Skip to Content

PREDNISOLONE 10MG/ML ORAL SOLUTION

Active substance(s): PREDNISOLONE SODIUM PHOSPHATE / PREDNISOLONE SODIUM PHOSPHATE / PREDNISOLONE SODIUM PHOSPHATE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the user

Prednisolone 10mg/ml Oral Solution
(prednisolone sodium phosphate)
This medicine is available as the above name but will be referred to as Prednisolone Oral
Solution throughout the remainder of this leaflet.
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, pharmacist or nurse.
 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, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
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
Your doctor has decided that you or your child, need this medicine to help treat your or their
condition.
Prednisolone Oral Solution 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.
2. What you need to know before you take Prednisolone Oral Solution
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.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Prednisolone Oral Solution:
 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.
Contact your doctor if you experience blurred vision or other visual disturbances.
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:
 if you have or have ever had, tuberculosis (TB) or blood poisoning (septicaemia);
 if you have liver or kidney problems;
 if you have high blood pressure (or a family history of high blood pressure), heart
disease or you have recently had a heart attack;
 if you have or have a family history of the following:
o diabetes
o osteoporosis
o glaucoma (raised eye pressure)
o epilepsy (fits)

 if you have ever previously suffered from muscle weakness when using prednisolone or
any other steroids in the past;
 if you have or have had a stomach ulcer;
 if 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.
Other medicines and Prednisolone Oral Solution
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
 Some medicines may increase the effects of Prednisolone Oral Solution and your
doctor may wish to monitor you carefully if you are taking these medicines
(including some medicines for HIV: ritonavir, cobicistat).
 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.
 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 neostigmine:
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.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.
Prednisolone Oral Solution contains sodium methyl parahydroxybenzoate, sodium
propyl parahydroxybenzoate and sodium:
 Sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate. May
cause allergic reactions (possibly delayed).
 Sodium. This medicinal product contains 3mg of sodium per 1 ml 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.
3. How to take Prednisolone Oral Solution
Always take this medicine exactly as your doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure. These instructions will have been added to
the dispensing label by your pharmacist.
Your doctor will decide on the most appropriate dose to treat you or your child.
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.

 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.

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

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.
Use in children and adolescents
 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.
Method of administration: For oral use only.
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 a double dose 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, pharmacist
or nurse.
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:
Not known: frequency cannot be estimated from the available
 if you have had tuberculosis in the past, it may return
 you may get infections more easily than usual
 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
 blurred vision
Additional side effects in 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, pharmacist or nurse. 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 which is stated on the carton and label
after EXP. The expiry date refers to the last day of that month.
 Store in a refrigerator (2°C - 8°C). Store in the original package in order to protect from
light.
 Once opened: Do not store above 25°C and use within 3 months.
 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 Oral Solution contains
 The active ingredient is prednisolone. Each 1ml of 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
(contains propylene glycol) and purified water (see section 2 What you need to know
before you take Prednisolone Oral Solution).
What Prednisolone Oral Solution looks like and contents of the pack
Prednisolone Oral Solution is a clear colourless to yellowish oral solution with a
characteristic odour of orange. It is available in an amber glass bottle with a child-resistant
cap containing 30ml of medicine. The pack also contains a 5ml plastic oral dosing syringe
and syringe/bottle adaptor.
PL: 15814/1310

POM

Prednisolone Oral Solution is manufactured by Vianex S.A., Plant A, 12km National Road
Athinon-Lamias, Metamorfosi Attiki, 144 51, Greece.
Procured from within the EU and repackaged by the Product Licence holder:
O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 11.07.2017.

To request a copy of this leaflet in Braille, large
print or audio please call 01923 332 796.

Expand Transcript

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.

Hide