Sialanar: Uses, Dosage & Side Effects

A quaternary ammonium anticholinergic oral solution for treating chronic pathological drooling (sialorrhoea) in children and adolescents aged 3 years and older

Rx Anticholinergic
Active Ingredient
Glycopyrronium
Available Forms
Oral solution
Strength
320 micrograms/mL
Manufacturer
Proveca Pharma Ltd

Sialanar (glycopyrronium) is a prescription anticholinergic medication formulated as an oral solution specifically designed for the treatment of chronic pathological drooling (sialorrhoea) in children and adolescents aged 3 years and older. Drooling is a common and often distressing symptom in many neurological and neuromuscular conditions, caused primarily by impaired control of the facial and oropharyngeal muscles rather than excessive saliva production. Sialanar works by blocking muscarinic receptors on salivary glands, thereby reducing salivary secretion. The dose is carefully titrated based on the child’s body weight, starting at a low level and increasing gradually as guided by the prescribing physician. As a quaternary ammonium compound, glycopyrronium has limited ability to cross the blood-brain barrier, which helps reduce the incidence of central nervous system side effects.

Quick Facts: Sialanar

Active Ingredient
Glycopyrronium
Drug Class
Anticholinergic
Indication
Sialorrhoea
Age Group
3–17 years
Available Forms
Oral Solution
Prescription Status
Rx Only

Key Takeaways

  • Sialanar (glycopyrronium) is the first licensed oral solution specifically developed for chronic pathological drooling in children and adolescents aged 3 to 17 years with neurological conditions.
  • The dose is individualised based on body weight and titrated in five dose levels, given three times daily at least 1 hour before or 2 hours after meals to optimise absorption.
  • Common side effects include dry mouth, constipation, diarrhoea, urinary retention, flushing, and nasal congestion; caregivers should monitor for signs of overheating, especially in warm weather.
  • Treatment should be reviewed by the prescribing physician at least every 3 months, as long-term efficacy and safety beyond 24 weeks have not been formally studied.
  • Reduced saliva production can increase the risk of dental disease, so daily tooth brushing and regular dental check-ups are essential during treatment with Sialanar.

What Is Sialanar and What Is It Used For?

Quick Answer: Sialanar (glycopyrronium) is an anticholinergic oral solution used to treat chronic pathological drooling (sialorrhoea) in children and adolescents aged 3 years and older. It works by blocking nerve signals to the salivary glands, reducing excessive saliva production that commonly occurs in neurological and neuromuscular conditions.

Sialanar contains the active substance glycopyrronium, supplied as glycopyrronium bromide. Glycopyrronium belongs to a class of medications known as quaternary ammonium anticholinergics, which are agents that block or reduce the transmission of signals between nerve cells at muscarinic receptor sites. This reduced signal transmission deactivates the cells responsible for saliva production, effectively decreasing the volume of saliva secreted by the salivary glands. The medication is formulated as a clear, colourless oral solution with a raspberry flavour, making it suitable for paediatric administration.

Sialorrhoea, commonly referred to as drooling, is the unintentional loss of saliva from the mouth. While drooling is a normal physiological process in infants, persistent drooling beyond the age of approximately 4 years is generally considered pathological and often indicates an underlying neurological condition. The primary cause of pathological drooling is not typically overproduction of saliva, but rather impaired oral motor function – specifically, difficulty coordinating the swallowing reflex, reduced lip closure, poor head posture, and decreased intraoral sensitivity. These difficulties are particularly prevalent in children with conditions such as cerebral palsy, acquired brain injury, intellectual disability, autism spectrum disorder, and other neurodevelopmental conditions.

The consequences of chronic drooling extend far beyond mere inconvenience. Excessive drooling can lead to skin maceration and perioral dermatitis around the mouth and chin, aspiration of saliva into the lungs (which increases the risk of respiratory infections and pneumonia), social stigma and embarrassment that can significantly impact quality of life, damage to clothing, books, and electronic devices, and increased caregiver burden. For children with neurological conditions, effective management of sialorrhoea is considered an important component of comprehensive care.

Sialanar acts on the salivary glands – principally the parotid, submandibular, and sublingual glands – by blocking muscarinic acetylcholine receptors (primarily M3 receptors). Acetylcholine is the primary neurotransmitter responsible for stimulating salivary secretion via the parasympathetic nervous system. By competitively inhibiting acetylcholine at these receptor sites, glycopyrronium reduces the volume and flow rate of saliva. As a quaternary ammonium compound, glycopyrronium carries a permanent positive charge that limits its ability to cross the blood-brain barrier. This pharmacological property is clinically important because it reduces the likelihood of central nervous system side effects (such as sedation, confusion, and behavioural disturbances) compared to tertiary amine anticholinergics like atropine or scopolamine.

Sialanar was granted marketing authorisation by the European Medicines Agency (EMA) specifically for the symptomatic treatment of chronic pathological drooling in children and adolescents aged 3 years and older. It represents an important advance in this therapeutic area because, prior to its approval, there was no licensed oral formulation of glycopyrronium specifically developed for paediatric use in sialorrhoea management. Clinicians had previously relied on unlicensed preparations with variable bioavailability and dosing accuracy. Sialanar’s standardised formulation, included oral dosing syringe, and weight-based dosing guidelines help ensure consistent and accurate dosing in this vulnerable patient population.

Understanding Sialorrhoea in Children

Sialorrhoea affects approximately 10–58% of children with cerebral palsy, depending on the severity of motor impairment. It is caused by impaired oral motor control rather than excessive saliva production. Management options include non-pharmacological approaches (positioning, oral motor therapy, biofeedback), pharmacological treatment (such as Sialanar), botulinum toxin injections into the salivary glands, and in refractory cases, surgical interventions. Sialanar is typically considered when non-pharmacological measures alone are insufficient.

What Should You Know Before Giving Sialanar?

Quick Answer: Do not give Sialanar if the child is allergic to glycopyrronium or any ingredients, has glaucoma, urinary retention, severe kidney disease, bowel obstruction, ulcerative colitis, paralytic ileus, myasthenia gravis, or is taking solid oral potassium chloride or other anticholinergic medicines. Discuss all medical conditions and current medications with the prescribing physician before starting treatment.

Contraindications

Sialanar must not be given to children or adolescents who have a known allergy (hypersensitivity) to glycopyrronium, glycopyrronium bromide, or any of the other ingredients in the formulation, including sodium benzoate (E211), raspberry flavouring (containing propylene glycol E1520), sucralose (E955), citric acid (E330), and purified water. Allergic reactions may manifest as rash, itching, hives, difficulty breathing or swallowing, or dizziness.

The medication is also contraindicated in patients with glaucoma (raised pressure in the eye), as anticholinergic agents can exacerbate this condition by causing pupil dilation and potentially blocking aqueous humour drainage. Patients with urinary retention (inability to completely empty the bladder) should not receive Sialanar, as the anticholinergic effect can worsen this condition by reducing detrusor muscle contractility. Severe kidney disease is another contraindication, since glycopyrronium is primarily eliminated through renal excretion, and impaired clearance could lead to drug accumulation and toxicity.

Gastrointestinal contraindications include pyloric stenosis or intestinal obstruction causing vomiting, frequent diarrhoea, ulcerative colitis (inflammatory bowel disease), and paralytic ileus (a condition where the intestinal muscles and nerves become paralysed, causing bowel obstruction). These conditions can be significantly worsened by the antimotility effects of anticholinergic agents. Additionally, Sialanar is contraindicated in patients with myasthenia gravis, a neuromuscular condition characterised by muscle weakness and fatigue, as anticholinergic agents can interfere with neuromuscular transmission.

Warnings and Precautions

Before starting Sialanar, the prescribing physician should be informed if the child has heart disease, heart failure, irregular heartbeat, or high blood pressure, as anticholinergic agents can affect heart rate and cardiac conduction. Patients with gastrointestinal disorders including chronic constipation or gastro-oesophageal reflux disease should be monitored closely, since anticholinergics reduce gut motility and can exacerbate these conditions. Children with fever (elevated body temperature) may be at increased risk of adverse effects, as anticholinergics can impair thermoregulation.

The inability to sweat normally (anhidrosis or hypohidrosis) is a particularly important consideration with anticholinergic medications. Caregivers should avoid exposing the child to heat or very high temperatures, including hot weather, high room temperatures, and excessive physical activity in warm environments. This precaution is essential to prevent overheating and the risk of heat stroke, which can be life-threatening. The prescribing physician should be consulted about potentially reducing the dose during warm weather.

Children with kidney problems may require a lower dose of Sialanar, as the drug is primarily cleared through renal excretion. Patients with a compromised blood-brain barrier (the protective layer of cells surrounding the brain) may be at increased risk of central nervous system effects, as glycopyrronium could potentially cross the barrier more readily in these individuals. The child’s heart rate should be checked if they appear unwell, and a very slow or very fast heart rate should be reported to the physician.

Reduced saliva production caused by Sialanar can increase the risk of dental disease, including dental caries (cavities), gingivitis, and oral infections. Saliva plays an important protective role in oral health by neutralising acids, washing away food particles, and providing antimicrobial activity. During treatment with Sialanar, the child’s teeth should be brushed daily (at least twice daily with fluoride toothpaste) and the child should attend regular dental check-ups at least every 6 months.

Pregnancy and Breastfeeding

Sialanar is intended for use in children and adolescents. It must not be given to patients who are pregnant or may be pregnant, or who are breastfeeding. If there is a need for contraception in adolescent patients, this should be discussed with the prescribing physician. Animal reproductive studies with glycopyrronium have not demonstrated teratogenic effects, but as a precaution, the medication should not be used during pregnancy due to limited human data.

Children Under 3 Years

Sialanar should not be used in children under 3 years of age. This age restriction is based on the fact that the oral solution formulation and the dosing regimen are specifically designed for children and adolescents aged 3 to 17 years. Younger children may have different pharmacokinetic profiles and swallowing capabilities that make this formulation unsuitable. The safety and efficacy of Sialanar have not been established in children under 3 years.

Long-Term Use

The efficacy and safety of Sialanar have not been studied in clinical trials beyond 24 weeks of continuous use. Therefore, continued treatment should be discussed with the child’s physician at least every 3 months to reassess whether Sialanar remains the appropriate treatment. This regular review should evaluate the ongoing effectiveness of the medication, monitor for adverse effects, and consider whether non-pharmacological strategies could complement or replace pharmacological treatment.

How Does Sialanar Interact with Other Drugs?

Quick Answer: Sialanar must not be taken with solid oral potassium chloride preparations or other anticholinergic medicines. It can interact with many drug classes including antispasmodics, antihistamines, antipsychotics, tricyclic antidepressants, opioids, topiramate, botulinum toxin, and corticosteroids, potentially increasing anticholinergic side effects or altering drug efficacy.

Drug interactions with Sialanar are primarily related to the additive anticholinergic effects that can occur when glycopyrronium is combined with other medications that possess anticholinergic properties. These interactions can lead to an increased risk and severity of side effects such as dry mouth, constipation, urinary retention, blurred vision, tachycardia, and thermoregulatory impairment. Additionally, some interactions are pharmacodynamic in nature, where Sialanar may oppose or enhance the effects of other medications through competing receptor mechanisms.

It is essential that caregivers inform the prescribing physician and pharmacist of all medications the child is currently taking, has recently taken, or might take. This includes prescription medicines, over-the-counter products, herbal supplements, and vitamins. Some interactions may require dose adjustments, enhanced monitoring, or avoidance of concurrent use.

Contraindicated Combinations

Drugs That Must Not Be Taken with Sialanar
Drug / Drug Class Reason for Contraindication Clinical Risk
Solid oral potassium chloride (tablets, capsules) Reduced GI motility prolongs mucosal contact GI ulceration, perforation, haemorrhage
Other anticholinergic agents Additive anticholinergic effects Severe constipation, urinary retention, overheating, tachycardia

Significant Interactions Requiring Caution

Drugs Requiring Caution When Used with Sialanar
Drug / Drug Class Examples Interaction Effect
Antispasmodics / Antiemetics Domperidone, metoclopramide Opposing effects on GI motility; may reduce antiemetic efficacy
Antiepileptics Topiramate Additive risk of reduced sweating, overheating, and metabolic acidosis
Antihistamines Cetirizine, diphenhydramine, chlorphenamine Enhanced anticholinergic effects; increased drowsiness
Antipsychotics / Neuroleptics Clozapine, haloperidol, phenothiazines Additive anticholinergic and sedative effects
Skeletal muscle relaxants Botulinum toxin Additive reduction of salivary secretion; increased dry mouth risk
Tricyclic antidepressants Amitriptyline, nortriptyline Enhanced anticholinergic effects including dry mouth, constipation
Opioids Morphine, codeine, oxycodone Additive constipation and sedation; reduced GI motility
Corticosteroids Prednisolone, dexamethasone Potential interaction affecting GI motility and immune function
Important Note on Prokinetic Agents

Domperidone and metoclopramide are commonly used to treat nausea and vomiting and to promote gastric motility. These medications work by enhancing gastrointestinal movement, which directly opposes the antimotility effects of Sialanar. When used concurrently, Sialanar may reduce the efficacy of these prokinetic agents, potentially leading to worsening of nausea, vomiting, or gastroparesis symptoms. The prescribing physician should carefully weigh the risks and benefits of combining these medications.

What Is the Correct Dosage of Sialanar?

Quick Answer: Sialanar is dosed based on body weight, starting at the lowest dose level (Dose Level 1) and gradually increasing as directed by the physician across up to five dose levels. It is given three times daily, 1 hour before or 2 hours after meals. The maximum single dose is 6 mL. It must not be given with high-fat foods.

Sialanar should always be used exactly as directed by the prescribing physician. The dose is individualised according to the child’s body weight. Treatment begins at the lowest dose level (Dose Level 1), and the physician will consider dose increases based on the balance between therapeutic effect and tolerability of side effects. Dose escalation is gradual and guided by clinical response, with regular reassessment at each clinical visit.

Children and Adolescents (3 to Under 18 Years)

Sialanar Weight-Based Dosing Guide (mL per dose, given three times daily)
Body Weight (kg) Level 1 Level 2 Level 3 Level 4 Level 5
13–17 kg 0.6 mL 1.2 mL 1.8 mL 2.4 mL 3.0 mL
18–22 kg 0.8 mL 1.6 mL 2.4 mL 3.2 mL 4.0 mL
23–27 kg 1.0 mL 2.0 mL 3.0 mL 4.0 mL 5.0 mL
28–32 kg 1.2 mL 2.4 mL 3.6 mL 4.8 mL 6.0 mL
33–37 kg 1.4 mL 2.8 mL 4.2 mL 5.6 mL 6.0 mL
38–42 kg 1.6 mL 3.2 mL 4.8 mL 6.0 mL 6.0 mL
43–47 kg 1.8 mL 3.6 mL 5.4 mL 6.0 mL 6.0 mL
≥48 kg 2.0 mL 4.0 mL 6.0 mL 6.0 mL 6.0 mL

Administration Instructions

Sialanar must be given by mouth using the oral dosing syringe provided with the medicine. Each dose should be administered 1 hour before meals or 2 hours after meals, and it is important that the dose is given at consistent times relative to food intake each day. The medication should not be given together with high-fat foods, as this can affect absorption. The maximum volume for any single dose is 6 mL.

How to Use the Oral Dosing Syringe

  1. Remove the child-resistant closure from the bottle.
  2. Push the syringe adapter into the bottle neck if not already in place. Insert the syringe tip into the adapter and ensure it is firmly attached.
  3. Hold the syringe in place and turn the bottle upside down. Gently pull the plunger down to the correct dose level as prescribed.
  4. Turn the bottle upright. Remove the syringe by gently twisting it from the adapter.
  5. Place the syringe inside the child’s mouth and slowly push the plunger to gently release the medicine.
  6. After use, leave the adapter in the bottle and replace the cap. Wash the syringe with warm water and allow to air dry after each use. Do not use a dishwasher.

If the child receives medicine through a feeding tube (nasogastric or gastrostomy tube), the tube should be flushed with 10 mL of water after administering Sialanar to ensure complete delivery of the dose.

Patients with Kidney Problems

Children with mild to moderate kidney impairment may require dose adjustment. The prescribing physician will determine the appropriate dose based on renal function. Sialanar is contraindicated in patients with severe kidney disease due to the risk of drug accumulation.

Missed Dose

If a dose of Sialanar is missed, skip the missed dose and give the next dose at the regular scheduled time. Do not give a double dose to make up for a forgotten dose. Maintaining a consistent dosing schedule is important for optimal therapeutic effect, but doubling the dose could lead to excessive anticholinergic side effects.

Overdose

Stopping Treatment

Sialanar is not expected to cause withdrawal symptoms when treatment is discontinued. The prescribing physician may decide to stop treatment if side effects cannot be adequately managed by reducing the dose. Drooling symptoms will typically return to pre-treatment levels after discontinuation, as the medication does not provide a permanent cure but rather symptomatic management of sialorrhoea.

What Are the Side Effects of Sialanar?

Quick Answer: Like all medicines, Sialanar can cause side effects, although not everybody gets them. The most common side effects (affecting more than 1 in 10 users) include dry mouth, constipation, diarrhoea, vomiting, flushing, nasal congestion, urinary retention, reduced bronchial secretions, and irritability. Stop treatment and seek immediate medical attention if the child develops pneumonia, severe allergic reactions, or is unable to pass urine.

Side effects from Sialanar are primarily related to its anticholinergic mechanism of action. By blocking muscarinic receptors, glycopyrronium affects not only the salivary glands but also other organ systems with parasympathetic innervation, including the gastrointestinal tract, urinary system, cardiovascular system, eyes, and skin. The severity and occurrence of side effects are generally dose-dependent, and many can be managed by reducing the dose to the previous tolerated level.

It is important to note that side effects can sometimes be difficult to recognise in patients with neurological conditions who may not be able to communicate how they are feeling. Caregivers should closely observe the child for any changes in behaviour, comfort, or physical function. If a troublesome side effect occurs after a dose increase, the dose should be reduced to the previously used level and the prescribing physician should be contacted.

Very Common

May affect more than 1 in 10 patients

  • Dry mouth
  • Constipation (difficulty passing stools)
  • Diarrhoea
  • Vomiting
  • Flushing (temporary skin redness)
  • Nasal congestion
  • Urinary retention (inability to fully empty the bladder)
  • Reduced bronchial secretions
  • Irritability

Common

May affect up to 1 in 10 patients

  • Upper respiratory tract infection
  • Pneumonia (serious lung infection)
  • Urinary tract infection
  • Drowsiness (somnolence)
  • Agitation
  • Fever (pyrexia)
  • Nosebleed (epistaxis)
  • Rash

Uncommon

May affect up to 1 in 100 patients

  • Bad breath (halitosis)
  • Oral thrush / oesophageal candidiasis (fungal infection)
  • Gastrointestinal motility disorder
  • Pseudo-obstruction (intestinal blockage without physical cause)
  • Pupil dilation (mydriasis)
  • Involuntary eye movements (nystagmus)
  • Headache
  • Dehydration
  • Thirst in hot weather

Not Known

Frequency cannot be estimated from available data (reported with anticholinergic class)

  • Allergic reactions (rash, itching, hives, difficulty breathing, dizziness)
  • Angioedema (swelling of tongue, lips, face, or throat)
  • Behavioural changes: restlessness, hyperactivity, shortened attention span, mood changes, frustration, temper outbursts, excessive sensitivity, frequent crying, fearfulness
  • Insomnia (difficulty sleeping)
  • Raised eye pressure (glaucoma risk), photophobia, dry eyes
  • Slow heart rate followed by rapid heart rate, palpitations, irregular heartbeat
  • Sinusitis (sinus inflammation)
  • Nausea
  • Dry skin
  • Reduced ability to sweat (risk of fever and heat stroke)
  • Sudden urge to urinate
Managing Side Effects in Children with Neurological Conditions

Children with underlying neurological conditions may have limited ability to communicate discomfort or adverse effects. Caregivers and healthcare professionals should maintain heightened vigilance for non-verbal signs of distress, including changes in behaviour, eating patterns, sleep quality, temperature, and bowel and bladder function. Any unexplained behavioural change should prompt a reassessment of Sialanar therapy, as anticholinergic agents can cause significant mood and behavioural disturbances in paediatric patients.

How Should You Store Sialanar?

Quick Answer: Store Sialanar at or below 25°C (77°F), out of sight and reach of children. Once the bottle has been opened, the solution must be used within 2 months. Do not use after the expiry date printed on the label. Do not use if the packaging has been opened or damaged.

Proper storage of Sialanar is essential to maintain the medication’s efficacy and safety throughout the period of use. The oral solution should be stored at a temperature not exceeding 25°C (77°F). It does not require refrigeration, but should be kept away from direct heat sources and sunlight. The bottle should be stored in a secure location, out of the sight and reach of children, to prevent accidental ingestion.

Once the bottle has been opened for the first time, the oral solution must be used within 2 months. After this period, any remaining solution should be discarded, even if the bottle is not empty, as the preservative system may no longer adequately protect the solution from microbial contamination. It is helpful to write the date of first opening on the bottle label as a reminder.

Do not use Sialanar after the expiry date printed on the label and carton (indicated as “EXP”). The expiry date refers to the last day of the indicated month. If the packaging has been opened or damaged prior to first use, do not use the product and return it to the pharmacy.

Medicines should not be disposed of via wastewater or household waste. Unused or expired medications should be returned to a pharmacy for proper disposal. These measures help protect the environment and prevent accidental exposure.

What Does Sialanar Contain?

Quick Answer: Each millilitre of Sialanar oral solution contains 400 micrograms of glycopyrronium bromide, equivalent to 320 micrograms of glycopyrronium (the active ingredient). Inactive ingredients include sodium benzoate (preservative), raspberry flavouring, sucralose (sweetener), citric acid, and purified water.

Active Ingredient

The active substance in Sialanar is glycopyrronium, supplied as glycopyrronium bromide. Each 1 mL of oral solution contains 400 micrograms of glycopyrronium bromide, which is equivalent to 320 micrograms of glycopyrronium (the active moiety). Glycopyrronium bromide is a synthetic quaternary ammonium compound with anticholinergic (antimuscarinic) properties. Its quaternary ammonium structure confers a permanent positive charge on the nitrogen atom, which limits its ability to cross lipid membranes including the blood-brain barrier.

Inactive Ingredients (Excipients)

  • Sodium benzoate (E211) – a preservative. Each mL contains 2.3 mg of benzoate. The solution contains less than 1 mmol sodium (23 mg) per maximum dose, making it essentially sodium-free.
  • Raspberry flavouring – contains propylene glycol (E1520) as a carrier. Added to improve palatability for paediatric patients.
  • Sucralose (E955) – a non-caloric artificial sweetener to enhance taste acceptability.
  • Citric acid (E330) – used as a pH buffer to maintain solution stability.
  • Purified water – the vehicle for the oral solution.

Packaging

Sialanar is provided in an amber glass bottle (available in 60 mL and 250 mL sizes) in a cardboard carton. Each carton includes one bottle, one 8 mL oral dosing syringe, and one syringe adapter. The amber glass protects the solution from light degradation. Not all pack sizes may be marketed in all countries.

Frequently Asked Questions About Sialanar

Sialanar (glycopyrronium) is used to treat chronic pathological drooling (sialorrhoea) in children and adolescents aged 3 years and older. Drooling is a common problem in children with neurological conditions such as cerebral palsy, where impaired facial muscle control leads to the inability to manage saliva effectively. Sialanar works by reducing the amount of saliva produced by the salivary glands through blocking muscarinic acetylcholine receptors.

Sialanar is given as an oral solution using the provided dosing syringe. It is administered three times daily, at consistent times each day, either 1 hour before or 2 hours after meals. The dose is drawn up using the syringe to the level prescribed by the doctor, placed inside the child’s mouth, and the plunger is slowly pushed to release the medicine. For children on feeding tubes, the solution can be administered through the tube followed by a 10 mL water flush.

Yes, Sialanar can reduce the ability to sweat, which is a known anticholinergic effect. This impairment in thermoregulation can lead to overheating and, in severe cases, heat stroke. Caregivers must take precautions to avoid exposing the child to excessive heat, keep the child well hydrated, and contact the prescribing physician about potentially reducing the dose during warm weather. This is particularly important for children who are already physically compromised due to their underlying neurological condition.

Yes, by reducing saliva production, Sialanar can increase the risk of dental disease. Saliva plays a crucial protective role in oral health: it neutralises acids produced by oral bacteria, helps remineralise tooth enamel, washes away food debris, and provides antimicrobial proteins. When saliva flow is reduced, the oral environment becomes more favourable for bacterial growth and acid erosion. Children taking Sialanar should brush their teeth at least twice daily with fluoride toothpaste and attend regular dental check-ups every 6 months.

The long-term efficacy and safety of Sialanar have not been studied beyond 24 weeks of continuous use. Therefore, continued use should be reviewed with the prescribing physician at least every 3 months to ensure the medication remains appropriate. During these reviews, the physician will assess whether Sialanar is still effective, monitor for adverse effects, and determine whether dose adjustments or alternative management strategies are needed. In clinical practice, many patients continue treatment for longer periods under medical supervision.

If you forget to give a dose of Sialanar, skip the missed dose and give the next dose at the usual scheduled time. Do not give a double dose to compensate for the missed one, as this could increase the risk of anticholinergic side effects such as dry mouth, constipation, and urinary retention. To help maintain consistency, consider setting alarms or reminders for each of the three daily doses.

References

  1. European Medicines Agency (EMA). Sialanar – Summary of Product Characteristics. Last updated December 2024. Available at: www.ema.europa.eu/en/medicines/human/EPAR/sialanar
  2. British National Formulary for Children (BNFc). Glycopyrronium bromide. National Institute for Health and Care Excellence (NICE). Updated 2025.
  3. Walshe M, Smith M, Pennington L. Interventions for drooling in children with cerebral palsy. Cochrane Database of Systematic Reviews. 2012;(11):CD008624. doi:10.1002/14651858.CD008624.pub3
  4. Zeller RS, Lee HM, Engel SH, Bhatt JA. Randomized phase III evaluation of the efficacy and safety of a topical glycopyrrolate wipe for the treatment of primary axillary hyperhidrosis. J Am Acad Dermatol. 2017;77(5):e34.
  5. Parr JR, Todhunter E, Pennington L, et al. Drooling Reduction Intervention randomised trial (DRI): comparing two anticholinergic drugs for sialorrhoea in children – a multi-centre study. Archives of Disease in Childhood. 2020;105(8):763–770.
  6. World Health Organization (WHO). WHO Model List of Essential Medicines for Children – 9th List. 2023.
  7. National Institute for Health and Care Excellence (NICE). Clinical Knowledge Summary: Drooling in Children. Updated 2024.
  8. Proveca Pharma Ltd. Sialanar Package Leaflet: Information for the User. Revised December 2024.

Medical Editorial Team

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Written by iMedic Medical Editorial Team – Specialists in Paediatric Neurology and Clinical Pharmacology

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