Omnitus syrup and tablets – butamirate for dry, irritating cough

Omnitus is a cough medicine containing the active substance butamirate (as butamirate citrate). It belongs to the group of centrally acting antitussives – it calms the cough reflex and is intended for the symptomatic treatment, i.e. relief, of dry, irritating (non-productive) cough of various origins.

In Serbia it is authorised in three forms: as a 4 mg/5 mL syrup (for children from 3 years of age and adults) and as 20 mg and 50 mg modified-release film-coated tablets. Dosing differs by form and age, so it is important to follow the leaflet for exactly the form you are using.

What is Omnitus (butamirate) used for and how is it dosed correctly for dry cough?

Key facts about the medicine

Overview of the authorised forms:

What is Omnitus used for?

According to the official documentation, Omnitus is used for:

• the symptomatic treatment, i.e. relief, of dry, irritating (non-productive) cough of various origins.

The medicine does not treat the cause of the cough (e.g. an infection) but calms the cough reflex itself. If the cough brings up thick mucus, this medicine is not an appropriate choice.

How is it used and dosed?

The syrup is measured with the supplied spoon (2.5 mL and 5 mL marks) and taken before or after meals with a little liquid. The interval between doses is 6 hours when the syrup is taken 4 times a day, or 8 hours when it is taken 3 times a day.

The modified-release film-coated tablets are swallowed whole with liquid, before or after meals, at about the same time every day. Dosing differs for each strength – do not transfer the dosing from one strength to another:

The maximum duration of treatment is 7 days. If symptoms get worse or the cough lasts longer than 7 days, a doctor must be consulted. The doses above are the general dosing from the leaflet and are not an individual recommendation.

Special patient groups

• Children: the syrup is not recommended for children under 3 years, the 20 mg tablets for children under 6 years and the 50 mg tablets for children under 12 years.
• Elderly: no dose adjustment is recommended; caution is needed if kidney function is reduced with age.
• Severe kidney or liver impairment: use with caution and talk to a doctor or pharmacist first, as side effects are more likely.

Contraindications – when the medicine must not be used

Omnitus must not be taken if you are allergic (hypersensitive) to butamirate or to any of the excipients. The other situations listed are not contraindications but require particular caution or medical advice.

Precautions and warnings

• If there is no improvement after 7 days or the cough gets worse, see a doctor.
• Use is not recommended for productive cough (with thick mucus) – suppressing the cough may lead to retained secretions, a higher risk of respiratory infection and bronchospasm.
• Caution in severe kidney and liver impairment.
• The tablets contain lactose monohydrate and azo colourings (e.g. E110; the 50 mg tablet also E122, E151, E124), which may cause allergic reactions.
• The syrup contains sorbitol (405 mg in 1 mL, i.e. 2025 mg in 5 mL) – a source of fructose; people with hereditary fructose intolerance should consult a doctor. Sorbitol may cause stomach discomfort and a mild laxative effect. The syrup also contains a small amount of ethanol (15 microlitres in 5 mL) and is essentially sodium-free.

Interactions with other medicines, alcohol and food

• Expectorants and mucolytics (medicines that help bring up and thin mucus): concomitant use should be avoided, as mucus may be retained in the airways.
• Alcohol: not recommended during treatment; because butamirate acts centrally, an interaction with alcohol and a depressant effect on the central nervous system cannot be ruled out.
• Food and non-alcoholic drinks do not affect the medicine.
• Tell your doctor or pharmacist about all medicines you take, including non-prescription medicines.

Pregnancy and breastfeeding

Although there are no data on harmful effects, use should be avoided in the first trimester of pregnancy; later in pregnancy the medicine is used only if a doctor judges that the benefit outweighs the possible risk. It is not known whether butamirate passes into breast milk, so use during breastfeeding is not recommended.

Driving and using machines

Omnitus tablets may cause drowsiness and thus affect the ability to drive and use machines. For the syrup the leaflet states that it is not known whether it affects these abilities. If you feel drowsy or dizzy, do not drive or operate machinery.

Possible side effects

• Rare (up to 1 in 1,000 patients): rash and hives (urticaria), nausea, vomiting, diarrhoea, dizziness and drowsiness.
• These symptoms usually disappear when the dose is reduced or treatment is stopped.
• According to the leaflet, no adverse effects on vital functions or other organs have been established, and the side effects typical of opioid cough suppressants have not been observed.

Report any suspected side effect to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Overdose: possible symptoms are drowsiness, vomiting, impaired coordination (ataxia), abdominal pain, diarrhoea, agitation and a fall in blood pressure. Contact a doctor or pharmacist immediately; there is no specific antidote.
• Missed dose: take it as soon as possible; if it is almost time for the next dose, continue with the usual schedule. Never take (or give a child) a double dose.
• Stopping treatment: the medicine is used briefly, for a maximum of 7 days; if the cough does not go away, do not extend treatment on your own but see a doctor.

Related information

• How to stop a cough quickly and easily

For additional care and support with dry, irritating cough, see also the Dry cough and hoarseness category – products in this category do not replace the medicine you have been prescribed.

Composition, packaging and manufacturer

• Active substance: butamirate citrate – 4 mg in 5 mL of syrup; 20 mg or 50 mg per film-coated tablet.
• Syrup – excipients: sorbitol liquid, non-crystallising; glycerol; saccharin sodium; benzoic acid; vanillin; anise essential oil; ethanol 96%; sodium hydroxide; purified water. Appearance: clear, colourless to yellowish solution with a sweet taste and vanilla odour.
• Tablets – core: lactose monohydrate, hypromellose, talc, magnesium stearate, colloidal anhydrous silica, povidone; coating: hypromellose, talc, ethylcellulose, macrogol 6000, titanium dioxide and colourings (20 mg: E110; 50 mg: E110, E122, E151, E124).
• Appearance of the tablets: 20 mg – round, yellow to orange; 50 mg – round, brick-red.
• Marketing authorisation holder and manufacturer: HEMOFARM AD VRŠAC, Beogradski put bb, Vršac, Republic of Serbia.

Storage

• Syrup: store below 25 °C in the original package to protect from light; after first opening use within 14 days (store below 25 °C).
• Tablets: store below 25 °C in the original package to protect from light and 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

Does Omnitus help with a cough that brings up mucus?

No. Omnitus is intended for dry, irritating cough. For productive cough, when thick mucus is coughed up, use is not recommended because suppressing the cough may lead to secretions being retained in the airways.

Can Omnitus be taken together with an expectorant syrup?

This is not recommended. The leaflet states that concomitant use with expectorants and mucolytics should be avoided, as a medicine that calms the cough and one that promotes expectoration act in opposite ways, so secretions may remain in the bronchi.

From what age can children use Omnitus?

The syrup is not recommended for children under 3 years. The 20 mg tablets are not recommended for children under 6 years, and the 50 mg tablets for children under 12 years. The dose should match the age according to the table in the leaflet.

How long can Omnitus be taken?

For a maximum of 7 days. If the cough lasts longer than 7 days or gets worse, see a doctor to find the cause.

Does Omnitus cause drowsiness?

Drowsiness and dizziness are rare side effects. For the tablets the leaflet states that they may affect the ability to drive, so do not drive if you feel drowsy. Avoid alcohol during treatment.

Sources

• ALIMS – Patient leaflet Omnitus®, 20 mg and 50 mg, modified-release film-coated tablets (December 2024)
• ALIMS – SmPC Omnitus®, 20 mg, modified-release film-coated tablets (December 2024)
• ALIMS – SmPC Omnitus®, 50 mg, modified-release film-coated tablets (December 2024)
• ALIMS – Patient leaflet Omnitus®, 4 mg/5 mL, syrup (January 2025)
• ALIMS – SmPC Omnitus®, 4 mg/5 mL, syrup (January 2025)

Sources checked on: 23 October 2026.