Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Chloral hydrate
Marlborough Pharmaceuticals Ltd
N05CC01
Chloral hydrate
28.66mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04010100; GTIN: 05060139530293
REGULATORY AUTHORITY APPROVAL CONFIRMATION Confirmation that this artwork has been approved by the appropriate market authority (if applicable, e.g. MHRA, IMB, etc and that Amdipharm have license approval to distribute this component for sale in the relevent market. Accept Artwork ................................................................ Reject Artwork ................................................................. Signature .......................................................................... Name ................................................................................ Date ................................................................................... PAGE 1 OF 2 Received Date: 14/04/2014 CDL JOB No. : 59387 Required By : 16/04/2014 PRODUCT NAME: Chloral Hydrate 143.3mg/5ml Oral Solution x 150ml PIP CODE: GB 723-0170-APIL COMPONENT: Leaflet SIZE: 250x148 mm MARKET: Great Britain PRODUCT SITE: TBC SCALE: 100% COLOURS: Black DATE: 15/04/2014 FONT SIZE: 8.5 pt VERSION NO: 3 AMENDED BY: VK PROJECT: Marlborough Pharmaceuticals PACKAGE LEAFLET: INFORMATION FOR THE USER CHLORAL HYDRATE 143MG PER 5ML ORAL SOLUTION Please read both sides of this leaflet carefully before you start to take your medicine. It will tell you what you need to know about Chloral Hydrate Oral Solution. If you have any questions or are not sure about anything, ask your doctor or pharmacist. Remember this medicine is only for YOU. Never give it to anybody else, even if their symptoms are the same as yours. If you are experiencing unpleasant side effects you should consult your doctor. IN THIS LEAFLET: 1. What Chloral Hydrate Oral Solution is and what it is used for 2. Before you take Chloral Hydrate Oral Solution 3. How to take Chloral Hydrate Oral Solution 4. Possible side effects 5. How to store Chloral Hydrate Oral Solution 6. Further information 1. WHAT CHLORAL HYDRATE ORAL SOLUTION IS AND WHAT IT IS USED FOR Chloral Hydrate Oral Solution contains Chloral Hydrate which is one of a group of medicines called hypnotics ( Read the complete document