Alanase

Main information

  • Trade name:
  • Alanase 50 mcg/dose Nasal spray solution
  • Dosage:
  • 50 mcg/dose
  • Pharmaceutical form:
  • Nasal spray solution
  • Units in package:
  • Spray bottle, metered, 1 x 200 metered doses, 200 dose units
  • Class:
  • Pharmacy only
  • Prescription type:
  • Pharmacy only
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Farmabios SpA

Documents

Localization

  • Available in:
  • Alanase 50 mcg/dose Nasal spray solution
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • For the short term prevention and treatment of seasonal allergic rhinitis (hay fever).

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 4629
  • Authorization date:
  • 09-07-1991
  • Last update:
  • 27-09-2017

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

Page 1 of 3

NEW ZEALAND CONSUMER MEDICINE INFORMATION

ALANASE

50 microgram (µg) per spray

Beclometasone dipropionate Nasal Spray

What is in this leaflet

This leaflet answers some common

questions about Alanase.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor or pharmacist

has weighed the risks of you using

Alanase against the benefits they

expect it will have for you.

If you have any concerns about

using this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the

medicine. You may need to read it

again.

What Alanase is

used for

Alanase contains 50 micrograms

(µg) of beclometasone dipropionate

per spray.

It belongs to a group of medicines

known as corticosteroids, frequently

referred to as ‘steroids’. They are

not ‘anabolic steroids’ that are

sometimes misused by athletes.

Alanase is normally used to prevent

and treat seasonal allergic rhinitis

(hayfever). It works by reducing the

swelling and irritation in the lining of

the nose. It relieves the symptoms

of blocked nose, runny nose, itchy

nose and sneezing.

Your doctor or pharmacist,

however, may recommend Alanase

for another purpose.

Alanase is available at a pharmacy.

There is no evidence that Alanase

is addictive.

Before you use

Alanase

When you must not use

it

Do not use Alanase if you have

an allergy to:

any medicine containing

beclometasone

any of the ingredients listed

at the end of this leaflet.

Some of the symptoms of an

allergic reaction may include:

shortness of breath; wheezing or

difficulty breathing; swelling of the

face, lips, tongue or other parts of

the body; rash, itching or hives on

the skin.

Do not use this medicine after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

If it has expired or is damaged,

return it to your pharmacist for

disposal.

If you are not sure whether you

should start using this medicine,

talk to your doctor or pharmacist.

Before you start to use it

Tell your doctor or pharmacist if

you:

have allergies to any other

medicines, foods,

preservatives or dyes

are already taking another

steroid product e.g. tablets,

asthma or nasal inhaler or

eye/nose drops

have had to stop taking

another medicine for your

hayfever

have recently had an injury

or surgery to your nose

have a nasal or sinus

infection

have ulceration in your

nose

bleed easily or get frequent

nose bleeds.

Tell your doctor or pharmacist if

you are pregnant or plan to

become pregnant or are breast-

feeding.

Your doctor or pharmacist can

discuss with you the risks and

benefits involved.

If you have not told your doctor

or pharmacist about any of the

above, tell him/her before you

start using Alanase.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines may affect the way

other medicines work. Your doctor

or pharmacist will be able to tell you

what to do when using Alanase with

other medicines.

How to use Alanase

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the information

contained in this leaflet.

If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

Instructions for use

Page 2 of 3

1. Shake the bottle well before use.

Remove the dust cap from the

nasal applicator.

2. Hold the nasal spray as shown.

Prime the pump by firmly

pressing downwards on the

white collar. Repeat until a fine

spray is produced. The nasal

spray is now ready for use. It

will not require repriming unless

infrequently used or

disassembled.

3. Gently blow your nose to clear

the nostrils. Tilt your head

forward slightly, close one nostril

and carefully insert the nasal

applicator into the other nostril.

4. Holding the bottle upright, press

firmly downwards once or twice

on the white collar to deliver the

number of sprays required.

Breathe gently inwards through

the nostril.

5. Then breathe out through your

mouth.

6. Repeat the procedure in the

other nostril.

7. Replace the dust cap.

Cleaning your applicator

Your nasal applicator should be

cleaned at least once a week, or

more often if it gets blocked. To

clean, remove the dust cap, press

gently upwards on the white collar

and the nasal applicator will come

free. Wash the applicator and dust

cap under lukewarm water. Dry and

replace.

If the nasal applicator becomes

blocked, remove the dust cap,

unscrew the pump mechanism from

the bottle and soak it in warm water

for a few minutes. Rinse under

lukewarm water, dry and

reassemble on the bottle. Do not

attempt to unblock the applicator

with a pin or other sharp object.

How much to use

It is important that you use

Alanase exactly as advised by

your doctor or pharmacist. Do

not use more than

recommended; using more or

less may make your symptoms

worse.

The usual dosage for adults and

children over 12 years of age is

initially one or two sprays into each

nostril twice daily (morning and

night), then after 2 to 3 days, one

spray into each nostril twice daily.

Do not use Alanase for children

under 12 years of age without first

consulting with a doctor.

Your doctor may tell you to use a

different dosage to this. If so, follow

their instructions.

You should not use more than

400 micrograms (µg) in a day.

You must use your spray for your

nose only. If you find it difficult to

use your spray, tell your doctor or

pharmacist.

Alanase should be shaken before

use.

Do not give this medicine to anyone

else, even if their symptoms seem

similar to yours.

How long to use it

It usually takes a few days for this

medicine to help your nasal

symptoms.

If you know you are going to be

allergic to, for example, pollen at a

particular time of the year, it is

helpful to start using your spray just

before your symptoms appear to

prevent them from starting.

If hayfever symptoms do not

improve within 7 days of treatment,

see your doctor.

Do not use Alanase for more than 6

months unless instructed by your

doctor or pharmacist.

If you forget a dose

If you forget a dose, just take the

next dose at the normal time. Do

not take a double dose. This may

increase the chance of you getting

an unwanted side effect.

If you are not sure what to do,

ask your doctor or pharmacist.

If you have trouble remembering to

use your medicine, ask your

pharmacist for some hints.

If you use too much

(overdose)

Immediately telephone your

doctor, pharmacist or the

National Poisons Information

Centre (0800 POISON or 0800 764

766) for advice, if you think that

you or anyone else may have

used too much Alanase. Do this

even if there are no signs of

discomfort or poisoning.

You may need medical attention.

While you are using

Alanase

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are using Alanase.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are using this medicine.

If you become pregnant while

using Alanase, tell your doctor

immediately.

Things you must not do

Do not use Alanase to treat any

other complaints unless your

doctor tells you to.

Page 3 of 3

Do not give your medicine to

anyone else, even if they have

the same condition as you.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not

feel well while you are using

Alanase.

Alanase helps most people with

seasonal allergic rhinitis

(hayfever), but it may have

unwanted side effects in a few

people. These effects are usually

mild and last only for a short

time. However sometimes they

are serious and may need

medical attention.

Do not be alarmed by the

following lists of side effects.

You may not experience any of

them.

You may sneeze a little immediately

after using your spray. You may

notice a taste or smell after using

your spray.

If your nose or throat becomes dry

and irritated or you have a

nosebleed after using your spray,

tell your doctor as soon as possible.

If you have red eyes or misty vision

and headache after using your

spray, tell your doctor immediately.

If you think you are having an

allergic reaction to Alanase, tell

your doctor immediately or go to

the Accident and Emergency

Department at your nearest

hospital. Symptoms usually

include some or all of the

following:

shortness of breath

wheezing or difficulty

breathing

swelling of the face, lips,

tongue or other parts of the

body

rash, itching or hives on the

skin.

Tell your doctor or pharmacist if

you notice anything that is

making you feel unwell.

Other side effects not listed above

may also occur in some people.

Studies have shown that active

ingredient in Alanase

(beclometasone dipropionate) when

taken through the nose for long

periods may affect how children

grow. In rare cases, some children

may be sensitive to the growth

effects of corticosteroids, so the

doctor may monitor a child's height.

Ask your doctor or pharmacist to

answer any questions you may

have.

After using Alanase

Storage

Keep Alanase in a place where

children cannot reach it.

A locked cupboard at least one-and-

a half metres above the ground is a

good place to store medicines.

Keep the bottle in an upright

position.

Keep your Alanase away from

direct sunlight and heat (store

below 25°C). Do not leave it in the

car on hot days.

Do not put your Alanase in the

refrigerator.

Once you have opened your

spray, you should not use this

particular bottle for more than

three months. Write down the

date that you opened the bottle

on the label or the box.

Disposal

If your doctor tells you to stop

using this medicine or the expiry

date has passed, ask your

pharmacist what to do with any

medicine that is left over.

Product description

Alanase comes in an amber glass

bottle fitted with a pump, and nasal

applicator. Each bottle provides

approximately 200 sprays, when

used as recommended.

Ingredients

Alanase contains 50 micrograms

(µg) of the active ingredient

beclometasone dipropionate per

spray.

It also contains:

polysorbate

dispersible cellulose

glucose (anhydrous)

purified water

benzalkonium chloride

(preservative)

phenethyl alcohol

(preservative).

This medicine does not contain

lactose, sucrose, gluten, tartrazine

or any other azo dyes.

If you want to know

more

Should you have any questions

regarding this product, please

contact your doctor or pharmacist.

Who supplies this

medicine

Distributed in New Zealand by:

Mylan New Zealand Ltd,

PO Box 11183,

Ellerslie,

Auckland.

Telephone: 0800 168 169

Date of Information

16 June 2015

(Based on datasheet dated 16 June

2015).

18-10-2018

Unauthorized "Surfaz-SN Triple Action Cream" seized from Mississauga store may pose serious health risks

Unauthorized "Surfaz-SN Triple Action Cream" seized from Mississauga store may pose serious health risks

Health Canada seized “Surfaz-SN Triple Action Cream”—an unauthorized skin cream promoted for antifungal, antibacterial and anti-inflammatory use—because it is labelled to contain prescription drugs (betamethasone dipropionate and neomycin sulphate). The product was seized from Kaf African Caribbean Market (2642 Liruma Road, Unit 2A) in Mississauga, Ontario.

Health Canada

1-8-2018

Unauthorized skin creams and lotions sold at various retailers in Quebec may pose serious health risks

Unauthorized skin creams and lotions sold at various retailers in Quebec may pose serious health risks

Health Canada seized eight unauthorized skin lotions and creams from Ayotai Canada because they are labelled to contain a prescription drug (clobetasol propionate or betamethasone dipropionate). The unauthorized lotions and creams were distributed by Ayotai and sold by various retailers in Quebec.

Health Canada

14-12-2018


Summary of opinion: Trimbow,beclometasone / formoterol / glycopyrronium bromide,  13/12/2018,  Positive

Summary of opinion: Trimbow,beclometasone / formoterol / glycopyrronium bromide, 13/12/2018, Positive

Summary of opinion: Trimbow,beclometasone / formoterol / glycopyrronium bromide, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Beclometasone dipropionate,formoterol fumarate dihydrate, decision type: , therapeutic area: , PIP number: P/0159/2018

Opinion/decision on a Paediatric investigation plan (PIP): Beclometasone dipropionate,formoterol fumarate dihydrate, decision type: , therapeutic area: , PIP number: P/0159/2018

Opinion/decision on a Paediatric investigation plan (PIP): Beclometasone dipropionate,formoterol fumarate dihydrate, decision type: , therapeutic area: , PIP number: P/0159/2018

Europe - EMA - European Medicines Agency

2-5-2018

Trydonis (Chiesi Farmaceutici S.p.A.)

Trydonis (Chiesi Farmaceutici S.p.A.)

Trydonis (Active substance: beclometasone / formoterol / glycopyrronium bromide) - Centralised - Authorisation - Commission Decision (2018)2713 of Wed, 02 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4702

Europe -DG Health and Food Safety

26-4-2018

Riarify (Chiesi Farmaceutici S.p.A.)

Riarify (Chiesi Farmaceutici S.p.A.)

Riarify (Active substance: beclometasone / formoterol / glycopyrronium bromide) - New authorisation - Commission Decision (2018)2581 of Thu, 26 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4836

Europe -DG Health and Food Safety