Hydrocortisone 5mg/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 those of the child for whom this medicine has been prescribed.
• If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your product is Hydrocortisone 5 mg/5 ml Oral Solution, but it will be referred to as Hydrocortisone oral solution throughout this leaflet.

If your child is given a steroid card by their doctor, make sure they carry it with them at all times. Show the Steroid card to any doctor or nurse treating your child.

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

• If your child is allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor or pharmacist before giving Hydrocortisone oral solution if your child is:

• unwell or has an infection. The doctor may need to increase the dose of Hydrocortisone oral solution temporarily; talk to your doctor if your child is unwell. If your child is vomiting or seriously unwell, your child may need an injection of hydrocortisone. Your doctor will train you how to do this in an emergency.
• due for a vaccination. Taking Hydrocortisone oral solution should not stop your child being vaccinated. Let your doctor know when your child is due for vaccinations.
• due for an operation. Let the anaesthetist know your child is receiving Hydrocortisone oral solution before your child has their operation.

You should not stop giving Hydrocortisone oral solution without the advice of your doctor as this could make your child seriously unwell very quickly.

As Hydrocortisone oral solution is replacing the normal hormone your child lacks, side effects are uncommon, however:

• Too much Hydrocortisone oral solution can affect your child’s growth, so your doctor will adjust the dose depending on your child’s size and monitor your child’s growth carefully. Let your doctor know if you are worried about your child’s growth (see section 4).
• Too much Hydrocortisone oral solution can affect your child’s bones so your doctor will adjust the dose depending on your child’s size.
• Some adult patients taking hydrocortisone (similar to Hydrocortisone oral solution) became anxious, depressed or confused. It is not known if this would happen with children, but tell your doctor if your child develops any unusual behaviour after starting Hydrocortisone oral solution (see section 4).
• In some patients with allergies to other medicines, allergy to hydrocortisone has been seen. Tell your doctor straight away if your child has any reaction like swelling or shortness of breath after being given Hydrocortisone oral solution (see section 4).
• Contact your doctor if your child experiences blurred vision or other visual disturbances.

Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines, including those which can be obtained without a prescription.

Some medicines can affect the way that Hydrocortisone oral solution works, and may mean that your doctor needs to alter your child’s dose of Hydrocortisone oral solution.

Medicines that may mean your doctor will increase your child’s dose of Hydrocortisone oral solution include:

• Medicines used to treat epilepsy: phenytoin, carbamazepine, and oxcarbazepine.
• Medicines used to treat infections (antibiotics): rifampicin and rifabutin.
• Medicines called barbiturates, which can be used to treat convulsions (including phenobarbital and primidone).
• Medicines used to treat AIDS: efavirenz and nevirapine.

Medicines that may mean your doctor will decrease your child’s dose of Hydrocortisone oral solution include:

• Medicines used to treat fungal diseases: itraconazole, posaconazole, and voriconazole.
• Medicines used to treat infections (antibiotics): erythromycin and clarithromycin.
• Medicine used to treat human immunodeficiency virus (HIV) infection and AIDS: ritonavir.

Some food and drink may affect the way Hydrocortisone oral solution works, and may mean that your doctor needs to decrease your child’s dose. These include:

• Grapefruit juice.
• Liquorice.

Hydrocortisone can be used during pregnancy and breast-feeding when the body is not making enough cortisol.

There is no information on any effects of Hydrocortisone oral solution on fertility.

Hydrocortisone oral solution has no influence on a child’s ability to perform skilled tasks (e.g. riding a bicycle) or using machines.

A steroid card would usually be given to your child by their nurse or doctor if they have adrenal insufficiency. If your child is given a steroid card, they must always carry it with them – it contains details of their steroid type and dosage, which is important information if they need medical treatment in an emergency. The doctor may also advise you that your child needs to carry this card for up to a year following completion of their steroid treatment.

This medicine contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate that may cause allergic reactions (possibly delayed).

This medicine contains 1.24 mg sodium (main component of cooking/table salt) in each ml. This is equivalent to 0.06 % of the recommended maximum daily dietary intake of sodium for an adult.

This medicine contains 0.80 mg propylene glycol in each ml.

Hydrocortisone oral solution should be given by mouth.

A 5 ml graduated oral syringe with intermediate graduations of 0.1 ml and a “Press-In” Bottle Adapter (PIBA) are provided with the product.

1. Open the bottle and at first use insert the “Press-In” Bottle Adapter (PIBA) (see pictures A-B).

2. Insert the syringe into the PIBA and draw out the required volume from the inverted bottle (see pictures C-D).

3. Remove the filled syringe from the bottle in the upright position (see picture E).

4. Giving the medicine:

• Make sure that your child is sitting up or standing.
• Put the syringe into your child’s mouth, placing the barrel-opening in the area between the gums and the inside of the cheek (see picture F).
• Push the plunger slowly, giving your child time to swallow the medicine as it squirts out. Do not push the plunger too quickly as the medicine may come out too quickly and your child may choke. Repeat steps 2 to 4 as needed to achieve the required dose.
• Give your child some water to drink in order to ensure that all the medicine is washed down.

5. Rinse the syringe and replace the cap on the bottle (PIBA remains in place).

If necessary, this medicine can be given down a feeding tube (called a nasogastric or gastrostomy tube). If this is the case, the following procedure should be followed and your doctor or nurse will show you how to do it:

Administering this medicine via NG or PEG tubes

1. Ensure the tube is clear before administering the medicine.
2. Administer the medicine into the tube with a suitable measuring device.
3. Immediately flush the tube with 5 ml of boiled cooled water.

If you give your child more Hydrocortisone oral solution than you should, contact your doctor or pharmacist for further advice as soon as possible.

If you forget to give your child a dose, give your child that dose as soon as you remember as well as their next dose at the usual time even if this means that your child receives two doses at the same time.

Do not stop giving your child Hydrocortisone oral solution without asking your doctor first. Stopping the medicine suddenly could quickly make your child very unwell.

Tell your doctor or pharmacist if your child becomes ill, suffers severe stress, gets injured or is about to have surgery because your doctor may need to increase the dose of Hydrocortisone oral solution in these circumstances (see section 2).

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 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.

• Each 5 ml of Hydrocortisone Oral Solution contains 5 mg of the active substance hydrocortisone (as hydrocortisone sodium phosphate).
• The other ingredients are: disodium edetate, sodium propyl parahydroxybenzoate, sodium methyl parahydroxybenzoate, sodium phosphate dihydrate, sucralose, sodium hydroxide, purified water and orange flavour (including propylene glycol, triacetine, orange oil, ethyl butyrate and acetaldehyde).

Hydrocortisone oral solution is a clear, colourless to yellowish solution with orange odour. It is supplied in amber type III glass bottle, safely closed with a child-resistant, screw cap with tamper evident closure. Each bottle contains 100 ml or 150 ml of this medicine. Not all pack sizes may be marketed.

A 5 ml graduated oral syringe with intermediate graduations of 0.1 ml and a “press-in” syringe/bottle adapter are also provided.