CEPTON ANTISEPTICSKIN WASH KILLS HARMFULBACTERIA ON THE SKIN
Kills harmful bacteria on theskin that cause spots and acneProvides a protective shieldagainst bacterial infectionsLasts for several hours
Summary of product characteristics - SPC
1 NAME OF THE MEDICINAL PRODUCT
Cepton Medicated Skin Wash
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Chlorhexidine Gluconate 1.0%w/v
3 PHARMACEUTICAL FORM
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For daily use in the treatment and prevention of spots and acne.
4.2 Posology and method of administration
Apply morning and night as follows:
Wash hands and face
Wash with undiluted medicated skin wash, then rinse. Repeat
For maximum effect, leave second wash on the skin for one minute before rinsing
Known hypersensitivity to any of the constituents.
4.4 Special warnings and precautions for use
For external use only.
Frequently repeated topical application on the same site could theoretically lead to skin irritation.
Consult your doctor if symptoms persist.
If skin irritation occurs stop using and talk to your doctor.
Keep out of the eyes and ears.
Treat accidental splashes into the eyes by washing out immediately with water and seek medical advice.
Keep all medicines out of the reach and sight of children.
4.5 Interaction with other medicinal products and other forms of interaction
Chlorhexidine is incompatible with anionic agents.
4.6 Fertility, pregnancy and lactation
The product is not contra-indicated during pregnancy and lactation. However, as with all medicines during pregnancy, caution should be exercised. Consult your doctor or pharmacist before use.
4.7 Effects on ability to drive and use machines
The ability to drive or use machines is not affected.
4.8 Undesirable effects
Rarely local irritation, rashes and other skin reactions such as contact dermatitis may occur. Anaphylactic allergic reactions have also been reported but are very rare.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Accidental ingestion: Chlorhexidine taken orally is poorly absorbed. Systemic effects are unlikely even if large amounts are ingested. However, gastric lavage may be advisable using milk, raw egg, gelatin or mild soap. Employ supportive measures as appropriate.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Dermal Antiseptic Group
ATC Code: D08AC02
Chlorhexidine is an effective antiseptic with a wide range of activity against microorganisms, including gram positive and gram negative bacteria, fungi and viruses.
5.2 Pharmacokinetic properties
Because of its cationic nature, chlorhexidine binds strongly to skin, mucosa and tissues and is thus very poorly absorbed and percutaneous absorption, if it occurs at all, is insignificant. The antiseptic ingredients are in intimate contact with the skin, and as they are in solution, their availability is optimal.
5.3 Preclinical safety data
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Polyoxyethylene polyoxypropylene block co-polymer
Lauryl dimethyl amine oxide
Ponceau 4R (E 124)
6.3 Shelf life
6.4 Special precautions for storage
Store below 25°C.
6.5 Nature and contents of container
High density polyethylene bottle with screw cap closure.
Pack sizes: 10ml, 25ml, 50ml, 100ml, 150ml and 250ml.
6.6 Special precautions for disposal
Medicines should be kept out of the reach of children.
7 MARKETING AUTHORISATION HOLDER
Boston Healthcare Limited Unit 6, Navigation Court Calder Park Wakefield West Yorkshire WF2 7BJ United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
27th January 2005
10 DATE OF REVISION OF THE TEXT
Information for the user
Cepton Medicated Skin Wash
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use Cepton Medicated Skin Wash 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.
- You must talk to your doctor if your condition does not improve or gets worse.
- What Cepton Medicated Skin Wash is and what it is used for
- What you need to know before you use Cepton Medicated Skin Wash
- How to use Cepton Medicated Skin Wash
- Possible side effects
- How to store Cepton Medicated Skin Wash
- Contents of the pack and other information
In this leaflet
1. What Cepton Medicated Skin Wash is and what it is used for
Cepton Medicated Skin Wash is a daily treatment that contains the antiseptic chlorhexidine gluconate which kills harmful bacteria on the skin that cause spots and acne, whilst providing a protective shield against bacterial infections for several hours after use to help prevent further outbreaks. It also removes oil and sebum, and helps spots to dry more quickly.
Acne is a common condition where tiny holes (pores) on the surface of the skin become blocked causing spots to develop, usually on the face, back and chest. The spots can range from whiteheads and blackheads to red, inflamed pus-filled spots and cysts.
2. What you need to know before you use Cepton Medicated Skin Wash
Do not use Cepton Medicated Skin Wash if you are allergic (hypersensitive) to chlorhexidine gluconate or any of the other ingredients of Cepton Medicated Skin Wash (see section 6).
Warnings and precautions
• Cepton Medicated Skin Wash should only be used on your skin.
• Do not let it get into your eyes. Treat accidental splashes into the eyes by rinsing them immediately with plenty of water and seek medical advice.
• Do not let it get into your ears. If it does, rinse thoroughly with water.
• If your spots or acne do not get better, or your skin becomes irritated, talk to your pharmacist or doctor.
Other medicines and Cepton Medicated Skin Wash
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Pregnancy and breast-feeding
Consult your doctor or pharmacist before using Cepton Medicated Skin Wash if you are pregnant, planning to become pregnant or are breast-feeding.
1. What Cepton Medicated Skin Wash is and what it is used for
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Apply Cepton Medicated Skin Wash to the area to be treated morning and night as follows:
• Remove any make-up
• Wet your hands and face with water
• Wash with undiluted skin wash, then rinse off. Avoid scrubbing the skin too hard as this could irritate it
• Wash with undiluted skin wash again then rinse. For maximum effect, leave the second wash on the skin for one minute before rinsing.
Do not mix Cepton Medicated Skin Wash with soap or detergents.
If you accidentally swallow Cepton Medicated Skin Wash: drink plenty of milk or water and consult a doctor or pharmacist immediately.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Cepton Medicated Skin Wash can cause side effects, although not everybody gets them.
• If you experience any of the following stop using Cepton Medicated Skin Wash and get immediate medical help: swelling of the face, lips, tongue or throat; a red itchy skin rash; wheezing or difficulty breathing; feeling faint and dizzy; a strange metallic taste in the mouth; collapse. You may be having an allergic reaction.
• If you develop a rash or your skin becomes itchy, red, dry or inflamed where you have used the skin wash, stop using it and talk to your doctor or pharmacist.
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
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Cepton Medicated Skin Wash
• Keep this medicine out of the sight and reach of children.
• Do not store above 25°C. Store it in the original packaging.
• Do not use Cepton Medicated Skin Wash after the expiry date shown on the bottle and carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Cepton Medicated Skin Wash contains
The active substance is chlorhexidine gluconate (1% w/v). The other ingredients are polyoxyethylene polyoxypropylene block co-polymer, lauryl dimethyl amine oxide, Ponceau 4R (E124), isopropyl alcohol, D-gluconolactone, sodium hydroxide and water.
What Cepton Medicated Skin Wash looks like and contents of the pack
Cepton Medicated Skin Wash is a clear red liquid. It is available in plastic bottles with screw caps containing 150ml.
Marketing Authorisation holder: Boston Healthcare Ltd., 6 Navigation Court, Calder Park, Wakefield WF2 7BJ, United Kingdom.
Manufacturer: Kleva S.A., 189 Parnithos Avenue, 136 71 Acharnai, Greece.
This leaflet was last revised in: December 2013
'Cepton' is a registered trademark