Glycopyrronium Bromide 1 mg / 5 ml oral solution – patient leaflet, side effects, dosage

1. What Glycopyrronium Bromide oral solution is and what it is used for

This medicine is called Glycopyrronium Bromide and belongs to a group of medicines called anticholinergic or antimuscarinic drugs. It contains the active substance glycopyrronium bromide. Each 5 ml dose of oral solution contains 1 mg of glycopyrronium bromide.

• Glycopyrronium bromide 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 muscles or nerves. It is mainly caused by poor control of muscles in the face. Acute sialorrhoea may be associated with inflammation, dental or mouth infections. Glycopyrronium Bromide oral solution acts on the salivary glands to reduce production of saliva.

2. What you need to know before you give Glycopyrronium Bromide oral solution

Do not give Glycopyrronium Bromide oral solution if the child:

• is allergic (hypersensitive) to

  glycopyrronium bromide or any of the other ingredients of this medicine (listed in section 6)

• has glaucoma (increased pressure in the eye)

• has a condition called myasthenia gravis

  which leads to muscle weakness and fatigue

• has an obstruction of the stomach

  (pyloric stenosis) or bowel causing vomiting, abdominal pain and swelling (paralytic ileus)

• has an enlarged prostate gland (prostatic

  hypertrophy)

• is unable to completely empty the bladder

  (urinary retention)

• suffers from chronic end stage kidney

  disease and require dialysis

• is taking potassium chloride solid dose

  products

• is taking anticholinergic medicines Warnings and precautions

Talk to a doctor or pharmacist before giving Glycopyrronium Bromide if the child:

• has gastric reflux (a condition in which the

  liquid stomach contents backs up into the gullet)

• has ulcerative colitis (a chronic

  inflammation of the large intestine (colon) which can cause abdominal pain, diarrhoea and bleeding from the back passage) ■ pre-existing constipation

• has just had a heart attack or are suffering

  from heart disease, irregular heartbeats or high blood pressure, because this medicine can cause a change to their normal heart rate

• has a condition characterised by a faster

  heartbeat than normal (this can be caused by conditions such as an overactive thyroid gland, heart failure or heart surgery)

• is due to have surgery (including at the

  dentist) during which they will be ‘put to sleep’ using inhalation anaesthesia. This is because this medicine may cause a change in their normal heart rhythm

• has diarrhoea, especially if they have had

  an ileostomy or colostomy

• has a high temperature (fever) or the

  environmental temperature is high (e.g. hot weather outside and high room temperature inside), as this medicine will reduce the amount they sweat, making it harder for their body to cool down. The doctor may need to temporarily reduce the dose given.

• has kidney disease, because this

  medicine’s dose may need to be decreased

• has compromised blood brain barrier

  (e.g. brain shunt/tumour and swollen brain can compromise blood brain barrier)

• has been told by their doctor that they

  have an intolerance to some sugars, because this medicine contains sorbitol In addition, stop treatment and talk to their doctor if the child is suffering with the following:

• seem unwell with a very fast or very slow

  heart rate

• constipation
• pneumonia
• changes in behaviour

The doctor will decide if treatment should continue and if there should be a dose reduction, after evaluating any of these events. If you are not sure any of the above applies to your child, talk to a doctor or pharmacist before giving Glycopyrronium Bromide oral solution. Glycopyrronium Bromide oral solution reduces salivation which can increase the risk of dental disease, therefore teeth should be brushed daily and have regular dental checks.

Children under 3 years

This medicine is not recommended for children younger than 3 years. Talk to a doctor or pharmacist before taking this medicine or if this medicine has been prescribed for a child less than 3 years. Other medicines and Glycopyrronium Bromide oral solution

Tell the doctor or pharmacist if your child is taking, have recently taken, or might take any other medicines. This includes medicines you have bought without a prescription.

• If their doctor tells you to give both this

  medicine and one or more similar medicines such as oxybutynin, then they may need to take less than the usual dose of this medicine. This is because of an increased risk of other side effects such as dry mouth, retention of urine and constipation when glycopyrronium bromide and similar medicines are taken together.

  Please tell the doctor if your child is taking or have recently taken:

  • Antidepressants such as amitriptyline, clomipramine, lofepramine or imipramine (known as tricyclic antidepressants) or monoamine oxidase inhibitors (MAOIs)

    such as phenelzine, moclobemide, rasagiline, selegiline or tranylcypromine

  • Phenothiazines such as chlorpromazine, fluphenazine, prochlorperazine or trifluoperazine, used to treat mental problems or nausea, vomiting or vertigo
  • Antihistamines such as promethazine, used to treat allergies

  • Parasympathomimetics such as

    carbachol, neostigmine or physostigmine which affect the transmission of nerve impulses to muscles

  • Skeletal muscle relaxants (botulinum toxin)
  • Opioids used to treat severe pain
  • Corticosteroids such as prednisolone, used to treat various conditions including asthma and inflammation
  • Inhaled anaesthetics, given before surgery (including at the dentist)
  • Clozapine or haloperidol, used to treat schizophrenia
  • Nefopam, used to treat acute and chronic pain
  • Domperidone or metoclopramide, used to treat nausea and vomiting

  • Amantadine or levodopa, used to treat

    Parkinson’s disease

  • Memantine, used to treat Alzheimer’s disease

  • Slow-dissolving digoxin tablets,

    disopyramide or atenolol, used to treat heart problems

  • Metformin, used to treat type 2 diabetes
  • Glyceryl trinitrate tablets, used to treat angina. These may not dissolve under the tongue as well as usual because this medicine can cause a dry mouth
  • Topiramate or zonisamide, used to treat epilepsy and to prevent migraines
  • Potassium chloride containing solid dose products (see section 2 “Do not give Glycopyrronium Bromide oral solution if”)

  • Anticholinergic medicines. (see section 2,

    “Do not give Glycopyrronium Bromide oral solution if”)

Long term use efficacy and safety of Glycopyrronium Bromide oral solution has not been studied beyond the recommended 24 weeks of use. Continued use should be discussed with child’s doctor every 3 months to check that Glycopyrronium Bromide oral solution is still right for the child.

Glycopyrronium Bromide oral solution with food and drink

The effect of Glycopyrronium Bromide oral solution may be reduced when taken with high fat foods. For this reason, this medicine should be given at least one hour before or two hours after meals. Speak to the child’s doctor if administration with a meal is required. Pregnancy and breastfeeding

Glycopyrronium is not recommended in pregnancy or breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

Glycopyrronium Bromide may make the patient feel drowsy or cause their eyesight to become blurred and this could interfere with their ability to drive or operate machinery safely. Do not drive or operate machinery until these effects have fully cleared. If there is any doubt, ask your doctor for advice.

Glycopyrronium Bromide oral solution contains E420 (sorbitol), E217 and E219

• This medicine contains 175 mg sorbitol

  (E420) per 1 ml. Sorbitol is a source of fructose. If you have been told by the doctor that your child has an intolerance to some sugars or if your child has been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before your child takes or receives this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

• This medicine contains sodium propyl parahydroxybenzoate (E217) and sodium methyl parahydroxybenzoate (E219).

  These may cause allergic reactions (possibly delayed) and exceptionally, bronchospasms (a narrowing of the airways).

• This medicinal product contains less than

  1 mmol sodium (23 mg) per maximum dose, i.e. essentially is ‘sodium free’.

3. How to use Glycopyrronium Bromide oral solution

Always give this medicine exactly as the doctor has told you.

There are other glycopyrronium bromide oral solutions available. This medicine is not interchangeable with other glycopyrronium medicines without dose adjustment. Do not change between medicines unless advised by your doctor. Read carefully how to use this medicinal product and check with your doctor or pharmacist if you are not sure. Use only the oral syringe included in the container of this product.

This medicine is for oral use only.

This medicine should be given at least one hour before or two hours after a meal. Do not give with high fat foods.

Use in children and adolescents aged 3 years and older

The initial dose will be calculated based on the weight of the child. The dose will be decided by the doctor, using the table below as a guide, and will depend on both the effect of Glycopyrronium Bromide oral solution and any side effects the patient is experiencing. Section 4 includes possible side effects related to the use of Glycopyrronium Bromide oral solution. These should be discussed with the child’s doctor, including those for dose increases and decreases, and at any other time should you be concerned. The child should be monitored at regular intervals to check that Glycopyrronium Bromide oral solution is still the right treatment for them.

Package Leaflet: Information for the Patient

Glycopyrronium Bromide 1 mg/5 ml Oral Solution

Country

UK

Body text

9pt

Dimensions in mm (H x W x D)

585 x 160

N/A

122962167_404528949

Operator

CG

Version No. Date

01 APR 2026

Directions for use

Give the dose prescribed by your doctor to the child three times each day. 1. Open the bottle and

at first use insert the

PIBA (see pictures

A-B). Note: this may

have been done

already by the

pharmacist.2. Insert the oral

syringe into the PIBA

and draw out the

required volume from

the inverted bottle (see

pictures C-D). Note:

check you have the

correct level. Maximum

dose of the highest

dose level is 15 ml.

1. 3. Remove the filled oral syringe from the bottle in the upright

position (see picture E).

1. 4. Discharge the oral syringe

contents into the child’s mouth.

1. 5. Replace the cap on the bottle,

the PIBA remains in place.

1. 6. Rinse the oral syringe with warm water and allow to dry after each

use.

If your child is given the medicine through a feeding tube, flush the tube with 20 ml of water after you have given the medicine.

This medicine is not recommended for children less than 3 years of age. Talk to your doctor or pharmacist before giving this medicine to a child if this medicine has been prescribed for a child less than 3 years. If you give more Glycopyrronium Bromide oral solution than you should

If you give more of this medicine than they have been prescribed, they are more likely to experience side effects. Consult the doctor or get medical advice immediately. If possible, give any leftover solution, the bottle and this leaflet to the medical staff so they know what you have given.

If you forget to give Glycopyrronium Bromide oral solution

• If you forget to give a dose, give it as soon

  as possible. Then give the next dose at the correct time, in accordance with the instructions given to you by the doctor. However, if the next dose is due, do not give the dose you have missed; just give the next dose as normal.

• Do not give a double dose to make up

  for the forgotten one.

If you have any further questions on the use of this medicine, ask the 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 giving the medicine and seek medical advice immediately:

• Severe allergic reaction (swelling of the

  tongue, lips, face or throat) - unknown

• Constipation (difficulty in passing stools)

  • very common

• Urinary retention (unable to completely

  empty the bladder) – common

• Pneumonia (severe chest infection)

  • common

• Allergic reaction (hives, difficulty breathing

  or swallowing, itching) – uncommon

• Fever (pyrexia) – common

• Changes in behaviour such as mood

  changes, irritability – very common Other side effects:

Very common side effects (may affect more than 1 in 10 people)

• Dry mouth
• Diarrhoea
• Being sick (vomiting)
• Flushing
• Nasal congestion
• Reduced secretions in the chest
• Reduced secretions in the airways Common side effects (may affect up to 1 in 10 people)

• Upper respiratory tract infection (chest

  infection)

• Urinary tract infection
• Drowsiness (sleepiness)
• Agitation
• Rash

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

• Allergy
• Headache
• Involuntary eye movement (nystagmus)
• Bad breath (halitosis)
• Rash (Hives)
• Nose bleeds (epistaxis)

• Fungal infection (thrush) of the throat

  (oesophageal candidiasis)

• Widening of the pupil of the eye (mydriasis)
• Dehydration
• Thirst
• Urgent need to urinate
• Insomnia (difficulty in sleeping)

• Abnormal contractions of digestive tract

  when food is ingested (gastrointestinal motility disorder)

• A disorder of the muscles and nerves in

  the intestine which causes an obstruction or blockage (pseudo-obstruction)

• Dizziness

Unknown side effects (frequency cannot be estimated from the available data)

• Nausea

• Angle-closure glaucoma (increased

  pressure in the eye)

• Photophobia
• Dry eyes
• Angioedema

• Decrease in heart rate (transient

  bradycardia)

• Sinus infection (sinusitis)
• Skin dryness
• Sweat inhibition

Reporting of side effects

If you notice 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 to the relevant medicines authority (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

5. How to store Glycopyrronium Bromide oral solution

• 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.

• This medicine should be stored below

  25°C in its original bottle.

• Do not freeze.

• Keep the bottle in the original carton in

  order to protect from light.

  • Once the bottle has been opened, this medicine should be used within 28 days.
  • Do not throw away any medicines via wastewater. 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 Glycopyrronium Bromide oral solution contains

• The active substance is glycopyrronium bromide. Each 5 ml of oral solution contains 1 mg of glycopyrronium bromide.

• The other ingredients are:

  o Glycerol

  o Sorbitol (E420) (see section 2)

  o Sodium methyl parahydroxybenzoate

  (E219) (see section 2)

  o Sodium propyl parahydroxybenzoate

  (E217) (see section 2)

  o Citric acid monohydrate

  o Trisodium citrate dihydrate

  o Strawberry flavour:

  • Flavouring substance
  • Maltodextrin (maize)
  • Acacia (E414)
  • Triacetin (E1518)

o Purified water

What Glycopyrronium Bromide oral solution looks like and contents of the pack

Glycopyrronium Bromide oral solution is a clear, colourless, strawberry flavoured liquid supplied in a 150 ml amber glass bottle with a child resistant cap. Each pack contains one 150 ml bottle, a 10 ml syringe and a syringe adaptor. Marketing Authorisation Holder

Colonis Pharma Limited

25 Bedford Square

Bloomsbury

London

WC1B 3HH

United Kingdom

Manufacturers

Labialfarma

Laboratório de Produtos Farmacêuticos e Nutracêuticos, S.A.

Felgueira

Sobral Mortágua

3450-336

Portugal

This leaflet was last revised in April 2026.

Country

UK

Body text

9pt

Dimensions in mm (H x W x D)

585 x 160

N/A

122962167_404528949

Operator

CG

Version No. Date

01 APR 2026