Adco-Prednisolone 15 mg/5 ml Syrup

Prednisolone (the active ingredient of ADCO-PREDNISOLONE SYRUP) is a corticosteroid medicine that is mainly used for its anti-inflammatory effects. ADCO-PREDNISOLONE SYRUP is used to provide relief from symptoms of inflammation that may be caused by a number of different diseases, as determined by your doctor.

Do not take ADCO - PREDNISOLONE SYRUP (or give to your child):

• if you are hypersensitive or allergic to prednisolone or other corticosteroids, or to any of the other ingredients in ADCO-PREDNISOLONE SYRUP (listed in section 6).
• if you are pregnant or breastfeeding.
• if you suffer from osteoporosis, inflammation of the gullet or stomach, stomach ulcer or psychological disturbances (mental health problems).
• if you have a fungal, bacterial or viral infection, or if you are suffering from active tuberculosis, unless advised by your doctor.
• if you recently had a vaccination (of a live vaccine) without your doctor’s approval. If you are receiving high doses of ADCO-PREDNISOLONE SYRUP, immunisation with a live vaccine should not be undertaken for up to 3 months after you have stopped using ADCO-PREDNISOLONE SYRUP.

Warnings and precautions

Take special care with ADCO-PREDNISOLONE SYRUP:

• if you are elderly. If you are elderly, your doctor will monitor you closely while taking ADCO-PREDNISOLONE SYRUP as you may be more likely to experience side effects, like high blood pressure, diabetes, increased risk of infections and thinning of the skin.
• if you have an infection. While taking ADCO-PREDNISOLONE SYRUP you may become more prone (susceptible) to infection and if you have an infection, the symptoms may be masked (covered up). Tell your doctor if you feel feverish as this may be a sign of a new infection or an existing infection may be worse.
• if you have kidney problems like chronic kidney failure and uraemia (retention of waste-products in the urine due to kidney failure).
• if you are taking a high dose of ADCO-PREDNISOLONE SYRUP you may experience a slower heart rate than normal (known as bradycardia). This can also happen at lower doses of ADCO-PREDNISOLONE SYRUP and especially if you have heart or kidney problems, if you are taking other medicine that slows down heart rate or if you have a salt (electrolyte) imbalance (which can be caused by water pills, also known as diuretics, or from excessive vomiting). Your doctor may advise you to stop taking ADCO-PREDNISOLONE SYRUP.
• you should take care not to come into contact with someone who has chickenpox or measles while taking ADCO-PREDNISOLONE SYRUP. Seek immediate medical advice if you are exposed to either chickenpox or measles.
• if you have ever had depression or manic-depression. This includes having had depression before or whilst taking steroid medicines such as ADCO-PREDNISOLONE SYRUP or if any of your close family members have had these illnesses. Mental health problems, which can be serious, can occur while taking ADCO-PREDNISOLONE SYRUP and treatment for this may be needed. If you (or someone taking this medicine) show any signs of mental health problems, talk to your (or their) doctor. This is particularly important if you are depressed or might be thinking about suicide.
• if you experience problems with your eyes or eyesight (vision), including blurred vision, while taking ADCO-PREDNISOLONE SYRUP. You may need to be referred to an ophthalmologist (eye specialist).
• if you have scleroderma (also known as systemic sclerosis, an autoimmune disorder). Daily doses of 15 mg or more of ADCO-PREDNISOLONE SYRUP may increase the risk of a serious complication called scleroderma renal crisis. Signs of scleroderma renal crisis include increased blood pressure and passing less urine. Your doctor may tell you that you should get your blood pressure and urine checked regularly.
• if you have a condition known as myasthenia gravis (a neuromuscular disorder that causes weakness in the skeletal muscles, which are the muscles your body uses for movement). The medicine you use to control the myasthenia gravis may not work as well if you are also taking ADCO-PREDNISOLONE SYRUP.
• if you have pheochromocytoma (a tumour / cancer of the adrenal gland). Tumour lysis syndrome (TLS) can occur after treatment of a fast-growing cancer, such as blood cancers or solid tumours. Symptoms of TLS include muscle cramping, muscle weakness, confusion, irregular heartbeat, visual loss or visual disturbances, and shortness of breath. Your health care provider will monitor you closely, especially if you are at high risk of developing tumour lysis syndrome. Your doctor may also have to monitor your treatment more closely, alter your dose or give you another medicine.

Do not share medicines prescribed for you (or your child) with any other person. Always take (or give) ADCO-PREDNISOLONE SYRUP exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. DO NOT TAKE MORE OF THIS MEDICINE THAN YOU SHOULD. YOUR DOSING REQUIREMENTS MAY VARY DEPENDING ON THE SPECIFIC DISEASE, ITS SEVERITY AND YOUR RESPONSE TO THE MEDICATION. YOUR DOSAGE WILL THEREFORE BE DETERMINED BY YOUR DOCTOR TO SUIT YOUR REQUIREMENTS.

Shake the bottle before use

Adults

The usual adult dose is about 5 mg to 60 mg daily in divided doses. ADCO-PREDNISOLONE SYRUP may be given daily as a single dose after breakfast or as a double dose on alternate (every other) days not exceeding the maximum dose.

Infants and children

The usual daily dose in infants and children of ADCO-PREDNISOLONE SYRUP is 0,5 mg to 2 mg per kg of body weight or 15 to 60 mg per square meter of body surface area in three divided doses. The dose varies according to the disease being treated. Your doctor may need to change the starting dose to obtain a satisfactory response. Your doctor will reduce the daily dose of the medicine once your condition has stabilised. Your doctor will tell you how long your treatment with ADCO-PREDNISOLONE SYRUP will last. Do not stop treatment early because this may result in undesirable side effects. If you have the impression that the effect of ADCO-PREDNISOLONE SYRUP is too strong or too weak, tell your doctor or pharmacist.

If you take (or give) more ADCO - PREDNISOLONE SYRUP 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 (or give) ADCO-PREDNISOLONE SYRUP

Do not take / receive a double dose to make up for forgotten individual doses. If you stop taking (or giving) ADCO - PREDNISOLONE SYRUP Your doctor will tell you how long your (or your child’s) treatment with ADCO-PREDNISOLONE SYRUP will last. Do not stop taking (or giving) this medicine without talking to your doctor first, because the dose might need to be reduced slowly over a period of time (weeks or months, depending on how long you, or your child, received treatment with ADCO-PREDNISOLONE SYRUP). Stopping ADCO-PREDNISOLONE SYRUP treatment (especially if stopped suddenly), can lead to serious problems of the adrenal gland, known as “withdrawal” symptoms. The most common are:

• high temperature (fever);
• muscle and joint pain;
• runny nose;
• red, sore and sticky eyes (conjunctivitis);
• painful itchy skin lumps;
• weight loss;
• being sick (vomiting);
• low blood pressure causing you to feel faint;
• headache;
• blurred vision;
• reappearance of your disease symptoms.

If you or your child experience withdrawal symptoms or think you (or your child) might have withdrawal symptoms, tell your doctor straight away. He/she may ask you to start taking ADCO-PREDNISOLONE SYRUP (or giving it to your child) again and then to start coming off it again more slowly. You (or your child) are more likely to experience withdrawal symptoms if:

• you (or your child) have been taking ADCO-PREDNISOLONE SYRUP for more than 3 weeks.
• you (or your child) have been treated with a steroid, like ADCO-PREDNISOLONE SYRUP, repeatedly.
• you (or your child) have previously taken a steroid, like ADCO-PREDNISOLONE SYRUP, for a long period of time (months or years), and now you have received an acute (short term) course of ADCO-PREDNISOLONE SYRUP.
• the daily dose is more than 40 mg daily (approximately 13,3 ml per day).
• you (or your child) repeatedly take doses of ADCO-PREDNISOLONE SYRUP at night.

ADCO-PREDNISOLONE SYRUP can have side effects. Not all side effects reported for ADCO-PREDNISOLONE SYRUP are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ADCO-PREDNISOLONE SYRUP, please consult your health care provider for advice.

If any of the following happens, stop taking ADCO-PREDNISOLONE SYRUP (or giving it to your child) 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 (or your child) may have had a serious reaction to ADCO-PREDNISOLONE SYRUP. 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:

• a very sore throat, sudden onset of fever, low body temperature, shaking, chills, confusion or difficulty breathing. These may be signs that your body is fighting an infection, which may be serious and severe. You may also have difficulty in swallowing and the inside of your mouth may have white areas on the surface. Remember that your sensitivity to all kinds of infection may be increased and ADCO-PREDNISOLONE SYRUP may mask the signs and symptoms of infection.
• coughing for a few weeks, coughing up blood or mucous, tiredness and night sweats (which may be due to tuberculosis, also known as TB).
• painless coloured (red, purple, brown or black) spots on the legs, feet or face which can also appear in the genital area or mouth. These skin lesions may be a sign of a rare type of cancer which can affect both the skin and internal organs known as Kaposi’s sarcoma.
• fits (also known as convulsions and seizures). If you have epilepsy you may notice you get fits (seizures) more often than usual or they are more severe.
• slow heart rate, chest pain, shortness of breath, fainting, swelling in the legs or feet. These may be signs and symptoms of heart problems like bradycardia (slow heart rate) and heart failure (where the heart is not pumping correctly).
• rapid or irregular heartbeat, feeling lightheaded (dizzy), excessive sweating, clammy or bluish discoloured skin or leg pain or swelling (or both), usually in the calf. These might be signs of a clot in your lungs or legs.
• severe headaches, nausea and vomiting and loss of vision. These may be signs of increased pressure in the brain known as benign intra-cranial hypertension, especially in children.
• severe upper stomach pain with nausea or vomiting. These may be signs of a problem with your pancreas (inflammation of the pancreas).
• severe stomach pain (in your mid-to upper abdomen), vomiting blood or blood in stool (which can look like dark or black stool). These may be due to ulcers in the stomach, intestines or food pipe (gullet). You may also experience nausea and vomiting, heartburn, chest pain, pain when swallowing or feeling bloated.
• ongoing pain in any joint, as this might be a sign of osteonecrosis (death of bone tissue). Initially, you may not have any symptoms due to osteonecrosis; however, as the condition worsens, affected joints might hurt only when putting weight on them. Eventually, you might feel the pain even when you're lying down. The pain can be mild or severe.
• sudden high blood pressure, kidney failure and passing less urine, due to scleroderma renal crisis. This can especially happen if you have sclerosis. You may experience symptoms due to an increase in blood pressure including headache, dizziness, nausea (feeling sick), shortness of breath, seizures or problems with your eyesight.
• signs of “withdrawal” after you have stopped taking ADCO-PREDNISOLONE SYRUP (see section 3: “If you stop taking (or giving) ADCO-PREDNISOLONE SYRUP”).

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

Tell a doctor straight away if you notice any of the following side effects:

Serious mental health problems

• feeling severely depressed, including thinking about suicide.
• feeling high (mania) or an exaggerated state of happiness (euphoria).
• moods that go up and down.
• feeling irritable or anxious.
• difficulty in thinking or being confused.
• loss of memory.
• having problems sleeping (insomnia).
• feeling, seeing and hearing things that are not real (or if you suffer from schizophrenia the condition may worsen).
• changes in how you feel or act.

Steroids like, and including, ADCO-PREDNISOLONE SYRUP can less frequently cause serious mental health problems. If you notice any of these problems talk to a doctor as soon as possible.

Wound heading

delayed (slow) or improper wound healing (wounds and cuts do not heal as quickly as usual or not as well as it should).

Eye problems

changes in your vision (how you see) like sudden appearance of many floaters or blurred vision or bulging (protruding) of the eyes. These may be signs of eye problems such as glaucoma (increased eye pressure), cataracts (clouding of the lens of the eyes) or other serious eye problems.

The following side effects have been reported:

Frequent:

• increased appetite.
• osteoporosis.
• spontaneous fractures (breaks in your bones).

Less frequent:

• increase in blood sugar levels which may cause (or worsen) diabetes. Your diabetic medication may need to be increased.
• increased sweating.

The following side effects have been reported and the frequencies are unknown:

• Moon-face (filling or rounding out of the face), sometimes hirsutism (excessive growth of hair of normal or abnormal distribution), buffalo hump (increased amount of fat in the upper back and neck), flushing, increased bruising, acne and striae (reddish purple lines on arms, face, groin, legs or trunk).
• sodium and water retention with swelling, high blood pressure and disturbances in electrolyte (salt) balance.
• low levels of potassium in the blood, which may result in tiredness, confusion or muscle cramps.
• muscle weakness or pain.
• menstrual (period) irregularities such as excessive, delayed or absence of period (amenorrhoea).
• disturbances of the nervous system, dizziness (feeling lightheaded) and headache.
• blurred vision.
• worsening of eye infections (viral or fungal).
• vertigo causing a spinning sensation or a feeling of being unbalanced with or without nausea and ringing in ears (or hearing loss).
• hiccups, indigestion, feeling bloated, feeling sick (nausea), being sick (vomiting), stomach pain, diarrhoea.
• thin delicate skin, unusual marks on the skin or bruising, appearance of stretch marks, acne, rash, itching and hives.
• tendon rupture (when a muscle is torn from the bone at the point of attachment).
• general feeling of being unwell.
• growth retardation in children.
• increase in weight.

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, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of ADCO-PREDNISOLONE SYRUP. You may also report to Adcock Ingram Limited using the following e-mail address: [email protected].

Store all medicines out of reach of children. Store at or below 25 °C. Protect from light. Store in the original container protected from light. Keep the container tightly closed and do not store the product in bathrooms in order to protect from moisture. Do not use after the expiry date on the label. Return all unused medicine to your pharmacist. Do not dispose unused medicine in drains or sewerage systems (e.g. toilets).