Tolperisone

For tolperisone no clinical data on exposed pregnancies are available.

Thus – and although animal studies do not indicate direct or indirect harmful effects with respect to pregnancy and embryonal/fœtal development – tolperison should not be prescribed to pregnant women during the first quarter of pregnancy.

As it is possible that tolperisone and/or its metabolites are excreted in the milk, breast-feeding should be avoided if treatment with tolperisone appears necessary.

In a study in healthy subjects tolperisone at doses of one tablet at 50 mg three times a day or 150 mg three times a day did not induce drowsiness and did not prolong reaction time, even after sensitisation of the test by acute alcohol intake. It can therefore be stated that tolperisone has no or negligible influence on the ability to drive and use machines. In the case of adverse reactions such as sleepiness or dizziness the patient’s ability to concentrate and to react properly may be impaired. In such cases, patients should refrain from driving cars and using machines.

Patients who experience dizziness, somnolence, disturbance in attention, epilepsy, blurred vision or muscular weakness while taking tolperisone should consult his/her doctor.

Less than 5% of patients can be expected to experience adverse reactions. In most cases they are of mild intensity and treatment can be continued, sometimes after reduction of the initial dose.

Following suspected adverse reactions were reported uncommonly (Nb of occurrence of an adverse reaction/Nb of patients exposed >1/1.000, <1/100), rarely (frequency <1/1.000) or very rarely (frequency <1/10.000).

Psychiatric disorders

Uncommon: Impaired concentration

Nervous system

Uncommon: Dizziness, balance difficulty, tremor

Vascular

Uncommon: Hypotension, palpitation

Gastrointestinal

Uncommon: Nausea, vomiting, diarrhoea, abdominal pain, xerostomia, flatulence

Skin

Uncommon: Erythematous rash, urticaria, sudation

General disorders

Uncommon: Fatigue, asthenia, pain

Very rare: Anaphylactic shock, anaphylactoid reaction, larynx oedema

The safety profile of tolperisone containing tablets is supported by data on more than 12,000 patients.
According to these data, the most frequently concerned system organ classes are skin and subcutaneous tissue disorders, general disorders, neurological disorders and gastrointestinal disorders.

In post-marketing data, hypersensitivity reactions associated with tolperisone administration account for about 50-60% of the reported cases. The majority of the cases express non-serious and self-limiting conditions. Life-threatening hypersensitivity reactions are reported very rarely.

confusion (very rare), hyperhidrosis (rare)