KEMADRIN Tablet Ref.[9751] Active ingredients:

As with all anticholinergics the benefit/risk ratio should be assessed when prescribing Kemadrin in patients with existing angle-closure (narrow angle) glaucoma or those considered to be predisposed to glaucoma. Cautious prescribing is also indicated in patients predisposed to obstructive disease of the gastro-intestinal tract and those with urinary symptoms associated with prostatic hypertrophy.

In a proportion of patients undergoing neuroleptic treatment, tardive dysknesias will occur. While anticholinergic agents do not cause this syndrome, when given in combination with neuroleptics they may exacerbate the symptoms of tardive dyskinesia or reduce the threshold at which these symptoms appear in predisposed patients. In such individuals subsequent adjustment of neuroleptic therapy or reduction in anticholinergic treatment should be considered.

Patients with mental disorders occasionally experience a precipitation of a psychotic episode when procyclidine is administered for the treatment of the extrapyramidal side effects of neuroleptics.

Elderly patients, especially those on high doses of anticholinergics may be more susceptible to the adverse events associated with such therapy (see section 4.8). Specifically, the elderly patient may be particularly vulnerable to Central Nervous System disturbances such as confusion, impairment of cognitive function and memory, disorientation and hallucinations. These effects are usually reversible on reduction or discontinuation of anticholinergic therapy.

There is no specific information available concerning the use of procyclidine hydrochloride in patients with impaired renal or hepatic function. However, since procyclidine is metabolised in the liver and excreted via the urine care should be exercised when administering procyclidine to patients with impairment of renal or hepatic function.

Kemadrin should not be withdrawn abruptly as rebound parkinsonian symptoms may occur.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Abuse

Kemadrin, along with other anticholinergic drugs, has the potential to be abused. Although the cases of abuse are rare, physicians should exercise caution in prescribing Kemadrin to patients with symptoms that may not be genuine.

Monoamine oxidase inhibitors or drugs with anticholinergic properties, such as amantadine, memantine, antihistamines, phenothiazines, tricyclic and related antidepressants, clozapine, disopyramide and nefopam may increase the anticholinergic action of procyclidine.

The use of drugs with cholinergic properties, such as tacrine, may reduce the therapeutic response to Kemadrin. Furthermore, drugs with anticholinergic properties may antagonise the effect of parasympathomimetic agents.

The concomitant use of procyclidine with some neuroleptics for the treatment of extrapyramidal symptoms has been associated with a reduction in neuroleptic plasma concentrations. However this reduction is unlikely to be associated with a significant reduction in clinical effect.

Drugs with anticholinergic properties may decrease salivation causing dry mouth and, in theory, may reduce the absorption and therefore the therapeutic effect of sublingual or buccal nitrate tablets.

Anticholinergics, including procyclidine, may reduce the efficacy of levodopa by increasing gastric emptying time, resulting in enhanced gastric degradation.

The effect of anticholinergics such as procyclidine may antagonise the gastrointestinal effects of cisapride, domperidone and metoclopramide.

Procyclidine may potentiate the vagolytic effects of quinidine.

Anticholinergics may reduce the absorption of ketoconazole.

Exposure to high environmental temperature and humidity in association with a phenothiazine/anticholinergic drug regimen has rarely resulted in hyperpyrexia.

Daily administration of paroxetine increases significantly the plasma levels of procyclidine. If anticholinergic effects are seen, the dose of procyclidine should be reduced.

Pregnancy

The safety of using Kemadrin during pregnancy has not been established. However, extensive clinical use has not given any evidence that it in any way compromises the normal course of pregnancy. Nevertheless, as with all drugs, use should be considered only when the expected clinical benefit of treatment for the mother outweighs any possible risk to the developing foetus.

Breastfeeding

No information is available on the passage of procyclidine into human breast milk following administration of Kemadrin.

Adverse events of a neurological character such as blurred vision, dizziness, confusion and disorientation have been reported with procyclidine. Therefore, if affected, patients should be advised not to drive or operate machinery.

For this preparation there is no modern clinical documentation which can be used as support for determining the frequency of adverse reactions.

Psychiatric disorders

Uncommon (≥1/1000 and <1/100): Agitation, anxiety, nervousness, confusion, disorientation, hallucinations

Rare (<1/1000): Psychotic disorder

Nervous system disorders

Uncommon (≥1/1000 and <1/100): Dizziness, memory impairment, impaired cognition

Eye disorders

Common (≥1/100): Blurred vision

Gastrointestinal disorders

Common (≥1/100): Dry mouth, constipation

Uncommon (≥1/1000 and <1/100): Nausea, vomiting, gingivitis

Skin and subcutaneous tissue disorder

Uncommon (≥1/1000 and <1/100): Rash

Renal and urinary disorders

Common (≥1/100): Urinary retention

The main undesirable effects are those to be expected from any anticholinergic agent – these are generally reversible on reducing the dosage.

With high doses of procyclidine dizziness, mental confusion, impaired cognition and memory, disorientation, anxiety, agitation and hallucinations may occur.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Not applicable.