Glycopyrronium is an active pharmaceutical ingredient in the Antihidrotics group (D11AA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised February 20, 2026[1]
Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) due to chronic neurological disorders of childhood onset in patients aged 3 years and older.
How to take
GB
CACanada· Health Canada
4 products
Uses
CAOfficial regulatory label· revised March 22, 2025[2]
SEEBRI® BREEZHALER® (glycopyrronium bromide) is indicated as a long-term once-daily maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. SEEBRI BREEZHALER is not indicated for the relief of an acute deterioration of COPD.
1 Pediatrics Pediatrics (< 18 years of age): SEEBRI BREEZHALER should not be used in patients under 18 years of age. 2 Geriatrics Geriatrics (> 65 years of age): SEEBRI BREEZHALER can be used at the recommended dose in elderly patients 65 years of age and older.
How to take
EUEuropean Union· EMA
2 products
Uses
EUOfficial regulatory label· revised September 30, 2025[3]
1).
How to take
EUOfficial regulatory label· revised September 30, 2025
Drug interactions
Known interactions involving Glycopyrronium. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
[1]MHRA (UK) · PL157640157 · revised February 20, 2026
[2]Health Canada (DPD) · 02394936 · revised March 22, 2025
[3]European Medicines Agency · EMEA/H/C/005311 · revised September 30, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
1). Glycopyrronium bromide tablets should be prescribed by physicians experienced in the treatment of patients with neurological disorders. 02 mg/kg every 5-7 days based on therapeutic response and adverse reactions. 5-3 mg per dose based upon weight.
For greater detail, see Table 1. During the four-week titration period, dosing can be increased with the recommended dose titration schedule while ensuring that the anticholinergic adverse events are tolerable. Prior to each increase in dose, review the tolerability of the current dose level with the patient's caregiver.
Younger children may be more susceptible to adverse events and this should be kept in mind when dose adjustments are carried out. Following the dose titration period, the child’s sialorrhoea should be monitored, in conjunction with the carer at no longer than 3 monthly intervals, to assess changes in efficacy and/or tolerability over time, and the dose adjusted accordingly.
0mg For doses which cannot be achieved using the tablet formulation, other pharmaceutical forms of glycopyrronium bromide are available. Paediatric population – children aged < 3 years Glycopyrronium bromide tablets are not recommended for use in children younger than 3 years.
Adult population For adolescents with chronic neurological disorders of childhood onset, their stable dose of glycopyrronium bromide tablets can be continued into adulthood. For adults with chronic neurological disorders of childhood onset who are initiating glycopyrronium bromide tablets, the dosing schedule described under the paediatric population subheading and summarised in Table 1 should be followed.
Elderly population The elderly have a longer elimination half-life and reduced medicinal product clearance as well as limited data to support efficacy in short-term use. As such glycopyrronium bromide tablets should not be used in patients over the age of 65 years.
Renal Impairment Elimination of glycopyrronium is severely impaired in patients with renal failure. 3). 73m2) doses should be reduced by 30%. Hepatic impairment Clinical studies have not been conducted in patients with hepatic impairment.
Glycopyrronium is cleared predominantly from the systemic circulation by renal excretion and hepatic impairment is not thought to result in a clinically relevant increase in systemic exposure of glycopyrronium. Other licensed glycopyrronium products are not all interchangeable on a milligram-for-milligram basis due to differences in bioavailability; please refer to the approved posology of the product if changing between products.
The specific dose recommendations for each product must be followed to avoid overdose and anticholinergic side effects. Method of administration For oral administration only. For patients who cannot swallow tablets, other pharmaceutical forms should be used.
Co-administration with food results in a marked decrease in systemic medicinal product exposure. Dosing should be at least one hour before or at least two hours after meals or at consistent times with respect to food intake. High fat food should be avoided.
2).
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised February 20, 2026[1]
Summary of the safety profile Adverse reactions are common with glycopyrronium due to its known pharmacodynamic anticholinergic effects. The efficacy of the medicinal product should be balanced against the adverse reactions and the dose monitored regularly and adjusted as necessary.
1) related to the gastrointestinal system and were dry mouth, constipation, diarrhoea and vomiting, all of which occurred at a rate of ≥15%. The safety profile is further characterised by other symptoms, related to the anticholinergic effects at a rate of ≥15%, including urinary retention, flushing and nasal congestion.
Adverse reactions are more common with higher doses and prolonged use Tabulated list of adverse reactions Adverse reactions reported in the literature for trials using glycopyrronium for sialorrhoea in the paediatric population (including 2 placebo controlled trials, an uncontrolled safety study using glycopyrronium for a 6 month period, and 3 supportive studies with adverse event data in the target population) are listed by MedDRA system organ class (Table 3).
Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
List of Adverse Reaction Frequency Adverse reaction Frequency category Infections and infestations Upper respiratory infection Common Pneumonia Common Urinary tract infection Common Psychiatric disorders Irritability Very common Agitation Common Drowsiness Common Restlessness Not known Over activity Not known Short attention span Not known Frustration Not known Mood variable Not known Temper tantrum Not known Intermittent explosive disorder Not known Sensitivity, shyness, and social withdrawal disorder specific to childhood or adolescence Not known Feeling sad Not known Crying Not known Fear Not known Nervous system disorders Headache Uncommon Insomnia Not known Eye disorders Mydriasis Uncommon Nystagmus Uncommon Angle-closure glaucoma Not known Photophobia Not known Dry Eyes Not known Cardiac disorders Flushing Very common Transient bradycardia Not known Respiratory, thoracic and mediastinal disorders Nasal congestion Very common Epistaxis Common Reduced bronchial secretions Very common Sinusitis Not known Gastrointestinal disorders Dry mouth Very common Constipation Very common Diarrhoea Very common Vomiting Very common Halitosis Uncommon Pseudo-obstruction Uncommon Gastrointestinal mobility disorder Uncommon Oesophageal candidiasis Uncommon Nausea Not known Skin and subcutaneous tissue disorders Rash Common Dryness of skin Not known Inhibition of sweating Not known Renal and urinary disorders Urinary retention Very common Urinary urgency Not known General disorders and administration site conditions Pyrexia Common Dehydration Uncommon Thirst in hot weather Uncommon Angioedema Not known Allergic reaction Not known Description of selected adverse reactions Urinary retention Urinary retention is a known adverse reaction associated with anticholinergic medicinal products (15%).
Glycopyrronium treatment should be withdrawn until the urinary retention resolves. 9%). Glycopyrronium treatment should be withdrawn until the pneumonia resolves. Constipation Constipation is a known adverse reaction associated with anticholinergic medicinal products (30%).
Glycopyrronium treatment should be withdrawn until the constipation resolves. Central Nervous System Although glycopyrronium has limited ability to cross the blood brain barrier, increased central nervous system effects have been reported in clinical trials (23%).
Such effects should be discussed with the carer during treatment reviews and a dose reduction considered. Cardiac disorders Glycopyrronium is known to have an effect on heart rate and blood pressure at doses used during anaesthesia although clinical trials in children with chronic drooling have not shown this effect.
An effect on the cardiovascular system should be considered when assessing tolerability. 2%) counts has been seen. 7%) concentrations. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised February 20, 2026[1]
Anticholinergic effects Anticholinergic effects such as urinary retention, constipation and overheating due to inhibition of sweating may be dose dependent and difficult to assess in a disabled child. Monitoring by physicians and caregivers is required with adherence to the management instructions below: Management of important anticholinergic side effects The carer should stop treatment and seek advice from the prescriber in the event of: - constipation - urinary retention - pneumonia - allergic reaction - pyrexia - very hot weather - changes in behaviour After evaluating the event, the prescriber will decide if treatment should remain stopped or if this should continue at a lower dose.
Lack of long-term safety data Published safety data are not available beyond 24 weeks treatment duration. Given the limited long-term safety data available and the uncertainties around the potential risk for carcinogenicity, total treatment duration should be kept as short as possible.
g. g. in the non-palliative setting treating chronic disease) benefits and risks should be carefully considered on a case by case basis and treatment should be closely monitored. Mild to moderate sialorrhoea Due to the low potential benefit and the known adverse effect profile, glycopyrronium bromide tablets should not be given to children with mild to moderate sialorrhoea.
Cardiac disorders Glycopyrronium should be used with caution in patients with acute myocardial infarction, hypertension, coronary artery disease, cardiac arrhythmias and conditions characterised by tachycardia (including thyrotoxicosis, cardiac insufficiency, cardiac surgery) due to the potential increase in heart rate, blood pressure and rhythm disorders produced by its administration.
The carer should be advised to measure the pulse rate if the child seems unwell and report very fast or very slow heart rate. Gastro-intestinal disorders Antimuscarinics such as glycopyrronium should be used with caution in patients with gastro-oesophageal reflux disease, pre-existing constipation and diarrhoea.
Dental Since reduced salivation can increase the risk of oral cavities and periodontal diseases, it is important that patients receive adequate daily dental hygiene and regular dental health checks. Respiratory Glycopyrronium can cause thickening of secretions, which may increase the risk of respiratory infection and pneumonia.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised February 20, 2026[1]
1.
In common with other antimuscarinics:
Pregnancy and breast-feeding. 73m2), including those with end-stage renal disease requiring dialysis. 5); potassium chloride solid oral dose products; anticholinergics.
This is not medical advice. Consult a qualified healthcare professional.
CAOfficial regulatory label· revised March 22, 2025[2]
e. chronic bronchitis (with or without airflow limitation) or emphysema. Cessation of smoking produces dramatic symptomatic benefits and has been shown to confer a survival advantage. Elderly patients, hepatically impaired patients, and renally impaired patients can use SEEBRI BREEZHALER at the recommended dose.
However, as with all renally excreted drugs, SEEBRI BREEZHALER use should be monitored closely in patients with renal impairment or end stage renal disease. There is no experience with SEEBRI BREEZHALER in infants and children and therefore it should not be used in this age group.
2 Recommended Dose and Dosage Adjustment The recommended dosage of SEEBRI BREEZHALER is the once-daily oral inhalation of the content of one 50 mcg capsule using the SEEBRI BREEZHALER inhaler. The clinical trials were conducted based on dosing in the morning.
PrSEEBRI® BREEZHALER® (glycopyrronium bromide) Page 5 of 35 The capsule must not be swallowed. Dosing in special populations Renal impairment SEEBRI BREEZHALER can be used at the recommended dose in patients with mild to moderate renal impairment.
In patients with severe renal impairment or end-stage renal disease requiring dialysis SEEBRI BREEZHALER should be used only if the expected benefit outweighs the potential risk (See also 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY).
Hepatic impairment No specific studies have been conducted in patients with hepatic impairment. SEEBRI BREEZHALER is predominantly cleared by renal excretion and therefore no major increase in exposure is expected in patients with hepatic impairment.
No dose adjustment is required in patients with hepatic impairment. Geriatric patients SEEBRI BREEZHALER can be used at the recommended dose in elderly patients 65 years of age and older. Pediatric patients SEEBRI BREEZHALER should not be used in patients under 18 years of age.
4 Administration SEEBRI BREEZHALER is recommended for once-daily administration at the same time each day. SEEBRI BREEZHALER capsules must be administered only by the oral inhalation route and only using the SEEBRI BREEZHALER inhaler.
SEEBRI BREEZHALER capsules must not be swallowed (see also
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[2]
1 Adverse Reaction Overview The safety and tolerability of SEEBRI BREEZHALER was evaluated at the recommended dose of 50 mcg once-daily in 1353 COPD patients. Of these, 842 patients have been treated for at least 26 weeks (6 months), and 351 patients for at least 52 weeks (12 months).
Patients with unstable cardiac disease, long QT syndrome or QT prolongation, narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction were excluded from the studies. g. blurred vision), urinary retention, gastrointestinal disorders, dry mouth, cough a nd immediate hypersensitivity reactions.
Adverse drug reactions to SEEBRI BREEZHALER related to local tolerability included throat irritation, nasopharyngitis, rhinitis and sinusitis. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Adverse drug reactions with SEEBRI BREEZHALER reported during the first 6 months of two pooled pivotal Phase III trials of 6- and 12-months duration are listed by MedDRA system organ class (Table 2). Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
7) 1 n= number of patients analysed 2 N= number of patients with an adverse reaction The most common anticholinergic adverse drug reaction was dry mouth. The majority of the reports of dry mouth were suspected to be drug related and of mild degree, none was severe.
Rash was uncommon and generally mild. 3 versus 0%, respectively. 5 Post-Market Adverse Reactions The following adverse drug reactions have been reported with SEEBRI BREEZHALER in post-marketing experience. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune system disorders: hypersensitivity, angioedema. Respiratory, thoracic and mediastinal disorders: paradoxical bronchospasm, dysphonia Skin and subcutaneous tissue disorders: pruritus
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[2]
and 10 CLINICAL PHARMACOLOGY). Hepatic impairment No specific studies have been conducted in patients with hepatic impairment. SEEBRI BREEZHALER is predominantly cleared by renal excretion and therefore no major increase in exposure is expected in patients with hepatic impairment.
No dose adjustment is required in patients with hepatic impairment. Geriatric patients SEEBRI BREEZHALER can be used at the recommended dose in elderly patients 65 years of age and older. Pediatric patients SEEBRI BREEZHALER should not be used in patients under 18 years of age.
4 Administration SEEBRI BREEZHALER is recommended for once-daily administration at the same time each day. SEEBRI BREEZHALER capsules must be administered only by the oral inhalation route and only using the SEEBRI BREEZHALER inhaler.
SEEBRI BREEZHALER capsules must not be swallowed (see also 5 OVERDOSAGE). SEEBRI BREEZHALER capsules must always be stored in the blister to protect from moisture, and only removed IMMEDIATELY BEFORE USE. When prescribing SEEBRI BREEZHALER, patients should be instructed on the correct use of the inhaler.
Patients who do not experience improvement in breathing should be asked if they are swallowing the medicine rather than inhaling it. 5 Missed Dose If a dose is missed, the next dose should be taken as soon as possible. Patients should be instructed not to take more than one dose in a day.
5 OVERDOSAGE High doses of glycopyrronium may lead to signs and symptoms of exaggerated anticholinergic effects for which symptomatic treatment may be indicated. Such effects may include increased intraocular pressure causing pain, vision disturbances or reddening of the eye, obstipation or voiding difficulties.
In COPD patients, repeated orally inhaled administration of SEEBRI BREEZHALER at total doses of 100 and 200 mcg once-daily for 28 days were well tolerated. PrSEEBRI® BREEZHALER® (glycopyrronium bromide) Page 6 of 35 Acute intoxication by inadvertent oral ingestion of SEEBRI BREEZHALER capsules is unlikely due to the low oral bioavailability (about 5%).
v. administration of 120 mcg glycopyrronium in healthy volunteers were about 50-fold and 6-fold higher, respectively, than the peak and total systemic exposure at steady-state achieved with the recommended dose (50 mcg inhaled once-daily) of SEEBRI BREEZHALER in COPD patients and were well tolerated.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[2]
SEEBRI BREEZHALER (glycopyrronium bromide) is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Patients with severe hypersensitivity to milk proteins.
This is not medical advice. Consult a qualified healthcare professional.
Posology The recommended and maximum dose is two inhalations twice daily (two inhalations in the morning and two inhalations in the evening). If a dose is missed, it should be taken as soon as possible and the next dose should be taken at the usual time.
A double dose should not be taken to make up for a forgotten dose. 2). Renal impairment This medicinal product can be used at the recommended dose in patients with mild to moderate renal impairment. 2). 3 Hepatic impairment This medicinal product can be used at the recommended dose in patients with mild to moderate hepatic impairment.
2). Paediatric population There is no relevant use of this medicinal product in children and adolescents (under 18 years of age) for the indication of COPD. Method of administration For inhalation use. Instructions for use To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler correctly by a physician or other healthcare professional, who should also regularly check the adequacy of the patient's inhalation technique.
The patient should be advised to read the package leaflet carefully and follow the instructions for use as given in the leaflet. It is important to instruct the patients to: • Not use the inhaler if the drying agent, which is inside the foil pouch, has leaked out of its packet.
For best results the inhaler should be at room temperature before use. • Prime the inhaler by shaking it well and actuating into the air four times before first use or two times when the inhaler has not been used for more than seven days, after weekly washing or if it has been dropped.
• Rinse their mouth out with water after inhaling the dose to minimise the risk of oropharyngeal thrush. Do not swallow. On actuation of Riltrava Aerosphere, a volume of the suspension is expelled from the pressurised container. When the patient inhales through the mouthpiece at the same time as actuating the inhaler, the substance will follow the inspired air into the airways.
Patients who find it difficult to coordinate actuation with inhalation may use Riltrava Aerosphere with a spacer to ensure proper administration of the medicinal product. 2).
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised September 30, 2025[3]
Summary of the safety profile The safety profile is characterised by corticosteroid, anticholinergic and β2-adrenergic class effects related to the individual components of the combination. 7%). Tabulated list of adverse reactions The tabulated list of adverse reactions is based on the experience with this medicinal product in clinical trials and experience with the individual components.
The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).
g. 4) Not known Cardiac disorders Palpitations Common Angina pectoris Cardiac arrhythmias (atrial fibrillation, supraventricular tachycardia and extrasystoles) Tachycardia Uncommon Respiratory, thoracic and mediastinal disorders Dysphonia Cough Common Bronchospasm Throat irritation Uncommon Gastrointestinal disorders Nausea Common Dry mouth Uncommon Skin and subcutaneous tissue disorders Bruising Uncommon Musculoskeletal and connective tissue disorders Muscle spasms Common Renal and urinary disorders Urinary retention Uncommon 9 System Organ Class Preferred term Frequency General disorders and administration site conditions Chest pain Uncommon Description of selected adverse reactions Pneumonia KRONOS was a 24-week study in a total of 1,896 patients with moderate to very severe COPD (mean post-bronchodilator screening FEV1 50% of predicted, standard deviation [SD] 14%), 26% of whom had experienced a COPD exacerbation in the year prior to study entry.
3% (4 patients) for open-labelled formoterol fumarate dihydrate/budesonide Turbuhaler (FOR/BUD) TBH 6/200 micrograms (n=318). ETHOS was a 52-week study in a total of 8,529 patients (in the safety population) with moderate to very severe COPD and a history of moderate or severe exacerbations within the prior 12 months (mean post-bronchodilator screening FEV1 43% of predicted, SD 10%).
5% (96 subjects) FOR/BUD MDI 5/160 micrograms (n=2136). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
EUOfficial regulatory label· Warnings and precautions· revised September 30, 2025[3]
e. as a rescue therapy. Paradoxical bronchospasm Administration of formoterol/glycopyrronium/budesonide may produce paradoxical bronchospasm with an immediate wheezing and shortness of breath after dosing and may be life-threatening.
Treatment with this medicinal product should be discontinued immediately if paradoxical bronchospasm occurs. The patient should be assessed, and alternative therapy instituted if necessary. 4 Deterioration of disease It is recommended that treatment with this medicinal product should not be stopped abruptly.
If patients find the treatment ineffective, they should continue treatment, but medical attention must be sought. Increasing use of reliever bronchodilators indicates a worsening of the underlying condition and warrants a reassessment of the therapy.
Sudden and progressive deterioration in the symptoms of COPD is potentially life-threatening and the patient should undergo urgent medical assessment. g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including glycopyrronium and formoterol.
This medicinal product should be used with caution in patients with clinically significant uncontrolled and severe cardiovascular disease such as unstable ischemic heart disease, acute myocardial infarction, cardiomyopathy, cardiac arrhythmias, and severe heart failure.
Caution should also be exercised when treating patients with known or suspected prolongation of the QTc interval (QTc > 450 milliseconds for males, or > 470 milliseconds for females), either congenital or induced by medicinal products.
Systemic corticosteroid effects Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur with inhalation treatment than with oral corticosteroids.
Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, cataract and glaucoma. Potential effects on bone density should be considered particularly in patients on high doses for prolonged periods that have co-existing risk factors for osteoporosis.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised September 30, 2025[3]
1.
This is not medical advice. Consult a qualified healthcare professional.
Glycopyrronium should be discontinued if pneumonia is present. Central nervous system adverse events Increased central nervous system effects have been reported in clinical trials including: irritability; drowsiness; restlessness; over activity; short attention span; frustration; mood changes; temper outbursts or explosive behaviour; excessive sensitivity; seriousness or sadness; frequent crying episodes; fearfulness.
Behavioural changes should be monitored. As a consequence of its quaternary charge, glycopyrronium has limited ability to penetrate the blood brain barrier, although the extent of penetration is unknown. g. intraventricular shunt, brain tumour, encephalitis.
Children below the age of 3 years Glycopyrronium bromide is not recommended in children below the age of 3 years since there is very limited data on the efficacy and safety of glycopyrronium in this age group. Growth and development The effects of glycopyrronium on the reproductive system have not been investigated.
Whilst clinical studies do not report any short or long-term effect of glycopyrronium on neurodevelopment or growth, no studies have been conducted to specifically address these issues. Lactose This medicine contains Lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging 50 mcg SEEBRI BREEZHALER contains: Aluminium blister-packaged glycopyrronium as (glycopyrronium bromide) transparent orange capsules with the product code GPL50 printed in black above a black bar and the Novartis company logo printed under a black bar.
Each capsule contains 63 mcg glycopyrronium bromide equivalent to 50 mcg glycopyrronium. The delivered dose (the dose that leaves the mouthpiece of the SEEBRI BREEZHALER inhaler) is equivalent to 44 mcg glycopyrronium. Each capsule also contains lactose monohydrate and magnesium stearate.
The capsule shell components are carrageenan, FDC Yellow 6 (110 Sunset Yellow FCF), hypromellose, potassium chloride and purified water. The following pack types are available: Carton of 30 SEEBRI BREEZHALER capsules (3 blister cards) and one SEEBRI BREEZHALER device.
Carton of 10 SEEBRI BREEZHALER capsules (1 blister card) and 5 SEEBRI BREEZHALER devices. e. as a rescue therapy. , four times a day) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief of acute respiratory symptoms.
Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral inhalation Inhalation powder hard capsules/ contain 50 mcg glycopyrronium as glycopyrronium bromide Carrageenan, FDC Yellow 6 (110 Sunset Yellow FCF), hypromellose, lactose monohydrate, magnesium stearate, potassium chloride, and purified water.
e. short-acting beta-agonist) for treatment of COPD symptoms that occur acutely, despite regular once-daily use of SEEBRI BREEZHALER. COPD Deterioration SEEBRI BREEZHALER should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition.
The use of SEEBRI BREEZHALER in this setting is inappropriate. COPD may deteriorate acutely over a period of hours or chronically over several days or longer. If SEEBRI BREEZHALER no longer controls the symptoms of bronchoconstriction, or the patient’s inhaled, short - acting beta2-agonist becomes less effective or the patient needs more inhalation of short-acting beta2- agonist than usual, these may be markers of deterioration of disease.
In this setting, a re-evaluation of the patient and the COPD treatment regimen should be undertaken at once. Increasing the daily dosage of SEEBRI BREEZHALER beyond the recommended dose is not appropriate in this situation. Excessive Use SEEBRI BREEZHALER should not be used more frequently than once daily or at higher doses than recommended.
SEEBRI BREEZHALER should not be administered concomitantly with other medicines containing a long-acting muscarinic antagonist, as this has not been studied, and an overdose may result. Anticholinergic Effects Like other anticholinergic drugs, SEEBRI BREEZHALER should be used with caution in patients with narrow-angle […]
Visual disturbances Visual disturbance may be reported with systemic and topical corticosteroid use. 8). Transfer from oral therapy Particular care is needed in patients transferring from oral steroids, since they may remain at risk of impaired adrenal function for a considerable time.
Patients who have required high dose corticosteroid therapy or prolonged treatment at the highest recommended dose of inhaled corticosteroids, may also be at risk. These patients may exhibit signs and symptoms of adrenal insufficiency when exposed to severe stress.
Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. Pneumonia in patients with COPD An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids.
There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies. There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products.
5 Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations. Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index (BMI) and severe COPD.
Hypokalaemia Potentially serious hypokalaemia may result from β2-agonist therapy. This has the potential to produce adverse cardiovascular effects. Particular caution is advised in severe COPD as this effect may be potentiated by hypoxia.
5). Hyperglycaemia Inhalation of high doses of β2-adrenergic agonists may produce increases in plasma glucose. Therefore, blood glucose should be monitored during treatment following established guidelines in patients with diabetes. Co-existing conditions This medicinal product should be used with caution in patients with thyrotoxicosis.
Anticholinergic activity Due to its anticholinergic activity, this medicinal product should be used with caution in patients with symptomatic prostatic hyperplasia, urinary retention or with narrow-angle glaucoma. Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using this medicinal product and to contact their doctor immediately should any of these signs or symptoms develop.
5). 2). Hepatic impairment In patients with severe […]