Decasone 4 mg Injection

DECASONE INJECTION 4 mg/ml contains dexamethasone. It belongs to a group of medicines called corticosteroids.

DECASONE INJECTION 4 mg/ml can be used to:

• Reduce inflammation.
• Treat a number of different diseases of the immune system.

DECASONE INJECTION 4 mg/ml is used as a treatment of coronavirus disease 2019 (COVID - 19) in adult and adolescent patients (aged 12 years and older with a body weight of at least 40 kg) with difficulty breathing and need of oxygen.

DECASONE INJECTION 4 mg/ml should not be administered to you:

• if you are hypersensitive (allergic) to dexamethasone or to any of the inactive ingredients (see section 6).
• if you have had any allergic reactions with corticosteroid treatment in the past.
• if you have a lung disease called tuberculosis (TB).
• If you have been diagnosed with Acute Respiratory Distress syndrome (ARDS, a serious lung disease) for 2 weeks.
• If you have an inflammation of a tendon.
• if you have an infection in the eye called ocular herpes simplex.
• if you have raised eye pressure (glaucoma) or there is a family history of glaucoma.
• if you have a mental disorder with or without symptoms of neurosis or stress (such as depression, anxiety or obsessive behaviour). Consult your doctor before receiving DECASONE INJECTION 4 mg/ml.
• if you have an infection that affects the whole body.
• if you have an active stomach (peptic) or intestinal ulcer.
• if you have a bone disorder called osteoporosis where your bones become less dense and are more likely to break.
• if you are to be vaccinated with live virus vaccines.
• if you have infection of joints.
• if you have unstable joints.

DECASONE INJECTION 4 mg/ml is usually administered by a doctor. It will be given as an injection into a muscle or under your skin. It can also be given as an injection into a vein. The dose depends on your condition. Your doctor will decide on the correct dose for you.

If you have the impression that the effect of DECASONE INJECTION 4 mg/ml is too strong or too weak, tell your doctor or pharmacist. It is unlikely that you need DECASONE INJECTION 4 mg/ml for more than a week or two, unless you receive it for treatment of arthritic joints. If treatment needs to continue you may be given tablets rather than an injection. You will not be expected to give yourself DECASONE INJECTION 4 mg/ml. It will be given to you by a person who is qualified to do so.

If you receive more DECASONE INJECTION 4 mg/ml than you should Since a healthcare provider will administer DECASONE INJECTION 4 mg/ml, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to receive DECASONE INJECTION 4 mg/ml Do not receive a double dose to make up for forgotten individual doses. Since a healthcare provider will administer DECASONE INJECTION 4 mg/ml, it is unlikely that a dose will be missed.

If you stop receiving DECASONE INJECTION 4 mg/ml If you need to stop this treatment, follow your doctor’s advice. The doctor may tell you to lower the amount of medicine you are having gradually until you stop having it altogether. If you stop having this medicine too quickly, your condition may get worse. Withdrawal symptoms may include fever, pain in your muscles and joints, inflammation of the lining of the nose, eye discomfort (conjunctivitis), painful itchy skin lumps, loss of weight and feeling or being sick.

DECASONE INJECTION 4 mg/ml can have side effects. Not all side effects reported for DECASONE INJECTION 4 mg/ml are included in this leaflet. Should your general health worsen while receiving DECASONE INJECTION 4 mg/ml, please consult your healthcare provider for advice.

If any of the following happens, stop receiving DECASONE INJECTION 4 mg/ml and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting,
• severe infection and/or fever which makes you feel ill,
• blood clots causing loss of blood supply to a part of the body; these may include conditions such as deep vein thrombosis (DVT) causing symptoms such as swelling of a leg, or pulmonary embolus (causing shortness of breath and chest pain),
• blistering of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Stevens - Johnson Syndrome (SJS).

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to DECASONE INJECTION 4 mg/ml. You may need urgent medical attention and/or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• blood in your stools (black, tarry stools),
• vomit any blood or dark particles that look like coffee grounds,
• yellowing of the skin and eyes, also called jaundice,
• stomach ulcers which may perforate or bleed,
• blood clots,
• heart failure,
• fits or epilepsy may become worse,
• experiencing delusions (false ideas or beliefs) or hallucinations (seeing, hearing or feeling things that are not real),
• depression including thinking about suicide,
• loss of vision.

These are all serious side effects. You may need urgent medical attention.

Keep out of the reach and sight of children. Store at or below 25 °C Protect from light. Do not use after the expiry date printed on the label or carton. Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets). Keep in original packaging until required for use.