PREDNISOLONE TABLETS BP 5 MG - patient leaflet, side effects, dosage

PREDNISOLONE TABLETS BP

1 mg and 5 mg

[prednisolone]

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, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Important things you need to know about Prednisolone Tablets

• 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 can cause side effects in some people (see section 4). Some side effects 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 round face (see section 4).
• If you take this medicine for more than 3 weeks, you will be given 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.

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.

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

The name of this medicine is Prednisolone Tablets BP 1mg and 5mg but is referred to as Prednisolone Tablets throughout this leaflet.

Prednisolone is one of a group of medicines called corticosteroids, prescribed for many different conditions including serious illness. You need to take regularly to get maximum benefit.

These medicines work by providing relief for inflamed areas of the body. They lessen swelling, redness, itching and allergic reactions.

Prednisolone may be used for:

• Blood disorders, such as anaemia and leukaemia.
• Certain skin and kidney problems.
• Ulcerative colitis and other stomach problems such as Crohn’s disease.
• Asthma and other lung diseases.
• Severe allergies.
• Diseases of the connective tissue collagen, such as rheumatic fever and systemic lupus erythematosus.
• Joint disease, such as certain forms of arthritis.

2. what you need to know before you take 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). (An allergic reaction may include a rash, itching or difficulty breathing).
• If you have an untreated infection.
• If you are being treated with live vaccines.
• If you have cold sores that affect the eyes.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Prednisolone Tablets:

• If you have been in contact with anyone who has chickenpox, shingles or measles. Contact your doctor immediately for advice.
• If you have or have a family history of diabetes or glaucoma.
• If you have osteoporosis, high blood pressure, a recent heart attack, a stomach ulcer, an underactive thyroid gland, epilepsy, seizures, tuberculosis or septicaemia.
• If you have taken prednisolone tablets (or a similar medicine) before and had muscular problems (steroid myopathy).
• If you have heart, kidney or liver problems/disease.
• If you suffer or have suffered from any mental illness.
• If you are to be treated with a live vaccine. Live vaccines should not be used until at least 3 months after stopping corticosteroid treatment.
• If you have ever had severe depression or manic-depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Prednisolone Tablets or any of your close family has had these illnesses.
• If you have Scleroderma (also known as systemic sclerosis, an autoimmune disorder) because daily doses of 15 mg or more may increase the risk of a serious complication called scleroderma renal crisis. Signs of scleroderma renal crisis include increased blood pressure and decreased urine production. The doctor may advise that you have your blood pressure and urine regularly checked.
• If you suffer from a muscle disease causing muscle weakness and fatigue.
• If you have a blood clotting disorder.
• If you are due to go for an operation as you need to inform your anaesthetist.
• If you have Cushing’s disease (a hormone imbalance).

If any of the above applies to you or if you are not sure, talk to your doctor before taking this medicine.

Contact your doctor if you experience blurred vision or other visual disturbances.

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.

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:

• Medicines used to treat pain e.g. aspirin, non-steroidal anti -inflammatory drugs such as indomethacin, phenylbutazone.
• Medicines used to treat certain types of cancer e.g. aminoglutethimide, methotrexate, etoposide.
• Medicines which contain oestrogens e.g. oral contraceptives and hormone replacement therapy.
• Medicines used as emergency contraceptives e.g. mifepristone.
• Medicines used to treat epilepsy e.g. carbamazepine, phenobarbital, phenytoin, primidone, phenylbutazone and any other barbiturates.
• Medicines used to treat infections e.g. rifampicin, rifabutin, erythromycin, tetracyclines, amphotericin, ketoconazole.
• Medicines used to treat gastrointestinal ulcers e.g. carbenoxolone.
• Medicines used to stop your blood clotting e.g. warfarin.
• Medicines to treat diabetes (including insulin).
• Medicines to treat HIV infections e.g. ritonavir.
• Medicines used to relax muscles e.g. pancuronium and vercuronium.
• Medicines used to treat growth hormone deficiency e.g somatropin.
• Medicines used to treat heart conditions e.g. cardiac glycosides.
• Medicines used to treat respiratory illness including asthma e.g. theophylline, and high doses of bambuterol, fenoteral, ritodrine, salbutamol, salmeterol and terbutaline.
• Medicines to treat high blood pressure (including water tablets).
• Medicines which you can buy without a prescription.
• Antacids for indigestion.
• Retinoids for skin conditions.
• Carbimazole to treat hyperthyroidism.
• Ciclosporin used to prevent organ transplant rejection.

Pregnancy and breast-feeding

If you become pregnant, or are planning to become pregnant, you must contact your doctor or pharmacist to discuss the potential adverse effects, and the benefits and risks of your Prednisolone therapy to you and your child. Pregnant women should be treated only if the expected benefit outweighs the possible risks to the pregnant woman and foetus.

Driving and using machines

If you do not have enough sleep you may be less alert and patients should make sure they are not affected before driving or operating machinery.

Prednisolone Tablets contain 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 prednisolone tablets

You will be supplied with a ‘Steroid Treatment Card’ which includes important details of your treatment. This card should be carried at all times.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Swallow the tablets with water in the morning after breakfast unless otherwise directed by the doctor.

The recommended doses are:

Adults: The usual initial dose is 20 to 80 mg daily as required for control, followed by a gradual reduction to a maintenance dose of 5 to 20 mg daily.

Elderly: Doses may be adjusted by the doctor depending on the severity of the side effects.

Use in children and adolescents

Children do not take as many tablets as adults. Your doctor will tell you the correct number of tablets for them to take.

Children should not take as many tablets as adults. Your doctor will suggest the correct number of tablets for them to take. Your doctor may advise you to take this medicine in a different way for example taking a different dose of Prednisolone Tablets every other day in the morning only.

Once a dose is established, it may be changed to use the lowest effective dose depending on your response to the drug.

If you are diabetic, you may find that you need to take more medication to balance the effect of Prednisolone Tablets. You should discuss this with your doctor.

Your doctor should check your progress at regular visits. Also, your progress may have to be checked after you have stopped using this medicine, since some of the effects may continue.

If you take more Prednisolone Tablets than you should

Do not take more tablets than your doctor tells you to. If an overdose of Prednisolone Tablets has been taken go to the nearest hospital casualty department or tell your doctor immediately. Take the container and any remaining tablets with you to show to the doctor.

If you forget to take Prednisolone Tablets

If you forget to take a dose, take one as soon as you remember. Then go on as before. Do not take a double dose to make up for a forgotten dose. If you are worried ask your pharmacist or doctor for advice.

If you stop taking Prednisolone Tablets

If you stop taking the tablets suddenly you may develop muscle or joint pain, conjunctivitis, fever, weight loss, painful itchy skin lumps or runny nose.

Talk to your doctor before you stop taking the tablets and follow their advice.

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

4. possible side effects

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

Please tell your doctor or pharmacist if you notice any of the following effects or any effects not listed.

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.

Tell your doctor straight away if the following happens:

• Inflammation of the pancreas (very severe abdominal pains).
• Steroids including Prednisolone Tablets 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. These side effects include:

• – 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 (hallucinations). Having strange and frightening thoughts, changing how you act or having feelings of being alone

• – feeling dependant or addicted to this product.

5. how to store prednisolone tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Do not store above 25°C. Keep in the original container.

Do not use this medicine if you notice visible signs of deterioration.

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.

6. contents of the pack and other information

What Prednisolone Tablets contain

The active substance is Prednisolone.

The other ingredients are lactose (see section 2), maize starch, sodium starch glycollate, stearic acid, magnesium stearate, colloidal silicon dioxide, starch paste 15%.

What Prednisolone Tablets looks like and contents of the pack

Prednisolone Tablets BP 5 mg : White, circular flat beveled edged tablets with breakline on one side and plain on the other side.

Contents of pack: Blister pack.

14 tablets in a blister, 2 blisters in a carton.

Marketing Authorisation Holder and Manufacturer Strides Pharma UK Ltd.

Unit 4, Metro Centre,

Tolpits Lane, Watford, Herts, UK, WD18 9SS

This leaflet was last revised in 05/2021.

BACK PAGE

190 × 310 mm