Patient Information Leaflet GB727-1570LF-AM01

22595244

Prednisolone acetate 25mg/ml Suspension for Injection

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AMDIPHARM

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 medicine is Prednisolone acetate 25mg/ml Suspension for Injection. It will be referred to as Prednisolone Injection for ease of use hereafter.

-    Prednisolone 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.

-    Prednisolone 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 may be especially important for you.

Prednisolone - benefit information

Prednisolone 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 prednisolone) is an effective way to treat various illnesses involving inflammation in the body. Prednisolone 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 Prednisolone Injection is and what it is used for

2.    Before you are given Prednisolone Injection

3.    How Prednisolone Injection will be given

4.    Possible side effects

5.    How to store Prednisolone Injection

6.    Further information

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

The name of your medicine is Prednisolone Injection. Prednisolone Injection contains the active ingredient prednisolone acetate which belongs to a group of medicines called corticosteroids or ‘steroids'. Steroids work by reducing inflammation and lowering the body's immune response.

Prednisolone Injection is used to treat swollen, painful joints and tendons in conditions such as arthritis, tennis elbow and golfer's elbow.

Prednisolone Injection can also be used to treat conditions such as asthma, severe allergic reactions, ulcerative colitis and Crohn's disease.

2.    BEFORE YOU ARE GIVEN PREDNISOLONE INJECTION

Do not receive the injection if:

•    You are allergic to prednisolone or any of the other ingredients of Prednisolone 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);

•    You just had a vaccination or have a vaccination planned;

•    You 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 Prednisolone Injection, 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 or heart failure;

•    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 prednisolone

Mental health problems can occur while taking steroids like prednisolone (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 a prescription.

This is especially important if you are taking:

•    Medicines for epilepsy such as carbamazepine phenobarbitone, phenytoin or primidone;

•    Antibiotics such as rifampicin, rifabutin;

•    Mifepristone (used to terminate pregnancy);

•    Ritonavir (used in HIV treatment);

•    Oral contraceptives;

•    Somatropin (used to treat growth problems);

•    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;

•    Theophylline (used to treat asthma);

•    Medicines to treat fungal infections such as amphotericin, ketoconazole;

•    Acetazolamide (used to treat glaucoma);

•    Carbenoxolone (used to treat stomach ulcers);

•    Methotrexate (used for rheumatoid arthritis, psoriasis and certain types of cancer);

•    Any medicine which belong to a group of medicines called sympathomimetics.

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 Prednisolone 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 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 PREDNISOLONE INJECTION WILL BE GIVEN

Prednisolone Injection will be injected into or around a joint, or into a muscle, depending on the condition being treated. It will be given by a doctor or nurse. The doctor will decide upon the most suitable dose for you, but the usual doses are:

Adults:

For joint injections: Between 5 mg and 25 mg depending on the size of the joint. Not more than 3 joints will be treated in one day. The injections may be repeated if needed.

For muscle (systemic) injections: Between 25 mg and 100 mg once or twice a week, depending on your condition.

Elderly:

Your doctor will use the lowest dose for the shortest period of time to treat your condition. This is important to reduce the possible side effects.

If you receive more Prednisolone Injection than you should

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

4.    POSSIBLE SIDE EFFECTS

As with all medicines, Prednisolone Injection can cause side effects, although not everybody gets them.

Steroids including prednisolone 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 prednisolone.

•    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 strange 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.

If you are having injections into a joint, 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.

If you are having muscle (systemic) injections the steroid will enter your system.

The side effects which can occur if steroids are given in high doses for a long time are: generally feeling unwell; feeling sick (nausea); hiccups;

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; muscle pain;

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,

marks which look like stretch marks and acne;

•    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 facies);

•    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 and visual impairment;

•    heart attack;

•    an increase in the number of white blood cells in the blood;

•    formation of blood clots;

•    Long term use of high dose steroids, may lead to a weakening of the immune system, which can increase the risk of malignancy.

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

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

If any of the side effects becomes 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 PREDNISOLONE INJECTION

Prednisolone 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.

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 Prednisolone Injection contains

Each 1 ml Prednisolone Injection ampoule contains 25 mg of the active ingredient Prednisolone Acetate.

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

What Prednisolone injection looks like and the contents of the pack

Prednisolone Injection is a white or almost white solution. Prednisolone injection is available in 1 ml clear glass ampoules.

It is available in packs containing 10 x 1 ml ampoules.

The Marketing Authorisation Holder and Manufacturer responsible for release is:

Amdipharm UK Limited Regency House,

Miles Gray Road,

Basildon,

Essex, SS14 3AF.

The information in this leaflet applies only to Prednisolone Injection.

Date of leaflet: October 2013

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