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PREDNISOLONE 5MG SUPPOSITORIES

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

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PAGE 2

Version No.:
Product Name:

LF-102166-01

Revision No.:
Revision Date:
Revised by:
CRF:

Prednisolone 5mg
Suppositories
10 Suppositories
Leaflet
103482
UK
Haupt Pharma Livron
Sas
2
04/04/2017
ADD
PR 9396

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref:
DCMF:
Print Colours:

210 x 157 mm
54000030
N/A
N/A
N/A
302 C

Pack Size:
Component:
SKU:
Market:
Production Site:

Non-Print Colours: Cutter
Tech App. Date:
Min. Font Size:

13/02/2017
9 pt

LF-102166-01

Additional care should be taken if this
• Higher blood pressure
• Increased pressure in the eye (glaucoma)
• Cataracts
• Worsening of viral or fungal eye diseases
• Thinning of the cornea or sclera (the outer
wall of the eye)
• Detachment of the retina
• Headaches or blurred vision
• Wasting of muscles
• 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
• If you have recently had a heart attack,
prednisolone can cause the tissues of the
heart to tear
• Severe stomach pain
• Stomach ulcers which may bleed
• Irregular menstrual periods
• Acne or extra hair growth
• Weight gain or increased appetite
• Increased risk of infection
• Water retention
• Low levels of potassium in your blood
• Bruising or poor wound healing
• Inflammation of the skin, abscesses or
changes in skin colour
• Separation of the top layer of the skin from
the lower skin layers
• Blood clots
• Changes in blood test results for lipids (e.g.
cholesterol)
• Thrush in the mouth or throat
• Feeling sick, hiccups, heartburn or indigestion
• Fungal infection (candidiasis)
• Loss of blood to your bones (avascular
osteonecrosis)
• Bone fractures.

This leaflet was last revised in 03/2017.
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 label. The expiry date
refers to the last day of that month.
Store below 25ºC and keep the suppositories in
the outer carton to protect from light.
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 protect
the environment.
5. How to store Prednisolone 5mg Suppositories
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.
• slowed growth in adolescence
• symptoms of blurred vision, seizures, lethargy,
vomiting or behavioral changes. These could
be signs of condition known as increased
intracranial pressure.
Additional side effects in children and
adolescents
medicine is given to elderly patients, as side
effects may be more serious.

Scottish Office of Home and Health.

Carrying your steroid card
• If your doctor asks you to carry a steroid
card, be sure to keep it 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 had steroid treatment.
• A steroid card may be obtained from
your doctor, pharmacist or local Family
Health Service Authority. In Scotland,
steroid cards are available from the
- The other ingredient is Witepsol H15 (hard fat).
What Prednisolone Suppositories look like and
contents of the pack
Prednisolone Suppositories are cream
coloured, large oval shaped suppositories. They
come in packs of 10.
Marketing Authorisation Holder
Focus Pharmaceuticals Limited, Capital House,
85 King William Street, London EC4N 7BL, UK.
Manufacturer
Haupt Pharma Livron, 1, rue Comte de Sinard,
F- 26 250 Livron, France.
- The active substance is prednisolone
sodium phosphate (5mg). One suppository
contains 5mg prednisolone as the sodium
phosphate ester
What Prednisolone Suppositories contains
6. Contents of the pack and other information

Talk to your doctor if:
• You have or have ever had tuberculosis (TB)
• You have epilepsy (fits), severe mental illness,
hypertension (high blood pressure),
osteoporosis (thinning of the bones), stomach
or duodenal ulcers
• You or any of your family have ever had
glaucoma (raised eye pressure)
• You have recently had a heart attack
• You have recently been in contact with
someone who has chickenpox, shingles or
measles or recently had chickenpox, shingles
or measles yourself. This product may make
chickenpox, shingles or measles much worse
• You are diabetic
• You have an underactive thyroid gland
• You have ever suffered from muscle wasting
due to corticosteroids
• You have liver, kidney or heart disease
• You have just been or are about to be
immunised
• You have myasthenia gravis (an illness that
causes you to have weak muscles)
• You have a bowel disease where you have
bloody diarrhoea
• You have diverticulitis (a digestive disease)
• You have stomach problems
• You have an infection.
If any of the above applies to you, talk to your
doctor before using Prednisolone Suppositories.
Other medicines and Prednisolone
Suppositories
using steroid medicines like Prednisolone
Suppositories
• If any of your close family has had these
illnesses.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
using Prednisolone Suppositories.

Tell your doctor 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 Suppositories and your doctor
may wish to monitor you carefully if you are
taking these medicines (including some
medicines for HIV: ritonavir, cobicistat)
• Medicines to thin your blood (e.g. Warfarin or
Aspirin)
• Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs) (e.g. Ibuprofen or Aspirin)
• Antibiotics (e.g. fluoroquinolones, rifabutin or
erythromycin)
• Medicines to treat diabetes (e.g. insulin)
• Medicines to treat epilepsy (e.g.
carbamazepine, phenytoin, primidone or
phenobarbital)
• Medicines to treat a fungal infection (e.g.
amphotericin or ketoconazole)
• Medicines to lower your blood pressure (e.g.
hydralazine)
• Water tablets (e.g. bendrofluazide)
• Medication that contains oestrogen (e.g.
contraceptives, hormone replacements)
• Medicines for your heart (e.g. digoxin)
• Medicines to treat cancer (e.g. methotrexate
or aminoglutethimide)
• Medicines to suppress your immune system
(e.g. ciclosporin)
• Mifepristone (used for termination of
pregnancy)
• Medicines to treat myasthenia gravis (e.g.
anticholinesterases)
• Medicines that contain liquorice
• Medicines used to cause paralysis during
operations (e.g. neuromuscular blockers)
• Human growth hormone called somatropin
• Medicines for asthma (e.g. bambuterol,
salbutamol, salmeterol or theophylline)

Tell your doctor immediately if you suspect you
may have come into contact with a person
who has chickenpox, shingles or measles.
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 using this medicine.
• Medicines to treat ulcers (e.g.
carbenoxolone)
• Any other medicine, including medicines
obtained without a prescription
If any of the above applies to you, talk to your
doctor or pharmacist.
Mental problems while using Prednisolone
Suppositories
Mental health problems can happen while
using steroids like Prednisolone Suppositories
(see also section 4).
• 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 who is using
this medicine), shows any signs of mental
problems. This is particularly important if you are
depressed or might be thinking about suicide.
In a few cases, mental problems have
happened when doses are being lowered or
stopped.
Chickenpox, shingles or measles
You should avoid contact with anyone who
has either chickenpox, shingles or measles as it
could be extremely serious if you caught it from
them.

REGULATORY AUTHORITY
APPROVAL CONFIRMATION

Package leaflet: Information for the user

Prednisolone 5mg
Suppositories

Prednisolone Sodium Phosphate
• Prednisolone 5mg Suppositories is a
steroid medicine, prescribed for many
different conditions, including serious
illnesses.
• You need to use it regularly to get the
maximum benefit.
• Don’t stop using this medicine without
talking to your doctor – you may need
to reduce the dose gradually.
• Prednisolone 5mg Suppositories can
cause side effects in some people
(read section 4 on side effects below).
Some problems such as mood changes
(feeling depressed or ‘high’) or
stomach problems can happen straight
away. If you feel unwell in any way,
keep using your medicine, 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 on side effects for more
information).
• If you use it for more than 3 weeks, you
will get a blue ‘steroid card’: always
keep it with you and show it to any
doctor or nurse treating you.

• Keep away from people who have
chickenpox or shingles, if you have
never had them. They could affect you
severely. If you do come into contact
with chickenpox 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 might be especially
important for you.
Read all of this leaflet carefully before you start
using 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
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, 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 5mg Suppositories are
and what they are used for
2. What you need to know before you use
Prednisolone 5mg Suppositories
3. How to use Prednisolone 5mg
Suppositories
4. Possible side effects
5. How to store Prednisolone 5mg Suppositories
6. Contents of the pack and other information
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1. What Prednisolone 5mg Suppositories are
and what they are used for
Prednisolone 5mg Suppositories (called
Prednisolone Suppositories throughout the rest
of this leaflet) 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
Suppositories) is an effective way to treat
various illnesses involving inflammation in the
body. Prednisolone Suppositories reduces this
inflammation, which could otherwise go on
making your condition worse. You must use this
medicine regularly to get the maximum
benefit.
Prednisolone Suppositories are used to reduce
tenderness, heat and swelling in the following
conditions where the bowel becomes
inflamed:
• haemorrhagic and granular proctitis
• Crohn’s disease.
2. What you need to know before you use
Prednisolone 5mg Suppositories
Do not use Prednisolone Suppositories:
• if you are allergic to Prednisolone sodium
phosphate or any of the other ingredients of
this medicine (listed in section 6).
If any of the above applies to you talk to your
doctor or pharmacist.
Check with your doctor first:
• If you have ever had severe depression or
manic depression (bipolar disorder). This
includes having had depression before while

3. How to use Prednisolone 5mg Suppositories
Always use this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Important:
Your doctor will choose the dose that is right for
you. Your dose will be shown clearly on the
label that your pharmacist puts on your
medicine. If it does not or you are not sure, ask
your doctor or pharmacist.
• When using this medicine you should follow
the instructions given by your doctor. The
usual dose is outlined below
• One suppository should be used each night
and one in the morning after emptying your
bowels
• Treatment usually continues for some months
and may be restarted if symptoms flare up
again after stopping, if your doctor thinks it
appropriate.
Instructions on how to use Prednisolone
Suppositories
1. Empty your bowels and wash your hands.
2. Unwrap a suppository.
3. Gently insert the suppository into your back
passage and allow it to dissolve.
4. Wash your hands.
While you are using this medicine, your doctor
may ask you to have check-ups. These are to
make sure that your medicine is working
properly and that the dose you are using is right
for you.
If you use more Prednisolone Suppositories than
you should
Do not use more Prednisolone Suppositories
than you should. If you accidentally use two
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PAGE 1

suppositories within a shorter period of time
than prescribed by your doctor, let your doctor
know.
If you forget to use Prednisolone Suppositories
If you forget to use your suppository, contact
your doctor who will tell you what to do. If you
only remember at the time of your next
suppository, use a single suppository and
continue as usual. Do not use a double dose to
make up for a forgotten dose.
If you stop using Prednisolone Suppositories
Do not stop using Prednisolone Suppositories
without first talking to your doctor.
It is very important that you do not suddenly
stop using Prednisolone Suppositories even if
you feel better, unless your doctor tells you to. If
you stop using your medicine too suddenly, you
may suffer from some of the following: Fever,
joint and muscle pain, itching eyes, nose or
skin, mood changes, loss of weight, low
hormone levels and low blood pressure,
symptoms of which may include dizziness,
headaches or fainting. In extreme cases this
can be fatal. Your doctor will tell you how to
stop using Prednisolone Suppositories.
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.
Serious effects: Tell a doctor straight away
Steroids including Prednisolone can cause
serious mental health problems. These are
common in both adults and children. They can
affect about 5 in every 100 people using
medicines like Prednisolone.

PAGE 3

• Feeling depressed, including thinking about
suicide
• Feeling high (mania) or moods that go up
and down
• Feeling anxious, having problems sleeping,
difficulty in thinking or being confused and
losing your memory
• Feeling, seeing or hearing things which do
not exist. Having strange and frightening
thoughts, changing how you act or having
feelings of being alone.
In addition, if you experience any of the
following side effects whilst using 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), shock
and feeling faint. If the swelling affects your
throat and makes breathing and swallowing
difficult, go to hospital straight away
• Serious skin reactions involving severe
blistering and peeling of the skin
• Symptoms of fever, bruising, bleeding, feeling
dizzy, sweating, trouble breathing, thinking, or
tingling in your arms, legs or gut. These could
be signs of a condition known as leucocytosis
• Symptoms of nausea, diarrhoea, indigestion,
high temperature, yellowing of skin or
swelling around your stomach. This could be
a sign of acute pancreatitis.
Other side effects are:
Not known: frequency cannot be estimated
from the available data
• Worsening of tuberculosis (TB), epilepsy or
schizophrenia if you already have any of
these problems
• Thinning of the bones (osteoporosis)
• Prominent veins or thinning of the skin

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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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