What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 20072/0221 .


Hydrocortisone Acetate 25mg/ml Suspension for Injection

Package leaflet: Information for the patient

Hydrocortisone Acetate 25mg/ml Suspension for Injection

Hydrocortisone Acetate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • 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 or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Hydrocortisone Acetate 25mg/ml Suspension for Injection; it will be called Hydrocortisone Injection for ease here after.

  • Hydrocortisone Injection is a steroid medicine, prescribed for many different conditions, including serious illnesses.
  • You need to take it regularly to get the maximum benefit.
  • Don’t stop taking this medicine without talking to your doctor - you may need to reduce the dose gradually.
  • Hydrocortisone Injection can cause side effects in some people (read section 4 below). Some problems such as mood changes (feeling depressed or ‘high’) or stomach problems can happen straight away. If you feel unwell in any way, keep taking your tablets, but see your doctor straight away.
  • Some side effects only happen after weeks or months. These include weakness of arms and legs or developing a rounder face (read section 4 for more information).
  • If you take this medicine for more than three weeks, you will get a blue ‘steroid card’: always keep it with you and show it to any doctor or nurse treating you.
  • Keep away from people who have chickenpox or shingles, if you have never had them. They could affect you severely. If you do come into contact with chickenpox or shingles, see your doctor straight away.

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 Acetate - benefit information.

Hydrocortisone Acetate 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 acetate) is an effective way to treat various illnesses involving inflammation in the body. Hydrocortisone Acetate reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.

What is in this leaflet

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

1. WHAT HYDROCORTISONE INJECTION IS AND WHAT IT IS USED FOR

The name of your medicine is Hydrocortisone Injection.

Hydrocortisone Injection contains the active ingredient hydrocortisone acetate which belongs to a group of medicines called corticosteroids or ‘steroids’. Steroids work by reducing inflammation and lowering the body’s immune response.

Hydrocortisone Injection is used to treat swollen, painful joints and tendons in conditions such as arthritis and osteoarthritis (inflammation of the joints).

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN HYDROCORTISONE INJECTION

Do not receive Hydrocortisone Injection if you:

  • are allergic to hydrocortisone acetate or any of the other ingredients of this medicine (listed in section 6) (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing);
  • have recently had a vaccination or have a vaccination planned;
  • have a viral infection such as measles, chickenpox or shingles or any other infection. Tell your doctor immediately if you have come into contact with anyone suffering with measles, chickenpox or shingles in the last three months.

Warnings and precautions:

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 acetate or if anyone in your family has suffered from these illnesses;
    • TB (tuberculosis);
    • diabetes;
    • epilepsy;
    • an eye disease caused by a rise of pressure within the eye (glaucoma);
    • osteoporosis (thinning of the bones);
    • muscle problems when steroids have been taken before;
    • stomach ulcers;
    • high blood pressure, heart failure or recently suffered a heart attack;
    • any liver or kidney problems.

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

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

Mental health problems while taking Hydrocortisone Injection

Mental health problems can occur while taking steroids like Hydrocortisone acetate (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 taking 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.

Other medicines and Hydrocortisone Injection

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Some medicines may increase the effects of Hydrocortisone and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

This is especially important if you are taking:

  • Medicines for epilepsy such as phenytoin;
  • Antibiotics such as rifampicin;
  • Medicines for diabetes such as insulin, glibenclamide or metformin;
  • Medicines to treat high blood pressure, such as diuretics (water tablets) like bendroflumethiazide and furosemide;
  • Warfarin or other medicines used to thin the blood;
  • Aspirin or similar medicines;
  • Medicines to treat fungal infections such as amphotericin;
  • Acetazolamide (used to treat glaucoma);
  • Methotrexate (used for rheumatoid arthritis, psoriasis and certain types of cancer).

Pregnancy, breast-feeding and fertility

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.

Driving and using machines

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

Hydrocortisone Injection contains benzyl alcohol and sodium

This medicine contains 10 mg of benzyl alcohol in each 1 ml which is equivalent to 10mg/ml.

Benzyl alcohol may cause allergic reactions.

Do not use for more than a week in young children (less than 3 years old), unless advised by your doctor or pharmacist.

Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).

Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).

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

Carrying a Steroid card

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.

3. HOW HYDROCORTISONE INJECTION WILL BE GIVEN

Always take this medicine exactly as your doctor or nurse has told you. Check with your doctor or pharmacist if you are not sure. Hydrocortisone Injection will be injected into or around a joint. It will be given to you by a doctor or nurse.

The recommended dose is:

Adults: 5 to 50 mg daily depending on the size of the joint.

Use in children:

5 to 30 mg daily (in divided doses).

Not more than 3 joints should be treated in one day. The injection(s) may be repeated at intervals of around three weeks, if needed.

If you receive more Hydrocortisone Injection than you should

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

General feeling of unease and discomfort in the stomach often with the urge to vomit (Nausea and vomiting), sodium and water retention, high blood sugar and bleeding arising from the esophagus, stomach, or duodenum. Blood may be observed in vomit (hematemesis) or in altered form in the stool (melena) (occasional gastrointestinal bleeding).

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Steroids including hydrocortisone acetate can cause severe mental health problems.

These are common in both adults and children. They can affect about five in every 100 people taking medicines like hydrocortisone.

  • Feeling depressed, including thinking about suicide.
  • Feeling high (mania) or having moods that go up and down.
  • Feeling anxious, having problems sleeping, having difficulty in thinking or being confused and losing your memory.
  • Feeling, seeing or hearing things which do not exist. Having stranger and frightening thoughts, changing how you act or having feelings of being alone.

If you notice any of these problems talk to a doctor immediately.

If you notice:

  • itching or skin rashes;
  • swelling of the face, lips or throat;
  • difficulty in breathing or wheeziness.

Tell your doctor immediately. These may be signs of an allergic reaction.

The most likely side effect is increased pain and swelling after the injection. This usually goes away after a few hours and you should rest the joint as much as possible.

High doses of steroids taken for a long time or repeated in short courses, can lead to side effects. The doctor will always give you the lowest dose possible to prevent these.

The side effects which can occur if steroids are given in high doses for a long time are

Not known: frequency cannot be estimated from the available data

  • generally feeling unwell;
  • feeling sick (nausea);
  • indigestion or stomach discomfort;
  • stomach ulcer (which can rupture and bleed) or ulcer in the oesophagus (gullet);
  • thrush;
  • inflammation of the pancreas causing abdominal pain (pancreatitis);
  • muscle weakness;
  • thinning of bones which makes fractures more likely (osteoporosis);
  • damage to tendons;
  • joint stiffness causing limited motion, pain and muscle spasms;
  • fluid retention causing swelling;
  • feeling dehydrated;
  • high blood pressure;
  • slow healing of wounds, thinning of the skin, bruising, acne, marks which look like stretch marks;
  • small red, purple or blue spots found along the surface of the skin (caused by blood vessels under the skin);
  • low adrenal gland function;
  • slowed growth in infants, children and teenagers;
  • irregular or stopped menstrual periods;
  • swollen, round face (Cushingoid faces);
  • excess hair growth;
  • increased appetite and weight gain;
  • intolerance to carbohydrates;
  • severe headaches with blurred vision or temporary visual problems in children (usually after stopping treatment);
  • worsening of epilepsy;
  • raised pressure in the eyes (glaucoma), cataracts, thinning and inflammation of the cornea (part of the eye), worsening of viral or fungal eye diseases;
  • heart attack (sudden severe chest pain);
  • changes in body chemistry;
  • an increase in the number of white blood cells in the blood;
  • formation of blood clots;
  • blurred vision;
  • dependence.

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

If any of the side effects become severe or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately.

Reporting of 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.

5. HOW TO STORE HYDROCORTISONE INJECTION

Keep this medicine out of the sight and reach of children.

Hydrocortisone Injection ampoules will be stored at the healthcare centre.

They should be stored at 15 - 25°C and kept in the carton to protect them from light.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Hydrocortisone Injection contains

Each 1ml ampoule contains 25 mg of the active ingredient Hydrocortisone Acetate Ph.Eur.

The other ingredients are: water for injections, benzyl alcohol, sodium chloride, sodium carboxymethylcellulose and polysorbate 80, with sodium hydroxide and/or hydrochloric acid as pH adjusters.

What Hydrocortisone Injection looks like and the contents of the pack

Hydrocortisone Injection is a white suspension. It is available in 1ml ampoules in packs containing 10 x 1ml ampoules.

Marketing Authorisation Holder and Manufacturer responsible for release:

Amdipharm UK Limited
Capital House
85 King William Street
London
EC4N 7BL
UK

Date of preparation of leaflet: July 2019.

22595259

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