KEMADRIN Tablet (2016)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Kemadrin Tablets 5 mg.
Qualitative and quantitative composition
Procyclidine Hydrochloride BP 5 mg per tablet. Excipients with known effect: Lactose. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White, round, biconvex tablets, one face with a break-line and coded KT above the break-line and 05 below the break-line, with a score-line on the other face. The tablet can be divided into equal ...
Therapeutic indications
Kemadrin is indicated for the treatment and symptomatic relief of all forms of Parkinsons disease e.g. idiopathic (paralysis agitans), postencephalitic and arteriosclerotic disease. Kemadrin is also indicated ...
Posology and method of administration
The variation in optimum dosage from one patient to another should be taken into consideration by the physician. Dosage in adults Parkinsons disease Treatment is usually started at 2.5 mg procyclidine ...
Contraindications
Kemadrin is contra-indicated in individuals with known hypersensitivity to any component of the preparation, untreated urinary retention, closed angle glaucoma and gastro-intestinal obstruction.
Special warnings and precautions for use
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 ...
Interaction with other medicinal products and other forms of interaction
Monoamine oxidase inhibitors or drugs with anticholinergic properties, such as amantadine, memantine, antihistamines, phenothiazines, tricyclic and related antidepressants, clozapine, disopyramide and ...
Pregnancy and lactation
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. ...
Effects on ability to drive and use machines
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 ...
Undesirable effects
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, ...
Overdose
Symptoms and signs Symptoms of overdosage include stimulant effects such as agitation, restlessness and confusion with severe sleeplessness lasting up to 24 hours or more. Visual and auditory hallucinations ...
Pharmacodynamic properties
Pharmacotherapeutic group: Anticholinergic group ATC code: N04AA04 Procyclidine is a synthetic anticholinergic agent which blocks the excitatory effects of acetylcholine at the muscarinic receptor. Idiopathic ...
Pharmacokinetic properties
Procyclidine is adequately absorbed from the gastro-intestinal tract with a bioavailability of 75% and disappears rapidly from the tissues. The relatively low clearance of 68 ml/min represents a predominantly ...
Preclinical safety data
Fertility A three generation study in rats dosed at 40 mg/kg/day via the diet before and during pregnancy showed only that the number of viable pups was slightly decreased from the second mating. No other ...
List of excipients
Lactose Sodium starch glycollate Povidone Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
5 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Amber glass bottles with low density polyethylene snap fit closures. Pack sizes 50, 100. Polypropylene containers with polyethylene snap-fit lids. Pack size 500. Round enamelled tins with lever lids. Pack ...
Special precautions for disposal and other handling
See section 4.2 posology and method of administration.
Marketing authorization holder
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Marketing authorization number(s)
PL 39699/0046
Date of first authorization / renewal of the authorization
19/09/2006
Date of revision of the text
21/02/2016
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