Alanase 100

Main information

  • Trade name:
  • Alanase 100 100 mcg/dose Nasal spray solution
  • Dosage:
  • 100 mcg/dose
  • Pharmaceutical form:
  • Nasal spray solution
  • Units in package:
  • Spray bottle, metered, 1 x 200 metered doses, 200 dose units
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Farmabios SpA

Documents

Localization

  • Available in:
  • Alanase 100 100 mcg/dose Nasal spray solution
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • ALANASE 100 Aqueous Nasal Spray (100 µg per actuation) is indicated for the prevention and treatment of seasonal and perennial allergic rhinitis and vasomotor rhinitis. ALANASE 100 can significantly delay the recurrence of nasal polyps in those patients who have undergone nasal polypectomy. In those polyps that do recur, ALANASE 100 can suppress their increase in size.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 4630
  • Authorization date:
  • 14-02-1992
  • 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 100

100 microgram (µg) per spray

Beclometasone dipropionate Nasal Spray

What is in this leaflet

This leaflet answers some common

questions about Alanase 100.

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 has weighed

the risks of you using Alanase 100

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 100 is

used for

Alanase 100 contains 100

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 100 is normally used to

prevent and treat seasonal and

perennial allergic rhinitis (including

hayfever) and vasomotor rhinitis. 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.

Alanase 100 may also be used to

delay the recurrence of nasal polyps

in patients who have undergone

nasal polypectomy. It can suppress

the increase in size of the polyps

that do recur.

Your doctor, however, may

prescribe Alanase 100 for another

purpose. Alanase 100 is only

available on prescription from your

doctor.

There is no evidence that Alanase

100 is addictive.

Before you use

Alanase 100

When you must not use

it

Do not use Alanase 100 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.

Before you start to use it

Tell your doctor 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 if you are

pregnant or plan to become

pregnant or are breast-feeding.

Your doctor can discuss with you

the risks and benefits involved.

If you have not told your doctor

about any of the above, tell

him/her before you start using

Alanase 100.

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 100

with other medicines.

How to use Alanase

100

Follow all directions given to you

by your doctor or pharmacist

carefully.

Page 2 of 3

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

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 on the

white collar. 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 take your

dose as stated on the

pharmacist’s label or as advised

by your doctor. You should use

only as much as your doctor

recommends; using more or less

may make your symptoms worse.

The usual dosage for adults and

children over 6 years of age is one

spray into each nostril twice daily

(morning and night).

Your doctor may tell you to use a

different dosage to this. If so, follow

their instructions.

Do 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 100 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.

Continuous long term treatment of

children is not recommended.

Do not use Alanase 100 for more

than 6 months unless instructed by

your doctor.

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

take 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 100. Do

this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

While you are using

Alanase 100

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 100.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are using Alanase 100.

If you become pregnant while

using Alanase 100, tell your

doctor immediately.

Things you must not do

Do not use Alanase 100 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 100.

Alanase 100 helps most people

with rhinitis, 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 100,

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 100

(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

100

Storage

Keep Alanase 100 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 100 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 100 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 100 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 100 contains 100

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: (09) 579 2792

Date of Information

16 June 2015

(Based on datasheet dated 16 June

2015).

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Therapeutic Goods Administration - Australia

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

12-6-2018

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Teer, nicotine en koolmonoxide gehalten in sigaretten die gemeten worden volgens de Canadian Intense (CI) methode zijn minimaal twee keer zo hoog als de gehalten gemeten met de wettelijke voorgeschreven ISO methode waarmee de EU en dus ook Nederland werkt. In sommige gevallen liggen de gehaltes zelfs tot meer dan 20 keer hoger. Dat blijkt uit onderzoek van het RIVM, dat 100 sigaretten onder de loep nam. Staatssecretaris Paul Blokhuis (VWS) heeft als opdrachtgever het onderzoek vandaag in ontvangst genome...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

3-5-2018

CVM eSubmitter Webinar 1 Agenda

CVM eSubmitter Webinar 1 Agenda

CVM will host the first of a three-part webinar series to provide information on the use of CVM’s electronic submission tool, eSubmitter, in the new animal drug application approval process. These webinars will support the use of eSubmitter as we move to 100% electronic submission.

FDA - U.S. Food and Drug Administration

28-2-2018

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim Capsules pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

8-9-2017

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector. The Agency is looking for a candidate who is willing and able to work on demanding and interesting tasks, including travels in Iceland and abroad on behalf of the Agency. The vacancy is a full post (100%).

IMA - Icelandic Medicines Agency

3-7-2017

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Agency advertises two vacancies for experts in its Quality Assessment Team. The Agency is looking for strong candidates who are willing to work on challenging and interesting tasks. Each vacancy is a full position (100%). Application deadline is up to and including 16 July 2017.

IMA - Icelandic Medicines Agency

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

12-12-2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

TGO 100 has been registered on the Federal Register of Legislation. It commences on 8 December 2018, repealing and replacing TGO 98

Therapeutic Goods Administration - Australia

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

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Active substance: Propagermanium) - Orphan designation - Commission Decision (2018)7810 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/103/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

19-9-2018

Kadcyla (Roche Registration GmbH)

Kadcyla (Roche Registration GmbH)

Kadcyla (Active substance: Trastuzumab emtansine) - Centralised - Renewal - Commission Decision (2018)6100 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2389/R/39

Europe -DG Health and Food Safety

23-8-2018

 Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Europe - EMA - European Medicines Agency

27-6-2018

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Active substance: pantoprazole) - PSUSA - Modification - Commission Decision (2018)4105 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1100/PSUSA/2285/201708

Europe -DG Health and Food Safety

6-6-2018

Agenda:  Agenda for the 100th meeting of the Management Board

Agenda: Agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

5-6-2018

Agenda:  Draft agenda for the 100th meeting of the Management Board

Agenda: Draft agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

24-5-2018

Tybost (Gilead Sciences International Limited)

Tybost (Gilead Sciences International Limited)

Tybost (Active substance: cobicistat) - PSUSA - Modification - Commission Decision (2018)3255 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10081/201708

Europe -DG Health and Food Safety

24-5-2018

Stribild (Gilead Sciences International Limited)

Stribild (Gilead Sciences International Limited)

Stribild (Active substance: elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (as fumarate)) - PSUSA - Modification - Commission Decision (2018)3277 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2574/PSUSA/10082/201708

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Active substance: 4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid) - Transfer of orphan designation - Commission Decision (2018)3149 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/14/T/01

Europe -DG Health and Food Safety

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