1.3.

2 PATIENT INFORMATION LEAFLET

SCHEDULING STATUS

S4

ASPELONE 15 mg per 5 ml liquid

Prednisolone

Contains sugar: Sorbitol liquid (70 %) 2,5 g/5 ml,

Contains sugar: Glycerol 0,5 g/5 ml

Contains sweetener: Saccharin sodium 7,5 mg/5 ml

Read all of this leaflet carefully before you start taking ASPELONE
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor,
pharmacist, nurse or other healthcare provider.
• ASPELONE has been prescribed for you personally and you
should not share your medicine with other people. It may
harm them, even if their symptoms are the same as yours.

What is in this leaflet

1. What ASPELONE is and what it is used for

2. What you need to know before you take ASPELONE
3. How to take ASPELONE
4. Possible side effects
5. How to store ASPELONE
6. Contents of the pack and other information

1. What ASPELONE is and what it is used for

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

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reactions.

2. What you need to know before you take ASPELONE

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 a 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

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 inefficiently).
− 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.
− 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).
• if you are taking a high dose of ASPELONE you may experience a slower heart rate than
normal (bradycardia), and your doctor may need to advise you on stopping your
treatment.

• if you suddenly stop treatment, increase, or reduce your dose of ASPELONE, this may
cause acute adrenal insufficiency (you may experience muscle and joint pain, shortness
of breath, nausea and vomiting, fever, low blood pressure, dehydration) requiring prompt,
emergency medical treatment.

• if you have an infection the symptoms may be masked (covered up) while you are taking
ASPELONE and new infections may appear. 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 ASPELONE has been prescribed to you, you should take care not to come into contact
with someone who has chickenpox or measles. You should seek immediate medical
advice if you are exposed to either chickenpox or measles.

• if your treatment with ASPELONE causes problems with your eyes, including blurred
vision, you may need to be referred to an ophthalmologist.

• if you have glaucoma (a condition of the eye that affects your vision).

• if you have a hormone disorder which can cause symptoms including gaining weight very
quickly, especially on the trunk and face, thinning of the skin and sweating (Cushing’s
disease), you should avoid taking ASPELONE as your symptoms may get worse.

• if you are elderly, your doctor will examine you regularly to avoid life threatening reactions
from some of the common side effects of ASPELONE like high blood pressure, diabetes,
increased risk of infections and thinning of the skin.

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 • if you have ever had depression or manic-depression. This includes having had depression
before or whilst taking steroid medicines such as ASPELONE or if any of your close
family has had these illnesses.

• if you (or someone taking this medicine) show any signs of mental health problems, talk
to your doctor. This is particularly important if you are depressed or might be thinking
about suicide. Mental health problems, which can be serious, can occur while taking this
medicine and they might need treatment.

Children

ASPELONE may cause growth retardation in infancy, childhood and adolescence, which may be
irreversible.

Other medicines and ASPELONE

Always tell your healthcare provider if you are taking any other medicines (this includes
complementary or traditional medicines).

Tell your doctor if you are taking any of the following:

• Carbamazepine, phenobarbitone, phenytoin and primidone, used for the treatment of

epilepsy (fits) as well as the use of barbiturates (sedatives) may result in ASPELONE being
less effective.
• Aminoglutethimide, used to treat certain patients with Cushing's syndrome and some types
of cancer.
• Rifampicin, used for the treatment of tuberculosis (TB).
• Erythromycin used to treat bacterial infections such as respiratory tract infections including
bronchitis and pneumonia.
• Warfarin or other anticoagulant medicines used to thin the blood.
• Insulin and other medicines used to treat diabetes, as your doctor may need to adjust the
dose (antidiabetic medicines)
• Antifungal medicines such as amphotericin, which may increase the risk of hypokalaemia
(low potassium levels), and ketoconazole.
• Antimuscarinics or anticholinesterases medicines used to treat conditions such as
myasthenia gravis (weakness and rapid fatigue of the muscles under your voluntary

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 control), if taken with ASPELONE may cause memory impairment if you are elderly.
• Ritonavir, or other antiviral medicines used to treat HIV.
• Ciclosporin, used to reduce pain, swelling and stiffness in rheumatoid arthritis, if taken with
ASPELONE may require your doctor to adjust your doses of these medicines.
• Methotrexate (medicine used to treat cancer) if taken together with ASPELONE may result
in haematological toxicity (a decrease in bone marrow and blood cells, which may lead to
infection, bleeding, or anaemia).
• Oral contraceptives may increase the blood level of ASPELONE resulting in an increased
chance of undesirable effects.
• Immunosuppressants, medicines which dampen down the activity of the body’s immune
system.
• Mifepristone (a medicine used to terminate pregnancy) will result in a reduced effect of
ASPELONE for 3 to 4 days after taking mifepristone.
• Salicylates, aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) such as
diclofenac used for treating inflammation and pain, should be used very cautiously as when
taken together with ASPELONE your risk of severe stomach problems increases.
• Female sex hormones (oestrogens) taken together with ASPELONE may require dosage
adjustments.
• Water tablets (diuretics) taken with ASPELONE may cause excessive loss of potassium in
the blood (potassium depleting diuretics).
• Somatropin (growth hormone) as the growth promoting effect may be inhibited.
• Medicines used to treat breathing difficulties, allergic rhinitis and conjunctivitis, such as
salbutamol and terbutaline, as they may result in an increased risk of hypokalaemia (low
potassium levels) if taken with high doses.
• Medicines used to treat heart conditions (such as high blood pressure) known as
antihypertensives.
• Theophylline, used to treat asthma and chronic obstructive pulmonary disease (COPD) and
other medicines like xanthines and b2 receptor agonists.
• Carbenoxolone which is used for ulcers.
• Acetazolamide which is used in the treatment of glaucoma and epilepsy.

ASPELONE with food and drink

ASPELONE may be taken with or without food.

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Pregnancy and breastfeeding

ASPELONE is contraindicated in pregnancy and lactation.

You should not take ASPELONE if you are pregnant or breastfeeding your baby.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby,
please consult your doctor, pharmacist or other healthcare provider for advice before taking
ASPELONE.

Driving and using machinery

ASPELONE has no or negligible influence on the ability to drive or operate machinery. However,
you should not drive, use machinery or perform any tasks that require concentration until you are
certain that ASPELONE does not adversely affect your ability to do so safely (see section 4).

It is not always possible to predict to what extent ASPELONE may interfere with your daily
activities. You should ensure that you do not engage in the above activities until you are aware of
the measure to which ASPELONE affects you (see section 4).

ASPELONE contains sorbitol

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an
intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance
(HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor
before you (or your child) take ASPELONE.

ASPELONE contains sorbitol and glycerol and may have a laxative effect.

ASPELONE contains propylene glycol

If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this
medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.

ASPELONE contains preservatives sodium methyl parahydroxybenzoate and sodium

propyl parahydroxybenzoate
ASPELONE contains sodium methyl parahydroxybenzoate and sodium propyl
parahydroxybenzoate and may cause allergic reactions (possibly delayed).

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 3. How to take ASPELONE
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.

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.

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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.

4. Possible side effects

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,

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 • 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,
• 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 (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),
• 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).

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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).

Less frequent side effects:

• excessive sweating.

Side effects with an unknown frequency:

• changes in behaviour, mood swings, difficulty concentrating, confusion, sleep disturbances,

memory loss,
• indigestion, increase in appetite,
• 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 (leukocytosis),
• 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),
• 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),
• salt imbalances or water retention in the body,
• low levels of potassium in the blood, which may result in tiredness, confusion, or muscle

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 cramps,
• loss of muscle mass,
• weight gain, increased appetite,
• feeling sick (nausea), stomach pain, diarrhoea,
• 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,
• bone problems such as fragile bones or wasting of the bones (osteoporosis),
• 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,
• growth suppression in children may occur.
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: https://www.sahpra.org.za/health-productsvigilance/

Aspen Pharmacare:

E-mail: [email protected]

Tel: 0800 118 088/ +27 (0)11 239-6200

By reporting side effects, you can help provide moreinformation on the safety of ASPELONE.

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 5. How to store ASPELONE

Store all medicines out of reach of children.

Store in a cool place at or below 25 °C, protected 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).

6. Contents of the pack and other information

What ASPELONE contains

The active substance is prednisolone sodium phosphate equivalent to 15 mg of prednisolone

base.
The other ingredients are colour raspberry red (C.I.14720), dipotassium hydrogen phosphate (for
pH adjustment), disodium edetate, flavour raspberry, glycerol, potassium dihydrogen phosphate
(for pH adjustment), propylene glycol, purified water, saccharin sodium, sodium chloride, sodium
methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, sorbitol liquid.
Preservatives:
Sodium methyl parahydroxybenzoate 0,21 % m/v
Sodium propyl parahydroxybenzoate 0,022 % m/v
Contains sugar: Sorbitol liquid (70 %) 2,5 g/5 ml, glycerol 0,5 g/5 ml
Contains sweetener: Saccharin sodium 7,5 mg/5 ml

What ASPELONE looks like and contents of the pack

ASPELONE is a clear, pinkish-red liquid, free from foreign particles with a sweet raspberry smell.

100 ml is packed in a round amber glass bottle sealed with a white, tamper evident, expanded
polyethylene lined polypropylene screw cap. The bottle is placed in a cardboard unit carton with a
leaflet.

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50 ml is packed in a round amber glass bottle sealed with a white, tamper evident, expanded
polyethylene lined polypropylene screw cap. The bottle is placed in a cardboard unit carton with a
leaflet.

Not all pack sizes may be marketed.

Holder of Certificate of Registration

PHARMACARE LIMITED
Healthcare Park
Woodlands Drive
Woodmead 2191
Hotline: 0800 122 912/+27 (0)11 239-6200

This leaflet was last revised in

19 September 2022

REGISTRATION NUMBER

41/21.5.1/0189

Access to the corresponding Professional Information

SAHPRA Repository of Professional Information and

Patient Information Leaflets:

https://www.sahpra.org.za/pi-pil-repository/

Aspen Pharmacare:

E-mail: [email protected]

Tel: 0800 118 088

Botswana: BOT1302417 S2

Namibia: NS2 11/21.5.1/0007

ZA_ASPELQD_2209_00

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