ORACUE GEL

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

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Active ingredient:
Cetalkonium Chloride; Choline Salicylate
Available from:
XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD
INN (International Name):
Cetalkonium Chloride; Choline Salicylate
Units in package:
10 gm
Manufactured by:
XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD
Authorization number:
MAL20076057XC

Documents in other languages

Patient Information leaflet Patient Information leaflet - Malay

18-05-2020

Consumer Medication Information Leaflet (RiMUP)

____________________________________________________________________________________________________________________________

________________________________________________________________________________________________________________

What is in this leaflet:

What is Oracue used for

How Oracue works

Before you use Oracue

How to use Oracue

While you are using Oracue

Side effects

Storage and disposal of Oracue

Product description

Manufacturer and Product Registration

Holder

Date of revision

What is Oracue used for

Oracue helps to relieve pain, inflammation,

and to treat minor infection due to common

mouth ulcers, cold sores, denture and sore

spots, as well as mouth ulcers and sore

spots due to orthodontic devices. To help

to fight minor mouth infection and healing

of sore spots and ulcers due to dentures and

orthodontic

devices.

Oracue

helps

relieve and soothe teething.

How Oracue works

Oracue

contains

non-steroidal

anti-

inflammatory (NSAID) and anti-infective

substances. Choline Salicylate is a NSAID

that

reduces

pain

inflammation.

Cetalkonium Chloride is an anti-infective

agent that fights against microbial growth.

Before you use Oracue

When you must not to use it

Do not use Oracue if:

You are allergic to Choline Salicylates,

Cetalkonium

Chloride,

Ethanol

Glycerin.

taking

medicines

blood

clots or gout.

have

stomach

intestinal

bleeding.

You have blood clotting disorders.

You are suffering from stomach ulcer.

Before you start to use it

Tell your doctor or pharmacist if:

You are pregnant or breast-feeding.

You have blood clotting disorders.

Taking other medicines

Tell your doctor or pharmacist if you

are taking or have recently taken any

other

medicines.

This

includes

medicines

which

have

bought

without a prescription.

Tell your doctor or pharmacist if you

are taking medicines for treating blood

clotting or gout.

How to use Oracue

How much to use

Babies (4 month-old and above) and

Children

With

clean

finger,

massage

approximately

half

centimeter

ORACUE gel onto the sore area. This

can be repeated after 3 hours.

Not to exceed 6 doses in 24 hours. Not to

be used in babies less than 4 month-old.

Adults

Massage

approximately

centimeter

of Oracue gel onto the sore area. This can

be repeated after 3 hours.

Dentures Sores:

Massage

approximately

centimeter

of Oracue onto the sore area and leave at

least 30 minutes before reinserting the

dentures. Do not apply

directly to the

dentures.

When to use it

Use only when necessary.

How long to use it

Follow the recommendation from your

doctor or pharmacist.

Ask your doctor or pharmacist before

prolonged using Oracue.

If you forget to use it

Simply apply the new dose and follow

the instructions stated above.

If you use too much (overdose)

Frequent

application

especially

children,

give

rise

salicylate

poisoning. Thus, apply when necessary.

Symptoms

salicylate

poisoning

such as

nausea, vomiting, tinnitus and

excessive sweating.

Contact your doctor immediately or go to

Emergency

Department

your

nearest

hospital,

think

anyone else may have taken too much of

this medicine. Do this even if there are no

signs of discomfort or poisoning. You

may need urgent medical attention.

While you are using Oracue

Things you must do

Oracue is for topical oral use only.

Always

wash

your

hand

before

applying the gel.

Make sure the hand is clean.

Things you must not do

apply

Oracue

directly

dentures.

Do not exceed the stated dose.

Things to be careful of

Please

always

consult

your

doctor,

dentist

pharmacist

before

using

Oracue,

especially

when

there

known to hypersensitivity.

Side effects

Asthma attacks may occasionally occur

in people who are sensitive to salicylates.

As this product containing glycerin, some

people

experience

headache,

stomach upset and diarrhea.

Like all medicines, Oracue can cause side

effects, although not everybody gets them.

experience

symptoms

persistently for more than 7 days, please

consult your doctor, dentist or pharmacist.

You may report any side effects or adverse

drug

reactions

directly

National

Centre

Adverse

Drug

Reaction

Monitoring

visiting

website

npra.gov.my

[Consumers

->

Reporting

Side Effects to Medicines (ConSERF) or

Vaccines (AEFI)].

Storage and disposal of Oracue

Storage

Store below 30ºC.

Keep out of reach of children.

expiry

date

this

product

indicated on the packaging.

Disposal

Medicines should not be disposed of via

wastewater or household waste. Ask your

pharmacist how to dispose of medicines

no longer required. These measures will

help to protect the environment.

Product description

What it looks like

Each

tube

contains

translucent

colourless gel.

Ingredients

- Active ingredient(s)

Choline Salicylate, Cetalkonium

Chloride

- Inactive ingredients

Ethanol,

Glycerol,

Menthol,

Hypromellose,

Saccharin

Sodium,

Aniseed Oil and Purified Water.

MAL Number

Manufacturer and Product Registration

Holder

Xepa-Soul Pattinson (Malaysia) Sdn Bhd

1-5, Cheng Industrial Estate,

75250 Melaka,

Malaysia.

ORACUE GEL

Choline Salicylate/ Cetalkonium Chloride (8.71% w/w/ 0.01% w/w)

Consumer Medication Information Leaflet (RiMUP)

____________________________________________________________________________________________________________________________

________________________________________________________________________________________________________________

Date of revision

18/05/2020

Serial Number

NPRA (R2) 20/038

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