Leaflet:information for the user

Mirtazapina Flas ratiopharm 15 mg buccodispersible tablets EFG

mirtazapina

Mirtazapina Flas ratiopharm belongs to a group of medicines calledantidepressants.

Mirtazapina Flas ratiopharm is used to treat depression in adults.

It may take 1 to 2 weeks for Mirtazapina Flas ratiopharm to start working. After 2 to 4 weeks, you may start to feel better. You should consult your doctor if you get worse or do not improve after 2 to 4 weeks.

For more information, see section 3 "When you can expect to feel better".

Do not take Mirtazapina Flas ratiopharm:

• if you areallergicto mirtazapina or any of the other ingredients of this medication (listed in section 6). In this case, consult your doctor as soon as possible before taking Mirtazapina Flas ratiopharm.
• if you are taking or have taken in the last two weeksmonoamine oxidase inhibitors (MAOIs).

Warnings and precautions

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

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

if you have ever had a severe skin rash or peeling of the skin, blisters or mouth soresafter taking mirtazapina or other medications.

Children and adolescents

Mirtazapina Flas ratiopharm should not be used normally in the treatment of children and adolescents under 18 years due to lack of demonstrated efficacy. At the same time, it should be noted that in patients under 18 years there is an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this class of medications. However, the doctor may prescribe Mirtazapina Flas ratiopharm to patients under 18 years when they decide it is the most appropriate for the patient. If the doctor has prescribed mirtazapina to a patient under 18 years and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed above appear or worsen in patients under 18 years who are taking Mirtazapina Flas ratiopharm. In addition, the long-term safety effects related to growth, maturation, and development of Mirtazapina Flas ratiopharm in this age group are not yet known. Furthermore, a significant weight gain has been observed more frequently in patients in this age group treated with mirtazapina compared to adults treated.

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 a normal effect.

You may be more prone to thinking this way if:

• you have previously had suicidal thoughts or self-harm.
• you are a young adult. The information from clinical trials has shown an increased risk of suicidal behavior in 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 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 particularly careful with Mirtazapina Flas ratiopharm

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

?inform your doctor about these situations before taking Mirtazapina Flas ratiopharm, if you have not already done so:

• seizures(epilepsy). If seizures occur or your seizures become more frequent, stop taking Mirtazapina Flas ratiopharm and contact your doctor immediately;
• liver disease, including jaundice. If jaundice appears, stop taking Mirtazapina Flas ratiopharm and contact your doctor immediately;
• kidney disease;
• heart diseaseorlow 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 elated or overexcited, stop taking Mirtazapina Flas ratiopharm and contact your doctor immediately;
• diabetes(you may need to adjust your insulin dose or other antidiabetic medications);
• eye diseases, such as increased eye pressure (glaucoma);
• difficulty urinating, which may be due to an enlarged prostate;
• certain types of heart diseasethat may change your heart rhythm, a recent heart attack, heart failure, or taking certain medications that may affect your heart rhythm.

• if you have signs of infection such as high fever, sore throat, and mouth sores.

?stop taking Mirtazapina Flas ratiopharm and contact your doctor immediately to have a blood test.

In rare cases, these symptoms may be signs of bone marrow production disorders. Although rare, these symptoms appear at 4-6 weeks of treatment.

• if you are elderly. You may be more sensitive to the adverse effects of antidepressant medications.

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, do not restart treatment with mirtazapina.

Taking Mirtazapina Flas ratiopharm with other medications

Inform your doctor or pharmacist that you are taking/using, have taken/used recently, or may need to take/use any other medication.

Do not take Mirtazapina Flas ratiopharmwith:

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

Be carefulif you take Mirtazapina Flas ratiopharm 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),methylene blue(used to treat high levels of methemoglobin in the blood) andSt. John's Wort(a medicinal plant for depression). In rare cases, Mirtazapina Flas ratiopharm alone or 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 mirtazapina in the blood. Inform your doctor if you are taking this medication. You may need to reduce the dose of mirtazapina or increase it again when stopping 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, mirtazapina may increase the drowsiness caused by these medications.

• infection medications:antibiotics for bacterial infections (such as erythromycin), antifungals (such as ketoconazole), and HIV/AIDS medications (protease inhibitors) andulcer medications(such as cimetidine).

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

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

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

• blood thinnerssuch as warfarin.

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

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

Taking Mirtazapina Flas ratiopharm with food and alcohol

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

It is recommended not to drink any alcohol.

You can take mirtazapina with or without food.

Pregnancy and breastfeeding

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

Pregnancy

The limited experience of administering mirtazapina to pregnant women does not indicate an increased risk. However, you should be careful if you use it during pregnancy.

If you use mirtazapina until, or shortly before, delivery, your baby will be examined to detect any possible adverse effects.

When taking during pregnancy similar medications (designated as serotonin reuptake inhibitors: SSRIs) may increase the risk of a severe disease called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear blue. These symptoms usually begin within the first 24 hours after birth. If this occurs in your case, you should contact your midwife and/or doctor immediately.

Breastfeeding

Consult your doctor if you can breastfeed while taking Mirtazapina Flas ratiopharm.

Driving and operating machinery

Mirtazapina Flas ratiopharm may affect your concentration or alertness. Make sure your faculties are not affected before driving or operating machinery. If your doctor has prescribed Mirtazapina Flas ratiopharm to a patient under 18 years, make sure concentration and alertness are not affected before driving (for example, on a bicycle).

Mirtazapina Flas ratiopharm chewable tablets contain aspartame, a source of phenylalanine.

This medication may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

How much to take

The initial recommended 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 it

?Take mirtazapine at the same time every day.

It is better to take the Mirtazapina Flas ratiopharm dose all at once before going to bed. However, your doctor may recommend taking your mirtazapine dose in the morning and at night before going to bed.

The highest dose should be taken before going to bed.

Take the buccal tablet in the following way

The tablets are taken orally.

1. Do not press the buccal tablet

To avoid crushing the buccal tablet, do not press the blister (Figure A)

Fig. A.

.

2. Separate a blister

Each blister is separated by perforations. Separate a blister by following the perforated lines (Figure 1)

Fig. 1

3. Open the blister

Remove the foil carefully, starting from the corner where the aluminum cover is not sealed(Figures 2 and 3)

Fig. 2

Fig. 3

4. Remove the buccal tablet

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

Fig. 4

It will dissolve quickly and can be swallowed without water.

When you can expect to feel better

Mirtazapina Flas ratiopharm usually starts to work after 1 or 2 weeks and after2 to4 weeks you may start to feel better.

It is essential to talk to your doctor about the effects of mirtazapine during the first weeks of treatment.

?between 2 and 4 weeks after starting to take mirtazapine, 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 ratiopharm until the symptoms of depression have disappeared for 4-6 months.

If you take more Mirtazapina Flas ratiopharm than you should:

?If you or someone takes too much Mirtazapina Flas ratiopharm, consult a doctor or pharmacist immediately. You can also call the Toxicological Information Service, phone:91 562 04 20.

The most likely symptoms of a Mirtazapina Flas ratiopharm overdose (without other medications or alcohol) aresleepiness, disorientation, and palpitations.The symptoms of a possible overdose may include changes in your heart rhythm (rapid or irregular heartbeat) and/or dizziness, which may be symptoms of a potentially life-threatening condition known as Torsades de pointes.

If you forget to take Mirtazapina Flas ratiopharm:

If you have to take your doseonce a day:

• do not take a double dose to compensate for the missed doses. Take the next dose at the usual time.

If you have to take your dosetwice a day:

• if you forgot the morning dose, simply take it with the evening dose
• if you forgot 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 forgot 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 Flas ratiopharm

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

If you stop taking 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 ratiopharm abruptly, even when depression has disappeared. If you stop taking mirtazapine abruptly, you may feel sick, dizzy, agitated, or anxious and have a headache. 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 any of the following serious side effects, stop taking mirtazapine and immediately inform your doctor.

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

• Yellowing of the eyes or skin, which may indicate liver dysfunction (jaundice)

Frequency not known(the frequency cannot be estimated from the available data):

• Signs of infection such as high fever, sore throat, and mouth sores (agranulocytosis)

In rare cases, mirtazapine may cause changes in blood cell production (bone marrow depression). Some people become less resistant to infections because mirtazapine may 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 white blood cells in the blood (eosinophilia).

• Seizure (convulsion)
• A combination of symptoms such as unexplained fever, sweating, palpitations, diarrhea, muscle contractions (involuntary), chills, exaggerated reflexes, agitation, mood changes, loss of consciousness, and increased saliva production. In very rare cases, these symptoms may be signs of a condition called "serotonin syndrome"
• Thoughts of self-harm or suicide
• 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, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other possible side effects with mirtazapine are:

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
• Nausea
• Diarrhea
• Vomiting
• Constipation
• Urticaria or skin rash (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
• Memory problems, which in most cases resolved when treatment was discontinued

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

• Strange sensation in the skin, such as burning, pinching, tingling, or numbness (paresthesia)
• Restless leg syndrome during sleep
• Fainting (syncope)
• Loss of 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
• Abdominal pain, nausea; this may indicate pancreatitis

Frequency not known(the frequency cannot be estimated from the available data):

• Abnormal sensations in the mouth (paresthesia oral)
• Swelling in the mouth (buccal edema)
• Generalized swelling
• Localized swelling
• Low sodium levels in the blood (hyponatremia)
• Inadequate secretion of antidiuretic hormone
• Severe skin reactions (dermatitis bullous, erythema multiforme)
• Sleepwalking (somnambulism)
• Speech problems
• Increased levels of creatine kinase in the blood
• Difficulty urinating (urinary retention)
• Muscle pain, stiffness, and/or weakness, dark or discolored urine (rhabdomyolysis)
• Increased levels of prolactin hormone in the blood (hyperprolactinemia, which includes symptoms of breast enlargement and/or nipple discharge)
• Prolonged and painful erection of the penis

Other side effects in children and adolescents

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

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 directly 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 usethis medicationafter the expiration date that appears onthe packaging and blister. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Mirtazapina Flas ratiopharm

Appearance of the product and contents of the package

Buccal dispersible tablets.

Round, white tablets, marked with “36” on one face and with “A” on the other face, with a circular raised edge.

Mirtazapina Flas ratiopharm 15 mg is available in packages containing 6, 10, 18, 20, 30, 48, 50, 60, 90, 96, and 100 buccal dispersible tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid) Spain

Responsible for manufacturing

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren (Germany)

O

Teva Operations Poland SP, Z.O.O.

Ul. Mogilska 80,

Krakow 31-546

Poland

This medicine is authorized in the EEA Member States with the following names:

Last reviewed date of this leaflet: July 2021

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/