Covocort 10 mg Tablets

COVOCORT belongs to a group of medicines known as corticosteroids. COVOCORT is used to replace adrenal hormones in your body, which you may be lacking.

Do not take COVOCORT:

• if you are allergic (hypersensitive) to hydrocortisone or to any of the excipients listed in section 6.
• if you have a stomach ulcer.
• if you have osteoporosis.
• if you have any mental disorders.
• if you have an infection and are not receiving treatment for it.
• if you have a viral infection known as shingles or a viral eye infection.
• if you had or have tuberculosis (TB).
• if you have been vaccinated recently or are going to have any vaccinations.

Warnings and precautions

Take special care with COVOCORT:

• if you have liver problems;
• if you have kidney problems;
• if you have high blood pressure;
• if you have heart problems including recent heart attacks;
• if you have diabetes (or a family history of diabetes);
• if you have glaucoma (increased pressure in the eye) or family history of glaucoma;
• if you have HIV infection;
• if you have epilepsy;
• if you have muscle weakness with steroids;
• if you have existing or previous history of severe mood-related disorders;
• if you have thyroid problems;
• if you have chickenpox or measles;
• if you experience an increase of body temperature (fever due to any reason), feeling unwell, undergoing a stressful situation or if you are undergoing any minor surgical procedure inform your doctor or pharmacist as your daily dose may be increased temporarily;
• if you have pheochromocytoma (a tumour of the adrenal gland);
• if you are elderly as side effects can be heightened in this age group.

You should see your doctor if you develop any new infections whilst taking these tablets. Taking COVOCORT for a long period of time increases your chance of getting infections, which might be worse than normal and may very rarely be fatal. Tell your doctor or health care provider if you have chickenpox or measles. It is important to avoid exposure to people who have chickenpox, measles or shingles, especially if you have not already had these illnesses or are not sure if you have had them. COVOCORT increases the risk of a severe bout of chickenpox. If exposed you must contact your doctor immediately. Contact your doctor if you experience blurred vision or other visual disturbances.

Do not share medicines prescribed for you with any other person. Always take COVOCORT exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is: 1 to 3 tablets (10 mg to 30 mg) daily. Your doctor will tell you how long your treatment with COVOCORT will last. If you have the impression that the effect of COVOCORT is too strong or too weak, tell your doctor or pharmacist.

If you take more COVOCORT than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take COVOCORT

Do not take a double dose to make up for forgotten individual doses.

If you stop taking COVOCORT

Do not stop taking COVOCORT just because you feel better. You should follow your doctor’s instructions on stopping this medicine. Your doctor may want you to reduce gradually the number of tablets you take before stopping completely. Never let your tablets run out before receiving the next prescription. It may be dangerous to go without treatment (see Section 2). Stopping COVOCORT may leave you without enough steroid hormones in your body. This may cause withdrawal symptoms such as fever, muscle and joint pain, blocked/runny nose, swelling of the eye, painful itchy skin rash and weight loss.

COVOCORT can have side effects. Not all side effects reported for COVOCORT are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking COVOCORT, please consult your health care provider for advice. If any of the following happens, stop taking COVOCORT and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to COVOCORT. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• depressed, including thinking about suicide,
• high (mania) or having moods that go up and down;
• 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.

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following: Side effects with unknown frequency:

• psychological dependence;
• increased damage to the heart in the event of a heart attack, heart failure, high blood pressure, formation of blood clots, thickening of the heart muscle (hypertrophic cardiomyopathy) in prematurely born babies;
• taking COVOCORT can make it easier for you to pick up infections which may very rarely be fatal. Infections such as chickenpox and measles can be made worse or TB may recur. some fungal and viral infections, including herpes, may be activated. Diarrhoea and vomiting, sore throat/cold, flu-like illness caused by a viral infection;
• bleeding ulcers (indicated by stomach pain, bleeding from the back passage, black stools or being sick with blood present), inflammation of the pancreas causing abdominal pain, stomach pain and discomfort, bloated feeling, infection, swelling or ulceration of the gullet (discomfort on swallowing, which can cause chest pain), thrush, indigestion, feeling sick, being sick, tooth erosion;
• fits (convulsions), worsening of epilepsy, sleepiness, dizziness/spinning sensation, raised pressure within the skull;
• muscle weakness or wasting, thinning of bones which makes fractures more likely (osteoporosis), broken bones or fractures, hip or shoulder pain due to poor blood circulation, risk of torn tendons, joint inflammation in the knee and groin (aseptic necrosis) or other joints;
• changes in vision as a result of cataracts (clouding of the lens in the eye) or glaucoma (increased pressure inside the eye), blurred vision, dry eyes, thinning of the surface of the eye, existing eye infections may get worse;
• increased or decreased number of white blood cells;
• irregular or lack of periods;
• development of Cushingoid facies (round or moon-shaped face, buffalo hump), excessive sweating, increased appetite and weight gain, increased hair on the body and face in women, increased blood sugar levels/ diabetes, loss of calcium and nitrogen (shown on medical tests), salt and water retention (causing swelling and raised blood pressure), low adrenal gland function which reduces the production of steroids in your body (particularly after surgery, an accident or illness);
• slow healing of cuts or wounds, thin or delicate skin, redness of the skin/small dilated blood vessels, acne, bruising, itchy rash, stretch marks;
• generally feeling unwell (malaise), tiredness;
• decrease in cholesterol (good cholesterol) in the blood (shown in blood tests), reduction in blood potassium levels, symptoms of which include fainting due to low blood pressure, feeling your heartbeat (palpitations), muscle weakness, tiredness or cramps, feeling sick or being sick, inability to pass stool regularly and properly, frequent passing of urine, excessive thirst and inability to eat properly.

Additional side effects in children and adolescents

• raised pressure within the skull (pseudotumour cerebri, indicated by headaches with vomiting, listlessness and drowsiness) has been reported in children; this usually occurs after treatment is stopped;
• suppression of normal growth in children. Because of these potential side effects, your doctor may want to monitor you at intervals during your treatment.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of COVOCORT.

• Store all medicines out of reach of children.
• Store at or below 30 °C in a dry, dark place.
• Do not store in a bathroom.
• Do not use after the expiry date stated on the label bottle.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).