Chlorhexidine gluconate 0.2% mouthwash aniseed

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Chlorhexidine gluconate

MAH:

Ecolab Healthcare Division

ATC_code:

A01AB03

INN:

Chlorhexidine gluconate

dosage:

2mg/1ml

pharmaceutical_form:

Mouthwash

administration_route:

Oromucosal

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 12030400

PIL

TREATS & PREVENTS GUM DISEASE
_CARE_
_CHLORHEXIDINE_
_DIGLUCONATE 0.2% W/V_
_ANTISEPTIC MOUTHWASH_
_ANISEED FLAVOUR_
PEEL
HERE
300ML
IMPORTANT: PEEL THIS LABEL
AT CORNER AND READ BEFORE
USE. DO NOT TEAR OFF, RE-FIX FOR
FUTURE USE.
For the treatment and prevention of gingivitis
(gum disease), gum ulceration, oral thrush,
denture sores and for maintaining oral
hygiene.
Use the solution only in the mouth. Do not
swallow.
ADULTS, THE ELDERLY AND CHILDREN:
• Measure 10ml in the cup provided.
• Rinse the mouth thoroughly for about
1 minute, then spit out.
• Use twice a day.
GINGIVITIS (GUM DISEASE): Use as above for
one month.
MOUTH ULCERS AND THRUSH: Use as above,
continuing for 2 days after symptoms go.
DENTURE SORES: Use as above, also soak
dentures for 15 minutes, twice a day.
If symptoms persist, stop use and
consult your doctor or dentist.
PEEL WHERE SHOWN FOR FURTHER
PRECAUTIONS.
ACTIVE INGREDIENT: chlorhexidine digluconate
0.2% w/v.
ALSO CONTAINS: ethanol, castor oil polyoxyl
hydrogenated, menthol, anise oil,
aspartame (E951) and purified water.
Alcohol 7 vol%.
Do not store above 25°C. Once opened use
within 28 days.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Manufactured by the licence holder Thornton
and Ross Ltd., Huddersfield, HD7 5QH, UK.
PL 00240/0373
24884101
This mouthwash contains chlorhexidine digluconate,
a disinfectant and antiseptic. It reduces the formation
of dental plaque and fights infection in the mouth.
1. BEFORE YOU USE THIS MEDICINE
DO NOT TAKE/USE THE MEDICINE IF YOU OR
YOUR CHILD….
• Are allergic (hypersensitive) to chlorhexidine
gluconate or any of the other ingredients listed on
the front.
SPECIAL WARNINGS AND PRECAUTIONS
This medicine may in rare cases cause severe
allergic reactions, leading to a drop in blood pressure
and even unconsciousness. Early symptoms of a
severe allergic reaction may be skin rash or asthma.
If you notice these symptoms, stop use and contact
your doctor as soon as possible (see under section 2:
Possible side effects).
TAKE CARE WITH THE MEDICINE�

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Care Chlorhexidine Digluconate 0.2%w/v Antiseptic Mouthwash Aniseed
Flavour
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Digluconate 0.2% w/v (equivalent to Chlorhexidine
Gluconate
Solution 1.0% v/v)
For full list of excipients see section 6.1
3
PHARMACEUTICAL FORM
Mouth wash.
A clear, colourless liquid with an odour of menthol and aniseed.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aids prevention of dental plaque formation. Aids the treatment and
prevention of
gingivitis. For the maintenance of oral hygiene. Promotes gingival
healing following
periodontal surgery. Management of recurrent oral ulceration. For the
treatment of
denture stomatitis and oral thrush.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oromucosal use.
Adults, the elderly and children: To be used as required up to twice
daily. Rinse the
mouth thoroughly for about 1 minute with 10ml. The mouthwash should be
expelled
from the mouth after rinsing.
Prior to dental surgery: Rinse the mouth thoroughly with 10ml for 1
minute. The
mouthwash should be expelled from the mouth after rinsing.
Treatment of gingivitis: A course of one month is recommended.
Treatment of denture stomatitis: Soak the denture(s) in solution for
15 minutes twice
daily.
Treatment of oral ulceration and oral thrush: Treatment should be
continued for 48
hours after clinical resolution.
4.3
CONTRAINDICATIONS
Known hypersensitivity to the product or any of its components,
especially in those
with a history of possible chlorhexidine-related allergic reactions
(see sections 4.4
and 4.8).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For oral use only. Keep away from the eyes and ears. If the solution
comes into
contact with the eyes, rinse well with water. Keep out of the sight
and reach of
children. Do not swallow. If symptoms persist, stop using and consult
your doctor or
dentist.
Chlorhexidine Mouthwash contains chlorhexidine. Chlorhexidine is known
to induce
hypersensitivity, including generalise