Aspelone 15 mg/5 ml

ASPELONE belongs to a group of medicines called corticosteroids and is used to provide relief for inflamed areas of the body. Corticosteroids lessen swelling, redness, itching, and allergic reactions.

Do not take ASPELONE:

• if you are hypersensitive (allergic) to cortisone-like medicines including prednisolone or any of the other ingredients of ASPELONE (listed in section 6).
• if you have a fungal infection throughout your body.
• if you have a severe infection caused by a virus (such as herpes zoster) or bacteria.
• if you have stomach and/or duodenal ulcers or any other painful stomach conditions.
• if you have osteoporosis.
• if you show any psychotic behaviour or suffer from any mental illnesses.
• if you have active or latent tuberculosis.
• if you had a vaccination without your doctor’s approval (specifically a live vaccine).
• if you are pregnant or breastfeeding.

Warnings and precautions

Take special care with ASPELONE:

• if you are elderly.
• if you currently have an infectious disease.
• if you have kidney problems.
• if you have scleroderma (also known as systemic sclerosis, an autoimmune disorder) because daily doses of 15 mg or more may increase the risk of a serious complication called scleroderma renal crisis. Signs of scleroderma renal crisis include increased blood pressure and decreased urine production. The doctor may advise that you have your blood pressure and urine regularly checked.
• if you have any of the following conditions your doctor will need to examine you regularly:
• High blood pressure, as ASPELONE 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) or recent heart attack.
• Under functioning thyroid gland (hypothyroidism).
• Muscle weakness from previous steroid use.
• Diabetes mellitus (high levels of sugar in the blood) or in those with a family history of diabetes.
• Liver problems.
• Severe affective disorders, particularly psychoses, (emotional and mental instability) may get worse if you are taking ASPELONE (see section ‘Do not take ASPELONE’).
• Epilepsy and/or seizures, as in some cases taking ASPELONE may aggravate your condition.
• Myasthenia gravis (characterised by weakness and rapid fatigue of the muscles under your voluntary control).

Do not share medicines prescribed for you with any other person. Always take ASPELONE exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The dose of ASPELONE can be different for different users. Follow your doctor’s instructions and do not use it for a longer time than your doctor ordered.

The dosage of ASPELONE depends on the condition being treated and your response to therapy.

Adults: The usual dose of ASPELONE is about 3 mg to 60 mg daily in divided doses depending on the underlying condition.

Paediatrics: When prescribing doses for infants and children, one should not only adhere to ratios indicated by age or body weight but should also consider the guidelines followed when prescribing doses in adults. The usual paediatric daily dose of ASPELONE is 0,5 mg to 2 mg per kg of body weight or 15 to 60 mg per square metre of body surface area in three divided doses.

ASPELONE may be given daily as a single dose after breakfast or as a double dose on alternate days. You may require higher initial doses, where low doses should be sufficient in less severe situations.

Your doctor will tell you how long your treatment with ASPELONE 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 ASPELONE is too strong or too weak, tell your doctor or pharmacist.

If you take more of ASPELONE 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 forget to take ASPELONE

Do not take a double dose to make up for forgotten individual doses. If you have missed a dose of ASPELONE, take the dose that you have missed as soon as you remember.

If you stop taking ASPELONE

ASPELONE should not be stopped suddenly. Only take ASPELONE for the time period indicated by your doctor. In this case, your doctor will advise you to reduce the dose slowly before stopping ASPELONE completely. 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.

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

If any of the following happens, stop taking ASPELONE 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 ASPELONE. 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, fainting, swelling in the legs or feet,
• tear in the heart after a recent heart attack (myocardial rupture),
• slow heart rate (bradycardia),
• feeling severely depressed, including thinking about suicide,
• seeing and hearing things that are not real or personality changes,
• wound healing may be delayed and you may have increased susceptibility to infection (sepsis, tuberculosis, fungal infections and viral infections). The signs of infection may be masked,
• you may retain water and have resultant swelling (oedema) and an increase in blood pressure (hypertension). This can result in abnormally low levels of potassium in the blood (hypokalaemia) and in extreme cases, heart failure,
• death of bone tissue (can lead to sepsis),
• fits (convulsions),
• severe headaches, nausea and vomiting and loss of vision, as these may be a sign of raised pressure in the brain (benign intra-cranial hypertension),
• blockage of blood vessels by blood clots (embolism and 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 (inflammation of the pancreas),
• 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, tiredness, night sweats (tuberculosis and recurrence of dormant 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),
• a rare type of cancer which can affect both the skin and internal organs (Kaposi’s sarcoma),
• 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 ( central serous chorioretinopathy) ; or bulging or protruding of the eyes (exophthalmos); or sudden appearance of many floaters, thinning of the cornea and sclera of the eyes, swelling of the discs in the eyes ( papilloedema),
• increased amount of fat in the upper back and neck (“buffalo hump”), the presence of coarse hair on the face, chest and upper back or abdomen, flushing, increased bruising, stretch marks, acne, osteoporosis (Cushingoid manifestations),
• growth suppression in children may occur.

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:
• Breaks in your bones (fractures),
• increase in appetite,
• bone problems such as fragile bones or wasting of the bones (osteoporosis).

Less frequent side effects:

• Excessive sweating,
• signs of diabetes, such as increased thirst, increased need to urinate, dry mouth, blurry vision, slow healing of cuts or sores,
• mental problems.

Side effects with an unknown frequency:

• Changes in behaviour, worsening of an existing mental illness, mood swings, difficulty concentrating, confusion, sleep disturbances, memory loss,
• dependence,
• indigestion,
• 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),
• general feeling of weakness, stomach pain, poor weight gain, headache (suppression of the adrenal gland),
• if you are diabetic, you may notice that you may need changes in your diabetes medicine (oral or insulin) and your tolerance to carbohydrates may change,
• salt imbalances or water retention in the body,
• low levels of potassium in the blood, which may result in tiredness, confusion, or muscle cramps,
• loss of muscle mass,
• weight gain,
• feeling sick (nausea), stomach pain, diarrhoea, vomiting,
• trouble falling and/or staying asleep (insomnia), dizziness, headache,
• thin delicate skin, unusual marks on the skin or bruising, appearance of stretch marks, acne,
• muscle pain or weakness in upper or lower limbs,
• 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 feeling of being unwell with extreme tiredness (malaise),
• hiccups,
• sensation of spinning (vertigo).

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 ASPELONE.

Store all medicines out of reach of children. Store at or below 25 °C. Protect from light. Shake the bottle before use and keep it well closed. Keep in original packaging until required for use. 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).