Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Zinc oxide; Lidocaine hydrochloride
Bayer Plc
C05AX04
Zinc oxide; Lidocaine hydrochloride
283.5mg ; 13.2mg
Suppository
Rectal
No Controlled Drug Status
Valid as a prescribable product
BNF: 01070100; GTIN: 5010605829093 5010605829109
Bayer Ref No: Reference No: Brand: Range: Product: Pack Type: Pack Size: Action: Date: Country: Finished Goods Code: Synaps Request Code: Component Code: CAD Ref No: Printer: Packaging Site: Substrate: Barcode 1 Type: Barcode 1 Mag: Barcode 2 Type: Barcode 2 Mag: Pharmacode No/NE: PIL 210 x 148 Delpharm Huningue Germoloids Triple Action Suppositories Leaflet UK Cutter Guides Technical & Non Printing Items BAYER ARTWORK PANEL 12/24CT Pack Packaging Site Approval: ARTWORK APPROVAL PANEL Name: Date: Action: Country Approval: Name: Date: Action: BAY437084 Main Text (body copy): Height (based on lower case x): 8 . 5 pt 1.6 mm FONT SIZE PANEL 16/11/20 OTH009079 00000000 84142328 84142336 D TR1983109 N/A N/A N/A N/A N/A Delpharm Huningue France [FR] Generic Bayer White Paper 1 LTH Process Black Colours 00000000 00000000 SUPPOSITORIES zinc oxide and lidocaine hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet._ See section 4._ • You must contact a doctor if you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET 1. What Germoloids Suppositories are and what they are used for 2. What you need to know before you use Germoloids Suppositories 3. How to use Germoloids Suppositories 4. Possible side effects 5. How to store Germoloids Suppositories 6. Contents of the pack and other information 1. WHAT GERMOLOIDS ® SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR Haemorrhoids (also known as piles) are swollen or enlarged blood vessels, which can cause discomfort, itching and bleeding, particularly after a bowel movement. They may be either internal (inside the anus) or externa Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Germoloids Suppositories 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Zinc oxide Ph. Eur. 283.5 mg Lidocaine hydrochloride Ph. Eur. 13.2 mg 3 PHARMACEUTICAL FORM Suppository for rectal administration 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The symptomatic relief of pain, swelling, irritation and itching associated with haemorrhoids, and pruritus ani. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults and children 12 years and over: _ One suppository to be inserted into the rectum on retiring at night and in the morning, preferably after bowel movement. If necessary Germoloids Suppositories may be used at any time during the day with a minimum 3 - 4 hours between suppositories. Do not use more than 4 suppositories in any 24-hour period. _Children under 12 years: _ Only as directed by a doctor. _The elderly: _ The normal adult dose may be used. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the constituents 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Persons who continually suffer from haemorrhoids or who have severe haemorrhoids or who experience excessive bleeding, are advised to consult a doctor. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known for suppositories 4.6 PREGNANCY AND LACTATION There is a lack of definitive evidence of safety of the product in human pregnancy and lactation. However, lidocaine hydrochloride and zinc oxide have been in wide use for many years without apparent ill consequence. It is not necessary to contraindicate this product in pregnancy and lactation provided caution is exercised and the directions for use are followed. However, as with all medicines, the advice of a doctor should be sought. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None stated. 4.8 UNDESIRABLE EFFECTS Very rarely increased irritation may occur at the site of application. REPORTING OF SUSPECTED ADVERSE REACTIONS Reporting suspected adverse reactions after authorisation of the medicinal product i Lugege kogu dokumenti