Tiaprid PMCS 100 mg

Basic information

Composition

Tiapridi hydrochloridum 111,10 mg, which corresponds to 100 mg of tiapride in each tablet.

Pharmacotherapeutic group

Antipsychotic, neuroleptic agent (ATC code: N05AL03)

Therapeutic indications

Adults: A short-term treatment of behavioural disorders in old age or in chronic alcohol abuse, intense, not subsiding pain, dyskinesias and abnormal movements. Adults and children aged 6 and over: Chorea, Gilles de la Tourett’s disease. Children aged 6 and over: Serious behavioural disorders with agitation and aggression.

Pharmacological properties

Tiapride is an atypical neuroleptic agent, a sulpiride analogue, which selectively blocks dopaminergic D2 receptors. It does not act on serotonin, adrenergic, histamine or muscarine receptors. It has a mild hypotensive effect, mild extrapyramidal symptoms; it has no sedative or anticholinergic effects. The anxiolytic effect of tiapride has been manifested on several animal stress models. Moreover, it has been established that tiapride has a positive effect on alertness in old age. The mechanism of its anxiolytic effect has not been explained yet but it differs from its antidopaminergic activity.

Pharmaceutical form

Tablets

More information

Posology and method of administration

The treatment should be initiated with the minimum efficient dose that is gradually up-titrated. With a short-term treatment of agitated and aggressive patients, in particular in old age or in chronic abuse of alcohol the usual dose is 200–300 mg/day for a period of 1 to 2 months. Chorea and Gilles de Tourett’s disease. Adults: 300—800 mg/day. Children aged 6 and over: 3—6 mg/day. Intense, not subsiding pain in adults: 200—400 mg/day. Serious behavioural disorders in children aged 6 and over with agitation and aggression: 100—150 mg/day. The tablets should be washed down with a small amount of fluid and may be taken with or without food.

Contraindications

Known hypersensitivity to tiapride or to any of the excipients, prolactin-dependent tumours, phaeochromocytoma, in combination with levodopa.

Interactions

Contraindicated combinations: levodopa. Not recommended combinations: alcohol, drugs containing alcohol, drugs increasing the risk of “torsades de pointes“ (some antiarrhythmics, bradycardia or hypokalemia inducing drugs). Combinations requiring caution: substances with CNS depressant action, H1-receptor antagonists, lithium.

Undesirable effects

Fatigue, somnolence, insomnia, agitation, apathy, dizziness, headache, extrapyramidal symptoms, endocrine disorders due to hyperprolactinemia (galaktorea, gynecomastia), restlesness, dystonia, increased body weight.

Special warnings and precautions for use

Tiapride may cause neuroleptic malignant syndrome, increase the risk of cerebrovascular accidents, venous tromboembolism or prolong QT-interval. The product may be used during pregnancy only if strictly necessary; there is a risk of undesirable effects in newborns exposed to tiapride in the third trimester of pregnancy. Breastfeeding is not recommended during treatment with tiapride. The ability to drive vehicles and machines may be transitorily reduced.

Availability

The medicinal product is available on prescription only and is partly covered by health insurance.

Contents of container

20, 30, 50, 60, 90, 100 or 500 tablets

Package available in the Czech Republic

50, 100 tablets

SPC and PIL

Detailed information

For more detailed product information, see the Summary of Product Characteristics.

Manufacturer and marketing authorisation holder

PRO.MED.CS Praha a.s., Telčská 1, 140 00 Prague 4, Czech Republic

Date of revision of the text

26 June 2015

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