INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
ASPELONE (Liquid)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ASPELONE (Liquid)

COMPOSITION:
Each 5 mL of ASPELONE liquid contains: prednisolone sodium phosphate which is equivalent to 15 mg prednisolone base.
Preservatives: Sodium methyl parahydroxybenzoate 0,21% m/v
Sodium propyl parahydroxybenzoate 0,022% m/v
Contains no sugar and no alcohol.

PHARMACOLOGICAL CLASSIFICATION:
A.21.5.1 Corticosteroids and analogues.

PHARMACOLOGICAL ACTION:
Prednisolone is a synthetically derived glucocorticoid analogue used mainly for its anti-inflammatory effects.

INDICATIONS:
ASPELONE is used for the relief of symptoms associated with inflammatory conditions, where a steroid is indicated.

CONTRA-INDICATIONS:
Hypersensitivity to ASPELONE or other corticosteroids.
ASPELONE should not be used by pregnant or breastfeeding women (see “PREGNANCY AND LACTATION”).
ASPELONE is contra-indicated in patients with osteoporosis, oesophagitis, gastritis, peptic ulcer, acute psychosis or severe psychoneuroses.
It should not be used in patients with systemic fungal infections, or in patients with uncontrolled, systemic or local bacterial or viral infections.
Patients with active or doubtfully quiescent tuberculosis should not be given ASPELONE, except, very rarely, as adjuncts to anti-tubercular treatment.
The presence of acute viral infections such as herpes zoster or ocular herpes simplex are contra-indications to the use of ASPELONE.
Patients receiving high-dose ASPELONE should not be immunized with live vaccines for up to 3 months after steroid therapy.

INTERACTIONS:
Concurrent use of barbiturates, carbamazepine, phenytoin, primidone, or rifampicin may lead to an increased metabolism and reduced effect of corticosteroids. Plasma levels of corticosteroids may be elevated by oral contraceptives or ritonavir.
Hypokalaemia may result from concurrent administration with potassium-depleting diuretics such as the thiazides or furosemide, amphotericin B or bronchodilator therapy with xanthines or beta2-receptor agonists.
Concomitant use with non-steroidal and anti-inflammatory drugs (NSAIDs) may cause an increased incidence of gastrointestinal bleeding and ulceration. ASPELONE alters the response to anti-coagulants and increases the requirements for anti-diabetic or anti-hypertensive drugs.
Serum concentrations of salicylates may be reduced. ASPELONE may lead to a reduced effect of antimuscarinics in the treatment of myasthenia gravis.

PREGNANCY AND LACTATION:
ASPELONE should not be used by pregnant or breast-feeding women.

DOSAGE AND DIRECTIONS FOR USE:
DOSING REQUIREMENT MAY VARY DEPENDING ON THE SPECIFIC DISEASE, ITS SEVERITY AND THE RESPONSE OF THE PATIENT. DOSAGES SHOULD THEREFORE BE MODIFIED TO SUIT EACH PATIENT.
The usual dose of ASPELONE is about 3 mg to 60 mg daily in divided doses and it varies according to the disease being treated. ASPELONE may be given daily as a single dose after breakfast or as a double dose on alternate days. Some patients may require higher initial doses, where low doses should be sufficient in less severe situations.
Careful adjustment of the initial dose may be required to obtain a satisfactory response and this dose should be maintained thereafter. 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.
Gradually discontinue the treatment if spontaneous remission occurs in a chronic condition.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Acute adrenal insufficiency may result from a rapid withdrawal of ASPELONE after prolonged therapy.
Infections and infestations:
Frequency unknown: Patients treated with ASPELONE may become susceptible to all kinds of infections, which include septicaemia, tuberculosis, fungal infections and viral infections.
The anti-inflammatory, analgesic and antipyretic effects of corticosteroids may mask the signs and symptoms of infection. Wound healing can be delayed.
Blood and lymphatic system disorders:
Frequency unknown: ASPELONE may cause sodium and water retention, with oedema, hypertension, and disturbances in electrolyte balance and hypokalaemic alkalosis resulting from increased excretion of potassium.
Rare: Cardiac failure may also occur in some patients.
Endocrine disorders:
Frequency unknown: Large doses of ASPELONE may cause Cushingoid manifestations.
These manifestations include moon-face, buffalo hump, flushing, ecchymosis, increased bruising, striae and acne, hypertension, hypokalaemia, glycosuria, gastric discomfort and mental disturbances.
Metabolism and nutrition disorders:
Frequency unknown: Osteoporosis, spontaneous fractures, myopathy, nitrogen depletion.
Hyperglycaemia may occur with accentuation or precipitation of the diabetic state.
Diabetic patients may also require more insulin.
Frequent: Increased appetite.
Reproductive system and breast disorders:
Frequency unknown: Menstrual irregularities, amenorrhoea.
Vascular disorders:
Frequency unknown: Benign intra-cranial hypertension, thromboembolic complications.
Musculoskeletal, connective tissue, skin and bone disorders:
Frequency unknown: Avascular necrosis of bone, muscular weakness, skin thinning.
Eye disorders:
Frequency unknown: Ocular changes involving the development of glaucoma and cataracts.
Other:
Frequency unknown: Growth retardation in children, acute pancreatitis.
Less frequent or rare: Hyperhidrosis

Special precautions:
Systemic ASPELONE should be used with caution in the elderly and in patients with heart failure, a recent myocardial infarction, hypertension, diabetes mellitus, epilepsy, glaucoma, hypothyroidism, heart failure, osteoporosis, peptic ulceration, psychoses or severe affective disorders and renal impairment

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
For symptoms of overdosage please see “SIDE-EFFECTS AND SPECIAL PRECAUTIONS”.
Treatment is symptomatic and supportive.

IDENTIFICATION:
A clear, pinkish-red liquid, free from foreign particles with a sweet raspberry odour and taste.

PRESENTATION:
50 mL round, amber, glass bottle with white, tamper evident, polypropylene screw cap (28 mm).

STORAGE INSTRUCTIONS:
Store below 25ºC. Protect from light. Shake the bottle before use and keep well closed.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
41/21.5.1/0189

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead
2191

DATE OF PUBLICATION OF PACKAGE INSERT:
12 February 2009

575399

PATIENT INFORMATION LEAFLET

Read 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 or pharmacist.

•        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.

SCHEDULING STATUS: S4

NAME, STRENGTH AND DOSAGE FORM:
ASPELONE Liquid

1. WHAT ASPELONE CONTAINS:
Each 5 mL of liquid contains the active, prednisolone sodium phosphate which is equivalent to 15 mg prednisolone base.
The other ingredients in ASPELONE Liquid are colour raspberry red, disodium edetate, dipotassium hydrogen phosphate, flavour raspberry, glycerol, potassium dihydrogen phosphate, propylene glycol, sodium chloride, non-crystallising sorbitol liquid.
ASPELONE Liquid is preserved with sodium methyl parahydroxybenzoate 0,21% m/v and sodium propyl parahydroxybenzoate 0,022% m/v.
Contains no sugar and no alcohol.

2. WHAT ASPELONE IS USED FOR:
ASPELONE is a corticosteroid and is used to provide relief for inflamed areas of the body. Corticosteroids lessen swelling, redness, itching, and allergic reactions.

3. BEFORE YOU TAKE ASPELONE:
Do not use ASPELONE Liquid:

•	If you are hypersensitive (allergic) to cortisone-like medicines including prednisolone or any of the other ingredients of ASPELONE Liquid
•	If you have a fungal infection throughout your body
•	If you have a severe infection caused by a virus
•	If you have stomach and/or duodenal ulcers
•	If you have osteoporosis
•	If you are psychotic
•	If you have active tuberculosis
•	And have a vaccination without your doctor’s approval

Take special care with ASPELONE Liquid:

•	In the elderly
•	If you are epileptic
•	If you have heart failure
•	If you have high blood pressure
•	If you have diabetes
•	If you currently have an infectious disease
•	If you have kidney failure
•	If you are on any of the following medicines: barbiturates, carbamazepine, phenytoin, primidone, rifampicin, oral contraceptives, ritonavir, potassium-depleting diuretics, amphotericin B, xanthines, beta2 agonists, non-steroidal anti-inflammatory medicines, salicylates, antidiabetic medicines, antihypertensives or anticholinesterases.

Taking ASPELONE Liquid with food and drink:
ASPELONE Liquid may be taken with or without food.

Pregnancy and breast-feeding:
ASPELONE Liquid is contra-indicated in pregnancy and lactation.

Driving and using machinery:
ASPELONE Liquid should not have an effect on driving and using machinery.

Important information about ASPELONE Liquid:
The dose of ASPELONE Liquid will be different for different patients. Follow the doctor’s instructions and do not use it for a longer time than your doctor ordered.

Taking other medicines with ASPELONE Liquid:
If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of ASPELONE Liquid with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional for advice.

4. HOW TO TAKE ASPELONE:
Dosage:
Always take ASPELONE Liquid exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
The dosage of ASPELONE Liquid depends on the condition being treated and your response to therapy.ASPELONE Liquid has a usual dose range of 3 mg to 60 mg daily in divided doses depending on the underlying condition.
If you have the impression that the effect of ASPELONE Liquid is too strong or too weak, talk to your doctor or pharmacist.
Do not share medicines prescribed for you with any other person.

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:
If you miss a dose of ASPELONE, take it as soon as you remember that day. If you only remember the next day, skip the missed dose and go back to your normal dosing schedule. Do not take a double dose to make up for forgotten individual doses.

Effects when treatment with ASPELONE is stopped:
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.

5. SIDE EFFECTS:
ASPELONE Liquid can have side effects.
Not all side effects reported for ASPELONE are included in this leaflet. Should your general health worsen while taking ASPELONE, please consult your doctor, pharmacist or other healthcare professional for advice.

•	ASPELONE may mask some signs of infection. Wound healing may be delayed and the patient may have increased susceptibility to infection.
•	Some patients may retain water and have resultant swelling due to retained water and an increase in blood pressure. This can result in abnormally low levels of potassium in the blood and in extreme cases, heart failure.
•	Other side effects include: 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, mental and neurological disturbances.
•	The insulin requirements of diabetic patients may be increased due to the fact that there may be an excess of glucose in the bloodstream.
•	An increase in appetite, the absence of menstrual periods, an increase in the blood pressure within the skull, blood clot complications, death of bone tissue, weakness of the muscles, inflammation of the pancreas and excessive sweating may also occur.
•	Growth suppression in children may occur.

6. STORING AND DISPOSING OF THIS MEDICINE:
Store in a cool place (below 25ºC), protected from light. Shake the bottle before use and keep it well closed.
Keep all medicines out of the reach and sight of children.
Return all unused medicine to your pharmacist.

7. PRESENTATION:
50 mL dark brown glass bottles closed with a white plastic screw on cap.

8. IDENTIFICATION:
This medicine is a clear, pinkish-red liquid, free from foreign particles with a sweet raspberry smell and taste.

9. REGISTRATION NUMBER:
41/21.5.1/0189

10. NAME AND ADDRESS OF REGISTRATION HOLDER:
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead
2191

11. DATE OF PUBLICATION:
12 February 2009

575399

New addition to this site: May 2010
Source: Pharmaceutical Industry
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