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PREDNISOLONE 2.5MG GASTRO-RESISTANT TABLETS

Active substance: PREDNISOLONE

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PATIENT INFORMATION LEAFLET

Deltacortril® 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, 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 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
might be especially important for you. This leaflet was last revised in May 2014.
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.
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
• 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
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
• 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
• 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
• 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

• drugs for diabetes including insulin
• 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
• 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
• theophylline which is used for asthma and chronic
obstructive 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.
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 chicken pox whilst taking Deltacortril. You should avoid contact with people
who have chicken pox 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
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:

































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 case 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
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.
Store below 25°C. Keep your medicine in a dry place.
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, magnesium stearate, maize starch, polyvinyl alcohol, titanium dioxide
(E171), purified talc, lecithin, xanthan gum (E415), polyvinyl acetate phthalate, polyethylene glycol, sodium hydrogen
carbonate, triethyl citrate, purified stearic acid, sodium alginate (E401), colloidal silicon dioxide, methylcellulose (E461),
sodium carboxymethyl cellulose, beeswax (E901), carnauba wax (E903), polysorbate 20 (E432) and sorbic acid (E200).
The Deltacortril 5 mg tablet also contains carmine (E120) and indigo carmine aluminium lake (E132).
The Deltacortril 2.5 mg tablet contains iron oxide (E172).
What Deltacortril looks like and contents of the pack
Deltacortril tablets come in two strengths.
Deltacortril 2.5 mg is a brown tablet.
Deltacortril 5 mg is a maroon tablet.
They are gastro-resistant tablets.
Deltacortril 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.
Deltacortril is manufactured by: Recipharm Stockholm AB, Lagervägen 7, SE-136 50 Jordbro, Sweden and 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 in May 2014.
Deltacortril is a registered trademark of Alliance Pharmaceuticals Limited.
Alliance and associated devices are registered trademarks of Alliance Pharmaceuticals Limited.
© Alliance Pharmaceuticals Limited 2014.

XXXXXX

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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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