Mizhaten 30 mg

Package Leaflet: Information for the Patient

Mirzaten, 30 mg, Film-Coated Tablets

Mirzaten, 45 mg, Film-Coated Tablets

Mirtazapine Hemihydrate

Read the Package Leaflet Carefully Before Taking the Medication, 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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Mirzaten and what is it used for

Mirzaten belongs to a group of medicines called antidepressants.
Mirzaten is indicated for the treatment of depression.
Mirzaten 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, "When can an improvement in well-being be expected".

2. Important information before taking Mirzaten

When Not to Take Mirzaten

• If the patient is allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6). In such cases, before taking Mirzaten, 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 Mirzaten, the patient should discuss it with their doctor or pharmacist.

Before Taking Mirzaten, the Patient Should Inform Their Doctor:

If they have ever experienced severe skin rash or peeling, blistering, or ulcers in the mouth after taking mirtazapine or other medications.

Children and Adolescents

Mirzaten is not usually recommended for children and adolescents under 18 years of age, as its efficacy has not been established. Additionally, patients under 18 years of age have a higher risk of side effects, such as suicidal thoughts, suicidal attempts, and hostility (mainly aggression, rebelliousness, and anger), when taking this class of medication. However, the doctor may prescribe Mirzaten to patients of this age group if they consider it to be in the patient's best interest. If the doctor prescribes Mirzaten to a patient under 18 years of age, and any concerns arise, the patient should consult their doctor. For patients under 18 years of age taking Mirzaten, the doctor should be informed if any of the above symptoms develop or worsen. The long-term effects of Mirzaten on safety, including growth, maturation, and cognitive development in this age group, have not been established. Furthermore, during treatment with mirtazapine in this age group, significant weight gain is more frequently observed than in adults.

Suicidal Thoughts and Depression Worsening

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 medications usually start working after about 2 weeks, sometimes later.

• Patients who have previously experienced suicidal thoughts or attempts;
• Young adult patients. Clinical trial data indicate an increased risk of suicidal behavior in patients under 25 years of age with mental disorders treated with antidepressants. If suicidal thoughts or attempts occur, the patient should immediately contact their doctor or go to the hospital. It may be helpful to inform relatives or friendsabout the depression and ask them to read this leaflet. The patient may ask them to monitor their condition and inform them if depression or anxiety worsens or if there are any disturbing changes in behavior.

Special caution is required when taking Mirzaten:

• If the patient has or has ever had the following diseases. The patient should inform their doctor about these diseases before starting treatment with Mirzaten, if they have not already done so:
• -epileptic seizures. If seizures occur or their frequency increases during treatment, Mirzaten should be discontinued, and the patient should immediately contact their doctor;
• -liver disease, including jaundice. If jaundice occurs, Mirzaten should be discontinued, and the patient should immediately contact their doctor;
• -kidney disease;
• -heart diseaseor low blood pressure;
• -schizophrenia. The patient should immediately contact their doctor if such psychiatric disorders as paranoid thoughts worsen or increase in frequency;
• -manic depression(alternating periods of elevated mood/excitement and depression). If the patient feels excessively excited, they should discontinue Mirzaten and immediately contact their doctor;
• -diabetes(may require a change in insulin or oral hypoglycemic medication dose);
• -eye disease, such as increased intraocular pressure (glaucoma);
• -urination difficulties, which may be caused by prostate enlargement;
• -certain heart rhythm disorders, which may cause changes in heart rhythm, recent myocardial infarction, heart failure, or the use of certain medications that may cause heart rhythm disorders.
• If symptoms of infection occur, such as unexplained high fever, sore throat, and mouth ulcers.

The patient should discontinue Mirzaten and immediately consult their doctor, who will order a blood morphology test. In rare cases, these symptoms may be a sign of blood cell production disorders in the bone marrow. Although rare, these symptoms usually occur within 4-6 weeks of treatment.

• Elderly patients may be more sensitive to the side effects of antidepressants.
• 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. The patient should discontinue the medication and seek medical attention immediately if they experience any of the symptoms listed in section 4.
• If the patient has ever experienced a serious skin reaction, they should not restart treatment with mirtazapine.

Mirzaten and Other Medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
Mirzaten should not be takenin combination with:

• -monoamine oxidase inhibitors (MAOIs)or within 2 weeks of stopping their use. The patient should not start taking Mirzaten until 2 weeks after stopping MAOIs. Examples of MAOIs include moclobemide and tranylcypromine (antidepressants), selegiline (used to treat Parkinson's disease).

Cautious use is recommendedwhen taking Mirzaten in combination with:

• -other antidepressants, such as SSRIs, venlafaxine, and L-tryptophan or triptans (used to treat migraines), buprenorphine (used to treat pain or opioid addiction), tramadol (a pain reliever), linezolid (an antibiotic), lithium salts (used to treat certain mental disorders), methylene blue (used to reduce high methemoglobin levels in the blood), and products containing St. John's Wort (Hypericum perforatum)(herbal products used to treat depression). In patients taking Mirzaten alone or in combination with these medications, serotonin syndrome may rarely occur. Some of its symptoms include sudden fever, sweating, increased heart rate, diarrhea, (uncontrolled) muscle contractions, shivering, increased reflexes, anxiety, mood changes, and loss of consciousness. The patient should immediately contact their doctor if they experience several of these symptoms.
• -the antidepressant nefazodone. It may increase the level of Mirzaten in the blood. The patient should inform their doctor about taking this medication. A dose reduction may be necessary, and after stopping nefazodone, the dose of Mirzaten may need to be increased.
• -medications used to treat anxiety or insomnia, such as benzodiazepines;
• -medications used to treat schizophrenia, such as olanzapine;
• -medications used to treat allergies, such as cetirizine;
• -medications used to treat severe pain, such as morphine. Mirzaten in combination with these medications may increase the sedation caused by these medications.
• -medications used to treat infections, such as antibacterial agents (e.g., erythromycin), antifungal agents (e.g., ketoconazole), and medications used to treat HIV/AIDS (e.g., HIV protease inhibitors) and medications used to treat stomach ulcers(e.g., cimetidine). When these medications are started in combination with Mirzaten, the level of Mirzaten in the blood may increase. The patient should inform their doctor about taking these medications. A dose reduction of Mirzaten may be necessary, and after stopping these medications, the dose of Mirzaten may need to be increased.
• -antiepileptic medications, such as carbamazepine and phenytoin;
• -medications used to treat tuberculosis, such as rifampicin. When taken in combination with Mirzaten, these medications may decrease the level of Mirzaten in the blood. The patient should inform their doctor about taking these medications. A dose increase of Mirzaten may be necessary, and after stopping these medications, the dose of Mirzaten may need to be decreased.
• -anticoagulant medications, such as warfarin. Mirzaten may enhance the effect of warfarin. The patient should inform their doctor about taking these medications. When treating with Mirzaten in combination with warfarin, it is recommended to monitor blood parameters.
• medications that may affect heart rhythm, such as certain antibiotics and antipsychotic medications.

Taking Mirzaten with Food, Drink, and Alcohol

Drinking alcohol while taking Mirzaten may cause drowsiness.
It is recommended to avoid consuming alcohol during treatment with Mirzaten.
Mirzaten 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 medication.
Limited experience with Mirzaten in pregnant women does not indicate an increased risk. However, caution should be exercised when using this medication during pregnancy.
If Mirzaten is taken during pregnancy or shortly before birth, it is recommended to monitor the newborn for possible side effects.
Taking similar medications during pregnancy (such as selective serotonin reuptake inhibitors (SSRIs)) may increase the risk of the newborn developing persistent pulmonary hypertension (PPHN), characterized by rapid breathing and bluish skin. These symptoms usually occur within the first day of life. If such symptoms occur in the newborn, the patient should immediately contact their doctor and/or midwife.

Driving and Using Machines

Mirzaten may reduce alertness and ability to concentrate. During treatment with Mirzaten, the patient should avoid performing potentially hazardous activities that require continuous attention, such as driving or operating machinery. If the doctor prescribes Mirzaten to a patient under 18 years of age, before participating in traffic (e.g., cycling), the patient should check if the medication affects their alertness and ability to concentrate.

Mirzaten Contains Lactose and Sodium

Lactose

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

Sodium

The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to Take Mirzaten

This medication should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.

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 (15-45 mg per day).
Usually, the same dose of Mirzaten is used for patients of different ages. However, elderly patients or those with kidney or liver disease may be prescribed a different dose by their doctor.

When to Take Mirzaten

Mirzaten should be taken daily at the same time, preferably in a single dose in the evening, before bedtime. However, the doctor may recommend taking the medication in two divided doses per 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 with water or juice.

When Can an Improvement in Well-being be Expected

Usually, the medication starts working after 1-2 weeks of treatment, and after 2-4 weeks, an improvement in well-being may occur.
It is essential to discuss the effects of Mirzaten with the doctor during the first few weeks of treatment.
After 2-4 weeks of taking Mirzaten, the patient should discuss with their doctor how the medication is working.
If there is no adequate clinical response, the doctor may increase the dose. After another 2-4 weeks, the patient should again discuss the treatment effects with their doctor.
Treatment should be continued until the symptoms have completely resolved, which usually takes 4-6 months.

Overdose of Mirzaten

If the patient (or someone else) has taken a larger dose of Mirzaten than recommended, they should immediately contact their doctor.
The most likely symptoms of Mirzaten overdose (without other medications 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. These may be symptoms of life-threatening ventricular arrhythmias, known as "torsades de pointes".

Missing a Dose of Mirzaten

If the patient forgets to take a dose that is supposed to be taken once a day:

• they should not take a double dose to make up for the missed dose. They should continue treatment by taking the next dose at the usual time the next day.

If the medication is supposed to be taken twice a day:

Stopping Treatment with Mirzaten

The patient should only stop taking Mirzaten under the strict guidance of their doctor.
The patient should not stop taking Mirzaten too early, as this may cause the disease to recur. If an improvement occurs, the patient should discuss it with their doctor, who will inform them when they can stop treatment. Suddenly stopping treatment with Mirzaten, even if the symptoms of depression have disappeared, may cause nausea, dizziness, agitation, or anxiety and headache. These symptoms will not occur during gradual discontinuation of the medication. The doctor will inform the patient how to gradually reduce the dose of Mirzaten.
If the patient has any further doubts about taking this medication, they should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Mirzaten can cause side effects, although not everybody gets them.

If the Patient Experiences Any of the Following Serious Side Effects, They Should Stop Taking Mirzaten and Immediately Contact Their Doctor:

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

• feeling excited or agitated (mania)

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

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

Side effects with unknown frequency(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 cell production disorders (bone marrow suppression). Some patients may become more susceptible to infections because mirtazapine can cause temporary decreases in white blood cell count (granulocytopenia). Mirtazapine can also rarely cause decreases in red blood cell, white blood cell, and platelet counts (aplastic anemia, thrombocytopenia), or increases in white blood cell count (eosinophilia).
• seizures (convulsions)
• a combination of symptoms such as unexplained high fever, sweating, increased heart rate, diarrhea, (uncontrolled) muscle contractions, shivering, increased reflexes, anxiety, mood changes, and loss of consciousness. 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, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. 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 side effects(may affect more than 1 in 10 people):

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

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

• lethargy
• dizziness
• seizures or tremors
• nausea
• diarrhea
• vomiting
• constipation
• skin 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
• vivid dreams
• disorientation
• feeling anxious
• sleep disturbances
• memory disturbances, which usually resolve after treatment is stopped

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

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

Rare side effects(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

Side effects with unknown frequency(frequency cannot be estimated from the available data):

• unusual sensations in the mouth (oral paresthesia)
• mouth swelling
• body swelling (generalized edema)
• local 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 paler urine (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 the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of this medication.

5. How to Store Mirzaten

The medication should be stored out of sight and reach of children.
Do not use this medication after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
There are no special storage precautions.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications they no longer use. This will help protect the environment.

6. Contents of the Pack and Other Information

What Mirzaten Contains

• The active substance of Mirzaten is mirtazapine hemihydrate. Each film-coated tablet contains 30 mg or 45 mg of mirtazapine hemihydrate.
• Other ingredients are: Mirzaten 30 mg:cellulose (α-lactose monohydrate - 75%, cellulose powder - 25%), sodium carboxymethylcellulose (type A), corn starch, colloidal silicon dioxide, magnesium stearate; coating: hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), talc, macrogol 6000. See section 2 "Mirzaten contains lactose and sodium". Mirzaten 45 mg:cellulose (α-lactose monohydrate - 75%, cellulose powder - 25%), sodium carboxymethylcellulose (type A), corn starch, colloidal silicon dioxide, magnesium stearate; coating: hypromellose, titanium dioxide (E 171), talc, macrogol 6000. See section 2 "Mirzaten contains lactose and sodium".

What Mirzaten Looks Like and Contents of the Pack

Mirzaten 30 mg: orange-brown, oval, biconvex film-coated tablets with a score line on one side
Mirzaten 45 mg: white, oval, biconvex film-coated tablets
Packaging: 30, 60, or 90 film-coated tablets in blisters in a cardboard box.

Marketing Authorization Holder and Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This Medication is Authorized in the Member States of the European Economic Area Under the Following Names:

To obtain more detailed information on this medication, the patient should contact their local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of the Last Revision of the Leaflet:06.01.2022