SUMMARY CMI

Sone^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor/pharmacist.

1. Why am I taking Sone?

Sone contains the active ingredient prednisone. Sone is used to help reduce inflammation in your body or suppress your immune system, when a disease may be due to an auto-immune reaction (where your body fights against itself).
For more information, see Section 1. Why am I using Sone? in the full CMI.

2. What should I know before I take Sone?

Do not use if you have ever had an allergic reaction to prednisone or any of the ingredients listed at the end of the CMI.
There are a number of circumstances in which a person should not use this medicine or may need to use caution. It is important to understand if these apply to you before taking Sone (see the full CMI for more details).
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Sone? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Sone and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take Sone?

Follow all directions given to you by your doctor carefully including:

• how many tablets to take each day (the dose needed depends on your medical condition, the treatment you are undergoing and your response to it).
• swallow the tablets with water. More instructions can be found in Section 4. How do I use Sone? in the full CMI.

5. What should I know while taking Sone?

For more information, see Section 5. What should I know while taking Sone? in the full CMI.

6. Are there any side effects?

Common side effects include mood changes, nausea, vomiting, increased appetite, stomach issues, diarrhoea or constipation.
Serious side effects include severe stomach or intestinal pain, epileptic fits, sudden changes in your vision, symptoms such as severe dizziness, fainting, weakness, chest pain or irregular heart-beat and psychiatric (mental) disturbances.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

Sone^®

Active ingredient(s): Prednisone (Pred-ni-sone)

Consumer Medicine Information (CMI)

This leaflet provides important information about using Sone. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Sone.

Where to find information in this leaflet:

1. Why am I using Sone?
2. What should I know before I use Sone?
3. What if I am taking other medicines?
4. How do I use Sone?
5. What should I know while using Sone?
6. Are there any side effects?
7. Product details

1. Why am I taking Sone?

Sone contains the active ingredient prednisone. Sone belongs to a group of medicines called corticosteroids.

Sone is used to help reduce inflammation in your body or suppress your immune system, when a disease may be due to an auto-immune reaction (where your body fights against itself).

Sone is used to treat a number of medical conditions.

Your doctor will be able to help decide if Sone is suitable for your condition.

If you have any concerns, you should discuss this with your doctor.

2. What should I know before I take Sone?

Warnings

Do not take Sone if:

• you are allergic to prednisone or other cortisone type medications, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine. Some of the symptoms of an allergic reaction may include:
  - urticaria and other skin rashes
  - difficulty breathing
  - swelling of the face or throat
  - faintness.
• you have a peptic ulcer
• you suffer from osteoporosis (brittle bones)
• you have severe disturbances in thoughts, feelings and behaviours (psychoneuroses)
• you have, have had or suspect you have tuberculosis, unless your doctor has prescribed Sone to help treat your tuberculosis
• you have a severe fungal infection in your body
• it is past the expiry date printed on the pack
• if the packaging is torn or shows any signs of tampering.

Check with your doctor if you:

• have or have had any other medical conditions including:
  - congestive heart failure or have any other heart disease
  - myasthenia gravis
  - diabetes
  - kidney failure or high levels of urea in the blood
  - an underactive thyroid gland (hypothyroidism)
  - a stomach ulcer
  - osteoporosis (brittle bone disease)
  - any infection (bacterial or fungal) including viral infections such as chicken pox or measles. Sone may mask some signs of infection, and new infections may appear during their use.
  - scleroderma (also known as systemic sclerosis, an autoimmune disorder). 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.
• take any vaccines. Talk to you doctor before you take live or attenuated vaccines.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Sone is not recommended when breastfeeding as it can be present in breast milk.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Sone and affect how it works.

These include:

• medicines used to treat upset stomachs such as antacids
• medicines used for diabetes including insulin and oral antidiabetic medicines
• medicines used to treat tuberculosis such as rifampicin
• medicines used to treat fungal infections such as ketoconazole
• some medicines which have a high sodium content and foods with a high sodium content - check with your pharmacist
• some fluid reducing tablets, also called diuretics
• barbiturates, medicine used to treat epilepsy
• high doses of aspirin
• potassium supplements
• growth hormones
• digoxin or digitalis glycosides
• vaccines, live viruses or other immunisations.

The above medicines may either reduce the effectiveness of Sone and/or react with Sone resulting in untoward or sometimes dangerous side effects.

Sone may interfere with laboratory tests that check your thyroid.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Sone.

4. How do I take Sone?

How much to take / use

• The dose needed depends on your medical condition, the treatment you are undergoing and your response to it. The recommended doses are:
  - Adults: 10 mg to 100 mg daily in divided doses.
  - Children: 1 to 5 years: 2.5 mg to 10 mg twice daily.
  - Children: 6 to 12 years: 5 mg to 20 mg twice daily.
• Swallow the tablets with water. If the dose is one-half tablet, there is a break-line on the tablet to help you divide it.
• Follow the instructions provided and use Sone until your doctor tells you to stop. High doses of Sone should be reduced gradually.

When to take Sone

• Sone should be taken after meals at the time directed by your doctor.

If you forget to take Sone

Sone should be taken regularly at the same time each day. If you miss your dose at the usual time, take the missed dose as soon as possible, but not later than 4 hours before your next dose.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you take too much Sone

If you think that you have taken too much Sone, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

If you take too much Sone you may have the following symptoms: weakness, convulsions, dizziness, headache, nausea, vomiting, blurred vision, menstrual irregularities, and symptoms associated with electrolyte and fluid depletion and high blood pressure (hypertension).

5. What should I know while taking Sone?

Things you should do

• Remind any doctor, dentist or pharmacist you visit that you are using Sone
• Take Sone exactly as your doctor has prescribed.
• Visit your doctor regularly. Your doctor needs to check your progress and see whether you need to keep taking Sone.
• Tell your doctor if you notice any changes to your eyesight. Prolonged use of Sone may cause eye issues, including cataracts, glaucoma with possible damage to the optic nerves.
• Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment or dose unnecessarily.
• Keep enough Sone to last weekends and holidays.

Call your doctor straight away if you:

• become pregnant while you are taking Sone.

Things you should not do

• Do not stop using this medicine suddenly. Stopping this medicine suddenly on your own accord may cause some unwanted and dangerous effects, or your condition may reappear. Your doctor will advise you when you can stop taking Sone completely.
• Do not change your dose without first checking with your doctor.
• Do not use this medicine to treat any other complaints unless your doctor says to.
• Do not take any other medicines while you are taking Sone without first telling your doctor.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Sone affects you.

Sone may cause dizziness in some people.

Make sure you know how you react to Sone before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or have blurred vision.

Drinking alcohol

Tell your doctor if you drink alcohol.

Drinking alcohol is not recommended whilst you are taking Sone tablets.

Looking after your medicine

Follow the instructions on the bottle on how to take care of your medicine properly.

Store Sone below 30°C in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Protect from light.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Side effects where the frequency is not known:

• Scleroderma renal crisis in patients already suffering from scleroderma (an autoimmune disorder). Signs of scleroderma renal crisis include increased blood pressure and decreased urine production.
• Slow heart rate (bradycardia).

Side effects detected by your doctor:

Some side effects can only be detected by your doctor. So it is important to visit your doctor for regular check-ups when Sone is taken for long periods of time.

Such side effects can include:

• osteoporosis or other changes in bone which can result in an increased chance of fractures due to brittleness or softening of the bone
• changes in other hormone levels in your body
• changes in the body's ability to handle glucose (steroid diabetes)
• effects on the parathyroid and thyroid glands which control calcium and body metabolism
• increased amounts of cholesterol in the blood
• changes to your white blood cells
• changes to your nervous system which may affect the way your nerves work
• increased blood pressure
• increased pressure in the skull
• increased pressure in the eye (glaucoma).
• rare eye diseases such as central serous chorioretinopathy (CSCR).

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Sone contains

Do not take this medicine if you are allergic to any of these ingredients.

What Sone looks like

Sone is available in two strengths as follows:

5 mg tablet - AUST R 56129

White, round biconvex tablet, uncoated, one face plain, and other face scored. It comes in a bottle of 60 tablets.

25 mg tablet - AUST R 13470

White, flat round, bevelled edges tablet, uncoated, one face plain and other face scored. It comes in a bottle of 30 tablets.

Who distributes Sone

iNova Pharmaceuticals (Australia) Pty Limited
ABN: 13 617 871 539
Level 10, 12 Help Street
Chatswood NSW 2067
Telephone: 1800 630 056

This leaflet was prepared in November 2023.

Published by MIMS December 2023

1 Name of Medicine

Prednisone.

2 Qualitative and Quantitative Composition

Sone tablets contain 5 mg or 25 mg prednisone as the active ingredient.

List of excipients with known effect.

3 Pharmaceutical Form

Tablet, uncoated.

5 mg tablet.

25 mg tablet.

4 Clinical Particulars

4.1 Therapeutic Indications

Wherever corticosteroid therapy is indicated.

4.2 Dose and Method of Administration

Adults.

Children.

1 to 5 years.

6 to 12 years.

4.3 Contraindications

Systemic fungal infections and known hypersensitivity to prednisone or any of the excipients.
Peptic ulcer, osteoporosis, psychoses or severe psychoneuroses. Patients with active or doubtfully quiescent tuberculosis should not be given these hormones except as adjuncts to treatment with tuberculostatic drugs.

4.4 Special Warnings and Precautions for Use

Corticosteroids should be used with caution in the presence of diminished cardiac reserve or congestive heart failure, in patients with diabetes mellitus, infectious diseases, chronic renal failure, uraemia and in elderly persons.
In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.
Corticosteroids may mask some signs of infection, and new infections may appear during their use. Infections with any pathogen including viral, bacterial, fungal, protozoan or helminthic infections, in any location of the body, may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. These infections may be mild, but can be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. There may be decreased resistance and inability to localize infection when corticosteroids are used.
Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.
Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known.

Scleroderma renal crisis.

Withdrawal symptoms.

Visual disturbance.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The following drug interactions with corticosteroids have been selected on the basis of their potential clinical significance: antacids, antidiabetic agents (oral or insulin), digitalis glycosides, diuretics, drugs which induce hepatic microsomal enzymes such as barbiturates, phenytoin and rifampicin; potassium supplements, ritodrine, sodium-containing medications or foods, somatrem or somatropin, vaccines, live viruses or other immunizations.
Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the clearance of corticosteroids and may require increases in corticosteroid dose to achieve the desired response.
Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of corticosteroids and thus decrease their clearance. Therefore, the dose of corticosteroid should be titrated to avoid steroid toxicity. Corticosteroids may increase the clearance of chronic high dose aspirin. This could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Aspirin should be used cautiously in conjunction with corticosteroids in patients suffering from hypoprothrombinemia.
The effect of corticosteroids on oral anticoagulants is variable. There are reports of enhanced as well as diminished effects of anticoagulants when given concurrently with corticosteroids. Therefore, coagulation indices should be monitored to maintain the desired anticoagulant effect.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of these medicines on a person's ability to drive and use machines were not assessed as part of their registration. However, adverse effects of Sone include vertigo, convulsions and blurred vision which could affect the ability to drive or use machines (see Section 4.8 Adverse Effects (Undesirable Effects)).

4.8 Adverse Effects (Undesirable Effects)

The side effects associated with the use of corticosteroids in the large doses necessary to produce a therapeutic response result from excessive action on electrolyte balance; excessive action on other aspects of metabolism including gluconeogenesis; the action on tissue repair and healing; and an inhibitory effect on the secretion of cortico-trophin by the anterior pituitary gland. Disturbance of electrolyte and water balance is manifest in sodium retention with oedema and hypertension, and in the increased excretion of potassium with the development of hypokalaemic alkalosis. In extreme cases, cardiac failure may be induced. Disturbances of electrolyte balance are common with the naturally occurring corticotrophins, cortisone, deoxycortone and hydrocortisone but are less frequent with the synthetic derivatives, prednisone and prednisolone. Other metabolic effects include mobilisation of calcium and phosphorus with osteoporosis and spontaneous fractures; nitrogen depletion; and hyperglycaemia with accentuation or precipitation of the diabetic state. The insulin requirements of diabetic patients are increased and appetite is often increased.
The effect on tissue repair manifests as peptic ulceration with haemorrhage and perforation, delayed wound healing and increased liability to infection. Increased susceptibility to all kinds of infection, including sepsis, fungal and viral infection, has been reported.
Large doses of corticosteroids or corticotrophins may produce symptoms typical of hyperactivity of the adrenal cortex, with moonface, buffalo hump, flushing, striae and acne, sometimes leading to a fully developed Cushing's syndrome. If administration of the hormone is discontinued immediately on the appearance of these symptoms, they are usually reversed, but such sudden cessation may be dangerous. The dose of corticosteroid required to cause a decrease or absence of corticotrophin in the blood with consequent atrophy of the adrenal cortex and the time required for its occurrence are very variable. Acute adrenal insufficiency with loss of consciousness may occur during prolonged treatment or on cessation of treatment and may be precipitated by an infection or trauma.
Growth retardation in children has been reported and in this respect cortisone is only one-tenth as potent as prednisone and prednisolone. Other toxic effects include mental and neurological disturbances, intracranial hypertension and, on sudden reduction of dosage during the treatment of rheumatoid arthritis, fatalities attributed to lesions of small arteries and arterioles similar to polyarteritis.
Infections may be masked since corticosteroids have marked anti-inflammatory and antipyretic properties and may produce a feeling of well-being. The administration of corticosteroids may also cause a reduction in the number of circulating lymphocytes.
Muscular weakness is an occasional side effect of most corticosteroids, particularly when they are taken in large doses.
Toxic effects occur with all corticosteroid preparations and their incidence rises steeply if dosage increases much above 8 mg daily of prednisolone or its equivalent.

Scleroderma renal crisis.

Fluid and electrolyte disturbances.

Musculoskeletal.

Gastrointestinal.

Dermatologic.

Metabolic.

Neurological.

Endocrine.

Ophthalmic (eye disorders).

Cardiac disorders.

Additional reactions.

Reporting suspected adverse effects.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Lactose monohydrate, propyl hydroxybenzoate, gelatin, maize starch, wheat starch and magnesium stearate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C. Protect from light.

6.5 Nature and Contents of Container

Supplied in HDPE bottles.

5 mg tablet.

25 mg tablet.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Prednisone occurs as white to practically white, odourless, crystalline powder. Prednisone is very slightly soluble in water, slightly soluble in alcohol, in chloroform, in dioxane, and in methanol.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes