Beclate

Main information

  • Trade name:
  • Beclate Aquanase Nasal Spray
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Beclate Aquanase Nasal Spray
    Malaysia
  • Language:
  • English

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL20013987
  • Last update:
  • 28-05-2018

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

Consumer Medication Information Leaflet (RiMUP)

BECLATE AQUANASE NASAL SPRAY

Beclomethasone dipropionate (50mcg/spray)

1

What is in this leaflet

What BECLATE AQUANASE is used

How BECLATE AQUANASE works

Before

BECLATE

AQUANASE

How to use BECLATE

AQUANASE

While you are using it

Side effects

Storage

Disposal

BECLATE

AQUANASE

Product Description

Manufacturer and Product Registration

Holder

10 Date of Revision

What BECLATE AQUANASE is

used for

Beclate Aquanase is used to prevent and

treat the common symptoms of seasonal

and perennial (throughout the year) allergic

vasomotor rhinitis (inflammation of the

mucous

membrane

inside

nose).

Beclate

Aquanase

also

prevent

small

growths

inside

nose

(nasal

polyps) from coming back after they are

removed.

How BECLATE AQUANASE works

The active ingredient is beclomethasone

dipropionate, a corticosteroid which has an

anti-inflammatory

vasoconstrictor

(constriction of blood vessels) effect to

reduce swelling and irritation in the nose

Before you use BECLATE AQUANASE

-When you must not use it

Do not use Beclate Aquanase:

if you have untreated fungal, bacterial or

viral infections

if you have tuberculosis (TB) infection

in your lungs

if you have viral infection of eye (ocular

herpes simplex)

if you have unhealed wounds in your

nose

if you have ever had an allergic reaction

to beclomethasone dipropionate or any of

the other ingredients

-Before you start to use it

Talk to your doctor or pharmacist

before using Beclate Aquanase if you have

an infection or ulcers in your nose, or you

have recently had surgery or an injury to

your nose.

Pregnancy and breastfeeding

Talk to your doctor or pharmacist before

using

Beclate

Aquanase

pregnant, trying to become pregnant or are

breast feeding.

Taking other medicines

Tell your doctor if you are taking any other

medicines,

including

that

without a prescription from a pharmacy,

supermarket or health food shop;

How

to

use

BECLATE

AQUANASE

Always shake well before use. Only use in

the nose. Do not swallow.

-How much to use

Adults and children over 6 years: Spray 1-

2 times into each nostril every morning and

evening. Do not use in children below 6

years

When to use it

You should use the spray regularly to get

the best results from it.

-How long to use

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.

-If you forget to use it

Take

missed

dose

soon

remember. If it is almost time for your next

dose, wait until then to take the medicine

and skip the missed dose. Do not take a

double dose to make up for the missed dose

-If you use too much (overdose)

Contact your doctor immediately or go to

the Emergency Department of your nearest

hospital, if you think you or anyone else

may have taken too much of this medicine.

this

even

there

signs

discomfort or poisoning. You may need

urgent

medical

attention.

Taking

large

amount of this medicine over a short time

period

cause

suppression

hypothalamic-pituitary-adrenal

(HPA)

function

While

you

are

using

BECLATE

AQUANASE

-Things you must do

-

Take

your

medicine

exactly

your

doctor has told you.

-

Tell

doctors,

dentists

pharmacists

treating

that

taking Beclate Aquanase.

-

Tell

your

doctor

immediately

become

pregnant

while

taking

this

medication

-Things you must not do

Use your Beclate Aquanase as directed

your

physician.

exceed

recommended dose.

This

medicine

been

specially

recommended by your doctor for you. Do

not allow any other person to use it.

-Things to be careful of

Change from systemic to topical treatment

The replacement of systemic corticosteroid

with

Beclate

Aquanase

accompanied

signs

adrenal

insufficiency. When transferred to Beclate

Aquanase careful attention must be given

individual

previously

treated

prolonged

periods

with

systemic

corticosteroids.

This

particularly

important in those individual who have

associated

asthma

other

clinical

conditions, where too rapid a decrease in

systemic

corticosteroids

cause

severe

exacerbations

symptoms.

Although

systemic

effects

have

been

minimal

with

recommended

doses,

this

potential increases with excessive doses.

Therefore, larger than recommended doses

should be avoided.

Side effects

Like all medicines, Beclate Aquanase can

have side effects, but not everybody gets

them. Stop taking the medicine and seek

immediate medical help if you experience:

Allergic reactions. These may include

developing a rash, swelling of the mouth or

face or having difficulty breathing.

The side effects are:

- discomfort of the nose such as dryness

and irritation

- sneezing

- epistaxis (bleeding from nose)

- impaired wound healing

- unpleasant taste and smell

- nasal septum perforation (hole in the

nasal septum the structure that divides the

nostrils)

- glaucoma (increased pressure inside the

eye)

You may report any side effects or adverse

drug

reactions

directly

National

Consumer Medication Information Leaflet (RiMUP)

BECLATE AQUANASE NASAL SPRAY

Beclomethasone dipropionate (50mcg/spray)

2

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

BECLATE

AQUANASE

-Storage

Store below 25

C but do not refrigerate.

Keep out of the reach and sight of children.

Do not use this medicine after the 'EXP'

date shown on the pack. Keep the container

in the outer carton to protect from light.

-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

white

homogenous,

redispersible

suspension filled in amber glass vials (10

ml) with crimped nasal spray assembly.

Ingredients

-

Active

Ingredient:

each

spray

contains

Beclomethasone

Dipropionate

micrograms.

-Inactive

ingredients:

Avicel

(microcrystalline

cellulose,

sodium

carboxymethylcellulose),

dextrose,

polysorbate

purified

water,

benzalkonium

chloride

phenylethyl

alcohol.

-MAL Number

:

MAL20013987AZ

Manufacturer

Cipla Ltd.

Verna Industrial Estate,

Goa, 403 722

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

14/08/2017

Serial Number

NPRA(R4/1)010817/00187

Consumer Medication Information Leaflet (RiMUP)

BECLATE AQUANASE NASAL SPRAY

Beclomethasone dipropionate (50mcg/spray)

3

Instructions for use

Parts of Beclate Aquanase

Before using

Shake the bottle gently, then remove the

dust cap.

Hold

bottle

shown

with

your

forefinger and middle finger on either side

of the nozzle and your thumb underneath

the bottle.

Before using your Beclate Aquanase for

the first time, or if you have not used it for

a period of time, follow the instructions

given below.

With

nozzle

pointing

away from you, press several times as

shown until a fine uniform mist comes out

of the nozzle.

Blow your nose gently.

Close one nostril and put the nozzle in

the other nostril as shown. Tilt your head

slightly forward keeping the nozzle in the

upright position.

Start to breathe in through your nose and

while breathing in press down with your

fingers once to release a spray.

Breathe out through your mouth. Repeat

steps 6 and 7 to inhale a second spray

Repeat steps 5, 6 and 7 for the other

nostril

After use:

Wipe the nozzle with a clean cloth and

replace the dust cap.

Note:

The first time you use

Beclate

Aquanase,

you may sneeze a few times. This is

because the lining of your nose is very

sensitive. This is not likely to happen after

the first few doses.

Cleansing

Your Beclate Aquanase should be cleaned

at least once a week.

To do this:

Push the nozzle upwards to detach from

the bottle.

Wash the nozzle and dust cap in warm

water. Shake off excess water and leave to

dry in a warm place. Avoid excessive heat.

Replace the nozzle and dust cap.

If the nozzle becomes blocked remove as

above and soak in warm water. Rinse under

a cold tap. Allow to dry and refit.

Do not use a pin or other sharp object to

unblock the nozzle.