Patient Information Leaflet GB 727-0903-APIL

22595254

Hydrocortistab Injection

Hydrocortisone acetate 25 mg/ml

AMDIPHARM

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.

Hydrocortistab 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.

-    Hydrocortistab 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 yourtablets, 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 may be especially important for you.

Hydrocortisone - benefit information

Hydrocortisone belongs to a group of medicines called steroids. Their lull name is corticosteroids. These corticosteroids occur naturally in the body, and help to maintain health and well-being. Boosting your bodywith extracorticosteroid (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 take this medicine regularly to get maximum benefit from it.

In this leaflet:

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

2.    Before you are given Hydrocortistab Injection

3.    How Hydrocortistab Injection will be given

4. Possible side effects

5. How to store Hydrocortistab Injection

6.    Further information

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

The name of your medicine is Hydrocortistab Injection. Hydrocortistab 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.

, Hydrocortistab 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 HYDROCORTISTAB INJECTION Do not receive this injection if you:

^Hydrocorti^l^^ion⁶ (allergic? reactions 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 breaming);

•    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 maniodepressive illness (bipolar disorder). This includes having had depression before while taking steroid medicines like hydrocortisone or if anyone in yourfamijy 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

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 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 stepped altogether.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a 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 furosemiae;

•    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 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 use machines.

or

Important Information about some of the ingredients of Hydrocortistab 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 TH IS 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 it 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 HYDROCORTISTAB INJECTION WILL BE GIVEN

Hydrocortistab 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 hydrocortistab than you should

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

4.    POSSIBLE SIDE EFFECTS

Like all medicines Hydrocortistab Injection can cause side effects, although not everybody gets them.

Steroids including hydrocortisone 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 difficurty in thinking or being confused and losing your memory.

•    Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.

If you notice any of these problems taTktoa 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 ¹ 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 in the oesophagus (gullet);

•    thrush;

•    inflammation of the pancreas causing abdominal pain (pancreatitis);

O

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Amdipharm UK Limited Regency House,

Miles Gray Road, Basildon,

Essex SS14 3AF.

Date of preparation of leaflet: August 2013.