TIACOB Tablet Ref.[8438] Active ingredients: Tiapride

Tiapride should be administered with particular caution in the following cases:

• The occurrence of neuroleptic malignant syndrome is described very rarely, characterised by high fever, muscular rigidity, autonomic instability, altered consciousness and raised CPK values. Following the development of such symptoms, particularly the development of hyperthermia, tiapride should be discontinued.

Tiapride belongs to the benzamide type neuroleptics, which all share certain rare unwanted effects, predominantly hyperprolactinemia and QT-interval prolongation.

New researches indicate that increased prolactine levels may be associated with an increased risk of breast cancer. Notwithstanding, due to a lack of epidemiologic studies, a final conclusion on hyper-prolactinemia as an independent risk factor of breast cancer can so far not be drawn.

According to clinical experience tiapride should be prescribed with caution to patients with manifest cardiovascular diseases e.g. organic heart failure or proneness to atrial fibrillation, because of the risk of QT-intervall prolongation or torsades de pointes, which rarely can be provoked by QT-prolongation. Alternative treatments should be considered for these patients. Otherwise the lowest effective dose should be chosen and the patient should be monitored carefully.

• As tiapride is predominantly excreted via the kidneys, in patients with impaired renal function (renal failure) the dose should be reduced by the physician, while in patients with severely impaired renal function tiapride should be discontinued on medical advice (see section 4.2).
• Tiapride can decrease the cerebral seizure threshold. Patients with a known history of epilepsy should be monitored carefully.
• Parkinson’s disease Because tiapride can have an increased sedative effect in elderly patients, caution should be exercised.

Tiapride potentiates the action of other central depressants. These include morphine derivatives, barbiturates, benzodiazepines, anxiolytics, most H₁-antihistamines and also centrally acting antihypertensives such as clonidine and analogues.

The action of neuroleptics can be potentiated by tiapride.

Alcohol potentiates the sedative action of tiapride. The use of alcoholic drinks and the consumption of alcohol-containing preparations should be avoided.

Anticholinergics such as biperiden can attenuate the action of tiapride.

Co-administration of levodopa and tiapride is contraindicated as these drugs exhibit a mutually antagonistic effect (see section 4.3).

Pregnancy

There are no adequate data from the use of tiapride in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. The long-term use of antipsychotics prior to parturition is known to cause extrapyramidal disorders and withdrawal reactions in the new-born infant. Tiapride should not be used during pregnancy unless clearly necessary.

Lactation

It is not known whether tiapride is excreted in human breast milk. The excretion of tiapride in milk has not been studied in animals. Based on the lack of data and the potential pharmacological effects on the newborn child, breastfeeding should be discontinued.

Fertility

There are no human data on the effect of tiapride on fertility. Experience with benzamides in schizophrenic patients suggests that increases in prolactin level may cause a reversible impairment of fertility. In animals, adverse reactions of tiapride on fertility have been observed (see section 5.3).

Tiapride has minor or moderate influence on the ability to drive and use machines.

Even when used correctly, tiapride can affect the reaction time to such an extent that the ability to drive or use machines is impaired. This applies to an increased extent in combination with alcohol.

The following frequency estimates are used in assessing the undesirable effects:

Very common: (>1/10)
Common: (>1/100, <1/10)
Uncommon: (>1/1,000, <1/100)
Rare: (>1/10,000, <1/1,000
Very rare: (<1/10,000) including isolated cases

Endocrine disorders

Uncommon: raised prolactin levels in the blood which can be the cause of breast pain, breast enlargement and milk production (gynaecomastia, galactorrhoea), cycle disorders (dysmenorrhoea, amenorrhoea) in women, and orgasm and potency disorders in men. These disorders generally regress within a short time after discontinuation of tiapride.

Psychiatric disorders

Common: agitation, apathy and insomnia.

Nervous system disorders

Common: dizziness, headache. At the beginning of treatment: extrapyramidal symptoms as in Parkinson’s syndrome (tremor, rigidity, hypokinesia and increased salivation). These symptoms generally regress after administration of an anticholinergic (e.g. biperiden).

Uncommon: early dyskinesia (spastic torticollis, oculogyric crises, lockjaw) and akathisia generally regress after administration of an anticholinergic (e.g. biperiden).

Very rare: after prolonged treatment (more than 3 months), the occurrence of tardive dyskinesia, characterised by rhythmic involuntary movements predominantly of the tongue and/or facial muscles, cannot be excluded. Antiparkinsonian agents should not be used in this case as they do not work or may exacerbate the symptoms.

Very rare: neuroleptic malignant syndrome (see section 4.4).

Vascular disorders

Common: orthostatic hypotension

General disorders

Common: asthenia (rapidly becoming tired/weakness), tiredness and drowsiness.

Uncommon: weight gain.

Not applicable.