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Mirzaten 30 mg and 45 mg film-coated tablets – mirtazapine for depression in adults
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- Stock: Zabrana online prodaje
- Brand: KRKA-EN
- Model: BR-165641651214
Mirzaten is an antidepressant in the form of film-coated tablets containing mirtazapine (ATC N06AX11), in strengths of 30 mg and 45 mg.
Mirzaten is used to treat episodes of depression in adults. It starts to work after 1 to 2 weeks, and improvement is usually felt after 2 to 4 weeks of regular use. According to the leaflet, the medicine usually needs to be taken for 4 to 6 months until the symptoms of depression have gone.
Important warning
- Mirzaten is a prescription-only medicine (regime R).
- It must not be taken with MAO inhibitors or within two weeks before or after them.
- Thoughts of self-harm or suicide, especially at the start of treatment and in people under 25, require urgent contact with a doctor.
- The medicine must not be stopped suddenly; do not drink alcohol during treatment.
- Read the package leaflet before use. This page is for information only and is not an offer to buy the medicine online.
What is Mirzaten used for and how is it taken correctly?
Key facts about the medicine
| Medicine name | Mirzaten® 30 mg and Mirzaten® 45 mg, film-coated tablets |
|---|---|
| Active substance | mirtazapine (as mirtazapine hemihydrate) |
| Strength | 30 mg or 45 mg per film-coated tablet |
| Pharmaceutical form | film-coated tablet (30 mg with a score line for dividing into equal doses) |
| Therapeutic group | other antidepressants (ATC N06AX11) |
| Pack | 30 film-coated tablets (3 blisters of 10) |
| Marketing authorisation holder / manufacturer | Krka-Farma d.o.o. Belgrade / Krka d.d., Novo Mesto, Slovenia |
| Dispensing regime | prescription only (R) |
What is Mirzaten used for?
- Treatment of episodes of depression (major depressive episodes) in adults.
How is Mirzaten taken and dosed?
- The usual starting dose is 15 or 30 mg daily; after a few days the doctor may increase it to the dose that suits you best – between 15 and 45 mg daily.
- Take the medicine every day at the same time, preferably as a single dose before going to bed. The doctor may advise splitting it into a morning and an evening dose, with the larger dose taken in the evening.
- Swallow the tablet without chewing, with a glass of water or juice; it can be taken with or without food.
- After 2 to 4 weeks, talk to your doctor about how the medicine is working; if there is no improvement, the doctor may increase the dose.
- In the elderly and in kidney or liver disease, the doctor may adjust the dose.
Special patient groups
- Children and adolescents under 18: the medicine is usually not used (efficacy has not been shown); a higher risk of suicidal behaviour and hostility, as well as significant weight gain, has been observed in young people.
- Elderly: may be more prone to side effects.
- Kidney or liver disease: the doctor may adjust the dose; if jaundice occurs, stop the medicine and contact a doctor immediately.
Contraindications – when the medicine must not be used
- hypersensitivity to mirtazapine or any of the excipients;
- current or recent (within the last two weeks) use of MAO inhibitors.
Warnings and precautions
- Tell your doctor if you have ever had a severe rash, skin peeling, blisters or mouth sores after mirtazapine or other medicines; SJS, TEN and DRESS have been reported.
- Special caution in epilepsy, liver or kidney disease, heart disease or low blood pressure, schizophrenia, bipolar disorder, diabetes (antidiabetic doses may need adjustment), glaucoma, difficulty urinating due to the prostate and heart rhythm disorders.
- In case of unexplained high fever, sore throat and mouth ulcers, stop the medicine and contact the doctor for a blood test (possible disorder of blood cell production, most often after 4–6 weeks).
- If elation or excessive excitement (mania) occurs, stop the medicine and contact a doctor immediately.
- The medicine contains lactose.
Interactions with other medicines, food and drink
- Contraindicated: MAO inhibitors (moclobemide, tranylcypromine, selegiline) – not within two weeks before or after.
- Risk of serotonin syndrome: SSRIs, venlafaxine, L-tryptophan, triptans, tramadol, linezolid, lithium, methylene blue and St John’s wort preparations.
- Increased drowsiness: benzodiazepines, olanzapine, cetirizine, morphine and alcohol.
- Increase mirtazapine levels: nefazodone, erythromycin, ketoconazole, HIV protease inhibitors, cimetidine. Decrease levels: carbamazepine, phenytoin, rifampicin.
- Warfarin: increased effect – clotting tests should be monitored. Caution also with medicines affecting heart rhythm.
- Alcohol: do not drink.
Pregnancy and breast-feeding
- Pregnancy: limited experience does not indicate an increased risk of birth defects, but caution is needed; if the medicine is taken in late pregnancy, the newborn will be closely monitored. Similar medicines (SSRIs) may increase the risk of persistent pulmonary hypertension of the newborn.
- Breast-feeding: talk to your doctor before taking the medicine.
Driving and using machines
- Mirzaten may reduce attention and concentration. Before driving or using machines, make sure your abilities are not impaired.
Possible side effects
Stop the medicine and contact a doctor immediately in case of: mania (uncommon), jaundice (rare), signs of infection with fever, sore throat and mouth ulcers (agranulocytosis), seizures, signs of serotonin syndrome, thoughts of self-harm or suicide and severe skin reactions (SJS, TEN, DRESS).
Very common: increased appetite and weight gain, drowsiness or sedation, headache, dry mouth.
Common: lethargy, dizziness, tremor, nausea, diarrhoea, vomiting, constipation, rash, joint, muscle and back pain, dizziness on standing up quickly, swelling of the ankles and feet, tiredness, unusual dreams, confusion, anxiety, insomnia, memory problems.
Uncommon and rare: paraesthesia, restless legs, fainting, low blood pressure, nightmares, agitation, hallucinations, myoclonus, aggression, pancreatitis. Not known: hyponatraemia, sleepwalking, difficulty urinating, rhabdomyolysis, hyperprolactinaemia, prolonged painful erection and others.
Overdose, missed dose and stopping treatment
- Overdose: contact a doctor immediately. The most common signs are drowsiness, disorientation and fast heartbeat; heart rhythm changes and fainting (torsades de pointes) are possible.
- Missed dose (once daily in the evening): do not take a double dose – take the next one at the usual time. With two daily doses: take a forgotten morning dose with the evening dose, and skip a forgotten evening dose.
- Stopping treatment: only in agreement with your doctor and gradually – stopping suddenly may cause nausea, dizziness, agitation, anxiety and headache, and the depression may return.
When to seek medical help immediately?
- thoughts of self-harm or suicide;
- high fever, sore throat and mouth ulcers;
- fever, sweating, fast heartbeat, diarrhoea, uncontrolled muscle twitching and restlessness (possible serotonin syndrome);
- a seizure, yellowing of the skin or eyes;
- widespread rash with blisters, skin peeling or fever;
- fast or irregular heartbeat and fainting.
Pharmacist's advice
Take Mirzaten in the evening, before bed – drowsiness, which is very common, is then less bothersome during the day. Be patient: improvement is usually felt only after 2–4 weeks, and do not stop the medicine when you feel better, but agree a gradual dose reduction with your doctor.
Increased appetite and weight gain are very common – weigh yourself once a week and choose balanced meals. Frequent sips of water and a dry-mouth gel help relieve dry mouth. Do not take St John’s wort or L-tryptophan preparations with this medicine, and avoid alcohol.
Availability and price
Mirzaten is a prescription-only medicine and cannot be bought online. No price is shown on this page.
Please check availability and dispensing conditions at a pharmacy, with a doctor’s prescription.
Related information
Treatment of depression requires regular medical check-ups, especially in the first weeks of therapy. It may help to tell someone close that you are being treated and ask them to point out changes in your behaviour. Always read the leaflet supplied with the medicine.
Composition, pack and manufacturer
- Active substance: mirtazapine 30 mg or 45 mg per film-coated tablet (as mirtazapine hemihydrate).
- Excipients – core: cellactose (lactose monohydrate and cellulose), sodium starch glycolate, pregelatinised starch, colloidal anhydrous silica, magnesium stearate. Coating: hypromellose, titanium dioxide (E171), talc, macrogol 6000; in 30 mg also yellow and red iron oxide (E172).
- Appearance: 30 mg – oval, orange-brown film-coated tablets with a score line for dividing into equal doses; 45 mg – oval white film-coated tablets.
- Pack: 3 PVC/PVDC-Al blisters of 10 film-coated tablets (30 tablets).
- Marketing authorisation holder: Krka-Farma d.o.o. Belgrade, Jurija Gagarina 26/V/II, Belgrade. Manufacturer: Krka d.d., Novo Mesto, Slovenia.
- Authorisations: 515-01-05134-21-001 (30 mg) and 515-01-05135-21-001 (45 mg) of 15.11.2022.
Storage
- The medicine does not require any special storage conditions.
- Keep out of the sight and reach of children; do not use after the expiry date.
Frequently asked questions
When will I feel the effect of Mirzaten?
The effect usually begins after 1 to 2 weeks, and you feel better after 2 to 4 weeks. During this period, talk to your doctor about how the medicine is working.
Why is Mirzaten taken in the evening?
It is best taken as a single dose at bedtime because drowsiness is a very common side effect. If the doctor splits the dose, the larger dose is taken in the evening.
Does Mirzaten cause weight gain?
Increased appetite and weight gain are very common side effects. Monitor your weight and discuss larger changes with your doctor.
Can I drink St John’s wort tea with Mirzaten?
No. St John’s wort is listed in the leaflet among preparations that may lead to serotonin syndrome together with mirtazapine.
Sources
- ALIMS – Package leaflet Mirzaten 30 mg and 45 mg film-coated tablets (PIL, Serbian, 11/2022)
- ALIMS – Summary of product characteristics Mirzaten (SmPC, Serbian)
Date sources were checked: 25.10.2026.
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