiated.

• the antidepressant nefazodone. It may increase the amount of Mirtazapine STADA in the blood. Inform your doctor if you are taking this medication. It may be necessary to decrease the dose of Mirtazapine STADA or increase it again when stopping nefazodone.

• medications for anxiety or insomniasuch as benzodiazepines.

medications for schizophreniasuch as olanzapine.

medications for allergiessuch as cetirizine.

medications for severe painsuch as morphine.

When combined with these medications, Mirtazapine STADA may increase the drowsiness caused by these medications.

• medications for infections; medications for bacterial infections (such as erythromycin),

medications for fungal infections(such as ketoconazole) and medications for HIV/AIDS (HIV protease inhibitors).

If taken with Mirtazapine STADA, these medications may increase the amount of Mirtazapine STADA in the blood. Inform your doctor if you are taking these medications. It may be necessary to decrease the dose of Mirtazapine STADA or increase it again when stopping these medications.

• medications for epilepsysuch as carbamazepine and phenytoin;

medications for tuberculosissuch as rifampicin.

If taken with Mirtazapine STADA, these medications may decrease the amount of Mirtazapine STADA in the blood. Inform your doctor if you are taking these medications. It may be necessary to increase the dose of Mirtazapine STADA or decrease it again when stopping these medications.

• medications to prevent blood clottingsuch as warfarin. Mirtazapine STADA may increase the effects of warfarin on the blood. Inform your doctor if you are taking this medication. In case of taking them together, it is recommended that the doctor perform blood tests.

Taking Mirtazapine STADA with food, drinks, and alcohol

You may feel drowsy if you drink alcohol while being treated with Mirtazapine STADA.

It is recommended not to drink any alcohol.

You can take Mirtazapine STADA 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 medication.

Make sure your midwife and/or doctor know that you are taking Mirtazapine STADA. When similar medications (SSRIs) are administered during pregnancy, they may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing and a bluish tone in the newborn. These symptoms usually appear in the first 24 hours after birth. If this happens, contact your midwife and/or doctor immediately.

If you are taking Mirtazapine STADA and become pregnant or want to become pregnant, consult your doctor if you can continue taking Mirtazapine STADA. If you use Mirtazapine STADA until or shortly before delivery, your child will be examined for possible adverse effects.

Consult your doctor if you can breastfeed while taking Mirtazapine STADA.

Driving and using machines

Mirtazapine STADA may affect your concentration or alertness. Make sure your abilities are not affected before driving or using machinery.

Mirtazapine STADA contains lactose

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

3. How to take Mirtazapine STADA

Follow the administration instructions for this medication indicated by your doctor or pharmacist exactly. 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). The dose is usually the same for all ages. However, if you are an elderly person or have kidney or liver disease, your doctor may change the dose.

When to take Mirtazapine STADA

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

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

When you can expect to feel better

Normally, Mirtazapine STADA will start to take effect after 1 or 2 weeks, and after 2 to 4 weeks, you may start to feel better.

It is essential that during the first few weeks of treatment, you talk to your doctor about the effects of Mirtazapine STADA:

• between 2 and 4 weeks after starting to take Mirtazapine STADA, talk to your doctor

about how this medication has affected you.

If you still do not feel better, your doctor may prescribe a higher dose. In this case, talk to your doctor again after another 2-4 weeks.

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

If you take more Mirtazapine STADA than you should

If you or someone else takes too much Mirtazapine STADA, consult a doctor immediately. You can also call the Toxicology Information Service, phone: 91 562 04 20.

The most likely symptoms of a Mirtazapine STADA overdose (without other medications or alcohol) are drowsiness, disorientation, and palpitations.

If you forget to take Mirtazapine STADA

Do not take a double dose to make up for forgotten doses.

If you need to take your dose once a day

• If you forget to take your dose of Mirtazapine STADA, do not take the forgotten dose. Skip it and take your usual dose the next day.

If you need 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 with your normal doses 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 treatment with Mirtazapine STADA

Stop taking Mirtazapine STADA only if you consult your doctor.

If you stop too soon, depression may recur. When you feel better, talk to your doctor. Your doctor will decide when you can stop treatment.

Do not stop taking Mirtazapine STADA abruptly, even if depression has disappeared. If you stop taking Mirtazapine STADA abruptly, you may feel unwell, dizzy, agitated, or anxious and have headaches.

These symptoms can be avoided by gradually stopping treatment. Your doctor will indicate how to gradually decrease the dose.

If you have any other questions about the use of this medication, 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. Some adverse effects are more likely than others. The possible adverse effects of Mirtazapina STADA are indicated below and can be divided into:

Very Frequent (may affect more than 1 in 10 people):

• increased appetite and weight gain

• drowsiness

• headache

• dry mouth

Frequent (may affect up to 1 in 10 people):

• lethargy

• dizziness

• tremor
• memory problems, which in most cases were resolved when treatment was discontinued

• nausea

• diarrhea

• vomiting

• difficult, incomplete, or infrequent bowel movements (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 (edema)

• fatigue

• vivid dreams

• confusion

• anxiety

• difficulty sleeping

In children under 18 years of age, the following adverse effects were frequently observed in clinical trials: significant weight gain, hives, and increased triglycerides in the blood.

Infrequent (may affect up to 1 in 100 people):

• feeling of exaggerated euphoria (mania). Stop taking Mirtazapina STADA and consult your doctor immediately.

• strange sensation in the skin, such as burning, pinching, tingling, or numbness (paresthesia)

• involuntary leg movements during sleep

• fainting (syncope)

• numbness 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):

• yellowing of the eyes or skin; may suggest liver function alterations (jaundice). Stop taking Mirtazapina STADA and consult your doctor immediately.

• tics or muscle contractions (myoclonus)

• aggression

• severe stomach pain, which can radiate to the back. This could be a sign of pancreatitis.

Unknown frequency (frequency cannot be estimated from available data):

• infection signs such as unexplained and sudden high fever, sore throat, and mouth ulcers (agranulocytosis). Stop taking Mirtazapina STADA and consult your doctor immediately for a blood test.

In rare cases, Mirtazapina STADA may cause alterations in blood cell production (bone marrow depression). Some people become less resistant to infections because Mirtazapina STADA may cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, Mirtazapina STADA may also cause a decrease in red and white blood cells and platelets (aplastic anemia), a decrease in platelets (thrombocytopenia), or an increase in white blood cells in the blood (eosinophilia).

• severe skin reactions (bullous dermatitis, erythema multiforme)
• red patches on the trunk, such as circumscribed or circular macules, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• generalized erythema, elevated body temperature, and lymph node enlargement (DRESS or drug hypersensitivity syndrome). Consult your doctor immediately if you experience these symptoms.

• epileptic seizure (convulsions). Stop taking Mirtazapina STADA and consult your doctor immediately.

• a combination of symptoms such as unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. In very rare cases, these symptoms may be signs of a disorder called "serotonin syndrome". Stop taking Mirtazapina STADA and consult your doctor immediately.

• thoughts of self-harm or suicide. Contact your doctor or go directly to the hospital.

• abnormal sensations in the mouth (oral paresthesia)

• swelling in the mouth (oral edema)

• increased salivation

• difficulty speaking (dysarthria)

• sleepwalking (somnambulism)

• hyponatremia

• inadequate secretion of antidiuretic hormone

• increased blood levels of creatine kinase

• difficulty urinating

• muscle pain with stiffness and/or weakness and darkening or discoloration of urine (rhabdomyolysis)

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them 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 Mirtazapina STADA

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date shown on the packaging and on the blister or vial, 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 wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. 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 Mirtazapina STADA

The active ingredient is mirtazapine.

Each Mirtazapina STADA 30 mg film-coated tablet contains 30 mg of mirtazapine.

The tablet can be divided into equal doses.

The other components are: lactose monohydrate, corn starch, hydroxypropylcellulose, colloidal anhydrous silica, magnesium stearate, hypromellose, macrogol 8000, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), and black iron oxide (E172)

Appearance of the Product and Package Contents

Mirtazapina STADA 30 mg are film-coated tablets of beige color, oblong, biconvex, and with a score line on one side.

Mirtazapina STADA 30 mg is available in PVC/PVDC/Al blister packs of 14, 20, 28, 30, 50, 56, 60, 70, 90, 100, 120, 200, and 500 tablets, and in PVC/PVDC/Al unit dose blister packs of 14x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, 70x1, 90x1, 100x1, 120x1, 200x1, and 500x1 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Manufacturer:

STADA Arzneimittel AG

Stadastrasse 2-18 (Bad Vilbel) - D- 61118

Germany

or

Clonmel Healthcare Ltd.

Waterfort Road (Clonmel, County Tipperary)

Ireland

or

Combino Pharm (Malta) Ltd

HF 60, Hal Far Industrial Estate (Hal Far)

BBG07 Malta

or

Combino Pharm, S.L.

Fructuós Gelabert, 6-8

08970 Sant Joan Despí (Barcelona)

or

STADA ARZNEIMITTEL GMBH.

Muthgasse 36 (Vienna)

A-1190 – Austria

or

Lamp San Prospero S.p.a.

Via Della Pace, 25/A

41030 San Prospero (MO)

Italy

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

This medicine is authorized in the Member States of the European Economic Area with the following names:

Austria Mirtazapin "Stada" 30 mg - Filmtabletten

Denmark Combar

Portugal Mirtazapina Ciclum 30 mg tablets

Spain Mirtazapina STADA 30 mg film-coated tablets EFG

Date of the last revision of this prospectus:October 2020

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