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AMDIPHARM

Patient Information Leaflet GB727-1547LF-AM01

22595254

Hydrocortisone Acetate 25mg/ml Suspension for Injection

Hydrocortisone Acetate

Read all of this leaflet carefully before you start taking this medicine. It provides a summary of the Information available on your medicine. If you have any questions or are not sure about anything ask your doctor or pharmacist.

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 chicken-pox or shingles, if you have never had them. They could affect you severely. If you do come into contact with chicken-pox 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 might 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.

In this leaflet

1.    What Hydrocortisone Injection is and what it is used for

2.    Before you are given Hydrocortisone Injection

3.    How Hydrocortisone Injection will be given

4.    Possible side effects

5.    How to store Hydrocortisone Injection

6.    Further 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.    BEFORE YOU ARE GIVEN HYDROCORTISONE INJECTION

Do not receive this injection if you:

• are allergic to hydrocortisone acetate or any of the other ingredients of Hydrocortisone Injection (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.

Take special care 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.

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 acetate

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.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

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).

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Pregnancy and breast-feeding

Tell your doctor before being given this medicine if you are or think you may be pregnant, or if you are breast-feeding. Driving and using machinery This medicine should not affect your ability to drive or use machines. Important information about some of the ingredients of Hydrocortisone Injection

This product contains benzyl alcohol which is not normally recommended in infants and young children of up to 3 years old. The doctor will decide if treatment is needed for children of this age.

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 of 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 Hydrocortisone Injection will be injected into or around a joint. It will be given to you by a doctor or nurse. The doctor will decide upon the most suitable dose for you, but the usual doses are as follows:

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

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

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Hydrocortisone Injection 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 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:

•    generally feeling unwell;

•    feeling sick (nausea);

•    indigestion or stomach discomfort;

•    stomach ulcer ( which can rupture and bleed ) or ulcer

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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; mood changes, dependence, depression, difficulty' sleeping, worsening of schizophrenia; 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.

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 By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE HYDROCORTISONE INJECTION 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 form light.

The doctor or nurse will check that the expiry date on the label has not passed before you are given the injection.

KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.

6.    FURTHER INFORMATION

What Hydrocortisone Injection contains

Each 1 ml 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 10x 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: January 2014.

REGULATORY AUTHORITY APPROVAL CONFIRMATION

Confirmation that this artwork has been approved by the appropriate market authority (if applicable, e.g. MHRA, IMB, etc and that Amdipharm have license approval to distribute this component for sale in the relevent market.

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