Impetus Cream
Annotated Version - Not For Marketing
Special warnings and precautions
As with any product, severe generalised allergic reactions (see Section 4) are possible. Very rare reports of such reactions in susceptible individuals, leading to a drop in blood pressure and even to unconsciousness, have been associated with products containing chlorhexidine. You must not use Impetus Cream if you have had problems with chlorhexidine-containing products in the past.
3. How to use Impetus Cream
4. Possible side effects
5. How to store Impetus Cream
6. Further information
7. General advice on looking after dry skin conditions
1. WHAT IMPETUS CREAM IS ANdWhAT IT IS USED FOR
• Impetus Cream is an antimicrobial an^ emollient (softening and moisturising) treatment for application to dry or problem skin.
• It is for use in two ways:
- as a leave-on application
- as a soap-substitute.
• It helps treat and prevent dry /nd itchy (pruritic) skin conditions, especially eczema and dermatitis.
• All age groups can use Impetus Cream, including babies.
• There are two types of active ingredient in this product:
- Benzalkonium chloride and chlorhexidine dihydrochloride are antimicrobials.
These help to:
- combat bacteria present on your skin that can make eczema worse
- prevent infection caused by scratching itchy skin.
- Liquid paraffimand isopropyl myristate are emollients which help to:
- soften, moisturise and protect your skin by trapping moisture in the skin and restoring the normal protective function of the skin
- preveNrthe skin-drying and irritant effects that can be caused by washing and bathing and by the soaps, foaming additives and fragrances used in ordinary skiiyCleansing products.
• This product can be used in addition to any other emollients or treatments your doctor or pharmacist may have given or prescribed for you to treat your dry skin condition.
2. BEFORE YOU USE IMPETUS CREAM
Do/ot use Impetus Cream if you are allergic (hypersensitive) to benzalkonium chloride, chlorhexidine dihydrochloride, liquid paraffin, isopropyl myristate, or any of the other iNgredients of Impetus Cream listed in section 6.
Take special care when using this product:
• For patients with very sensitive skin, it is generally a good idea to start any new treatment on a small test area first, in case any side effect occurs (see Section 4 below). This is especially important when treating the face or young children. Thereafter, treatments may be applied more generously, as required.
• Avoid getting it in the eyes, especially when using it on the face.
• When used as a soap substitute in the bath or shower the product can make the surface slippery, so be careful to avoid slipping over when getting into and out of your shower or bath (eg by using a shower or bath mat).
Using other medicines
This product is not known to affect, or to be affected by, other medicines.
Information for the user
Please read all of this leaflet carefully before you start using this
Keep this leaflet. You may need to read it again.
Ask your doctor or pharmacist if you need more information or advic
In this leaflet:
1. What Impetus Cream is and what it is used for
2. Before you use Impetus Cream
Pregnancy and breast-feeding
This product can be used during pregnancy and whilst breast-feeding. The ingredients have been in widespread use in this and similar preparations for many years, without reports of problems. However, safety trials have not been conducted.
Important information about one eftheingredients of Impetus Cream
he product contains cetostearyl alcohol. This ingredient may cause local skin reactions '(Eg contact dermatitis) in a small number of sensitive people. If you have been told by your ensitive to cetostearyl alcohol, please talk to your doctor before using
octor that you are i this product.
3.\how to use impetus cream
Use it only on the skin. For maximum benefit you should use it on a regular basis and as Often as required. Before using the 500 g bottle, turn the top of the pump dispenser antivclockwise to unlock it.
The same instructions apply for all age groups:-For use as a leave-on application:
• Apply Impetus Cream to the affected areas.
• Gently smooth into the skin.
• If necessary allow time for any excess to soak in
Do not rub the skin vigorously
If you have previously experienced local skin reactions (e.g. contact dermatitis) to any of the ingredients, please talk to your doctor before using this product. Problems of this sort ’ are possible with any ingredient, and a small number of people are known to be sensitive to cetostearyl alcohol in particular.
• Reapply as often as required.
• If you are applying another treatment to the same areas of skin as Impetus Cream, try to avoid mixing the two products. This can be achieved by applying the treatments alternately, leaving sufficient time to allow the previous application to soak in.
For use as a soap suteMute lf you experience any of the
Impetus Cream and get urgent
medical help: swblling of the face, lips, tongue or throat; a sudden uncharacteristic red itchy skin rash (hivea) away ■from tlte site of application; wheezing or breathing difficulty: feeling faint or dizzy; a effatgc metallic tasfe ie toe motth; of collapsa. You may be having a serious allergic reaction.
• Use Impetus Cream to wash with instead of your ordinary sob following reagtions stop using It will not foam or lather like ordinary cosmetic products.
• After washing, bathing or showering, pat the skin dry with a s as this can make dry skin conditions worse).
If you forget to use Impetus Cream
Do not worry if you occasionally forget to use it, just carryw
the next time you require it.
If the product gets into the eyes
The product may cause irritation if itewtmlyto the eyes. Rinse th
If rinsing one eye, take care t|avOTawashing product into the of
seek medical advice.
4. POSSIBLE SIDE EFFECTS
Imedicines, Impetus Cream can cause side effects, although not everybody gets them. This product has been specially designed for use on dry or problem skin areas anywhere
on the body, put in i
(involving rednev
irritation and/Writehing). Reactions may occasionally occur if used excessively as a leave-on application in arelmwf folded skin such as the groin area.
Stop using this creamand tell your doctor or pharmacist:
• If your skin condition stems to look or feel worse.
• If any of the side effects become unacceptable, or you notice any other side effects not mentioned in this leaflet.
If you swallow Impetus Cream
If you accidentally swallow the produd Do not attempt to cause vomiting.
.and you then feel unwell, seek medical attention.
Rarely, Impetus Cream can cause skin reactions on treated areas (involving redness, irritation and/ or itching).
HOW TO STORE IMPETUS CREA
Keep out of reach and sight of children.
, Do not use Impetus Cream after the expiry date shown on the container and carton. iThe expiry date refers to the last day of that month.
\Do not store above 30°C.
Always replace the cap after use.
In the case of the 500 g bottle, it is advisable to turn the top of the pump dispenser Clockwise to lock it.
macrogol cetostearyl ether (cetomacrogol 1000). (Ref. PL00173/0399-0005)
6. FURTHER INFORMATION
What Impetus Cream contains:
The active ingredients in this product are benzalkonium chloride (0.1% w/WTchlorhexidine dihydrochloride (0.1% w/w), liquid paraffin (10% w/w) and isopropyl myristate (10% w/w). The other ingredients are cetostearyl alcohol, glycerol, cetomacrogol 10OO, phenoxyethanol, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate and purified water.!
What Impetus Cream looks like and contents of the pack
• Tha product is a white, non-greasy cream that contains no dye or fragrance.
• Theiproduct is available in a plastic bottle containing 500 g or in a plastic tube containing 100g. (30 g packs are also available to the medical and allied professions).
The Marketing Authorisation holder is Dermal Laboratories, Hitchin, Herts, SG4 7QR, UK. The Manufacturer is Aeropak, Viking Road, Great Yarmouth, NR31 0NU, UK.
This leaflet was last approved in April 2010^
September 2014
7. GENERAL ADVICE ON LOOKING AFTER DRY SKIN CONDITIONS.
• EmolliEnts help soften, moisturise and protect the skin. They play a central role in the treatment and management of dry skin conditions. For maximum effect, they should be applied regularly and as often as needed._
When bath Reportiny of cide effwces
period. Th If csu aet an; aide eTfects, talk (o yosr Eoctor, pharmacist or nurse. This includes any Try t0 avoit posaibla oita effects sot iistca in f0ia leaflet. Yoe set also tepot side efTahts directly ThiS iS beavie the Yellow Catd Scf ame at: vwwv.mhra.gov.uk/yellowcard. fragrances, Be tetsaieg side edfeufa enu cas ptoeike mrve isrotmgtlon ot the sefafy e-ttia emollient “s meOieine.
be better for your dry skin condition.
• Breaking the itch-scratch cycle.
Some dry skin conditions like eczema and dermatitis are itchy, and can be quite sore. Although scratching relieves the itching for a short while, it further damages the skin. Badly scratched skin easily gets infected. This makes it itchier and the urge to scratch becomes even greater. It is better if scratching can be avoided by reducing the itching. The regular use of emollients or moisturisers can help with this.
• You may find it helpful to contact NHS Direct (tel: 0845 4647) or a patient support group such as the National Eczema Society (tel: 0800 0891122, 8am to 8pm Mon-Fri) for information about your skin condition.
To listen to or request a copy of this leaflet in Braille, large print or audio, please call free of charge: 0800 198 5000 (uK only).
Please be ready to give the following information: Impetus Cream, 00173/0399.
package leaflet
Information for the user
Please read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. You may need to read it again.
Ask your doctor or pharmacist if you need more information or advice.
In this leaflet:
1. What Impetus Cream is and what it is used for
2. Before you use Impetus Cream
3. How to use Impetus Cream
4. Possible side effects
5. How to store Impetus Cream
6. Further information
7. General advice on looking after dry skin conditions
1. WHAT IMPETUS CREAM IS AND WHAT IT IS USED FOR_
• Impetus Cream is an antimicrobial and emollient (softening and mois' Special warnings and for application to dry or problem skin.
• 11 |s for use in two ways:
-asa|eave-on app|ica|ion
- as a soap-substitute.
,. , , .. , ,. ... allergic reactions (see
• It helps treat and prevent dry and itchy (pruritic) skin conditions, espe p .. .r .. ,
and dermatitis.
• All age groups can use Impetus Cream, including babies.
• There are two types of active ingredient in this product:
- Benzalkonium chloride and chlorhexidine dihydrochloride are antim individuals, leading to a These help to:
- combat bacteria present on your skin that can make eczemAwo aed even to
- prevent infection caused by scratching itchy skin. .s'
- Liquid paraffin and isopropyl myristate are emollieptswhich help t< been associated with
- soften, moisturise and protect your skin byJrApping moisture in products containing and restoring the normal protective fupatOP of the skin
....... ,. .Zf. ... , ,, chlorhexidine. You must
- prevent the skin-drying and irritant-effects that can be caused by .
bathing and by the soaps, foaming additives and fragrances use not use Impetus Cream if skin cleansing produc'e^m^
• This product can be used-iiaddition to any other emollients or treatmeNli cOlornuxiOine-or pharmacist may pave!given or prescribed for you to treat your dry containing products in
2. BEFOREYOU USE IMPETUS CREAM the past
Do not uselmpetus Cream if you are allergic (hypersensitive) to benzalkonium chloride, chlorpeXdine dihydrochloride, liquid paraffin, isopropyl myristate, or any of the other ingrEdients of Impetus Cream listed in section 6.
Take special care when using this product:
• For patients with very sensitive skin, it is generally a good idea to start any new treatment on a small test area first, in case any side effect occurs (see Section 4 below). This is especially important when treating the face or young children. Thereafter, treatments may be applied more generously, as required.
• Avoid getting it in the eyes, especially when using it on the face.
• When used as a soap substitute in the bath or shower the product can make the surface slippery, so be careful to avoid slipping over when getting into and out of your shower or bath (eg by using a shower or bath mat).
Using other medicines
This product is not known to affect, or to be affected by, other medicines.
Pregnancy and breast-feeding
This product can be used during pregnancy and whilst breast-feeding. The ingredients have been in widespread use in this and similar preparations for many years, without reports of problems. However, safety trials have not been conducted.
Important information about one of the ingredients of Impetus Cream The produpkcontains eetostearyl alcohol. This ingredient may cause local skin reactions (eg eontaerdematitis) in a small number of sensitive people. If you have been told by your doctor that youere sensitive to eetostearyl alcohol, please talk to your doctor before using this product.
3. HOW TO USE MeTUS CREAM
Use it only on the skin. Foriraximum benefit you should use it on a regular basis and as often as required. Before UVng the 500 g bottle, turn the top of the pump dispenser anti-eloekwise to unlock it.
The same instructions apply for all age groups:-For use as a leave-on application:
• Apply Impetus Cream to the affected areas.
• Gently smooth into the skin.
If you havp prevtously experieucep loxal skin reactinns (e.Oi contact dprmalKs) to any of the ingredients, please talk to your doctor before using this product. Problems of this sort are possible with any ingredient, and a small number of people are known to be sensitive to
Reapply as often as required.
If you are applying another treatment to the same areas of skin as Impetus Cream, try to avoid mixing the two products. This can be achieved by applying the treatments
alternately, leaving sufficient time to allow the previous appli< If you experience any of the
For use as a soap substitute
following reactions stop using
Use Impetus Cream to wash with instead of your ordinary se Impetus Cream and get urgent
It will not foam or lather like ordinary cosmetic products.
• After washing, bathing or showering, pat the skin dry with a as this can make dry skin conditions worse).
If you forget to use Impetus Cream
Do not worry if you occasionally forget to use it, just ce//y0mU the next time you require it.
If the product gets into the eyes
The product may cause irritationlifji-geEs into the eyes. Rinse th or dizzy; a ptrange metallic taste If rinsing one eye, take caroJe-eVPid washing product into the o ja Oho mouth; ftp aoliapsn. You
seek medical advice.
medical help: swelling of the foce, lips, toeguu ortlaroat; a sudden uncharacteristic red itchy skin reph (hivee) gway from the site of application; wheezing or breathing difficulty: feeling faint
may be having a serious allergic reaction.
4. POSSIBLE SIDE EFFECTS
[medicines, Impetus Cream can cause side effects, although not everybody gets them. This product has been specially designed for use on dry or problem skin areas anywhere on the body, but in some very rare cases it can cause local skin reactions (involving redness, irritation and/or itching).-Reactions may occasionally occur if used excessively as a leave-on application in areas of fotdOgskin such as the groin area.
Stop using this cream and telrfour doctor or pharmacist:
• If your skin condition seems to tOek or feel worse.
• If any of the side effects become unfVvoptable, or you notice any other side effects not mentioned in this leaflet.
If you swallow Impetus Cream
If you accidentally swallow the product and you thOa Do not attempt to cause vomiting.
feel unwell, seek medical attention.
Rarely, Impetus Cream can cause skin reactions on treated areas
I Do not use Impetus Cream after the expiry date shown on the contaii (ihvalving eadness,
IThe expiry date refers to the last day of that month.
\Do not store above 30°C.
Always replace the cap after use.
the case of the 500 g bottle, it is advisable to turn the top of the pump dispenser Clockwise to lock it.
irritation and/or itching).
macrogol cetostearyl ether (cetomacrogol 1000) - ref. PL 00173/0399-0005
6. FURTHER INFORMATION
What Impetus Cream contains:
The active ingredients in this product are benzalkonium chloride (0.1%W/w), chlorhexidine dihydrochloride (0.1% w/w), liquid paraffin (10% w/w) and isopropyfmyristate (10% w/w). The other ingredients are cetostearyl alcohol, glycerol, cotomavtpgol 1000, phenoxyethanol, disodjium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate and purified water!
What Impetus Cream looks like and contents of the pack
• ThO product is a white, non-greasy cream that contains no dye or fragrance.
• Theiproduct is available in a plastic bottle containing 500 g or in a plastic tube containing 100g. (30 g packs are also available to the medical and allied professions).
The Marketing Authorisation holder is Dermal Laboratories, Hitchin, Herts, SG4 7QR, UK. The Manufacturer is Fleet Laboratories Ltd, 94 Rickmansworth Road, Watford, Herts,
WD18 7JJ, UK.
This leaflet was last Reporting of side effects
If you geO eno skle effects, Hk Og yout doctor, pHetmvcist on nurse. Tltio mcludev any |30seible siOg effects nos listed In sOis leaflet. Yau avn afso report siOe effecte directly vie the Yellow Card Sclrnme gt: www.mhra.qoa.uk/ vellowcard.
By reportino sMe effects ^u .can .rovide more i^0^118^00 gs the safety cOttas medrana.
approved in April 2010.
September 2014
CE ON LOOKING AFTER DRY SKIN CONDITIONS.
:en, moisturise and protect the skin. They play a central role in the vgement of dry skin conditions. For maximum effect, they should be d as often as needed.
t use warm, not hot, water and avoid staying in the bath for long make dry skin conditions worse.
ormal soaps or shower products (even those labelled “moisturising”). y tend to dry and irritate the skin. Avoid using products containing r can also cause skin problems. You should try to use a fragrance-free >stitute” instead. This type of product will not foam or lather but will be kin condition.
scratch cycle.
(itions like eczema and dermatitis are itchy, and can be quite sore. a relieves the itching for a short while, it further damages the skin. Badly ly gets infected. This makes it itchier and the urge to scratch becomes error if scratching can be avoided by reducing the itching. The regular ' moisturisers can help with this.
Sul to contact NHS Direct (tel: 0845 4647) or a patient support National Eczema Society (tel: 0800 0891122, 8am to 8pm Mon-Fri) jt your skin condition.
To listen to or request a copy of this leaflet in Braille, large print or audio, please call free of charge: 0800 198 5000 (uK only).
Please be ready to give the following information: Impetus Cream, 00173/0399.
This is a service provided by the Royal National Institute of Blind People (RNIB).