Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Zinc oxide; Lidocaine hydrochloride
Bayer Plc
C05AX04
Zinc oxide; Lidocaine hydrochloride
66mg/1gram ; 7mg/1gram
Rectal cream
Cutaneous; Rectal
No Controlled Drug Status
Valid as a prescribable product
BNF: 01070100; GTIN: 5010605829086 5010605829727
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 190 x 120 Germoloids Triple Action Cream Leaflet UK Cutter Guides Technical & Non Printing Items BAYER ARTWORK PANEL 25/55g Pack Packaging Site Approval: ARTWORK APPROVAL PANEL Name: Date: Action: Country Approval: Name: Date: Action: BAY437456 Main Text (body copy): Height (based on lower case x): 7 pt 1.3 mm FONT SIZE PANEL 02/11/20 OTH009060 000000000 84349577 B TR1985395 N/A N/A N/A N/A N/A Famar Avlona 49km Greece [GR] Generic Bayer White Paper 1 LTH Process Black Colours 000000000 CREAM CREAM FOR PILES zinc oxide, 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 Cream is and what it is used for 2. What you need to know before you use Germoloids Cream 3. How to use Germoloids Cream 4. Possible side effects 5. How to store Germoloids Cream 6. Contents of the pack and other information 1. WHAT GERMOLOIDS ® CREAM IS AND WHAT IT IS 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 external (outside the anus). Germoloids Cream is used to relieve the symptoms of pain, swelling a Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Germoloids Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Zinc oxide Ph. Eur. 6.6% w/w Lidocaine hydrochloride Ph. Eur. 0.7% w/w 3 PHARMACEUTICAL FORM Cream for topical and 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 aged 12 years and over: Apply at least twice a day with a minimum of three to four hours between applications. Further applications can be made at any time of day and are particularly recommended after bowel movement. Do not use more than four times in any 24 hour period. External piles and pruritus ani: Apply to the affected area. Internal piles: Gently insert applicator into the anal opening and expel a small amount of the cream by squeezing the tube gently. Children under 12 years: Only as directed by a doctor. The elderly: Use as per adult directions. 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 topical preparations 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 4.8 UNDESIRABLE EFFECTS Very rarely increased irritation may occur at the site of application. REP Přečtěte si celý dokument