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Hydrocortisone 10 mg/5 ml Oral Solution
Hydrocortisone 10 mg/5 ml Oral Solution
The name of your product is Hydrocortisone 10 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
Hydrocortisone oral solution contains a medicine called hydrocortisone. This belongs to a group of medicines called corticosteroids, often referred to as ‘steroids’. Hydrocortisone is a synthetic version of the naturally occurring hormone cortisol which is made by the adrenal glands. Hydrocortisone is used when the body is not making enough cortisol because part of the adrenal gland is not working properly (this is called adrenal insufficiency). This is often caused by an inherited condition called congenital adrenal hyperplasia.
Talk to your doctor or pharmacist before giving Hydrocortisone oral solution if your child is:
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:
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 that may mean your doctor will decrease your child’s dose of Hydrocortisone oral solution include:
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:
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 1.34 mg sodium (main component of cooking/table salt) in each ml. This is equivalent to 0.07 % of the recommended maximum daily dietary intake of sodium for an adult.
This medicine contains 0.80 mg propylene glycol in each ml.
Always use this medicine exactly as your doctor, nurse or pharmacist has told you. Check with your doctor, nurse or pharmacist if you are not sure. Hydrocortisone oral solution can be used in children and adolescents aged between 1 month and 18 years. It is given by mouth, usually in three doses during the day. Your doctor will decide on the right dose of Hydrocortisone oral solution based on your child’s size (height and weight) and will adjust the dose according to response and as your child grows. During illness, when undergoing surgery and during times of serious stress, your doctor may recommend additional doses of Hydrocortisone oral solution or may advise that your child receives other forms of hydrocortisone as well as, or instead of, Hydrocortisone oral solution.
Hydrocortisone oral solution should be given by mouth.
A 10 ml graduated oral syringe with intermediate graduations of 0.5 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:
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 have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side-effects have been reported with hydrocortisone medicines used to replace cortisol:
Contact your doctor if your child complains of these.
Hydrocortisone can sometimes upset the level of potassium in the blood. Your doctor will monitor your child’s potassium levels to check for any changes.
Long-term treatment with hydrocortisone may be associated with changes in the development of bones and reduced growth. Your doctor will monitor your child’s growth and bones (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.
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 carton and label after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2oC – 8oC).
After first opening use within 3 months.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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 10 ml graduated oral syringe with intermediate graduations of 0.5 ml and a “press-in” syringe/bottle adapter are also provided.
This leaflet was last revised in May 2023.