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PREDNISOLONE 1 MG GASTRO-RESISTANT TABLETS

Active substance(s): PREDNISOLONE

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PATIENT INFORMATION LEAFLET
Deltacortril® 1mg Gastro-resistant Tablets
prednisolone
Deltacortril Leaflet – Headlines









Deltacortril is a steroid medicine, prescribed for many different
conditions, including serious illnesses.
You need to take it regularly to get the maximum benefit.
Don’t stop taking this medicine without talking to your doctor – you may
need to reduce the dose gradually.
Deltacortril can cause side effects in some people (read Section 4
Possible 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 taking your tablets, 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
Possible Side Effects for more information)
If you take 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. This leaflet was last revised: July 2016.
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. See section 4.

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What is in this leaflet:
1. What Deltacortril is and what it is used for
2. What you need to know before you take Deltacortril
3. How to take Deltacortril
4. Possible side effects
5. How to store Deltacortril
6. Contents of the pack and other information

1. What Deltacortril is and what it is used for
Deltacortril 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 corticosteroid
(such as Deltacortril) is an effective way to treat various illnesses involving
inflammation in the body. Deltacortril reduces this inflammation, which could
otherwise go on making your condition worse. You must take this medicine
regularly to get maximum benefit from it.
Deltacortril is used in a wide range of inflammatory and auto-immune
conditions including:








allergies, including severe allergic reactions
inflammation affecting the:
 lungs, including asthma
 blood vessels and heart
 bowel or kidneys
 muscles and joints, including rheumatoid arthritis
 eye or nervous system
skin conditions
some infections
some cancers, including leukaemia, lymphoma and myeloma
to prevent organ rejection after a transplant.

Also:



to boost steroid levels when the body is not making enough natural steroid
on its own.
to treat high calcium levels.

2. What you need to know before you take Deltacortril
Check with your doctor first

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• If you have ever had severe depression or manic-depression (bipolar
disorder). This includes having had depression before while taking steroid
medicines like Deltacortril.
• If any of your close family has had these illnesses.
If either of these applies to you, talk to a doctor before taking Deltacortril.
Do not take Deltacortril if you:
• are allergic to prednisolone or any of the other ingredients of this medicine
(listed in section 6)
• are suffering from a serious infection which is not being treated
• are suffering from a herpes infection of the eye
• are suffering from galactose or lactose intolerance or glucose-galactose
malabsorption.
Warnings and precautions
Before you take Deltacortril tell your doctor if you:





















suffer from or have ever been treated for tuberculosis (TB)
have high blood pressure
have a heart condition
have liver or kidney problems
suffer from diabetes or diabetes runs in your family
have osteoporosis (thinning of the bone), particularly if you are past the
menopause (the change of life)
are going through, or are past the menopause
suffer from epilepsy (fits)
suffer from stomach ulcers
have taken Deltacortril (or other steroids) before and had muscular problems
(steroid myopathy)
are receiving treatment for a condition called myasthenia gravis (a rare
muscle weakness disorder)
have ever had blood clots, (for example, deep vein thrombosis [DVT], or,
thromboembolism)
are planning to have a vaccination
have Cushing’s disease. (A hormone disorder which can cause symptoms
including gaining weight very quickly, especially on the trunk and face,
thinning of the skin and sweating)
suffer from hypothyroidism (an underactive thyroid gland which can cause
tiredness or weight gain)
have Duchenne’s muscular dystrophy
have inflammatory bowel disease such as Crohn’s disease
have an eye disease caused by fluid build-up at the back of the eye that
causes visual impairment.
are undergoing immunosuppression therapy for example in the treatment of
cancer.

Children and adolescents

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The use of steroids can slow down normal growth of children and
adolescents. Your doctor may need to stop treatment or adjust the dose for
your child accordingly.
If any of the above applies to you, or if you are not sure, speak to your doctor
or pharmacist before you take Deltacortril.
Other medicines and Deltacortril
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any of the following medicines as they may affect, or be affected by
Deltacortril:
















antivirals such as ritonavir which
can be used to treat HIV infection
antifungals such as ketoconazole
and amphotericin which are used
to treat fungal infections
antibiotics such as erythromycin
and rifamycin which are used to
treat bacterial infections
antiepileptic drugs such as
carbamazepine, phenobarbital,
phenytoin and primidone which
are used to treat epilepsy.



drugs for diabetes including insulin



oestrogens, for example in the
contraceptive pill or HRT
thiazide diuretics (“water tablets”)
for example bendroflumethiazide
used for water retention or high
blood pressure
medicines to treat high blood
pressure



ciclosporin which is used to treat
rheumatic disease, skin complaints
or after a transplant
cardiac glycosides for example
digoxin which is used to help
strengthen a weak heart
non-steroidal anti-inflammatory
drugs (NSAIDs) for example
aspirin, ibuprofen and indometacin
used for pain relief or to treat
rheumatic disease.
mifepristone, used to induce labour
or abortion.
cytotoxic drugs for example
methotrexate which is used to treat
cancer



vaccinations: You must tell your
doctor or nurse that you are taking
a steroid before you are given any
vaccinations. Steroids affect your
immune response and you must
not be given any live vaccines.

anticoagulants for example
warfarin which is used to thin the
blood
carbenoxolone which is used for
ulcers
salbutamol, formoterol,
bambuterol, fenoteral, ritodrine,
salmeterol and terbutaline used to
treat asthma
antimuscarinics/ anticholinergics



somatropin which is a growth
hormone



acetazolamide which is used in the
treatment of glaucoma and epilepsy
loop diuretics for example
furosemide which is used to treat
heart failure

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theophylline which is used for
asthma and chronic obstructive




immunosuppressants which

dampen down the activity of the
body’s immune system
antacids such as magnesium

trisilicate or aluminium hydroxide,
used to treat the symptoms of
heartburn and indigestion

pulmonary disease (COPD)
antithyroids such as carbimazole

isoniazid which is used to treat
tuberculosis.

Deltacortril with food and drink
Deltacortril should be swallowed with water. You can take Deltacortril before
or after a meal.
Avoid eating liquorice whilst taking Deltacortril.
Pregnancy and breast-feeding
If you are pregnant or trying to become pregnant, you must tell your doctor
before you start the treatment.
If you are breast-feeding you must tell your doctor before you start the
treatment. Your doctor will want to examine your baby during your time of
treatment. Small amounts of steroids are present in breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
If you feel dizzy or tired after taking Deltacortril do not drive or operate
machinery until these effects have worn off.
Deltacortril contains lactose
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.
3. How to take Deltacortril
Always take Deltacortril exactly as your doctor has told you to. You
should check with your doctor or pharmacist if you are not sure.
Different illnesses require different doses of Deltacortril. Depending on your
illness your daily dose may be between 5 and 60 mg. In some cases you may
be instructed to take it every other day. Your doctor will decide when and how
to treat you with Deltacortril.
Once your condition starts to get better, your doctor may change your dosage
to a lower one. Your doctor may also reduce your dosage before stopping
treatment completely. This may depend on your illness, your dosage and how
long you have been taking this medicine. In all cases you should be careful to
follow any changes.

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Stopping taking Deltacortril: It is important to discuss your treatment with
your doctor before stopping treatment. Sudden stopping of treatment can
cause the following symptoms: fever, painful muscles and joints, inflammation
of the eyes and nasal passages, painful and itchy skin lumps, loss of weight.
Treatment of children: The use of steroids can slow down normal growth of
children and adolescents. In order to lessen this effect the tablets are often
taken in a single dose every other day.
Treatment of the elderly: When steroids are taken by elderly patients some
of the unwanted side effects can be more serious especially brittle bone
disease, diabetes, high blood pressure, infections and thinning of the skin.
Whilst you are taking Deltacortril, if any of the following occur tell your
doctor straight away:
• Infections: If you think you might have an infection. You are more likely to
develop illnesses due to infection whilst you are taking Deltacortril. Also any
existing infections may become worse. This is especially so during periods
of stress. Certain infections can be serious if not controlled.
• Chickenpox and Shingles: If you, anyone in your family or regular contacts
catches chickenpox or shingles. This is because you may become very ill if
you get chickenpox whilst taking Deltacortril. You should avoid contact with
people who have chickenpox or shingles whilst taking Deltacortril and for up
to 3 months after you have stopped taking Deltacortril. Do not stop taking
Deltacortril.
• Measles: If you, anyone in your family or regular contacts catches measles.
You should avoid contact with people who have measles.
Your doctor will give you a steroid treatment card. You must carry it with you
at all times. You should show your steroid treatment card to anyone who is
giving you treatment such as a doctor, nurse or dentist.
Mental problems while taking Deltacortril
Mental health problems can happen while taking steroids like Deltacortril (see
also Section 4 Possible side effects).
• 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 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.
What to do if you take more Deltacortril than you should

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If you accidentally take too many Deltacortril tablets or someone else takes
any of your medicine, you should tell your doctor at once or contact your
nearest accident and emergency department. Show any left-over medicines
or the empty packet to the doctor.
If you forget to take Deltacortril
Do not worry. If you forget to take a dose, take it as soon as possible, unless it
is almost time to take the next dose. Do not take a double dose. Then go on
as before.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.

4. Possible side effects
Do not worry. Like all medicines, Deltacortril can cause side effects, although
not everyone gets them.
Stop taking Deltacortril and contact your doctor straight away if the
following allergic reaction happens:
• Puffy, swollen face, tongue or body, which may cause shortness of
breath, shock and collapse
Serious effects: tell a doctor straight away



inflammation of the pancreas (very severe abdominal pains)
painful skin ulcers

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 taking medicines like prednisolone.
• 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.
If you notice any of these problems talk to a doctor straight away.
Other side effects you may experience:

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• tiredness
• increased number of white blood cells
• blood clotting
• nausea and vomiting
• heart problems which can cause
shortness of breath
• convulsions
• dizziness
• vertigo
• headache
• raised pressure in the brain (which can
cause headaches, nausea and
vomiting)
• sleeplessness
• thinning of the skin
• bruising
• stretch marks
• patches of skin reddening
• itching
• rash
• hives
• acne
• extra hair growth
• slow healing of wounds
• increased sweating
• hiding or altering reactions to skin tests
such as for tuberculosis
• reduction of growth in babies, children
and adolescents
• absence or irregularity of menstrual
periods
• face becomes very round
• weight gain
• increased blood sugar
• carbohydrate imbalance in diabetes
• euphoria (feeling high)
• feeling of dependency on treatment
• depression
• general unwell feeling

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• vision problems
• worsening of schizophrenia
• worsening of epilepsy
• risk of stroke is increased in Horton
disease
• increased pressure in the eyeball
(glaucoma)
• whitening or clouding of the lens
(cataracts)
• pressure on the nerve to the eye,
thinning of the tissues of the eye
(sclera and cornea)
• bulging eyes
• worsening of viral or fungal infections
of the eye
• risk of contracting infection is
increased
• existing infections can worsen
• signs of infection can be masked
• previous infections, such as
tuberculosis (TB) may be re-activated
(flare up).
• muscle wasting of the upper arms
and legs
• muscle pain
• brittle bone disease or wasting of the
bones
• bone fractures
• tendon rupture
• indigestion
• stomach ulcers with bleeding or
perforation
• bloating
• ulcers in the gullet (oesophagus)
which may cause discomfort on
swallowing
• candidiasis (thrush)
• abdominal (stomach) pain
• increased appetite which may result
in weight gain
• diarrhoea
• water and salt retention
• high blood pressure (hypertension)
• a change in the levels of some
hormones, mineral balance or protein
in blood tests
• increased cholesterol or fat levels in

blood.

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 internet 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 Deltacortril
Keep this medicine out of the sight and reach of children.
Do not take Deltacortril after the expiry date which is stated on the packaging.
The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original container in order to protect
from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist on how to dispose of medicines no longer required. These
measures will help protect the environment.

6. Contents of the pack and other information
What Deltacortril contains
The active ingredient in this medicine is prednisolone.
The other ingredients are: calcium carbonate, lactose monohydrate,
magnesium stearate, maize starch, polyvinyl alcohol, titanium dioxide (E171),
talc, lecithin (soya), xanthan gum (E415), polydimethylsiloxane, polyethylene
glycol sorbitan tristearate, silica gel, polyethylene glycol stearate, benzoic
acid (E210), sulfuric acid, polyvinyl acetate phthalate, macrogol 4000,
sodium hydrogen carbonate, triethyl citrate, purified stearic acid, sodium
alginate (E401), colloidal anhydrous silica, methylcellulose (E461), sodium
carboxymethylcellulose, iron oxide yellow (E172), white beeswax (E901),
carnauba wax (E903), polysorbate 20 (E432) and sorbic acid (E200).
What Deltacortril looks like and contents of the pack
Deltacortril 1mg is a yellow, round biconvex tablet.
They are gastro-resistant tablets.
Deltacortril 1mg Gastro-resistant Tablets come in packs of 30 or 100 tablets.
Marketing Authorisation Holder and Manufacturer
The product licence holder is: Alliance Pharmaceuticals Limited, Avonbridge
House, Chippenham, Wiltshire, SN15 2BB, UK.

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Deltacortril 1mg is manufactured by: Piramal Healthcare UK Limited, Whalton
Road, Morpeth, Northumberland, NE61 3YA, UK.
The information in this leaflet applies only to Deltacortril. If you have any
questions or you are not sure about anything, ask your doctor or a
pharmacist.
This leaflet was last revised: July 2016
Deltacortril is a registered trademark of Alliance Pharmaceuticals Limited.
Alliance and associated devices are registered trademarks of Alliance
Pharmaceuticals Limited.
© Alliance Pharmaceuticals Limited 2016.

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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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