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.
for 2. What you need to know before you take Glycopyrronium bromide Oral Solution 3. How to take Glycopyrronium bromide Oral Solution 4. Possible side effects 5. How to store Glycopyrronium bromide Oral Solution 6. Contents of the pack and other information 1. WHAT GLYCOPYRRONIUM BROMIDE ORAL SOLUTION IS AND WHAT IT IS USED FOR
Glycopyrronium bromide Oral Solution is used to treat excessive production of saliva (sialorrhoea) in patients suffering from long term neurological disorders which have occurred in childhood, in patients aged 3 years and older. Sialorrhoea (drooling or excessive salivation) is a common symptom of many diseases of the nerves and muscles. It is mostly caused by poor control of muscles in the face. Acute sialorrhoea may be associated with inflammation, dental infections or infections of the mouth. Glycopyrronium bromide Oral Solution acts on the salivary glands to reduce the production of saliva.
E GLYCOPYRRONIUM BROMIDE ORAL SOLUTION DO NOT take Glycopyrronium bromide Oral Solution and talk to your doctor if you:
® are allergic to glycopyrronium bromide or any of the ingredients of this medicine (listed in section 6 at the end of the leaflet) are pregnant or breastfeeding suffer from glaucoma (increased pressure in the eye) are unable to completely empty the bladder (urinary retention) have severe kidney disease have an enlarged prostate gland (prostatic hypertrophy) have an obstruction of the stomach (pyloric stenosis) or bowel causing vomiting have ulcerative colitis (inflammation of the intestine) have diarrhoea (frequent, loose watery stools) have a stomach ache and swelling (paralytic ileus) have myasthenia gravis (muscle weakness and fatigue) are over 65 years of age are taking any of the following medicines (see section Other medicines and Glycopyrronium bromide Oral Solution):
can
increase
the
risk
of
dental
Taking Glycopyrronium bromide Oral Solution with the following medicines can affect the way Glycopyrronium bromide Oral Solution or the listed medicine works or can increase the risk of side effects: ® potassium chloride solid oral dose (see section above "DO NOT take Glycopyrronium bromide Oral Solution if you:")
* e
¢
©
Glycopyrronium bromide (the active substance in Glycopyrronium bromide Oral Solution) belongs to a group of medicines called quatemary ammonium anticholinergics, which are agents that block or reduce the transmission between nerve cells. This reduced transmission can de-activate the cells that produce saliva.
Reduced
or have recently taken any other medicines, including medicines obtained without a prescription.
disease,
therefore the patient's teeth should be brushed daily and they should have regular dental health checks. Patients with kidney problems may be given a lower dose. If you (or the patient) feel unwell, check your pulse and report any slow or very fast heart rate to your doctor. Children
This medicine is NOT recommended for use in children under 3 years of age (see section 3). Other medicines and Glycopyrronium bromide Oral Solution Tell your doctor or pharmacist if you or the patient are taking
anticholinergic medicines (see section above "DO NOT take Glycopyrronium bromide Oral Solution if you:") antispasmodics used to treat sickness or vomiting e.g. domperidone and metoclopramide topiramate used to treat epilepsy antihistamines such as promethazine used to treat some allergies neuroleptics/antipsychotics (clozapine, haloperidol, phenothiazine), used to treat some mental illnesses skeletal muscle relaxants (botulinum toxin) antidepressants such as amitriptyline, clomipramine, lofepramine or imipramine (known as tricyclic antidepressants) opioids used to treat severe pain corticosteroids used to treat inflammatory diseases (e.g. prednisolone).
Talk to your doctor or pharmacist for further information about any medicines to avoid or if you are in doubt about any of the above medicines. Glycopyrronium bromide oral solution is not interchangeable with other glycopyrronium products without dose adjustment and when switching between products, the specific dose recommendations for each product must be followed to avoid overdose and anticholinergic side effects. Long term use Long term efficacy and safety of Glycopyrronium bromide Oral Solution has not been studied beyond 24 weeks of use. Continued use should be discussed with the patient's doctor every 3 months to check that Glycopyrronium bromide Oral Solution is still right for the patient. Pregnancy and breast-feeding Glycopyrronium bromide Oral Solution must not be given if the patient is pregnant or thinks they may be pregnant or is breastfeeding (see section 2 'Do not take'). Discuss with the patient's doctor whether there is a need for contraception. Driving and using machines Glycopyrronium bromide Oral Solution may affect vision and co-ordination. This may affect the performance of skilled tasks such as driving, riding a bicycle, or using machines. If the patient is affected in this way, DO NOT drive, ride a bicycle or operate machinery until their vision and co-ordination have completely recovered. If there is any doubt, ask your doctor for advice. Glycopyrronium bromide Oral Solution contains:
medical consultations, including those for dose increases and decreases, and at any other time should you be concerned.
e
The patient should be monitored at regular intervals (at least every 3 months) to check that Glycopyrronium bromide Oral Solution is still the right treatment for you or them.
Gommon side effects (may affect up to 1 in 10 people) © Upper respiratory tract infections (chest infection) Pneumonia (severe chest infection) Urinary tract infection Drowsiness (sleepiness) Agitation Fever (pyrexia) Nose bleeds (epistaxis) Rash
Glycopyrronium bromide Oral Solution is recommended for shortterm intermittent use. tronium bromide 1 mg/5 ml Oral Solution:
Weight
Dose
Dose
Dose
Dose
Dose
Level 1 |
Level2 |
Level3 |
Level4 |
Level5
1.5
3
45
6
1.9
18-22
2
4
6
8
10
23-27
2.5
5
15
10
12.5
28-32
3
6
9
12
15
33-37
3.5
7
10.5
14
15
38-42
4
8
12
15
15
43-47
45
9
13.5
15
15
248
5
10
16
15
a4 7
the oral syringe Remove the child-resistant closure from the bottle. Insert the syringe adaptor with the hole into the neck of the bottle. Insert the end of the oral syringe into the syringe adaptor and ensure it is secure. Hold the oral syringe in place and tum the bottle upside down. (Fig. 1) Gently pull down the plunger to the correct level (see the table for the correct dose). Check you have the correct level. The maximum Tum
Uncommon side effects (may affect up to 1 in 100 people) © Bad breath (halitosis) e Fungal infection (thrush) of the throat (oesophageal candidiasis) ¢ Abnormal contractions of the 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) Widening of the pupil of the eye (mydriasis) Involuntary eye movement (nystagmus) Headache Dehydration
Thirst in hot weather
Give the dose prescribed by your doctor 3 times each day.
volume of the highest dose is 15ml.
Reduced secretion in the chest Irritability
Fig. 1
the bottle upright. Remove the oral syringe by
holding the bottle and twisting the oral syringe gently. Place the oral syringe inside the patient's mouth and press the plunger slowly to gently release the medicine. Repeat the above steps if a higher dosage (e.g. above 12m) is recommended for you. After the bottle is tumed to the upright position, the
dosing syringe can be removed (Fig. 2). Replace the closure after removing the inserted adaptor.
Other side effects that occur with anticholinergics but their frequency with glycopyrronium is not known Allergic reaction (rash, itching, red raised itchy rash (hives), difficulty breathing or swallowing, dizziness) Severe allergic reaction (angioedema); signs include swelling mainly of the tongue, lips, face or throat Restlessness; overactivity; short attention span; frustration; mood changes; temper outbursts or explosive behaviour; excessive sensitivity; seriousness or sadness; frequent crying episodes; fearfulness Insomnia (difficulty in sleeping) Raised pressure in the eye (which might cause glaucoma) Photophobia (sensitivity to light) Dry eyes
Slow heart rate followed by rapid heart rate, palpitations and irregular heartbeat Inflammation and swelling of sinuses (sinusitis) Feeling sick (nausea) Dry skin Reduced ability to sweat, which can cause fever and heatstroke Urgent need to urinate
The oral syringe should be washed with warm water and allowed to dry after each use (ie. three times per day).
Side effects can sometimes be difficult to recognise in patients with neurological problems who cannot easily tell you how they feel. If you think a troublesome side effect is occurring after increasing a dose, the dose should be decreased to the previous one used and your doctor contacted.
Children under 3 years of age MUST NOT take Glycopyrronium bromide Oral Solution.
Tell your doctor if you notice any behavioural changes or any other changes.
If you take more Glycopyrronium bromide Oral Solution than you should If you take more than the prescribed amount of this medicine consult your doctor or get medical advice immediately. Always take any leftover medicine with you, as well as the bottle and this leaflet, so that the medical staff Know what you have been given.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information
If you forget to take Glycopyrronium bromide Oral Solution Do not worry. If you remember later on that day, take that day's dose as usual. If you miss a whole day's dose, take the normal dose on the next day. DO NOT take a double dose to make up for a forgotten dose. If you are not sure, ask your doctor or pharmacist.
Like all medicines, Glycopyrronium bromide Oral Solution can cause side effects, although not everybody gets them. If any of the following serious side effects occur, stop using the medicine and seek urgent medical advice. Constipation (difficulty in passing stools) – very common Difficulty in passing urine (urinary retention) – very common Pneumonia (severe chest infection) – common Allergic reaction (rash, itching, red raised itchy rash (hives), difficulty breathing or swallowing, dizziness) – frequency not known The following side effects may be a sign of a severe allergic reaction. If they occur, take the patient to your nearest emergency medical facility and take the medicine with you. © Swelling mainly of the tongue, lips, face or throat (possible signs of angioedema) – frequency not known. Other side effects are: Very Common side effects (may affect more than 1 in 10 people) e Dry mouth ¢ Difficulty in passing stools (constipation) Diarrhoea Being sick (vomiting) Flushing Nasal congestion Unable to completely empty the bladder (urinary retention)
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 bottle label and carton. The expiry date refers to the last day of that month. After first opening the bottle, Glycopyrronium bromide Oral Solution can be used for 35 days. Store in the original package in order to protect from light. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
GLYCOPYRRONIUM BROMIDE ORAL SOLUTION
If you stop taking Glycopyrronium bromide Oral Solution Your doctor will tell you how long to take the treatment for. DO
NOT stop earlier than you are told, even if you feel better. Your doctor may decide to stop treatment if side effects cannot be managed by reducing the dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
What Glycopyrronium bromide Oral Solution contains The active substance is glycopyrronium bromide. Each 5 ml of Glycopyrronium bromide 1 mg/5 ml Oral Solution contains 1 mg of glycopyrronium bromide.
The other ingredients are citric acid monohydrate, glycerol, methyl parahydroxybenzoate (E218), propylene glycol, propyl parahydroxybenzoate (E216), saccharin sodium, sodium citrate, sorbitol liquid (E420) and cherry flavour (which contains ethanol). What Glycopyrronium bromide Oral Solution looks like and contents of the pack Glycopyrronium bromide 1 mg/5 ml Oral Solution is a clear cherry flavoured solution. It is supplied in a 100mI or 150ml amber glass bottle in a cardboard carton. Each carton contains one bottle, one oral syringe and one syringe adaptor. Marketing Authorisation Holder Somex Pharma, Ilford, Essex, IG3 8BS. UK. Manufacturer: SIDEFARMA
Farmacéutica,
S.A. Rua da Guiné, n° 26, 2689-514 Prior Velho, Portugal This leaflet was last revised in 09/2025
Other sources of information To request a copy of this leaflet in braille or large print, please call 020 8590 9399 (UK Only).
Glycopyrronium bromide 1mg/5ml 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 1mg/5ml 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 1mg/5ml 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) due to chronic neurological disorders of childhood-onset in patients 3 years and older.
Glycopyrronium bromide oral solution should be prescribed by physicians experienced in the treatment of paediatric patients with neurological disorders. The drug must be measured and administered with an accurate measuring device supplied with this product.
Posology
Due to the lack of long-term safety data, glycopyrronium bromide oral solution is recommended for short-term intermittent use (see sections 4.4 and 5.1).
Paediatric population – children and adolescents aged 3 years and older
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. Before 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 borne in mind when any dose adjustments are carried out.
Following the dose titration period, the child's sialorrhoea should be monitored, in conjunction with the caregiver at no longer than 3 monthly intervals, to assess changes in efficacy and/or tolerability over time, and the dose adjusted accordingly.
Table 1 shows the dose in ml of the solution to be given for each weight range at each dosing increase.
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)
14-17
0.3 mg
1.5ml
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
Paediatric population – children aged <3 years
Glycopyrronium bromide oral solution is not recommended in children aged <3 years.
Adult population
For adolescents with chronic neurological disorders of childhood-onset, their stable dose of glycopyrronium bromide can be continued into adulthood. For adults with chronic neurological disorders of childhood-onset who are initiating glycopyrronium bromide, the dosing schedule described under the paediatric population subheading and summarised in Table 1 should be followed.
Elderly population
The elderly population 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 oral solution 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. Glycopyrronium is contraindicated in those with severe renal failure (see section 4.3). For patients with Mild to moderate renal impairment (eGFR <90 - ≥30 ml/min/1.73m2) 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.
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. Where 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).
Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Pregnancy and breast-feeding.
Glaucoma
Urinary retention
Severe renal impairment (eGFR <30 ml/min/1.73m2), including those with end-stage renal disease requiring dialysis
History of intestinal obstruction, ulcerative colitis, paralytic ileus, pyloric stenosis and myasthenia gravis
Concomitant treatment with (see section 4.5)
- potassium chloride solid oral dose
- anticholinergics.
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 patient. 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 of 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. 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 should not be given to patients 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 a very fast or very slow heart rate.
Gastrointestinal 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. Glycopyrronium should be discontinued if pneumonia is present.
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 patients with compromised blood-brain barrier e.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.
This medicinal product contains the following:
- Sorbitol; this medicine contains 3750mg sorbitol in each 5ml dose. Sorbitol is a source of fructose. If your doctor told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HF1), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
- Methyl hydroxybenzoate (E218) and Propyl hydroxybenzoate (E216); which may cause allergic reactions (possibly delayed).
- Propylene glycol; this medicine contains 150mg propylene glycol in each 5ml dose.
- Sodium; this medicine contains less than 1 mmol sodium (23 mg) per 5ml dose, which is to say essentially 'sodium-free.
- Ethanol (present in the cherry flavour); this medicine contains 0.000011mg of alcohol (ethanol) in each 5ml dose. The small amounts of alcohol in this medicine will not have any noticeable effects.
No interaction studies have been performed.
Paediatric population
There are limited data available relating to interactions with other medicinal products in the paediatric age group.
The following medicinal product interaction information is relevant to glycopyrronium.
Contraindications of concomitant use
Concomitant use of the following medicinal products is contraindicated (see section 4.3):
Potassium chloride solid oral dose: glycopyrronium may potentiate the risk of upper gastrointestinal injury associated with oral solid formulations of potassium chloride due to increased gastrointestinal transit time creating a high localized concentration of potassium ions. An association with upper GI bleeding and small bowel ulceration, stenosis, perforation, and obstruction has been observed.
Anticholinergics: concomitant use of anticholinergics may increase the risk of anticholinergic side effects. Anticholinergics may delay the gastrointestinal absorption of other anticholinergics administered orally and also increase the risk of anticholinergic side effects.
Concomitant use to be considered with caution
Concomitant use of the following medicinal products should be considered with caution:
Antispasmodics: glycopyrronium may antagonize the pharmacologic effects of gastrointestinal prokinetic active substances such as domperidone and metoclopramide.
Topiramate: glycopyrronium may potentiate the effects of oligohidrosis and hyperthermia associated with the use of topiramate, particularly in paediatric patients.
Sedating antihistamines: may have additive anticholinergic effects. A reduction in anticholinergic and/or antihistamine dosage may be necessary.
Neuroleptics/antipsychotics: the effects of active substances such as phenothiazine's, clozapine and haloperidol may be potentiated. A reduction in anticholinergic and/or neuroleptic/antipsychotic dose may be necessary.
Skeletal muscle relaxants: Use of anticholinergics after administration of botulinum toxin may potentiate systemic anticholinergic effects.
Tricyclic antidepressants and MAOIs: may have additive anticholinergic effects. A reduction in anticholinergic and/or tricyclic antidepressants and MAOIs dosage may be necessary.
Opioids: active substances such as pethidine and codeine may result in additive central nervous system and gastrointestinal adverse effects, and increase the risk of severe constipation or paralytic ileus and CNS depression. If concomitant use cannot be avoided, patients should be monitored for potentially excessive or prolonged CNS depression and constipation.
Corticosteroids: Steroid-induced glaucoma may develop with topical, inhaled, oral or intravenous, steroid administration. Concomitant use may result in increased intraocular pressure via open or a closed-angle mechanism.
Other
Medicinal products with anticholinergic properties (e.g. antihistamines, antidepressants) may cause cumulative parasympatholytic effects including dry mouth, urinary retention, constipation and confusion, and an increased risk of anticholinergic intoxication syndrome.
Women of child-bearing potential
Women of childbearing potential must use effective contraception during treatment.
Pregnancy
There are no data on the use of glycopyrronium bromide 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 breastfeeding has not been established. Use whilst breastfeeding is contraindicated (see section 4.3).
Fertility
There are no data on the effects of glycopyrronium bromide on male or female fertility. Reproductive performance in rats given glycopyrronium shows a decrease in the rate of conception and 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, riding a bicycle, or performing hazardous work while taking this drug.
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. The most common anticholinergic adverse reactions in the placebo-controlled studies 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 summary 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 6 months, 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).
Table 3. List of Adverse Reaction Frequency
Adverse reactions
Frequency category
Infections and infestations
Upper respiratory tract 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
Oesophageal candidiasis
Uncommon
Gastrointestinal motility disorder
Uncommon
Pseudo-obstruction
Uncommon
Nausea
Not known
Skin and subcutaneous tissue disorders:
Rash
Common
Dryness of the 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.
Pneumonia
Pneumonia is a known adverse reaction associated with anticholinergic medicinal products (7.9%). Glycopyrronium treatment should be withdrawn until pneumonia resolves.
Constipation
Constipation is a known adverse reaction associated with anticholinergic medicinal products (30%). Glycopyrronium treatment should be withdrawn until 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 affect 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.
Haematology and chemistry
A decrease of >10% from the normal reference range at baseline for absolute neutrophil (11.2%) and red blood cell (11.1%) count, and increases >10% from the normal reference range at baseline for monocyte (16.7%) and absolute monocyte (11.2%) counts has been seen. Decreases >10% from the normal reference range at baseline were observed for carbon dioxide (15.1%), bicarbonate (13.3%), and creatinine (10.7%) 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. Healthcare professionals are asked to report any suspected adverse reactions via:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
Symptoms
Overdose of glycopyrronium can result in anticholinergic syndrome, produced by the inhibition of cholinergic neurotransmission at muscarinic receptor sites. Clinical manifestations are caused by CNS effects, peripheral nervous system effects, or both. Common manifestations include flushing, dry skin and mucous membranes, mydriasis with loss of accommodation, altered mental status and fever. Additional manifestations include sinus tachycardia, decreased bowel sounds, functional ileus, urinary retention, hypertension, tremulousness and myoclonic jerking.
Management
Patients presenting with anticholinergic toxicity should be transported to the nearest emergency facility with advanced life support capabilities. Pre-hospital gastrointestinal decontamination with activated charcoal is not recommended because of the potential for somnolence and seizures and the resulting risk of pulmonary aspiration. At the hospital, activated charcoal can be administered if the patient's airways can be adequately protected. Physostigmine salicylate is recommended when tachydysrhythmia with subsequent hemodynamic compromise, intractable seizure, severe agitation or psychosis is present.
Patients and/or parents/caregivers should be counselled to ensure an accurate dose is given each time, to prevent the harmful consequences of anticholinergic reactions of glycopyrronium seen with dosing errors or overdose.
Ask anything about Glycopyrronium bromide 1mg/5ml 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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