Important Information for the PatientsßrJVLPhr \jq kP~J\jL~ fgq

Before using your Aeronid® inhaler, please read this leaflet carefully andfollow these instructions to get the results you expect from this prescribedmedication.FqJPrJKjc® AjPyuJr mqmyJPrr IJPV IJkKj FA KulPuaKa kzMj FmÄ xfTtfJr xJPg FA mqmyJrKmKiIjMxre TÀjÇ FPf IJkKj nJu lu kJPmjÇ

What does it mean when we say “Aeronid® is CFC - FREE”?FqJPrJKjc® KxFlKx oMÜ muPf KT mM J~?

The CFC propellant that was once in Aeronid® inhaler has now beenreplaced with a more environment friendly 'non CFC' propellant, calledHFA.If you have used the old (CFC-containing) Aeronid®, you may notice adifference in the taste, and a softer feel of the 'puff'Even though you may feel that the puff is softer, the amount of Aeronid®

in each puff is the same as in the old CFC Aeronid®.KxFlKx kPkuqJ≤ pJ IJPV FqJPrJKjc® AjPyuJPr mqmyJr TrJ yf fJ FUj kKrPmv mJºm KxFlKxoMÜ kPkuqJ≤, FAY Fl F KhP~ kKf˙Jkj TrJ yP~PZÇpKh IJkKj kMrJfj (KxFlKx pMÜ) FqJPrJKjc® AjPyuJr mqmyJr TPr gJPTj fJyPu FaJ mqmyJr TrPu˝JPh KnjúfJ kJPmj FmÄ kJPl jro IjMnm yPmÇpKhS IJkKj Fr kJPl jro IjMnëKf kJPmj KT∂á ßp kKroJj SwMi kKf kJPl ßmr yPm fJ kMrJfj KxFlKxpMÜ AjPyuJPrr xoJjÇ

Prime your Aeronid® Inhaler

IJkjJr FqJPrJKjc®FAYFlF AjPyuJrKa kJAo TÀj

Aeronid® inhaler should be primed before using it for the first time. Youshould also prime your inhaler when the inhaler has not been used formore than 10 days.kgo mJr FqJPrJKjc® AjPyuJr mqmyJPrr xo~ IJkjJPT AjPyuJr kJAo TPr KjPf yPmÇ FojKT 10Khj mJ fJr ßYP~ ßmvL KmrKfPf AjPyuJr mqmyJr TrJ yPu FKaPT kJAo TPr ßj~J kP~J\jÇ

What do we mean by 'Priming' of the inhaler?AjPyuJr kJAo TrJ muPf KT mM J~?

When using your new inhaler for the first time or if it has not been used for10 days or more, you should prime your inhaler before use. This is knownas priming.AjPyuJr kgo mqmyJPrr xo~ IgmJ 10 Khj mJ Fr ßmvL KmrKfPf mqmyJPrr xo~ FKar krLãJoNuTmqmyJr kP~J\jÇ FPTA kJAo TrJ mPuÇ

How to prime the inhaler?KTnJPm kJAo TrPmj?

To prime simply release two actuations into the air away from your face.kJAo TrJr \jq TqJKjˆJrKaPT 2 mJr YJk Khj IgJt“ 2 Ka oJ©J mJfJPx KjÏíf TPr ßhUPf yPmÇ

Why priming of the inhaler is important?AjPyuJr kJAo TrJ kP~J\j ßTj?

Priming ensures that your inhaler delivers the correct dose. Once primed,your inhaler is ready to use and deliver the correct amount of medicine.kJAKoÄ IJkjJr AjPyuJrKa xKbTnJPm SwMi xrmrJy TPr KTjJ KjKÁf TPrÇ kJAo yS~Jr xJPg xJPgFaJ mqmyJr CkPpJVL yPm FmÄ xKbT oJ©J~ SwMi xrmrJy TrPf kJrPmÇ

Aeronid®

HFA Inhalation AerosolBudesonide BP

DescriptionBudesonide BP Inhaler is a corticosteroid designated that exhibits potent glucocorticoid activityand weak mineralocorticoid activity. Corticosteroids have been shown to have a wide range ofinhibitory activities against multiple cell types (e.g., mast cells, eosinophils, neutrophils,macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, andcytokines) involved in allergic and non-allergic-mediated inflammation. These anti-inflammatoryactions of budesonide contribute to their efficacy in asthma. Indications and UsageBudesonide Inhaler is indicated for the maintenance treatment of asthma as prophylactic therapyin adult and pediatric patients six years of age or older. It is also indicated for patients requiringoral corticosteroid therapy for asthma. Many of those patients may be able to reduce or eliminatetheir requirement for oral corticosteroids over time. Budesonide Inhaler is NOT indicated for therelief of acute bronchospasm. Dosage and administrationBudesonide Inhaler should be administered by the orally inhaled route in asthmatic patients age6 years and older. Individual patients will experience a variable onset and degree of symptomrelief. Generally, Budesonide Inhaler has a relatively rapid onset of action for an inhaledcorticosteroid. Improvement in asthma control following inhaled administration of BudesonideInhaler can occur within 24 hours of initiation of treatment, although maximum benefit may not beachieved for 1 to 2 weeks, or longer. The safety and efficacy of Budesonide Inhaler whenadministered in excess of recommended doses have not been established.The recommended starting dose and the highest recommended dose of Budesonide Inhaler,based on prior asthma therapy, are listed in the following table.

*In patients with mild to moderate asthma who are well controlled on inhaled corticosteroids,dosing with Budesonide Inhaler 200 mcg or 400 mcg once daily may be considered. BudesonideInhaler can be administered once daily either in the morning or in the evening. If the once-dailytreatment with Budesonide Inhaler does not provide adequate control of asthma symptoms, thetotal daily dose should be increased and/or administered as a divided dose. Patients Maintainedon Chronic Oral Corticosteroids. Initially, Budesonide Inhaler should be used concurrently with thepatient's usual maintenance dose of systemic corticosteroid. After approximately one week,gradual withdrawal of the systemic corticosteroid is started by reducing the daily or alternate dailydose. The next reduction is made after an interval of one or two weeks, depending on theresponse of the patient. Generally, these decrements should not exceed 2.5 mg of prednisone orits equivalent. A slow rate of withdrawal is strongly recommended. During reduction of oralcorticosteroids, patients should be carefully monitored for asthma instability, including objectivemeasures of airway function, and for adrenal insufficiency. During withdrawal, some patients mayexperience symptoms of systemic corticosteroid withdrawal, e.g., joint and/or muscular pain,lassitude and depression, despite maintenance or even improvement in pulmonary function. Suchpatients should be encouraged to continue with Budesonide Inhaler but should be monitored forobjective signs of adrenal insufficiency. If evidence of adrenal insufficiency occurs, the systemiccorticosteroid doses should be increased temporarily and thereafter withdrawal should continuemore slowly. During periods of stress or a severe asthma attack, transfer patients may requiresupplementary treatment with systemic corticosteroids.ContraindicationsBudesonide inhalation aerosol is contraindicated in the primary treatment of status asthmaticusor other acute episodes of asthma where intensive measures are required. Hypersensitivity tobudesonide contraindicates the use of Budesonide Inhaler.PrecautionsGeneral During withdrawal from oral corticosteroids, some patients may experience symptoms ofsystemically active corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and

Aeronid® is now CFC-Freeto help protect our environment more

kKrPmvPT IJPrJ nJunJPm rãJ TrJr \jqFqJPrJKjc® FUj KxFlKx oMÜ

Aeronid 240 mm x 188 mm FS

depression, despite maintenance or even improvement of respiratory function. BudesonideInhaler will often permit control of asthma symptoms with less suppression of HPA function thantherapeutically equivalent oral doses of prednisone. Since budesonide is absorbed into thecirculation and can be systemically active at higher doses, the full beneficial effects of BudesonideInhaler in minimizing HPA dysfunction may be expected only when recommended dosages arenot exceeded and individual patients are titrated to the lowest effective dose. Since individualsensitivity to effects on cortisol production exists, physicians should consider this informationwhen prescribing Aeronid Inhaler. Because of the possibility of systemic absorption of inhaledcorticosteroids, patients treated with these drugs should be observed carefully for any evidenceof systemic corticosteroid effects. Particular care should be taken in observing patientspostoperatively or during periods of stress for evidence of inadequate adrenal response. It ispossible that systemic corticosteroid effects such as hypercorticism and adrenal suppression mayappear in a small number of patients, particularly at higher doses. If such changes occur,Budesonide Inhaler should be reduced slowly, consistent with accepted procedures formanagement of asthma symptoms and for tapering of systemic steroids. A reduction of growthvelocity in children or teenagers may occur as a result of inadequate control of chronic diseasessuch as asthma or from use of corticosteroids for treatment. Physicians should closely follow thegrowth of all pediatric patients taking corticosteroids by any route and weigh the benefits ofcorticosteroid therapy and asthma control against the possibility of growth suppression. Althoughpatients in clinical trials have received Budesonide Inhaler on a continuous basis for periods of 1to 2 years, the long-term local and systemic effects of Budesonide Inhaler in human subjects arenot completely known. In particular, the effects resulting from chronic use of Budesonide Inhaleron developmental or immunological processes in the mouth, pharynx, trachea, and lung areunknown. In clinical trials with Budesonide Inhaler, localized infections with Candida albicansoccurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, itshould be treated with appropriate local or systemic (i.e., oral) antifungal therapy while stillcontinuing with Budesonide Inhaler therapy, but at times therapy with Budesonide Inhaler mayneed to be temporarily interrupted under close medical supervision. Inhaled corticosteroidsshould be used with caution, if at all, in patients with active or quiescent tuberculosis infection ofthe respiratory tract, untreated systemic fungal, bacterial, viral or parasitic infections; or ocularherpes simplex. Rare instances of glaucoma, increased intraocular pressure, and cataracts havebeen reported following the inhaled administration of corticosteroids.Side EffectsThe following adverse reactions were reported in patients treated with Budesonide Inhaler. Body as a Whole: Headache, flu syndrome, pain, back pain, fever, neck pain, asthenia;Respiratory System: Respiratory infection, pharyngitis, sinusitis, rhinitis, voice alteration, coughaggravation; Digestive System: Oral candidiasis, dyspepsia, gastroenteritis, nausea, abdominalpain, dry mouth, vomiting; Cardiovascular: syncope; Metabolic and Nutritional: weight gain;Musculoskeletal: fracture, myalgia; Nervous: hypertonia, migraine; Platelet, Bleeding andClotting: ecchymosis; Psychiatric: insomnia; Resistance Mechanisms: infection; Special Senses:taste perversion; Musculoskeletal: arthralgia. Pediatric Studies: There were no clinically relevantdifferences in the pattern or severity of adverse events in children compared with those reportedin adults. Adverse Event Reports From Other Sources: Rare adverse events reported include:immediate and delayed hypersensitivity reactions including rash, contact dermatitis, urticaria,angioedema and bronchospasm; symptoms of hypocorticism and hypercorticism; psychiatricsymptoms including depression, aggressive reactions, irritability, anxiety and psychosis.Pharmaceutical PrecautionsPressurised canister, do not puncture, break or incinerate even when apparently empty. Avoidstorage in direct sunlight or heat. Store below 30oC. Keep away from eyes. Keep away fromchildren.Commercial PackAeronid® : Each canister contains 200 metered doses for inhalation aerosol with each actuation(Puff) containing 200 mcg of Budesonide BP.

Manufactured by

BEXIMCO PHARMACEUTICALS LTD.Tongi, Bangladesh 5000096 230408

® Aeronid is a registered trademark of Beximco Pharmaceuticals Ltd.

PTG-3836/11-06/60,000ARK

A handy tip for Children

Aeronid 240 mm x 188 mm FS

4. Raise the Inhaler to your mouth. Put the mouthpiecebetween your teeth, but do not bite it. Close your lips aroundthe mouthpiece. Breathe out slowly and gently through theInhaler until your lungs feel comfortably empty. 4. AjPyuJrKa oMPUr oPiq rJUPf yPmÇ AjPyuJPrr Kj:xreÆJr oMPUr oPiq hJÅPfrlJÅPT ˙Jkj TrPf yPm KT∂á TJozJPjJ pJPm jJÇ FqJTYMP~aPrr oMU KjP\r ßbJÅa KhP~FojnJPm iÀj ßpj ßTJj lJÅT jJ gJPT, If:kr oMU KhP~ iLPr iLPr mJfJx ßmr TPrKhPf yPm pfãj jJ IJkjJr láxláxKa UJKu y~Ç

5. Tilt your head back slightly. Start to breathe in slowlythrough your mouth. As you start to breathe in, press downfirmly on the top of the can to release your medicinecontinue to breathe in steadily and deeply.5. oJgJ xJoJjq ßkZj KhPT ßyuJPf yPmÇ oMU KhP~ iLPr iLPr võJx Vye TrPf yPmFmÄ FTA xoP~ TqJKjˆJrKaPT YJk KhPf yPmÇ FnJPm iLPr iLPr VnLrnJPm võJxßj~Jr xo~ FTKa oJ©J KjPf yPmÇ

6. Hold your breath. Remove the inhaler from your mouth.Continue to hold your breath as long as possible, up to 10seconds. Then breathe out gently. If you are taking a secondpuff, wait about one minute, then repeat steps 3 to 6.6. võJx iPr rJUPf yPmÇ AjPyuJrKaPT oMU ßgPT xKrP~ ßluPf yPmÇ 10 ßxPT¥IgmJ pfãj x÷m võJx iPr rJUPf yPmÇ If:kr iLPr iLPr võJx ZJzPf yPmÇ pKhFTJKiT oJ©J VyPer hrTJr y~ fPm TokPã 1 KoKja IPkãJ TrJr kr kMPrJk≠KfKa kMjrJmOK• TrPf yPmÇ

7. Replace the mouthpiece cap after each use 7. mqmyJPrr kr TnJrKa FqJTYMP~aPrr oMPUr xKbT \J~VJ~ ˙Jkj TrPf yPmÇ

HOW TO USE YOUR INHALER CORRECTLYKTnJPm IJkKj xKbT k≠KfPf AjPyuJr mqmyJr TrPmj

Cleaning your Inhaler How to clean your Inhaler?KTnJPm IJkjJr AjPyuJr kKrÛJr TrPmj?

In case of emergency situation when you feel you are notrelieved despite using your inhaler, you can use inhaleralong with spacer (a device that your doctor advise to usewith your inhaler). This may save your life on the way tohospital. For more information, consult with your doctor.pUj \ÀrL kP~J\Pj AjPyuJr mqmyJr xP•ôS Ckvo yPmjJ, fUj IJkKj߸xJr (FTKa KcnJAx pJ IJkjJr cJÜJr IJkjJPT AjPyuJPrr xJPg mqmyJrTrPf muPmj) mqmyJr TrPf kJPrjÇ

Precaution (xfTtfJ)Pressurised canister, do not puncture, break or incinerate even when apparently empty. YJkpMÜ TqJKjˆJr, IJkJfhOKˆPf UJKu oPj yPuS KZhs TrJ, nJñJIgmJ ßkJzJPjJ pJPm jJÇAvoid storage in direct sunlight or heat. xrJxKr xNpJtPuJT mJ fJk ßgPT hNPr rJUMjÇStore below 30°C 300 ßx: Fr jLPY xÄrãe TÀjÇKeep away from eyes ßYJPUr xĸPvt IJxPf ßh~J pJPm jJÇKeep away from children KvÊPhr jJVJPur mJAPr rJUMjÇ

Keeping the plastic actuator clean is very important toprevent medicine buildup and blockage. The actuatorshould be washed, shaken to remove excess water andair-dried thoroughly at least once a week. The inhaler maystop spraying if not properly cleaned.FqJTYMP~aPrr oMU SwMi \Po gJTJ mJ SwMi KhP~ mº yP~ pJS~J ßgPT rãJ TrPfkäJKÓPTr FqJTYMP~arKa kKrÛJr rJUJ UMmA \ÀrLÇ x¬JPy I∂f: FTmJrFqJTYMP~arKa kKrÛJr TrPf yPm If:kr IKfKrÜ kJKj hMr TrPf FqJTYMP~arKanJunJPm ^JÅTJPf yPm FmÄ mJfJPx ÊTJPf yPmÇ pKh AjPyuJr KbTof kKrÛJrTrJ jJ y~ fPm FaJ KhP~ ß s TrJ pJPm jJÇ

1. Remove the metal canister from the plastic casing of theinhaler and remove the mouthpiece cover.xJmiJPj iJfm TqJKjˆJrKaPT käJKˆPTr mKyrJmre ßgPT oMÜ TÀj, oJCgKkx TnJrKaUMPu ßluMjÇ2. Rinse the actuator thoroughly with warm water.käJKˆT mKyrJmre FmÄ oJCgKkx TnJrKaPT Vro kJKj KhP~ iMP~ ßluMjÇ3. Dry the actuator thoroughly inside and outside.ÊTJPjJr \jq ßTJj ÊÏ ˙JPj rJUMjÇ4. Replace the metal canister and the mouthpiece coverTqJKjˆJr FmÄ oJCgKkx TnJrKaPT xKbT \J~VJ~ ˙Jkj TÀjÇ5. Do not put the metal canister in water.iJfm TqJKjˆJrKaPT TUPjJA kJKjPf ßn\JPmj jJÇ

Children and others whohave weaker hands mayhave difficulty pressingdown on the top of thecan with just one hand.They can use bothhands to make theirInhaler work.

KvÊ FmÄ IjqJjq ßrJVL pJPhr yJPfß\Jr To fJrJ FT yJf KhP~TqJKjˆJPrr CkKrnJPV nJunJPm YJk kP~JV TrPf kJPr jJÇ lPu AjPyuJr ßgPTSwMi KbTof ßmr y~ jJÇ ßxPãP© fJrJ fJPhr hMyJf FTxJPg mqmyJr TrPfkJPrÇ

1. Remove the cap from the mouthpiece of the actuator1. FqJTYMP~ar oJCgKkx& ßgPT TnJrKa kgPo xrJPf yPmÇ

2. Make sure the mouthpiece is clean inside and outside. 2. FqJTYMP~aPrr oMU kKrÛJr KTjJ xfTtfJr xJPg krLãJ TrPf yPmÇ

3. Hold the inhaler by placing your index finger on top of themetal canister and thumb on the bottom of the plasticmouthpiece. Shake it well. 3. f\tjL S mMPzJ IJñMPur oPiq AjPyuJrKaPT irPf yPmÇ If:kr AjPyuJrKanJunJPm ^JÅTJPf yPmÇ

Your Inhaler should be cleaned at least once a weekkKf x¬JPy I∂f: FTmJr IJkjJr AjPyuJr kKrÛJr TÀjÇ

Shake well the inhaler before each usekKfmJr mqmyJPrr kNPmt ImvqA nJunJPm ^JÅKTP~ KjPmjÇ

Mouthpiece(oJCgKkx&)

Actuator(FqJTYMP~ar) Canister

(TqJKjˆJr)

Cap(TqJk)

Adults:

Children:

PreviousTherapy

RecommendedStarting Dose

HighestRecommendedDose

Bronchodilatorsalone

200 to 400 mcgtwice daily

400 mcg twicedaily

InhaledCorticosteroids*

200 to 400 mcgtwice daily

800 mcg twicedaily

OralCorticosteroids

400 to 800 mcgtwice daily

800 mcg twicedaily

Bronchodilatorsalone

200 mcg twicedaily

400 mcg twicedaily

InhaledCorticosteroids*

200 mcg twicedaily

400 mcg twicedaily

OralCorticosteroids

The highest recommended dose in childrenis 400 mcg twice daily