Tolvon 30 mg film-coated tablets (mianserin) – antidepressant to relieve the symptoms of depression

Tolvon belongs to the group of antidepressants. It contains the active substance mianserin (as mianserin hydrochloride), which is chemically not a tricyclic antidepressant. Mianserin enhances noradrenaline transmission in the central nervous system; it also has a calming effect and a favourable effect on sleep.

The medicine relieves depressed mood, the most important feature of depression. It usually takes two to four weeks of regular use before improvement is felt. In Serbia it is registered as 30 mg film-coated tablets, in a pack of 30 tablets.

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

Basic information about the medicine

What is Tolvon used for?

According to the summary of product characteristics, Tolvon is indicated for the reduction of the symptoms of depression where depression requires drug treatment. In addition to its antidepressant effect, mianserin has anxiolytic (calming) properties and a positive effect on sleep, which is important in depression accompanied by anxiety and sleep disturbance.

How is Tolvon taken and dosed?

The dose is set individually by the doctor. According to the package leaflet and the summary of product characteristics:

Swallow the tablet without chewing, with a little water or other liquid, at the same time each day. If there is no response after a further 2–4 weeks on the increased dose, the doctor decides whether to stop treatment. Do not stop the medicine on your own, even if you feel better.

Special patient groups

• Children and adolescents under 18: the medicine should not be used; in patients under 18, antidepressants carry a higher risk of suicidal thoughts and hostile behaviour, and the safety of long-term use has not been established.
• Elderly patients: the dose is set individually; blood count disorders occur more often in older people.
• Liver impairment: the medicine must not be used in severe liver impairment; caution is needed in milder forms.
• Kidney impairment, diabetes, heart disease: the usual precautions and careful dose monitoring are required.

Contraindications – when the medicine must not be used

• mania (a state of excessively elevated mood and increased activity);
• severe liver disease (impairment);
• hypersensitivity to mianserin or any of the excipients;
• concomitant use, or use within the last two weeks, of monoamine oxidase inhibitors (MAO inhibitors – e.g. moclobemide, tranylcypromine, selegiline, linezolid).

Precautions and warnings

• Suicidal thoughts: the risk is particularly increased at the start of treatment and after a dose change, in people under 25 and in those who have had such thoughts before – careful monitoring is needed; it helps if a close person knows about the treatment.
• Blood count: mianserin can reduce the number of white blood cells (granulocytopenia, agranulocytosis), most often after 4–6 weeks of treatment; with fever, sore throat, mouth ulcers or other signs of infection, treatment is stopped and a full blood count is done.
• Caution in epilepsy, diabetes, liver or kidney disease, urination problems due to an enlarged prostate, glaucoma, blood pressure disorders and psychiatric illnesses such as schizophrenia and bipolar disorder.
• Heart: QT prolongation and rhythm disorders (including torsades de pointes) have been reported; caution with risk factors (congenital long QT, age over 65, female sex, heart disease, QT-prolonging medicines); low potassium and magnesium are corrected before treatment.
• In bipolar depression the medicine may cause hypomania – treatment is then stopped.
• Treatment is stopped if jaundice or seizures occur.
• Because of the risk of suicide, especially at the start of treatment, the doctor prescribes a limited number of tablets.

Interactions with other medicines, food and drink

• MAO inhibitors (moclobemide, tranylcypromine, selegiline, linezolid) – must not be taken at the same time, nor within two weeks before or after treatment with Tolvon.
• Carbamazepine and phenytoin may reduce mianserin levels – the doctor may adjust the dose.
• Warfarin and other coumarin anticoagulants: Tolvon may affect their action – regular laboratory checks are required.
• Medicines that prolong the QT interval (e.g. some antibiotics and antipsychotics) increase the risk of heart rhythm disorders.
• Blood pressure medicines: no clinically relevant interactions with clonidine, methyldopa, guanethidine, betanidine or propranolol have been found, but blood pressure monitoring is recommended.
• Alcohol: do not drink alcohol during treatment – Tolvon increases the depressant effect of alcohol on the central nervous system.

Pregnancy and breastfeeding

• If you are pregnant, breastfeeding or planning a pregnancy, ask your doctor for advice before taking this medicine.
• Animal studies and limited human data do not indicate harmful effects on the foetus or newborn; mianserin passes into breast milk in small amounts.
• The doctor weighs the benefit of use during pregnancy or breastfeeding against the possible risks to the child.

Driving and using machines

• Tolvon may cause drowsiness and, especially in the first days, affect psychomotor abilities.
• According to the package leaflet, do not drive and do not use tools or machines during treatment.

Possible side effects

The frequency of side effects is not known (cannot be estimated from the available data). Some symptoms, such as dry mouth, constipation and problems with focusing the eyes, may be caused by depression itself. Possible side effects:

• Nervous system and mind: dizziness, drowsiness and sedation (most pronounced at the start of treatment), convulsions, restless legs syndrome, hypomania, neuroleptic malignant syndrome (body stiffness, involuntary movements, high temperature).
• Blood: reduced number of white blood cells (granulocytopenia, agranulocytosis).
• Metabolism: weight gain.
• Heart and blood vessels: slow heartbeat after the initial dose, QT prolongation and rhythm disorders (torsades de pointes), low blood pressure (dizziness when standing up quickly).
• Liver: increased liver enzymes, jaundice, hepatitis.
• Other: swelling due to fluid retention, joint pain, rash.
• Cases of suicidal thoughts and behaviour have been reported during treatment or shortly after stopping.

Overdose, missed dose and stopping treatment

• Overdose: contact a doctor or pharmacist immediately. The most common symptom is prolonged dizziness or drowsiness; rarely, heart rhythm disorders (fast, irregular heartbeat, torsades de pointes), fainting, convulsions, severe drop in blood pressure and slowed breathing occur. ECG monitoring is required; there is no specific antidote.
• Missed dose (once daily in the evening): do not take the missed dose the next morning – it may cause daytime drowsiness; continue in the evening with the usual dose.
• Missed dose (twice daily): take a forgotten morning dose together with the evening dose; do not take a forgotten evening dose with the morning dose; if you have missed both doses, do not make them up.
• Stopping treatment: the medicine is not addictive, but stopping abruptly after long-term use can cause dizziness, restlessness, anxiety, headache and nausea – reduce the dose gradually as instructed by your doctor.

Related information

During treatment of depression, regular follow-up visits to the doctor, a blood count when signs of infection appear and open conversations with people close to you about how you feel are important.

Composition, pack and manufacturer

• Active substance: mianserin hydrochloride – 30 mg per film-coated tablet.
• Excipients: core – potato starch; colloidal anhydrous silica (E551); magnesium stearate (E470b); methylcellulose (E461); calcium hydrogen phosphate dihydrate (E341). Film coating – hypromellose (E464); macrogol 8000; titanium dioxide (E171).
• Appearance and pack: oval, biconvex white tablets marked "CT" and "7" above and below the score line and "Organon" on the other side; 3 blisters of 10 tablets in a box.
• Marketing authorisation holder: Organon d.o.o., Milutina Milankovića 1i, Belgrade – Novi Beograd. Manufacturers: N.V. Organon, Oss, the Netherlands; Schering-Plough Labo NV, Heist-op-den-Berg, Belgium. Authorisation 515-01-02414-21-001 of 15 April 2022.

Storage

• Store below 30 °C, in the original package to protect from light and moisture.
• Shelf life: 5 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 Tolvon start to work?

According to the package leaflet, it usually takes two to four weeks of regular use before improvement is felt. Drowsiness may appear from the first days, and the calming effect and better sleep are sometimes noticed before mood improves.

Why is Tolvon taken in the evening?

Mianserin has a calming effect and causes drowsiness, so taking it once daily just before bedtime is recommended. The doctor may also prescribe a divided dose, in the morning and evening.

Can I split the tablet in half?

The score line on the tablet is only to make it easier to break for swallowing, not to divide it into equal doses. The dose is set by the doctor according to the available 30 mg strength.

Is Tolvon addictive and how is it stopped?

The medicine is not addictive, but stopping abruptly after long-term use can cause dizziness, restlessness, anxiety, headache and nausea. The dose is therefore reduced gradually, as instructed by the doctor.

Sources

• ALIMS – Patient information leaflet Tolvon 30 mg (PIL)
• ALIMS – Summary of product characteristics Tolvon 30 mg (SmPC)

Sources checked on: 25 October 2026.