MIRTAZAPINE STADA 15 mg ORALLY DISINTEGRATING TABLETS

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

Do not take Mirtazapine Flas STADA

• If you are allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6). If so, consult your doctor immediately before taking Mirtazapine Flas STADA.

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

Do not take - or consult your doctor before taking Mirtazapine Flas STADA:

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

Warnings and precautions

Consult your doctor or pharmacist before taking Mirtazapine Flas STADA.

Children and adolescents

Mirtazapine Flas STADA should not normally be used in the treatment of children and adolescents under 18 years. You should also know that in patients under 18 years there is an increased risk of adverse effects such as suicidal attempts, suicidal thoughts/ideas and hostility (predominantly aggression, confrontational behavior and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Mirtazapine Flas STADA to patients under 18 years when he decides what is best for the patient. If your doctor has prescribed Mirtazapine Flas STADA to a patient under 18 years and you wish to discuss this decision, please go back to your doctor. You should inform your doctor if any of the above symptoms appear or worsen in patients under 18 years taking Mirtazapine Flas STADA. Additionally, the long-term effects on safety related to growth, maturation, and development of knowledge and behavior of Mirtazapine Flas STADA in this age group have not yet been established.

Suicidal thoughts and worsening of depression

If you are depressed you may sometimes have thoughts of harming or killing yourself. This may be more likely when you first start taking antidepressants, as these medicines can take between two weeks or sometimes longer to start working.

You may be more likely to think this way:

• If you have previously had thoughts of killing or harming yourself.

• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in young adults under 25 years with psychiatric disorders who are being treated with an antidepressant.

• If you have thoughts of killing or harming yourself 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 may 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 very careful with Mirtazapine Flas STADA

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

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

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

• liver disease, including jaundice. If jaundice occurs, stop taking Mirtazapine Flas STADA 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(alternating periods of excitement/hyperactivity and periods of depression). If you start to feel excited or overexcited, stop taking Mirtazapine Flas 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 unexplained high fever, sore throat, and mouth ulcers

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

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

• If you are an elderly person. You may be more sensitive to the adverse effects of antidepressant medicines.
• 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 had severe skin reactions, do not restart treatment with mirtazapine.

Other medicines and Mirtazapine Flas STADA

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

Do not take Mirtazapine Flas STADAin combination with:

• monoamine oxidase inhibitors(MAOIs). Also, do not take Mirtazapine Flas STADA during the two weeks after you stop taking MAOIs. If you stop taking Mirtazapine Flas STADA, 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 Flas STADA in combination with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxineand L-tryptophan or triptans(used for migraine), tramadol(for pain), linezolid(an antibiotic), lithium(used to treat some psychiatric disorders) and preparations based on St. John's Wort–Hypericum perforatum(a medicinal plant for depression). In very rare cases, Mirtazapine Flas STADA alone or in combination with these medicines may lead to the so-called serotonin syndrome. Some 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 may increase the amount of Mirtazapine Flas STADA in the blood. Inform your doctor if you are taking this medicine. It may be necessary to decrease the dose of Mirtazapine Flas STADA, or increase it again when you stop taking nefazodone.

• medicines for anxiety or insomniasuch as benzodiazepines;
• medicines for schizophreniasuch as olanzapine;
• medicines for allergiessuch as cetirizine;

• strong pain relief medicinessuch as morphine.

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

• infection medicines:medicines for bacterial infections (such as erythromycin),
• medicines for fungal infections(such as ketoconazole) and medicines for HIV/AIDS (HIV protease inhibitors).

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

• medicines for stomach ulcers and heartburn(cimetidine).

Cimetidine may increase the amount of Mirtazapine Flas STADA in the blood. Inform your doctor if you are using cimetidine. It may be necessary to reduce the dose of Mirtazapine Flas STADA or, when you stop taking these medicines, increase the dose of Mirtazapine Flas STADA.

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

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

• medicines to prevent blood clottingsuch as warfarin.

Mirtazapine Flas STADA may 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 your doctor perform blood tests.

Taking Mirtazapine Flas STADA with food and alcohol

You may feel drowsy if you drink alcohol while being treated with 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, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Make sure your midwife and/or doctor know you are taking Mirtazapine Flas STADA. When similar medicines (SSRIs) are taken during pregnancy, they may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn, which causes rapid breathing and a bluish tint 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, giving birth, your baby will be checked for possible adverse effects. Consult your doctor if you can breastfeed while taking Mirtazapine Flas STADA.

Driving and using machines

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

Mirtazapine Flas STADA contains aspartame

This medicine contains 6 mg of aspartame in each tablet. Aspartame is a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

3. How to take Mirtazapina Flas STADA

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

How much to take

The normal 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 patient or if you have kidney or liver problems, your doctor may change the dose.

When to take Mirtazapina Flas STADA

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

It is best to take the dose of Mirtazapina Flas STADA once before bedtime. However, your doctor may recommend that you divide your dose of Mirtazapina Flas STADA in the morning and at night before bedtime. The highest dose should be taken before bedtime.

Take the oral dispersible tablets as follows

Take the tablets orally.

Mirtazapina Flas STADA oral dispersible 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 oral dispersible tablet

To avoid breaking the oral dispersible tablet, do not push the tablet blister (Figure 1).

Figure 1

1. Separate a tablet compartment

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

Figure 2

1. Separate the blister sheet

Carefully separate the blister sheet starting from the corner indicated with arrows (Figures 3).

Figure 3

1. Remove the oral dispersible tablet

Remove the oral dispersible 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 you can expect to feel better

Normally, Mirtazapina Flas 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 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. You will usually 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 a Mirtazapina Flas STADA overdose (without other medications or alcohol) are drowsiness, disorientation, and palpitations.

If you forget to take Mirtazapina Flas STADA

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

If you have to take your dose once a day

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

If you have to take your dose twice a day

• If you have forgotten the morning dose, simply take it with the night dose.
• If you have forgotten the night dose, do not take it the next morning; skip it and continue with your normal doses in the morning and at night.
• 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 at night.

If you stop treatment with Mirtazapina Flas STADA

? Stop taking Mirtazapina Flas 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 Flas STADA abruptly, even if 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.

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people 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 can be signs of serotonin syndrome.

• epileptic seizure (convulsions).

• signs of infection such as sudden unexplained high fever, sore throat, and ulcers in the mouth (agranulocytosis). In rare cases, Mirtazapina Flas STADA can cause alterations in blood cell production (bone marrow depression). Some people become less resistant to infections because Mirtazapina Flas STADA can cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, Mirtazapina Flas STADA can 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, 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 rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• generalized erythema, elevated body temperature, and enlarged lymph nodes (DRESS 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 suggest alterations in liver function (jaundice).

Some side effects are more likely than others. The possible side effects of Mirtazapina Flas STADA are indicated 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):

• sluggish behavior, slow or indifferent (lethargy)

• dizziness

• tremors or shaking
• memory problems, which in most cases were resolved when treatment was discontinued.

• nausea

• diarrhea

• vomiting

• 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
• 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)

• 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):

• tics or muscle contractions (myoclonus)

• aggression

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

Unknown (frequency cannot be estimated from available data):

• abnormal sensations in the mouth (oral paresthesia)

• swelling in the mouth (oral edema)

• increased salivation

• difficulty speaking (dysarthria)
• sleepwalking (somnambulism)

• low sodium levels in the blood that can cause fatigue and confusion, muscle contractions, convulsions, 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 electrolyte levels in the blood (such as sodium) [inadequate secretion of antidiuretic hormone].

In children under 18 years of age, 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 are:

Increased levels of creatine kinase in the blood, difficulty urinating, and muscle pain, stiffness, and/or weakness, and darkening or discoloration of the 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 Medicines and Healthcare Products Agency (AEMPS) https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Mirtazapina Flas STADA

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on 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 container and keep it perfectly closed to protect it from light and moisture.

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Mirtazapina Flas STADA

The active ingredient is mirtazapine.

Mirtazapina Flas STADA 15 mg oral dispersible tablets contain 15 mg of mirtazapine per oral dispersible tablet.

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

Appearance of the product and package contents

Mirtazapina Flas STADA are oral dispersible tablets.

15 mg tablets: white or almost white, round, 8 mm in diameter, biconvex, uncoated, and marked with M1.

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

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

Bottle: 50, 100 tablets (desiccant included)

Some package sizes may only 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:

Coripharma ehf.

Reykjavíkurvegur 78

P.O Box 420

IS-220 Hafnarfjördur

Iceland

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

Laboratori Fundació Dau

c/ C 12-14,

Polígono Industrial de la Zona Franca,

08040 Barcelona

Spain

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

BE: Mirtazapine EG Instant 15mg

DE: Mirtazapin AL 15mg Schmelztabletten

DK: Mirtazapin STADA

ES: Mirtazapina Flas STADA 15 mg oral dispersible tablets EFG

PT: Mirtazapina Ciclum 15 mg oral dispersible tablets

Date of the last revision of this leaflet:October 2020

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