Skip to Content

PREDNISOLONE 5 MG GASTRO-RESISTANT TABLETS

Active substance(s): PREDNISOLONE / PREDNISOLONE / PREDNISOLONE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

12mm

11 mm

8 mm

6 mm

7 mm

Package leaflet: Information for the user

Muscle problems:
Muscle wasting of the upper arms and legs, muscle pain, brittle
bone disease or wasting of the bones, bone fractures, tendon
rupture.
Metabolism & nutritional problems:
Water and salt retention, a change in the levels of some hormones,
mineral balance or protein in blood tests, increased cholesterol
or fat levels in blood.
Hormone system problems:
Reduction of growth in babies, children and adolescents, absence
or irregularity of menstrual periods, face becomes very round,
weight gain, carbohydrate imbalance in diabetes.
Immune system problems:
Risk of contracting infections is increased, existing infections can
worsen, signs of infection can be masked, previous infections such
as tuberculosis (TB) may be re-activated (flare up).
If any of the above side effects are troublesome or last more than
a few days or if you notice any side effects not mentioned in this
leaflet, please inform your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or 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.

• Prednisolone 2.5 mg Tablets also contain black iron oxide
(E172), red iron oxide (E172) and yellow iron oxide (E172)
• Prednisolone 5 mg Tablets also contain ponceau 4R red (E124),
indigo carmine aluminium lake (E132) and sunset yellow FCF
(E110).

PREDNISOLONE 2.5 MG AND 5 MG
GASTRO-RESISTANT TABLETS
Prednisolone





Prednisolone 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 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 anyway, 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 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.

What Prednisolone Tablets look like and contents of the pack
• Prednisolone 2.5 mg Tablets are dark brown, circular, deep
biconvex, enteric coated tablets.
• Prednisolone 5 mg tablets are red, circular, deep biconvex,
enteric coated tablets.
• Prednisolone Tablets are available in blister packs of 28 tablets.
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
E-mail:
info@bristol-labs.co.uk

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.

Prednisolone 2.5 mg Gastro-Resistant Tablets; PL 17907/0553,
PL 17907/ 0555
Prednisolone 5 mg Gastro-Resistant Tablets; PL 17907/0554,
PL 17907/0556
This leaflet was last revised in October 2016.
To request a copy of this leaflet in Braille, large print or audio then
please contact the licence holder at the address (or telephone,
fax, email) above.

What is in this leaflet:
1. What Prednisolone Tablets are and what are they 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

5. How to store Prednisolone Tablets

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

• Keep this medicine out of the sight and reach of children.
• Do not use these tablets after the expiry date shown on the
pack after EXP. The expiry date refers to the last day of that
month.
• Store below 30°C.
• 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.

Prednisolone 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 wellbeing. Boosting your body with extra corticosteroids (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 is used in a wide range of inflammatory and autoimmune 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.

V7 25-10-16 D1

XXXX

6. Contents of the pack and other information
What Prednisolone Tablets contain
• The active ingredient is prednisolone.
• Each Prednisolone 2.5 mg Tablet contains 2.5 mg of
prednisolone.
• Each Prednisolone 5 mg Tablet contains 5 mg of prednisolone.
• The tablets also contain lactose monohydrate, microcrystalline
cellulose, pregelatinised maize starch, magnesium stearate,
hypromellose, titanium dioxide (E171), triethyl citrate, sorbic
acid, methacrylic acid ethyl acrylate copolymer, talc, colloidal
anhydrous silica, sodium bicarbonate, sodium lauril sulfate,
polyvinyl alcohol and macrogol 3350.

296 mm

SAME SIZE ARTWORK
Front

210 mm

Stomach problems:
Indigestion, feeling sick, stomach ulcers with bleeding or
perforation, bloating, abdominal (stomach) pain, increased
appetite which may result in weight gain, diarrhoea, ulcers in the
gullet (oesophagus) which may cause discomfort on swallowing,
oral thrush (candidiasis), inflammation of the pancreas.

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
Prednisolone Tablets
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.
• If any of your close family has had these illnesses.
If either of these applies to you, talk to a doctor before taking
prednisolone.
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)

6 mm

8 mm

6 mm

8 mm

Other medicines and Prednisolone Tablets
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. In particular, tell your doctor or
pharmacist if you are taking or have recently taken any of the
following medicines:
• Antivirals such as ritonavir or cobicistat 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 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.
• 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
• Oestrogens, for example in the contraceptive pill or HRT
• Cytotoxic drugs for example methotrexate which is used to treat
cancer
• Thiazide diuretics (“water tablets”) for example bendroflumethiazide used for water retention or high blood pressure
• Vaccinations: You must tell your doctor or nurse that you are
taking a steroid before you are given any vaccinations. Steroids

SAME SIZE ARTWORK
Back















affect your immune response and you must not be given any
live vaccines
Medicines to treat high blood pressure
Somatropin which is a growth hormone
Anticoagulants for example warfarin which is used to thin the
blood
Acetazolamide which is used in the treatment of glaucoma and
epilepsy
Carbenoxolone which is used for ulcers
Loop diuretics for example furosemide which is used to treat
heart failure
Salbutamol, formoterol, bambuterol, fenoterol, ritodrine,
salmeterol and terbutaline used to treat asthma
Theophylline which is used for asthma and chronic obstructive
pulmonary disease (COPD)
Antimuscarinics/ anticholinergics
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.

Prednisolone with food and drink
Prednisolone should be swallowed with water. You can take
prednisolone before or after a meal.
Pregnancy and breast feeding
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 do not drive or
operate machinery until these effects have worn off.
Important information about some of the ingredients of
Prednisolone Tablets
This product contains lactose. If you have been told by your doctor
that you have intolerance to some sugars, please contact your
doctor before taking this medicinal product.
Prednisolone 5 mg Tablets also contains sunset yellow FCF (E110)
and ponceau 4R red (E124). This may cause allergic reactions.

3. How to take Prednisolone Tablets
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not
sure.
Adults:
Different illnesses require different doses of Prednisolone.
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. Once your condition starts to get better, 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.
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.
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.
Whilst you are taking Prednisolone, 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 illness due to infection whilst you are
taking Prednisolone. 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 ill if you get chickenpox whilst taking
Prednisolone. You should avoid contact with people who have
chickenpox or shingles whilst taking Prednisolone and for up
to 3 months after you stopped taking Prednisolone. Do not stop
taking Prednisolone.
• 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 doctor, nurse or dentist.
Mental problems while taking prednisolone:
Mental health problems can happen while taking steroids like
prednisolone (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 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 Prednisolone Tablets
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 to make up for a forgotten dose. Then go on as before.

If you 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: fever, painful muscles and joints,
inflammation of the eyes and nasal passages, painful and itchy
skin lumps, loss of weight.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can have side effects, although
not everybody gets them.
Stop taking this medicine 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.
Other side effects you may experience:
General:
Allergic reaction, tiredness, increased number of white blood cells,
general unwell feeling, blood clotting and vertigo.
Heart problems:
High blood pressure (hypertension), heart problems which can
cause shortness of breath, risk of stroke is increased in Horton
disease.
Mental & nervous system problems:
Euphoria (feeling high), sleeplessness, feeling of dependency
on treatment, depression, convulsions, dizziness, headache,
raised pressure in the brain (which can cause headaches, nausea
and vomiting), worsening of schizophrenia, worsening of epilepsy.
Eye problems:
Pressure on the nerve to the eye, increased pressure in the eyeball
(glaucoma), whitening or clouding of the lens (cataracts), bulging
eyes, thinning of the tissues of the eye (sclera and cornea),
pressure on the nerve to the eye (sometimes in children after
stopping treatment, worsening of viral or fungal infections of the
eye).
Skin problems:
Slow healing of wounds, thinning of the skin, extra hair growth,
bruising stretch marks, patches of skin reddening, acne, increased
sweating, hiding or altering reactions to skin tests such as for
tuberculosis, itching, rash, hives.

210mm

Have high blood pressure
Have a heart condition
Have liver or kidney problems
Suffer from diabetes or diabetes runs in your family
Are going through, or are past the menopause
Have osteoporosis (thinning of the bone), particularly if you
are past the menopause (the change of life)
• Suffer from epilepsy (fits)
• Suffer from stomach ulcers
• Have taken Prednisolone (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
• Suffer or have suffered from any mental illness
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking this medicine.

XXXX






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.

Hide