Mirtazapine bluefish

Package leaflet: Information for the patient

Mirtazapine Bluefish, 15 mg, film-coated tablets
Mirtazapine Bluefish, 30 mg, film-coated tablets
Mirtazapine Bluefish, 45 mg, film-coated tablets
Mirtazapinum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

Mirtazapine Bluefish belongs to a group of medicines known as antidepressants.
Mirtazapine Bluefish is indicated for the treatment of depression in adults.
The effect of Mirtazapine Bluefish begins after 1-2 weeks of treatment, and improvement in well-being may occur after 2-4 weeks. If no improvement occurs or if the patient feels worse after 2-4 weeks of treatment, medical advice should be sought. Further information is provided in section 3 under "When to expect improvement in well-being".

2. Important information before using Mirtazapine Bluefish

When not to use Mirtazapine Bluefish

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

Warnings and precautions
Before starting treatment with Mirtazapine Bluefish, discuss this with your doctor or
pharmacist.
Before starting to take Mirtazapine Bluefish, tell your doctor:
If the patient has ever experienced severe skin rash, skin peeling, blistering, and/or oral ulcers after taking Mirtazapine Bluefish.

Children and adolescents
Mirtazapine Bluefish is generally not recommended for use in children and adolescents under 18 years of age, as its efficacy has not been established. It should also be noted that patients under 18 years of age taking medicines of this class have a higher risk of experiencing adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, defiant behaviour, and anger). Nevertheless, a doctor may prescribe Mirtazapine Bluefish to patients under 18 years of age if they consider it to be in their best interest. If Mirtazapine Bluefish has been prescribed to a patient under 18 years of age and any doubts arise, consult the prescribing doctor. In patients under 18 years of age taking Mirtazapine Bluefish, inform the doctor immediately if any of the symptoms listed above develop or worsen.
The long-term impact of Mirtazapine Bluefish on safety regarding growth, maturation, and cognitive and behavioural development in this age group has not yet been established. Additionally, during treatment with Mirtazapine Bluefish in this age group, significant weight gain has been observed more frequently than in adults.

Suicidal thoughts and worsening of depression
Patients with depression may sometimes have thoughts of self-harm or suicide. Such symptoms or behaviours may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually start to work only after about two weeks, sometimes later.

These symptoms are more likely in:

• patients who previously experienced thoughts of self-harm or suicide.
• young adult patients. Clinical trial data show an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who were treated with antidepressant medicines. Contact a doctor immediately or go to hospital if thoughts of self-harm or suicidal thoughts occur.

It may be helpful to inform family members or friends about the depression and ask them to read this leaflet. The patient may ask them to inform him/her if they notice worsening depression or anxiety, or concerning changes in behaviour.

Take special care when using Mirtazapine Bluefish:

• if the patient has or has ever had any of the following conditions. Inform the doctor about the presence of any of the following conditions before starting treatment with Mirtazapine Bluefish, if not already done:
  • epileptic seizures. If seizures occur or their frequency increases during treatment, discontinue Mirtazapine Bluefish and contact a doctor immediately;
  • liver diseases, including jaundice. If jaundice occurs, discontinue Mirtazapine Bluefish and contact a doctor immediately;
  • kidney diseases;
  • heart diseases or low blood pressure;
  • schizophrenia. Contact a doctor immediately if psychiatric disorders such as paranoid thoughts worsen or increase in frequency;
  • manic depression (alternating periods of elevated mood/excitement and depression). If feelings of excessive excitement occur, discontinue Mirtazapine Bluefish and contact a doctor immediately;
  • diabetes (a change in insulin or other antidiabetic medication dose may be necessary);
  • eye diseases, such as increased intraocular pressure (glaucoma);
  • difficulty in urination, which may be caused by benign prostatic hyperplasia;
  • certain heart conditions that may cause changes in heart rhythm, recent myocardial infarction, heart failure, or use of certain medicines that may cause heart rhythm disturbances.
• if symptoms of infection occur, such as unexplained fever, sore throat, or oral ulcers. Discontinue Mirtazapine Bluefish and consult a doctor immediately, who will order a blood count test. In rare cases, these symptoms may indicate bone marrow suppression affecting blood cell production. Although rare, these symptoms most commonly occur after 4-6 weeks of treatment.
• if the patient is elderly, they may be more sensitive to the adverse effects of antidepressant medicines.
• serious skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Mirtazapine Bluefish. Discontinue the medicine and seek immediate medical help if any of the symptoms listed in section 4 occur due to these severe skin reactions. Do not restart treatment with Mirtazapine Bluefish if the patient has ever experienced a severe skin reaction.

Mirtazapine Bluefish with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Do not take Mirtazapine Bluefish in combination with:

• monoamine oxidase inhibitors (MAOIs) or within two weeks of stopping them. Do not start taking Mirtazapine Bluefish within two weeks of stopping MAOIs. MAOIs include, for example, moclobemide, tranylcypromine (antidepressants), and selegiline (used in the treatment of Parkinson's disease).

Take special care when using Mirtazapine Bluefish in combination with:

• other antidepressants such as SSRIs (selective serotonin reuptake inhibitors), venlafaxine, L-tryptophan, or triptans (used to treat migraine), tramadol (a painkiller), linezolid (an antibiotic), lithium salts (used to treat certain psychiatric disorders), methylene blue (used to reduce high methemoglobin levels in blood), and St. John's wort products (herbal remedies used to treat depression). In patients taking only Mirtazapine Bluefish or in combination with these medicines, serotonin syndrome may very rarely occur. Some of its symptoms include: unexplained fever, sweating, increased heart rate, diarrhoea, (involuntary) muscle contractions, shivering, increased reflexes, restlessness, mood changes, and loss of consciousness. Contact a doctor immediately if several of these symptoms occur simultaneously.
• the antidepressant nefazodone. It may increase the blood concentration of Mirtazapine Bluefish. Inform the doctor if taking this medicine. A dose reduction of Mirtazapine Bluefish may be necessary, and after stopping nefazodone, the dose of Mirtazapine Bluefish may need to be increased.
• 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 drowsiness caused by them.
• medicines used to treat infections, such as antibacterial agents (e.g., erythromycin), antifungal agents (e.g., ketoconazole), and medicines used to treat HIV/AIDS (such as HIV protease inhibitors) and medicines used to treat stomach ulcers (e.g., cimetidine). If these medicines are started together with Mirtazapine Bluefish, the blood concentration of Mirtazapine Bluefish may increase. Inform the doctor if taking these medicines. A dose reduction of Mirtazapine Bluefish may be necessary, and after stopping these medicines, the dose of Mirtazapine Bluefish may need to be increased.
• antiepileptic medicines, such as carbamazepine and phenytoin; medicines used to treat tuberculosis, such as rifampicin. In combination with Mirtazapine Bluefish, these medicines may reduce its blood concentration. Inform the doctor if taking these medicines. A dose increase of Mirtazapine Bluefish may be necessary, and after stopping these medicines, the dose of Mirtazapine Bluefish may need to be reduced.
• anticoagulant medicines, such as warfarin. Mirtazapine Bluefish may enhance the effect of warfarin. Inform the doctor if taking these medicines. Monitoring of blood parameters is recommended during combined treatment with Mirtazapine Bluefish.
• medicines that may affect heart rhythm, such as certain antibiotics and antipsychotic medicines.

Taking Mirtazapine Bluefish with food and alcohol
Drinking alcohol while taking Mirtazapine Bluefish may cause drowsiness. It is best to avoid alcohol consumption.
Mirtazapine Bluefish can be taken independently of meals.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using 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 for possible adverse effects.
Taking similar medicines during pregnancy [such as serotonin reuptake inhibitors (SSRIs)] may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN), which manifests as rapid breathing and cyanosis. These symptoms usually appear within the first 24 hours after birth. If such symptoms occur in the newborn, contact a doctor and/or midwife immediately.

Driving and using machines
Mirtazapine Bluefish may reduce alertness and the ability to concentrate. During treatment with Mirtazapine Bluefish, avoid potentially dangerous activities requiring sustained attention, such as driving or operating machinery. If Mirtazapine Bluefish has been prescribed to a person under 18 years of age, check whether the medicine affects alertness and concentration before participating in road traffic (e.g., cycling).

Mirtazapine Bluefish contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

3. How to use Mirtazapine Bluefish

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Dosage
The recommended starting dose is 15 mg or 30 mg once daily. After a few days of treatment, your doctor
may recommend increasing the dose to the most appropriate level for the patient (from 15 to 45 mg daily).
Usually, the same dose is used in patients of different ages. However, your doctor may recommend a different dose
for elderly patients or patients with kidney or liver disease.
When to take Mirtazapine Bluefish
Mirtazapine Bluefish should be taken every day at the same time. It is best taken as a single dose in the evening,
before going to bed. However, your doctor may recommend taking the medicine in two divided doses during the day –
one in the morning and one in the evening before bedtime.
The larger dose should be taken in the evening, before going to bed.
The tablets should be taken by mouth. Do not chew the tablets. Swallow the tablets with water or juice.
Tablets of 15 mg and 30 mg may be divided into equal doses.
When to expect improvement in well-being
Usually, Mirtazapine Bluefish starts to work after 1 to 2 weeks of treatment, and improvement in well-being may occur
after 2 to 4 weeks.
It is important to discuss the effects of Mirtazapine Bluefish with your doctor during the first few weeks of treatment.
Two to four weeks after starting Mirtazapine Bluefish, you should discuss with your doctor how the medicine is affecting you.
If there is still no improvement in your condition, your doctor may increase the dose. After another 2 to 4 weeks, you should
discuss this again with your doctor.
Usually, it will be necessary to continue taking Mirtazapine Bluefish until depressive symptoms have resolved, which typically takes
4 to 6 months.
Taking more than the recommended dose of Mirtazapine Bluefish
If you (or anyone else) take more than the recommended dose of Mirtazapine Bluefish, you should contact your doctor immediately.
The most likely symptoms of overdose with Mirtazapine Bluefish (without other medicines and without alcohol) are drowsiness, confusion, and rapid heartbeat.
Symptoms of overdose may include changes in heart rhythm (increased heart rate, irregular heartbeat) and/or fainting, which may be life-threatening symptoms known as
“torsade de pointes”.
If you miss a dose of Mirtazapine Bluefish
If the medicine is to be taken once daily

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

If the medicine is to be taken twice daily

• If you forget the morning dose, take it together with the evening dose;
• If you forget the evening dose, do not take it together with the morning dose; skip it. Continue treatment by taking the usual morning and evening doses;
• If you forget both doses, do not try to make them up; skip them. The next day, continue treatment by taking the usual morning and evening doses.

Stopping Mirtazapine Bluefish
You should stop taking Mirtazapine Bluefish only strictly according to your doctor's instructions.
Do not stop taking the medicine too early, as this may cause depression to return. If improvement occurs, discuss this with your doctor, who will advise you when it is safe to stop treatment.
Do not suddenly stop taking Mirtazapine Bluefish, even if your depression has resolved. If you stop taking Mirtazapine Bluefish suddenly, you may experience nausea,
dizziness, agitation or anxiety, and headaches. These symptoms do not usually occur when the medicine is gradually withdrawn. Your doctor will advise you on how to gradually reduce the dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following serious adverse reactions occur, stop taking
mirtazapine and contact your doctor immediately.
Uncommon (may occur in up to 1 in 100 people):

• feeling of excitement or agitation (mania)

Rare (may occur in up to 1 in 1000 people):

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

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

• signs of infection such as sudden high fever of unknown cause, sore throat and mouth ulcers (agranulocytosis). Mirtazapine rarely may cause disturbances in blood cell production (bone marrow suppression). Some patients may become less resistant to infections because mirtazapine may cause a temporary decrease in white blood cells (granulocytopenia). Rarely, mirtazapine may also cause a reduction in red blood cells and white blood cells as well as platelets (aplastic anaemia), low platelet count (thrombocytopenia), or increased number of white blood cells (eosinophilia).
• seizures (fits)
• combination of symptoms such as fever of unknown cause, sweating, increased heart rate, diarrhoea, (uncontrolled) muscle contractions, chills, increased reflexes, restlessness, mood changes, loss of consciousness and increased salivation. In very rare cases, these may be signs of serotonin syndrome.
• thoughts of self-harm or suicide
• severe skin reactions:
• red, target-shaped or circular rashes, often with blisters in the centre, peeling of the skin, mouth, throat, nose, genital or eye ulcers. Such severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other possible adverse reactions:
Very common (may occur in more than 1 in 10 people):

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

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

• lethargy
• dizziness
• tremors or trembling
• nausea
• diarrhoea
• vomiting
• constipation
• rash or skin eruptions
• joint pain or muscle pain
• back pain
• dizziness or fainting on sudden change of body position (orthostatic hypotension)
• swelling (usually of the ankles or feet) due to fluid retention
• fatigue
• vivid dreams
• disorientation
• feeling of anxiety
• sleep disturbances
• memory disturbances, which in most cases resolved after discontinuation of treatment

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

• unusual skin sensations such as burning, stinging or tingling (paraesthesiae)
• restless legs syndrome
• fainting
• numbness sensation in the mouth (oral hypoaesthesia)
• low blood pressure
• nightmares
• agitation
• hallucinations
• urgent need for movement

Rare (may occur in up to 1 in 1000 people):

• muscle twitching or cramps (clonic muscle spasms)
• aggressive behaviour
• upper abdominal pain and nausea which may indicate pancreatitis

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

• unnatural sensations in the mouth (oral paraesthesia)
• swelling of the mouth
• body swelling (generalised oedema)
• localised swelling
• low sodium levels in the blood (hyponatraemia)
• inappropriate antidiuretic hormone secretion
• severe skin reactions (bullous dermatitis, erythema multiforme)
• sleepwalking (somnambulism)
• speech disorders
• increased creatine kinase levels in blood
• difficulty in passing urine (urinary retention)
• muscle pain, stiffness and (or) weakness, darker or discoloured urine (rhabdomyolysis)
• increased levels of prolactin hormone in blood (hyperprolactinaemia, including symptoms such as breast enlargement and (or) milky discharge from the nipples)
• prolonged painful erection

Additional adverse reactions in children and adolescents
In clinical studies in children under 18 years of age, the following adverse reactions were observed more frequently: marked weight gain, urticaria and increased blood triglyceride levels.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Mirtazapine Bluefish

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and on the blister after
"Expiry date (EXP)" / "EXP". The expiry date refers to the last day of the stated month.
No special requirements for storage.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use. Such measures help
protect the environment.

6. Contents of the package and other information

What Mirtazapine Bluefish contains
The active substance is mirtazapine.
Each Mirtazapine Bluefish film-coated tablet contains 15 mg, 30 mg or 45 mg of mirtazapine.
The other ingredients are:
Tablet core: maize starch, 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, embossed with the code "MH" on one side and the digits "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: Reddish-brown, oval, biconvex film-coated tablets, embossed with the code "MH" on one side and the digits "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, embossed with the code "MH" on one side and the number "45" on the other side, approximately 14 mm x 8 mm in size.
Mirtazapine Bluefish film-coated tablets 15 mg, 30 mg and 45 mg are packed in blisters.
Pack sizes:
28, 30 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder
Bluefish Pharmaceuticals AB
P.O. Box 49013
100 28 Stockholm
Sweden
Tel. +46 8 51 91 16 00

Manufacturer/Importer
Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm
Sweden

This medicinal product is authorised in the European Economic Area under the following names: