Hedrin 4% lotion

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Dimeticone

Dostopno od:

Thornton & Ross Ltd

Koda artikla:

P03AX05

INN (mednarodno ime):

Dimeticone

Odmerek:

40mg/1gram

Farmacevtska oblika:

Cutaneous solution

Pot uporabe:

Cutaneous

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 13100400; GTIN: 5011309885019 5011309885217

Navodilo za uporabo

_Data Matrix:_
VERIFIED
23279110
PCP HEADER BOX
APPROVED BY DATE
OPERATOR
ARTWORK NO
CRN
FIX
REASON F
SUF
OR
CHANGE
ISSUED BY
DATE
MHRA/IMB
SUBMISSION
REQUIRED
Yes
A
gill.kennedy
548862
11161
Update at request of Stada
following a signal jour fixe
meeting regarding safety and
addition of reporting of side
effects statement MHRA approved.
MHRA HEADER BOX
PRODUCT TITLE
C
FONTS USED
OLOURS USED
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
Leaflet
150ml
23279110
210 x 148mm flat (27 x 148mm folded)
3
15.12.2014
PANTONE 280 C
PANTONE 326 C +60%+15%
Keyline (Does not print)
Hedrin 4% Lotion UK P pack
Frutiger
Frutiger LT
23279110
P
PATIENT INFORMATION
A TOPICAL LOTION FOR THE
ERADICATION OF HEAD LICE.
You can use this medicine to treat
adults and children over 6 months old
without seeing a doctor, but use it
carefully to get the best results.
READ ALL THIS LEAFLET CAREFULLY BEFORE YOU
START USING THIS MEDICINE.
•
Keep this leaflet. You may need to
read it again.
•
Ask your pharmacist for further advice
if live lice are detected after the
second treatment with Hedrin
®
, or if
head lice are a persistent or recurring
problem.
•
If you have any other questions, ask
your doctor or pharmacist.
•
If you notice any side effects or any
side effects not mentioned in this
leaflet, talk to your doctor or
pharmacist.
IN THIS LEAFLET
1 What is Hedrin
®
Lotion and what does it do?
2 Before using Hedrin
®
3 How to use Hedrin
®
4 Possible side effects
5 Storing Hedrin
®
6 Further information
®
1 WHAT IS HEDRIN
®
LOTION
AND WHAT DOES IT DO?
DIRECTIONS
• APPLY SUFFICIENT LOTION EVENLY OVER
DRY HAIR ENSURING THAT THE SCALP IS
FULLY COVERED.
• WORK INTO THE HAIR SPREADING THE
LIQUID EVENLY FROM THE ROOTS TO TIPS.
ALLOW THE HAIR TO DRY NATURALLY.
• LEAVE ON THE HAIR FOR AT LEAST 8 HOURS
OR OVERNIGHT.
• WASH THE HAIR WITH NORMAL SHAMPOO,
RINSE THOROUGHLY WITH WATER AND DRY.
DURATION OF TREATMENT
• It is important that Hedrin
®
Lotion is
applied again after SEVEN DAYS to deal
with any lice which may hatch i

Lastnosti izdelka

OBJECT 1
HEDRIN 4% CUTANEOUS SOLUTION (P)
Summary of Product Characteristics Updated 15-Dec-2014 | Thornton &
Ross Ltd
1. Name of the medicinal product
Hedrin® 4% cutaneous solution
Packaging to state: Hedrin 4% lotion dimeticone
2. Qualitative and quantitative composition
Dimeticone 4%w/w
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Cutaneous solution
Hedrin is a clear, colourless liquid
4. Clinical particulars
4.1 Therapeutic indications
Hedrin is indicated for the eradication of headlice infestations
4.2 Posology and method of administration
Adults and children (aged six months and above)
For topical external use only
Apply sufficient lotion to cover dry hair from the base to the tip to
ensure that no part of the scalp is left
uncovered. Work into the hair spreading the liquid evenly from roots
to tips. Allow hair to dry naturally.
Hedrin should be left on hair for a minimum of 8 hours or overnight.
Wash out with normal shampoo,
rinsing thoroughly with water. Repeat the treatment after seven days.
Children under the age of six months should only be treated under
medical supervision.
4.3 Contraindications
Hypersensitivity to any of the ingredients
4.4 Special warnings and precautions for use
Discontinue at the first appearance of a skin rash or any other signs
of local or general hypersensitivity.
Should any signs of hypersensitivity occur (e.g. rashes, urticaria,
generalised pruritus, breathing
difficulties), the product should be shampooed off immediately, and if
symptoms do not resolve, medical
advice sought.
For external use only.
Avoid contact with the eyes but if accidentally introduced into the
eyes, flush with water.
Hedrin 4% cutaneous solution is combustible when on the hair and in
direct contact with an open flame or
other source of ignition; therefore during treatment hair should be
kept away from open flames or other
sources of ignition.
The labels and leaflets will state:
“Warning:
Keep hair away from sources of ignition, especially naked flames and
burning cigarettes, w