Χώρα: Μάλτα
Γλώσσα: Αγγλικά
Πηγή: Medicines Authority
PROCHLORPERAZINE MESILATE
Mercury Pharma International Limited 4045 Kingswood Road, City West Business Park, Co, Dublin, Ireland
N05AB04
PROCHLORPERAZINE MESILATE 12.5 mg/ml
SOLUTION FOR INJECTION
PROCHLORPERAZINE MESILATE 12.5 mg/ml
POM
PSYCHOLEPTICS
Withdrawn
2006-08-31
The name of your medicine is Prochlorperazine Mesilate 12.5mg/ml Solution for Injection. It will be referred to as Prochlorperazine Injection for ease hereafter. In this leaflet: 1. What Prochlorperazine Injection is and what it is used for 2. Before you are given Prochlorperazine Injection 3. How you are given Prochlorperazine Injection 4. Possible side effects 5. How to store Prochlorperazine Injection 6. Further information 1. WHAT PROCHLORPERAZINE INJECTION IS AND WHAT IT IS USED FOR Prochlorperazine Injection belongs to a class of drugs called phenothiazine neuroleptics. It influences the activity of certain brain cells by decreasing the effect of dopamine, a natural chemical in the brain. Prochlorperazine Injection may be used to improve the symptoms of major mental disorders such as in schizophrenia, acute mania, and short term treatment of anxiety. It may also be used to treat the symptoms of nausea (feeling sick) and vomiting (being sick), as well as symptoms of vertigo due to Menieres syndrome or labyrinthitis (inner ear disorders). 2. BEFORE YOU ARE GIVEN PROCHLORPERAZINE INJECTION YOU SHOULD NOT BE GIVEN PROCHLORPERAZINE INJECTION IF: • you know that you are allergic to Prochlorperazine Mesilate or any of the other ingredients of Prochlorperazine Injection (see section 6 of this leaflet) • the person is a child. This is because children may develop unusual face and body movements (dystonic reactions). BEFORE YOU ARE GIVEN PROCHLORPERAZINE INJECTION, YOUR DOCTOR WILL TAKE SPECIAL CARE IF ANY OF THE FOLLOWING SITUATIONS APPLY TO YOU. MAKE SURE YOUR DOCTOR IS AWARE IF YOU SUFFER FROM ANY OF THE FOLLOWING: • you suffer from any disease involving Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prochlorperazine Mesilate 12.5mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml of solution contains 12.5mg (1.25% w/v) of Prochlorperazine Mesilate 3 PHARMACEUTICAL FORM Colourless or almost colourless sterile solution for injection intended for parenteral administration to human beings 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS It is used in the symptomatic treatment of vertigo due to Meniere's syndrome or labyrinthitis and for nausea and vomiting from whatever cause including that associated with migraine, schizophrenia (especially in the chronic stage), acute mania and as an adjunct to the short term management of anxiety. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Prochlorperazine injection is for administration by intramuscular injection. Treatment of nausea and vomiting: 12.5mg by deep I.M. injection followed by oral medication six hours later, if necessary. Schizophrenia and other psychotic disorders: 12.5 to 25mg two or three times a day by deep I.M. injection until oral treatment becomes possible. Intramuscular prochlorperazine should not be administered to children. Elderly: Prochlorperazine should be used with caution in the elderly with psychotic disorders. Because elderly patients are susceptible to centrally-acting drugs, lower initial dosage is recommended. Correct initial diagnosis of the disorder is important. Care should also be taken not to confuse adverse effects of prochlorperazine e.g. orthostatic hypotension with effects due to the primary disorder. 4.3 CONTRAINDICATIONS Should not be used in patients who Διαβάστε το πλήρες έγγραφο