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PREDNISOLONE DOMPE 1.0 MG/ML ORAL SOLUTION

Active substance(s): PREDNISOLONE SODIUM PHOSPHATE

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Package leaflet: Information for the patient

Prednisolone 1 mg/ml oral solution
Prednisolone sodium phosphate

Read all of this leaflet carefully before you
start 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 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 get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet.
-- Prednisolone is a steroid medicine, prescribed
for many different conditions, including serious
illnesses.
-- You need to take it regularly to get the
maximum benefit.
-- Do not stop taking this medicine without
talking to your doctor. You may need to reduce
the dose gradually.
-- Prednisolone can cause side effects in
some people (read section 4 below). Some
side effects such as mood changes (feeling
depressed or “high”) or stomach problems can
happen straight away. If you feel unwell in any
way, keep taking your oral solution, but see
your doctor straight away.
-- Some side effects only happen after weeks or
months. These include weakness of arms and
legs or developing a rounder face (read section
4 for more information).
-- Keep away from people who have chicken-pox
or shingles, if you have never had them. They
could affect you severely. If you do come into
contact with chicken-pox or shingles, see your
doctor straight away.
Now read the rest of this leaflet. It includes other
important information on the safe and effective
use of this medicine that may be especially
important for you.
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 take Prednisolone Oral Solution
4. Possible side effects
5. How to store Prednisolone Oral Solution
6. Content of the pack and other information
1. What Prednisolone Oral Solution is and what
it is used for
The full name of your medicine is ‘Prednisolone
1 mg/ml Oral Solution’, but in this leaflet it will be
called ‘Prednisolone Oral Solution’. This medicine
contains the active ingredient prednisolone,
which belongs to a group of medicines called
corticosteroids or “steroids”. Steroids work by
reducing inflammation and lowering the body’s
immune response.
Prednisolone Oral Solution is used to treat a
variety of inflammatory diseases including severe
asthma, rheumatoid arthritis, allergic reactions,
severe skin conditions, and some blood disorders.
Prednisolone – benefit information
Prednisolone belongs to a group of medicines
called steroids. Their full name is corticosteroids.
These corticosteroids occur naturally in the body
and help to maintain health and well-being.
Boosting your body with extra corticosteroids
(such as prednisolone) is an effective way to treat
various illnesses involving inflammation in the
body. Prednisolone reduces this inflammation,
which could otherwise go on making your condition
worse. You must take this medicine regularly to get
maximum benefit from it.
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). Allergic reactions include mild
symptoms such as itching and/or rash. More
severe symptoms include swelling of the face,
lips, tongue and/or throat with difficulty in
swallowing or breathing;
• if you have recently had a vaccination or have a
vaccination planned.
• if you have a viral infection such as measles,
chickenpox or shingles or any other infection.
Tell your doctor immediately if you have
come into contact with anyone suffering with
measles, chickenpox or shingles in the last three
months.
Warnings and precautions
Talk to your doctor of pharmacist before taking
Prednisolone Oral solution, especially if you have,
have ever had or if anyone in your family has
suffered from:
-- severe depression or manic-depressive illness
(bipolar disorder). This includes having had
depression before or while taking steroid
medicines like Prednisolone Oral Solution.
-- TB (tuberculosis);
-- diabetes;
-- epilepsy;
-- depression or other mental illness;
-- an eye disease caused by a rise of pressure
within the eye (glaucoma);
-- thinning of the bones (osteoporosis);
-- muscle problems when steroids were taken
before;
-- stomach ulcers;
-- renal failure, high blood pressure, heart failure
or recently suffered a heart attack;
-- any liver problem;
-- an under-active thyroid (hypothyroidism).
If any of the above applies to you, or if you
are not sure, talk to your doctor or pharmacist
before you use this medicine.

Mental health problems while taking
prednisolone
Mental health problems can occur while taking
steroids like prednisolone (see also section 4,
‘Possible side effects’).
• These illnesses can be severe.
• 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 occur, 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 also
happened when the doses have been lowered or
the medicine stopped altogether.
If you take this medicine for more than three
weeks, you will get a blue ‘steroid card’: always
keep it with you and show it to any doctor or nurse
treating you.
Carrying a Steroid card
Your doctor or pharmacist will have given you a
Steroid Treatment Card with your prescription
or medicine. YOU SHOULD ALWAYS CARRY THIS
CARD WITH YOU as it must be shown to any of the
following persons:
Doctor or Nurse - before having any surgery or
emergency treatment or if any new treatment is
prescribed.
Dentist - before having any dental surgery.
Pharmacist - before buying any medicine.
Optician - it is advisable to have regular eye tests
Other medicines and Prednisolone Oral Solution
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, including medicines obtained without a
prescription.
This is especially important if you are taking:
• Medicines for epilepsy such as carbamazepine,
phenobarbitone, phenytoin or primidone;
• Antibiotics such as rifampicin, erythromycin;
• Mifepristone (used to terminate pregnancy);
• Ritonavir (used in HIV treatment);
• Oral contraceptives;
• Somatropin (used to treat growth problems);
• Medicines for diabetes such as insulin,
glibenclamide or metformin;
• Medicines used to treat high blood pressure,
such as diuretics (water tablets) like
bendroflumethiazide and furosemide;
• Warfarin or other medicines used to thin the
blood;
• Aspirin or similar medicines;
• Theophylline (used to treat asthma);
• Medicines to treat fungal infections such as
amphotericin, ketoconazole;
• Acetazolamide (used to treat glaucoma);
• Carbenoxolone (used to treat stomach ulcers);
• Methotrexate (used for rheumatoid arthritis,
psoriasis and certain types of cancer);
• Any medicine which belongs to a group of
medicines called sympathomimetics;
• Medicines used to treat myasthenia gravis;
• Medicines used to make x-rays clearer;
• Ciclosporin (used to stop the body rejecting
bone marrow or organ transplants).
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 pharmacist for advice before
taking this medicine.
Driving and using machines
This medicine should not affect your ability to
drive or use machines.
Prednisolone Oral Solution contains sucrose,
glycerol and sodium.
This medicine contains 1.5 g of sucrose per dose.
This should be taken into account in patients
with diabetes mellitus. If you have been told by
your doctor that you have an intolerance to some
sugars, contact your doctor before taking this
medicinal product.
This medicine contains glycerol and sodium.

3. How to take Prednisolone Oral Solution
Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure.
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It is best to take the oral solution undiluted.
The solution should be taken by mouth.
Shake well before use.
If you are on long-term therapy, make sure your
supply of oral solution does not run out.
Since opening many containers in the same
day could lead to dosing errors, the 5 ml
presentation is suitable for treatments not
exceeding 30 mg daily. The dosage depends on
the condition being treated and, for an adult,
can vary widely between 10 mg and 30 mg daily
in divided doses. Your doctor will give you the
smallest dose that works for your condition.
When you need to take more than two units
all at once, each opened unit should be placed
on a tray or suitable surface after opening
and dispensing the content. This can help you
avoiding dosing errors due to losing count.
The package contains a measuring spoon dosing
3.75 ml, 2.5 ml and 1.25 ml corresponding to
partial doses.
All opened units should be discarded once the
required dose is removed.

Instructions for use
1. Flex the single-dose
container in the two
directions (see figure A).
2. Separate the single-dose
container from the
strip (see figure B).
3. Turn the cap counter
clockwise as indicated in figure C.
4. Apply mild pressure on the
container to dispense the medicine
as prescribed (see figure D). For the
dose of 5 ml, drink the full amount
of the single-dose container. In case
a partial dose has to be dispensed,
the measuring spoon included in the
package should be used to dispense
1.25 ml, or 2.5 ml, or 3.75 ml (see
figure E).
5. After administering a partial dose,
the opened container must be
discarded.
Use in children
To treat acute asthma attacks, your child’s doctor
may prescribe:
• For children younger than 2 years old, 10 mg
daily, for up to three days;
• For children 2 to 5 years old, 20 mg daily.
Treatment for up to three days is usually
sufficient, but the length of the course will be
decided by your doctor, according to the number
of days necessary to recover.
• For children older than 5 years old, 30 mg daily
or more (up to 40 mg daily). Since opening many
containers in the same day could lead to dosing
errors, in case more than 30 mg daily have been
prescribed, ask your child’s doctor, as a different
prednisolone presentation (e.g. high dosage
tablets) might be more appropriate.
If you have the impression that the effect of this
medicine is too strong or too weak, talk to your
doctor or pharmacist.
If you take more Prednisolone Oral Solution than
you should
If you take more Prednisolone Oral Solution than
prescribed, contact your doctor or nearest hospital
emergency department immediately. Take this
leaflet and/or the package with you to show the
doctor what you have taken.

If you forget to take Prednisolone Oral Solution
If you forget to take Prednisolone Oral Solution,
take the next dose as soon as you remember unless
it is almost time for your next dose. Do not take a
double dose to make up for a forgotten dose.
If you stop taking Prednisolone Oral Solution
Talk to your doctor if you want to stop taking the
oral solution – your doctor may want to reduce your
dose gradually.
Do not stop taking the oral solution unless you
have been told to do so by your doctor, even if
you feel better, as it can make you ill. If you stop
taking the oral solution suddenly, this can cause
withdrawal symptoms such as fever, sickness, pain
in the muscles and joints, runny nose, sore, red
and sticky eyes (conjunctivitis), itchy skin and
weight loss.
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.
Steroids including prednisolone can cause severe
mental health problems, such as those listed
below. These are common in both adults and
children. They can affect about 5 in every 100
people taking medicines like prednisolone. If you
notice any of these problems talk to a doctor
immediately:
• Feeling depressed, including thinking about
suicide.
• Feeling high (mania) or having moods that go up
and down.
• Feeling anxious, having problems sleeping,
having difficulty in thinking or being confused
and losing your memory.
• Feeling, seeing or hearing things which do
not exist (hallucinations). Having strange and
frightening thoughts, changing how you act or
having feelings of being alone.
The following side effects may be signs of an
allergic reaction. If you notice any of the below,
stop taking Prednisolone Oral Solution and tell
your doctor immediately:
• itching or skin rashes;
• swelling of the face, lips or throat;
• difficulty in breathing or wheeziness.
The following side effects can occur if steroids are
given in high doses for a long time:
• generally feeling unwell;
• feeling sick (nausea);
• hiccups;
• indigestion or stomach discomfort;
• stomach ulcer (which can rupture and bleed) or
ulcer in the oesophagus (gullet);
• thrush;
• inflammation of the pancreas causing abdominal
pain (pancreatitis);
• muscle weakness;
• muscle pain;
• thinning of bones which makes fractures more
likely (osteoporosis);
• damage to tendons;
• joint stiffness causing limited movement, pain
and muscle spasms;
• fluid retention causing swelling;
• feeling dehydrated;
• high blood pressure (hypertension);
• slow healing of wounds, thinning of the skin,
bruising, acne, marks which look like stretch
marks;
• small red, purple or blue spots found along the

surface of the skin (caused by blood vessels
under the skin);
• low adrenal gland function;
• slowed growth in infants, children and
teenagers;
• irregular or stopped menstrual periods;
• swollen round face (Cushingoid facies or moonface);
• excess hair growth;
• increased appetite and weight gain;
• intolerance to carbohydrates;
• mood changes, dependence, depression,
difficulty sleeping, worsening of schizophrenia;
• severe headaches with blurred vision or
temporary visual problems in children (usually
after stopping treatment);
• worsening of epilepsy;
• raised pressure in the eyes (glaucoma),
cataracts, thinning and inflammation of the
cornea (part of the eye), worsening of viral or
fungal eye diseases and visual impairment;
• heart attack (sudden severe chest pains);
• changes in body chemistry;
• an increase in the number of while blood cells;
• formation of blood clots;
• long-term use of high dose steroids, may lead to
a weakening of the immune system, which can
increase the risk of your condition getting worse
(malignancy).
Kaposi’s sarcoma (a type of cancer) has also
been reported to occur in patients receiving
corticosteroids. However, once the treatment has
been stopped, this may go away.
This medicine can make it easier for you to pick
up infections which may very rarely be fatal.
Infections such as chickenpox and measles can be
made worse or TB (tuberculosis) may recur.
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.
Store your oral solution in a safe place below 30°C.
Store in the original package.
Do not use this medicine after the expiry date
which is stated on the packet, after “use by”. The
expiry date refers to the last day of that month.
Container for single-use only. Once opened you
must discard any unused solution.
Do not throw away any medicine via wastewater
of household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.
6. Contents of the pack and other information
What Prednisolone Oral Solution contains
-- The active substance is prednisolone (as sodium
phosphate). One (1) ml of oral solution contains
1 mg prednisolone (as sodium phosphate).
-- The other ingredients are: sucrose, glycerol,
edetate disodium (EDTA), disodium phosphate
anhydrous, sodium dihydrogen phosphate
monohydrate, vanilla/cream flavour, honey
flavour, masking flavour, purified water.
What Prednisolone Oral Solution looks like and
contents of the pack
Prednisolone Oral Solution is a clear, light brown,
homogeneous solution.
It is available in single-dose polyethylene
containers. One container has 5 ml of oral solution.
Containers are grouped in strips of five. Each strip
is packaged in a PET/Al/PE over-pouch. Each unit
carton contains two over-pouches (ten singledoses), a measuring spoon (dosing 3.75 ml, 2.5 ml
and 1.25 ml, corresponding to partial doses) and a
patient leaflet.
Pack size of 10 single-dose containers.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Dompé farmaceutici S.p.A.
Via San Martino 12
20122 Milano - Italia
Manufacturer
GENETIC SpA – Contrada Canfora – Nucleo
Industriale 84084 Fisciano- Salerno (Italy)
This leaflet was last revised in 11/2014

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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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