Glycopyrronium Bromide 1mg/5ml 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 Oral Solution
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
• has stomach ache and swelling (paralytic ileus)
• is unable to completely empty the bladder (urinary retention)
• suffers from severe kidney disease
• is pregnant or breastfeeding
• has diarrhoea (frequent, loose watery stools)
• has ulcerative colitis (inflammation of the intestine)
• is taking any of the following medicines (see Other medicines and Glycopyrronium Bromide Oral Solution):
  • potassium chloride solid dose products
  • anticholinergic medicines.

Talk to your doctor or pharmacist before giving Glycopyrronium Bromide Oral Solution if the child or adolescent:

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

If you are not sure any of the above applies to the child or adolescent, talk to a doctor or pharmacist before giving Glycopyrronium Bromide Oral Solution.

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 Glycopyrronium Bromide Oral Solution 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.

This medicine is formulated as an oral formulation and a dose specifically for use in children and adolescents aged 3 years and older.

Glycopyrronium Bromide Oral Solution is not recommended for children under 3 years of age.

Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines. This includes medicines you have bought without a prescription. In particular taking Glycopyrronium Bromide Oral Solution with the following medicines can affect the way Glycopyrronium Bromide Oral Solution or the listed medicine works or can increase the risk of side effects:

• potassium chloride solid oral dose (see section above “Do not give Glycopyrronium Bromide Oral Solution if the child or adolescent:”)
• anticholinergic medicines (see section above “Do not give Glycopyrronium Bromide Oral Solution 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 Glycopyrronium Bromide Oral Solution.

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

This medicine is intended for use in children and adolescents. Glycopyrronium Bromide Oral Solution 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.

Glycopyrronium Bromide Oral Solution may affect vision and co-ordination. This may affect performance at skilled tasks such as driving, riding a bicycle, or using machines. After receiving Glycopyrronium Bromide Oral Solution, 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.

• This medicine contains 175 mg sorbitol (E420) in each 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 1 mg benzoic acid (E210) in each ml.
• This medicine contains 21 mg propylene glycol (E1520) in each ml.
• If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol.
• If you are pregnant, breast-feeding, suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.
• This medicine contains less than 1 mmol sodium (23 mg) per dose, 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 child may have. Section 4 includes possible side effects related to the use of Glycopyrronium Bromide Oral Solution (this is why several dose levels appear in the table below). These should be discussed with the child’s doctor, including the need for dose increases as the child grows, 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 Glycopyrronium Bromide Oral Solution remain appropriate treatment for them.

Weight 13-17 kg:

Dose level 1 (~0.02 mg/kg) = 1.5ml

Dose level 2 (~0.04 mg/kg) = 3ml

Dose level 3 (~0.06 mg/kg) = 4.5ml

Dose level 4 (~0.08 mg/kg) = 6ml

Dose level 5 (~0.1mg/kg) = 7.5ml

Weight 18-22 kg:

Dose level 1 (~0.02 mg/kg) = 2ml

Dose level 2 (~0.04 mg/kg) = 4ml

Dose level 3 (~0.06 mg/kg) = 6ml

Dose level 4 (~0.08 mg/kg) = 8ml

Dose level 5 (~0.1mg/kg) = 10ml

Weight 23-27 kg:

Dose level 1 (~0.02 mg/kg) = 2.5ml

Dose level 2 (~0.04 mg/kg) = 5ml

Dose level 3 (~0.06 mg/kg) = 7.5ml

Dose level 4 (~0.08 mg/kg) = 10ml

Dose level 5 (~0.1mg/kg) = 12.5ml

Weight 28-32 kg:

Dose level 1 (~0.02 mg/kg) = 3ml

Dose level 2 (~0.04 mg/kg) = 6ml

Dose level 3 (~0.06 mg/kg) = 9ml

Dose level 4 (~0.08 mg/kg) = 12ml

Dose level 5 (~0.1mg/kg) = 15ml

Weight 33-37 kg:

Dose level 1 (~0.02 mg/kg) = 3.5ml

Dose level 2 (~0.04 mg/kg) = 7ml

Dose level 3 (~0.06 mg/kg) = 10.5ml

Dose level 4 (~0.08 mg/kg) = 14ml

Dose level 5 (~0.1mg/kg) = 15ml

Weight 38-42 kg:

Dose level 1 (~0.02 mg/kg) = 4ml

Dose level 2 (~0.04 mg/kg) = 8ml

Dose level 3 (~0.06 mg/kg) = 12ml

Dose level 4 (~0.08 mg/kg) = 15ml

Dose level 5 (~0.1mg/kg) = 15ml

Weight 43-47 kg:

Dose level 1 (~0.02 mg/kg) = 4.5ml

Dose level 2 (~0.04 mg/kg) = 9ml

Dose level 3 (~0.06 mg/kg) = 13.5ml

Dose level 4 (~0.08 mg/kg) = 15ml

Dose level 5 (~0.1mg/kg) = 15ml

Weight ≥48 kg:

Dose level 1 (~0.02 mg/kg) = 5ml

Dose level 2 (~0.04 mg/kg) = 10ml

Dose level 3 (~0.06 mg/kg) = 15ml

Dose level 4 (~0.08 mg/kg) = 15ml

Dose level 5 (~0.1mg/kg) = 15ml

The maximum recommended dose is 0.1 mg/kg three times daily not to exceed 1.5-3 mg (7.5 ml – 15 ml) per dose based upon weight (for further detail see Table above).

• Remove the child-resistant closure from the bottle. Insert the oral 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. Each graduation step of the oral syringe corresponds to 0.5 ml.
• 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 15 ml.
• 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). Do not use a dishwasher.

If you give more of this medicine than the child has been prescribed, side effects are more likely. Consult the doctor or a pharmacist immediately or go to the emergency department of the nearest hospital. Always take any leftover medicine with you, as well as the container and label, so that the medical staff knows 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 you have missed; just give the next dose as normal.

Do not give a double dose to make up for the forgotten one.

If this is necessary it is best to reduce the dose gradually. Contact your doctor, pharmacist or nurse immediately for advice if they have not given directions to do this.

If you notice 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 dose of oral solution contains 1 mg of glycopyrronium bromide.

The other ingredients are glycerol; sorbitol, liquid (Non-crystallising) (E420); benzoic acid (E210); propylene glycol (E1520); saccharin sodium; sodium citrate; citric acid monohydrate and purified water.

Glycopyrronium Bromide 1 mg/5 ml Oral Solution is a clear colourless solution and is available in amber coloured bottles of 150 ml solution packed in an outer carton along with 10 ml oral Syringe (0.5ml graduation) with Adapter.