Conotrane cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dimeticone; Benzalkonium chloride

Available from:

Evolan Pharma AB

ATC code:

D08AJ01

INN (International Name):

Dimeticone; Benzalkonium chloride

Dosage:

220mg/1gram ; 1mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13020200; GTIN: 5013346050023 5013346051112

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CONOTRANE CREAM
Benzalkonium chloride 0.1% w/w and dimeticone 22% w/w
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Always use this medicine exactly as described in this leaflet or as
your doctor, pharmacist
or nurse 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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
•
You must talk to a doctor if you do not feel better after 14 days or
if you feel worse.
WHAT IS IN THIS LEAFLET
1.
What Conotrane is and what it is used for
2.
What you need to know before you use Conotrane
3.
How to use Conotrane
4.
Possible side effects
5.
How to store Conotrane
6.
Contents of the pack and other information
1.WHAT CONOTRANE IS AND WHAT IT IS USED FOR
Conotrane Cream contains the active substances benzalkonium chloride
and dimeticone.
Conotrane Cream is used to protect the skin from moisture, irritants,
chafing and
contamination with bacteria or yeasts. It is used in the prevention
and treatment of nappy rash,
and can also be used in the prevention of pressure sores and for other
skin irritations caused
by rubbing or moisture.
HOW CONOTRANE CREAM WORKS
Conotrane Cream acts as a barrier cream. The active substance,
dimeticone, is water repellent
and the other active substance, benzalkonium chloride, has antiseptic
properties.
2.WHAT YOU NEED TO KNOW BEFORE YOU USE CONOTRANE DO NOT USE CONOTRANE
CREAM:
•
if you are allergic to benzalkonium chloride or dimeticone or any of
the other ingredients
of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Conotrane Cream.
Conotrane contains paraffin. Do not smoke or go near naked flames -
risk of severe burns.
Fabric (clothing, bedding, dressings etc) that has been in

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Conotrane cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Conotrane cream contains the active substances benzalkonium chloride
(0.1% w/w)
and dimeticone (22.0% w/w).
Excipient(s) with known effect: cetostearyl alcohol
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cream
A smooth, white cream for topical administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Conotrane is used for protection of the skin from moisture, irritants,
chafing and
contamination with bacteria or yeasts.
It may be used in situations such as in the prevention/treatment of
napkin rash, the
prevention of pressure sores and in the management of incontinence.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use. The cream should be applied to the affected area(s)
several times a
day, as necessary or after every napkin change.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section
6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Cetostearyl alcohol may cause local skin reactions (e.g. contact
dermatitis).
Conotrane contains paraffin. Instruct patients not to smoke or go near
naked flames -
risk of severe burns. Fabric (clothing, bedding, dressings etc) that
has been in contact
with this product burns more easily and is a serious fire hazard.
Washing clothing and
bedding may reduce product build-up but not totally remove it.
Benzalkonium chloride may irritate the skin.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No interaction studies have been performed.
4.6
FERTILITY, PREGNANCY AND LACTATION
There are no or limited amount of data from the use of Conotrane in
pregnant women.
It is unknown whether benzalkonium chloride, dimeticone or their
metabolites are
excreted in human milk.
If used during breast-feeding Conotrane should not be applied to the
breasts to avoid
accidental ingestion by the infant.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
N