PROCHLORPERAZINE Tablets (2019)
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Περιεχόμενα
Name of the medicinal product
PROCHLORPERAZINE TABLETS BP 5mg.
Qualitative and quantitative composition
Each tablet contains 5mg Prochlorperazine Maleate PhEur. Excipients with known effect: Each 5mg tablet contains 61.00mg lactose monohydrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
White to off-white, uncoated tablets. White to off-white, circular, flat bevelled-edge uncoated tablets impressed C on one face and the identifying letters Z and P on either side of a central division ...
Therapeutic indications
Prochlorperazine is a potent phenothiazine neuroleptic. It is indicated in vertigo due to Menieres syndrome, labyrinthitis and other causes, and for nausea and vomiting from any cause including that associated ...
Posology and method of administration
Posology Elderly Use with caution in this age group in psychotic disorders. Owing to the susceptibility of elderly patients to centrally acting drugs, lower initial dosage is recommended. Care should be ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Phaeochromocytoma.
Special warnings and precautions for use
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine, as it contains lactose. Prochlorperazine should ...
Interaction with other medicinal products and other forms of interaction
Adrenaline (epinephrine): Adrenaline (epinephrine) must not be used in patients who have overdosed with prochlorperazine maleate. (See section 4.9). Anticholinergic agents: Anticholinergic agents may reduce ...
Pregnancy and lactation
Pregnancy There is inadequate evidence of the safety of prochlorperazine in human pregnancy. There is evidence of harmful effects in animals. Prochlorperazine should be avoided in pregnancy unless the ...
Effects on ability to drive and use machines
Transient drowsiness may occur in some patients during the initial stages of therapy and patients should be advised against the performance of potentially hazardous tasks such as driving a car or operating ...
Undesirable effects
Blood and the lymphatic system disorders: Mild leucopenia occurs in up to 30% of patients on prolonged high dosage. Agranulocytosis may occur rarely; it is not dose related. The occurrence of unexplained ...
Overdose
Symptoms of phenothiazine overdosage include drowsiness or loss of consciousness, hypotension, tachycardia, ECG changes, ventricular arrhythmias and hypothermia. Severe extrapyramidal dyskinesias may occur. ...
Pharmacodynamic properties
*Pharmacotherapeutic group: *Phenothiazines with piperazine structure. ATC code: NO5AB04 Prochlorperazine maleate is a phenothiazine. Prochlorperazine has a wide range of activity arising from its depressant ...
Pharmacokinetic properties
Prochlorperazine is well absorbed from the GI tract but is subject to considerable first pass metabolism from the gut wall. It is also extensively metabolised in the liver and is excreted in the urine ...
Preclinical safety data
Not applicable.
List of excipients
Also contains: Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose (E460)
Incompatibilities
None known.
Shelf life
Shelf-life: Three years from the date of manufacture (PVC blister packs). Two years from the date of manufacture (polypropylene containers; polyethylene containers; amber glass bottles).
Special precautions for storage
Store below 25°C in a dry place. Protect from light.
Nature and contents of container
The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene tablet containers with polyfoam wad or polyethylene ullage filler and snap-on polyethylene lids; ...
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
Marketing authorization number(s)
PL 0142/0312
Date of first authorization / renewal of the authorization
Date of first authorisation: 6<sup>th</sup> May 1992 Date of latest renewal: 6<sup>th</sup> May 1997
Date of revision of the text
29<sup>th</sup> May 2019
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