Urutal 8 mg and 24 mg tablets (betahistine) – vertigo, tinnitus and Ménière's disease

Urutal is a medicine in tablet form containing the active substance betahistine (as betahistine dihydrochloride). Betahistine is a so-called histamine analogue and belongs to the anti-vertigo medicines. According to the leaflet, it works by improving blood flow in the inner ear, thereby reducing the build-up of pressure there.

Urutal is used in Ménière's disease – to treat vertigo, ringing in the ears and hearing loss – and for vertigo caused by a disorder of the part of the inner ear that controls balance. Two strengths are registered in Serbia, Urutal 8 mg and Urutal 24 mg, and the medicine is available on prescription. The effect does not appear immediately: improvement is sometimes noticed only after several weeks of regular use.

How does Urutal (betahistine) work in vertigo and how is it taken correctly?

Key facts about the medicine

What is Urutal used for?

According to the package leaflet, Urutal is used to treat:

• vertigo, ringing in the ears (tinnitus) and hearing loss in patients with Ménière's disease;
• a sensation of vertigo caused by a disorder of the part of the inner ear that controls balance.

The summary of product characteristics states that improvement is sometimes seen only after several weeks of treatment, with the best results after several months. The cause of vertigo should always be established by a doctor, as vertigo may have other causes that require different treatment.

How is it used and dosed?

Dosing in adults according to the leaflet and the SmPC:

• Swallow the tablet with water. It can be taken with or without food, but taking it during or immediately after a meal reduces mild stomach complaints.
• If you take more than one tablet a day, spread them evenly over the day (for example one in the morning and one in the evening) and try to take them at the same time every day.
• Continue taking the tablets even when you feel better – your doctor may decide to continue treatment for some time so that the medicine works fully.
• The score line on the 8 mg tablet only makes swallowing easier; it is not for dividing into equal doses.

Special patient groups

• Children and adolescents under 18 years: use is not recommended because safety and efficacy have not been established.
• Elderly patients: based on post-marketing experience no dose adjustment is needed.
• Kidney or liver impairment: no specific studies have been carried out, but experience indicates that no dose adjustment is needed.

Contraindications – when the medicine must not be used

Urutal must not be taken:

• if you are allergic (hypersensitive) to betahistine or any of the excipients;
• if you have phaeochromocytoma (a tumour of the adrenal medulla).

Precautions and warnings

• Tell your doctor if you have or have had a stomach ulcer – caution and careful monitoring are needed during treatment.
• If you have asthma, your doctor may monitor you, as intolerance to betahistine has been observed in a small number of patients with bronchial asthma.
• Tell your doctor if you are pregnant, planning a pregnancy or breastfeeding.

Interactions with other medicines, alcohol and food

Tell your doctor or pharmacist about all medicines you are taking, especially:

• antihistamines (medicines for allergy) – in theory they may reduce the effect of Urutal, and Urutal may reduce the effect of antihistamines;
• monoamine oxidase inhibitors (MAOIs) – used for depression or Parkinson's disease; they may increase the effect of Urutal.

Urutal can be taken with or without food; taking it with a meal may reduce stomach complaints.

Pregnancy and breastfeeding

Urutal should not be taken during pregnancy unless your doctor has decided that it is clearly necessary. It is not known whether the medicine passes into breast milk – do not breastfeed during treatment unless your doctor tells you otherwise.

Driving and using machines

Urutal is unlikely to affect your ability to drive or use machines. However, the conditions for which the medicine is taken may cause vertigo, nausea or vomiting, which can affect safe driving.

Possible side effects

Serious side effects: severe allergic reactions – red or raised skin rash, inflamed itchy skin, swelling of the face, lips, tongue or neck, drop in blood pressure, loss of consciousness, difficulty breathing. In that case stop taking the medicine immediately and tell your doctor or go to the nearest hospital.

Taking the medicine with food may help reduce stomach complaints. If any side effect becomes serious or you notice an effect not listed, tell your doctor or pharmacist.

Overdose, missed dose and stopping treatment

• Overdose: nausea, drowsiness or abdominal pain may occur. Contact your doctor or go to hospital immediately and take the pack with you.
• Missed dose: skip the missed dose and take the next one at the usual time; do not take a double dose.
• Stopping treatment: keep taking the tablets until your doctor tells you to stop, even if you feel better.

Composition, packaging and manufacturer

• Active substance: betahistine dihydrochloride – 8 mg (Urutal 8 mg) or 24 mg (Urutal 24 mg) per tablet.
• Excipients (both strengths): microcrystalline cellulose; mannitol; citric acid monohydrate; colloidal anhydrous silica; talc.
• Urutal 8 mg: round, flat, white to almost white bevelled tablet with a score line and the embossed name; 5 PVC/PVDC//Al blisters of 20 tablets.
• Urutal 24 mg: flat, round, white tablet; 2 PVC/PVDC//Al blisters of 10 tablets.
• Marketing authorisation holder: PREDSTAVNIŠTVO BELUPO, LJEKOVI I KOZMETIKA D.D., BEOGRAD (VOŽDOVAC), Mosorska 1, Belgrade. Manufacturer: BELUPO D.D., Koprivnica, Croatia.

Storage

• Keep out of the sight and reach of children.
• Store below 25 °C.
• Do not use after the expiry date stated on the outer package.
• Return unused medicine to a pharmacy that collects unused medicines from the public.

Frequently asked questions

How quickly does Urutal start to work?

According to the summary of product characteristics, improvement is sometimes noticed only after several weeks of treatment, with the best results after several months. It is therefore important to take the medicine regularly as prescribed.

What is the difference between Urutal 8 mg and Urutal 24 mg?

They differ in the amount of betahistine per tablet and in pack size. The total daily dose is usually 24–48 mg, and the doctor decides which strength and how many tablets a day you take. If 48 mg a day is prescribed, one 24 mg tablet is taken twice a day.

What should I do if I forget a dose of Urutal?

Skip the missed dose and take the next one at the usual time. Do not take a double dose.

Can I take Urutal with an allergy medicine?

Antihistamines may in theory reduce the effect of betahistine, and betahistine may reduce the effect of antihistamines. Ask your doctor or pharmacist before combining them.

Related information

For additional care and support with dizziness, see also the Vertigo category – products in this category do not replace the medicine you have been prescribed.

Sources

• ALIMS – Package leaflet for Urutal, 8 mg and 24 mg, tablets (PDF, Serbian)
• ALIMS – Summary of product characteristics for Urutal, 24 mg, tablets (PDF, Serbian)
• ALIMS – Summary of product characteristics for Urutal, 8 mg, tablets (PDF, Serbian)
• ALIMS – List of interchangeable medicines, May 2026 (XLSX, Serbian)

Sources checked on: 23 October 2026.