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PREDNISOLONE 5MG TABLETS BP

Active substance(s): PREDNISOLONE

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Package leaflet: Information for the user

• To treat high calcium levels.

Prednisolone 1 mg Tablets
Prednisolone 5 mg Tablets

2. What you need to know before you take
Prednisolone Tablets

Prednisolone

Check with your doctor first
• If you have ever had severe depression or manic-depression (bipolar
disorder). This includes having had depression before or while taking
steroid medicines like Prednisolone Tablets;
• If any of your close family has had these illnesses.
If either of these applies to you, talk to a doctor before taking Prednisolone
Tablets.
Do not take Prednisolone Tablets 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine 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 Prednisolone Tablets (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.
Other medicines and Prednisolone Tablets
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
Prednisolone Tablets:
• Antivirals such as ritonavir which can be used to treat HIV infection;
• Drugs for diabetes including insulin;
• Antifungals such as ketoconazole and amphotericin which are used
to treat fungal infections;
• Ciclosporin which is used to treat rheumatic disease, skin complaints
or after a transplant;
• Antibiotics such as erythromycin, troleandomycin and rifamycin which
are used to treat bacterial infections;
• Cardiac glycosides for example digoxin which is used to help strengthen
a weak heart;
• Antiepileptic drugs such as carbamazepine, phenobarbital, phenytoin
and primidone which are used to treat epilepsy;

• Prednisolone Tablets 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.
• Prednisolone Tablets 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 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.
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 Prednisolone Tablets are and what they are used for
2. What you need to know before you take Prednisolone Tablets
3. How to take Prednisolone Tablets
4. Possible side effects
5. How to store Prednisolone Tablets
6. Contents of the pack and other information

1. What Prednisolone Tablets are and
what they are used for

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3. How to take Prednisolone Tablets
Always take this medicine exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.
Different illnesses require different doses of Prednisolone Tablets.
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 Prednisolone Tablets.
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.
IXXXXXX

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The name of your medicine is Prednisolone 1 mg Tablets or Prednisolone
5 mg Tablets. They contain the active ingredient called prednisolone.
Prednisolone Tablets belongs to a group of medicines called steroids. Their
full name is corticosteroids. Corticosteroids occur naturally in the body, and
help to maintain health and well-being. Boosting your body with extra
corticosteroid (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.
Prednisolone Tablets are used to treat 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;

• Non-steroidal anti-inflammatory drugs (NSAIDS) for example aspirin,
ibuprofen and indomethacin used for pain relief or to treat rheumatic
disease;
• Oestrogens, for example in the contraceptive pill or HRT;
• Mifepristone, used to induce labour or abortion;
• Thiazide diuretics (“water tablets”) for example bendroflumethiazide
used for water retention or high blood pressure;
• Cytotoxic drugs for example methotrexate which is used to treat
cancer;
• Medicines to treat high blood pressure;
• Vaccinations: You must tell your doctor or nurse that you are taking a
steroid before you are given any vaccinations as some vaccines should
not be given to individuals taking prednisolone.
• Steroids affect your immune response and you must not be given
anticoagulants for example warfarin which is used to thin the blood.
Your INR or prothrombin time may be closely monitored if you are taking
anticoagulants;
• Somatropin which is a growth hormone;
• Carbenoxolone which is used for ulcers;
• Acetazolamide which is used in the treatment of glaucoma and
epilepsy;
• Salbutamol, formoterol, bambuterol, fenoterol, ritodrine, salmeterol and
terbutaline used to treat asthma;
• Loop diuretics for example furosemide which is used to treat heart failure;
• Antimuscarinics/ anticholinergics;
• Theophylline which is used for asthma and chronic obstructive
pulmonary disease (COPD);
• Immunosuppressants which dampen down the activity of the body’s
immune system;
• Antithyroids such as carbimazole;
• Antacids such as magnesium trisilicate or aluminium hydroxide, used
to treat the symptoms of heartburn and indigestion;
• Isoniazid which is used to treat tuberculosis;
• Rifampicin and rifabutin which are used to treat tuberculosis and other
bacterial infections;
• Aminoglutethimide which is used to treat some cancers.
Prednisolone Tablets with food and drink
Prednisolone Tablets should be swallowed with water. You can take
Prednisolone Tablets before or after a meal. Avoid eating liquorice whilst
taking Prednisolone Tablets.
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
taking this medicine. 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 Prednisolone Tablets do not drive or
operate machinery until these effects have worn off.
Prednisolone Tablets 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.

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4. Possible side effects

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Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Stop taking Prednisolone Tablets 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.

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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;
• Irritability;
• Accumulation of fat tissue on localised parts of the body, manifesting as
different presentations for example back pain or weakness (epidural
lipomatosis);
• Diabetes or worsening of existing diabetes;
• Inflammation and ruptures of tendons
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 Prednisolone Tablets
• Keep this medicine out of the sight and reach of children.
• Do not store the tablets above 25°C. Store in the original container.
Keep the container tightly closed.
• Do not take these tablets after the expiry date shown on the pack after
EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater. Ask your pharmacist
how to throw away medicines you no longer use. These measures will
help protect the environment.

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• 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 cause headaches, nausea and
vomiting);
• Sleeplessness;
• 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;
• 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;
• 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;
• 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;
• Indigestion;
• Stomach ulcers with bleeding or perforation;
• Bloating;
• Ulcers in the gullet (oesophagus) which may cause discomfort on
swallowing;

6. Contents of the pack and other information
What Prednisolone Tablets contain
The active ingredient in this medicine is prednisolone.
The other ingredients are: Lactose, Maize Starch, Colloidal Silicon Dioxide,
Sodium Starch Glycollate, Stearic Acid and Magnesium Stearate.
What Prednisolone Tablets look like and contents fo the pack
Prednisolone 1 mg and 5 mg Tablets are white, circular, biconvex tablets
with P1 on one side and plain on the reverse (for Prednisolone 1 mg Tablets)
or P5 on one side and breakline on the reverse (for Prednisolone 5mg
Tablets) respectively.
Prednisolone 1 mg and 5 mg Tablets are available in packs of 28, 100, 250,
500 and 1000. The 5 mg tablet is also available in a pack of 5000. Not all
pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and Address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG,
United Kingdom
Telephone: 0044 (0)1442 200922
Fax:
0044 (0)1442 873717
Email:
info@bristol-labs.co.uk
Prednisolone 1 mg Tablets; PL 17907/0455
Prednisolone 5 mg Tablets; PL 17907/0456
This leaflet was last revised in June 2016
To request a copy of this leaflet in Braille, large print or audio format, please
contact the licence holder at the address (or telephone, fax, email) above.

IXXXXX

Stop taking Prednisolone Tablets: It is important to discuss your treatment
with your doctor before stopping treatment. Sudden stopping of treatment
can cause the following symptoms: loss of appetite, nausea, vomiting,
tiredness, headache, fever, painful muscles and joint pains, peeling and
loss of skin, inflammation of the eyes and nasal passages, painful and itchy
skin lumps, loss of weight and/or low blood pressure.
Children and adolescents: 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.
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 Prednisolone Tablets, 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 Prednisolone
Tablets. Also any existing infections may become worse. This is especially
so during periods of stress. Certain infections can be serious if not
controlled;
• Chicken pox and Shingles: If you, anyone in your family or regular
contacts catches chicken pox or shingles. This is because you may
become very ill if you get chickenpox whilst taking Prednisolone Tablets.
You should avoid contact with people who have chickenpox or shingles
whilst taking Prednisolone Tablets and for up to 3 months after you have
stopped taking Prednisolone Tablets. Do not stop taking Prednisolone
Tablets;
• 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 Prednisolone Tablets
Mental health problems can happen while taking steroids like Prednisolone
Tablets (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.
If you take more Prednisolone Tablets than you should
If you accidentally take too many Prednisolone Tablets or someone else
takes any of your medicine you should, contact your doctor or nearest hospital
emergency department immediately. Show any left-over medicines or the
empty packet to the doctor.
If you forget to take Prednisolone Tablets
If you forget to take a dose, take it 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
tablet. Then go on as before.

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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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