Mirtazapine Flas Bluefish 30 mg orodispersible tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the user

Mirtazapine Flas Bluefish 30 mg orodispersible tablets EFG

mirtazapine

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Leaflet Contents:

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. How to store Mirtazapine Flas Bluefish 30 mg orodispersible tablets
6. Contents of the pack and other information

1. What Mirtazapina Flas Bluefish 30 mg orodispersible tablets is and what it is used for

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 before mirtazapine starts to work. After 2 to 4 weeks you may begin 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 start feeling 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 to any of the other ingredients of this medicine (listed in section 6).
if you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

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

DO NOT TAKE OR CONSULT YOUR DOCTOR BEFORE STARTING mirtazapine:
If you have ever experienced a severe skin rash or peeling of the skin, blisters, or sores in the mouth after taking mirtazapine or other medicines.

Children and adolescents

Mirtazapine Flas Bluefish should not normally be used to treat children and adolescents under 18 years of age because its efficacy has not been demonstrated. At the same time, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Mirtazapine Flas Bluefish to patients under 18 years of age if they decide it is in the patient's best interest. If your doctor has prescribed Mirtazapine Flas Bluefish to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You must inform your doctor if any of the symptoms listed above worsen or develop complications while patients under 18 years of age are taking Mirtazapine Flas Bluefish. In addition, the long-term effects on safety regarding growth, maturation, and cognitive and behavioural development of Mirtazapine Flas Bluefish in this age group have not yet been established. A more pronounced weight gain has also been observed more frequently in this age group when treated with mirtazapine, compared to adults.

Suicidal thoughts and worsening of your depression:

If you are depressed, you may sometimes have thoughts of harming yourself. This may happen especially when starting antidepressants, as these medicines usually take about two weeks to take effect and sometimes even longer.

You should consider the following:

• If you have previously had suicidal or self-harming thoughts.

• If you are a young adult, be aware that clinical trial data have shown an increased risk of suicidal behaviour in patients under 25 years of age with psychiatric conditions 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 close relative or friend that you are depressed and ask them to read this leaflet. You may ask them whether they think your depression or anxiety is worsening or if they are concerned about changes in your behaviour.

Also, take special care with Mirtazapine Flas Bluefish:

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

Inform your doctor about these conditions 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 disease, including jaundice. If jaundice occurs, stop taking Mirtazapine Flas Bluefish 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 elevated mood/hyperactivity and periods of depression). If you start feeling elated or overexcited, stop taking Mirtazapine Flas Bluefish and contact your doctor immediately;

• diabetes (you may need to adjust your insulin dose or other antidiabetic medicines);

• eye diseases, such as increased pressure in the eye (glaucoma);

• difficulty urinating, which could be due to an enlarged prostate;

• certain types of heart disease that may alter your heart rhythm, a recent heart attack, heart failure, or taking certain medicines that may affect heart rhythm.

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

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

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

• Severe skin reactions have been reported with the use of mirtazapine, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Discontinue use and seek immediate medical attention if you notice any of the symptoms described in section 4 related to these severe skin reactions.

If you have previously experienced severe skin reactions, re-initiation of treatment with Mirtazapine Bluefish should not be undertaken.

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

Other medicines and Mirtazapine Flas Bluefish

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

Do not take Mirtazapine Flas Bluefish together with:

• monoamine oxidase inhibitors (MAOIs). Also, do not take Mirtazapine Flas Bluefish during the two weeks following discontinuation of MAOIs. If you stop taking Mirtazapine Flas Bluefish, do not take MAOIs for the following two weeks.

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

Be careful if you take Mirtazapine Flas Bluefish together 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 certain psychiatric disorders), methylene blue (used to treat high levels of methemoglobin in the blood), and St. John's wort – Hypericum perforatum (herbal remedy for depression). In very rare cases, Mirtazapine Flas Bluefish alone or in combination with these medicines may lead to a condition known as serotonin syndrome. Some symptoms of this syndrome include: unexplained fever, sweating, palpitations, diarrhoea, uncontrollable muscle contractions, 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. This may increase the amount of Mirtazapine Flas Bluefish in the blood. Inform your doctor if you are taking this medicine. It may be necessary to reduce the dose of Mirtazapine Flas Bluefish, or increase it again when stopping nefazodone.
  • medicines for anxiety or insomnia such as benzodiazepines
  • medicines for schizophrenia such as olanzapine
  • medicines for allergies such as cetirizine
  • medicines for severe pain such as morphine

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

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

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

• medicines to prevent blood clotting such as warfarin.

Mirtazapine Flas Bluefish may enhance the effects of warfarin in the blood. Inform your doctor if you are taking this medicine. If taken together, it is recommended that your doctor performs blood monitoring.

• medicines that may 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 may take Mirtazapine Flas Bluefish with or without food.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Inform your doctor and/or midwife that you are taking Mirtazapine Flas Bluefish. Medicines similar to this (SSRIs) taken during pregnancy may increase the risk of a serious condition in newborns called persistent pulmonary hypertension in the newborn (PPHN), which causes the newborn to breathe faster and appear bluish. These symptoms begin within 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 whether you should continue taking Mirtazapine Flas Bluefish. If you are taking Mirtazapine Flas Bluefish up to or shortly before delivery, your baby should be monitored for adverse effects.

Ask your doctor if you can breast-feed while taking Mirtazapine Flas Bluefish.

Driving and using machines

Mirtazapine Flas Bluefish may reduce alertness and the ability to concentrate. Therefore, when starting this medicine, make sure your abilities are not affected before driving or operating machinery. 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 medicine contains 3 mg, 6 mg, and 9 mg of aspartame in each 15 mg, 30 mg, and 45 mg orodispersible tablet, respectively.

Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

3. How to take Mirtazapine Flas Bluefish 30 mg orodispersible tablets EFG.

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much to take

The recommended starting dose is 15 or 30 mg once daily. Your doctor may recommend increasing the dose after a few days to the amount that is best for you (between 15 and 45 mg daily). Normally, the dose is the same for all age groups. However, if you are elderly or have kidney or liver disease, your doctor may adjust the dose.

When to take it

Take Mirtazapine Flas Bluefish at the same time each day.

It is best to take the mirtazapine dose as a single dose before bedtime. However, your doctor may recommend that you split your daily dose into a morning and an evening dose, with the larger dose taken before bedtime.

How to take the orodispersible tablet

The tablets are taken by mouth.

1. Do not crush the orodispersible tablet.

To avoid breaking the tablets, it is important not to press on the blister to remove them (Figure A).

Fig. A.

1. Separate one blister

Each strip contains 6 blisters separated by a perforated line. Separate one blister with its tablet by following the perforated line (Figure 1).

Fig. 1

1. Open the blister

Carefully peel back the foil covering the tablet, starting at 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 should then be swallowed with water.

When you can expect to feel better

Mirtazapine usually starts to take effect after 1 or 2 weeks, and you may begin to feel better after 2 to 4 weeks.

It is important that during the first weeks of treatment you discuss the effects of mirtazapine with your doctor:

→ 2 to 4 weeks after starting mirtazapine, talk to your doctor about how this medicine has affected you.

If you still do not feel better, your doctor may prescribe a higher dose. In that case, speak with your doctor again after another 2–4 weeks. Normally, you will need to continue taking mirtazapine until depressive symptoms have been absent for 4–6 months.

If you take more Mirtazapine Flas Bluefish than you should

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

The most likely symptoms of an overdose of mirtazapine (without other medicines or alcohol) are drowsiness, confusion, and palpitations. Symptoms of a possible overdose may include changes in your heart rhythm (fast, irregular heartbeat) and/or fainting, which could be signs of a potentially life-threatening condition known as Torsades de Pointes.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Mirtazapine Flas Bluefish

If you are supposed to take your dose once daily

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

If you are supposed to take your dose twice daily

• if you forget the morning dose, simply take it together with your evening dose
• if you forget the evening dose, do not take it the next morning; skip it and continue with your normal morning and evening doses
• if you forget both doses, do not try to make them up. Skip both doses and continue with your normal morning and evening doses the next day.

If you stop taking Mirtazapine Flas Bluefish

→ Only stop taking mirtazapine after consulting your doctor.

If you stop too early, depression may return. 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 resolved. If you stop Mirtazapine Flas Bluefish suddenly, you may feel unwell, dizzy, agitated, or anxious, and may experience headaches. These symptoms can be avoided by stopping treatment gradually. Your doctor will advise you on how to gradually reduce the dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist immediately.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop taking mirtazapine and contact your doctor or seek immediate medical attention if you experience any 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 indicate liver problems (jaundice).

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

• signs of infection such as sudden unexplained high fever, sore throat, and mouth ulcers (agranulocytosis). In rare cases, Mirtazapine Bluefish may cause disturbances 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 anaemia), 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, diarrhoea, uncontrollable muscle contractions, chills, exaggerated reflexes, agitation, mood changes, loss of consciousness, and increased salivation. In very rare cases, these symptoms may be signs of a disorder called serotonin syndrome
• thoughts of harming yourself or of suicide
• serious skin reactions:
  • red patches on the trunk, as well-defined or circular spots, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes 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).

Other possible adverse 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
• diarrhoea
• 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 (oedema)
• fatigue
• vivid dreams
• confusion
• anxiety
• difficulty sleeping
• Memory problems, which in most cases resolved when treatment was discontinued.

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

• unusual skin sensations such as burning, prickling, tingling, or numbness (paraesthesia)
• involuntary restless leg movements during sleep
• fainting (syncope)
• numbness sensation 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 jerks (myoclonus)
• aggression
• abdominal pain and nausea; this may indicate inflammation of the pancreas (pancreatitis)

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

• sleepwalking (somnambulism)
• abnormal sensations in the mouth (oral paraesthesia)
• swelling of the mouth (oral oedema)
• swelling throughout the body (generalized oedema)
• localized swelling
• serious skin reactions (bullous dermatitis, erythema multiforme)
• difficulty speaking
• hyponatraemia
• inappropriate 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 urine (rhabdomyolysis)
• increased levels of prolactin hormone in the blood (hyperprolactinaemia, including symptoms of breast enlargement and/or milky nipple discharge)
• painful and prolonged penile erection.

Other adverse effects in children and adolescents

In clinical trials, the following adverse effects were commonly observed in individuals under 18 years of age: considerable weight gain, urticaria, and increased blood triglyceride levels.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mirtazapine Flas Bluefish 30 mg Orodispersible Tablets.

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mirtazapine Flas Bluefish 30 mg orodispersible tablets

The active substance 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 flavour (maltodextrin, propylene glycol, artificial flavours, acetic acid), mint flavour (artificial flavours, gluten-free corn starch).

Appearance of the product and contents of the pack

Orodispersible tablet.

Mirtazapine Flas Bluefish 30 mg orodispersible tablets are round orodispersible tablets, printed with "37" on one side and "A" on the other, with a raised circular rim.

Mirtazapine Flas Bluefish 30 mg orodispersible tablets are available in perforated unit dose blisters made of polyamide/aluminum/PVC/paper/polyester/aluminum, containing 6, 18, 30, 48, 60, 90 and 96 tablets.

Only certain 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.,
P.O. Box 36007, 2832094 Madrid, Branch Office 36
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Member State	Proposed Names
Austria	Mirtazapin Bluefish 15 mg /30 mg/ 45 mg Schmelztabletten
Denmark	Mirtazapin Bluefish 15 mg / 30 mg/ 45 mg smeltetabletter
France	MIRTAZAPINE BLUEFISH 15 mg orodispersible tablets
Ireland	Mirtazapine Bluefish 15 mg /30 mg / 45 mg orodispersible tablets
Iceland	Mirtazapin Bluefish 15 mg / 30 mg / 45 mg munndreifitöflur
Norway	Mirtazapin Bluefish 15 mg/ 30 mg/ 45 mg smeltetabletter
Portugal	Mirtazapina Bluefish
Spain	Mirtazapina Bluefish 15 mg/ 30 mg/ 45 mg buccodispersible tablets EFG
Sweden	Mirtazapin Bluefish 15 mg/ 30 mg/ 45 mg munsönderfallande tabletter
United Kingdom (Northern Ireland)	Mirtazapine 15 mg/ 30 mg/ 45 mg orodispersible tablets

Date of the most recent review of this leaflet: March 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/