Solu – Cortef ® 100 mg Injection

SOLU - CORTEF is a type of cortisone. It will be injected by a doctor if your body cannot produce enough corticosteroid due to problems with your adrenal glands (e.g. adrenal insufficiency). Corticosteroids can also help treat shock following surgery, injuries, hypersensitivity (anaphylactic) reactions or other stressful conditions, swelling and pain caused by autoimmune diseases, or to control very strong allergic reactions or severe infections. These include inflammatory or allergic conditions e.g. lupus (systemic lupus erythematosus), severe asthma or breathing vomit into your lungs while unconscious.

Apart from in an emergency, SOLU - CORTEF should not be administered to you:

• if you are hypersensitive (allergic) to hydrocortisone sodium succinate or any of the other ingredients of SOLU - CORTEF (listed in section 6); an allergic reaction may cause a skin rash or reddening, swollen face or lips or shortness of breath
• if you have a systemic fungal infection
• if you have brain injury due to trauma
• if you have a herpes eye infection
• if you suffer from severe depression, manic depression (bipolar disorder) or psychotic tendencies
• if you have suffered tuberculosis (TB) in the past
• if you have recently had, or are about to have certain types of vaccines

Speak to your doctor or health care provider immediately if any of the above applies to you.

Warnings and precautions

Tell your doctor or health care provider before being given the injection: Take special care with SOLU - CORTEF:

• if you have unusual stress
• if your treatment with SOLU - CORTEF is stopped quickly. Stopping treatment too quickly may cause withdrawal symptoms including loss of appetite, nausea, vomiting, tiredness, headache, fever, joint pain, skin peeling, muscle aches, weight loss and low blood pressure.
• if you have Cushing’s disease (condition caused by an excess of cortisol hormone in your body)
• if you are suffering from an infection of any type (including fungal infections)
• if you have chickenpox, measles or shingles If you think you have been in contact with someone with chickenpox, measles or shingles and you have not already had these illnesses, or if you are unsure if you have had them
• if you have tuberculosis (TB) or if you have suffered TB in the past

Do not share medicines prescribed for you with any other person. While you are receiving SOLU - CORTEF, you should tell any health care provider who gives you treatment that you are receiving SOLU - CORTEF. You will not be expected to give yourself SOLU - CORTEF. It will be given to you by a person who is qualified to do so.

Dosage information

Your doctor will decide on whether to inject into a vein (intravenous) or into a muscle (intramuscular), how much SOLU - CORTEF and how many injections you will receive depending on the condition being treated and its severity. Your doctor will inject you with the lowest dose for the shortest possible time to get effective relief of your symptoms. SOLU - CORTEF is not recommended for intrathecal or epidural use.

SOLU - CORTEF can have side effects. Not all side effects reported for SOLU - CORTEF are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving SOLU - CORTEF, please consult your health care provider for advice. In certain medical conditions, medicines like SOLU - CORTEF (steroids) should not be stopped abruptly. If you suffer from any of the following symptoms seek medical attention immediately. Your doctor will then decide whether you should continue receiving SOLU - CORTEF.

Tell your doctor immediately if any of the following happens:

• Allergic reactions, such as skin rash, swelling of the face or wheezing and difficulty breathing. This type of side effect is rare, but can be serious.
• Pancreatitis, stomach pain which may spread through to your back, possibly accompanied by vomiting, shock and loss of consciousness.
• Burst or bleeding ulcers, symptoms of which are severe stomach pain which may go through to the back and could be associated with bleeding from your rectum, black or blood-stained stools and/or vomiting blood.
• Infections, SOLU - CORTEF can hide or change the signs and symptoms of some infections, or reduce your resistance to the infection, so that they are hard to diagnose at an early stage. Symptoms might include a raised temperature and feeling unwell. Symptoms of a flare up of a previous TB infection could be coughing blood or pain in the chest. SOLU - CORTEF may also make you more likely to develop a severe infection.
• Raised pressure within the skull, the symptoms of which are headaches with vomiting, lack of energy and drowsiness. These are all very serious side effects. If you have them, you may have had a serious reaction to SOLU - CORTEF. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects

• infections
• round or moon-shaped face (Cushingoid)
• hypothalamic pituitary adrenal axis suppression; steroid withdrawal syndrome - a short supply of one or more pituitary hormones. This can affect a number of things including growth (in children, poor overall growth and short height; in adults, reduced energy), blood pressure (may be lowered) and reproduction (in women, periods may stop; in men, decreased sperm production and loss of sexual function; in children, delayed puberty may occur)
• sodium retention, which causes thirst due to dehydration
• diabetes or need for existing diabetics to use more insulin
• high blood pressure, symptoms of which are headaches, or generally feeling unwell
• small purple/red patches/blisters on or under the skin
• brittle bones (bones that break easily)
• slowing of normal growth
• decreased carbohydrate tolerance
• decreased blood potassium

• Store all medicines out of reach of children.

• SOLU - CORTEF 100 mg Vial and 100 mg Act - O - Vial: Store the unmixed medicine at or below 25 °C. Once the medicine has been mixed as directed the solution should be used straight away. Any unused liquid should be disposed of safely.

• Do not use SOLU - CORTEF after the expiry date stated on the label and carton.

• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).