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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• 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 take Glycopyrronium bromide oral solution
3. How to take Glycopyrronium bromide oral solution
4. Possible side effects
5. How to store Glycopyrronium bromide oral solution
6. Contents of the pack and other information

• is allergic 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 or bowel causing vomiting, abdominal pain and swelling
• has an enlarged prostate gland
• is unable to completely empty the bladder
• suffers from chronic end-stage kidney disease and requires dialysis
• is pregnant or breastfeeding
• is taking a medicine containing potassium chloride
• is taking anticholinergic medicines

Talk to a doctor or pharmacist before giving this medicine 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, diarrhea and bleeding from the back passage)
• has just had a heart attack or is suffering from heart disease, irregular heartbeats or high blood pressure, because this medicine can cause a change to their normal heart rate
• has 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 a general anaesthetic.
• has diarrhoea, especially if they have had an ileostomy or colostomy
• has a high temperature (fever) or the environmental temperature is high,
• has kidney disease
• has compromised blood brain barrier
• has been told by their doctor that they have an intolerance to some sugars

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

This medicine reduces salivation which can increase the risk of dental disease, therefore teeth should be brushed daily and the child should have regular dental checks.

This medicine is not recommended for children younger than 3 years.

Please tell the doctor if your child is taking or has recently taken any of the following medicines:

• 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
• Medicines 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
• Medicines such as carbachol, neostigmine or physostigmine which affect the transmission of nerve impulses to muscles
• 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 medicines (see section 2 “Do not give Glycopyrronium Bromide oral solution if”)
• Anticholinergic medicines (see section 2 “Do not give Glycopyrronium Bromide oral solution if”)

If the doctor tells you to give this medicine together with one or more similar medicines such as oxybutynin, then they may need to take less than the usual dose of this medicine.

This medicine must not be given if the patient is pregnant or breastfeeding.

Discuss the need for contraception with the doctor.

This medicine may make the patient feel drowsy or cause their eyesight to become blurred.

Do not drive or operate machinery until these effects have fully cleared.

If there is any doubt, ask your doctor for advice.

• If you have been told by the doctor that your child has an intolerance to some sugars, contact the doctor before giving this medicine. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.
• 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 5 ml of oral solution.

The initial dose will be calculated based on the weight of the child.

The dose may be adjusted depending on how well they respond to treatment, and if any side effects occur.

The child should be checked by your doctor every 3 months to check that this medicine is still the right treatment for them.

The medicine should be given to your child three times each day.

It should be given at least one hour before or two hours after a meal.

• Remove the cap from the bottle. Insert the syringe adaptor into the neck of the bottle (this may have been done already by the pharmacist). Insert the end of the syringe into the adaptor and ensure it is secure.
• Hold the syringe in place and turn the bottle upside down. Gently pull down the plunger to the correct level The maximum volume of the highest dose is 15 ml.
• Turn the bottle upright. Remove the syringe by holding the bottle and twisting the syringe gently.
• Place the 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.
• Repeat the above steps if a higher dosage is recommended.
• Replace the cap.
• Wash the 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 at least 20 ml of water after you have given the medicine.

Consult the doctor or get medical advice immediately, as your child may experience side effects. If possible, take the bottle and this leaflet with you so that the medical staff know what you have given.

• Give it as soon as possible, then give the next dose at the normal time.
• However, if the next dose is due, do not give the missed dose; just give the next dose as normal.
• Do not give a double dose to make up for a forgotten dose.

If any of the following serious side effects occur, stop giving the medicine and seek medical advice immediately:

• Allergic reaction such as swelling of the tongue, lips, face or throat, hives, difficulty breathing or swallowing, itching
• Constipation (difficulty in passing stools)
• Urinary retention (unable to completely empty the bladder)
• Pneumonia (severe chest infection)
• Fever
• Changes in behaviour such as mood changes, irritability

Very common (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 (may affect up to 1 in 10 people)

• Upper respiratory tract infection (chest infection)
• Urinary tract infection
• Drowsiness (sleepiness)
• Agitation
• Rash

Uncommon (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)

Unknown (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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information 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 anhydrous (E422), sorbitol (E420), sodium benzoate (E211), sucralose (E955), citric acid (E330), strawberry flavouring (containing propylene glycol E1520) and purified water.

Glycopyrronium bromide oral solution is a clear, colourless, strawberry flavoured liquid.

Glycopyrronium bromide oral solution is supplied in an amber glass bottle or polyethylene terephthalate (PET) bottle of 150 ml with child resistant tamper evident polypropylene closure, a 10 ml syringe and a syringe adaptor.