Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
This medicine contains glycopyrronium bromide which belongs to a group of medicines called 'anticholinergic' or 'antimuscarinic' drugs.
This medicine is used to treat 'drooling' or excessive production of saliva (sialorrhoea) in children and adolescents aged 3 years and older.
Sialorrhoea (drooling or excessive salivation) is a common symptom of many diseases of the muscles or nerves. It is mainly caused by poor control of muscles in the face. Acute sialorrhoea may be associated with inflammation, dental or mouth infections. Glycopyrronium Bromide oral solution acts on the salivary glands to reduce production of saliva.
Do not give Glycopyrronium Bromide oral solution if the child: • is allergic to glycopyrronium bromide or any of the other ingredients of this medicine (listed in section 6)
• has glaucoma (increased pressure in the eye)
• has a condition called myasthenia gravis which leads to muscle weakness and fatigue
• has an obstruction of the stomach or bowel causing vomiting, abdominal pain and swelling
• has an enlarged prostate gland
• is unable to completely empty the bladder
• suffers from chronic end-stage kidney disease and requires dialysis
• is pregnant or breastfeeding
• is taking a medicine containing potassium chloride
• is taking anticholinergic medicines
Warnings and precautions Talk to a doctor or pharmacist before giving this medicine if the child:
• has gastric reflux (a condition in which the liquid stomach contents backs up into the gullet)
• has ulcerative colitis (a chronic inflammation of the large intestine (colon) which can cause abdominal pain, diarrhea and bleeding from the back passage)
• has just had a heart attack or is suffering from heart disease , irregular heartbeats or high blood pressure , because this medicine can cause a change to their normal heart rate
• has a faster heartbeat than normal (this can be caused by conditions such as an overactive thyroid gland, heart failure or heart surgery)
• is due to have surgery (including at the dentist) during which they will be 'put to sleep' using a general anaesthetic.
• has diarrhoea , especially if they have had an ileostomy or colostomy
• has a high temperature (fever) or the environmental temperature is high,
• has kidney disease
• has compromised blood brain barrier
• has been told by their doctor that they have an intolerance to some sugars
In addition, stop treatment and talk to their doctor if the child is suffering with the following:
• seem unwell with a very fast or very slow heart rate
• constipation
• pneumonia
• changes in behaviour
This medicine reduces salivation which can increase the risk of dental disease, therefore teeth should be brushed daily and the child should have regular dental checks.
Children This medicine is not recommended for children younger than 3 years.
Other medicines and Glycopyrronium Bromide oral solution Please tell the doctor if your child is taking or has recently taken any of the following medicines:
• Antidepressants such as amitriptyline, clomipramine, lofepramine or imipramine (known as tricyclic antidepressants) or monoamine oxidase inhibitors (MAOIs) such as phenelzine, moclobemide, rasagiline, selegiline or tranylcypromine
• Medicines such as chlorpromazine, fluphenazine, prochlorperazine or trifluoperazine, used to treat mental problems or nausea, vomiting or vertigo
• Antihistamines such as promethazine, used to treat allergies
• Medicines such as carbachol, neostigmine or physostigmine which affect the transmission of nerve impulses to muscles
• Corticosteroids such as prednisolone, used to treat various conditions including asthma and inflammation
• Inhaled anaesthetics , given before surgery (including at the dentist)
• Clozapine or haloperidol, used to treat schizophrenia
• Nefopam, used to treat acute and chronic pain
• Domperidone or metoclopramide, used to treat nausea and vomiting
• Amantadine or levodopa, used to treat Parkinson's disease
• Memantine, used to treat Alzheimer's disease
• Slow-dissolving digoxin tablets, disopyramide or atenolol, used to treat heart problems
• Metformin, used to treat type 2 diabetes
• Glyceryl trinitrate tablets, used to treat angina . These may not dissolve under the tongue as well as usual because this medicine can cause a dry mouth
• Topiramate or zonisamide, used to treat epilepsy and to prevent migraines
• Potassium chloride containing medicines (see section 2 "Do not give Glycopyrronium Bromide oral solution if")
• Anticholinergic medicines (see section 2 "Do not give Glycopyrronium Bromide oral solution if")
If the doctor tells you to give this medicine together with one or more similar medicines such as oxybutynin, then they may need to take less than the usual dose of this medicine.
Pregnancy and breastfeeding This medicine must not be given if the patient is pregnant or breastfeeding.
Discuss the need for contraception with the doctor.
Driving and using machines This medicine may make the patient feel drowsy or cause their eyesight to become blurred.
Do not drive or operate machinery until these effects have fully cleared.
If there is any doubt, ask your doctor for advice.
Glycopyrronium bromide oral solution contains sodium benzoate (E211) and sorbitol (E420) • If you have been told by the doctor that your child has an intolerance to some sugars, contact the doctor before giving this medicine. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.
• This medicine contains less than 1 mmol sodium (23 mg) per maximum dose, i.e. essentially 'sodium free'. This medicine contains 2.3 mg benzoate salt (E211) in each 5 ml of oral solution.
Always give this medicine exactly as the doctor has told you. Check with your doctor or pharmacist if you are not sure.
Dose for children and adolescents aged 3 years and older: The initial dose will be calculated based on the weight of the child.
The dose may be adjusted depending on how well they respond to treatment, and if any side effects occur.
The child should be checked by your doctor every 3 months to check that this medicine is still the right treatment for them.
When to take the medicine The medicine should be given to your child three times each day.
It should be given at least one hour before or two hours after a meal.
Directions for use • Remove the cap from the bottle. Insert the syringe adaptor into the neck of the bottle (this may have been done already by the pharmacist). Insert the end of the syringe into the adaptor and ensure it is secure.
• Hold the syringe in place and turn the bottle upside down. Gently pull down the plunger to the correct level The maximum volume of the highest dose is 15 ml.
• Turn the bottle upright. Remove the syringe by holding the bottle and twisting the syringe gently.
• Place the syringe inside the child's mouth and press the plunger slowly to gently release the medicine. After use, leave the syringe adaptor in the neck of the bottle.
• Repeat the above steps if a higher dosage is recommended.
• Replace the cap.
• Wash the syringe with warm water and allow to dry after each use.
If your child is given the medicine through a feeding tube, flush the tube with at least 20 ml of water after you have given the medicine.
If you give more Glycopyrronium Bromide oral solution than you should Consult the doctor or get medical advice immediately, as your child may experience side effects. If possible, take the bottle and this leaflet with you so that the medical staff know what you have given.
If you forget to give Glycopyrronium Bromide oral solution • Give it as soon as possible, then give the next dose at the normal time.
• However, if the next dose is due, do not give the missed dose; just give the next dose as normal.
• Do not give a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects If any of the following serious side effects occur, stop giving the medicine and seek medical advice immediately:
• Allergic reaction such as swelling of the tongue, lips, face or throat, hives, difficulty breathing or swallowing, itching
• Constipation (difficulty in passing stools)
• Urinary retention (unable to completely empty the bladder)
• Pneumonia (severe chest infection)
• Fever
• Changes in behaviour such as mood changes, irritability
Other side effects: Very common (may affect more than 1 in 10 people)
• Dry mouth
• Diarrhoea
• Being sick (vomiting)
• Flushing
• Nasal congestion
• Reduced secretions in the chest
• Reduced secretions in the airways
Common (may affect up to 1 in 10 people)
• Upper respiratory tract infection (chest infection)
• Urinary tract infection
• Drowsiness (sleepiness)
• Agitation
• Rash
Uncommon (may affect up to 1 in 100 people)
• Allergy
• Headache
• Involuntary eye movement (nystagmus)
• Bad breath (halitosis)
• Rash (Hives)
• Nose bleeds (epistaxis)
• Fungal infection (thrush) of the throat (oesophageal candidiasis)
• Widening of the pupil of the eye (mydriasis)
• Dehydration
• Thirst
• Urgent need to urinate
• Insomnia (difficulty in sleeping)
• Abnormal contractions of digestive tract when food is ingested (gastrointestinal motility disorder)
• A disorder of the muscles and nerves in the intestine which causes an obstruction or blockage (pseudo-obstruction)
Unknown (frequency cannot be estimated from the available data)
• Nausea
• Angle-closure glaucoma (increased pressure in the eye)
• Photophobia
• Dry eyes
• Angioedema
• Decrease in heart rate (transient bradycardia)
• Sinus infection (sinusitis)
• Skin dryness
• Sweat inhibition
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use Glycopyrronium bromide oral solution after the expiry date which is stated on the label, carton or bottle after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Use within 35 days of opening the bottle.
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.
What Glycopyrronium bromide oral solution contains • The active substance is glycopyrronium bromide. Each 5 ml of oral solution contains 1 mg of glycopyrronium bromide.
• The other ingredients are glycerol anhydrous (E422), sorbitol (E420), sodium benzoate (E211), sucralose (E955), citric acid (E330), strawberry flavouring (containing propylene glycol E1520) and purified water.
What Glycopyrronium bromide oral solution looks like and contents of the pack Glycopyrronium bromide oral solution is a clear, colourless, strawberry flavoured liquid.
Glycopyrronium bromide oral solution is supplied in an amber glass bottle or polyethylene terephthalate (PET) bottle of 150 ml with child resistant tamper evident polypropylene closure, a 10 ml syringe and a syringe adaptor.
Marketing Authorisation Holder Glenmark Pharmaceuticals Europe Limited
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Manufacturer Glenmark Pharmaceuticals Europe Limited
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Glenmark Pharmaceuticals s.r.o.
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Czech Republic
This leaflet was last revised in 08/2024
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Glycopyrronium Bromide 1 mg/5 ml oral solution comes as oral solution containing 1mg / 5ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Glycopyrronium Bromide 1 mg/5 ml oral solution is glycopyrronium bromide.
Medicines with the same active substance, strength and form include: Glycopyrronium Bromide 1 mg/5 ml Oral Solution, Glycopyrronium Bromide 1 mg/5 ml Oral Solution, Glycopyrronium Bromide 1 mg/5 ml Oral solution. In total there are 6 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Glycopyrronium Bromide 1 mg/5 ml oral solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.
Posology
Glycopyrronium bromide oral solution is recommended for short-term intermittent use (see section 4.4 and 5.1)
The dosage must be measured and administered with the graduated syringe included in the pack.
The dosing schedule for Glycopyrronium bromide oral solution is based on the weight of the child with the initial dosing of 0.02 mg/kg to be given orally three times daily and titrate in increments of 0.02 mg/kg every 5-7 days based on therapeutic response and adverse reactions. The maximum recommended dosage is 0.1 mg/kg three times daily not to exceed 1.5-3 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.
Table 1: Dosing tables for children and adolescents aged 3 years and older
Weight
Dose Level 1
Dose Level 2
Dose Level 3
Dose Level 4
Dose Level 5
kg
(~0.02 mg/kg)
(~0.04 mg/kg)
(~0.06 mg/kg)
(~0.08 mg/kg)
(~0.1 mg/kg)
13-17
0.3 mg
1.5 ml
0.6 mg
3 ml
0.9 mg
4.5 ml
1.2 mg
6 ml
1.5 mg
7.5 ml
18-22
0.4 mg
2 ml
0.8 mg
4 ml
1.2 mg
6 ml
1.6 mg
8 ml
2.0 mg
10 ml
23-27
0.5 mg
2.5 ml
1.0 mg
5 ml
1.5 mg
7.5 ml
2.0 mg
10 ml
2.5 mg
12.5 ml
28-32
0.6 mg
3 ml
1.2 mg
6 ml
1.8 mg
9 ml
2.4 mg
12 ml
3.0 mg
15 ml
33-37
0.7 mg
3.5 ml
1.4 mg
7 ml
2.1 mg
10.5 ml
2.8 mg
14 ml
3.0 mg
15 ml
38-42
0.8 mg
4 ml
1.6 mg
8 ml
2.4 mg
12 ml
3.0 mg
15 ml
3.0 mg
15 ml
43-47
0.9 mg
4.5 ml
1.8 mg
9 ml
2.7 mg
13.5 ml
3.0 mg
15 ml
3.0 mg
15 ml
≥48
1.0 mg
5 ml
2.0 mg
10 ml
3.0 mg
15 ml
3.0 mg
15 ml
3.0 mg
15 ml
Glycopyrronium Bromide oral solution is not recommended for use in children younger than 3 years.
Hepatic Impairment
Clinical studies have not been evaluated in patients with hepatic impairment. Glycopyrrolate is eliminated largely from the renal excretion and hepatic impairment is not thought to result in an increase in a systemic exposure of Glycopyrronium.
Renal impairment
Elimination of glycopyrrolate is severely impaired in patients with renal failure therefore reduction in doses should be considered.
High fat food should be avoided. The presence of high fat food reduces the oral bioavailability of Glycopyrronium Bromide if given shortly after a meal. Therefore, it should be given at least one hour before or two hours after meals. If the patient's specific needs determine that co-administration with food is required, dosing of the medicinal product should be consistently performed during food intake (see section 5.2).
Method of administration
For oral use and use with nasogastric and or PEG tubes.
The correct quantity of Glycopyrronium Bromide oral solution should be measured and administered using the syringe included in the pack.
Nasogastric feeding tubes, if used, should be flushed with minimum 20 ml of water immediately after dosing. See Section 6.6 for instructions for use.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
In common with other antimuscarinics:
• Angle-closure glaucoma
• Myasthenia gravis (large doses of quaternary ammonium compounds have been shown to antagonise end plate nicotinic receptors)
• Pyloric stenosis
• Paralytic ileus
• Prostatic enlargement
• Urinary retention
• Severe renal impairment (eGFR <30 ml/min/1.73m2, including those with end-stage renal disease requiring dialysis
• Intestinal obstruction
• Pregnancy and breast-feeding
• Potassium chloride solid oral dose products
• Anticholinergic medicines
Glycopyrronium Bromide oral solution should be used with caution in gastro-oesophageal reflux disease, ulcerative colitis, pre-existing constipation, acute myocardial infarction, hypertension, conditions characterised by tachycardia (including hyperthyroidism, cardiac insufficiency, cardiac surgery) because of the increase in heart rate produced by its administration, coronary artery disease and cardiac arrhythmias.
Due to the potential change to normal heart rhythm, Glycopyrronium Bromide should be used with caution in patients receiving inhalation anaesthesia.
Diarrhoea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with this drug would be inappropriate and possibly harmful.
As Glycopyrronium Bromide inhibits sweating, patients with increased temperature should be observed closely. In the presence of a high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with use of Glycopyrronium Bromide oral solution.
Because of prolongation of renal elimination, repeated or large doses of Glycopyrronium Bromide should be avoided in patients with uraemia.
Patients with rare hereditary problems of fructose intolerance should not take this medicine. This is due to the presence of sorbitol (E420) in this medicine.
Glycopyrronium Bromide oral solution contains sorbitol. This may cause gastrointestinal discomfort and mild laxative effect.
This medicinal product contains less than 1 mmol sodium (23 mg) per maximum dose, i.e. essentially is 'sodium free '. Glycopyrronium Bromide is not recommended for use in children younger than 3 years of age.
Anticholinergic effects
Anticholinergic effects such as urinary retention, constipation and overheating due to inhibition of sweating are dose dependent. 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
Safety data are not available beyond 24 weeks treatment duration. Given the limited long-term safety data available and the uncertainties around the long term use of the product, the treatment duration should be kept as short as possible. If continuous treatment is needed (e.g. in a palliative setting) or the treatment is repeated intermittently (e.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 oral solution should not be given to children with mild to moderate sialorrhoea.
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.
CNS adverse events
Increased central nervous system effects have been reported in clinical trials including: irritability; drowsiness; restlessness; overactivity; 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. Caution should be exercised in children with compromised blood brain barrier eg. Intraventicular shunt, brain tumour, encephalitis.
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.
Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per maximum dose, i.e. essentially 'sodium free'.
Sodium benzoate
This medicinal product contains 2.3 mg sodium benzoate (E211) in each 5 ml of oral solution.
Class interactions
Many drugs have antimuscarinic effects; concomitant use of two or more of such drugs can increase side-effects such as dry mouth, urine retention and constipation. Concomitant use can also lead to confusion in the elderly. The Glycopyrronium Bromide dosage may need to be decreased in patients receiving two or more antimuscarinic drugs concomitantly.
Increased antimuscarinic side-effects: amantadine; tricyclic antidepressants; antihistamines; clozapine; disopyramide; MAOIs; nefopam; memantine; phenothiazines (increased antimuscarinic side effects of phenothiazines but reduced plasma concentrations)
Possibly increased antimuscarinic side-effects: tricyclic (related) antidepressants Anticholinergic agents may delay absorption of other medication given concomitantly.
Concurrent administration of anticholinergics and corticosteroids may result in increased intraocular pressure.
Concurrent use with slow-dissolving tablets of digoxin, atenolol or metformin may result in increased serum levels of these medicines.
Concurrent use with parasympathomimetics may antagonise the effect.
Specific interactions
Domperidone/Metoclopramide: antagonism of effect on gastro-intestinal activity
Levodopa: absorption of levodopa possibly reduced
Haloperidol: effects of haloperidol possibly reduced
Nitrates: possibly reduced effect of sublingual nitrates (failure to dissolve under the tongue owing to dry mouth)
Topiramate and zonisamide: enhanced effect (reduction of sweating)
Inhaled anaesthetics: potential change to normal heart rhythm
Women of child-bearing potential
Women of childbearing potential have to use effective contraception during the treatment.
Pregnancy
There are no data on the use of Glycopyrronium bromide 1mg/5ml oral solution in pregnant women. The assessment of reproductive endpoints for glycopyrronium is limited (see section 5.3). Glycopyrronium is contraindicated in pregnancy (see section 4.3).
Breastfeeding
Safety in breast-feeding has not been established. Use whilst breast feeding is contraindicated (see section 4.3). Fertility
There are no data on the effects of Glycopyrronium Bromide 1mg/5ml oral solution on male or female fertility. Reproductive performance in rats given glycopyrronium shows a decrease in the rate of conception and in survival rate at weaning. There are insufficient data in the public domain to adequately assess effects on the reproductive system in young adults (see section 5.3).
Glycopyrronium Bromide oral solution may influence the ability to drive and use machines because it may produce drowsiness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery, or performing hazardous work while taking this drug.
Glycopyrronium Bromide may produce the following effects, which are extensions of its fundamental pharmacological actions: dry mouth, diminished gastrointestinal motility, difficulty in micturition, increased body temperature and inhibition of sweating.
Side-effects of antimuscarinics include difficulty swallowing, difficulty talking, thirst, constipation, transient bradycardia (followed by tachycardia, palpitation and arrhythmias), reduced bronchial secretions, urinary urgency and retention, dilatation of the pupils with loss of accommodation, photophobia, flushing, and dryness of the skin.
Other side-effects that occur less frequently include confusion (particularly in the elderly), nausea, vomiting, drowsiness, dizziness and angle-closure glaucoma.
Summary of the safety profile
The highest incidence of adverse reactions associated with Glycopyrronium Bromide therapy is related to its anticholinergic properties1 i.e. dry mouth (13%), constipation (16%), diarrhoea (9.4%), nasal congestion (8.4%), vomiting (11.4%), urinary retention (5.4%) etc.
Pulmonary undesirable effects including upper respiratory infection and pneumonia have been reported. The incidence rate cannot be calculated from the available data (See Section 4.4).
There is no data on the long-term use of the product. (see section 4.4).
Tabulated list of adverse reactions
Adverse reactions associated with Glycopyrronium Bromide obtained from published studies1 are tabulated below according to the following convention: Very common (>1/10); Common (>1/100, <1/10); Uncommon (>1/1,000, <1/100); Unknown (cannot be estimated from the available data)
System Organ Class/ Adverse reaction
Frequency
Immune system disorder
Allergic reaction
Uncommon
Nervous system disorder
Headache
Unknown
Somnolence
Unknown
Drowsiness
Unknown
Seizure (worsening)
Uncommon
Dizziness
Unknown
Insomnia
Uncommon
Gastrointestinal disorder
Dry mouth
Very common
Constipation
Very common
Diarrhoea
Very common
Vomiting
Very common
Pseudo-obstruction
Uncommon
Gastrointestinal mobility disorder
Uncommon
Eosophageal candidiasis
Uncommon
Breath odour
Uncommon
Nausea
Unknown
Infections and infestations
Upper respiratory infection
Unknown
Pneumonia
Common
Otitis media
Unknown
Streptoccocal pharyngitis
Unknown
Urinary tract infection
Unknown
Psychiatric disorder
Behavioural changes2
Very common
Eye disorder
Nystagmus
Uncommon
Mydriasis
Unknown
Blurred vision
Unknown
Angle-closure glaucoma
Unknown
Photophobia
Unknown
Dry Eyes
Unknown
Cardiac disorder
Flushing
Very common
Angioedema
Unknown
Transient bradycardia
Unknown
Respiratory, thoracic and mediastinal disorders
Nasal congestion
Very common
Reduced bronchial secretions
Very common
Epistaxis
Unknown
Sinusitis
Unknown
Skin and subcutaneous tissue disorder
Rash
Unknown
Hives
Uncommon
Skin dryness
Unknown
Sweat inhibition
Unknown
Renal and urinary disorders
Urinary retention
Common
Urinary urgency
Uncommon
General disorders and administration site conditions
Pyrexia
Common
Dehydration
Uncommon
Thirst
Uncommon
1Frequency categories are assigned from the pooled data from the following published studies: double blinded placebo controlled trials Mier et al. and Zeller et al. 2012a, one retrospective review Bachrach et al., and three one open –label studies Zeller et al 2012b, Stern and Blasco et al. with a total of 297 patients exposed to glycopyrromium.
2Behavioural changes include agitation, drowsiness, restlessness, overactivity, short attention span, frustration, irritability, mood changes, temper outbursts, explosive behaviour, excessive sensitivity, seriousness, sadness, frequent crying, fearfulness.
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 Yellow Card Scheme at www.mhra.gov.co.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Since glycopyrronium bromide is a quaternary ammonium agent, symptoms of overdosage are peripheral rather than central in nature. Theoretically, with overdosage, a curare-like action may occur, i.e. neuro-muscular blockade leading to muscular weakness and possible paralysis. Furthermore, the likelihood of experiencing anticholinergic side effects is increased.
Treatment of overdose is symptomatic and supportive.
• To guard against further absorption of the drug, use gastric lavage, cathartics and/or enemas.
• To combat peripheral anticholinergic effects (residual mydriasis, dry mouth, etc.), utilise a quaternary ammonium anticholinesterase, such as neostigmine. Proportionately smaller doses should be used in children.
• To combat hypotension, use pressor amines (norepinephrine, metaraminol) i.v. and supportive care.
• To combat respiratory depression, administer oxygen; utilise a respiratory stimulant such as Doxapram hydrochloride i.v. and artificial respiration.
Ask anything about Glycopyrronium Bromide 1 mg/5 ml oral solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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