Orrepaste

Main information

  • Trade name:
  • Orrepaste
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Orrepaste
    Malaysia
  • Language:
  • English

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL19990624
  • Last update:
  • 28-05-2018

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Consumer Medication Information Leaflet (RiMUP)

ORREPASTE

Triamcinolone Acetonide (0.1%w/w)

1

What is in this leaflet

What Orrepaste is used for

How Orrepaste works

Before you use Orrepaste

How to use Orrepaste

While you are using

Orrepaste

Side effects

Storage and Disposal of

Orrepaste

Product description

Manufacturer and Product

Registration Holder

Date of revision

This leaflet answers some common

questions about Orrepaste. It does

not contain all the available

information. It does not take the

place of talking to your pharmacist

or doctor.

All medicines have risks and

benefits. Your pharmacist or

doctor has weighed the risks of

you taking Orrepaste against the

benefits they expect it will have

for you.

Keep this leaflet with the medicine.

You may need to read it again.

What Orrepaste is used for

Orrepaste is an oral paste used as

adjunctive treatment and for

temporary relief of symptoms

associated with oral inflammatory

lesions and ulcerative lesions

resulting from trauma.

How Orrepaste works

Orrepaste contains triamcinolone,

a corticosteroid.

Triamcinolone reduces the actions

of chemicals in the body that cause

inflammation, redness, and

swelling.

Ask your pharmacist or doctor if

you have any questions about this

medicine.

Before you use Orrepaste

-When you must not use it

Allergic (hypersensitive) to

Triamcinolone Acetonide and

Propylene Glycol or any of the

ingredients listed at the end of this

leaflet.

If you have tuberculosis (bacterial

infection that mainly affects the

lung), ulcer in digestive tract,

diabetes, fungal, viral or bacterial

infections of the mouth or throat.

If the packaging shows signs of

tampering.

If the expiry date (EXP) printed on

the pack has passed.

-Before you start to use it

Ask your doctor or pharmacist for

advice before taking this medicine

if you are pregnant or breast-

feeding.

-Taking other medicines

Inform your pharmacist or doctor

if you are taking any other

products (such as medicines

purchased without a doctor's

prescription, prescription

medicines and herbal products) .

How to use Orrepaste

-How much to use

Apply a small dab (about ¼ inch)

to the lesion at bedtime. It may be

necessary to apply twice to three

times daily depending on the

severity of symptoms.

Follow all directions given to you

by your doctor and pharmacist

carefully. They may differ from

the information contained in this

leaflet.

-When to use it

During bedtime.

-How long to use it

Continue using Orrepaste for as

long as your doctor recommends.

Review treatment in 7 days is

required if significant regeneration

or repair of oral tissues has not

occurred.

-If you forget to use it

Do not worry if you occasionally

forget to use the product just

carry on using it when you

remember.

-If you use too much (overdose)

Corticosteroid applied to the skin

can be absorbed in sufficient

amount to produce systemic effect

such as hypothalamic-pituitary-

adrenal axis suppression,

manifestation of Cushing’s

syndrome (high level of hormone),

hyperglycaemia (an excess of

glucose in bloodstream) and

glycosuria (excess sugar in urine).

If the hypothalamic-pituitary-

adrenal axis suppression is found,

then the medicine should be

withdrawn, frequency of

application reduced or a weaker

steroid used.

Supplemental systemic

corticosteroid may be required if

signs and symptoms of steroid

withdrawal occur.

While you are using Orrepaste

-Things you must do

If you become pregnant while you

are using Orrepaste, tell your

doctor. If you are about to start

taking any new medicines, tell

your doctor and pharmacist that

you are using Orrepaste.

-Things you must not do

Do not give Orrepaste to anyone

else, even if they have the same

condition as you.

When applied topically,

particularly to large areas, when

the skin is broken, or under

occlusive dressings, corticosteroid

may be absorbed in sufficient

amounts to cause systemic effects.

Discontinue use if local reactions

develop. Normal body responses

decreased in people receiving

topical corticosteroid therapy.

-Things to be careful of

Avoid contact with eyes

Side effects

Like other medicines, Orrepaste

can cause some side effects. If they

occur, most are likely to be minor

and temporary. However, some

may be serious and need medical

attention.

Consumer Medication Information Leaflet (RiMUP)

ORREPASTE

Triamcinolone Acetonide (0.1%w/w)

2

Prolonged use may elicit the

adverse reactions known to occur

with systemic steroid preparation

for example, adrenal suppression,

and alteration of glucose

metabolism, protein catabolism

(protein degradation), ulcer

activation in the digestive tract and

others. These are usually reversible

and disappear when the hormone is

discontinued.

You may report any side effects or

adverse drug reactions directly to

the National Centre for Adverse

Drug Reaction Monitoring by

calling Tel: 03-78835550, or

visiting the website

npra.moh.gov.my

(Public

Reporting Medicinal

Problem / Side Effects / AEFI /

Vaccine Safety).

Storage and Disposal of

Orrepaste

-Storage

For external use only.

Store below 30ºC.

Keep out of reach of children.

-Disposal

Dispose the medicine after the

expiry date. 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

Orrepaste is a light green paste

with mint flavour and odour.

Orrepaste is available in 5g

aluminium tubes.

-Ingredients

-Active ingredient(s):

Each tube contains 0.1%w/w

Triamcinolone Acetonide.

-Inactive ingredients:

Quinoline Yellow, Brilliant Blue

FCF, Sorbitol 70% Solution,

Purified Water, Peppermint Oil,

Pectin, Propylparaben,

Methylparaben, Sodium

Polyacrylate, Propylene Glycol,

Sodium Carboxymethylcellulose

MAL number:

MAL19990624AZ

Manufacturer

HOE Pharmaceuticals Sdn. Bhd.

Lot 10, Jalan Sultan Mohamed 6,

Bandar Sultan Suleiman,

42000 Port Klang, Selangor,

Malaysia.

Product Registration Holder:

HOE Pharmaceuticals Sdn. Bhd.

Lot 10, Jalan Sultan Mohamed 6,

Bandar Sultan Suleiman,

42000 Port Klang, Selangor,

Malaysia.

Date of revision

-02/08/2017

Serial Number:

BPFK(R4/1)240717/00183