Tofisopam

Tofisopam is an anxiolytic, a medicine intended to ease anxiety and the physical tension that comes with it. Although its name links it to the benzodiazepines, it belongs to a separate 2,3-benzodiazepine subgroup and acts differently from familiar drugs such as diazepam: in the manufacturer’s information it is described as having little sedative or muscle-relaxant effect and no anticonvulsant action. The original brand, Grandaxin, is made by the pharmaceutical company Egis. Its labelled uses are anxiety states with tension, restlessness and bodily symptoms, and some cases of alcohol withdrawal.

There is no UK-licensed tofisopam product, so you will not find a UK SmPC or patient leaflet for it on the electronic medicines compendium. The tablets on this page are an imported product, and the photograph shows the brand pack in which they are supplied. Because it is unlicensed here, any use in the UK relies on a prescriber taking personal responsibility for it. Anxiety medicines that are licensed in the UK include SSRIs such as sertraline and escitalopram, pregabalin and, for short periods, certain classical benzodiazepines.

One strength is listed: 50mg tablets, in packs of 10, 20, 30, 60, 90, 120 or 180 tablets. The smaller packs suit a short trial agreed with a prescriber; the larger ones only reflect quantity, not a stronger product.

The leaflet that comes with the brand gives 50–100mg taken one to three times a day for adults, with a daily ceiling of 300mg. Lower doses are generally advised for older people and those with kidney problems. It is not intended for children. Tablets are swallowed whole with water. Since there is no UK product information to rely on, the dose and length of any course should be set individually by the prescriber.

The manufacturer advises against use with known hypersensitivity to the ingredients or to benzodiazepines, in decompensated breathing problems, during the first three months of pregnancy and while breastfeeding. Tofisopam is broken down by the liver enzyme CYP3A4, so it can raise blood levels of medicines handled the same way; combination with tacrolimus, sirolimus or ciclosporin is listed as contraindicated. Antifungals such as ketoconazole and itraconazole may raise tofisopam levels, while enzyme inducers can lower them. Extra care is needed with alcohol and other medicines acting on the brain, in epilepsy and in people with a history of dependence. The tablets contain lactose.

Effects mentioned in the brand’s information include headache, sleeplessness, irritability, agitation, loss of appetite, constipation, wind, nausea, dry mouth, skin rash and itching, and muscle or joint tension. Confusion and seizures have been reported rarely in people who already had epilepsy. Stop taking the tablets and seek urgent help if you notice swelling of the face or throat or difficulty breathing.

Anxiety has many causes, and a GP can look at thyroid problems, caffeine, alcohol, other medicines and talking therapies alongside any drug treatment. Whether Tofisopam is appropriate at all, given that it is unlicensed in the UK, is for your doctor or prescriber to decide.