Dermidex Dermatological cream

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Cetrimide; Alcloxa; Chlorobutanol; Lidocaine

Dostopno od:

Actavis UK Ltd

INN (mednarodno ime):

Cetrimide; Alcloxa; Chlorobutanol; Lidocaine

Odmerek:

5mg/1gram ; 2.5mg/1gram ; 10mg/1gram ; 12mg/1gram

Farmacevtska oblika:

Cutaneous cream

Pot uporabe:

Cutaneous

Razred:

No Controlled Drug Status

Tip zastaranja:

Never Valid To Prescribe As A VMP

Povzetek izdelek:

BNF: 13030000; GTIN: 5012617018175 5011309891416

Navodilo za uporabo

Dermidex Dermatological
Cream
Important information about Dermidex
• This medicine treats cuts, scratches, grazes,
skin reactions, bites and stings when applied
to the skin.
• It can be used on adults, the elderly and
children over 4 years.
Do not use….
• On children under 4 years.
Now read the rest of the leaflet before you
use this medicine. It includes other
information which might be especially
important for you.
• Keep this leaflet. You may need to read it
again.
• Ask your pharmacist if you need any more
information or advice.
• If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
1. What the medicine is for
Dermidex is a cream which contains lidocaine,
a local anaesthetic, chlorobutanol and cetrimide
which are antiseptics and Alcloxa to soothe
and relieve irritation.
It is used to treat mild pain caused by minor
cuts, scratches and grazes.
It also relieves the soreness caused by reaction
to detergents, soaps, deodorants and jewellery.
Dermidex can be used to relieve the pain of
bites and stings.
2. Before you use this
medicine
Do not use the medicine if you or
your child have ….
• An allergy to any of the ingredients listed in
section 6.
• An allergy to other local
anaesthetics.
• Or on a child under 4 years old.
Talk to your doctor if you or your
child have….
r
e
t
f
a
p
u
d
e
r
a
e
l
c
t
o
n
e
v
a
h
t
a
h
t
s
m
o
t
p
m
y
S
•
using the cream for 7 days.
Pregnant or breastfeeding….
Ask your doctor or pharmacist for advice before
using this medicine if you are pregnant, might
be pregnant or are breastfeeding.
Lidocaine, one of the active ingredients, can be
absorbed through the skin and pass into breast
milk.
Important information about some
of the ingredients
• This product contains cetyl alcohol and
stearyl alcohol which may cause local skin
reactions (e.g. contact dermatitis).
3. How to use this medicine
Apply it to the skin.
Adults, the elderly and children
over 4 years
• Apply a smal

Lastnosti izdelka

DERMIDEX DERMATOLOGICAL CREAM
Summary of Product Characteristics Updated 31-Oct-2011 | Actavis UK
Ltd
1. Name of the medicinal product
Dermidex Dermatological Cream.
2. Qualitative and quantitative composition
Dermidex Dermatological Cream contains:
Lidocaine 1.20% w/w
Alcloxa 0.25% w/w
Chorobutanol 1.00% w/w
Cetrimide 0.50% w/w
For excipients, see 6.1
3. Pharmaceutical form
Cream. A smooth white cream, free from lumps, non greasy with an even
distribution of emulsion
droplets.
4. Clinical particulars
4.1 Therapeutic indications
Antiseptic, anaesthetic, anti-irritant, and emollient agent. For the
treatment of mild pain caused by minor
skin cuts, scratches and grazes (chapping) and soreness caused by
detergents, soaps, deodorants and
jewellery and bites and stings.
4.2 Posology and method of administration
_Adults, Children (age 4 and above) and the Elderly:_
Apply to the affected area every 3 hours
Not suitable for children aged less than 4 years.
_Route of administration:_ Cream for cutaneous use.
4.3 Contraindications
Dermidex Cream is contraindicated where there is hypersensitivity to
cetrimide, chlorobutanol, lidocaine
or other local anaesthetics of the amide type, or any of the other
ingredients.
4.4 Special warnings and precautions for use
For external use only. Keep out of reach and sight of children.
The product should not be used for longer than 7 days without seeking
medical advice.
Avoid contact with the eyes.
4.5 Interaction with other medicinal products and other forms of
interaction
None known.
4.6 Pregnancy and lactation
Lidocaine crosses the placenta and is distributed into breast milk. As
with all medicines use with care.
4.7 Effects on ability to drive and use machines
No or negligible influence.
4.8 Undesirable effects
Occasionally there have been reports of skin reaction with all such
preparations.
4.9 Overdose
Overdose is unlikely.
Accidental ingestion may result in anaesthesia of the upper
respiratory tract, nausea, vomiting and
abdominal discomfort. Ingestion of very large quantities could