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PREDNISOLONE DOMPE 1.0 MG/ML ORAL SOLUTION

Active substance(s): PREDNISOLONE SODIUM PHOSPHATE / PREDNISOLONE SODIUM PHOSPHATE / 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
• These illnesses can be severe.
taking this medicine because it contains important
• Usually they start within a few days or weeks of
information for you.
starting the medicine.
-- Keep this leaflet. You may need to read it again.
• They are more likely to happen at high doses.
-- If you have any further questions, ask your doctor or • Most of these problems go away if the dose is
pharmacist.
lowered or the medicine is stopped. However, if
-- This medicine has been prescribed for you only. Do
problems do occur, they might need treatment.
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
Talk to a doctor if you (or someone taking this
-- If you get any side effects, talk to your doctor or
medicine) show any signs of mental health problems.
pharmacist. This includes any possible side effects
This is particularly important if you are depressed or
not listed in this leaflet.
might be thinking about suicide. In a few cases, mental
health problems have also happened when the doses
-- Prednisolone is a steroid medicine, prescribed
have been lowered or the medicine stopped altogether.
for many different conditions, including serious
illnesses.
Talk to a doctor if blurred vision, difficulty in reading
-- You need to take it regularly to get the maximum
or any other change in vision occurs during or after
benefit.
treatment.
-- Do not stop taking this medicine without talking
to your doctor. You may need to reduce the dose
Regular checkups with doctors (including vision
gradually.
checkups in three month-intervals) are advised during
-- Prednisolone Dompé can cause side effects in some
long term treatment.
people (read section 4 below). Some side effects
such as mood changes (feeling depressed or “high”) “If you take this medicine for more than three
or stomach problems can happen straight away. If
weeks, you will get a blue ‘steroid card’: always keep
you feel unwell in any way, keep taking your oral
it with you and show it to any doctor or nurse treating
solution, but see your doctor straight away.
you.”
-- Some side effects only happen after weeks or
months. These include weakness of arms and legs or Carrying a Steroid card
developing a rounder face (read section 4 for more
Your doctor or pharmacist will have given you a Steroid
information).
Treatment Card with your prescription or medicine.
-- Keep away from people who have chicken-pox or
YOU SHOULD ALWAYS CARRY THIS CARD WITH YOU as it
shingles, if you have never had them. They could
must be shown to any of the following persons:
affect you severely. If you do come into contact with Doctor or Nurse - before having any surgery or
chicken-pox or shingles, see your doctor straight
emergency treatment or if any new treatment is
away.
prescribed.
Now read the rest of this leaflet. It includes other
Dentist - before having any dental surgery.
important information on the safe and effective use
Pharmacist - before buying any medicine.
of this medicine that may be especially important for
Optician - it is advisable to have regular eye tests
you.
Other medicines and Prednisolone Dompé Oral
Solution
What is in this leaflet
Tell your doctor or pharmacist if you are taking, have
1. What Prednisolone Dompé Oral Solution is and
what it is used for
recently taken or might take any other medicines,
2. What you need to know before you take
including medicines obtained without a prescription.
Prednisolone Dompé Oral Solution
This is especially important if you are taking:
3. How to take Prednisolone Dompé Oral Solution
• Medicines for epilepsy such as carbamazepine,
4. Possible side effects
phenobarbitone, phenytoin or primidone;
5. How to store Prednisolone Dompé Oral Solution
• Antibiotics such as rifampicin, erythromycin;
6. Content of the pack and other information
• Mifepristone (used to terminate pregnancy);
• Ritonavir (used in HIV treatment);
• Oral contraceptives;
1. What Prednisolone Dompé Oral Solution is and
• Somatropin (used to treat growth problems);
what it is used for
• Medicines for diabetes such as insulin, glibenclamide
or metformin;
The full name of your medicine is ‘Prednisolone Dompé
• Medicines used to treat high blood pressure, such
1.0 mg/ml Oral Solution’, but in this leaflet it will
as diuretics (water tablets) like bendroflumethiazide
be called ‘Prednisolone Dompé Oral Solution’. This
and furosemide;
medicine contains the active ingredient prednisolone,
• Warfarin or other medicines used to thin the blood;
which belongs to a group of medicines called
• Aspirin or similar medicines;
corticosteroids or “steroids”. Steroids work by
reducing inflammation and lowering the body’s immune • Theophylline (used to treat asthma);
response.
• Medicines to treat fungal infections such as
amphotericin, ketoconazole;
Prednisolone Dompé Oral Solution is used to treat
• Acetazolamide (used to treat glaucoma);
a variety of inflammatory diseases including severe
• Carbenoxolone (used to treat stomach ulcers);
asthma, rheumatoid arthritis, allergic reactions, severe • Methotrexate (used for rheumatoid arthritis,
skin conditions, and some blood disorders.
psoriasis and certain types of cancer);
• Any medicine which belongs to a group of medicines
Prednisolone Dompé – benefit information
called sympathomimetics;
Prednisolone Dompé belongs to a group of medicines
• Medicines used to treat myasthenia gravis;
called steroids. Their full name is corticosteroids.
• Medicines used to make x-rays clearer;
These corticosteroids occur naturally in the body and
• Ciclosporin (used to stop the body rejecting bone
help to maintain health and well-being. Boosting your
marrow or organ transplants).
body with extra corticosteroids (such as prednisolone)
is an effective way to treat various illnesses involving
Pregnancy and breastfeeding and fertility
inflammation in the body. Prednisolone Dompé reduces If you are pregnant or breastfeeding, think you may
this inflammation, which could otherwise go on making be pregnant or are planning to have a baby, ask your
your condition worse. You must take this medicine
doctor or pharmacist for advice before taking this
regularly to get maximum benefit from it.
medicine.
2. What you need to know before you take
Prednisolone Dompé Oral Solution
Do not take Prednisolone Dompé 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.
• If you have a tropical worm infections
• If you have systemic fungal infections
Warnings and precautions
Talk to your doctor of pharmacist before taking
Prednisolone Dompé 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 Dompé 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’).

Pregnancy
During pregnancy treatment should only be initiated
after a careful benefit/risk assessment has been
performed. Because growth retardation and damage to
the unborn child cannot be excluded upon prolonged
treatment with glucocorticoids during pregnancy,
please inform your doctor if you want to become
pregnant, are already pregnant or if you are assuming
that you are pregnant.
Breastfeeding
Glucocorticoids, such as Prednisolone Dompé 1,0 mg/
ml oral solution pass into breast milk. Damage to the
infant is not reported to date. Nevertheless, when
high doses of prednisolone are given you should avoid
breast-feeding for 4 h after a dose. Please consult your
doctor.
Fertility
After high prednisolone doses (30 mg/day for at least 4
weeks) reversible disturbances of spermatogenesis has
been observed, which lasted for several months after
stop taking the medicine.
Driving and using machines
This medicine should not affect your ability to drive or
use machines.
Prednisolone Dompé Oral Solution contains sucrose
and glycerol.
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.
3. How to take Prednisolone Dompé Oral Solution
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
- It is best to take the oral solution undiluted.
- The solution should be taken by mouth.
- The solution should preferably be taken as a single
dose in the morning. However, divided daily dosage
may be employed if required

BIANCA / FRONT

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Dompé

QUALITY SYSTEM - ISO 9001:2008

PRODUCT NAME:

INS-Prednisolone 1mg/ml
PRODUCT CODE:

ZDMP085

ISSUE DATE

OPERATOR

19/09/16 RI001

COUNTRY: UK
SEPARATIONS:

DRAFT

01

FONT TYPE: Trebouchet MS
Size: 9 - Spacing: 9,3

( BLACK )
MEASURES (mm): 160 x 450
MATERIAL: XX
g/sq.mt: XXX

Licence: PL32162/0001

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Aprilia (LT) tel. +39 06 92732420 produzione@grafifarma.it
Robecco s/N (MI) tel. +39 02 94974002 milano@grafifarma.it
Ricordiamo che il risultato cromatico delle stampe potrà essere diverso in funzione del supporto e della tecnica utilizzata. We
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EURPACK GRAFIFARMA GRAFIFLEX Srl, termina con l’approvazione del seguente documento. EURPACK GRAFIFARMA GRAFIFLEX’s
responsability ends with the approval of the present document. - Vietato l’utilizzo del presente tassello di informazioni se non
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- In children, the medicine should preferably be taken
as a single dose on alternate days.
- 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, this 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 loss of 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.

• 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);
Instruction for use
• slow healing of wounds, thinning of the skin,
1. Flex the single-dose container in the two directions
bruising, acne, marks which look like stretch marks;
(see figure A).
• small red, purple or blue spots found along the
surface of the skin (caused by blood vessels under
2. Separate the single-dose container from the strip
the skin);
(see figure B).
• low adrenal gland function;
3. Turn the cap counter clockwise as indicated in figure • slowed growth in infants, children and teenagers;
• irregular or stopped menstrual periods;
C.
• swollen round face (Cushingoid facies or moon-face);
4. Apply mild pressure on the container to dispense the • excess hair growth;
medicine as prescribed (see figure D). For the dose • increased appetite and weight gain;
of 5 ml, drink the full amount of the single-dose
• intolerance to carbohydrates;
container. In case a partial dose has to be dispensed, • mood changes, dependence, depression, difficulty
the measuring spoon included in the package should
sleeping, worsening of schizophrenia;
be used to dispense 1.25 ml, or 2.5 ml, or 3.75 ml
• severe headaches with blurred vision or temporary
(see figure E).
visual problems in children (usually after stopping
treatment);
5. After administering a partial dose, the opened
• worsening of epilepsy;
container must be discarded.
• 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, choroid and retinal disorders
(chorioretinopathy);
• heart attack (sudden severe chest pains);
• changes in body chemistry;
• an increase in the number of while blood cells;
• formation of blood clots;
• porphyria;
• Steven-Johnson syndrome;
• 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).
E

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 Dompé Oral Solution
than you should
If you take more Prednisolone Dompé 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 Dompé Oral
Solution
If you forget to take Prednisolone Dompé 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 Dompé 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.

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 Dompé 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
discarded 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 Dompé 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, Water for injections.

What Prednisolone Dompé Oral Solution looks like
and contents of the pack
Prednisolone Dompé Oral Solution is a clear, light
brown, homogeneous solution.
4. Possible side effects
It is available in single-dose polyethylene containers.
Like all medicines, this medicine can cause side effects, One container has 5 ml of oral solution. Containers are
grouped in strips of five. Each strip is packaged in a
although not everybody gets them.
PET/Al/PE over-pouch. Each unit carton contains two
over-pouches (ten single-doses), a measuring spoon
Steroids including prednisolone can cause severe
(dosing 3.75 ml, 2.5 ml and 1.25 ml, corresponding to
mental health problems, such as those listed below.
partial doses) and a patient leaflet.
These are common in both adults and children. If
Pack size of 10 single-dose containers.
you notice any of these problems talk to a doctor
immediately:
• Feeling depressed, including thinking about suicide. Marketing Authorization Holder and Manufacturer
• Feeling high (mania) or having moods that go up and Marketing Authorisation Holder
Dompé farmaceutici S.p.A.
down.
Via San Martino 12
• Feeling anxious, having problems sleeping, having
20122 Milano - Italy
difficulty in thinking or being confused and losing
your memory.
Manufacturer
• Feeling, seeing or hearing things which do not exist
GENETIC SpA – Contrada Canfora – Nucleo Industriale
(hallucinations). Having strange and frightening
thoughts, changing how you act or having feelings of 84084 Fisciano- Salerno (Italy)
being alone.
The following side effects may be signs of an allergic This leaflet was last revised in 10/2016
reaction. If you notice any of the below, stop taking
Prednisolone Dompé Oral Solution and tell your
doctor immediately:
• itching or skin rashes;
ZDMP085

VOLTA / BACK

ARTWORK

PDF 1.5

Realized by:

THIS ARTWORK IS PROPERTY OF:

Dompé

QUALITY SYSTEM - ISO 9001:2008

PRODUCT NAME:

INS-Prednisolone 1mg/ml
PRODUCT CODE:

ZDMP085

ISSUE DATE

OPERATOR

19/09/16 RI001

COUNTRY: UK
SEPARATIONS:

DRAFT

01

FONT TYPE: Trebouchet MS
Size: 9 - Spacing: 9,3

( BLACK )
MEASURES (mm): 160 x 450
MATERIAL: XX
g/sq.mt: XXX

Licence: PL32162/0001

EURPACK Grafifarma Grafiflex
Aprilia (LT) tel. +39 06 92732420 produzione@grafifarma.it
Robecco s/N (MI) tel. +39 02 94974002 milano@grafifarma.it
Ricordiamo che il risultato cromatico delle stampe potrà essere diverso in funzione del supporto e della tecnica utilizzata. We
remind you that prints chromatic results could be different depending on support and used technique. - La responsabilità della
EURPACK GRAFIFARMA GRAFIFLEX Srl, termina con l’approvazione del seguente documento. EURPACK GRAFIFARMA GRAFIFLEX’s
responsability ends with the approval of the present document. - Vietato l’utilizzo del presente tassello di informazioni se non
espressamente autorizzato dalla EURPACK GRAFIFARMA GRAFIFLEX Srl. It is forbidden the use of the present information if not
officially allowed from EURPACK GRAFIFARMA GRAFIFLEX Srl.
v.01-2013

CLIENT APPROVAL
DATE

SIGNATURE

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.

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