Leaflet: Information for the user

Mirtazapina STADA 30 mg Film-coated Tablets EFG

Read this 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, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. How to take Mirtazapina STADA

1. Possible side effects

1. Storage of Mirtazapina STADA
2. Contents of the pack and additional information

Mirtazapina STADA belongs to a group of medicines called antidepressants.

Mirtazapina STADA is used to treat depression.

Do not take Mirtazapina STADA

• if you are allergic to mirtazapina or any of the other ingredients of this medicine (listed in section 6). In that case, consult your doctor as soon as possible before taking Mirtazapina STADA.
• if you are taking or have taken in the last two weeks monoamine oxidase inhibitors (MAOIs).

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

• If you have ever had a severe skin rash or skin peeling, blisters or mouth sores after taking mirtazapina or other medicines.

Warnings and precautions

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

Children and adolescents

Mirtazapina STADA should not be used normally in the treatment of children and adolescents under 18 years since its efficacy has not been demonstrated. At the same time, it should be known that in patients under 18 years there is a higher risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medication. Nevertheless, the doctor may prescribe Mirtazapina STADA to patients under 18 years when he decides that it is the most convenient for the patient. If the doctor has prescribed Mirtazapina STADA to a patient under 18 years and wants to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms mentioned above in patients under 18 years taking Mirtazapina STADA appear or worsen. Furthermore, the long-term safety effects related to growth, maturity, and development of Mirtazapina STADA in this age group are still unknown. Moreover, significant weight increases have been observed more frequently in patients of this age category treated with Mirtazapina STADA compared to adults treated.

Suicidal thoughts and worsening of depression

If you are depressed you may sometimes have thoughts of harming yourself or of suicide. This could worsen when you start taking antidepressants for the first time, since these medicines usually take two weeks or more to have their normal effect. You may be more prone to think this way if:

• if you have previously had suicidal thoughts or self-harm.

• if you are a young adult. The information from clinical trials has shown an increased risk of suicidal behavior in young adults under 25 years with psychiatric disorders and who are being treated with an antidepressant.

If you have thoughts of harming yourself or 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 leaflet. 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 particularly careful with Mirtazapina STADA

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

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

• if you have or have had any of the following symptoms

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

In rare cases, these symptoms may be signs of changes in blood cell production in the bone marrow. Although rare, thesesymptoms appear at 4-6 weeks of treatment.

• if you are an older person. You may be more sensitive to the adverse effects of antidepressant medicines.
• Severe skin reactions, such as Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (NET), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of mirtazapina. 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 had severe skin reactions, you should not restart treatment with mirtazapina.

Other medicines and Mirtazapina STADA

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

Do not takeMirtazapina STADA with:

• monoamine oxidase inhibitors(MAOIs). Also, do not take Mirtazapina STADA during the two weeks after stopping MAOIs. If you stop taking Mirtazapina STADA, do not take MAOIs during the following two weeks. Examples of MAOIs are moclobemida, tranilcipromina (both are antidepressants), and selegilina (for Parkinson's disease).

Be carefulif you take Mirtazapina STADA with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxina, and L-tryptophan or triptans(used for migraines),tramadol(for pain),linezolid(an antibiotic),lithium(used to treat some psychiatric disorders) andSt. John's Wortpreparations.

In rare cases, Mirtazapina STADA alone or in combination with these medicines may cause the so-called serotonin syndrome. Some of the symptoms of this syndrome are: unexplained fever, sweating, palpitations, diarrhea, muscle contractions (uncontrollable), chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. If you experience a combination of these symptoms, consult your doctor immediately, as treatment must be discontinued and supportive symptomatic treatment initiated.

• the antidepressant nefazodona. It may increase the amount of Mirtazapina STADA in the blood. Inform your doctor if you are taking this medicine. You may need to reduce the dose of Mirtazapina STADA, or increase it again when stopping nefazodona.

schizophrenia medicinessuch as olanzapina.

allergy medicinessuch as cetirizina.

intense pain medicinessuch as morphine.

In combination with these medicines, Mirtazapina STADA may increase the drowsiness caused by these medicines.

fungus infection medicines(such as ketoconazol) and HIV/AIDS medicines (protease inhibitors).

If taken together with Mirtazapina STADA, these medicines may increase the amount of Mirtazapina STADA in the blood. Inform your doctor if you are taking these medicines. You may need to reduce the dose of Mirtazapina STADA, or increase it again when stopping these medicines.

tuberculosis medicinessuch as rifampicina.

If taken together with Mirtazapina STADA, these medicines may reduce the amount of Mirtazapina STADA in the blood. Inform your doctor if you are taking these medicines. You may need to increase the dose of Mirtazapina STADA, or reduce it again when stopping these medicines.

Taking Mirtazapina STADA with food, drinks, and alcohol

You may feel drowsy if you drink alcohol while taking Mirtazapina STADA.

It is recommended not to drink any alcohol.

You can take Mirtazapina STADA with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Make sure your midwife and/or doctor know that you are taking Mirtazapina STADA. When administered during pregnancy, similar medicines (SSRIs) may increase the risk of a severe 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 Mirtazapina STADA and become pregnant or want to become pregnant, consult your doctor if you can continue taking Mirtazapina STADA. If you use Mirtazapina STADA until, or shortly before, delivery, your baby will be examined to detect any possible adverse effects.

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

Driving and operating machinery

Mirtazapina STADA may affect your concentration or alertness. Make sure your faculties are not affected before driving or operating machinery.

Mirtazapina STADA contains lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult him before taking this medicine.

Follow exactly the administration instructions of this medication 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 older person or if you have a kidney or liver disease, your doctor may change the dose.

When to take Mirtazapina STADA

Take Mirtazapina STADA at the same time every day. It is better to take the Mirtazapina STADA dose all at once before going to bed. However, your doctor may recommend that you divide your Mirtazapina STADA dose into the morning and evening before going to bed. The highest dose should be taken before going to bed.

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

When to expect improvement

Normally, Mirtazapina 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 weeks of treatment, you talk to your doctor about the effects of Mirtazapina STADA:

• between 2 and 4 weeks after starting to take Mirtazapina 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 that case, talk to your doctor again after another 2-4 weeks.

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

If you take more Mirtazapina STADA than you should

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

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

If you forget to take Mirtazapina STADA

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

If you have to take your doseonce a day

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

If you have to take your dosetwice 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 usual doses in the morning and evening.

• If you have forgotten both doses, do not try to recover them. Skip both doses and the next day continue with the usual dose in the morning and evening.

If you interrupt the treatment with Mirtazapina STADA

Stop taking Mirtazapina STADA only if you consult your doctor.

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

Do not stop taking Mirtazapina STADA abruptly, even when depression has disappeared. If you stop taking Mirtazapina STADA abruptly, you may feel sick, dizzy, agitated, or anxious and have headaches.

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Some side effects are more likely than others. The possible side effects of Mirtazapina STADA are listed below and can be divided into:

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

• Tremor
• Memory problems, which in most cases resolved when treatment was discontinued

• Nausea

• Diarrhea

• Vomiting

• Difficulty, incomplete, or infrequent bowel movements (constipation)

• Urticaria or skin rash (exanthema)

• Pain in the joints (arthralgia) or muscles (myalgia)

• Back pain

• Dizziness or fainting when standing up quickly (orthostatic hypotension)

• Swelling (usually in the ankles or feet) due to fluid retention (edema)

• Fatigue

• Vivid dreams

• Confusion

• Anxiety

• Difficulty sleeping

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

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

• Exaggerated feeling of 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 movements of agitation of the legs during sleep

• Fainting (syncope)

• Feeling of numbness in the mouth (hypoaesthesia oral)

• 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 indicate liver dysfunction (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 may be a sign of pancreatitis.

Not known (frequency cannot be estimated from available data):

• Signs of infection, such as unexplained and sudden high fever, sore throat, and mouth sores (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 (dermatitis bullosa, erythema multiforme)
• Red patches on the trunk, often with blisters in the center, skin peeling, mouth sores, throat, nose, genital, and eye sores. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized erythema, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). Consult your doctor immediately if you experience these symptoms.

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

• 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 condition called "serotonin syndrome." Stop taking Mirtazapina STADA and consult your doctor immediately.

• Thoughts of self-harm or suicide. Contact your doctor or go to the hospital immediately.

• Abnormal sensations in the mouth (paresthesia oral)

• Swelling in the mouth (edema bucal)

• Increased salivation

• Difficulty speaking (dysarthria)

• Somnambulism (sleepwalking)

• Hyponatremia

• Inadequate secretion of antidiuretic hormone

• Increased levels of creatine kinase in the blood

• Difficulty urinating

• Muscle pain with stiffness and/or weakness and/or dark or discolored urine (rhabdomyolysis)

Reporting of side effects

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

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

Do not use this medication after the expiration date that appears on the packaging and in the blister or bottle, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and the

medications that you no longer need at the SIGRE collection pointof the pharmacy. Ask your pharmacist how to dispose of the packaging and the medications that you no longer need. In this way, you will help protect the environment.

Composition of Mirtazapina STADA

The active ingredient is mirtazapine.

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

The tablet can be divided into equal doses.

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

Appearance of the product and contents of the package

Mirtazapina STADA 30 mg are film-coated tablets of beige color, oblong, biconvex, and with a notch 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 single-dose PVC/PVDC/Al blister packs of 14x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, 70x1, 90x1, 100x1, 120x1, 200x1, and 500x1 tablets.

Not all package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Responsible for manufacturing:

STADA Arzneimittel AG

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

Germany

or

Clonmel Healthcare Ltd.

Waterfort Road (Clonmel, Country 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:

AustriaMirtazapin "Stada" 30 mg - Filmtabletten

DenmarkCombar

PortugalMirtazapina Ciclum 30 mg comprimidos

SpainMirtazapina STADA 30 mg film-coated tablets EFG

Date of the last review of this leaflet:October 2020

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/