PREDNISOLONE 5MG SOLUBLE TABLETS

Active substance: PREDNISOLONE SODIUM PHOSPHATE

View full screen / Print PDF » Download PDF ⇩

Transcript
Ref: 1325/040913/1/F

Prednisolone 5mg Soluble Tablets
(prednisolone sodium phosphate)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine. It
provides a summary of the information available on your medicine. If
you have any questions or are not sure about anything ask your doctor
or pharmacist.
* 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
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
for more information).
* If you take this medicine for more than three 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 may be especially
important for you.
Prednisolone - benefit information.
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 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.
Your medicine is called Prednisolone 5mg Soluble Tablets and will be
referred to as Prednisolone Soluble Tablets throughout the leaflet.
In this leaflet:
1 What Prednisolone Soluble Tablets are and what they are used for
2 Before you take Prednisolone Soluble Tablets
3 How to take Prednisolone Soluble Tablets
4 Possible side effects
5 How to store Prednisolone Soluble Tablets
6 Further information

1

What Prednisolone Soluble Tablets are and what
they are used for

The name of your medicine is Prednisolone Soluble Tablets. Prednisolone
Soluble Tablets contain the active ingredient prednisolone which belongs to
a group of medicines called corticosteroids or “steroids”. Steroids work by
reducing inflammation and lowering the body’s immune response.
Prednisolone Soluble Tablets are used to treat a variety of inflammatory
diseases including severe asthma, rheumatoid arthritis, allergic reactions,
bowel diseases, severe skin conditions, kidney disorders and some blood
disorders.
2

Before you take Prednisolone Soluble Tablets

Do not take this medicine if you:
* are allergic to prednisolone or any of the other ingredients of
Prednisolone Soluble Tablets (allergic reactions include mild symptoms
such as itching and/or rash. More severe symptoms include swelling of
the face, lips, tongue and/or throat with difficulty in swallowing or
breathing);
* have recently had a vaccination or have a vaccination planned;
* have a viral infection such as measles, chickenpox or shingles, or any
other infection. Tell your doctor immediately if you have come into
contact with anyone suffering with measles, chickenpox or shingles in the
last three months.
Take special care if you:
* have or have ever had:
- severe depression or manic-depressive illness (bipolar disorder). This
includes having had depression before while taking steroid medicines like
Prednisolone Soluble Tablets or if anyone in your family has suffered
from these illnesses;

- TB (tuberculosis);
- diabetes;
- epilepsy;
- depression or other mental illness;
- an eye disease caused by a rise of pressure within the eye (glaucoma);
- osteoporosis (thinning of the bones);
- muscle problems when steroids have been taken before;
- stomach ulcers;
- high blood pressure, heart failure or recently suffered a heart attack;
- any liver or kidney problems;
- an under-active thyroid (hypothyroidism).
If any of the above applies to you, or you are not sure please tell your
doctor or pharmacist before you use this medicine.
Mental health problems while taking Prednisolone
Mental health problems can occur while taking steroids like
prednisolone (see also section 4 Possible Side Effects).
* These illnesses can be severe.
* 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 occur they might need treatment.
Talk to a doctor if you (or someone taking this medicine) show any signs of
mental health problems. This is particularly important if you are depressed or
might be thinking about suicide. In a few cases, mental health problems
have happened when doses are being lowered or the medicine stopped
altogether.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
This is especially important if you are taking:
Medicines for epilepsy such as carbamazepine, phenobarbitone,
phenytoin or primidone;
* Antibiotics such as rifampicin, erythromycin;
* Mifepristone (used to terminate pregnancy);
* Ritonavir (used in HIV treatment);
* Oral contraceptives;
* Somatropin (used to treat growth problems);
* Medicines for diabetes such as insulin, glibenclamide or metformin;
* Medicines to treat high blood pressure, such as diuretics (water tablets)
like bendroflumethiazide and furosemide;
* Warfarin or other medicines used to thin the blood;
* Aspirin or similar medicines;
* Theophylline (used to treat asthma);
* Medicines to treat fungal infections such as amphotericin, ketoconazole;
* Acetazolamide (used to treat glaucoma);
* Carbenoxolone (used to treat stomach ulcers);
* Methotrexate (used for rheumatoid arthritis, psoriasis and certain types of
cancer);
* Any medicine which belong to a group of medicines called
sympathomimetics;
* Medicines used to treat myasthenia gravis;
* Medicines used to make x-rays clearer;
* Ciclosporin (used to stop the body rejecting bone marrow or organ
transplants).

*

Pregnancy and breast-feeding
Tell your doctor before being given this medicine if you are or think you may
be pregnant, or if you are breast-feeding.
Driving and using machinery
This medicine should not affect your ability to drive or use machines.
Carrying a Steroid card
Your doctor or pharmacist will have given you a Steroid Treatment Card
with your prescription or medicine.
YOU SHOULD ALWAYS CARRY THIS CARD WITH YOU as it must be
shown to any of the following persons:
Doctor or Nurse - before having any surgery or emergency treatment or if
any new treatment is prescribed.
Dentist before having any dental surgery.
Pharmacist before buying any medicine.
Optician it is advisable to have regular eye tests.

3

How to take Prednisolone Soluble Tablets

Always take Prednisolone Soluble Tablets exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are not sure.
The tablets can be swallowed whole, but they are best taken as a drink
after dissolving them in a glass of water. Take your tablets as a single dose
each morning, unless your doctor has told you otherwise.

Ref: 1325/200213/1/B

Prednisolone 5mg Soluble Tablets
(prednisolone sodium phosphate)
Patient Information Leaflet (continued)
Adults:
The dose will depend on the condition you are being treated for and can
vary between 10 mg and 100 mg daily. Your doctor will always reduce the
dose to the smallest dose that works for you.

* intolerance to carbohydrates;
* mood changes, dependence, depression, difficulty sleeping, worsening of

Children:
To treat asthma attacks:
Children aged 5 years and above – 30 mg to 40 mg
Children aged 2 to 5 years old - 20 mg daily
Children under 2 years old – up to 10 mg daily for up to three days
Treatment for up to three days is usually enough, but may be longer.

* worsening of epilepsy;
* raised pressure in the eyes (glaucoma), cataracts, thinning and

schizophrenia;

* severe headaches with blurred vision or temporary visual problems in
children (usually after stopping treatment);

Do not stop taking the tablets unless you have been told to do so by your
doctor, even if you feel better, as it can make you ill.
It can cause withdrawal symptoms such as fever, sickness, pain in the
muscles and joints, runny nose, sore, red and sticky eyes (conjunctivitis),
itchy skin and weight loss.
Talk to your doctor if you want to stop taking the tablets - your doctor may
want to reduce your dose gradually.
If you take more tablets than you should
If you take more Prednisolone Soluble Tablets than you should, contact your
doctor or nearest hospital emergency department immediately. Remember
to take this leaflet and/or the package with you to show the doctor what you
have taken.
If you forget to take your medicine
If you forget to take Prednisolone Soluble Tablets, take the next dose 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 dose.

4

Possible side effects

Like all medicines, Prednisolone Soluble Tablets can cause side effects,
although not everybody gets them.
Steroids including prednisolone can cause severe mental health
problems.
These are common in both adults and children. They can affect
about five in every 100 people taking medicines like Prednisolone.
* Feeling depressed, including thinking about suicide.
* Feeling high (mania) or having moods that go up and down.
* Feeling anxious, having problems sleeping, having 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 immediately.
If you notice;

* itching or skin rashes;
* swelling of the face, lips or throat;
* difficulty in breathing or wheeziness.

Stop taking the tablets and tell your doctor immediately. These may be
signs of an allergic reaction.

The side effects which can occur if steroids are given in high doses for a
long time are:
* generally feeling unwell;
* feeling sick (nausea);
* hiccups;
* indigestion or stomach discomfort;
* stomach ulcer (which can rupture and bleed) or ulcer in the oesophagus
(gullet);
thrush;
*
* inflammation of the pancreas causing abdominal pain (pancreatitis);
* muscle weakness;
* muscle pain;
* thinning of bones which makes fractures more likely (osteoporosis);
* damage to tendons;
* joint stiffness causing limited movement, pain and muscle spasms;
* fluid retention causing swelling;
* feeling dehydrated;
* high blood pressure;
* slow healing of wounds, thinning of the skin, bruising, acne, marks which
look like stretch marks;
small red, purple or blue spots found along the surface of the skin (caused
*
by blood vessels under the skin);
* low adrenal gland function;
* slowed growth in infants, children and teenagers;
* irregular or stopped menstrual periods;
* swollen, round face (Cushingoid facies);
* excess hair growth;
* increased appetite and weight gain;

*
*
*
*
*

inflammation of the cornea (part of the eye), worsening of viral or fungal
eye diseases and visual impairment;
heart attack (sudden severe chest pains);
changes in body chemistry;
an increase in the number of white blood cells;
formation of blood clots;
Long term use of high dose steroids, may lead to a weakening of the
immune system, which can increase the risk of malignancy.

Kaposi's sarcoma (a type of cancer) has also been reported to occur in
patients receiving corticosteroids. However, once the treatment has been
stopped, this may go away.
Prednisolone Soluble Tablets can make it easier for you to pick up infections
which may very rarely be fatal. Infections such as chicken-pox and measles
can be made worse or TB (tuberculosis) may recur.
If any of the side effects becomes severe, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist
immediately.

5

How to store Prednisolone Soluble Tablets

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
Do not store above 25°C.
Store in the original package in order to protect from light.
Do not take this medicine after the expiry date shown on the carton or blister
label. If your doctor tells you to stop taking the medicine, take any remaining
medicine back to the pharmacist for safe disposal. Only keep this medicine if
your doctor tells you to.
If your medicine becomes discoloured or shows any signs of deterioration,
ask your pharmacist who will advise you what to do.
Medicines should not be disposed of via waterwaste or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
6

Further information
What this medicine contains:
Each tablet contains 5mg prednisolone (as prednisolone sodium phosphate).
The other ingredients are: povidone, sodium acid citrate,
sodium bicarbonate, sodium benzoate (E211), erythrosine (E127) and
saccharin sodium.
What this medicine looks like and contents of the pack
The tablets are small, pink soluble tablets engraved with ‘PRED 5 SOV’ on
one side and a break line on the other side. Each blister pack contains 30
tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Losan Pharma GmbH, Otto-Hahn-Strasse
13, D79395 Neuenburg, Germany and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1325

Prednisolone 5mg Soluble Tablets

Revision date: 04/09/13

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Expand view ⇕

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
(web2)