Mirtazapine Bluefish

PATIENT INFORMATION LEAFLET

Information leaflet accompanying the packaging: patient information

Mirtazapine Bluefish, 15 mg, film-coated tablets

Mirtazapine Bluefish, 30 mg, film-coated tablets

Mirtazapine Bluefish, 45 mg, film-coated tablets

Mirtazapine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Mirtazapine Bluefish and what is it used for
• 2. Important information before taking Mirtazapine Bluefish
• 3. How to take Mirtazapine Bluefish
• 4. Possible side effects
• 5. How to store Mirtazapine Bluefish
• 6. Contents of the pack and other information

1. What is Mirtazapine Bluefish and what is it used for

Mirtazapine Bluefish belongs to a group of medicines known as antidepressants.
Mirtazapine Bluefish is indicated for the treatment of depression in adults.
Mirtazapine Bluefish starts working after 1-2 weeks of treatment, and after 2-4 weeks, an improvement in well-being may occur. If after 2-4 weeks of treatment, no improvement occurs or the patient feels worse, they should consult their doctor. More information is provided in section 3, under "When can an improvement in well-being be expected".

2. Important information before taking Mirtazapine Bluefish

When not to take Mirtazapine Bluefish

• if the patient is allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6). In this case, before taking Mirtazapine Bluefish, the patient should contact their doctor as soon as possible.
• if the patient is currently taking or has taken in the recent past (within the last 2 weeks) monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Before starting treatment with Mirtazapine Bluefish, the patient should discuss it with their doctor or pharmacist.

Before starting treatment with Mirtazapine Bluefish, the patient should tell their doctor:

If the patient has ever experienced severe skin rash or peeling of the skin, blistering, and (or) ulcers in the mouth after taking Mirtazapine Bluefish.

Children and adolescents

Mirtazapine Bluefish is not usually given to children and adolescents under 18 years of age, as its efficacy has not been established. It should also be noted that in patients under 18 years of age, there is a higher risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, rebellious behavior, and anger), when they take medicines of this class. Nevertheless, the doctor may prescribe Mirtazapine Bluefish to patients under 18 years of age if they consider it to be in their best interest. If the doctor has prescribed Mirtazapine Bluefish to a patient under 18 years of age and any doubts arise, the doctor should be consulted. In the case of patients under 18 years of age taking Mirtazapine Bluefish, the doctor should be informed if any of the above symptoms develop or worsen.
The long-term effects of Mirtazapine Bluefish on safety, including growth, maturation, and cognitive and behavioral development in this age group, have not been established. Additionally, during treatment with Mirtazapine Bluefish in this age group, weight gain is more frequently observed than in adults.

Suicidal thoughts and worsening of depression

Patients with depression may sometimes have thoughts of self-harm or suicide.
Such symptoms or behavior may worsen at the beginning of treatment with antidepressants, as these medicines usually start working after about two weeks, sometimes later.
These symptoms are more likely to occur in:

• patients who have previously experienced thoughts of self-harm or suicide.
• young adult patients. Clinical trial data indicate an increased risk of suicidal behavior in adults under 25 years of age with mental disorders treated with antidepressants. If suicidal thoughts or self-harm occur, the doctor or hospital should be contacted immediately.

It may be helpful to inform relatives or friendsabout the depression and ask them to read this leaflet. The patient may ask them to inform them if they notice that the depression or anxiety has worsened or if there are any worrying changes in behavior.
Particular caution should be exercised when taking Mirtazapine Bluefish:

• if the following diseases occur or have occurred. The doctor should be informed about the occurrence of the following diseases before starting treatment with Mirtazapine Bluefish, if this has not been done before:
• epileptic seizures. If seizures occur or their frequency increases during treatment, Mirtazapine Bluefish should be discontinued and the doctor should be contacted immediately;
• liver disease, including jaundice. If jaundice occurs, Mirtazapine Bluefish should be discontinued and the doctor should be contacted immediately;
• kidney disease;
• heart diseaseor low blood pressure;
• schizophrenia. The doctor should be contacted immediately if such mental disorders as paranoid thoughts worsen or increase in frequency;
• manic depression(alternating periods of elevated mood/excitement and depression). If the patient feels overly excited, Mirtazapine Bluefish should be discontinued and the doctor should be contacted immediately;
• diabetes(may require a change in insulin or other antidiabetic medication dose);
• eye diseases, such as increased intraocular pressure (glaucoma);
• urination difficulties, which may be caused by prostate enlargement;
• certain heart rhythm disordersthat can cause changes in heart rhythm, recent myocardial infarction, heart failure, or the use of certain medications that can cause heart rhythm disorders.
• if symptoms of infection occur, such as unexplained high fever, sore throat,

mouth ulcers. Mirtazapine Bluefish should be discontinued and the doctor should be consulted immediately, who will order a blood morphology test. In rare cases, these symptoms may be a sign of disorders of blood cell production by the bone marrow. Although rare, these symptoms usually occur after 4-6 weeks of treatment.

• if the patient is elderly, they may be more sensitive to the side effects of antidepressants.
• serious skin reactions have been reported with Mirtazapine Bluefish, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Treatment with Mirtazapine Bluefish should be discontinued and medical help should be sought immediately if any of the symptoms listed in section 4 occur. If the patient has ever experienced a severe skin reaction, treatment with Mirtazapine Bluefish should not be restarted.

Mirtazapine Bluefish and other medicines

The doctor or pharmacist should be told about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Mirtazapine Bluefish should not be takenin combination with:

• monoamine oxidase inhibitors (MAOIs)or within 2 weeks of stopping their use. Mirtazapine Bluefish should not be started until 2 weeks after stopping MAOIs. Examples of MAOIs include moclobemide, tranylcypromine (antidepressants), and selegiline (used in the treatment of Parkinson's disease).

Caution should be exercisedwhen taking Mirtazapine Bluefish in combination with:

• other antidepressants, such as SSRIs, venlafaxine, and L-tryptophan or triptans (used to treat migraines), tramadol (a pain reliever), linezolid (an antibiotic), lithium salts (used to treat certain mental disorders), methylene blue (used to lower high methemoglobin levels in the blood), and products containing St. John's Wort (Hypericum perforatum) (herbal products used to treat depression). In patients taking only Mirtazapine Bluefish or in combination with these medicines, serotonin syndrome can occur very rarely. Some of its symptoms include unexplained fever, sweating, increased heart rate, diarrhea, (uncontrolled) muscle contractions, shivering, increased reflexes, restlessness, mood changes, loss of consciousness, and increased salivation. If several of these symptoms occur, the doctor should be contacted immediately.
• the antidepressant nefazodone. It may increase the level of Mirtazapine Bluefish in the blood. The doctor should be informed about the use of this medicine. It may be necessary to reduce the dose of Mirtazapine Bluefish and, after stopping nefazodone, increase the dose of Mirtazapine Bluefish.
• medicines used to treat anxiety or insomnia, such as benzodiazepines; medicines used to treat schizophrenia, such as olanzapine; medicines used to treat allergies, such as cetirizine; medicines used to treat severe pain, such as morphine. Mirtazapine Bluefish in combination with these medicines may increase the sedation caused by these medicines.
• medicines used to treat infections, such as antibacterial agents (e.g., erythromycin), antifungal agents (e.g., ketoconazole), and medicines used to treat HIV/AIDS (e.g., HIV protease inhibitors), and medicines used to treat stomach ulcers(e.g., cimetidine). When these medicines are started in combination with Mirtazapine Bluefish, the level of Mirtazapine Bluefish in the blood may increase. The doctor should be informed about the use of these medicines. It may be necessary to reduce the dose of Mirtazapine Bluefish and, after stopping these medicines, increase the dose of Mirtazapine Bluefish.
• antiepileptic drugs, such as carbamazepine and phenytoin; medicines used to treat tuberculosis, such as rifampicin. In combination with Mirtazapine Bluefish, these medicines may decrease its level in the blood. The doctor should be informed about the use of these medicines. It may be necessary to increase the dose of Mirtazapine Bluefish and, after stopping these medicines, decrease the dose of Mirtazapine Bluefish.
• anticoagulant medicines, such as warfarin. Mirtazapine Bluefish may increase the effect of warfarin. The doctor should be informed about the use of these medicines. In the case of combination therapy with Mirtazapine Bluefish, it is recommended to monitor blood parameters.
• medicines that may affect heart rhythm, such as certain antibiotics and antipsychotic medicines

Taking Mirtazapine Bluefish with food and alcohol

Drinking alcohol during treatment with Mirtazapine Bluefish may cause drowsiness.
It is best to avoid drinking alcohol.
Mirtazapine Bluefish can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Limited experience with the use of Mirtazapine Bluefish in pregnant women does not indicate an increased risk. However, caution should be exercised when using this medicine during pregnancy.
If Mirtazapine Bluefish is taken during pregnancy or shortly before delivery, the newborn should be monitored due to the possibility of side effects.
Taking similar medicines during pregnancy (such as selective serotonin reuptake inhibitors (SSRIs)) may increase the risk of severe complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN), which is characterized by rapid breathing and bluish discoloration. These symptoms usually occur within the first day of life. If such symptoms occur in the newborn, the doctor and (or) midwife should be contacted immediately.

Driving and using machines

Mirtazapine Bluefish may reduce alertness and concentration. During treatment with Mirtazapine Bluefish, the patient should avoid performing potentially hazardous activities that require continuous attention, such as driving or operating machinery. If the doctor has prescribed Mirtazapine Bluefish to a person under 18 years of age, before participating in traffic (e.g., cycling), it should be checked whether the medicine affects alertness and concentration.

Mirtazapine Bluefish contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Mirtazapine Bluefish

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.

Dosage

The recommended initial dose is 15 mg or 30 mg per day.After a few days of treatment, the doctor may recommend increasing the dose to the most suitable for the patient (from 15 to 45 mg per day).
Usually, the same dose of the medicine is used in patients of different ages. However, elderly patients or patients with kidney or liver disease may be prescribed a different dose by their doctor.

When to take Mirtazapine Bluefish

Mirtazapine Bluefish should be taken every day at the same time. It is best to take it in a single dose in the evening, before bedtime. However, the doctor may recommend taking the medicine in two divided doses throughout the day - one dose in the morning and one in the evening before bedtime.
The larger dose should be taken in the evening, before bedtime.
The tablets should be taken orally. The tablets should not be chewed. The tablets should be swallowed, washed down with water or juice.
The 15 mg and 30 mg tablets can be divided into equal doses.

When can an improvement in well-being be expected

Usually, Mirtazapine Bluefish starts working after 1 to 2 weeks of treatment, and after 2 to 4 weeks, an improvement in well-being may occur.
It is essential to discuss the effects of Mirtazapine Bluefish with the doctor during the first few weeks of treatment.
After 2 to 4 weeks from the start of Mirtazapine Bluefish treatment, the doctor should be consulted to discuss how the medicine is working.
If the patient still does not experience an improvement in well-being, the doctor may increase the dose. After another 2 to 4 weeks, the doctor should be consulted again.
Usually, it will be necessary to take Mirtazapine Bluefish until the symptoms of depression disappear, which can take from 4 to 6 months.

Taking a higher dose of Mirtazapine Bluefish than recommended

In case of taking a higher dose of Mirtazapine Bluefish than recommended, the doctor should be contacted immediately.
The most likely symptoms of Mirtazapine Bluefish overdose (without other medicines and without alcohol) are drowsiness, disorientation, and rapid heart rate. Overdose symptoms may include changes in heart rhythm (rapid heart rate, irregular heart rhythm) and (or) fainting, which can be life-threatening and are known as "torsade de pointes".

Missing a dose of Mirtazapine Bluefish

If the medicine is taken once a day

• A double dose should not be taken to make up for a missed dose. The next dose should be taken at the usual time.

If the medicine is taken twice a day

• if the morning dose is missed, it should be taken together with the evening dose;
• if the evening dose is missed, it should not be taken together with the morning dose; it should be skipped; treatment should be continued, taking the usual morning and evening doses;
• if both doses are missed, they should not be made up; they should be skipped. The next day, treatment should be continued, taking the usual morning and evening doses.

Stopping treatment with Mirtazapine Bluefish

Treatment with Mirtazapine Bluefish should only be stopped under the strict guidance of the doctor.
Treatment should not be stopped too early, as it may cause a relapse of depression. If an improvement occurs, it should be discussed with the doctor, who will inform when it is possible to stop treatment.
Treatment with Mirtazapine Bluefish should not be stopped abruptly, even if depression has disappeared. If treatment with Mirtazapine Bluefish is stopped abruptly, nausea, dizziness, restlessness or anxiety, and headaches may occur. These symptoms will not occur during gradual withdrawal of the medicine. The doctor will inform the patient how to gradually reduce the dose.
In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Mirtazapine Bluefish can cause side effects, although not everybody gets them.

If any of the following serious side effects occur, stop taking mirtazapine and contact your doctor immediately.

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

• feeling of excitement or agitation (mania)

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

• yellowing of the eyes or skin; this may indicate liver problems (jaundice)

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

• infection symptoms, such as sudden unexplained high fever, sore throat, and mouth ulcers (agranulocytosis). Mirtazapine can rarely cause blood disorders (bone marrow depression). Some patients may become less resistant to infections because mirtazapine can cause a temporary decrease in the number of white blood cells (granulocytopenia). Rarely, mirtazapine can also cause a decrease in the number of red and white blood cells and platelets (aplastic anemia), low platelet count (thrombocytopenia), or an increased number of white blood cells (eosinophilia).
• seizures (convulsions)
• a combination of symptoms such as unexplained fever, sweating, increased heart rate, diarrhea, (uncontrolled) muscle contractions, shivering, increased reflexes, restlessness, mood changes, loss of consciousness, and increased salivation. In very rare cases, these may be symptoms of serotonin syndrome.
• thoughts of self-harm or suicide
• severe skin reactions:
• red spots on the torso in a target shape or round, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence of such severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other possible side effects:

Very common(may affect more than 1 in 10 people):

• increased appetite and weight gain
• calmness or drowsiness
• headache
• dry mouth

Common(may affect up to 1 in 10 people):

• lethargy
• dizziness
• seizures or tremors
• nausea
• diarrhea
• vomiting
• constipation
• rash or skin eruptions
• joint or muscle pain
• back pain
• dizziness or fainting when changing body position quickly (orthostatic hypotension)
• swelling (usually of the ankles or feet) due to fluid retention in the body
• fatigue
• intense dreams
• disorientation
• feeling of anxiety
• sleep disturbances
• memory disturbances, which in most cases disappeared after stopping treatment

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

• unusual skin sensations, e.g., burning, tingling, or numbness (paresthesia)
• restless legs syndrome
• fainting
• feeling of numbness in the mouth (oral hypoesthesia)
• low blood pressure
• nightmares
• agitation
• hallucinations
• urge to move

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

• muscle twitching or contractions (clonic muscle spasms)
• aggressive behavior
• abdominal pain and nausea, which may indicate pancreatitis

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

• unusual sensations in the mouth (oral paresthesia)
• swelling of the mouth
• generalized swelling (generalized edema)
• localized swelling
• low sodium levels in the blood (hyponatremia)
• inappropriate antidiuretic hormone secretion
• severe skin reactions (bullous dermatitis, erythema multiforme)
• sleepwalking (somnambulism)
• speech disturbances
• increased creatine kinase levels in the blood
• urination difficulties (urinary retention)
• muscle pain, stiffness, and (or) weakness, darker or lighter urine color

or muscle cramps (rhabdomyolysis)

• increased prolactin levels in the blood (hyperprolactinemia, including symptoms such as breast enlargement and (or) milk secretion from the nipples)
• prolonged painful erection

Additional side effects in children and adolescents

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

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Mirtazapine Bluefish

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the blister after "Expiry date" / "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste.
The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Mirtazapine Bluefish contains

The active substance of the medicine is mirtazapine.
Each film-coated tablet of Mirtazapine Bluefish contains 15 mg, 30 mg, or 45 mg of mirtazapine.
The other ingredients of the medicine are:
Tablet core: cornstarch, hypromellose, magnesium stearate, colloidal anhydrous silica, lactose monohydrate
Tablet coating:
15 mg:hypromellose 2910, polyethylene glycol (E1521), titanium dioxide (E171), yellow iron oxide (E172).
30 mg:hypromellose 2910, polyethylene glycol (E1521), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
45 mg:hypromellose 2910, polyethylene glycol (E1521), titanium dioxide (E171).

What Mirtazapine Bluefish looks like and contents of the pack

Mirtazapine Bluefish is a film-coated tablet.
15 mg:Yellow, oval, biconvex film-coated tablets, with "MH" embossed on one side and "1" and "5" separated by a score line on the other side, approximately 10 mm x 6 mm in size.
The tablet can be divided into equal doses.
30 mg:Red-brown, oval, biconvex film-coated tablets, with "MH" embossed on one side and "3" and "0" separated by a score line on the other side, approximately 13 mm x 7 mm in size.
The tablet can be divided into equal doses.
45 mg:White, oval, biconvex film-coated tablets, with "MH" embossed on one side and "45" on the other side, approximately 14 mm x 8 mm in size.
Mirtazapine Bluefish 15 mg, 30 mg, and 45 mg film-coated tablets are packaged in blisters.
Pack sizes: 28, 30, and 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder

Bluefish Pharmaceuticals AB
P.O. Box 49013
100 28 Stockholm
Sweden
Phone: +46 8 51 91 16 00

Manufacturer/Importer

Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm
Sweden

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

Date of last revision of the leaflet: