Package Insert: Information for the User

Mirtazapina Flas Bluefish 15 mg Bucodispersable Tablets EFG

mirtazapina

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

Mirtazapina Flas Bluefish belongs to a group of medicines called antidepressants. This medicine is used for the treatment of depression in adults. It takes 1 to 2 weeks for mirtazapina to start taking effect. 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 Bluefish

• if you are allergic to mirtazapine or any of the other ingredients (listed in section 6).
• if you are taking or have taken in the last two weeks, medications called monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Mirtazapina Flas Bluefish.

DO NOT TAKE OR CONSULT YOUR DOCTOR BEFORE STARTING TO TAKE mirtazapine: If you have ever had a severe skin rash or peeling, blisters, or mouth sores after taking mirtazapine or other medications.

Children and adolescents

Mirtazapina Flas Bluefish should not be used in the treatment of children and adolescents under 18 years oldbecause its efficacy has not been demonstrated.. At the same time, there is an increased risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) wheningesting this type of medication. Although, the doctor who prescribes it may prescribe Mirtazapina Flas Bluefish to patients under 18 years old when they decide what is best for the patient. If the doctor who prescribes it has prescribed Mirtazapina Flas Bluefish 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 listed above progress or if you experience complications when patients under 18 years old are taking

Mirtazapina Flas Bluefish. At the same time, the long-term effects regarding safety and related to growth, maturity, and cognitive and behavioral development of Mirtazapina Flas Bluefish in this age group have not yet been demonstrated.Also, a considerable weight gain has been observed more frequently in this age group when treated with mirtazapine, compared to adults.

Thoughts of suicide and worsening of your depression:

If you feel depressed, you may sometimes have thoughts of harming yourself. This can happen especially when you start taking antidepressants, as these medications usually take two weeks to take effect and sometimes longer.

You shouldbe aware of the following:

• If you have had thoughts of suicide or self-harm in the past.
• If you are an adult young patient, be aware that information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years old with psychiatric conditions treated with an antidepressant.

• If you ever have thoughts of harming or killing yourself,consult your doctor or go to the hospital immediately.

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

Also, be especially careful with Mirtazapina Flas Bluefish:

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

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

−seizures(epilepsy). If seizures or your seizures are more frequent, stop taking Mirtazapina Flas Bluefish and contact your doctor immediately;

−liver diseases, including jaundice. If jaundice appears, stop taking Mirtazapina Flas Bluefish and contact your doctor immediately;

−kidney diseases;

−heart diseaseorlow blood pressure;

−schizophrenia. If psychotic symptoms, such as paranoid thoughts, are more frequent or severe, contact your doctor immediately;

−bipolar depression(periods of excitement/hyperactivity and periods of depression). If you start feeling excited or overexcited, stop taking Mirtazapina Flas Bluefish 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 develop signs of infection such as unexplained high fever, sore throat, and mouth ulcers.

→ Stop taking Mirtazapina Flas Bluefish and consult your doctor immediately for a blood test.

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

-Severe skin reactions, such as Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (NET), and drug reactions 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 Mirtazapina Bluefish.

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

Other medications and Mirtazapina Flas Bluefish

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

Do not takeMirtazapina Flas Bluefish with:

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

Be careful ifyou take Mirtazapina Flas Bluefish with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, L-tryptophan, or triptans(used for migraines),tramadol(for pain),linezolid(an antibiotic),lithium(used to treat certain psychiatric conditions),methylene blue(used to treat high levels of methemoglobin in the blood),and St. John's Wort – Hypericum perforatum(a medicinal plant for depression). In rare cases, Mirtazapina Flas Bluefish alone or with these medications, may cause a condition 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 Flas Bluefish in the blood. Inform your doctor if you are taking this medication. You may need to reduce the dose of Mirtazapina Flas Bluefish, 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, Mirtazapina Flas Bluefish may increase the drowsiness caused by these medications

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

Mirtazapina Flas Bluefish 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

Taking Mirtazapina Flas Bluefish with food, drinks, and alcohol

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

It is recommended not to drink any alcohol.

You can take Mirtazapina Flas Bluefish with or without food.

Pregnancy, breastfeeding, and fertility

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.

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

Inform your doctor and/or midwife that you are taking Mirtazapina Flas Bluefish. Taking it during pregnancy, similar medications (SSRIs) may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the newborn to breathe faster and have a blue appearance. These symptoms begin in the first 24 hours after birth. If this happens to your baby, contact your doctor and/or midwife immediately.

If you become pregnant or plan to become pregnant while taking Mirtazapina Flas Bluefish, ask your doctor if you should continue taking Mirtazapina Flas Bluefish. If you are taking Mirtazapina Flas Bluefish until, or until shortly before delivery, your baby should be monitored for adverse effects.

Ask your doctor if you can breastfeed while taking Mirtazapina Flas Bluefish.

Driving and operating machinery

Mirtazapina Flas Bluefish may reduce your alertness and ability to concentrate. Therefore, when you start taking this medication, make sure your faculties are not affected before driving or operating machinery.If your doctor has prescribed Mirtazapina Bluefish to a patient under 18 years old, make sure that concentration and alertness are not affected before participating in traffic (for example, on a bicycle).

Mirtazapina Bluefish contains aspartame (E951)

This medication contains 3 mg, 6 mg, and 9 mg of aspartame in each 15 mg, 30 mg, and 45 mg buccal dispersible tablet.

Aspartame contains a source of phenylalanine that may be harmful in cases 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 again.

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 Mirtazapina Flas Bluefish at the same time every day.

It is better to take the mirtazapine dose all at once before going to bed. However, your doctor may recommend that you divide your mirtazapine dose into morning and evening 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 crush the buccal tablet

To avoid breaking the tablets, it is essential not to press the alveolus where it is located to remove it (Figure A).

Fig. A.

2. Separate an alveolus

Each strip contains 6 separated alveoli between them by a perforated line. Separate an alveolus with your tablet following the perforated line (Figure 1).

Fig. 1

3. Open the alveolus

Peel off the cover that covers the tablet carefully. Start from the corner marked with an arrow (Figures 2 and 3).

Fig. 2

Fig. 3

4. Remove the buccal tablet

The buccal tablets should be removed from the alveolus with dry hands and placed on the tongue (Figure 4).

Fig. 4

The tablet will disintegrate and be swallowed afterwards with the help of water.

When to expect to feel better

Mirtazapine usually starts to work after 1 or 2 weeks and after 2 to 4 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 mirtazapine until the symptoms of depression have disappeared for 4-6 months.

If you take more Mirtazapina Flas Bluefish than you should

→ If you or someone takes too much mirtazapine, consult a doctor immediately.

The most likely symptoms of a mirtazapine overdose (without other medications or alcohol) are drowsiness, 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.

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

If you forget to take Mirtazapina Flas Bluefish

If you have to take your doseonce a day

Do not take a double dose to compensate for the missed doses. Take the usual dose the next day..If you have to take your dosetwice a day

• If you have forgotten the morning dose, 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 your usual dose in the morning and evening.

If you interrupt the treatment with Mirtazapina Flas Bluefish

→ Stop taking mirtazapine 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 mirtazapine abruptly, even when depression has disappeared. If you stop taking Mirtazapina Flas Bluefish 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 product, ask your doctor or pharmacist immediately.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop using mirtazapine and contact your doctor or seek medical attention immediately if you experience any of the following severe side effects.

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

• exaggerated feeling of euphoria (mania).

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(cannot be estimated from available data):

• signs of infection such as high fever, sudden onset, sore throat, and mouth sores (agranulocytosis). In rare cases, Mirtazapine Bluefish may cause alterations in blood cell production (bone marrow depression). Some people become less resistant to infections because Mirtazapine Bluefish may cause a temporary decrease in white blood cells.(granulocytopenia). In rare cases, Mirtazapine Bluefish 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 salivation. In very rare cases, these symptoms may be signs of a condition called serotonin syndrome
• thoughts of self-harm or suicide
• severe skin reactions:
• • red patches on the trunk, often with blisters in the center, skin peeling, mouth sores, throat sores, genital sores, 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)

Other possible side effects with Mirtazapine Bluefish 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
• constipation
• vomiting
• 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 stopped.

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

• strange sensation in the skin, such as burning, pinching, tingling, or numbness (paresthesia)
• involuntary movements of leg agitation during sleep
• fainting (syncope)
• numbness of 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 and nausea; this may involve inflammation in the pancreas (pancreatitis)

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

• sleepwalking (somnambulism)
• abnormal sensations in the mouth (paresthesia oral)
• swelling in the mouth (buccal edema)
• swelling throughout the body (generalized edema)
• localized swelling
• severe skin reactions (dermatitis bullous, erythema multiforme)
• speech difficulties
• low sodium levels in the blood (hyponatremia)
• inadequate secretion of antidiuretic hormone
• 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)
• painful and prolonged 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: a significant weight gain, urticaria, and increased triglycerides in the blood.

If you consider any of the side effects you experience to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist immediately.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: 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 blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers of medications you no longer need. By doing so, you will help protect the environment.

Composition of Mirtazapina Flas Bluefish 15 mg buccal tablets

The active ingredient is mirtazapina. Each buccal tablet contains 15 mg of mirtazapina.

The other components (excipients) are: crospovidone (type B), mannitol (E421), microcrystalline cellulose, aspartame (E951), anhydrous colloidal silica, magnesium stearate, strawberry guarana flavor (maltodextrin, propylene glycol, artificial flavors, acetic acid), peppermint flavor (artificial flavors, cornstarch without gluten)

Appearance of the product and contents of the package

Buccal tablet.

Mirtazapina Flas Bluefish 15 mg buccal tablets are round buccal tablets printed with “36” on one face and with “A” on the other with a circular raised edge.

Mirtazapina Flas Bluefish 15 mg buccal tablets are available in blister packs of poliamide/aluminum/PVC/paper/polyester/aluminum with 6, 18, 30, 48, 60, 90, and 96 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bluefish Pharmaceuticals AB

P.O.Box 49013,

100 28 Stockholm

Sweden.

Manufacturer

Bluefish Pharmaceuticals AB,

Gävlegatan 22,

113 30Stockholm,

Sweden.

Local Representative

Bluefish Pharma S.L.U.,

AP 36007 2832094 Madrid, Branch 36

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:March 2023

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/