Remirta 30 mg film-coated tablets – mirtazapine for the treatment of major depression in adults

Remirta is an antidepressant containing mirtazapine. According to the package leaflet, it is used to treat major depression in adults.

Each film-coated tablet contains 30 mg mirtazapine. The medicine usually starts to work after 1 to 2 weeks, and improvement can be expected after 2 to 4 weeks of regular use.

What is Remirta used for and how should it be taken?

Basic information about the medicine

What is Remirta used for?

According to the package leaflet and the summary of product characteristics, Remirta is used for the treatment of major depression in adults.

Talk to your doctor if there is no improvement after 2 to 4 weeks or if you feel worse.

How is Remirta taken and dosed?

• The usual starting dose is 15 mg or 30 mg daily; after a few days your doctor may increase the dose to the one that suits you best (between 15 mg and 45 mg daily).
• Take the medicine at the same time every day, preferably as a single dose before going to bed. If your doctor advises splitting the dose (morning and evening), take the larger dose at bedtime.
• Swallow the tablet without chewing, with a glass of water or juice; it can be taken with or without food.
• The tablet is scored and can be divided into equal doses if prescribed.
• 2 to 4 weeks after starting treatment, talk to your doctor about how the medicine is working; if there is no improvement, your doctor may prescribe a higher dose.
• The medicine is usually taken until depressive symptoms have been gone for 4 to 6 months; your doctor decides when to stop.

Special patient groups

• Children and adolescents under 18: the medicine should not be used because efficacy has not been shown; in young people an increased risk of suicidal behaviour, hostility and significant weight gain has been observed.
• Elderly patients: may be more sensitive to the side effects of antidepressants; the doctor may adjust the dose.
• Impaired kidney or liver function: clearance of mirtazapine may be reduced, so the doctor may adjust the dose.

Contraindications – when the medicine must not be used

• allergy (hypersensitivity) to mirtazapine or any of the excipients;
• current use, or use within the last two weeks, of MAO inhibitors.

Precautions and warnings

• suicidal thoughts and worsening of depression, especially at the start of treatment and in adults under 25 – contact your doctor immediately;
• epileptic seizures – if they occur or become more frequent, stop taking the medicine and contact your doctor immediately;
• liver disease, including jaundice – if jaundice occurs, stop the medicine and contact your doctor;
• kidney disease, heart disease or low blood pressure, heart rhythm disorders, recent heart attack or heart failure;
• schizophrenia or manic depression – feeling elated or worsening psychotic symptoms require urgent contact with your doctor;
• diabetes – the dose of insulin or other medicines may need adjusting;
• increased eye pressure (glaucoma) and difficulty passing urine due to an enlarged prostate;
• signs of infection (unexplained high fever, sore throat, mouth ulcers) – stop the medicine and contact your doctor for a blood test;
• serious skin reactions (SJS, TEN, DRESS) – if you have ever had them, mirtazapine treatment should not be restarted;
• the medicine contains lactose.

Interactions with other medicines, food and drink

Tell your doctor or pharmacist about all medicines you take, including herbal products and non-prescription medicines.

• Do not combine: MAO inhibitors (also for two weeks before and after treatment).
• Risk of serotonin syndrome: SSRI antidepressants, venlafaxine, L-tryptophan, triptans, tramadol, linezolid, lithium, methylene blue and St John’s wort preparations.
• Increased drowsiness: benzodiazepines, olanzapine, antihistamines (e.g. cetirizine), morphine and alcohol.
• Increased mirtazapine levels: nefazodone, erythromycin, ketoconazole, HIV protease inhibitors, cimetidine.
• Reduced mirtazapine levels: carbamazepine, phenytoin, rifampicin.
• warfarin – mirtazapine may increase its effect; blood monitoring is needed;
• medicines that affect heart rhythm (certain antibiotics and antipsychotics).

Pregnancy and breastfeeding

• Pregnancy: limited experience does not indicate an increased risk, but caution is needed. If you take the medicine until delivery, the baby must be monitored. Similar medicines (SSRIs) may increase the risk of persistent pulmonary hypertension of the newborn (fast breathing and bluish skin in the first 24 hours) – contact your doctor or midwife immediately if this happens.
• Breastfeeding: ask your doctor for advice before using the medicine.

Driving and using machines

• Mirtazapine can affect concentration and alertness. Before driving or using machines, make sure your abilities are not impaired.

Possible side effects

• Stop the medicine and contact your doctor immediately: feeling elated (mania; uncommon), yellowing of the skin or eyes (rare), signs of infection with high fever and mouth ulcers, epileptic seizure, symptoms of serotonin syndrome, thoughts of self-harm, severe skin reactions.
• Very common: increased appetite and weight gain, drowsiness or sleepiness, headache, dry mouth.
• Common: lethargy, dizziness, shaking, nausea, diarrhoea, vomiting, constipation, rash, joint, muscle or back pain, dizziness on standing up quickly, swelling (usually of ankles and feet), tiredness, vivid dreams, confusion, anxiety, sleep disturbances, memory problems.
• Uncommon: tingling, restless legs, fainting, numbness in the mouth, low blood pressure, nightmares, agitation, hallucinations.
• Rare: muscle twitching, aggression, inflammation of the pancreas (abdominal pain and nausea).
• Frequency not known: swelling in the mouth or body, hyponatraemia, sleepwalking, slurred speech, difficulty passing urine, rhabdomyolysis, increased prolactin, prolonged painful erection.

Overdose, missed dose and stopping treatment

• Overdose: contact a doctor immediately. The most likely symptoms are drowsiness, disorientation and fast heartbeat; changes in heart rhythm and fainting are also possible.
• Missed dose (once daily): do not make up for it – take the next dose at the usual time.
• Missed dose (twice daily): take a forgotten morning dose with the evening dose; skip a forgotten evening dose; if you missed both, continue the next day as usual.
• Stopping treatment: only after talking to your doctor. Stopping suddenly may cause nausea, dizziness, agitation, anxiety and headache, and stopping too early may cause depression to return.

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 mood or behaviour. Always read the leaflet supplied with the medicine.

Composition, pack and manufacturer

• active substance: mirtazapine – 30 mg per film-coated tablet;
• excipients – core: lactose monohydrate; pregelatinised maize starch; colloidal anhydrous silica; croscarmellose sodium; magnesium stearate;
• film coating (Opadry 03F 23252 Orange): hypromellose 6cP, titanium dioxide, macrogol 8000, yellow and red iron oxide;
• oval, biconvex, light brown film-coated tablets with a score line on both sides and the marking “I”;
• pack: 3 PVC/Al blisters of 10 film-coated tablets (30 tablets);
• marketing authorisation holder: Actavis d.o.o. Beograd, Đorđa Stanojevića 12, Belgrade; manufacturer according to the ALIMS renewal list: Actavis Ltd, Malta.

Storage

• the medicine does not require any special storage conditions;
• shelf life: 3 years;
• keep out of the sight and reach of children; return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

When does Remirta start to work?

According to the leaflet, the medicine usually starts to work after 1 to 2 weeks, and you may feel better after 2 to 4 weeks. If there is no improvement after this time, talk to your doctor.

Why is Remirta taken in the evening?

Mirtazapine often causes drowsiness, so it is recommended as a single dose before bedtime. If the dose is split, the larger part is taken in the evening.

Does Remirta cause weight gain?

Increased appetite and weight gain are very common side effects. Monitor your weight and talk to your doctor if it changes significantly.

Can I drink alcohol while taking Remirta?

It is not recommended. Alcohol together with mirtazapine increases drowsiness and may affect concentration.

Sources

• ALIMS – Package leaflet Remirta 30 mg film-coated tablets (PIL, Serbian, 11/2023)
• ALIMS – Summary of product characteristics Remirta (SmPC, Serbian)

Date sources were checked: 25.10.2026.