Bromazepam 1.5 mg, 3 mg and 6 mg tablets – medicine for short-term treatment of severe anxiety

Bromazepam is an anxiolytic from the benzodiazepine group. In Serbia, Bromazepam HF (Hemofarm AD Vršac) is authorised as 1.5 mg, 3 mg and 6 mg tablets, and Bromazepam Dr. Max (1.5 mg and 3 mg) is also authorised with the same active substance. The information on this page refers to Bromazepam HF tablets, according to the official patient leaflet and Summary of Product Characteristics.

Bromazepam is used only to treat severe anxiety that is disabling or causes marked distress and interferes with everyday activities. It is prescribed for the shortest possible time – no more than 8 to 12 weeks in total, including gradual dose reduction.

What is bromazepam used for and how should it be taken correctly?

Key facts about the medicine

Overview of the strengths authorised in Serbia. The tablet strength does not indicate the daily dose – the dose is determined by a doctor.

What is bromazepam used for?

According to the official documentation, Bromazepam HF is intended to treat anxiety – a very strong, unjustified fear or deep worry that affects feelings, mood, behaviour and thinking. Benzodiazepines are indicated only when the disorder is severe, disabling or subjects the patient to extreme distress.

Bromazepam is not a medicine for mild nervousness, everyday stress or occasional sleeplessness, and it does not treat the cause of anxiety. The decision on treatment is made by a doctor.

How is it used and dosed?

• Treatment is started with the lowest dose, which the doctor increases gradually if needed until symptoms are controlled.
• The usual dose in adults is 3–18 mg of bromazepam daily, divided into several doses.
• Only exceptionally, in hospitalised patients, the daily dose may be up to 60 mg, divided into several doses.
• Swallow the tablet with enough water. The tablet has a score line and can be divided into equal doses.
• The total duration of treatment, including gradual withdrawal, should not exceed 8 to 12 weeks; extending treatment requires re-evaluation by a specialist.

These values are the general dosing from the official documentation and are not an individual recommendation. The tablet strength and dosing schedule are determined by a doctor.

Special patient groups

• Children under 12 years must not use bromazepam.
• Elderly and debilitated patients: lower doses are used – no more than half of the usual adult dose; the risk of drowsiness, confusion and falls is higher.
• Mild to moderate liver or kidney impairment: the lowest possible dose is used, with regular medical monitoring.
• Severe liver impairment: the medicine must not be used.

Contraindications – when the medicine must not be used

• hypersensitivity to bromazepam, other benzodiazepines (e.g. diazepam, clonazepam) or any of the excipients
• marked breathing problems or severe lung disease (severe respiratory insufficiency)
• severe liver disease
• myasthenia gravis
• sleep apnoea syndrome
• children under 12 years

The other conditions listed below are not contraindications, but require special caution and medical supervision.

Precautions and warnings

• Dependence and tolerance: if after a few weeks you notice the medicine works less well, contact your doctor – do not increase the dose yourself.
• Withdrawal symptoms can occur even with usual doses and short-term use: headache, muscle pain, restlessness, tension, confusion, irritability, diarrhoea, and occasionally hypersensitivity to light, noise and touch, tingling, hallucinations and epileptic seizures.
• Anterograde amnesia (difficulty remembering new events) usually occurs several hours after taking the medicine – make sure you can have several hours of uninterrupted sleep.
• Paradoxical reactions (restlessness, aggressiveness, rage, nightmares, hallucinations, inappropriate behaviour) are more common in children and the elderly – the doctor will usually stop treatment.
• Depression or anxiety associated with depression: bromazepam may contribute to suicidal thoughts.
• Caution in liver, kidney or lung disease, in the elderly and in people with a history of alcohol or drug abuse.
• Before surgery or dental treatment, tell the doctor or dentist that you are taking bromazepam.
• All strengths contain lactose; the 3 mg tablets contain the azo colouring E124, which may cause allergic reactions.

Interactions with other medicines, alcohol and food

• Opioids (strong painkillers, medicines for treating dependence, some cough medicines): risk of drowsiness, respiratory depression, coma and death – concomitant use only when other options are not possible, with limited dose and duration.
• Other medicines acting on the CNS: antipsychotics, other anxiolytics (e.g. diazepam), sleeping medicines (e.g. zolpidem), sedating antihistamines (e.g. diphenhydramine), antiepileptics, strong analgesics (e.g. morphine), antitussives.
• Medicines that may increase the effect of bromazepam: cimetidine, propranolol, fluvoxamine, ketoconazole, erythromycin, clarithromycin and protease inhibitors for HIV infection.
• Alcohol must not be consumed during treatment – it increases sedation and may cause serious problems with breathing and heart function.
• Tell your doctor and pharmacist about all medicines you take, including non-prescription and herbal medicines.

Pregnancy and breastfeeding

Bromazepam may harm the baby. Use during pregnancy is decided by a doctor; if you become pregnant while on treatment, inform your doctor immediately. Breastfeeding is not recommended during treatment because bromazepam passes into breast milk.

Driving and using machines

Bromazepam has a strong effect on psychophysical abilities (triangle-marked medicine ▲). Driving and operating machinery are not allowed during treatment – the medicine can cause drowsiness, forgetfulness, poor concentration, muscle weakness and slowed reactions.

Possible side effects

• At the start of treatment: sleepiness, drowsiness and tiredness, reduced attention, confusion, disorientation, headache, dizziness, nausea and vomiting, muscle weakness, unsteady walking, double vision – these usually disappear after some time.
• During treatment: difficulty remembering new events, depression, constipation, diarrhoea, rash, itching, hives, changes in libido, inability to urinate, allergic reactions, dependence.
• Serious: angioedema and anaphylactic shock, heart failure and cardiac arrest, respiratory depression, marked restlessness, aggressiveness, hallucinations and loss of contact with reality.
• Injuries: higher risk of falls and fractures, especially in the elderly and with other sedatives or alcohol.

Report suspected side effects to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Overdose: drowsiness, loss of coordination, slurred speech, involuntary eye movements; in more severe overdose a drop in blood pressure, cessation of breathing and coma. Contact a doctor or the nearest healthcare facility immediately and take the medicine pack with you.
• Missed dose: do not take the missed dose – take the next dose at the usual time. Do not take a double dose.
• Stopping treatment: never abruptly and never without a doctor; the dose is reduced gradually to lower the risk of withdrawal symptoms and return of anxiety.

Related information

For questions about anxiety, sleep and stress management alongside prescribed treatment, our pharmacists are available at the pharmacy. Medicines for anxiety are always used under medical supervision.

Composition, pack and manufacturer

• Active substance: bromazepam 1.5 mg, 3 mg or 6 mg per tablet.
• Excipients (all strengths): lactose monohydrate, acacia, maize starch, talc, sodium lauryl sulfate, magnesium stearate, croscarmellose sodium.
• Colourings: 1.5 mg – Quinoline Yellow (E104); 3 mg – Cochineal red A (E124); 6 mg – Quinoline Yellow (E104) and Indigotine (E132).
• Pack: Al/PVC blister in a carton with a patient leaflet.
• Marketing authorisation holder and manufacturer: HEMOFARM AD VRŠAC, Beogradski put bb, Vršac, Serbia.

Storage

• Store below 25 °C.
• Keep out of the sight and reach of children; do not use after the expiry date stated on the pack.
• Return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

Does bromazepam cause dependence?

Yes, there is a risk of physical and psychological dependence. The risk increases with dose and duration, so the medicine is prescribed for the shortest possible time – up to 8–12 weeks in total, including gradual dose reduction.

Can bromazepam be stopped abruptly?

No. Abrupt discontinuation can cause headache, restlessness, tension, irritability and, less often, hallucinations or epileptic seizures, together with the return of anxiety. The dose is reduced gradually according to the doctor’s plan.

Can I drink alcohol while taking bromazepam?

No. Alcohol increases the sedative effect of bromazepam and can cause deep sleep with serious breathing and heart problems.

Can I drive while taking bromazepam?

No. The medicine is triangle-marked and, according to the leaflet, driving and operating machinery are not allowed during treatment.

Are magnesium or herbal products a substitute for bromazepam?

No. Food supplements are not a substitute for medicine in severe anxiety. Before starting any herbal product with a calming effect, consult a doctor or pharmacist, as it may increase drowsiness.

Sources

• ALIMS – Bromazepam HF 1.5 mg, 3 mg and 6 mg tablets, Patient Information Leaflet (January 2022)
• ALIMS – Bromazepam HF 1.5 mg, 3 mg and 6 mg tablets, Summary of Product Characteristics

Sources checked on: 23 October 2026.