Patient leaflet - Germolene Antiseptic cream
1. WHAT IS GERMOLENE®
ANTISEPTIC CREAM AND WHAT IS IT USED FOR?
Germolene Antiseptic Cream is used to ease pain and help prevent infections of minor cuts and grazes, minor burns, scalds, blisters, stings and insect bites, spots and chapped or rough skin. The cream contains two active substances, phenol and chlorhexidine digluconate. Phenol and chlorhexidine digluconate have antiseptic properties for the disinfection of skin, wounds and burns. Phenol also has a local anaesthetic action for the relief of pain. The cream base helps to soften the skin and soothe irritation.
2. BEFORE YOU USE GERMOLENE®
ANTISEPTIC CREAM
DO NOT use Germolene Antiseptic Cream:
If you are allergic (hypersensitive) to
phenol or chlorhexidine digluconate or any of the other ingredients of
Germolene Antiseptic Cream (See section 6, Further information).
Warnings and precautions
Rare but serious allergic reactions including anaphylaxis have been reported with use of chlorhexidine containing antiseptic products.
If symptoms of a serious allergic reaction appear (e.g. wheezing or difficulty breathing, swelling of the face, hives that can quickly progress to more serious symptoms, severe rash, or shock), immediately stop using this product and tell your doctor straight away or contact the Accident and Emergency Department of your nearest hospital.
Germolene Antiseptic Cream must not come into contact with the eye due to risk of visual damage. If it comes into contact with the eyes, wash out immediately and thoroughly with water. In case of any irritation, redness or pain in the eye, or visual disturbance, ask for medical advice promptly.
Serious cases of persistent corneal injury (injury to the surface of the eye) potentially requiring corneal transplant have been reported when similar products have accidentally come in contact with the eye during surgical procedures, in patients under general anaesthesia (deep painless sleep).
Pregnancy and breast-feeding:
You may use the cream if you are pregnant or breast-feeding but as with all medicines at this time, you should discuss it with your doctor first. Important information about some of the ingredients of Germolene Antiseptic Cream:
This cream contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
3. HOW TO USE GERMOLENE® ANTISEPTIC CREAM
Follow the directions below carefully. Wash your hands before and after using the cream.
- 1.
Before using the product for the first time, check that the tube seal is not broken. 2. Break the tube seal by peeling from the tag. 3. Thoroughly clean the affected area of skin with warm water (do not use soap). 4. Minor cuts, grazes etc - apply the cream directly or on a dressing.
Minor burns, scalds and blisters -apply the cream generously and massage in gently.
148 mm
Bayer Ref No:
Trident Reference No:
Brand:
Range:
Product:
Pack Type:
Pack Size:
Action:
Date:
Country:
Finished Goods Code:
Synaps Request Code:
Barcode 2 Type:
Barcode 2 Mag:
Road, Kings 3AP, England.
Please note that any low resolution paper Canon colour copies associated with this job should be referred to for
content, layout and colour separation only.
PERMISSION FROM TRIDENT.
BAY615012
TR3230974
Germolene
Antiseptic Cream Dual Action
Leaflet
30G/55G/30G g D
08/07/2024
UK
84149004 84149012 84149020
N/A
N/A
110100111 (934) Ke n ES] PIL 148 x 210 (P041) TL032487
Process black
1
LTH
Main Text (body copy): 9.0pt
Height (based on lower case x): 1.4mm Barcode 3 Type:
Barcode 3 Mag:
N/A
N/A
antiseptic cream
- 5. Replace the cap firmly after use. If your condition does not improve, tell your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist. This cream is for external use only.
Avoid contact with your mouth.
If some of the cream is swallowed accidentally, tell your doctor straight away or contact your nearest Accident and Emergency Department.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Germolene Antiseptic Cream can cause side effects, although not everybody gets them.
As with all medicines, some people may be allergic to the cream. Seek medical advice straight away if you experience any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body). These are signs of an allergic reaction which may be serious and require medical treatment. Rarely, you may experience local irritation, rash, or other skin reactions at the site of application after applying the cream. Frequent application of the cream to the same area for long periods of time or over large areas of skin may lead to skin irritation. Other possible side effects include corneal injury (injury to the surface of the eye), and permanent eye damage including permanent visual impairment (following accidental ocular exposure during head, face and neck surgical procedures) in patients under general anaesthesia (deep painless sleep).
If you are concerned about this, or if the cream affects you in any other way, stop using Germolene Antiseptic Cream and tell your doctor or pharmacist immediately.
Reporting of side effects:
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE GERMOLENE®
ANTISEPTIC CREAM
Keep out of the sight and reach of children.
Do not store above 25°C.
This product should be stored in its original carton.
Do not use Germolene Antiseptic Cream after the expiry date which is stated on the carton and on the end of the tube. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Germolene Antiseptic Cream contains:
The active substances are phenol 1.2% w/w and chlorhexidine digluconate 0.25% w/w. The other ingredients are cetostearyl alcohol, light liquid paraffin, polyoxyethylene stearyl ethers, colours (ponceau 4R (E124), sunset yellow (E110)), dimeticone, methyl salicylate and water.
See the end of section 2 'Important information about some of the ingredients of Germolene Antiseptic Cream' for cetostearyl alcohol advice.
What Germolene Antiseptic Cream looks like and contents of the pack:
Germolene Antiseptic Cream is available in tubes containing 20g, 30g, 35g, 40g or 55g of a pale pink cream (not all pack sizes may be marketed).
Marketing Authorisation Holder:
Bayer plc,
400 South Oak Way,
Reading
RG2 6AD, UK
Manufacturer:
Kern Pharma, S.L.
Polígono Industrial Colon II
C/ Venus, 72
E-08228-Terrassa (Barcelona)
SPAIN
This leaflet was last revised in June 2024. Remember: if you have any doubts about using Germolene® Antiseptic Cream correctly, seek the advice of your doctor or pharmacist.
® = Registered Trademark of Bayer AG,
Germany.
8080899000-04 148 mm