Glycopyrronium Bromide 1 mg/5 ml Oral solution

• 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Glycopyrronium Bromide oral solution is and what it is used for
2. What you need to know before you give Glycopyrronium Bromide oral solution
3. How to use Glycopyrronium Bromide oral solution
4. Possible side effects
5. How to store Glycopyrronium Bromide
6. Contents of the pack and other information

• 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

Talk to a doctor or pharmacist before giving Glycopyrronium Bromide oral solution 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.

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.

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 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 has not been studied beyond recommended 24 weeks of use. Continued use should be discussed with child's doctor every 3 months to check that Glycopyrronium Bromide is still right for the child.

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.

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.

Glycopyrronium Bromide oral solution 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.

• This medicine contains 875 mg of sorbitol (E420) in each 5 ml, which is equivalent to 175 mg/1 ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
• This medicine contains 4.0 mg sodium benzoate (E211) in each 5 ml, which is equivalent to 0.80 mg/ml.

This medicinal product contains less than 1 mmol sodium (23 mg) per 1 ml, that is to say essentially 'sodium free'.

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.

Weight 13-17 kg:

Dose level 1 = 1.5ml

Dose level 2 = 3ml

Dose level 3 = 4.5ml

Dose level 4 = 6ml

Dose level 5 = 7.5ml

Weight 18-22 kg:

Dose level 1 = 2ml

Dose level 2 = 4ml

Dose level 3 = 6ml

Dose level 4 = 8ml

Dose level 5 = 10ml

Weight 23-27 kg:

Dose level 1 = 2.5ml

Dose level 2 = 5ml

Dose level 3 = 7.5ml

Dose level 4 = 10ml

Dose level 5 = 12.5ml

Weight 28-32 kg:

Dose level 1 = 3ml

Dose level 2 = 6ml

Dose level 3 = 9ml

Dose level 4 = 12ml

Dose level 5 = 15ml

Weight 33-37 kg:

Dose level 1 = 3.5ml

Dose level 2 = 7ml

Dose level 3 = 10.5ml

Dose level 4 = 14ml

Dose level 5 = 15ml

Weight 38-42 kg:

Dose level 1 = 4ml

Dose level 2 = 8ml

Dose level 3 = 12ml

Dose level 4 = 15ml

Dose level 5 = 15ml

Weight 43-47 kg:

Dose level 1 = 4.5ml

Dose level 2 = 9ml

Dose level 3 = 13.5ml

Dose level 4 = 15ml

Dose level 5 = 15ml

Weight ≥48 kg:

Dose level 1 = 5ml

Dose level 2 = 10ml

Dose level 3 = 15ml

Dose level 4 = 15ml

Dose level 5 = 15ml

Give the dose prescribed by your doctor to the child three times each day.

1. Open the bottle and at first use insert the Plug-in-Bottle adaptor. Note: this may have been done already by the pharmacist
2. Insert the oral syringe into the Plug-in-Bottle adaptor and draw out the required volume from the inverted bottle. Note: check you have the correct level. Maximum dose of the highest dose level is 15 ml.
3. Remove the filled oral syringe from the bottle in the upright position.
4. Discharge the oral syringe contents into the child’s mouth.
5. Replace the cap on the bottle, the Plug-in-Bottle adaptor remains in place.
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 of this medicine to the child than 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 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 missed; just give the next dose as normal.
• Do not give a double dose to make up for the forgotten one.

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

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is glycopyrronium bromide.
  Each 5 ml of oral solution contains 1 mg of glycopyrronium bromide.
• The other ingredients are:
  Glycerol (E422) (see section 2)
  Sorbitol (E420) (see section 2)
  Sodium citrate
  Sodium benzoate (E211) (see section 2)
  Citric acid
  Cherry flavor
  Sodium saccharin
  Sodium hydroxide/Citric acid (for pH-adjustment)
  Purified water

Glycopyrronium Bromide oral solution is a clear, colourless, cherry 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.

PL 58713/0020

Or