Lenisolone 5 mg Tablets

LENISOLONE TABLETS belongs to a group of medicines called corticosteroids.

LENISOLONE TABLETS are used in a wide range of inflammatory and auto - immune conditions including:

• blood cell disorders including low red blood and platelet counts,
• allergies, including severe allergic reactions,
• asthma,
• cancer of the white blood cells (leukaemia),
• an immune reaction to eating gluten,
• excess glucose in the blood reducing the ability of the blood cells to absorb and use blood sugar for energy (insulin resistance),
• when the immune system is not functioning as it should be (immunosuppression),
• liver disorders,
• inflammatory bowel disease that causes inflammation in the digestive tract.

Do not take LENISOLONE TABLETS:

• if you are hypersensitive (allergic) to prednisolone or any of the other ingredients of LENISOLONE TABLETS (listed in section 6).
• if you have ulcers in the intestines (peptic ulcers).
• if you have weakened bones (osteoporosis).
• if you have a mental illness (psychoses).
• if you have active tuberculosis (TB) or if your doctor suspects you have inactive TB.
• if you currently have an infection including a viral infection such as shingles and/or an eye infection.

Warnings and precautions

Take special care with LENISOLONE TABLETS:

• if you have any of the following conditions your doctor will need to examine you regularly:
• High blood pressure, as LENISOLONE TABLETS can increase your blood pressure, you may need more frequent blood pressure checks. You may need to limit your intake of salt and your doctor might need to prescribe a blood pressure lowering supplement.
• Congestive heart failure (fluid build - up within the heart which causes it to pump inefficiently).
• Diabetes mellitus (high levels of sugar in the blood) or in those with a family history of diabetes.
• Kidney problems.
• Liver problems.
• Menopause, post menopause (the effect of LENISOLONE TABLETS may be reduced).
• Sever affective disorders, particularly psychoses, (emotional and mental instability) may get worse if you are taking LENISOLONE TABLETS.
• Epilepsy and/or seizures, as in some cases taking LENISOLONE TABLETS may aggravate your condition.
• Previous muscle weakness associated with steroid treatment, as LENISOLONE TABLETS may result in further muscle weakness.
• Myasthenia gravis (characterised by weakness and rapid fatigue of the muscles under your voluntary control).
• Blood clotting (thromboembolic) disorders.

Do not share medicines prescribed for you with any other person. Always take LENISOLONE TABLETS exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will prescribe a specific dose and duration of treatment based on your condition. Your doctor will tell you how long your treatment with LENISOLONE TABLETS will last. Do not stop treatment early because this may result in undesirable side effects. Your doctor will advise you on a gradual withdrawal of treatment and will also monitor you. If you have the impression that the effect of LENISOLONE TABLETS is too strong or too weak, tell your doctor or pharmacist.

If you take more LENISOLONE TABLETS than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. If you take high doses of LENISOLONE TABLETS, you may experience side effects such as psychosis (mental state where thoughts and emotions are impaired), depression, hallucinations (seeing or hearing things which do not exist), cardiac dysrhythmias (abnormal heart rhythm) and Cushing’s syndrome (signs are fatty hump between the shoulders, a rounded face and pink or purple stretch marks).

In the event of overdose your doctor may reduce your dosage gradually and slowly withdraw treatment with LENISOLONE TABLETS.

If you forget to take LENISOLONE TABLETS

Do not take a double dose to make up for forgotten individual doses. If you stop taking LENISOLONE TABLETS LENISOLONE TABLETS should not be stopped suddenly. Your doctor will advise you how to stop treatment in a gradual manner. Your doctor will also monitor you during this period. If treatment is stopped too quickly it can lead to severe problems of the adrenal gland. You may experience ‘withdrawal symptoms’ which include fever, muscular pain, weakness, joint pain, runny nose, an eye infection (conjunctivitis), painful itchy skin lumps, loss of weight, mental changes, mood changes, feeling sick and/or being sick, low blood pressure, feeling faint, headache, dizziness and reappearance of your disease symptoms. You may also experience swelling of the nerves in the eyes due to increase in pressure in and around the brain.

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

If any of the following happens, stop taking LENISOLONE TABLETS 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 LENISOLONE TABLETS. 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:

• Failure of the heart to pump correctly (heart failure). Symptoms include chest pain, shortness of breath (dyspnoea), fainting, swelling in the legs or feet,
• slow heart rate (bradycardia), high blood pressure (hypertension),
• feeling severely depressed, including thinking about suicide,
• seeing and hearing things that are not real or personality changes,
• fits (convulsions),
• severe headaches, nausea and vomiting and loss of vision, as these may be a sign of raised pressure in the brain,
• numbness, weakness or tingling, nausea (stroke - like symptoms),
• vision loss,
• blockage of blood vessels by blood clots (thromboembolism),
• ulcers in the stomach, intestines, or food pipe, which show symptoms such as severe stomach pain, vomiting blood, or blood in stool,
• severe upper stomach pain with nausea or vomiting, as this may be a sign of a swollen pancreas (pancreatitis),
• deep, very painful lumps that develop into open sores that do not heal, purple net - like patterns on the skin (calciphylaxis),
• sudden high blood pressure, kidney failure and decreased urine production, particularly if you have sclerosis (scleroderma renal crisis),
• coughing for a few weeks, coughing up blood or mucous, unintentional weight gain, tiredness, night sweats (tuberculosis),
• sudden onset of fever, low body temperature, shaking, chills, confusion, difficulty breathing, may be signs that your body is fighting a severe infection (sepsis).

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

Tell your doctor if you notice any of the following:

• Frequent side effects:
• Changes in behaviour, mood swings, difficulty concentrating, confusion, sleep disturbances, memory loss,
• feeling irritable, anxious, restless or nervous,
• indigestion.
• Side effects with an unknown frequency:
• A feeling of intense excitement and happiness,
• a feeling of whirling and loss of balance (vertigo),
• eye problems such as blurred vision as this may be an indication of the development of increased pressure in the eye (glaucoma) or a cataract (clouding of the lens of the eyes); or changes in the way you see things due to a fluid collection within your eye; or bulging or protruding of the eyes; or sudden appearance of many floaters,
• redness or blisters on an affected area of skin, peeling or cracking skin, itching, stinging or burning sensation on the skin, abnormal vaginal discharge (fungal infection),
• dry mouth, difficulty swallowing, white lesions in your food pipe (candidiasis),
• fever, bleeding, bruising, sweating, loss of weight without trying (leucocytosis),
• a hormone imbalance causing Cushing’s syndrome. Typical symptoms include a round face (moon face) and fatty hump between the shoulders (buffalo hump),
• general feeling of weakness, stomach pain, poor weight gain, headache (suppression of the adrenal gland),
• signs of diabetes, such as increased thirst, increased need to urinate, dry mouth, blurry vision, slow healing of cuts or sores,
• if you are diabetic, you may notice that you may need changes in your diabetes medicine (oral or insulin),
• acid - base imbalance in the blood due to low potassium levels. Symptoms include confusion, hand tremor, light - headedness, muscle twitches, nausea or vomiting,
• swelling (water and salt retention),
• muscle spasm and/or weakness, twitching, convulsions (altered levels of electrolytes in the blood),
• loss of muscle mass,
• weight gain, obesity, increased appetite,
• feeling sick (nausea), stomach pain, diarrhoea,
• high levels of bad cholesterol in the blood,
• increased sweating,
• trouble falling and/or staying asleep (insomnia), dizziness, headache,
• back pain and weakness, loss of sensation or slow reflexes may be a sign of excessive fat build up on or outside the lining of the spine,
• thin fragile skin, excess hair, skin bruises, flushing, stretch marks, spider veins, acne,
• muscle pain or weakness in upper or lower limbs,
• bone problems such as fragile bones or wasting of the bones (osteoporosis),
• breaks in your bones (fractures),
• tendon rupture (when a muscle is torn from the bone at the point of attachment), particularly of the ankle and knee tendons,
• menstrual irregularities such as excessive, delayed or no monthly periods,
• slow healing,
• general sense of being unwell and/or discomfort, tiredness (fatigue).

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 “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 Aspen Pharmacare: E - mail: [email protected]

Store all medicines out of reach of children. Store at or below 25 ºC in airtight containers. Protect from light. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).