MIRTAZAPINE BLUEFISH 30 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Mirtazapine Flas Bluefish 30 mg Orodispersible Tablets EFG

mirtazapine

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

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

Contents of the Package Leaflet:

1. What Mirtazapine Flas Bluefish 30 mg Orodispersible Tablets are and what they are used for
2. What you need to know before taking Mirtazapine Flas Bluefish 30 mg Orodispersible Tablets
3. How to take Mirtazapine Flas Bluefish 30 mg Orodispersible Tablets
4. Possible side effects
5. Storage of Mirtazapine Flas Bluefish 30 mg Orodispersible Tablets
6. Package Contents and Additional Information

1. What Mirtazapine Flas Bluefish 30 mg Orodispersible Tablets are and what they are used for

Mirtazapine Flas Bluefish belongs to the group of medications called antidepressants. This medication is used to treat depression in adults. It may take 1 to 2 weeks before mirtazapine starts to take effect. After 2 to 4 weeks, you may start to feel better. You should consult your doctor if you worsen or do not improve after 2 to 4 weeks. For more information, see section 3 "When can you expect to feel better".

2. What you need to know before taking Mirtazapine Flas Bluefish 30 mg Orodispersible Tablets

Do not take Mirtazapine Flas Bluefish

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

Warnings and Precautions

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

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

Children and Adolescents

Mirtazapine Flas Bluefish should not normally be used in the treatment of children and adolescents under 18 years of age, as its efficacy has not been demonstrated. At the same time, you should be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritation) when taking this class of medications. Nevertheless, the doctor may prescribe Mirtazapine Flas Bluefish to patients under 18 years of age when deemed necessary. If the doctor has prescribed Mirtazapine Flas Bluefish to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor. You should inform your doctor if any of the symptoms mentioned above progress or if complications occur when patients under 18 years of age are taking Mirtazapine Flas Bluefish. At the same time, the long-term effects on safety, growth, maturity, and cognitive and behavioral development of Mirtazapine Flas Bluefish in this age group have not yet been demonstrated. Additionally, a significant increase in weight has been observed more frequently in this age group when treated with mirtazapine, compared to adults.

Suicidal Thoughts and Worsening of 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 generally need a few weeks to take effect and sometimes even longer.

You shouldtake the following into account:

• If you have previously had thoughts of suicide or self-harm.
• If you are an adult young patient, note that information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders treated with an antidepressant.

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

It may be helpful to tell a relative or close friendthat you are feeling depressed and ask them to read this package leaflet. You could ask them 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 Mirtazapine Flas Bluefish:

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

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

• seizures (epilepsy). If seizures occur or your seizures become more frequent, stop taking Mirtazapine Flas Bluefish and contact your doctor immediately;
• liver diseases, including jaundice. If jaundice occurs, stop taking Mirtazapine Flas Bluefish and contact your doctor immediately;
• kidney diseases;
• 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 Bluefish 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;
• certain types of heart disease that can change your heart rhythm, a recent heart attack, heart failure, or taking certain medications that can affect your heart rhythm.

• If you develop signs of infection such as unexplained high fever, sore throat, and ulcers in the mouth.

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

These symptoms can be rare signs of alterations in blood cell production in the bone marrow. Although rare, these symptoms can occur more frequently at 4-6 weeks of treatment.

- Serious 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 serious skin reactions.

If you have ever suffered from serious skin reactions, do not restart treatment with Mirtazapine Bluefish.

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

Other Medications and Mirtazapine Flas Bluefish

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

Do not take Mirtazapine Flas Bluefish with:

• monoamine oxidase inhibitors (MAOIs). Also, do not take Mirtazapine Flas Bluefish during the two weeks after stopping MAOIs. If you stop taking Mirtazapine Flas Bluefish, 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 careful if you take Mirtazapine Flas Bluefish with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, and L-tryptophan or triptans(used for migraine), 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), and St. John's Wort (Hypericum perforatum)(a medicinal plant for depression). In very rare cases, Mirtazapine Flas Bluefish alone or with these medications can cause a condition 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 can increase the amount of Mirtazapine Flas Bluefish in the blood. Inform your doctor if you are taking this medication. It may be necessary to decrease the dose of Mirtazapine Flas Bluefish or increase it again when stopping nefazodone.
  • medications for anxiety or insomniasuch as benzodiazepines.
  • medications for schizophreniasuch as olanzapine.
  • medications for allergiessuch as cetirizine.
  • medications for severe painsuch as morphine.

When combined with these medications, Mirtazapine Flas Bluefish can increase the drowsiness caused by these medications.

• medications for infections:medications for bacterial infections (such as erythromycin), medications for fungal infections (such as ketoconazole), and medications for HIV/AIDS (HIV protease inhibitors) and medications for stomach ulcers (such as cimetidine). If taken with Mirtazapine Flas Bluefish, these medications can increase the amount of Mirtazapine Flas Bluefish in the blood. Inform your doctor if you are taking these medications. It may be necessary to decrease the dose of Mirtazapine Flas Bluefish or increase it again when stopping these medications.
• medications for epilepsysuch as carbamazepine and phenytoin.
• medications for tuberculosissuch as rifampicin.

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

• medications to prevent blood clottingsuch as warfarin.

Mirtazapine Flas Bluefish can increase the effects of warfarin on 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 Mirtazapine Flas Bluefish with Food, Drinks, and Alcohol

You may feel drowsy if you drink alcohol while being treated with Mirtazapine Flas Bluefish.

It is recommended not to drink any alcohol.

You can take Mirtazapine 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.

Limited experience with the administration of Mirtazapine Flas Bluefish to pregnant women does not indicate an increased risk. However, caution should be exercised when used during pregnancy.

Tell your doctor and/or midwife that you are taking Mirtazapine Flas Bluefish. When taken during pregnancy, similar medications (SSRIs) may increase the risk of a serious condition in newborns called persistent pulmonary hypertension in newborns (PPHN), which causes the newborn to breathe faster and have a bluish appearance. These symptoms start 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 being treated with Mirtazapine Flas Bluefish, ask your doctor if you should continue taking Mirtazapine Flas Bluefish. If you are taking Mirtazapine Flas Bluefish until or until shortly before birth, your baby should be monitored for adverse effects.

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

Driving and Using Machines

Mirtazapine Flas Bluefish can decrease alertness and concentration. Therefore, when you start taking this medication, make sure your abilities are not affected before driving or operating machines. If your doctor has prescribed Mirtazapine Bluefish to a patient under 18 years of age, ensure that concentration and alertness are not affected before participating in traffic (e.g., cycling).

Mirtazapine 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 orodispersible tablet.

Aspartame contains a source of phenylalanine, which can 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 Mirtazapine Flas Bluefish 30 mg orodispersible tablets EFG.

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 elderly person or if you have kidney or liver disease, your doctor may change the dose.

When to take it

Take Mirtazapine Flas Bluefish at the same time every day.

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

Take the orodispersible tablet as follows

The tablets are taken orally.

1. Do not crush the orodispersible tablet

To avoid breaking the tablets, it is essential that you do not press the blister to remove them (Figure A).

Fig. A.

1. Separate a blister

Each strip contains 6 blisters separated from each other by a perforated line. Separate a blister with your tablet following the perforated line (Figure 1).

Fig. 1

1. Open the blister

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

Fig. 2

Fig. 3

1. Remove the orodispersible tablet

The orodispersible tablets should be removed from the blister 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 you can expect to feel better

Normally, mirtazapine 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 mirtazapine:

→ 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 Mirtazapine 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 (fast, irregular heartbeat) and/or fainting, which could 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Mirtazapine Flas Bluefish

If you have to take your dose once a day

• Do not take a double dose to make up for the forgotten doses. Take the usual dose the next day.

If you have to take your dose twice a day

If you stop treatment with Mirtazapine Flas Bluefish

→ Stop taking mirtazapine 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 mirtazapine abruptly, even if depression has disappeared. If you stop taking Mirtazapine 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 decrease the dose.

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

4. Possible side effects

Like all medications, this medication can have side effects, although not everyone experiences them.

Suspend the use of mirtazapine and contact your doctor or seek medical attention immediately if you suffer from one of the following serious side effects.

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

• feeling of exaggerated euphoria (mania).

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

• yellowing of the eyes or skin; may suggest alterations in liver function (jaundice).

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

• signs of infection such as high, unexplained, and sudden fever, sore throat, and sores in the mouth (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 the number of white blood cells in the blood (eosinophilia)
• epileptic seizure (convulsions)
• 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 can be signs of a disorder called serotonin syndrome
• thoughts of self-harm or suicide
• severe skin reactions:
• • red patches on the torso, such as circumscribed or circular spots, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • widespread redness, elevated body temperature, and swelling of the lymph nodes (DRESS 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
• 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
• Memory problems, which in most cases were resolved when treatment was discontinued.

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 agitation of the legs during sleep
• 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):

• twitches or muscle contractions (myoclonus)
• aggression
• abdominal pain and nausea; this may involve inflammation in the pancreas (pancreatitis)

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

• sleepwalking (somnambulism)
• abnormal sensations in the mouth (oral paresthesia)
• swelling in the mouth (oral edema)
• swelling throughout the body (generalized edema)
• localized swelling
• severe skin reactions (bullous dermatitis, erythema multiforme)
• difficulty speaking
• hyponatremia
• inadequate secretion of antidiuretic hormone
• increased levels of creatine kinase in the blood
• difficulty urinating (urinary retention)
• muscle pain, stiffness, and/or weakness, darkening or discoloration of the urine (rhabdomyolysis).
• increased levels of prolactin in the blood (hyperprolactinemia, which includes symptoms of breast enlargement and/or milky discharge from the nipple)
• painful and prolonged erection of the penis.

Other side effects in children and adolescents

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

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist immediately.

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 is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Mirtazapine Flas Bluefish 30 mg orodispersible tablets.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the box and blister 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 thrown away in drains or trash. Deposit the containers and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers of the medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Mirtazapine Flas Bluefish 30 mg orodispersible tablets

The active ingredient is mirtazapine. Each orodispersible tablet contains 30 mg of mirtazapine.

The other components (excipients) are: crospovidone (type B), mannitol (E421), microcrystalline cellulose, aspartame (E951), colloidal anhydrous 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 package contents

Orodispersible tablet.

Mirtazapine Flas Bluefish 30 mg orodispersible tablets are round orodispersible tablets printed with “37” on one side and with “A” on the other with a raised circular edge.

Mirtazapine Flas Bluefish 30 mg orodispersible tablets are available in single-dose blister packs of polyamide/aluminum/PVC/paper/polyester/aluminum with 6, 18, 30, 48, 60, 90, and 96 tablets.

Only some pack 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 30 Stockholm,

Sweden.

Local Representative

Bluefish Pharma S.L.U.,

AP 36007 2832094 Madrid, Branch 36

Spain

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

Date of the last revision of this leaflet: March 2023

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