Skip to content
This is a text only leaflet, designed for the visually impaired. Please visit our electronic Medicines Compendium (eMC) website to view the original document which may contain images or tables.

You may be able to get this leaflet in large print, Braille or as an audio CD, call the RNIB Medicine Leaflet line on 0800 198 5000 for more information.

The product codes for this leaflet are: PL 29831/0177, PL 29831/0178

 

Prednisolone Tablet

Company Details

Wockhardt UK Ltd


Ash Road NorthWrexham Industrial EstateWrexhamLL13 9UF
Telephone:
Fax:
[view all information leaflets from this company]

PACKAGE LEAFLET: INFORMATION FOR THE USER

Prednisolone 1mg and 5mg Tablets

(Referred to as Prednisolone Tablets in the remainder of the leaflet)

Prednisolone is a steroid medicine, prescribed for many different conditions, including serious illnesses.

  • You need to take it regularly to get the maximum benefit.
  • Do not 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 for more information). Some problems such as mood changes (feeling depressed, or ‘high’), or stomach problems may be experienced straight away. If you feel unwell in any way, keep taking your tablets, but see your doctor straight away.
  • Some side effects only occur 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 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 might be especially important for you.

You should keep this leaflet throughout your course of treatment.

In this leaflet:

1. What Prednisolone Tablets are and what they are used for
2. Before you take Prednisolone Tablets
3. How to take Prednisolone Tablets
4. Possible side effects
5. How to store Prednisolone Tablets
6. Further information

Go to top of the page

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

The name of your medicine is Prednisolone Tablets.

The active ingredient in your medicine is prednisolone. Prednisolone 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 corticosteroids (such as Prednisolone Tablets) 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.

Go to top of the page

2. Before you take Prednisolone Tablets

Do not take Prednisolone Tablets if you:

  • are allergic (hypersensitive) to prednisolone or to any of the other ingredients in this medicine (see section 6. Further information)
  • have any infection, unless you are receiving specific treatment for it.

Talk to your doctor before taking Prednisolone Tablets if:

  • you have ever had severe depression or manic-depression (bipolar disorder). This includes having had depression before whilst taking steroid medicines like prednisolone
  • any of your close family has had these illnesses.

If any of these apply to you, talk to your doctor before taking Prednisolone Tablets.

Also talk to your doctor before taking Prednisolone Tablets if you have:

  • osteoporosis (weakening of the bones), especially in women who have passed menopause
  • high blood pressure or heart failure
  • diabetes or a history of diabetes in your family
  • tuberculosis (a disease of the lungs) or a history of tuberculosis
  • glaucoma (a condition of the eye that affects the vision) or a history of glaucoma or a history of glaucoma in your family
  • a history of muscle weakness caused by treatment with steroids
  • severe liver or kidney problems
  • suffered from fits/seizures
  • stomach ulcers
  • an under active thyroid gland
  • suffered a recent heart attack.

Talk to your doctor before giving this medicine to babies, children or adolescents as it may slow their growth.

If you are an elderly patient speak to your doctor before taking Prednisolone Tablets. You may need to be supervised closely to avoid any life threatening reactions as you may have an increased risk of infections, weakening of the bones, high blood pressure, diabetes, increased potassium levels in your blood or thinning of your skin.

If you come into contact with chicken pox or shingles within 3 months of taking Prednisolone contact your doctor immediately.

Keep away from people who have measles. If you do come into contact with measles, see your doctor immediately.

Mental health problems while taking Prednisolone Tablets

Mental health problems can occur while taking this medicine (read section 4. Possible side effects for more information).

  • these mental health problems can be serious
  • these problems are usually experienced within a few days or weeks of starting the medicine
  • these problems 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 mental 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 been experienced when doses are being lowered or stopped.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The following medicines can affect or can be affected by Prednisolone Tablets:

  • carbamazepine, phenytoin, primidone and phenobarbitone, used to treat fits/seizures
  • rifampicin and rifabutin, used to treat some infections
  • thalidomide and aminoglutethimide, used to treat some cancers
  • coumarin anticoagulants, used to thin the blood
  • aspirin and other non-steroidal anti-inflammatory drugs, used to treat pain and inflammation due to increased risk of bleeding in the gut or ulcers
  • somatropin or growth hormones
  • isoniazid, used to treat tuberculosis
  • ketaconazole and amphotericin, used to treat fungal infections
  • ciclosporin, used to treat inflammation
  • ritonavir and indinavir, used to treat viral infections
  • live vaccines
  • medicines used to relax muscles during surgery
  • digoxin and related drugs called cardiac glycosides, used to treat heart failure
  • salbutamol, bambuterol, salmeterol and terbutaline or other sympathomimetic drugs, used to treat breathing difficulties
  • insulin and other medicines used to treat diabetes
  • medicines used to treat high blood pressure
  • theophylline, used to treat asthma
  • loop diuretics and thiazide diuretics, used to remove excess water from the body
  • female sex hormones in the oral contraceptive pill.

Prednisolone Tablets may also reduce the effectiveness of the contraceptive coil (IUD or intra-uterine device) in preventing pregnancy.

If you have any doubts about whether you should take this medicine, talk to your doctor.

Pregnancy and breast-feeding

If you are pregnant/planning to become pregnant or breastfeeding talk to your doctor before you use Prednisolone Tablets. Your doctor will decide if you should take them.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machinery

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 medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Go to top of the page

3. How to take Prednisolone Tablets

Always take Prednisolone Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

You need to take Prednisolone Tablets regularly to get the maximum benefit.

Swallow Prednisolone Tablets whole (do not chew) with water. Take your tablets with or after food.

Adults and Elderly

Your doctor may start your treatment with the lowest dose for a minimum period of time to minimise side effects.

Your doctor may decide to start your treatment with Prednisolone Tablets at a dose of 5mg to 60mg taken daily either in several doses throughout the day, or as a single dose in the morning after breakfast, or as a double dose on alternate days. The dose may be lowered after a few days to 2.5mg to 15mg per day, but your doctor may decide higher doses may be needed for several weeks or months.

Children

Prednisolone Tablets may be given to children very rarely to treat specific conditions. The smallest dose may be given for the shortest time possible.

If you take more Prednisolone Tablets than you should

Tell your doctor or go to your nearest hospital straight away. Take any Prednisolone Tablets that are left and this leaflet with you.

If you forget to take Prednisolone Tablets

If you forget a dose, take it as soon as you remember. However, if it is almost time for your next dose, then do not take the missed dose at all. NEVER take a double dose to make up for the one missed.

If you stop taking Prednisolone Tablets

Do not stop taking this medicine without talking to your doctor – you may need to reduce the dose gradually.

Your doctor will decide how to lower the dose gradually depending on how long you have been taking Prednisolone Tablets, how you are responding to the treatment, your normal dose and what you are being treated for.

If treatment is stopped too quickly it can lead to severe problems of the adrenal gland. You may also experience ‘withdrawal symptoms’ which include fever, muscular pain, weakness, joint pain, runny nose, an eye infection (conjunctivitis), painful itchy skin lumps, loss of weight, mental changes, mood changes, feeling sick and/or being sick, low blood pressure, feeling faint, headache, dizziness and reappearance of your disease symptoms.

Children may also experience swelling of the nerves in the eyes due to increase in pressure in and around the brain. Fits/seizures may also be aggravated.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Go to top of the page

4. Possible side effects

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

A severe form of allergic reaction (anaphylactic/anaphylactoid reaction) is extremely rare. Symptoms of a severe allergic reaction include rash, swelling of the face and difficulty breathing.

If you experience any severe allergic reaction, contact your doctor or nearest hospital casualty department immediately.

If you experience any serious side effects tell your doctor straight away.

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 Tablets.

If you notice any of these problems talk to your doctor straight away:

  • 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, or 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.

High dose or prolonged use of Prednisolone Tablets may cause:

  • Cushing’s syndrome (a rare hormonal disorder that causes sudden weight gain and bloating around the chest and stomach, along with other symptoms)
  • temporary or permanent loss of blood supply to bones
  • protruding eye balls.

Other side effects that may be experienced while taking this medicine are:

  • a higher risk of allergic skin reactions such as reddish painful tender lumps or damage to the blood vessels of the skin (Stevens-Johnson syndrome, Lyell syndrome)
  • slowing of growth in babies, children and young people
  • irregular periods or periods stopping completely in women
  • excess facial and body hair growth in women
  • weight gain
  • change in your tolerance to carbohydrates
  • increase in your blood sugar levels
  • diabetes or an increase in diabetic conditions if already diabetic
  • an imbalance in the levels of nitrogen and calcium in your body
  • increase in your appetite
  • high levels of cholesterol/triglycerides (a type of fatty substance) in the blood
  • higher tendency to pick up infections
  • return of tuberculosis (a disease affecting the lungs)
  • weakening of the bones, or bone fractures
  • damage to tendons
  • muscle weakness
  • buffalo hump (build up of fat on the back of the neck)
  • swelling due to a build up of fluid
  • change in fluid and salt level in the body. Symptoms include swelling, feeling excessively tired, feeling weak and irritable
  • extreme loss of potassium which may cause weakness or pain and cramping in the muscles
  • increase in the capability of blood to form clots
  • high blood pressure which may cause headaches, tiredness, feelings of confusion, visual disturbances, and feeling or being sick
  • feeling anxious
  • loss of memory
  • problems of the eye including glaucoma, detached retina, cataracts and sudden blindness
  • indigestion, stomach ache and back ache
  • yeast infection of the mouth (candidiasis)
  • hiccups
  • feeling sick
  • problems of the skin including bruises, thinning of skin, red spots under the skin, acne, increased sweating, flushing and reduced healing capacity
  • increased levels of blood cells, shown in blood tests
  • formation of blood clots and rupture following a recent heart attack
  • complications following treatment for cancer.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Go to top of the page

5. How to store Prednisolone Tablets

Keep out of the reach and sight of children.

  • do not store above 25°C
  • do not take Prednisolone Tablets after the expiry date stated on the packaging. The expiry date refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

Go to top of the page

6. Further information

What Prednisolone Tablets contain

The active ingredient is prednisolone.

Each Prednisolone 1mg Tablet contains 1mg of prednisolone. Each Prednisolone 5mg Tablet contains 5mg of prednisolone.

The other ingredients are lactose, maize starch, stearic acid, purified talc and magnesium stearate.

What Prednisolone Tablets look like and the contents of the pack:

Prednisolone 1mg Tablets are white circular, flat-faced tablets with a break line and marked CP on one side and PL1 on the other side.

Prednisolone 5mg Tablets are white circular, flat-faced tablets with a break line and marked CP on one side and PL5 on the other side.

Both strengths of tablet are available in 1000 tablet containers or 28 tablet blister packs.

Marketing Authorisation Holder:

Wockhardt UK Ltd
Ash Road North
Wrexham
LL13 9UF
UK

Manufacturer:

CP Pharmaceuticals Ltd
Ash Road North
Wrexham
LL13 9UF
UK
Go to top of the page

Leaflet Prepared: August 2012.

103498/5

215317


Text size normal Text size at 110% Text size at 120%

CHANGE FORMAT

 

USEFUL INFO

 

QUICK LINKS