Helex 0.25 mg, 0.5 mg and 1 mg tablets – alprazolam for anxiety and panic disorder

Helex is a medicine containing the active substance alprazolam, a benzodiazepine (anxiolytic). It works by reducing anxiety, agitation and emotional imbalance, and it also has a calming (sedative) effect and helps you fall asleep faster.

The tablets are available in three strengths – 0.25 mg, 0.5 mg and 1 mg. According to the leaflet, Helex is intended only for severe, disabling forms of anxiety and for panic attacks, and is not indicated for short-term treatment of mild tension due to everyday stress. The medicine can cause dependence, so treatment should be as short as possible.

What is Helex used for and how is it taken safely?

Key facts about the medicine

What is Helex used for?

According to the leaflet, Helex is used for:

• treatment of anxiety, tension and other physical (somatic) or psychiatric symptoms associated with anxiety;
• treatment of panic attacks with or without agoraphobia (fear of open spaces).

Like other benzodiazepines, the medicine is intended only for severe forms of illness that are disabling and cause marked distress. Helex must not be the only medicine used to treat anxiety associated with depression, and it is not recommended as primary treatment of psychosis.

How is it taken and dosed?

Always take the medicine exactly as your doctor has told you – the doctor determines the dose according to your condition.

• Anxiety: the recommended starting dose is 0.25–0.5 mg three times a day. The dose may be increased gradually up to a maximum of 4 mg a day, taken in divided doses; the evening dose is increased first, then the daytime doses.
• Panic attacks with or without agoraphobia: the starting dose is 0.5–1 mg just before bedtime for one or two days. The dose may be increased at intervals of 3–4 days by no more than 1 mg – first at midday, then in the morning and finally in the afternoon/evening, until a regimen of 3 to 4 doses a day is reached.
• Older, debilitated patients and patients with liver or kidney impairment: the starting dose is 0.25 mg 2 to 3 times a day.
• Duration: as short as possible – no longer than 8–12 weeks for anxiety and 8 weeks for panic attacks, including the period of gradual dose reduction. Any continuation is decided by the doctor.

After a few weeks of treatment the effect of the medicine may weaken (tolerance). Do not increase the dose yourself – contact your doctor.

Special patient groups

• Children and adolescents: safety and efficacy have not been established under 18 years; use is decided by the doctor.
• Older patients: a lower dose is needed because of the risk of sedation and muscle weakness, which can cause falls, often with serious consequences; digoxin toxicity is also more likely in older people when taken together.
• Kidney impairment and mild to moderate liver impairment: caution and a lower starting dose. Severe liver failure is a contraindication.
• Chronic breathing problems: the medicine may worsen the condition.

Contraindications – when the medicine must not be used

Do not take Helex:

• if you are allergic to alprazolam, other benzodiazepines or any of the excipients;
• if you have myasthenia gravis (marked muscle weakness and fatigue);
• if you have severe respiratory insufficiency (severe breathing problems);
• if you have severe liver disease (liver failure);
• if you have sleep apnoea (brief pauses in breathing during sleep).

Warnings and precautions

• Dependence: the risk is higher with larger doses, longer treatment and in people who have had problems with alcohol, drugs or medicines.
• Memory impairment: anterograde amnesia may occur – difficulty remembering events in the hours after taking the medicine.
• Paradoxical reactions: restlessness, irritability, aggression, nightmares, hallucinations or inappropriate behaviour occur more often in children and the elderly – treatment must then be stopped.
• Depression and suicidal thoughts: contact your doctor immediately; Helex may increase suicidal tendencies if used as the only medicine for anxiety associated with depression.
• Other medicines acting on the brain: Helex may enhance their effect.
• Lactose: the medicine contains lactose – if you have an intolerance to some sugars, consult your doctor.

Interactions with other medicines, food and drink

Tell your doctor or pharmacist about all medicines you take. Caution is needed with:

• medicines acting on the brain: antipsychotics, hypnotics, sedatives, anxiolytics, antidepressants (e.g. nefazodone, fluvoxamine, fluoxetine, imipramine, desipramine), narcotic analgesics, antiepileptics, anaesthetics and sedating antihistamines;
• opioid-based pain and cough medicines – like Helex, they can reduce the ability to breathe spontaneously;
• antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), antibiotics (erythromycin, clarithromycin, telithromycin, troleandomycin) and HIV medicines (e.g. ritonavir);
• cimetidine, propoxyphene, oral contraceptives and diltiazem;
• digoxin – in older people the likelihood of digoxin toxicity increases.

Pregnancy and breast-feeding

• Pregnancy: the medicine must not be used in pregnancy unless the woman's clinical condition requires it – the decision is made by the doctor. Use in the last months of pregnancy or before delivery may cause floppiness, breathing and feeding difficulties, low body temperature and withdrawal symptoms in the newborn (temporary, from a few days to 1–3 weeks).
• Breast-feeding: the medicine passes into breast milk and is not recommended during breast-feeding.

Driving and using machines

Helex may cause drowsiness, light-headedness, reduced concentration and muscle weakness. According to the leaflet, it is very important that you do not drive or operate machinery during treatment; the effects are more pronounced if you have not slept enough or have drunk alcohol.

Possible side effects

Like all medicines, Helex can cause side effects, although not everybody gets them.

• Very common (more than 1 in 10): depression, sedation, drowsiness, ataxia (uncoordinated movements), memory impairment, speech disorder, dizziness, headache, constipation, dry mouth, fatigue, irritability.
• Common (up to 1 in 10): decreased appetite, change in body weight, confusion, disorientation, changes in libido and sexual function, anxiety, insomnia, nervousness, balance disorder, attention disturbance, daytime sleepiness, lethargy, tremor, blurred vision, nausea, dermatitis.
• Uncommon (up to 1 in 100): mania, hallucinations, anger, loss of memory of recent events, muscle weakness, urinary incontinence, menstrual disorders.
• Not known: increased prolactin, hypomania, hostile and aggressive behaviour, hyperactivity, autonomic nervous system disorder, dystonia, gastrointestinal complaints, hepatitis, abnormal liver function, jaundice, photosensitivity, angioedema, urinary retention, swelling of hands and feet, increased eye pressure.

Overdose, missed dose and stopping treatment

• Overdose: contact a doctor or go to the nearest emergency department immediately. Mild cases cause confusion, drowsiness and slurred speech; severe cases loss of coordination, low muscle tone, low blood pressure, breathing difficulties, coma and death.
• Missed dose: do not take the missed dose – take the next one at the usual time. Do not take a double dose.
• Stopping treatment: never suddenly – the dose is reduced gradually as agreed with your doctor. Sudden stopping may cause severe withdrawal symptoms (feeling detached from yourself or the world, numbness and tingling in the hands and feet, hypersensitivity to light, sound and touch, hallucinations, epileptic seizures, cramps, vomiting, sweating, tremor), milder symptoms (headache, muscle pain, restlessness, confusion, insomnia) and a rebound effect with stronger panic attacks, anxiety and insomnia.

Related information

For questions about the duration of treatment, gradual dose reduction and combining with other medicines, contact the doctor who prescribed Helex or the pharmacist at your pharmacy.

Composition, pack and manufacturer

• Active substance: alprazolam – 0.25 mg, 0.5 mg or 1 mg per tablet.
• Excipients: lactose monohydrate; maize starch; crospovidone (type A); povidone K 25; magnesium stearate (E470b); polysorbate 80. The 0.5 mg tablet also contains the colour Carmines (E120) and the 1 mg tablet the colour Patent Blue V (E131).
• Pack: PVC/PE/PVDC//Al blister with 15 tablets; carton with 2 blisters (30 tablets).
• Marketing authorisation holder: Krka-Farma d.o.o. Belgrade, Jurija Gagarina 26/V/II, Belgrade. Manufacturers: Krka d.d., Novo mesto, Slovenia; Krka-Farma d.o.o., Jastrebarsko, Croatia.

Storage

• Store below 25 °C in the original package to protect from moisture.
• Keep out of the sight and reach of children.
• Do not use after the expiry date; return unused medicine to a pharmacy that collects it.

Frequently asked questions

How long can I take Helex?

As short as possible. According to the leaflet, treatment lasts no longer than 8–12 weeks for anxiety and no longer than 8 weeks for panic attacks, including gradual dose reduction. Any continuation is decided by the doctor.

Can I stop taking Helex suddenly?

No. Sudden stopping can cause withdrawal symptoms, including hallucinations and epileptic seizures, and the return of symptoms with greater intensity. The dose is reduced gradually, as instructed by your doctor.

Can I drink alcohol with Helex?

No. Alcohol enhances the sedative effect of the medicine and increases the risk of dangerous drowsiness and breathing difficulties.

What should I do if I forget a dose?

Do not take the missed dose – take the next one at the usual time and never take a double dose.

Sources

• ALIMS – Summary of Product Characteristics, Helex® 0.25 mg, 0.5 mg and 1 mg tablets (SmPC, Serbian)
• ALIMS – Patient leaflet, Helex® 0.25 mg, 0.5 mg and 1 mg tablets (PIL, February 2021, Serbian)

Sources checked on: 25 October 2026.