Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Prochlorperazine maleate
Dr Reddy's Laboratories (UK) Ltd
N05AB04
Prochlorperazine maleate
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000
1220895-V2 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. WHAT PROCHLORPERAZINE MALEATE 5MG TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROCHLORPERAZINE MALEATE 5MG TABLETS 3. HOW TO TAKE PROCHLORPERAZINE MALEATE 5MG TABLETS 4. POSSIBLE SIDE-EFFECTS 5. HOW TO STORE PROCHLORPERAZINE MALEATE 5MG TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT PROCHLORPERAZINE MALEATE 5MG TABLETS ARE AND WHAT THEY ARE USED FOR Prochlorperazine belongs to a group of medicines called ‘phenothiazine antipsychotics’. It works by blocking the effects of a chemical in the brain. Prochlorperazine can be used to: • treat balance problems or dizziness (vertigo). This includes problems of the inner ear such as ‘Meniere’s Syndrome’ or ‘labyrinthitis’ • stop you feeling sick (nausea) or being sick (vomiting). This can be from any cause including migraines • treat anxiety in the short-term, when used in addition to other medicines • treat schizophrenia • treat over-active behaviour or thoughts (mania) 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROCHLORPERAZINE MALEATE 5MG TABLETS: DO NOT TAKE PROCHLORPERAZINE MALEATE 5MG TABLETS IF: You are allergic (hypersensitive) to prochlorperazine or any of the other ingredients of prochlorperazine maleate 5mg tablets (listed in Section 6 below) Signs of an allergic reaction include; a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue TAKE SPECIAL CARE WITH PROCHLORPERAZINE MALEATE 5MG TABLETS. Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prochlorperazine maleate 5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each uncoated tablet contains 5 mg of prochlorperazine maleate It also contains 103 mg lactose monohydrate. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. White to off white coloured, circular shaped biconvex tablets, with monogram P5 on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vertigo due to Meniere's Syndrome, labyrinthis and other causes, and for nausea and vomiting from whatever cause including that associated with migraine. It may also be used for schizophrenia (particularly in the chronic stage), acute mania and as an adjunct to the short-term management of anxiety. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS INDICATION DOSAGE Prevention of nausea and vomiting 5 to 10 mg twice or three times a day. Treatment of nausea and vomiting 20 mg immediately, followed if necessary by 10 mg two hours later. Vertigo and 5 mg three times a day increasing if necessary INDICATION DOSAGE Meniere's syndrome to a total of 30 mg daily. After several weeks dosage may be reduced gradually to 5-10 mg daily. Adjunct in the short term management of anxiety 15-20 mg daily in divided doses initially but this may be increased if necessary to a maximum of 40 mg daily in divided doses. Schizophrenia and other psychotic disorders Usual effective daily oral dosage is in the order of 75-100 mg daily. Patients vary widely in response. The following schedule is suggested: Initially 12.5 mg twice daily for 7 days, the daily amount being subsequently increased 12.5 mg at 4 to 7 days interval until a satisfactory response is obtained. After some weeks at the effective dosage, an attempt should be made reduce this dosage. Total daily amounts as small as 50 mg or even 25 mg have sometimes been found to be effective. PAEDIATRIC POPULATION INDICATION DOSAGE Prevention and treatment of nausea and vomiting If it i Lire le document complet