Sialanar

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1 NAME OF THE MEDICINAL PRODUCT 
 
Sialanar 320 micrograms /ml oral solution 
 
 
2 QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each ml contains 400 micrograms glycopyrronium bromide equivalent to 320 micrograms of 
glycopyrronium. 
 
Each ml contains 2.3 mg sodium benzoate (E211). 
   
For the full list of excipients, see section 6.1 
 
 
3 PHARMACEUTICAL FORM 
 
Oral solution. 
Clear, colourless solution. 
 
 
4 CLINICAL PARTICULARS 

 
4.1 Therapeutic indications 
 
Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and 
adolescents aged 3 years and older with chronic neurological disorders. 
 
4.2 Posology and method of administration 
 
Sialanar should be prescribed by physicians experienced in the treatment of paediatric patients with 
neurological disorders. 
 
Posology 
 
Due to the lack of long term safety data, Sialanar is recommended for short -term intermittent use (see 
section 4.4) 
 
Paediatric population – children and adolescents aged 3 years and older  
The dosing schedule for glycopyrronium is based on the weight of the child, starting with 
approximately 12.8 micrograms/kg per dose (equivalent to 16 micrograms/kg per dose 
glycopyrronium bromide), three times per day and increasing by the doses shown in Table 1 below, 
every 7 days. Dose titration should be continued until efficacy is balanced with undesirable effects and 
amended up or down as appropriate, to a maximum individual dose of 64 micrograms/kg body weight 
glycopyrronium or 6 ml (1.9 mg glycopyrronium, equivalent to 2.4 mg glycopyrronium bromide) three 
times a day, whichever is less. Dose titrations should be conducted in discussion with the carer to 
assess both efficacy and undesirable effects until an acceptable maintenance dose is achieved.  
 
Undesirable effects may be minimised by using the lowest effective dose necessary to control 
symptoms. It is important that the carer checks the dose volume in the syringe before administration. 
The maximum volume of the highest dose is 6ml. In the event of a known anticholinergic adverse 
event occurring when the dose is increased, the dose should be reduced to the previous lower dose and 
the event monitored. If the event does not resolve treatment should be discontinued. In the event of 
constipation, urinary retention or pneumonia treatment should be stopped and the prescribing 
physician contacted. 
Younger children may be more susceptible to adverse events and this should be borne in mind when 
any dose adjustments are carried out. 



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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. 

 
The Table 1 shows the dose in ml of solution to be given for each weight range at each dosing 
increase. 
 
 
Table 1. Dosing table for children and adolescents with normal renal function. 
 

Weight Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4 Dose Level 5 
Kg (~12.8µg/kg) 1 (~25.6µg/kg) 1 (~38.4µg/kg) 1 (~51.2µg/kg) 1 (~64µg/kg) 1 

 ml ml ml ml ml 
13-17 0.6 1.2 1.8 2.4 3* 
18-22 0.8 1.6 2.4 3.2 4* 
23-27 1 2 3 4 5* 
28-32 1.2 2.4 3.6 4.8 6* 
33-37 1.4 2.8 4.2 5.6 6* 
38-42 1.6 3.2 4.8 6* 6 
43-47 1.8 3.6 5.4 6* 6 
≥48 2 4 6* 6 6 

1 refers to µg/kg glycopyrronium 
*Maximum individual dose in this weight range 
  
Paediatric population – children aged <3 years 
Sialanar is not recommended in children aged <3 years in the symptomatic treatment of sialorrhoea 
(chronic pathological drooling) (see section 4.4). 
 
Adult population 
Sialanar is indicated for the paediatric population only. There is limited clinical trial evidence on the 
use of glycopyrronium in the adult population with pathological drooling.  
 
Elderly population 
Sialanar is indicated for the paediatric population only. 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 Sialanar should not be used in patients over the age of 65 years. 
 
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. 
 
Renal impairment 
Severe renal impairment (see section 4.3). 
 
Mild to moderate renal impairment (eGFR <90 - ≥30 ml/min/1.73m2) doses should be reduced by 30% 
(see Table 2). 
 
 
Table 2. Dosing table for children and adolescents with mild to moderate renal impairment. 
 

Weight Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4 Dose Level 5 
Kg (~8.8µg/kg) 1 (~17.6µg/kg) 1 (~27.2µg/kg) 1 (~36µg/kg) 1 (~44.8µg/kg) 1 

 ml ml ml ml ml 
13-17 0.4 0.8 1.2 1.7 2.1* 



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18-22 0.6 1.1 1.7 2.2 2.8* 
23-27 0.7 1.4 2.1 2.8 3.5* 
28-32 0.8 1.7 2.5 3.4 4.2* 
33-37 1 2 2.9 3.9 4.2* 
38-42 1.1 2.2 3.4 4.2* 4.2 
43-47 1.2 2.5 3.8 4.2* 4.2 
≥48 1.4 2.8 4.2* 4.2 4.2 

1 refers to µg/kg glycopyrronium 
*Maximum individual dose in this weight range 
 
 
Method of administration 
 
For oral use 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 child’s specific needs determine 
that co-administration with food is required, dosing of the medicinal product should be consistently 
performed during food intake.  
 
Nasogastric / feeding tubes, if used, should be flushed with 10 ml water immediately after dosing. 
 
See section 6.6 for instructions for use. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to 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; 
 

4.4 Special warnings and precautions for use 
 
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  



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• 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. If continuous treatment is needed (eg 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 likelihood of benefit and the known adverse effect profile, Sialanar 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. 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 children 
with compromised blood brain barrier eg. Intraventicular shunt, brain tumour, encephalitis. 
 
Children below the age of 3 years 
Sialanar 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.  



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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 ml. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
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 pediatric 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 phenothiazines, 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; 
 



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Corticosteroids: Steroid-induced glaucoma may develop with topical, inhaled, oral or intravenous, 
steroid administration. Concomitant use may result in increased intraocular pressure via an 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.  
 
 
4.6 Fertility, pregnancy and lactation 
 
Women of child-bearing potential 
Effective contraception should be considered prior to treating women of childbearing age, where 
appropriate. 
 
Pregnancy 
There are no data on the use of Sialanar 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).  
 
Breast-feeding 
Safety in breast-feeding has not been established. Use while breast-feeding is contraindicated (see 
section 4.3). 
 
Fertility 
There are no data on the effects of Sialanar 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). 
 
4.7 Effects on ability to drive and use machines 
 
Sialanar has moderate influence on the ability to drive and use machines. The anticholinergic effects 
of glycopyrronium may cause blurred vision, dizziness and other effects that may impair a patient's 
ability to perform skilled tasks such as driving, riding a bicycle and using machines. The undesirable 
effects are increased with increasing dose. 
 
4.8 Undesirable effects 
 
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 (see section 5.1) 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 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 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 



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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 
Overactivity 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 



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Adverse reactions Frequency category 
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 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. 
 
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 



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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 the national reporting system 
listed in Appendix V. 
 
4.9  Overdose 
 
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 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 acurate dose is given each time, in 
order to prevent the harmful consequences of anticholinergic reactions of glycopyrronium seen with 
dosing errors or overdose.   
 
 
5 PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Medicinal products for functional gastrointestinal disorders, synthetic 
anticholinergics, quaternary ammonium compounds. ATC Code: A03AB02.  
 
Glycopyrronium is a quaternary ammonium antimuscarinic with peripheral effects similar to those of 
atropine.  
 
Antimuscarinics are competitive inhibitors of the actions of acetylcholine at the muscarinic receptors 
of autonomic effector sites innervated by parasympathetic (cholinergic postganglionic) nerves. They 
also inhibit the action of acetylcholine where smooth muscle lacks cholinergic innervation. 
 
Salivation is primarily mediated by parasympathetic innervation of the salivary glands. 
Glycopyrronium competitively inhibits cholinergic muscarinic receptors in salivary glands and other 
peripheral tissues, thus indirectly reducing the rate of salivation. Glycopyrronium has little effect on 
cholinergic stimuli at nicotinic acetylcholine receptors, on structures innervated by postganglionic 
cholinergic neurons, and on smooth muscles that respond to acetylcholine but have no cholinergic 
innervation. 
 
Peripheral antimuscarinic effects that are produced as the dose increases are: decreased production of 
secretions from the salivary, bronchial and sweat glands; dilatation of the pupils (mydriasis) and 



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paralysis of accommodation (cyclopegia); increased heart rate; inhibition of micturition and reduction 
in gastrointestinal tone; inhibition of gastric acid secretion. 
 
Placebo controlled efficacy data includes patients with a treatment duration of 8 weeks. There is no 
placebo or comparator controlled data beyond 8 weeks. 
 
Zeller et al 2012a evaluated the efficacy of glycopyrronium bromide oral solution (1 mg/5 mL) in 
managing problem drooling associated with cerebral palsy and other neurologic conditions.  Thirty-
eight patients aged 3–23 years weighing at least 27 lb (12.2 kg) with severe drooling (clothing damp 
5–7 days/week) were randomized to eight-weeks treatment with glycopyrronium (n = 20), 
20-100 μg/kg (not exceeding 3 mg in total) three times a day, or matching placebo (n = 18). The first 
four weeks were an individual titration period in fixed steps depending on response followed by 
4-weeks maintenance treatment. Primary efficacy endpoint was responder rate, defined as percentage 
showing ≥3-point improvement on the modified Teacher’s Drooling Scale (mTDS). The primary 
analysis population was revised to only comprise patients with an age of 3 -16 years which rendered 
19 patients in the glycopyrrolate oral solution group an 17 in the placebo group. Responder rate was 
defined as at least a 3-point improvement in modified Teacher’s Drooling Scale (mTDS). 

 

Responder rate at week 8 At least a 3-point improvement in 
mTDS 

Mean improvements in mTDS 

Glycopyrronium 14 of 19 patients (73.7%) 3.94 points  
(SD: 1.95; 95%; CI: 2.97–4.91) 

Placebo 3 of 17 patients (17.6%) 0.71 points  
(SD: 2.14; 95% CI: –0.43–1.84) 

p value p = 0.0011 p <0.0001 
 
 
In addition, 84% of physicians and 100% of parents/caregivers regarded glycopyrrolate as worthwhile 
compared with 41% and 56%, respectively, for placebo (p≤0.014). Most frequently reported 
treatment-emergent adverse events (glycopyrrolate vs placebo) were dry mouth, constipation, 
vomiting and nasal congestion. 
 
The safety and efficacy of glycopyrronium have been studied in an open labelled study with no control 
group over a 24-week period in children aged 3 to 18 years. At the week 24/exit visit, 52.3% (95% 
confidence interval 43.7–60.9) of patients (n=130) had an at least three-point decrease in mTDS from 
baseline and were classified as responders to treatment with oral glycopyrrolate solution..  The adverse 
event profile was consistent with the one seen with anticholinergics (see section 4.4 and 4.8).  
 
5.2 Pharmacokinetic properties  
 
Mean absolute oral bioavailability of glycopyrronium comparing a single 50 µg/kg oral dose and a 
single 5 µg/kg i.v. dose was low at approximately 3% (range 1.3–13.3%) in children aged 7–14 years 
undergoing intraocular surgery (n = 6) due to the medicinal product’s low lipid solubility. Data from 
sparse PK sampling in children suggests dose proportional PK.  
 
The bioavailability of oral glycopyrronium in children was between that of adults under fed and fasted 
conditions. Co-administration with food results in a marked decrease in systemic glycopyrronium 
exposure. 
 
In adults, distribution of glycopyrronium was rapid following a single 6 µg/kg i.v. dose; distribution 
half-life was 2.2 ± 1.3 minutes.  Following administration of 3H-labelled glycopyrronium more than 
90% of the radiolabel disappeared from the plasma in 5 minutes, and almost 100% within 30 minutes, 
reflecting rapid distribution. Analyses of population pharmacokinetic data from healthy adults and 
children with cerebral palsy-associated chronic moderate to severe drooling who received 
glycopyrronium (route of administration and dosages not specified) did not demonstrate linear 
pharmacokinetics of the medicinal product. 
 



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The volume of distribution, 0.64 ± 0.29 L/kg in adults is similar to that of total body water. Volume of 
distribution is somewhat higher in the paediatric population(s), in the range 1.31 to 1.83 L/kg. 
 
The PK of glycopyrronium has been shown to be essentially independent of age in children in the age 
range 0.19 – 14 years administered a 5 µg/kg i.v. single-dose. In most paediatric subjects, plasma 
glycopyrronium vs. time plots are reported to show a triexponential curve; adults generally show a 
biexponential curve.  Modest changes in volume of distribution (Vss) and clearance (Cl) have been 
observed in children between 1 and 3 years of age, leading to a statistically significant shorter 
elimination half-life (t½, z) than that observed in younger (<1 year of age; p = 0.037) or older (>3 years 
of age; p = 0.042) groups.  
 
In a study in healthy adults, a 2000 µg single dose of  glycopyrronium bromide resulted in an AUC of 
2.39 µg.h/L (fasted). An AUC0-6 h of 8.64 µg.h/L was observed after 6 µg/kg i.v. glycopyrronium. 
 
Based upon theoretical physicochemical considerations, the quaternary ammonium compound 
glycopyrronium would be expected to have low central bioavailability; no glycopyrronium was 
detectable in the CSF of anaesthetised surgical patients or patients undergoing caesarean section 
following a 6 – 8 µg/kg i.v. dose.  In the paediatric population 5 µg/kg i.v. glycopyrronium has low 
central bioavailability, except in the case where the blood brain barrier has been compromised (e.g. a 
shunt infection). 
 
The primary route of elimination of glycopyrronium is via renal excretion, mainly as unchanged 
medicinal product.  Approximately 65% of an i.v. dose is renally excreted within the first 24 hours. A 
small proportion (~5%) is eliminated in the bile.   
 
The elimination half-life of glycopyrronium appears to be dependent on route of administration being 
0.83 ± 0.27 hours after i.v. administration, 75 minutes after i.m. administration and in the region of 
2.5 - 4 h after oral (solution) administration, though again this was highly variable. That the latter two 
half-lives, and especially that for oral administration, are longer than for i.v. administration probably 
reflects the complex absorption and distribution of glycopyrronium by each route.  It is possible that 
prolonged absorption after oral administration translates into elimination being faster than absorption 
(known as flip-flop kinetics, characterized by Ka < Ke). 
 
The total body clearance of the medicinal product following an i.v. dose is relatively high at between 
0.54 ± 0.14 L/h/kg and 1.14 ± 0.31 L/h/kg.  As this exceeds the glomerular filtration rate and it 
appears that more than 50% of the dose is excreted unchanged in the urine, it is probable that the renal 
elimination of glycopyrronium involves both glomerular filtration and proximal tubular secretion by 
the base secretory mechanism.   
 
A mean increase in total systemic exposure (AUClast) of up to 1.4 fold was seen in adult subjects with 
mild and moderate renal impairment (GFR ≥30mL/min/1.73m2) and up to 2.2 fold in subjects with 
severe renal impairment or end stage renal disease (estimated GFR <30 mL/min/1.73m2). A 30% dose 
reduction (see Table 2) is required for patients with mild to moderate renal impairment. 
Glycopyrronium is contraindicated in patients with severe renal impairment. 
 
Baseline characteristics (age, weight, gender and race) do not affect the pharmacokinetics of 
glycopyrronium. 
 
Impaired hepatic function is not expected to affect the pharmacokinetics of glycopyrronium since the 
majority of the medicinal product is eliminated through the kidneys. 
 
Co-administration with food results in a marked decrease in systemic glycopyrronium exposure (see 
section 4.2.).  
 
5.3 Preclinical safety data 
 
Non-clinical data, including genotoxicity or carcinogenicity studies have not been performed for 



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Sialanar. 
Limited non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology or repeated dose toxicity.  
 
The single dose toxicity of glycopyrronium has been tested in a range of investigations, although only 
limited experimental details are available. Upon oral administration, high LD50 values of 550 mg/kg in 
mice and above 1,000 mg/kg in rats were reported.  In rats at higher doses (1500-2000 mg/kg) tremors, 
clonic and tonic convulsions and laboured breathing were observed prior to death, resulting from 
respiratory failure.  
 
Chronic oral administration of glycopyrronium at doses of 4, 16 and 64 mg/kg for up to 27 weeks in 
dogs produced mydriasis, cycloplegia, xerostomia, emesis, occasional lacrimation, injection of sclera 
and rhinorrhoea.  

Extrapolation of safety margins to the paediatric population is not possible, as no exposure data are 
available from repeated dose toxicology studies and no studies in juvenile animals have been 
performed with glycopyrronium. 

 
Data on reproductive endpoints for glycopyrronium are very limited. A reduction in corpora lutea was 
observed in female rats administered glycopyrronium. No effects on fertility were observed in male 
rats. Reproductive performance in rats given glycopyrronium shows a decrease in the rate of 
conception and in survival rate at weaning. The significance of the non-clinical findings for humans is 
not clear, and the lack of human data on the medicinal product leads to glycopyrronium being 
contraindicated in pregnant women.There are insufficient data in the public domain to adequately 
assess effects on the reproductive system in young adults, and safety in human pregnancy has not been 
established.  

 
6 PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium benzoate (E211) 
Raspberry flavouring (containing propylene glycol E1520) 
Sucralose (E955) 
Citric acid (E330) 
Purified water 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products.  
 
6.3 Shelf life 
 
2 years.  
 
2 months after first opening. 
 
6.4 Special precautions for storage 
 
Do not store above 25°C. 
 
6.5 Nature and contents of container 
 
Amber coloured glass bottle with a high density polyethylene tamper evident child resistant closure 
with expanded low density polyethylene liner.  The bottle contains 60 ml or 250 ml of oral solution.  
 



 14 

Pack size of one bottle, one 8 ml low density polyethylene oral syringe (0.1 ml graduations) and one 
syringe adaptor.  
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
Instructions for use 
Insert the syringe adaptor into the neck of the bottle. Insert the end of the oral syringe into the syringe 
adaptor and ensure it is secure. Turn the bottle upside down. Gently pull down the plunger to the 
correct level (see Tables 1 and 2 for the correct dose). Turn the bottle upright. Remove the oral 
syringe. Place the oral syringe inside the child’s mouth and press the plunger slowly to gently release 
the medicinal product. If the child is given the medicinal product through a feeding tube, flush the tube 
with 10 ml of water after you have given the medicinal product. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7 MARKETING AUTHORISATION HOLDER 
 
Proveca Pharma Limited 
Marine House 
Clanwilliam Place 
Dublin 2 
Ireland. 
 
 
8 MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/16/1135/001 (250 ml bottle) 
EU/1/16/1135/002 (60 ml bottle) 
 
 
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 15 September 2016 
 
 
10 DATE OF REVISION OF THE TEXT 
 
MM/YYYY 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu 
  



 15 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 

 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE  
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 



 16 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturer responsible for batch release 

BCM Limited 
Thane Road 
Beeston 
Nottingham 
Nottinghamshire NG90 2PR 
UK 
 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION  

• Periodic safety update reports  
 

The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 

The marketing authorisation holder shall submit the first periodic safety update report for this 
product within 6 months following authorisation. 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT 

• Risk Management Plan (RMP) 
 

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent 
updates of the RMP. 

An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 

• Whenever the risk management system is modified, especially as the result of new 
information being received that may lead to a significant change to the benefit/risk profile or 
as the result of an important (pharmacovigilance or risk minimisation) milestone being 
reached.  

 

• Additional risk minimisation measures  
 



 17 

Prior to launch of Sialanar in each Member State, the Marketing Authorisation Holder (MAH) must 
agree about the content and format of the educational materials, including communication media, 
distribution modalities, and any other aspects of the programme, with the National Competent 
Authority.  

The objectives of the programme are:  

• to provide information on the administration of Sialanar, specifically on the accurate use of 
the prescribed dosing, the time of administration before the meals, the avoidance of the 
administration of Sialanar with high fat meals, use of the oral syringe and the need to 
complete the administration table at the end of the reminder card for patient's carer to remind 
the carer of the correct dose to be given to the child.  
 

• to provide information on the management and minimisation of anticholinergic reactions, 
especially on management of constipation, urinary retention, pneumonia, risk of overheating, 
CNS effects or overdose; and on allergic reactions. In addition, the materials should highlight 
the difficulty of the detection of anticholinergic reactions in the treated population and the 
need to decrease the dose to the previous one in case of suspicion of adverse drug reactions 
and contact the physician. The materials should also cover the need to avoid exposure to hot 
weather and overheating; risk of caries associated to reduced salivation and need for regular 
dental hygiene and dental checks and the requirement to check the pulse at regular intervals.  
 

The MAH shall ensure that in each Member State where Sialanar is marketed, all healthcare 
professionals and patients/carers who are expected to prescribe, dispense or use Sialanar have access 
to or are provided with the following educational packages:  
 

The physician educational material should contain:  

o The Summary of Product Characteristics 
o Information about the drug utilisation study to monitor and assess effectiveness of 

additional risk minimisation measures for anticholinergic side effects that may be dose 
dependent and the importance of contributing to such a study 

o Remarks on the importance of reporting on specific adverse drug reactions, namely: 
urinary retention, constipation, pneumonia, allergic reactions, dental caries, cardiovascular 
effects, CNS effect and overheating 

o The Prescriber checklist, which shall contain the following key messages:  
• Information on the administration of Sialanar  
• Management and minimisation of anticholinergic reactions 
 

• The patient information pack should contain:  
o Patient information leaflet 
o The reminder card for patient's carer, which shall contain the following key messages:  

• Information on the administration of Sialanar  
• Management and minimisation of anticholinergic reactions 

  



 18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



 19 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 



 20 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Sialanar 320 micrograms/ml oral solution 

Glycopyrronium 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each ml of solution contains 400 micrograms glycopyrronium bromide equivalent to 320 micrograms 
glycopyrronium. 

 

 

3. LIST OF EXCIPIENTS 

 

Contains sodium benzoate (E211). See leaflet for further information. 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Oral solution  

One 60 ml bottle  

One 8 ml oral syringe  

One syringe adaptor. 

One 250 ml bottle   

One 8 ml oral syringe   

One syringe adaptor. 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Oral use. 

 

Read the package leaflet before use. 

 

 



 21 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

After first opening, use within 2 months. 

Open date: _________ 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 25°C. 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE. 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Proveca Pharma Ltd 
Marine House 
Clanwilliam Place 
Dublin 2 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1135/001 – 250 ml bottle 

EU/1/16/1135/002 – 60 ml bottle 
 

13. MANUFACTURER'S BATCH NUMBER 



 22 

 

BN 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Sialanar 

Oral Solution 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included  

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

 



 23 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING  

GLASS BOTTLE 

 

 

1. NAME OF THE MEDICINAL PRODUCT  

 

Sialanar 320 micrograms/ml oral solution 

Glycopyrronium  

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each ml of solution contains 400 micrograms glycopyrronium bromide equivalent to 320 micrograms 
glycopyrronium. 

 

 

3. LIST OF EXCIPIENTS 

 

Contains sodium benzoate (E211). See leaflet for further information. 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Oral solution  

60 ml  

250 ml  

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Oral use. 

 

Read the package leaflet before use. 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 



 24 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

After first opening, use within 2 months. 

Open date: ____________ 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 25°C. 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE. 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Proveca Pharma Ltd 
Marine House 
Clanwilliam Place  
Dublin 2 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/16/1135/001 – 250 ml bottle 

EU/1/16/1135/002 – 60 ml bottle 
 

 

13. MANUFACTURER'S BATCH NUMBER 

 

BN 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 



 25 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

 

 

 

 

 

 

 

 

  



 26 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



 27 

Package Leaflet: Information for the user 
 

Sialanar 320 micrograms/ml oral solution 
Glycopyrronium  

 
Read all of this leaflet carefully before your child starts taking this medicine because it contains 
important information for you.   

− Keep this leaflet. You may need to read it again. 
− If you have any further questions, ask your doctor or pharmacist. 
− This medicine has been prescribed for your child only. Do not pass it on to others. It may 

harm them, even if their signs of illness are the same as your child’s. 
− If your child gets any side effects, talk to your doctor or pharmacist. This includes any 

possible side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1.  What Sialanar is and what it is used for 
2.  What you need to know before you give Sialanar 
3.  How to use Sialanar 
4. Possible side effects 
5.  How to store Sialanar 
6.  Contents of the pack and other information 
 
 
1.  What Sialanar is and what it is used for 
 
Sialanar is a medicine that contains the active substance glycopyrronium.  
Glycopyrronium belongs to a group of medicines known as quaternary 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. 

 
Sialanar is used to treat 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 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. 
 
Sialanar acts on the salivary glands to reduce production of saliva.  
 
 
2.  What you need to know before you give Sialanar 
 
Do not give Sialanar if the child or adolescent: 

− is allergic to glycopyrronium or any of the other ingredients of this medicine (listed in section 
6)  

− is pregnant or breast feeding 
− has glaucoma (raised pressure in the eye) 
− is unable to completely empty the bladder (urinary retention) 
− has severe kidney disease 
− has an obstruction of the stomach (pyloric stenosis) or bowel causing vomiting  
− has diarrhoea (frequent, loose watery stools) 
− has ulcerative colitis (inflammation of the intestine) 
− stomach ache and swelling (paralytic ileus) 
− has myasthenia gravis (muscle weakness and tiredness) 
− is taking any of the following medicines (see section Other medicines and Sialanar):  



 28 

potassium chloride solid oral dose;  
anticholinergic medicines.   

 
Warnings and precautions 
 
Talk to your doctor or pharmacist before using Sialanar if your child has: 

• heart disease, heart failure, irregular heartbeats or high blood pressure   
• digestive disorders (constipation; chronic heartburn and indigestion) 
• a high temperature (fever) 
• inability to sweat normally 
• kidney problems or difficulty passing urine 
• abnormal blood brain barrier (the layer of cells surrounding the brain) 

 
If you are not sure if any of the above applies to your child, talk to a doctor or pharmacist before 
giving Sialanar. 
 
Avoid exposing the child to hot or very warm temperature (hot weather, high room temperature) to 
avoid over heating and the possibility of heat stroke. Check with the child’s doctor during hot weather 
to see if the dose of Sialanar should be reduced. 
 
Reduced salivation can increase the risk of dental disease therefore the child’s teeth should be brushed 
daily and they should have regular dental health checks. 
 
Children with kidney problems may be given a lower dose. 
 
Check the child’s pulse if they seem unwell. Report a very slow or very fast heart rate to their doctor. 
 
 
Children under 3 years 
This medicine is formulated as an oral formulation and a dose specifically for use in children and 
adolescents aged 3 years and older. 
Sialanar is not recommended for children under 3 years of age. 
 
Other medicines and Sialanar 
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other 
medicines. 
 
In particular taking Sialanar with the following medicines can affect the way Sialanar or the listed 
medicine works or can increase the risk of side effects: 

• potassium chloride solid oral dose (see section above “Do not give Sialanar if the child or 
adolescent:”)  

• anticholinergic medicines (see section above “Do not give Sialanar if the child or 
adolescent:”)    

• antispasmodics used to treat sickness or vomiting e.g.domperidone and metaclopramide 
• topiramate used to treat epilepsy 
• antihistamines, used to treat some allergies 
• neuroleptics/antipsychotics (clozapine, haloperidol, phenothiazine), used to treat some 

mental illnesses 
• skeletal muscle relaxants (botulinum toxin) 
• antidepressants (tricyclic antidepressants)  
• opioids used to treat severe pain 
• corticosteroids, used to treat inflammatory diseases  

 
Talk to your doctor or pharmacist for further information about medicines to avoid whilst taking 
Sialanar.   
 



 29 

Long-term use 
The long-term efficacy and safety of Sialanar has not been studied beyond 24 weeks of use. Continued 
use of Sialanar should be discussed with the child’s doctor every 3 months to check that Sialanar is 
still right for the child.  
 
Pregnancy and breast-feeding 
This medicine is intended for use in children and adolescents. Sialanar must not be given if the patient 
is pregnant (or could be pregnant), or is breast-feeding (see section 2 ‘Do not give’). Discuss with the 
child’s doctor whether there is a need for contraception. 
 
Driving and using machines 
Sialanar may affect vision and co-ordination. This may affect performance at skilled tasks such as 
driving, riding a bicycle, or using machines. After receiving Sialanar, the patient should not drive a 
vehicle, ride a bicycle or use a machine until the effect in their vision and co-ordination has 
completely recovered. Ask your doctor if you need further advice. 
 
Sialanar contains sodium and benzoate salt (E211) 
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 ml. 
 
 
3.  How to use Sialanar 
 
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not 
sure. 
 
Children and adolescents 3 years to less than 18 years: 
Your doctor will decide the correct dose of Sialanar. The initial dose will be calculated based on the 
weight of the child.  Dose increases will be decided by the child’s doctor, using the table below as a 
guide, and will depend on both the effect of Sialanar and any side effects the patient is experiencing 
(this is why several dose levels appear in the table below). Section 4 includes possible side effects 
related to the use of Sialanar. These should be discussed with the child’s doctor at all medical 
consultations, including those for dose increases and decreases, and at any other time should you be 
concerned.  
 
The child should be monitored at regular intervals (at least every 3 months) to check that Sialanar is 
still the right treatment for them. 
 

Weight Dose Level 1  Dose Level 2 Dose Level 3 Dose Level 4 Dose Level 5 
kg ml ml ml ml ml 

13-17 0.6 1.2 1.8 2.4 3.0 
18-22 0.8 1.6 2.4 3.2 4.0 
23-27 1.0 2.0 3.0 4.0 5.0 
28-32 1.2 2.4 3.6 4.8 6.0 
33-37 1.4 2.8 4.2 5.6 6.0 
38-42 1.6 3.2 4.8 6.0 6.0 
43-47 1.8 3.6 5.4 6.0 6.0 
≥48 2.0 4.0 6.0 6.0 6.0 

 
 
Give the dose prescribed by your doctor to the child three times each day. 
The dose should be given 1 hour before meals or 2 hours after meals. 
It is important that the dose is given at consistent times in relation to food intake.  Do not give with 
high fat foods. 
 
Route of administration 
Sialanar should be taken by mouth.  



 30 

 
Instructions for use 
 
How to use the oral syringe 
Remove the child-resistant closure from the bottle. 
Insert the syringe adaptor with the hole into the neck of the bottle (this may have been done already by 
the pharmacist). 
Insert the end of the oral syringe into the syringe adaptor and ensure it is secure. 
 

 
 
Hold the oral syringe in place and turn the bottle upside down. Gently pull down the plunger to the 
correct level (see the tables for the correct dose). Check you have the correct level. The maximum 
volume of the highest dose is 6ml. 
 

 
 
Turn the bottle upright. 
Remove the oral syringe by holding the bottle and twisting the oral syringe gently. 

 
 
 
Place the oral 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. 
Replace the closure. 
The oral syringe should be washed with warm water and allowed to dry after each use (i.e. three times 
per day). 
 
If your child is given the medicine through a feeding tube, flush the tube with 10 ml of water after you 
have given the medicine. 
 
If you give too much Sialanar to your child 



 31 

It is important to make sure an acurate dose is given each time, in order to prevent harmful effects of 
Sialanar seen with dosing errors or overdose.   
 
Check that you have drawn up the correct level on the syringe before giving Sialanar. 
 
Seek medical advice immediately if the child is given too much Sialanar, even if the child seems well.  
 
If you forget to give Sialanar 
Give the next dose when it is due. Do not give a double dose to make up for the forgotten dose.  
 
If you stop giving Sialanar to your child 
Withdrawal effects are not expected when stopping Sialanar. The child’s doctor may decide to stop 
treatment with Sialanar if side effects cannot be managed by reducing the dose.  
 
If you have any further questions about the use of this medicine, ask your doctor or pharmacist. 
 
 
4.  Possible side effects 
 
Like all medicines, this medicine 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 stool) – very common 
• Difficulty in passing urine (urinary retention) – very common 
• Pneumonia (sever 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 severe allergic reaction. If they occur, take the child to the 
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)  

• Dry mouth  
• Difficulty in passing stools (constipation)  
• Diarrhoea 
• Being sick (vomiting) 
• Flushing 
• Nasal congestion 
• Unable to completely empty the bladder (urinary retention) 
• Reduced secretions in the chest; 
• Irritability 

 
Common side effects (may affect up to 1 in 10 people)  

• Upper respiratory tract infection (chest infection);  
• Pneumonia (severe chest infection) 
• Urinary tract infection 
• Drowsiness (sleepiness) 
• Agitation 
• Fever (pyrexia) 
• Nose bleeds (epistaxis)  
• Rash  



 32 

 
Uncommon side effects (may affect up to 1 in 100 people)  

• Bad breath (halitosis)  
• 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  

 
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 heart beat 
• 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;  

 
Side effects can sometimes be difficult to recognise in patients with neurologic 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. 
 
Tell your doctor if you notice any behavioural changes or any other changes in the child.  
 
Reporting of side effects 
If your child gets 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 national reporting 
system listed in Appendix V.  
By reporting side effects you can help provide more information on the safety of this medicine.  
 
 
5.  How to store Sialanar 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date, which is stated on the label after EXP: The expiry date 
refers to the last day of that month. 
 
Do not store above 25°C. 



 33 

This medicine must be used within 2 months of first opening the bottle. 
 
Sialanar should not be used if the packaging has been opened or damaged. 
 
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. 
 
 
6.  Contents of the pack and other information 
 
What Sialanar contains 
The active substance is glycopyrronium. 
Each ml of solution contains 400 micrograms glycopyrronium bromide equivalent to 320 micrograms 
of glycopyrronium. 
The other ingredients are sodium benzoate (E211), see section 2  (Sialanar contains sodium and 
benzoate salt), raspberry flavouring (containing propylene glycol E1520), sucralose (E955), citric acid 
(E330) and purified water.  
 
What Sialanar looks like and contents of the pack 
Sialanar oral solution is a clear, colourless liquid.  It is supplied in a 60 ml or 250 ml amber glass 
bottle in a cardboard carton.  Each carton contains one bottle, one 8 ml oral syringe and one syringe 
adaptor.  Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
Proveca Pharma Ltd 
Marine House 
Clanwilliam Place 
Dublin 2 
Ireland 
 
Manufacturer 
BCM Ltd 
Nottingham  
NG90 2PR 
United Kingdom 
 
This leaflet was last revised in Month YYYY 
 
Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 
 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET