Product Index

For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only

Qualitative and Quantitative Composition

CICLOHALE 80 Inhaler

Each actuation (delivered dose from the mouthpiece) delivers

Ciclesonide IP…………………….80 mcg

In propellant HFA 134a…………q.s.

Absolute alcohol content ………..8.8%v/v

CICLOHALE 160 Inhaler

Each actuation (delivered dose from the mouthpiece) delivers

Ciclesonide IP…………………….160 mcg

In propellant HFA 134a…………q.s.

Absolute alcohol content ………..8.8%v/v

Dosage Form and Strength

CICLOHALE 80 Inhaler

Inhalation aerosol containing 80 mcg per actuation

CICLOHALE 160 Inhaler

Inhalation aerosol containing 160 mcg per actuation

Clinical Particulars

Therapeutic Indications

CICLOHALE is indicated for treatment of persistent asthma in adults (18 years and older).

Posology and Method of Administration

CICLOHALE is for oral inhalation use only.

Symptoms start to improve with ciclesonide within 24 hours of treatment. However, due to its prophylactic nature, CICLOHALE should be taken regularly even when patients are asymptomatic.

Dosing recommendation for adults aged 18 years and older

The recommended dose range is 80 to 320 mcg once daily in adult patients. Patients should be given a starting dose of CICLOHALE which is appropriate to the severity of their disease. In patients with severe asthma and while reducing or discontinuing oral corticosteroids, a higher dose of up to 640mcg/day (given as 320mcg twice daily) may be used.

Contraindications

CICLOHALE is contraindicated in patients with history of hypersensitivity to ciclesonide or any of the components of the formulation

Special Warnings and Precautions for Use

As with all inhaled corticosteroids (ICS), CICLOHALE should be administered with caution in patients with active or quiescent pulmonary tuberculosis fungal, bacterial or viral infections, and only if these patients are adequately treated.  As with all ICS, CICLOHALE is not indicated in the treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

As with all ICS, CICLOHALE is not designed to relieve acute asthma symptoms for which an inhaled short-acting bronchodilator is required. Patients should be advised to have such rescue medication available.  Patients with severe asthma are at risk of acute attacks and should have regular assessments of their asthma control including pulmonary function tests. Increasing use of short-acting bronchodilators to relieve asthma symptoms indicate deterioration of asthma control. If patients find that short-acting relief bronchodilator treatment becomes less effective, or they need more inhalations than usual, medical attention must be sought. In this situation, patients should be reassessed and consideration given to the need for increased anti-inflammatory treatment therapy (eg higher doses of ICS or a course of oral corticosteroids). The maximal daily dose is 640 μg/day (given as 320 μg twice a day but the superiority of this dose over 320 μg/day has not been unequivocally demonstrated (see Clinical trials).

Systemic Effects

Inhaled steroid products are designed to direct glucocorticoid delivery to the lungs in order to reduce overall systemic glucocorticoid exposure and side effects. In sufficient doses however, all ICS can have adverse effects, notably depression of the hypothalamic-pituitary-adrenal (HPA) axis, reduction of bone density, cataract, glaucoma and retardation of growth rate in children and adolescents. In steroid dependent patients, prior systemic steroid usage may be a contributing factor, but such effect can occur amongst patients who use only ICS regularly.

HPA axis suppression and adrenal insufficiency

The lowest dose of ciclesonide that causes suppression of the HPA axis (as indicated by 24-hour urinary cortisol concentrations), effects on bone mineral density or growth retardation in patients has not yet been established.

A controlled study compared 24-hour plasma cortisol AUC in 26 adult asthmatic patients following 7 days of treatment. Compared to placebo, treatment with ciclesonide 320, 640 and 1280 μg/day did not statistically lower the 24-hour time averages of plasma cortisol (AUC(0-24)/24 hours) nor was a dose-dependent effect seen. Hence, at therapeutic doses, no significant difference was detected between inhaled ciclesonide and placebo on HPA function and serum cortisol levels. However, potential effects on the HPA axis may occur in individual patients particularly at times of physiological stress (eg hot climate, illness or surgery). Similar results were seen in other studies in asthmatic children aged 4 to 12 years.

Growth

It is recommended that the height of children and adolescents receiving prolonged treatment with ICS is regularly monitored. In addition, consideration should be given to referring the patient to a paediatric respiratory specialist.

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Transfer from oral corticosteroids

The benefits of inhaled ciclesonide should minimise the need for oral corticosteroids. However, patients transferred from oral steroids may remain at risk of impaired adrenal reserve for a considerable time after transferring to inhaled ciclesonide. The possibility of adverse effects may persist for some time. These patients may require specialised advice to determine the extent of adrenal impairment before elective procedures. The possibility of residual impaired adrenal response should always be considered in emergency (medical or surgical) and elective situations likely to produce stress, and appropriate corticosteroid treatment considered. Transfer of patients from systemic corticosteroid therapy to CICLOHALE may unmask pre-existing allergic conditions such as allergic rhinitis or eczema, previously suppressed by systemic corticosteroid therapy.

General

Paradoxical bronchospasm with an immediate increase of wheezing or other symptoms of bronchoconstriction after dosing should be treated with an inhaled short-acting bronchodilator, which usually results in quick relief. If the patients find short-acting bronchodilator treatment ineffective, or they need more inhalations than usual, medical attention must be sought. This indicates a worsening of the underlying conditions, and warrants a reassessment of the therapy.

The patient should be assessed and therapy with CICLOHALE should only be continued, if after careful consideration the expected benefit is greater than the possible risk. Correlation between severity of asthma and general susceptibility for acute bronchial reactions should be kept in mind.

The patient should be advised against abrupt discontinuation of therapy with CICLOHALE.

Patient inhaler technique should be checked regularly to make sure that inhaler actuation is synchronized with inhalation to ensure optimum delivery to the lungs.

Concomitant treatment with ketoconazole or other potent CYP3A4 inhibitors should be avoided unless the benefit outweighs the increased risk of systemic side effects of corticosteroids.

Use in hepatic impairment

Systemic exposure to the active metabolite (M1) is increased in patients with hepatic impairment. Although no dosage reduction is necessary, prescribers should be aware of the possibility of an increased risk of systemic adverse effects.

Use in the elderly

Systemic exposure to M1 is also increased in elderly patients. Although no dosage reduction is necessary, prescribers should be aware of the possibility of an increased risk of systemic adverse effects in such patients.

Paediatric use

To date, there is insufficient data available in the treatment of children of 5 years and younger with Ciclesonide.

Effects on laboratory tests

No data available.

Drug Interactions

In a drug-drug interaction study at steady state with ciclesonide and ketoconazole as a potent CYP3A4 inhibitor, the exposure to the active metabolite M1 increased approximately 3.5-fold, whereas the exposure to ciclesonide was not affected. Therefore, the concomitant administration of potent inhibitors of CYP3A4 (eg ketoconazole, itraconazole and ritonavir or nelfinavir) should be avoided unless the benefit outweighs the increased risk of systemic side effects of corticosteroids

Use in Special Populations

Geriatrics: In a comparison between one study in elderly subjects and another study in young healthy subjects, there was an approximately 2-fold increase in the rate and extent of exposure to the active metabolite in elderly patients. However, in a population pharmacokinetic analysis of 9 studies, age did not impact the clearance or volume of distribution of the active metabolite.

Pediatrics: In two 12 week clinical studies investigating the safety and efficacy of Ciclesonide in asthmatic patients between 4-11 years of age, serum samples were taken from 53 patients for pharmacokinetic analysis. The pharmacokinetics of the active metabolite M1 were found to be similar to adults.

Hepatic Insufficiency: Reduced liver function may affect the elimination of corticosteroids. In a study including patients with hepatic impairment suffering from liver cirrhosis, a higher systemic exposure (1.8 to 2.8 times) to the active metabolite was observed.

Renal Insufficiency: Due to the low rate of renal excretion of ciclesonide metabolites, studies on renally impaired patients have not been performed.

Pregnancy: Category B3

There are no adequate and well controlled studies in pregnant women.  In animal studies glucocorticoids have been shown to induce malformations. Corticosteroids are known to induce foetotoxic and teratogenic effects in rodent and rabbit studies.  Embryofoetal development studies with daily SC dosing of ciclesonide in rabbits, abnormal foetal development (cleft palate, hind paw flexure, enlarged fontanelle, parchment like skin) was observed at systemic exposure levels (based on plasma AUC) ranging from about 3 to 12 times that anticipated clinically at the maximum recommended human dose.  Embryofoetal development studies in rats showed reduced foetal weight, skeletal anomalies, hydronephrosis and maternotoxicity at oral doses of 300-900 μg/kg/day.  Similar studies with these doses extended until weaning revealed maternotoxicity, reduced pup weight gain, changes in pup organ weight and changes in behavioural development tests. The systemic exposure of dams relative to human exposure in these studies is not known, but doses represented 2-6 times the maximum recommended human dose on a body surface area basis.  As with other ICS preparations, CICLOHALE is not to be used during pregnancy unless the potential benefit to the mother justifies the potential risk to the mother or foetus. The lowest effective dose of ciclesonide needed to maintain adequate asthma control should be used. Infants born of mothers who received corticosteroids during pregnancy are to be observed carefully for hypoadrenalism.

Lactation:

The excretion of ciclesonide or its metabolites into human milk has not been investigated. There was limited excretion of ciclesonide and/or its metabolites into milk in lactating rats after intravenous or oral administration (respective maxima of 0.23% and 0.03% of dose/g tissues). Oral administration of ciclesonide to rats from early pregnancy until weaning was associated with adverse effects on pups.  In breastfeeding mothers, the therapeutic benefits of the drug should be weighed against the potential hazards to mother and baby.

Effects on Ability to Drive and Use Machines

Inhaled ciclesonide has no or negligible influence on the ability to drive and use machines

Undesirable Effects

Clinical trial data in adults and adolescents

Approximately 5% of patients experienced adverse reactions in clinical trials with Ciclesonide given in the dose range 80 to 1280 μg per day. In the majority of cases, these were mild and did not require discontinuation of treatment with Ciclesonide.

The table below shows the adverse events reported with a frequency of ≥2% from participants in studies of up to 1-year duration.

Adverse events that occurred ≥2% from participants in studies of up to 1-year duration

% = percentage of patients with specified event based on N

The following adverse reactions have also been reported in clinical trials with Ciclesonide:

Adverse reactions also reported in clinical trials with Ciclesonide

Paradoxical bronchospasm may occur immediately after dosing and is an unspecific acute reaction to all inhaled medications, which may be related to the drug, the excipient, or evaporation cooling in the case of metered dose inhalers. In the majority of cases, this reaction is mild and does not require withdrawal of CICLOHALE. In severe cases, withdrawal of CICLOHALE should be considered.

Post marketing experience

Very rare cases of immediate or delayed hypersensitivity reactions such as angioedema with swelling of lips, tongue and pharynx have been reported from spontaneous reporting with Ciclesonide.  There have been very rare reports of psychiatric symptoms such as agitation, insomnia, depression, anxiety and behavioural changes with ciclesonide as well as with other ICS.

Systemic effects of ICS may occur, particularly at doses higher than recommended. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents and decrease in bone mineral density. Eye disorders with frequency unknown, such as blurred vision, cataract or glaucoma, have been reported with systemic and topical corticosteroid use.

If you experience any side-effects, talk to your doctor or pharmacist or write to drugsafety@cipla.com. You can also report side effects directly via the national pharmacovigilance program of India by calling on 1800 180 3024 or you can report to Cipla Ltd on 18002677779. By reporting side-effects, you can help provide more information on the safety of this product

Overdose

Acute

Inhalation by healthy volunteers of a single dose of 2880 mcg of ciclesonide was well tolerated. The potential for acute toxic effects following overdose of inhaled CICLOHALE is low. After acute overdosage no specific treatment is necessary.

Chronic

After prolonged administration of 1280 mcg of ciclesonide no significant clinical signs of adrenal suppression were observed. However, if higher than recommended dosage is continued over prolonged periods, some degree of adrenal suppression cannot be excluded. Monitoring of adrenal reserve may be necessary. In cases of ciclesonide overdose, therapy may still be continued at a suitable dosage for symptom control.

Pharmacological Properties

Mechanism of Action

Ciclesonide (pure R-epimer) belongs to a new class of on-site activated non-halogenated ICS. Ciclesonide is an ester pro-drug with approximately 100-fold lower affinity for the glucocorticoid receptor than its active metabolite (M1; 21-des-isobutyryl-ciclesonide) and budesonide and fluticasone. Endogenous activation occurs primarily via esterases located in the lung, to give M1.

Bronchial inflammation is known to be an important component in the pathogenesis of asthma. Inflammation occurs in both large and small airways and also causes an associated increase in airway responsiveness to a variety of inhaled stimuli. In clinical trials, ciclesonide has been shown to reduce airway reactivity to adenosine monophosphate in hyperreactive patients. Pre-treatment with ciclesonide for seven days significantly attenuated the early and late phase reactions following inhaled allergen challenge. Inhaled ciclesonide treatment was also shown to attenuate the increase in inflammatory cells (total eosinophils) and inflammatory mediators in induced sputum.

Pharmacodynamic Properties

Ciclesonide exhibits low binding affinity to the glucocorticoid-receptor. Once orally inhaled, ciclesonide is enzymatically converted in the lungs to the principal metabolite (C21-des-methylpropionyl-ciclesonide) which has a pronounced anti-inflammatory activity and is thus considered as the active metabolite. In four clinical trials, ciclesonide has been shown to reduce airway hyperresponsiveness to adenosine monophosphate in hyperreactive patients with maximal effect observed at the dose of 640 micrograms. In another trial, pretreatment with ciclesonide for seven days significantly attenuated the early and late phase reactions following inhaled allergen challenge. Inhaled ciclesonide treatment was also shown to attenuate the increase in inflammatory cells (total eosinophils) and inflammatory mediators in induced sputum.

A controlled study compared 24-hour plasma cortisol AUC in 26 adult asthmatic patients following 7 days of treatment. Compared to placebo, treatment with ciclesonide 320, 640, and 1,280 micrograms/day did not statistically significantly lower the 24-hour time averages of plasma cortisol (AUC(0-24)/24 hours) nor was a dose-dependent effect seen. In a clinical trial involving 164 adult male and female asthmatic patients, ciclesonide was given at doses of 320 micrograms or 640 micrograms/day over 12 weeks. After stimulation with 1 and 25 micrograms cosyntropin, no significant changes in plasma cortisol levels were observed versus placebo. Double-blind placebo-controlled trials of 12-weeks duration in adults and adolescents have shown that treatment with ciclesonide resulted in improved lung function as measured by FEV₁ and PEF, improved asthma symptom control, and decreased need for inhaled beta-2 agonist.

In a 12-week study of 680 severe asthmatics, previously treated with 500-1,000 micrograms fluticasone propionate per day or equivalent, 87.3% and 93.3% of patients remained exacerbation-free during treatment with 160 or 640 micrograms of ciclesonide, respectively. At the end of the 12 week study period, the results showed a statistically significant difference between the doses of 160 micrograms and 640 micrograms/day ciclesonide with regard to the occurrence of an exacerbation after the first day of the study: 43 patients/339 (= 12.7%) in the 160 micrograms/day group and 23 patients/341 (6.7%) in the 640 micrograms/day group (Hazard ratio=0.526; p= 0.0134). Both ciclesonide doses resulted in comparable FEV₁ values at 12 weeks. Treatment-related adverse events were seen in 3.8% and 5% of patients treated with 160 or 640 micrograms per day of ciclesonide respectively. A further 52 week trial involving 367 patients with mild to moderate asthma, was unable to demonstrate a significant difference in the effect of higher doses of Ciclesonide (320 or 640 mcg per day) as compared to a lower dose (160 mcg per day) on asthma control.

Pharmacokinetic Properties

Ciclesonide is formulated in HFA-134a propellant and ethanol as a solution aerosol, which demonstrates a linear relationship between different doses, puff strengths and systemic exposure.

Absorption:

Studies with oral and intravenous dosing of radiolabeled ciclesonide have shown an incomplete extent of oral absorption (24.5%). The oral bioavailability of both ciclesonide and the active metabolite is negligible (<0.5% for ciclesonide, <1%for the metabolite). Based on a γ-scintigraphy experiment, lung deposition in healthy subjects is 52%. The systemic bioavailability for the active metabolite is >50% by using the ciclesonide metered dose inhaler. As the oral bioavailability for the active metabolite is <1%, the swallowed portion of the inhaled ciclesonide does not contribute to systemic absorption.

Distribution:

Following intravenous administration to healthy subjects, the initial distribution phase for ciclesonide was rapid and consistent with its high lipophilicity. The volume of distribution averaged 2.9 l/kg. The total serum clearance of ciclesonide is high (average 2.0 l/h/kg) indicating a high hepatic extraction. The percentage of ciclesonide bound to human plasma proteins averaged 99%, and that of the active metabolite 98-99%, indicating an almost complete binding of circulating ciclesonide/active metabolite to plasma proteins.

Metabolism:

Ciclesonide is primarily hydrolysed to its biologically active metabolite by esterase enzymes in the lung. Investigation of the enzymology of further metabolism by human liver microsomes showed that this compound is mainly metabolized to hydroxylated inactive metabolites by CYP3A4 catalysis. Furthermore, reversible lipophilic fatty acid ester conjugates of the active metabolite were detected in the lung.

Excretion:

Ciclesonide is predominantly excreted via the faeces (67%), after oral and intravenous administration, indicating that excretion via the bile is the major route of elimination.

Pharmacokinetic characteristics in patients:

Asthmatic patients

Ciclesonide shows no pharmacokinetic changes in mild asthmatic patients compared to healthy subjects.

Elderly According to population pharmacokinetics, age has no impact on the systemic exposure of the active metabolite.

Renal or hepatic impairment

Reduced liver function may affect the elimination of corticosteroids. In a study including patients with hepatic impairment suffering from liver cirrhosis, a higher systemic exposure to the active metabolite was observed.

Due to the lack of renal excretion of the active metabolite, studies on renal impaired patients have not been performed.

Non Clinical Properties

Carcinogenesis, mutagenesis and impairment of fertility

Ciclesonide demonstrated no carcinogenic potential in a study of oral doses up to 900 mcg/kg/day (approximately 6 times the maximum human daily inhalation dose based on mcg/m²/day) in mice for 104 weeks and in a study of inhalation doses up to 193 mcg/kg/day (approximately 2 times the maximum human daily inhalation dose based on mcg/m²/day) in rats for 104 weeks.  Ciclesonide was not mutagenic in an Ames test or in a forward mutation assay and was not clastogenic in a human lymphocyte assay or in an in vitro micronucleus test. However, ciclesonide was clastogenic in the in vivo mouse micronucleus test. The concurrent reference corticosteroid (dexamethasone) in this study showed similar findings.  No evidence of impairment of fertility was observed in a reproductive study conducted in male and female rats both dosed orally up to 900 mcg/kg/day (approximately 10 times the maximum human daily inhalation dose based on mcg/m²/day).

Description

The active component of CICLOHALE 80 mcg Inhalation Aerosol, and CICLOHALE 160 mcg Inhalation Aerosol is ciclesonide, a non-halogenated glucocorticoid having the chemical name pregna-1,4-diene-3,20-dione,16,17-bis(oxy)]-11-hydroxy-21(2-methyl-1-oxopropoxy)-,(11beta,16alpha). The empirical formula is C32H44O7 and its molecular weight is 540.7. Its structural formula is as follows:

Ciclesonide is a white to yellow-white powder. It is soluble in dehydrated alcohol, acetone, dichloromethane, and chloroform.  CICLOHALE 80 mcg Inhalation Aerosol and CICLOHALE160 mcg Inhalation Aerosol are pressurized, metered-dose aerosol units. CICLOHALE is intended for oral inhalation only. Each unit contains a solution of ciclesonide in propellant HFA-134a (1,1,1,2 tetrafluoroethane) and ethanol. After priming, CICLOHALE 80 mcg delivers 100 mcg from the valve and 80 mcg of ciclesonide from the actuator. CICLOHALE 160 mcg delivers 200 mcg from the valve and 160 mcg of ciclesonide from the actuator.  The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the device and inspiration through the delivery system.

Pharmaceutical Particulars

Incompatibilities

Not applicable

Shelf Life

As on the pack

Storage and Handling Instructions

Store below 30^O C.

Do not freeze

Patient Counselling Information

CICLOHALE (Ciclesonide) Inhalation Aerosol

Note: For Oral Inhalation Only

Do not use your CICLOHALE Inhalation Aerosol near heat or an open flame.

Read this Patient Information leaflet before you start using CICLOHALE Inhalation Aerosol and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. If you have any questions about CICLOHALE Inhalation Aerosol, ask your healthcare provider.

What is CICLOHALE Inhalation Aerosol?

CICLOHALE Inhalation Aerosol is a prescription medicine used for the control and prevention of asthma in adults and children 12 years of age and older.

CICLOHALE Inhalation Aerosol contains ciclesonide, which is a man-made (synthetic) corticosteroid. Corticosteroids are natural substances found in the body and reduce inflammation. When you inhale CICLOHALE Inhalation Aerosol it may help to control and prevent your symptoms of asthma by reducing your airway inflammation.

CICLOHALE Inhalation Aerosol is not for the relief of acute bronchospasm. CICLOHALE Inhalation Aerosol is not a bronchodilator and does not treat sudden symptoms of an asthma attack such as wheezing, cough, shortness of breath, and chest pain or tightness. Always have a fast-acting bronchodilator medicine (rescue inhaler) with you to treat sudden symptoms.

It is not known if CICLOHALE Inhalation Aerosol is safe and effective in children 5 years of age and younger.

Who should not use CICLOHALE Inhalation Aerosol?

Do not use CICLOHALE Inhalation Aerosol:

• to treat status asthmaticus or other sudden symptoms of asthma. CICLOHALE Inhalation Aerosol is not a rescue inhaler and should not be used to give you fast relief from your asthma attack. Always use a rescue inhaler such as salbutamol/levosalbutamol, during a sudden asthma attack.
• if you are allergic to ciclesonide or any of the ingredients in CICLOHALE Inhalation Aerosol.

What should I tell my healthcare provider before using CICLOHALE Inhalation Aerosol?

Before you use CICLOHALE Inhalation Aerosol tell your healthcare provider if you:

• have or have had eye problems such as increased ocular pressure, glaucoma, or cataracts.
• have any infections including tuberculosis or ocular herpes simplex.
• have not had or been vaccinated for chicken pox or measles.
• are pregnant or plan to become pregnant. It is not known if CICLOHALE Inhalation Aerosol will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if CICLOHALE Inhalation Aerosol passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you are using CICLOHALE Inhalation Aerosol.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use CICLOHALE Inhalation Aerosol?

• Read the Instructions for Use provided in the cartonfor specific information about the right way to use CICLOHALE Inhalation Aerosol.
• Use CICLOHALE Inhalation Aerosol exactly as your healthcare provider tells you to use it. Do not take more of your medicine, or take it more often than your healthcare provider tells you.
• You must use CICLOHALE Inhalation Aerosol regularly. It may take 4 weeks or longer after you start using CICLOHALE Inhalation Aerosol for your asthma symptoms to get better. Do not stop using CICLOHALE Inhalation Aerosol even if you are feeling better, unless your healthcare provider tells you to.
• If your symptoms do not improve or get worse, call your healthcare provider.
• Your healthcare provider may prescribe a rescue inhaler for emergency relief of sudden asthma attacks. Call your healthcare provider if you have:  an asthma attack that does not respond to your rescue inhaler or  you need more of your rescue inhaler than usual.
• If you use another inhaled medicine, ask your healthcare provider for instructions on how to use it while you use CICLOHALE Inhalation Aerosol.

What are the possible side effects of CICLOHALE Inhalation Aerosol?

CICLOHALE Inhalation Aerosol may cause serious side effects, including:  Thrush (Candida), a fungal infection of your nose, mouth, or throat. Tell your healthcare provider if you have discomfort or pain in your throat, have hoarseness in your voice or have any redness or white colored patches in your mouth or throat. Rinse your mouth after you use your CICLOHALE Inhalation Aerosol.

• Immune system problems that may increase your risk of infections.

You are more likely to get infections if you take medicines that may weaken your body’s ability to fight infections. Avoid contact with people who have contagious diseases such as chicken pox or measles while you use CICLOHALE Inhalation Aerosol. Symptoms of an infection may include: fever, pain, aches, chills , feeling tired , nausea , vomiting

Adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Your healthcare provider will follow you closely if you take steroids by mouth and are having them decreased (tapered) or you are being switched to CICLOHALE Inhalation Aerosol. People have died while steroids are being decreased and when people have been switched from steroids by mouth to inhaled steroids like CICLOHALE. If you are under stress, such as with surgery, after surgery or trauma, you may need steroids by mouth again.

Call your healthcare provider right away if you have the following symptoms of adrenal insufficiency:  tiredness  weakness  dizziness  nausea that does not go away  vomiting that does not go away

• Decreased bone mass (bone mineral density). People who use inhaled steroid medicines for a long time may have an increased risk of decreased bone mass which can affect bone strength. Talk to your healthcare provider about any concerns you may have about bone health.
• Slowed or delayed growth in children. A child’s growth should be checked regularly while using CICLOHALE Inhalation Aerosol.
• Eye problems such as glaucoma and cataracts. If you have a history of glaucoma or cataracts or have a family history of eye problems, you should have regular eye exams while you use CICLOHALE Inhalation Aerosol.
• Increased wheezing (bronchospasm) can happen right away after using CICLOHALE  Inhalation Aerosol. Stop using CICLOHALE Inhalation Aerosol and use an inhaled fast-acting bronchodilator (rescue inhaler) right away.

Tell your healthcare provider right away so that a new medicine can be prescribed to control your asthma.

The most common side effects with CICLOHALE Inhalation Aerosol include:

• headache
• swelling of nose and throat (nasopharyngitis)
• swelling of the sinuses (sinusitis)
• throat pain
• upper respiratory infection
• joint pain (arthralgia)
• nasal congestion
• pain in arms, legs, and back

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all of the possible side effects with CICLOHALE Inhalation Aerosol. For more information, ask your healthcare provider. Call your doctor for medical advice about side effects.

If you experience any side-effects, talk to your doctor or pharmacist or write to drugsafety@cipla.com. You can also report side effects directly via the national pharmacovigilance program of India by calling on 1800 180 3024 or you can report to Cipla Ltd on 18002677779. By reporting side-effects, you can help provide more information on the safety of this product.

How should I store CICLOHALE Inhalation Aerosol?

Store your CICLOHALE Inhalation Aerosol at room temperature around 30^OC. Do not freeze.  Do not puncture the CICLOHALE Inhalation Aerosol canister. Do not store the CICLOHALE Inhalation Aerosol canister near heat or a flame. Do not throw the CICLOHALE Inhalation Aerosol canister into a fire or an incinerator. Keep CICLOHALE Inhalation Aerosol clean and dry at all times. Keep CICLOHALE Inhalation Aerosol and all medicines out of reach of children.

General Information about the safe and effective use of CICLOHALE Inhalation Aerosol

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use CICLOHALE Inhalation Aerosol for a condition for which it was not prescribed. Do not give your CICLOHALE Inhalation Aerosol to other people, even if they have the same symptoms that you have. It may harm them.

Details of Manufacturer

Cipla Ltd.

Peninsula Business Park, Ganapatrao Kadam Marg,

Lower Parel West, Mumbai,

Maharashtra 400013

Details of Permission or License number

721/456/MFG/DFDA/2019/1737

Date of Revision

10/11/2019