Hydrocortisone 500mg/5ml solution for injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Hydrocortisone 100mg/1ml Solution for Injection and Hydrocortisone 500mg/5ml Solution for Injection; it will be called Hydrocortisone Injection for ease here after.

Now read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that may be especially important for you.

Hydrocortisone reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.

1. What Hydrocortisone Injection is and what it is used for
2. What you need to know before you are given Hydrocortisone Injection
3. How Hydrocortisone Injection will be given
4. Possible side effects
5. How to store Hydrocortisone Injection
6. Contents of the pack and other information

Hydrocortisone belongs to a group of medicines called steroids. Their full name is corticosteroids. These corticosteroids occur naturally in the body, and help to maintain health and well-being. Boosting your body with extra corticosteroid (such as hydrocortisone) is an effective way to treat various illnesses involving inflammation in the body.

Hydrocortisone reduces this inflammation, which could otherwise go on making your condition worse. You must use this medicine regularly to get maximum benefit from it.

Talk to your doctor, pharmacist or nurse before receiving Hydrocortisone Injection :

• if you have or have ever had:
  • severe depression or manic-depressive illness (bipolar disorder). This includes having had depression before while taking steroid medicines like hydrocortisone, or if anyone in your family has suffered from these illnesses;
  • TB (tuberculosis);
  • diabetes; (or a family history of diabetes);
  • epilepsy;
  • an eye disease caused by a rise of pressure within the eye ( glaucoma, or a family history of glaucoma);
  • osteoporosis (thinning of the bones);
  • muscle problems when steroids have been taken before;
  • stomach ulcers or other digestive problems;
  • high blood pressure or heart failure or recently suffered a heart attack
  • thyroid problems;
  • a stroke or acute head injury;
  • herpes infection in the eye called ocular herpes simplex;
  • HIV infection;
  • cerebral malaria;
  • a type of muscle weakening problem called 'myasthenia gravis';
  • thrombophlebitis (swelling and redness along a vein which is tender when touched);
  • metastatic carcinoma (cancer that has spread from one part of the body to another);
  • history of drug allergies;
  • any liver or kidney problems.

If hydrocortisone is given to a prematurely born baby, monitoring of heart function and structure may be needed.

If any of the above applies to you, or you are not sure please tell your doctor or nurse before you are given this medicine.

Contact your doctor if you experience blurred vision or other visual disturbances.

You should see your doctor if you develop any new infections whilst using this medication. Using Hydrocortisone for a long period of time increases your chance of getting infections, which might be worse than normal and may very rarely be fatal.

If the patient is a child, it is important that the doctor monitors growth and development at intervals during treatment.

Hydrocortisone should be used with caution in the elderly as side effects can be heightened in this age group.

If you are using or have recently used (within the last 3 months) Hydrocortisone Injection and you become ill, suffer stress, get injured or are about to have a surgical procedure you must tell your doctor immediately that you are using Hydrocortisone Injection. Your dose of hydrocortisone may need to be increased (or you may have to start using it again for a short time) to prevent a sharp fall in blood pressure.

If you have been on Hydrocortisone Injection for longer than 3 weeks and wish to stop using it, do not stop suddenly as this could result in a severe drop in blood pressure which could be fatal. Your doctor will advise on how to reduce the dose you are taking.

It is important to avoid exposure to people who have chickenpox, measles or shingles, especially if you have not already had these illnesses or are not sure if you have had them. Hydrocortisone Injection increases the risk of a severe bout of chickenpox. If exposed you must contact your doctor immediately.

Mental health problems can occur while taking steroids like hydrocortisone (see also section 4 Possible Side Effects).

• These illnesses can be severe.
• Usually they start within a few days or weeks of starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is lowered or the medicine is stopped. However, if problems do occur they might need treatment.

Talk to a doctor if you (or someone using this medicine) show any signs of mental health problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental health problems have happened when doses are being lowered or the medicine stopped altogether.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.,

• Some medicines may increase the effects of Hydrocortisone Injection and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat);
  Hydrocortisone Injection and some other medicines can affect the way each other work.

The effectiveness of Hydrocortisone Injection may be altered if other medicines are being taken at the same time.

In particular, you should not be given this medicine if you are taking any of the following:

• anticoagulants such as warfarin (medicines used to thin the blood);
• salicylates such as aspirin;
• non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, diclofenac or naproxen (medicines used to treat mild to moderate pain);
• medicines for diabetes (including insulin);
• erythromycin, telithromycin or clarithromycin (medicines used to treat bacterial infections);
• an oral contraceptive pill;
• somatropin (a type of growth hormone);
• ritonavir, efavirenz or nevirapine (medicines used in the treatment of HIV infections);
• acetazolamide (a medicine used to treat glaucoma);
• amphotericin, ketoconazole, itraconazole, posaconazole or voriconazole (used to treat fungal infections);
• mifepristone (a medicine used to assist medical termination of pregnancy);
• diuretics (water tablets);
• carbenoxolone (a medicine used to treat ulcers);
• methotrexate (a medicine used to treat rheumatoid arthritis);
• medicines used to treat epilepsy such as phenytoin, phenobarbital, carbamazepine and primidone;
• rifabutin and rifampicin (antibiotics used to treat TB);
• aminoglutethimide (a medicine used in the treatment of cancer);
• cardiac glycosides, such as digoxin (used to treat heart failure and irregular heartbeat);
• theophylline and sympathomimetics such as bambuterol, fenoterol, formoterol, ritodrine, salbutamol, salmeterol and terbutaline (used to treat asthma and other breathing problems);
• cough and cold medicines that contain ephedrine (a decongestant);
• calcium supplements;
• St. John's Wort (a herbal medicine used for treating depression);
• sodium phenyl butyrate (a medicine used to treat urea cycle disorders, where you are unable to eliminate nitrogen waste from your body);
• sodium benzoate (a preservative);
• medicines used to treat myasthenia gravis;
• orally ingested chemicals used to make X-rays clearer;
• antihypertensives (medicines used to treat high blood pressure).

Hydrocortisone could affect the results of some tests performed by your doctor or in hospital, so tell your doctor or nurse that you are using this medicine before any tests are carried out.

Do not use this medicine with grapefruit juice as the juice will conflict with the action of this medicine.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

This medicine should not affect your ability to drive or use machines.

Your doctor or pharmacist will have given you a Steroid Treatment Card with your prescription or medicine.

YOU SHOULD ALWAYS CARRY THIS CARD WITH YOU as it must be shown to any of the following persons:

Doctor or Nurse

• before having any surgery or emergency treatment or if any new treatment is prescribed.

Dentist

• before having any dental surgery.

Pharmacist

• before buying any medicine.

Optician

• it is advisable to have regular eye tests.

This medicine contains less than 1 mmol sodium (23 mg) per dosage, that is to say essentially ‘sodium-free’.

Overdosing is unlikely. If it does happen the doctor will treat any symptoms that follow.

If you have been on hydrocortisone for longer than 3 weeks and wish to stop using it, do not stop suddenly as this could result in a severe drop in blood pressure which could be fatal. Your doctor will advise on how to reduce the dose you are taking.

• slowed growth in infants, children and teenagers.

Injections like these can make it easier for you to pick up infections. Infections such as chicken-pox and measles can be made worse, or TB (tuberculosis) may recur.

Kaposi's sarcoma (a type of cancer) has also been reported to occur in patients receiving corticosteroids. However, once the treatment is stopped, this may go away.

In the elderly, the side effects caused by corticosteroids may be more serious. This is especially in cases of osteoporosis (thinning of the bones), high blood pressure, low potassium levels in the blood, diabetes, higher risk of infections and thinning of the skin.

Elderly people being given Hydrocortisone Injection will be monitored closely by their doctor in order to avoid any serious side effects.

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 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 hydrocortisone (as hydrocortisone sodium phosphate).

Each 1 ml Hydrocortisone Injection ampoule contains 100 mg of the active ingredient hydrocortisone (as hydrocortisone sodium phosphate)

Each 5 ml Hydrocortisone Injection ampoule contains 500 mg of the active ingredient hydrocortisone (as hydrocortisone sodium phosphate)

The other ingredients are: disodium edetate, , formaldehyde sodium bisulphite monohydrate disodium hydrogen phosphate anhydrous, sodium acid phosphate, phosphoric acid and water for injections.

Hydrocortisone Injection is a clear, colourless to pale yellow solution, which is available in 1 ml or 5 ml clear glass ampoules.

It is available in packs containing 5 x 1 ml (100 mg) or 5 x 5 ml (500 mg) ampoules.