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PACKAGE LEAFLET INFORMATION FOR USER

PREVENTER

^Beco^|ex® ^Mo^du^|ite® ⁵⁰ mⁱcro^grams ^per ac^tua^tion ^pressurⁱse^{d i}n^ha^|a^tion scHuhon ^Beco^|ex® ^Mo^du^|ite® ¹⁰⁰ mⁱcro^grams ^per ac^tua^tion ^pressurⁱse^{d i}n^ha^|a^tion so^|u^tion ^Beco^|ex® ^Mo^du^|ite® ²⁰⁰ mⁱcro^grams ^per actuation ^pressurⁱse^{d i}n^ha^|a^tion so^|u^tion ^Beco^|ex® ^Mo^du^|ite® ²⁵⁰ mⁱcro^grams ^per ac^tua^tion pressurised ⁱn^ha^|a^tion so^|u^tion

^bec^|ome^tasone ^dipro^piona^te

Read all of tMs leaflet carefully ^be^fore you start usin^g ttiis medicine.

-    ^Keep toto lea^fle^t. ^You ma^y need ^to read tt again.

-    ^{|f y}ou ^have an^{y f}ur^ther ^ques^tions^, as^{k y}our ^doc^tor^, or ^pharmacⁱs^t.

-    ^This me^dicⁱne ^has been ^prescribe^{d f}or ^you. ^Do no^{t p}ass ^it on ^to o^thers. ^|t ma^{y h}arm them even ^if theⁱr s^ym^ptoms are ^the same as ^yours.

-    ^If an^y o^{f th}e s^ide e^ffec^ts ^become serⁱous^, or^{if y}ou notice an^y s^ide e^ffec^ts no^t Nste^{d i}n ^this ^|ea^f|e^{t, pl}ease teN ^your ^doc^tor or ^pharmacⁱs^t.

In ^this lea^fle^t:

1.    Wha^t Becotex ^Mo^duNte is an^d wha^t i^t is use^{d f}or

².    ^Be^fore ^you use ^Beco^lex ^Mo^du^lite

3.    How ^to use ^Beco^lex IMo^Mte

⁴.    Poss^ible s^ide e^ffec^ts

⁵.    ^How ^to s^tore ^Beco^lex IMo^Mte

6.    Furt^her ⁱn^forma^tion

¹.    ^Wha^{t B}eco^lex ^Mo^du^lite ⁱs an^d w^ ^{it i}s use^{d f}or

^Beco^lex Mo^du^lite ^pressurⁱse^{d i}n^ha^la^tion so^lu^tion ⁱs use^{d t}o ^he^{lp p}revent ^the s^ym^ptoms o^f m^i|d, mo^dera^te or severe as^thma. ^The ac^tive ⁱn^gre^dien^t, tedometosone ^dipro^piona^te^{, i}s one o^f a ^grou^p o^f me^dicⁱnes ca^lle^d cor^ticos^tero^ids wNc^h are o^ften re^ferre^{d t}o sⁱm^ply as s^tero^ids. ^Stero^ids ^have an antiⁱnflamma^tory ac^tion re^ducⁱn^{g th}e swe^llin^g an^{d i}rr^ita^tion ⁱn ^the wa^lls o^{f th}e sma^|| am ^passa^ges ⁱn ^the ^|un^gs^, an^d so ease ^brea^thin^{g p}ro^blems.

².    ^Be^fore ^you use ^Beco^lex ^Mo^du^lite

Do no^t use ^Beco^lex ^Mo^duMte:

•    ^{if y}ou are a^ller^gic ^to an^y o^{f th}e to^edento o^{f thi}s me^dicⁱne or to an^y o^ther me^dicⁱnes use^d to

treat asthma.

•    to ^trea^t a su^dden attack o^{f b}reat^hlessness. ^|t wN¹ no^{t h}e^lp. ^Use a ciuto^actinig ‘re^liever' ⁱn^ha^ler ^for ^this ^pur^pose an^d carr^{y it} w^{ith y}ou a^t a^{|| ti}mes.

^Ta^ke s^pecⁱa^l care w^{ith B}eco^lex ^Mo^du^lite an^d always ^te^{|| y}our ^doctor ^if:

•    ^you are ^beⁱn^g, or ^have ever ^been^{, t}rea^te^{d f}or ^tu^bercu^losⁱs (^TB).

•    ^you mus^t avo^id a^lco^ho^{l f}or an^y reason.

•    ^your as^thma seems to ^be ^ge^ttin^g worse. ^per^ha^ps ^you are more w^heez^y an^d stert o^{f b}rea^th than usua^{|, y}our ‘re^liever' ⁱn^ha^ler seems ^to ^be toss ef^fec^tive^{, y}ou re^quⁱre more ^puffs ^from ^your ‘re^liever' ⁱn^ha^ler toan usua^|, or ^you ^do no^t seem ^to ^be ^ge^ttin^g tetter.

^Your ^doc^tor ma^y nee^d to mcrease ^the ^dose o^{f y}our s^tero^{id i}n^ha^ler or ^give ^you a course o^f s^tero^{id t}a^b|e^ts^, or c^han^ge ^your ^trea^tmen^t atto^ge^ther. ^{|f y}ou ^have an tofedton ⁱn ^your c^hes^{t y}our ^doctor ma^{y p}rescr^ibe a course o^f an^tibio^tics.

•    w^hen ^trans^ferrⁱn^{g f}rom s^tero^{id t}a^ble^ts ^to an totetor ^you ^fin^{d th}a^t, even ^{if y}our c^hes^{t i}s ^ge^ttin^g tetter ^you ^fee^{l g}enera^lly unwe^{||, y}ou ^deve^lo^p a ras^h, eczema ora runn^y nose an^d sneezⁱn^g (totottto). ^Do no^t s^to^p trea^tmen^t wtt^{h y}our ⁱn^ha^ler un^less ^your tector ^te^lls ^you ^to.

^{|f y}ou ^have ^been ^trea^te^{d f}or a ton^{g t}ime w^{ith high d}oses o^{f i}n^ha^le^d s^tero^{id, y}ou ma^y re^quⁱre a course o^f steroto ^ta^ble^ts or ^poss^ibly a steroto ⁱnjec^tion ⁱn ^times o^f sttess. ^For exam^p|e^{, d}urⁱn^g a^dmⁱssⁱon to ^hos^pita^l a^fter a serⁱous acctoenb ^be^fore an o^pera^tion^{, d}urⁱn^g an acute attac^k o^f as^thma or^{if y}ou ^have a c^hes^{t i}n^fec^tion or o^ther serⁱous Ntoess. Your ^doc^tor w^{i|| d}ec^ide ^{if y}ou nee^d an^y ex^tra steroto toeateed an^d w^i|| a^lso a^dvtoe ^you as ^to ^how ton^{g y}ou nee^{d t}o ^ta^ke toe course o^f s^tero^{id t}a^ble^ts an^{d h}ow ^you s^hou^ld re^duce toese as ^you ^ge^{t b}e^tter.

^{|f y}ou are usⁱn^{g B}eco^lex ^Mo^duNte ⁱns^tea^d o^f, or as weN as ^ta^kin^g s^tero^{id t}a^b|e^ts^, or^{if y}our ^doc^tor ⁱs ^tr^yin^{g t}o re^duce ^the ^dose o^{f y}our s^tero^{id t}a^b|e^ts^{, y}ou steuto carr^y a s^tero^id warnⁱn^g car^d un^{til y}our ^doc^tor ^te^lls ^you ^tha^{t y}ou ^don'^t nee^d to.

^Ta^kin^g ot^her me^dicⁱnes:

^Be^fore sterttn^{g t}rea^tmen^{t, pl}ease ^te^{|| y}our tector or ^pharmacⁱs^{t if y}ou are ^ta^kin^g or ^have recen^tly toten an^y o^ther me^dicⁱnes^{, i}nc^lu^din^g me^didnes o^btaⁱne^d w^ithou^t a ^prescr^iption. ^Rememt>er ^to ^ta^ke ^these me^dicⁱnes an^{d y}our ⁱn^ha^lers w^{ith y}ou ^{if y}ou ^have ^to ^go toto ^hos^pita^l.

^pre^gnanc^y an^{d b}reast-^fee^din^g:

^{|f y}ou are ^pre^gnan^t or teeasttfeedn^ or cou^{ld b}ecome ^pre^gnan^t, toto to ^your ^doc^tor ^be^fore usto^{g y}our ⁱn^ha^ler.

Important information about some of the ingredients of Becolex:

Becolex Modulite contains a small amount of alcohol. Each actuation (puff) from your inhaler contains about 9 mg of ethanol. 3. How to use Becolex Modulite

Becolex Modulite is available in 4 different strengths. Your doctor will have decided which strength you need. Becolex Modulite 200 and Becolex Modulite 250 are not suitable for children.

Always use your inhaler exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Instructions for using your inhaler are given after the dosage section.

It takes a few days for your inhaler to work. 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. Do not stop using your inhaler abruptly.

While you are using Becolex Modulite your doctor will want to check your asthma regularly by carrying out simple breathing tests and may need to carry out blood tests from time to time.

Dosage:

The starting dose will depend on how severe your asthma is and will be decided by your doctor.

It may be higher than the doses given below. Your doctor will prescribe the lowest dose of Becolex Modulite that will control your symptoms.

A device called a Volumatic spacer should always be used when:

•    adults, the elderly and adolescents 16 years of age and older are taking total daily doses of Becolex Modulite of 1,000 micrograms or more,

•    when Becolex Modulite is used in children and adolescents 15 years of age and under whatever dose has been prescribed.

Becolex Modulite 50 micrograms

The common starting dose is:

Adults and the elderly: 200 micrograms (4 puffs) twice a day Children:    100 micrograms (2 puffs) twice a day

Usually the most you would take in a day is:

Adults and the elderly: 800 micrograms (16 puffs) Children:    400 micrograms (8 puffs)

The total daily dose may be divided into two, three or four doses per day.

Becolex Modulite 100 micrograms

The common starting dose is:

Adults and the elderly: 200 micrograms (2 puffs) twice a day Children:    100 micrograms (one puff) twice a day

Usually the most you would take in a day is:

Adults and the elderly:    800 micrograms (8 puffs)

Children:    400 micrograms (4 puffs)

The total daily dose may be divided into two, three or four doses per day.

Becolex Modulite 200 micrograms

The common starting dose is:

Adults and the elderly only: 200 micrograms (one puff) twice a day

Usually the most you would take in a day is: 800 micrograms (4 puffs)

The total daily dose may be divided into two, three or four doses per day. This product strength is not suitable for children

Becolex Modulite 250 micrograms

The common starting dose is:

Adults and the elderly only: 500 micrograms (2 puffs) twice a day

Usually the most you would take in a day is: 2,000 micrograms (8 puffs)

The total daily dose may be divided into two, three or four doses per day. This product strength is not suitable for children

It takes a few days for this medicine to work. 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. Do not stop using your inhaler abruptly.

If you use more Becolex Modulite than you should:

Tell your doctor as soon as possible. Your doctor may want to check the cortisol levels in your blood and therefore, may need to take a blood sample (cortisol is a steroid hormone which occurs naturally in the body).

It is important that you take your dose as stated on the pharmacist's label or as advised by your doctor. You should not increase or decrease your dose without seeking medical advice.

If you forget to use Becolex Modulite:

If you forget to take your Becolex Modulite, miss out your forgotten dose and take the next dose when it is due. Do not take more puffs than you were told to take.

Please read back of this leaflet

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Instructions for use:

It is important that you know how to use your inhaler properly. Your doctor, nurse or pharmacist will show you how to use your inhaler correctly and will check regularly that you are using your inhaler correctly. You must follow their instructions carefully, so that you know how, when and how many [3uffs to inhale and how often you must use your inhaler. The instructions should be on the pharmacist's label and are given in this leaflet. If you ares not sure what to do or have problems inhaling then ask youe doctof, nursn or pharmacist nor advicn.

1. To remove thu mouthpiece cover, hold between thu thumb and forefinger, nquuuzu gently and pull apart an shown. Check innidu and outnidu to make nure that the mouthpiucais olean, and that there are no foreign objectn.

Testing Your Inhaler: If the inhaler in new or if it haonot been unud for three dayn or more, one puff ohould au ruluanud into the air to make nure that it workn.

2.    Hold thu inhaler upright an nhown, with your thumb on thu bane, below thu mouthpiece.

Brea thu o ut an far an in comfortable.

3.    Place thu mouthpiece in your mouth between your teeth and clone your lipn around it but do not bite it

4. Junt after starting to breathe in through your mouth prunn dawn on thu top of thu inhaler to ruleanu a puff while ntill breathing in ntuadily and deeply.

5. Hold yaur breath; take thu iuha ler from your mouth and your wing ur orom the top of thu inhaler. Continue hctlding your breath for a few nucondn or an long an in comfortable. Breathe out nlowly.

6.    If you nre to take another puff, keep thu inhaler upright and wait about half a minute before repeating ntupn 2 to 5.

7.    After unu alwayn replace thu mouthpiece cover to keep out dunt and fluff. Replace firmly and snap into uosition.

Important: Do not rush steps 2, 3, 4 and 5.

It in importaut that youstart to Urea thu in an nlowly un poanible junt before operating thu inhaler. Practice in front of a mieror for thu firnt few timun.

If you see ‘mist’ coming from the top of the inhaler or the sides of your mouth, Becolex will not get into your lungs as it should. Take another puff, carefully following the instructions from Step 2 onwards.

People with weak handn or children may find it uaniur to hold thu inhaler with both handn. Put thu two forefingurn on top of thu inhaler and both thembn on the bottom below thu mouthpiece.

If you find it difficuft to operate the mhaler while starting te breathe in you may use the Volumatic spacer device. Ask your doctor, pharmacist or a ourse about this device.

However, thu Volumaticspacer device munt alwayn tie unud if:

•    you are an adult, elderly or an adoluncunt l6 yearn of age and older and are taking total daily donun of Becolex Modulitu of 1,000 microgramn or more,

•    Becolex Modulitu in unud in children and adoluncuntn 15 yearn of age and younger, whatever done han been pruncribud.

Young children may find it difficult to unu thu inhaler properly and will require help. Uning thu inhaler with thu Volumatic npacur device with a face mank may help in children under 5 yearn. Tell your doctor, nurse or pharmacist if you have any difficulties.

Cleaning:

It in important to clean your inhaler at leant once a week, to ntop it blocking up.

•    Pull tile metal canintur out of thu plantic cane of thu inhaler and remove thu mouthpiece cover.

•    Rinnu the plantic oanu and thu mouthpiece cover in warm weter. If you unu a mild liquid detprgent, rinnu (^rafally with clean water be fore drying. Do not putthe metal canintur into water.

•    Leave to dry thoroughly in a warmplacel Avoid uxcunnivu heat.

• Reylacu the caninter and moutnpiuce cover.

It in important that you alno read thu Package leaflet which in nuppliud with your Volumatic npacur device and that you follow thu inntructionn on how to unu thu Volumatic and on how to clean it, carefully.

4. Possible; side effects

Like all mediciann, Becolex Modulitu can cauee nidu effectn, although not eaernbodn getnthum.

If you nooice an tmmediate iacrease in whdezing, shortness of breath and cough straight after using your inhaler, stop uning Becolex Modulitu and unu a quick-acting ‘reliever' inhaler immediately. Contact your doctor ntraightaway. Your doctor will review your anthma and may change your treatment and may pruncribu a different inhaler to treat your anthma.

The following side effects have been reported. Tell your doctor as soon as possible if you suffer from any of these side effects but do not stop treatment unless told to do so. Your doctor will try to prevent these effects by prescribing Becolex Modulite in the lowest dose possible to control your asthma.

• Allergic reactions including skin rashes, hives, itching or redness, or swelling of the face, eyes, lips and throat.

• Thrush in the mouth and throat. This is more likely if the daily dose taken is greater than 400 micrograms. Thrush can be treated with anti-fungal medicines whilst you continue to use Becolex Modulite. Brushing your teeth, or throughly rinsing your mouth with water immediately after each dose may help prevent thrush.

• Hoarse voice or a sore throat or tongue. Using a Volumatic spacer device or rinsing your mouth with water immediately after using your inhaler may help prevent this.

• Changes to the normal production of the steriods in the body, particularly after treatment with Becolex Modulite at high doses over a long period oftime.

• If you become unwell or develop symptoms such as loss of appetite, abdominal pain, weight loss, tiredness, nausea (feeling sick), vomiting (being sick), feeling faint, sweating and possible convulsions (fits), you should consult your doctor. This is particularly important if you have been exposed to stress such as surgery, infection, an acute attack of asthma, or other serious illness.

Your doctor may carry out blood test from time to time to monitor the levels of steroids in your body.

• Children and adolescents may grow more slowly and may need to have their height checked regularly by their doctor. This occurs particularly after treatment with Becolex Modulite at high doses over a long period of time.

• A decrease in bone mineral density (thinning and weakening of the bones) and eye problems which include the formation of cataracts and glaucoma (increased pressure in the eye).

•    Sleeping problems, depression or feeling worried, restless, nervous, over-excited or irritable. These effects are more likely to occur in children.

•    Headaches

•    Nausea (feeling sick)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. Howto store Becolex Modulite

•    Keep out of the sight and reach of children.

•    Do not use Becolex Modulite after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month.

•    Do not store the inhaler above 30^oC. Protect from frost and direct sunlight.

•    If the inhaler gets very cold, take the metal canister out of the plastic case and warm it in your hands for a few minutes before use. Never use anything else to warm it up.

•    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.

Warning: The canister contains a pressurised liquid. Keep away from heat and direct sunlight, do not expose to high temperatures (above 50°C) and do not puncture or burn (incinerate), even when empty.

6. Further information

What Becolex Modulite contains

The active substance of your inhaler is beclometasone dipropionate. Each puff contains 50, 100, 200 or 250 micrograms of beclometasone dipropionate.

The other ingredients are glycerol, ethanol and the CFC-free propellant norflurane (HFA-134a).

To help protect the environment, the inhaler contains the CFC-free propellant HFA-134a, which replaces completely the chlorofluorocarbon (CFC) propellants and appears to have a less damaging effect on the ozone layer. The only differences you might notice from your previous CFC-containing inhaler are the taste and the feel of the spray in your mouth.

What Becolex Modulite looks like and content of the pack

Becolex Modulite is a pressurised inhalation solution contained in an aluminum can with plastic actuator and protective cap. Each canister contains 200 puffs.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder of Becolex Modulite is Chiesi Limited, 333 Styal Road, Manchester,

M22 5LG, United Kingdom.

The manufacturer of Becolex Modulite is Chiesi Farmaceutici S.p.A., 26/A Via Palermo,

43122 Parma, Italy.

Is this leaflet hard to see or read?

Phone 0161 488 5555 for help.

The leaflet was last revised in 07/2015

Volumatic is a registered trademark of the GlaxoSmithKline Group of Companies.

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