SOLONE

Prednisolone (Pred-NISS-oh-lone)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about SOLONE (prednisolone tablets). It does not contain all the available information about SOLONE tablets. It does not replace talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you or your child taking SOLONE against the benefits he or she expects it will have.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What is SOLONE

The name of your medicine is SOLONE and is available in 5 mg and 25 mg tablet strengths.

The active ingredient is called prednisolone.

Prednisolone belongs to a group of medicines called corticosteroids.

Corticosteroids are 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).

What SOLONE is used for

SOLONE is used to treat a number of medical conditions.

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

Ask your doctor if you have any questions about why SOLONE has been prescribed for you.

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

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

Before you take SOLONE

When you must not take it

Do not take Solone if you are allergic to:

• Prednisolone or other cortisone type medications, or any of the ingredients listed at the end of this leaflet including lactose.

Some of the symptoms of an allergic reaction to SOLONE may include urticaria and other skin rashes, difficulty breathing, swelling of the face or throat or faintness.

Do not take SOLONE if you:

• have a peptic ulcer
• suffer from osteoporosis (brittle bones)
• have severe disturbances in thoughts, feelings and behaviours (psychoneuroses)
• have tuberculosis.

Do not take SOLONE if you are breastfeeding or plan to breast-feed.

Do not take SOLONE if you have any infections, including mumps, measles or chickenpox.

Do not use SOLONE after the expiry date (EXP.) printed on the pack. If you take it after the expiry date has passed, it may have no effect at all, or worse, there may be an entirely unexpected effect.

Do not use SOLONE if the packaging is torn or shows any signs of tampering.

Do not give SOLONE to children, unless your doctor has prescribed it.

Before you start to take it

You must tell your doctor if:

1. You are allergic to any other medicines or any foods, dyes or preservatives
2. You have or have had any other medical conditions/health problems, including:

• tuberculosis (TB)
• a stomach ulcer
• osteoporosis (brittle bone disease)
• myasthenia gravis
• congestive heart failure or have any other heart disease
• diabetes
• kidney failure
• an underactive thyroid gland (hypothyroidism)
• any infection (bacterial or fungal) including viral infections such as chicken pox or measles

1. 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.
2. Take Typhoid Vaccine. 
   Live or attenuated vaccines such as oral typhoid vaccine must not be taken with SOLONE.
3. You are pregnant or plan to become pregnant. 
   SOLONE like all medicines should not be used during pregnancy, unless your doctor tells you.
4. You are breastfeeding or plan to breastfeed. 
   SOLONE is expelled in breast milk and therefore should only be taken if your doctor tells you.

If you have not told your doctor about any of the above, tell them before you take any SOLONE.

Taking other medicines

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

Some medicines may interfere with SOLONE. These include:

• medicines used to treat upset stomachs such as antacids
• medicines used for diabetes including insulin
• 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 also 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
• course of vaccinations

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

Tell your doctor if you are taking SOLONE tablets before you undergo any laboratory test. SOLONE may interfere with laboratory tests that check your thyroid.

Alcohol may interfere whilst you are taking SOLONE tablets.

This list is not exhaustive. Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking SOLONE.

How to take SOLONE

How much to take

Your doctor will decide the right dose for you.

The dose you need 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.

Follow your doctor's instructions carefully, if you need to reduce your dose of SOLONE.

High doses of SOLONE should be reduced gradually.

How to take it

Swallow the medicine with water. If the dose is one-half tablet, there is a break-line on the tablet to help you divide it.

When to take it

Take SOLONE after meals at the time directed by your doctor.

How long to take it

Continue taking SOLONE as long as your doctor recommends it.

If you forget to take it

If your dosing schedule is one dose a day, 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.

Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.

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

If you are unsure about whether to take your next dose, speak to your doctor or pharmacist.

Do not try to make up for missed doses by taking more than one dose at a time. This may increase the chance of you getting an unwanted side effect.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much SOLONE. Do this even if there are no signs of discomfort or poisoning. Also report any other medicine or alcohol which has been taken. You may need urgent medical attention.

Keep telephone numbers for these places handy.

If you take too much SOLONE 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).

While you are using SOLONE

Things you must do

Use SOLONE exactly as your doctor has prescribed.

Tell all doctors, dentists and pharmacists who are treating you that you are taking SOLONE.

Tell your doctor promptly if you become pregnant while you are taking SOLONE.

Tell your doctor if you feel SOLONE is not helping your condition.

Visit your doctor regularly. Your doctor needs to check your progress and see whether you need to keep taking SOLONE.

Always discuss with your doctor any problems or difficulties during or after taking SOLONE.

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 unnecessarily.

Keep enough SOLONE to last weekends and holidays.

Things you must not do

Do not take any other medicines while you are taking SOLONE without first telling your doctor.

Do not drive or operate machinery until you know how SOLONE affects you.

SOLONE may cause dizziness in some people and therefore may affect alertness.

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

Do not take SOLONE for a longer time than your doctor has prescribed.

Do not change your dose without first checking with your doctor.

Do not stop taking SOLONE or lower the dose, without first checking with your doctor. 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 SOLONE completely.

Do not use this medicine to treat any other complaints unless your doctor says to.

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking SOLONE.

SOLONE helps most people with medical conditions listed in the beginning of this leaflet, but it may have unwanted side effects in some people.

All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist any questions you may have.

Short term use

When Solone is taken for short periods of time it is unlikely to cause any major problems.

Tell your doctor if you notice any of the following side effects and they worry you:

• mood changes
• nausea (feeling sick)
• vomiting
• increased appetite (which may result in weight gain)
• stomach bloating or irritation
• diarrhoea or constipation.

Long term use

When Solone is taken for long periods of time and in high doses the risk of side effects is greater.

Tell your doctor if you notice any of the following and they worry you:

General changes to the body:

• bloating and rounding of the face (moon face)
• headache
• dizziness
• high blood pressure
• weight gain
• redistribution of body fat
• water retention leading to swollen legs and feet, high blood pressure or an irregular heart beat
• cramps or weakness in the muscles of the arms and legs
• slowed growth in children
• irregular menstrual periods.

Changes to the skin:

• acne
• red or flushed face
• red or purple streaks
• easy bruising
• skin thinning
• increased sweating
• poor wound healing
• skin rashes.

Changes to the immune system:

• an increased seriousness or frequency of infections.

Changes in behaviour:

• excessive mood swings (such as changes in personality and loss of contact with reality)
• anxiety or nervousness
• depression
• euphoria
• restlessness
• trouble sleeping.

Changes in eyes:

• decreased or blurred vision
• eyes sticking out too far
• cataracts.

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.

Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital if you notice any of the following symptoms:

• 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
• psychiatric (mental) disturbances.

These are all serious side effects of Solone. You may need urgent medical attention or hospitalisation.

Some side effects can only be detected by your doctor. So it is important to visit your doctor for regular check-ups when Solone 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).

Tell your doctor if you notice anything else that is making you feel unwell. Some people may get other side effects while using SOLONE.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Your doctor may lower the dose to help control serious side effects and decide on necessary tests to monitor any of the above problems.

Check with your doctor as soon as possible if you have any problems while taking SOLONE, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

After using SOLONE

Storage

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Keep SOLONE in a cool dry place where the temperature stays below 30°C and protect from light.

Do not store it, or any other medicines, in a bathroom or near a sink.

Do not leave it in the car or on windowsills. Heat and dampness can destroy some medicines.

Do not take SOLONE if the tablets do not look quite right.

Keep your tablets in the bottle they were provided in until it is time to take them.

Disposal

If your doctor tells you to stop taking the tablets or they have passed their expiry date, ask your pharmacist what to do with any left over.

Product description

What it looks like

SOLONE 5 mg tablet is a white round uncoated tablet, one side with marking 'L' and the other scored with a break-line. It comes in a bottle of 60 tablets.

SOLONE 25 mg tablet is a white round plain uncoated tablet, one side plain and the other scored with a break-line. It comes in a bottle of 30 tablets.

Ingredients

Each SOLONE 5 mg tablet contains 5 mg of the active ingredient, prednisolone.

The other ingredients are:

• lactose
• propyl hydroxybenzoate
• starch-maize
• starch-wheat
• gelatin
• magnesium stearate

Each SOLONE 25 mg tablet contains 25 mg of the active ingredient, prednisolone.

The other ingredients are:

• lactose
• propyl hydroxybenzoate
• starch-maize
• starch-wheat
• gelatin
• magnesium stearate

SOLONE contains lactose and gluten but does not contain sucrose.

Sponsor

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

The Australian Registration Number for SOLONE 5 mg tablet is
AUST R 13469.

The Australian Registration Number for SOLONE 25 mg tablet is
AUST R 13468.

This leaflet was prepared in November 2017.