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PREDNISOLONE 10MG/ML ORAL SOLUTION

Active substance(s): PREDNISOLONE SODIUM PHOSPHATE

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180 mm

Package leaflet: Information for the user

Prednisolone 10mg/ml Oral Solution

Read all of this leaflet carefully before you, or your child, starts
taking this medicine because it contains important information for
you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, or your child, only. Do
not pass it on to others. It may harm them, even if their signs of
illness are the same as yours.
• If you, or your child, get any side effects, talk to your doctor, or
pharmacist. This includes any possible side effects not listed in this
leaflet.
What is in this leaflet:
1. What Prednisolone Oral Solution is and what it is used for
2. What you need to know before you take Prednisolone Oral
Solution
3. How to use Prednisolone Oral Solution
4. Possible side effects
5. How to store Prednisolone Oral Solution
6. Contents of the pack and other information

1. What Prednisolone Oral Solution is and what it is
used for

Do not take Prednisolone Oral Solution:
• if you are allergic to prednisolone or any of the other ingredients
of this medicine (listed in section 6). Signs of a severe allergic
reaction may include a red and lumpy skin rash, difficulty
breathing, swelling of face, mouth, lips or eyelids, unexplained
high temperature (fever) and feeling faint. If the swelling affects
your throat and makes breathing and swallowing difficult, go to
hospital straight away;
• if you have an infection which affects your entire body (unless
you are receiving treatment for the infection);
• if you have recently had any “live” vaccinations.
Talk to your doctor or pharmacist before taking this medicine:
• if you have ever had severe depression or manic depression
(bipolar disorder). This includes having had depression before or
while taking steroid medicines like Prednisolone Oral Solution;
• if any of your close family has had these illnesses.
Mental health problems while taking Prednisolone Oral Solution
Mental health problems can happen while taking steroids like
Prednisolone Oral Solution.
• These illnesses can be serious.
• Usually they start within a few days or weeks of starting the
medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is lowered or the
medicine is stopped. However, if problems do happen, they
might need treatment.
Talk to a doctor if you (or someone taking this medicine) show any
signs of mental health problems. This is particularly important if you
are depressed, or might be thinking about suicide. In a few cases,
mental health problems have happened when doses are being
lowered or stopped.
Chickenpox, shingles or measles
• Tell your doctor if you have previously had chickenpox, shingles or
measles, or if you have been vaccinated against these infections.
• It is important that whilst you are taking this medicine, you avoid
contact with anybody who has chickenpox, shingles, or measles
especially if you have not already had them. If you think you may
have come into contact with a person who has chickenpox,
shingles or measles, you should contact your doctor
immediately.
• If you catch chickenpox, shingles or measles, tell your doctor
immediately. Your doctor will advise you on how to take
prednisolone. Your doctor may want to change your dose of
Prednisolone Oral Solution.
Please also tell your doctor or pharmacist if any of the following
apply to you:
• you have, or have ever had, tuberculosis (TB) or blood poisoning
(septicaemia);
• you have liver or kidney problems;
• you have high blood pressure (or a family history of high blood
pressure), heart disease or you have recently had a heart attack;
• you have, or have a family history of, the following:
o diabetes
o osteoporosis
o glaucoma (raised eye pressure)
o epilepsy (fits)
• you have ever previously suffered from muscle weakness when
using prednisolone, or any other steroids, in the past;

• Hold the syringe in place and then turn the bottle upside down (refer to
Figure 1).
• Still holding the syringe in place, pull the plunger down to the correct
mark on the syringe (refer to Figure 1 and Figure 2).
• Turn the bottle the right way up.
• Remove the syringe, from the adaptor, by holding onto the bottle and
gently twisting the syringe.
• After use replace the bottle cap and wash the syringe in warm water.
Allow to dry.
• Do not remove the adaptor from the bottle.

Figure 1.

Each graduation on the syringe provided
is equivalent to 0.25ml of solution
5.0
(refer to Figure 2).

4.5

4.0

2.5

4.5
4.0

2.0

3.5
3.0

1.0

2.0
1.5

0.5

1.0
0.25

The recommended dose is:
Adults
• The usual starting dose is 1ml to 10ml per day.
• Your doctor may reduce the dose, after a few days or weeks,
depending on how well your condition is responding to the treatment.
For Rheumatoid Arthritis
• The usual starting dose is between 0.75ml and 1ml per day.
Children
• Your doctor will decide the most appropriate dose to treat your child.
• If Prednisolone Oral Solution has been prescribed for your child, for the
treatment of acute asthma attacks the following dosing regime may be
given for up to three days:
o For children over 5 years of age, 3 to 4ml may be prescribed;
o For children aged 2-5 years of age, 2ml may be prescribed;
o For children aged under 2 years, 1ml may be prescribed if your child
is being treated in a hospital.
Important: If you are unsure how much medicine to take, please contact
your doctor or pharmacist for advice.
If you take more Prednisolone Oral Solution than you should
If you take more oral solution than your doctor has told you to, contact a
doctor or your nearest hospital casualty department immediately and
take this medicine with you.
If you forget to take Prednisolone Oral Solution
• If you forget to take a dose, take it as soon as you remember unless it is
almost time for the next dose.
• Do not take double the amount to make up for a forgotten dose.
If you stop taking Prednisolone Oral Solution
Speak to your doctor before you stop taking Prednisolone Oral Solution.
• Do not stop taking this medicine suddenly. Your doctor will tell you how
to reduce your dose slowly over a number of weeks or months to help
lower the chance of you getting withdrawal symptoms.
• Stopping Prednisolone Oral Solution (particularly if stopped suddenly)
can lead to withdrawal symptoms. The most common are:
- high temperature
- muscle and joint pain
- runny nose
- weight loss
- itchy skin
- red, sore and sticky eyes (conjunctivitis)
- headache
- being sick
- blurred vision
- low blood pressure
• If you get severe withdrawal symptoms tell your doctor straight away.
He/she may ask you to start taking your medicine again and then to
start coming off it again more slowly.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
If you experience any of the following side effects after you have been
given your medicine, tell your doctor or pharmacist immediately:
• Severe allergic reaction which may include a red and lumpy skin rash,
difficulty breathing, swelling of face, mouth, lips or eyelids, unexplained
high temperature (fever) and feeling faint. If the swelling affects your
throat and makes breathing and swallowing difficult, go to hospital
straight away.
• Serious mental health problems. Steroids, including prednisolone, can
cause serious mental health problems. These are common in both adults
and children. They can affect about five in every 100 people using
medicines like prednisolone. The symptoms include:
o feeling depressed, including thinking about suicide;
o feeling high (mania) or moods that can go up and down;
o feeling anxious, having problems sleeping, difficulty in thinking or
being confused and losing your memory;
o feeling, seeing or hearing things that do not exist. Having strange and
frightening thoughts, changing how you act or have feelings of
being alone.
• If you have epilepsy and you have more fits than normal.
The following side effects may occur if prednisolone is given for a long
period of time:
• if you have had tuberculosis in the past, it may return
• you may get infections more easily than usual

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Prednisolone 10mg/ml
Oral Solution - PIL

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Your doctor will decide on the most appropriate dose to treat you, or your
child. Always take this medicine exactly as your doctor or pharmacist has
told you. These instructions will have been added to the dispensing label
by your pharmacist. You should check with your doctor or pharmacist if
you are not sure.
Using the syringe
A 5ml graduated syringe and a syringe/bottle adaptor is provided with
your medicine. Use the syringe to withdraw, from the bottle, the amount
of Prednisolone Oral Solution that has been prescribed for you by your
doctor.
• Insert the bottle adaptor firmly into the neck of the bottle.
• Push the tip of the syringe into the hole in the top of the adaptor and
ensure that it is secure.
(continued overleaf)

Focus Contact:

3.0

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3. How to take Prednisolone Oral Solution

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• a rare type of cancer which can affect both the skin and internal organs
(Kaposi’s sarcoma)
• raised level of white blood cells
• facial puffiness and weight gain (Cushingoid)
• intolerance to carbohydrates which might result in a requirement for
anti-diabetic treatment, or you may develop a mild form of diabetes,
but without any obvious symptoms
• salt imbalances or water retention in the body
• low levels of potassium in the blood, which may result in tiredness,
confusion, muscle weakness or muscle cramps
• increased appetite
• loss of protein and calcium balance
• dizziness
• headache
• increased pressure in the eye, swelling in the eye, cataracts
• detachment of the retina causing visual impairment
• protrusion of the eyeballs
• thinning of the eye membranes, worsening of existing eye infections
• vertigo
• tearing of the heart muscle tissues, particularly if you have recently had
a heart attack
• heart failure in susceptible people
• high blood pressure
• blocked blood vessel (embolism)
• hiccups or indigestion
• feeling or being sick
• swollen stomach, or stomach ache
• diarrhoea
• ulcers in the oesophagus (gullet)
• thrush
• inflammation of the pancreas causing abdominal pain
• stomach ulcers (which may bleed)
• thin delicate skin, unusual marks on the skin or bruising
• appearance of stretch marks
• acne
• visible swollen capillaries
• increased sweating
• rash, itching skin
• excess body hair (particularly in women)
• muscle wasting, weakness or pain
• thinning of the bones with an increased risk of fractures (osteoporosis)
• bone disease
• irregular periods, or your periods may stop altogether
• slow wound healing
• generally feeling unwell
• weight gain
• breaking of tendons. Symptoms can include hearing or feeling a pop or
a snap, severe pain, immediate bruising and an inability to put weight
on, or use, the affected area
Children and adolescents
Children and teenagers taking this medicine may grow more slowly than
normal. If you, as the patient or carer, are worried about the effects of
taking this medicine, go back and discuss it with your doctor.
Elderly
If you are elderly, your doctor will monitor you closely whilst you are taking
this medicine as you may be more likely to experience side effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Prednisolone Oral Solution

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and
label. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C). Once opened, your medicine can be
stored at a temperature below 25°C and must be used within 3 months.
Keep this medicine in the original packaging, in order to protect from light.
Do not use this medicine if you notice any visible signs of damage to the
bottle or deterioration in your medicine. Return it to your pharmacist.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help to protect the environment.

6. Contents of the pack and other information

What Prednisolone 10mg/ml Oral Solution contains
- The active ingredient is prednisolone. Each 1ml of oral solution contains
10mg prednisolone (as prednisolone sodium phosphate).
- The other ingredients are sodium methyl parahydroxybenzoate (E219),
sodium propyl parahydroxybenzoate (E217), glycerol, sodium saccharin,
disodium edetate, sodium dihydrogen phosphate dihydrate, sodium
hydroxide (as pH adjuster), orange flavour and purified water (see
section 2 Before you take Prednisolone Oral Solution).
What Prednisolone Oral Solution looks like and contents of the pack
Prednisolone 10mg/ml Oral Solution is a clear colourless to yellowish oral
solution with a characteristic odour of orange. It is available in an amber
glass bottle containing 30ml of medicine. The pack also contains a 5ml
plastic oral dosing syringe and an adaptor.
Marketing Authorisation Holder
Focus Pharmaceuticals Limited, Capital House, 1st Floor, 85 King William
Street, London EC4N 7BL, UK.
Tel: 00 44 (0)1283 495280 Fax: 00 44 (0)1283 495290
Email: medinfo@focuspharma.co.uk
Manufacturer
Vianex S.A., Plant A, 12km National Road Athinon-Lamias, Metamorfosi
Attiki, 14451, Greece.
For any information about this medicinal product, please contact the
Marketing Authorisation Holder, details provided above.
This leaflet was last revised in 06/2015.
Other sources of information

For information in large print, audio CD or Braille please
telephone 00 44 (0)1283 495 280 or email
medinfo@focuspharma.co.uk.

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2. What you need to know before you take
Prednisolone Oral Solution

• you have, or have had, a stomach ulcer;
• you have an underactive thyroid gland.
If you have any of the above conditions, your doctor may monitor
you carefully whilst you are taking this medicine.
Using other medicines and Prednisolone Oral Solution
Make sure your doctor or pharmacist knows if you are taking, or
have recently taken, any of the following medicines.
• Rifampicin and rifabutin (antibiotics used to treat tuberculosis):
taking these medicines with prednisolone may stop prednisolone
from working properly.
• Carbamazepine, phenytoin, primidone and phenobarbitone (for
epilepsy): taking these medicines with prednisolone may stop
prednisolone from working properly.
• Ephedrine (a nasal decongestant): taking ephedrine with
prednisolone may stop prednisolone from working properly.
• Aminoglutethimide (anti-cancer treatment): taking this medicine
with prednisolone may stop prednisolone from working properly.
• Mifepristone (used for termination of pregnancy): taking
mifepristone with prednisolone may stop prednisolone from
working properly for several days.
• Erythromycin (an antibiotic, used to treat infections): if taken with
prednisolone, your doctor may need to change your dose of
prednisolone, or you may experience more side effects.
• Ketoconazole (used to treat fungal infections): if taken with
prednisolone, your doctor may need to change your dose of
prednisolone, or you may experience more side effects.
• Ciclosporin (used to prevent rejection after transplants): if taken
with prednisolone, your doctor may need to change your dose
of prednisolone, or you may experience more side effects.
• Ritonavir (for HIV infections): if taken with prednisolone, your
doctor may need to change your dose of prednisolone, or you
may experience more side effects.
• Oestrogen hormones including the contraceptive pill: if taken
with prednisolone, you may experience more side effects and
your doctor may need to change your dose of prednisolone.
• Medicines for diabetics (such as insulin): if taken with
prednisolone, then these medicines may not work properly.
• Medicines used to treat high blood pressure (e.g. hydralazine): if
taken with prednisolone, then these types of medicines may not
work properly.
• Diuretics also known as water tablets (e.g. bendrofluazide): if
taken with prednisolone, then these types of medicine may not
work properly.
• Somatotropin (a growth hormone): if taken with prednisolone,
your medicine may no longer work properly.
• Medicines used to treat myasthenia gravis (muscle weakness),
such as neostigamine: if taken with prednisolone, these
medicines may not work as well.
• Medicines used to make x-rays clearer: if taken with
prednisolone, these medicines may not work as well.
• Anticoagulant medicines which thin the blood (e.g. warfarin and
coumarin): if taken with prednisolone, you may be at an
increased risk of bleeding, therefore your doctor is likely to
monitor you more closely.
• Aspirin and Non-Steroidal Anti-Inflammatory Drugs (e.g
ibuprofen): if taken with prednisolone you may be more likely to
develop ulcers or bleeding from the stomach.
• Salicylates (e.g. Aspirin): if taken with prednisolone you may
experience an increase in side effects of the salicylate once you
stop taking prednisolone.
• Methotrexate (anti-cancer treatment): if taken with prednisolone
you may experience more severe side effects.
In addition, please tell your doctor or pharmacist if you are taking
any of the following medicines, as taking these medicines with
Prednisolone Oral Solution may cause you to have a lower level of
potassium in your blood than normal (hypokalaemia):
• Acetazolamide (used for glaucoma and epilepsy);
• Diuretics also known as water tablets e.g. furosemide and
bendroflumethiazide (used to treat high blood pressure);
• Carbenoxolone (used in the treatment of stomach ulcers);
• Medicines used to treat asthma (e.g. theophylline, bambuterol,
fenoterol, formoterol, ritodrine, salbutamol, salmeterol and terbutaline);
• Amphotericin (used to treat fungal infections).
Vaccinations
If you have recently had, or are planning to have any
vaccinations, tell your doctor before taking Prednisolone Oral
Solution. This is because some injections or vaccinations should not
be given to people who are taking prednisolone.
Please tell your doctor or pharmacist if you are taking, or have
recently taken, any other medicines, including medicines
obtained without a prescription.
Pregnancy and breast-feeding
• If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
nurse for advice before taking this medicine.
Important information about some of the other ingredients in
Prednisolone Oral Solution
Prednisolone Oral Solution contains:
• Sodium methyl parahydroxybenzoate and sodium propyl
parahydroxybenzoate. May cause allergic reactions (possibly
delayed).
• Sodium. The pharmaceutical product contains 3mg of sodium
per 1ml oral solution (10mg prednisolone) and 30mg of sodium
per 10ml of oral solution (100mg prednisolone) daily. To be taken
into consideration by patients on a controlled sodium diet.
Carrying a Steroid card
If you take this medicine for more than three weeks, your doctor or
pharmacist will give you a Steroid Treatment Card with your
prescription or medicine.
• Keep this card with you always.
• Show it to any doctor, dentist, nurse, midwife or anyone else who is
giving you treatment.
• Even after your treatment has finished, tell any doctor, dentist, nurse,
midwife, or anyone else who is giving you treatment that you have
taken steroids.

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Your doctor has decided that you, or your child, need this
medicine to help treat your, or their, condition.
Prednisolone 10mg/ml Oral Solution (called Prednisolone Oral
Solution throughout the rest of this leaflet) contains the active
ingredient prednisolone. Prednisolone belongs to a group of
medicines called steroids (the full name is corticosteroids).
Corticosteroids occur naturally in the body and help to maintain
health and wellbeing. Boosting your body with extra corticosteroid
(such as prednisolone) is an effective way to treat various illnesses
involving inflammation in the body.
Prednisolone Oral Solution reduces this inflammation, which could
otherwise go on making your condition worse. You must take this
medicine regularly to get the maximum benefit from it.
Prednisolone Oral Solution can be used:
• to treat breathing difficulties associated with asthma;
• to treat severe allergic reactions;
• to treat illnesses which cause inflammation of the skin, small and
medium sized arteries, muscles and joints (including rheumatoid
arthritis);
• to treat problems with your immune system, where the immune
system attacks the cells in your body;
• to treat certain kidney problems;
• to treat certain illnesses resulting in inflammation of the bowels
e.g. ulcerative colitis or Crohn’s disease;
• to treat inflammation of the heart;
• to treat problems with your blood including haemolytic anaemia
(a disorder which breaks down red blood cells) and leukaemia;
• to prevent rejection following an organ transplant.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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