Budenase

Main information

  • Trade name:
  • Budenase Aq Nasal Spray 100 mcg / dose
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Budenase Aq Nasal Spray 100 mcg /dose
    Malaysia
  • Language:
  • English

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL 2003174
  • Last update:
  • 28-05-2018

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

Consumer Medication Information Leaflet (RiMUP)

BUDENASE AQ NASAL SPRAY 100MCG/DOSE

Budesonide (100mcg/dose)

1

What is in this leaflet

1. What BUDENASE AQ is used for

2. How BUDENASE AQ works

Before you use BUDENASE AQ

How to use BUDENASE AQ

While you are using it

Side effects

Storage and Disposal of BUDENASE

Product Description

Manufacturer and Product Registration

Holder

10. Date of Revision

What BUDENASE AQ is used for

BUDENASE

used

treat

prevent

effects

seasonal

perennial (throughout the year) allergies

(such

hayfever)

which

cause

inflammation inside the nose (rhinitis).

-It is also used to treat non-allergic rhinits

and small growths inside the nose (nasal

polyps).

-It can also prevent the nasal polyps from

coming back after they are removed.

How

BUDENASE

AQ

works

BUDENASE

contains

medicine

called budesonide. This belongs to a group

of medicines called

corticosteroids.

works by reducing and preventing swelling

and inflammation in your nose

Before you use BUDENASE AQ

-When you must not use it

Do not use BUDENASE AQ if:

allergic

(hypersensitive)

budesonide or any of the other ingredients

of BUDENASE AQ

you have untreated fungal, bacterial or

viral infections

you have viral infection of eye (ocular

herpes simplex)

you have tuberculosis (TB) infection in

your lungs

you have unhealed nasal wounds.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant, trying

pregnant

think

pregnant or if you are breast-feeding. Ask

your doctor or pharmacist for advice before

taking

medicine.

BUDENASE

should only be used in pregnancy if your

doctor feels the benefit of using the spray

outweighs any risks.

-Before you start to use it

Talk to your doctor or pharmacist before

using BUDENASE AQ. You should tell

your

doctor

before

taking

following medicines:

if you have fungal or viral infection.

BUDENASE

long-term

your doctor will check the lining of your

nose every 6 months to check that it is in

good condition.

-Taking other medicines

Tell your doctor or pharmacist if you are

taking, or have recently taken, any other

medicines including the following:

medicine to treat a fungal infection (e.g.

ketoconazole)

taking

antibiotics

(such

erythromycin)

taking

medicines

treat

depression such as (fluoxetine)

you are taking medicines to treat HIV

infection such as (ritonavir)

you are taking medicines to relieve pain

or fever such as (aspirin)

you are taking

medicine

for abortion

such as (mifepristone)

you are taking steroids tablet/syrup

Vaccines can be taken as recommended in

healthy persons.

How to use BUDENASE AQ

-How much to use it

Always use BUDENASE AQ exactly as

your doctor or pharmacist has told you.

Check with your doctor or pharmacist if

you are not sure.

The recommended dose is:

Rhinitis

Adults and children over 6 years: Two

sprays into each nostril every morning. In

some cases, your doctor may advise one

spray into each nostril every morning and

evening.

Maintenance

dose:

lowest

effective dose (1 spray in each nostril once

daily

Your doctor may reduce this dose once

your symptoms improve.

You will need to use the Budesonide spray

regularly.

Nasal polyps

usual

dose

spray

BUDENASE AQ into each nostril every

morning and evening.

BUDENASE AQ is not recommended for

use in children below 6 years

-When to use it

directed

your

doctor

pharmacist.

-How long to use

-

Speak

your

doctor

first

before

stopping this medicine.

-

Treatment for nasal polyps can continue

for up to 3 months.

If you have any further questions on the use

this

medicine,

your

doctor

pharmacist.

-If you forget to use it

If you forget to take a dose, take it as soon

as you remember. However, if it is almost

time to take the next dose, wait until then.

Do not take a double dose to make up for

a forgotten dose

-If you use too much (overdose)

It is important that you take your dose as

stated on the label or as advised by your

doctor. You should use only as much as

your doctor recommends; using more may

make

your

symptoms

worse.

accidently take too much of your medicine

tell your doctor. Using too much may cause

signs

symptoms

hypercorticism

(high level of hormones), suppression of

hypothalamic-pituitary-adrenal

(HPA)

function

suppression

growth

children

While you are using it

-Things you must do

Tell

doctors,

dentists

pharmacists

treating

that

taking BUDENASE AQ.

Tell

your

doctor

immediately

become

pregnant

while

taking

this

medication

-Things you must not do

It takes a few days for this medicine to

work hence it is very important that you

use it regularly. Do not stop treatment even

if you feel better unless told to do so by

your doctor.

This

medicine

been

specially

recommended by your doctor for you. Do

not allow any other person to use it.

-Things to be careful of

-Long term use of budesonide may cause

suppression of growth in children. Closely

monitor the growth of children.

-During long-term high-dose therapy,

Consumer Medication Information Leaflet (RiMUP)

BUDENASE AQ NASAL SPRAY 100MCG/DOSE

Budesonide (100mcg/dose)

2

monitoring of blood and adrenal function

is advisable.

Side effects

Possible side effects

Like all medicines, BUDENASE AQ can

cause side effects, although not everybody

gets them.

If any of the following allergic reaction

happen to you, stop using BUDENASE AQ

and tell your doctor immediately:

Skin rash, itching, lumpy rash (hives),

blistering of the skin. Swelling of your

face, lips, tongue or throat (this may make

it difficult to swallow).

Other possible side effects:

Discomfort in your nose or stinging in

your nose. These can happen straight after

using BUDENASE AQ.

Bleeding from the nose.

Throat irritation, increased cough.

Extremely rare, ulceration on the inside

nose

perforation

membrane separating the nostrils (the nasal

septum) may occur.

If any side effect gets serious, or if you

notice any side effects not listed in this

leaflet,

please

tell

your

doctor

pharmacist.

You may report any side effects or adverse

drug

reactions

directly

National

Centre

Adverse

Drug

Reaction

Monitoring by calling Tel: 03-78835550,

or visiting the website npra.moh.gov.my

(Public --> Reporting Medicinal Problems

/ Side Effects / AEFI/Vaccine Safety).

Storage

and

Disposal

of

BUDENASE

AQ

-Storage

Store below 25°C Protect from light. Keep

this medicine out of the sight and reach of

children. Do not use this medicine after the

expiry date which is stated on the label

after EXP. The expiry date refers to the last

day of that month.

-Disposal

throw

away

medicines

wastewater or household waste. Ask your

pharmacist how to throw away medicines

you no longer use. These measures will

help protect the environment.

Product description

-What it looks like

white

homogenous

redispersible

suspension filled in 10 ml amber glass

vial with crimped nasal spray assembly

-Ingredients

Active ingredient: Budesonide

Inactive

ingredients:

Anhydrous

glucose,

Avicel

polysorbate

potassium

sorbate,

disodium

edetate,

hydrochloric acid and water for injection.

-MAL Number:

MAL 20031746AZ

Manufacturer

Cipla Ltd.

Plot 9 & 10,

Indore SEZ Pithampur,

M.P. 454775 INDIA

Product Registration Holder

Cipla Malaysia Sdn Bhd

Suite 1101, Amcorp Tower, Amcorp

Trade Centre,

18 Persiaran Barat,

46 050 Petaling Jaya, Selangor, Malaysia.

Date of revision

29/08/2017

Serial Number

NPRA(R4/1)290817/00234