Carbosan 2% w/w Gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CARBENOXOLONE SODIUM

Available from:

Rowa Pharmaceuticals Limited

ATC code:

A02BX01

INN (International Name):

CARBENOXOLONE SODIUM

Dosage:

2 percent weight/weight

Pharmaceutical form:

Gel

Prescription type:

Product not subject to medical prescription

Therapeutic area:

carbenoxolone

Authorization status:

Marketed

Authorization date:

1987-03-13

Patient Information leaflet

Package leaflet: Information for the user
CARBOSAN 2% W/W GEL
CARBENOXOLONE SODIUM
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 or pharmacist 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 or pharmacist. 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 or if you feel
worse after 2 weeks.
WHAT IS IN THIS LEAFLET:
1.
What Carbosan is and what it is used for
2.
What you need to know before you use Carbosan
3.
How to use Carbosan
4.
Possible side effects
5.
How to store Carbosan
6.
Contents of the pack and other information
1.
WHAT CARBOSAN IS AND WHAT IT IS USED FOR
Carbosan Gel is used for the treatment of lip sores and mouth ulcers.
It contains a medicine called carbenoxolone sodium, which has
anti-diuretic and anti-inflammatory
properties. It acts by enhancing the production of protective mucous
in the mouth.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CARBOSAN
DO NOT USE CARBOSAN IF YOU:

are allergic to carbenoxolone sodium or any of the other ingredients
of this medicine (listed in
section 6)

suffer from any severe heart, liver or kidney complaints

suffer from high blood pressure

are under 3 years or elderly

have a low level of albumin (protein) in your blood

are pregnant or breastfeeding

are on medication for a heart condition.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Carbosan.

If an infection is present, you may also need an antibiotic.
If symptoms persist for more than 2 weeks, consult your doctor.
OTHER MEDICINES AND CARBOSAN
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other
medicines, including medicines obtained without a prescriptio

Summary of Product characteristics

Health Products Regulatory Authority
26 November 2020
CRN009Z66
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Carbosan 2% w/w Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 g of Carbosan Gel contains 100 mg carbenoxolone sodium.
Excipient(s) with known effect:
0.60 % w/w parahydroxybenzoic acid esters, sodium salt
0.10 % w/w lemon oil containing limonene in a range of 0.056 % w/w -
0.078 % w/w
16.50 % w/w polyoxyethylene 30 cetylstearyl alcohol
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gel
A translucent, colourless gel with a lemon odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Carbosan Gel is indicated in the symptomatic relief and treatment of
lip sores, mouth ulcers or aphthous changes in the oral
mucous membranes.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of Administration: For cutaneous use
RECOMMENDED DOSAGE SCHEDULE:
Adults and children over 3 years only:
Apply thickly to lesions after meals and at bedtime.
4.3 CONTRAINDICATIONS
Carbosan Gel is contra-indicated in patients suffering from severe
cardiac, renal and hepatic impairment, patients with
hypertension or those who are receiving cardiac glycosides.
Carbosan Gel is contra-indicated in elderly patients and in those
patients who have low serum albumin.
Carbosan Gel is also contra-indicated during pregnancy and lactation.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If bacterial infection is superimposed, appropriate therapy should be
instituted. If symptoms persist for more than 2 weeks
consult your doctor.
CARBOSAN CONTAINS PARAHYDROXYBENZOATE.
Health Products Regulatory Authority
26 November 2020
CRN009Z66
Page 2 of 3
May cause allergic reactions (possibly delayed).
CARBOSAN CONTAINS CETYLSTEARYL ALCOHOL:
May cause local skin reactions (e.g. contact dermatitis).
CARBOSAN CONTAINS FRAGRANCE:
This medicine contains lemon oil fragrance with allergens, where
limonene is one of the fragrance allergens listed.
Allergens may cause allergic reactions.
In addition to allergi