PATIENT INFORMATION LEAFLET

Mirtazapina Flas STADA 30 mg orally disintegrating 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. Do 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. What you need to know before taking Mirtazapina Flas STADA

1. How to take Mirtazapina Flas STADA

1. Possible side effects
2. Storage of Mirtazapina Flas STADA

1. Contents of the pack and additional information

Mirtazapina Flas STADA belongs to a group of medicines calledantidepressants.

Mirtazapina Flas STADA is used to treat depression.

Do not take Mirtazapina Flas STADA

• If you are allergic to mirtazapine or any of the other ingredients of this medication (listed in section 6). In that case, consult your doctor as soon as possible before taking Mirtazapina Flas STADA.

• If you are taking or have taken in the last two weeks monoamine oxidase inhibitors (MAOIs) medications.

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

If you have ever had a severe skin rash or skin peeling, blisters or mouth sores after taking mirtazapine or other medications.

Warnings and precautions

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

Children and adolescents

Mirtazapina Flas STADA should not be used normally in the treatment of children and adolescents under 18 years old. Also, be aware that in patients under 18 years old, there is a higher risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medication. However, your doctor may prescribe Mirtazapina Flas STADA to patients under 18 years old when they decide what is best for the patient. If your doctor has prescribed Mirtazapina Flas STADA to a patient under 18 years old and wants to discuss this decision, please return to your doctor. You must inform your doctor if any of the symptoms mentioned above appear or worsen in patients under 18 years old who are taking Mirtazapina Flas STADA. Additionally, the long-term effects on safety related to growth, maturity, and development of Mirtazapina Flas STADA in this age group have not yet been demonstrated.

Suicidal thoughts and worsening of depression

If you are depressed, you may sometimes have thoughts of harming yourself or suicide. This could worsen when you start taking antidepressants for the first time, as these medications usually take two weeks or more to have their normal effect.

You may be more prone to thinking this way:

• 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 adults under 25 years old 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 the 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 especially careful with Mirtazapine Flas STADA

• If you have or have had any of the following conditions.

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

• If you have or have had any of the following symptoms.

• Stop taking Mirtazapine Flas STADA and contact your doctor immediately to perform a blood test.

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

• 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 (SSJ), 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 had severe skin reactions, do not restart treatment with mirtazapine.

Other medications and Mirtazapine Flas STADA

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

Do not take Mirtazapine Flas STADAin combination with:

• monoamine oxidase inhibitors(MAOIs). Also, do not take Mirtazapine Flas STADA during the two weeks after stopping MAOIs. If you stop taking Mirtazapine Flas STADA, do not take MAOIs for the next two weeks.

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

Be carefulif you take Mirtazapine Flas STADA in combination with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxineandL-tryptophan or triptans(used for migraines), tramadol(for pain), linezolid(an antibiotic),lithium(used to treat some psychiatric disorders) and herbal preparations based onSt. John's Wort–Hypericum perforatum(medicinal plant for depression). In rare cases, Mirtazapine Flas STADA alone or in combination with these medications 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.

• the antidepressant nefazodone. It may increase the amount of Mirtazapine Flas STADA in the blood. Inform your doctor if you are taking this medication. You may need to reduce the dose of Mirtazapine Flas STADA, or increase it again when you stop taking nefazodone.

• anxiety or insomnia medicationssuch as benzodiazepines;
• schizophrenia medicationssuch as olanzapine;
• allergy medicationssuch as cetirizine;
• intense pain medicationssuch as morphine;

In combination with these medications, Mirtazapine Flas STADA may increase the drowsiness caused by these medications.

• infection medications:infection medications (such as erythromycin),
• antifungal medications(such as ketoconazole) and HIV/AIDS medications (protease inhibitors).

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

• medications for heartburn and stomach ulcers(cimetidine).

Cimetidine may increase the amount of Mirtazapine Flas STADA in the blood. Inform your doctor if you are using cimetidine. You may need to reduce the dose of Mirtazapine Flas STADA, or increase it again when you stop taking these medications.

• epilepsy medicationssuch as carbamazepine and phenytoin;
• tuberculosis medicationssuch as rifampicin.

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

• blood thinnerssuch as warfarin.

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

Taking Mirtazapine Flas STADA with food and alcohol

You may feel drowsy if you drink alcohol while taking Mirtazapine Flas STADA. It is recommended not to drink any alcohol. You can take Mirtazapine Flas 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 medication.

Make sure your midwife and/or doctor know that you are taking Mirtazapine Flas STADA. When administered during pregnancy, similar medications (SSRIs) may increase the risk of a severe condition in newborns, called persistent pulmonary hypertension of the newborn, 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 Flas STADA and become pregnant or want to become pregnant, consult your doctor if you can continue taking Mirtazapine Flas STADA. If you use Mirtazapine Flas 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 Mirtazapine Flas STADA.

Driving and operating machinery

Mirtazapine Flas STADA may affect your concentration or alertness. Make sure these abilities are not impaired before driving or operating machinery.

Mirtazapine Flas STADA contains aspartame

This medication contains 12 mg of aspartame in each tablet. Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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

How much to take

The initial normal 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 if you have kidney or liver problems, yourdoctor may change the dose.

When to take Mirtazapina Flas STADA

? Take Mirtazapina Flas STADA at the same time every day.

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

Take the buccal tablets in the following way

Take the tablets orally.

Mirtazapina Flas STADA buccal tablets are available in bottles or in two different types of blisters: normal blister and peelable blister. You should follow the following information if your tablets are in a peelable blister.

Follow the 4 stages described below to open the peelable blister and take the tablet:

1. Do not break the buccal tablet

To avoid breaking the buccal tablet, do not push the alveolus of the tablet (Figure 1).

Figure 1

2. Separate a compartment with a tablet

Each blister contains six compartments with tablets, separated by perforated lines. Separate one by the perforated line (Figure 2)

Figure 2

3. Separate the blister sheet

Separate carefully the blister sheet starting from the corner indicated with arrows (Figures 3).

Figure 3

4. Remove the buccal tablet

Remove the buccal tablet with dry hands and place it on the tongue (Figure 4).

Figure 4

It will quickly disintegrate and can be swallowed without water.

When to expect to feel better

Mirtazapina Flas STADA usually starts to work 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 Flas STADA:

• between 2 and 4 weeks after starting to take Mirtazapina Flas 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 Flas STADA until the symptoms of depression have disappeared for 4-6 months.

If you take more Mirtazapina Flas STADA than you should

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

The most likely symptoms of an overdose of Mirtazapina Flas STADA (without other medications or alcohol) aresleepiness, disorientation, and palpitations.

If you forgot to take Mirtazapina Flas STADA

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

If you have to take your doseonce a day

• If you forget to take your dose of Mirtazapina Flas STADA, 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 nottry 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 Flas STADA

? Stop taking Mirtazapina Flas STADA only if you consult with your doctor.

If you lead it 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 Flas STADA abruptly, even when depression has disappeared. If you stop taking Mirtazapina Flas 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.

If you experience one or more of the following side effects, stop taking Mirtazapina Flas STADA and inform your doctor immediately!

Unknown (frequency cannot be estimated from available data):

• Thoughts of self-harm or suicide (please go to the nearest hospital)

• A combination of symptoms such as unexplained fever, sweating, increased heart rate, diarrhea, muscle contractions (involuntary), chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. In very rare cases, these may be signs of serotonin syndrome.

• Seizure (convulsion).

• Signs of infection such as unexplained high fever, sore throat, and mouth ulcers (agranulocytosis). In rare cases, Mirtazapina Flas STADA may cause alterations in blood cell production (bone marrow depression). Some people become less resistant to infections because Mirtazapina Flas STADA may cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, Mirtazapina Flas 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).

• Red patches on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat ulcers, nasal ulcers, genital ulcers, and eye ulcers. These severe skin eruptions 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).

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

• Feeling euphoric or emotionally "high" (mania).

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

• Yellowing of the eyes or skin, which may indicate liver function alterations (jaundice).

Some side effects are more likely than others. The possible side effects of Mirtazapina Flas 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, sluggishness, or indifference

• Dizziness

• Tremors or shivering
• Memory problems, which in most cases resolved when treatment was suspended.

• Nausea

• Diarrhea

• Vomiting

• Hives or skin eruptions (exanthema)

• Joint or muscle pain (arthralgia or 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
• Constipation

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

• Strange sensation in the skin, e.g. burning, pinching, tingling, or numbness (paresthesia)

• Restless legs

• Fainting (syncope)

• Reduced sensation 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):

• Tics or muscle contractions (myoclonus)

• Aggression

• Severe stomach pain, which may reach the back. This could be a sign of pancreatitis.

Unknown (frequency cannot be estimated from available data):

• Abnormal sensations in the mouth (paresthesia oral)

• Swelling in the mouth (buccal edema)

• Increased salivation

• Difficulty speaking (dysarthria)
• Sleepwalking (somnambulism)

• Low sodium levels in the blood, which may cause fatigue and confusion, muscle contractions, seizures, and coma (hyponatremia)

• Excessive production of antidiuretic hormones (hormones that help the kidneys and body conserve the correct amount of water). The syndrome causes the body to retain water and certain levels of electrolytes in the blood (such as sodium) [inadequate secretion of antidiuretic hormone].

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

Other possible side effects of mirtazapine include:

Increased levels of creatine kinase in the blood, difficulty urinating, and muscle pain, stiffness, and/or weakness and dark or discolored urine.

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 Pharmacovigilance 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, after CAD. The expiration date is the last day of the month indicated.

Storage conditions (blister): Store in the original packaging to protect it from light and moisture.

Storage conditions (bottle): Store in the original packaging and keep it perfectly closed to protect it from light and moisture.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Mirtazapina Flas STADA Composition

The active ingredient is mirtazapine.

Mirtazapina Flas STADA 30 mg buccal tablets contain 30 mg of mirtazapine per buccal tablet.

The other components are: mannitol, microcrystalline cellulose, heavy magnesium carbonate, hydroxypropylmethylcellulose, crospovidone, anhydrous colloidal silica, L-methionine, microcrystalline cellulose, and guar gum, aspartame (E951), orange aroma, and magnesium stearate.

Product appearance and packaging contents

Mirtazapina Flas STADA are buccal tablets.

30 mg tablets: white or almost white, round, 10 mm in diameter, biconvex, non-coated, and with the mark M2.

Blister pack with 6, 10, 18, 30, 48, 60, 84, 90, 96, 100, and 180 (clinical packs of 18x10) tablets.

Perforated single-dose blister pack with 6, 10, 18, 30, 48, 60, 84, 90, 96, 100, and 180 (clinical packs of 18x10) tablets.

Bottle: 50, 100 tablets (desiccant included)

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

STADA Laboratorios, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Manufacturer responsible:

Coripharma ehf.

Reykjavíkurvegur 78

P.O. Box 420

IS-220 Hafnarfjördur

Islandia

or

Actavis Ltd.

BLB 016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

or

STADA Arzneimittel AG

Stadastr. 2-18,

D-61118 Bad Vilbel

Germany

or

Lamp S. Prospero S.p.A.

Via della Pace, 25/A

41030 – San Prospero (Modena)

Italy

or

SANICO NV

Veedijk 58 – 59

BE – 2300 Turnhout

Belgium

or

Fundació Dau Laboratories

c/ C 12-14,

Industrial Zone of the Free Zone,

08040 Barcelona

Spain

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

BE:Mirtazapine EG Instant 30 mg

DE:Mirtazapin AL 30 mg Schmelztabletten

DK:Mirtazapin STADA

ES:Mirtazapina Flas STADA 30 mg buccal tablets EFG

IT:MIRTAZAPINA EG STADA 30 mg orodispersible tablets

PT:Mirtazapina Ciclum 30 mg orodispersible tablets

Last review date of this leaflet:October 2020

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/