PREDNISOLONE TABLETS BP 1 MG - patient leaflet, side effects, dosage

Package Leaflet: Information for the user

PREDNISOLONE TABLETS B.P. 1 mg

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 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 it for more than 3 weeks, you will get a blue ‘Steroid card': always keep it with you and show it to a 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

The name of this medicine is Prednisolone Tablets BP 1 mg (referred to as Prednisolone Tablets throughout this leaflet).

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

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

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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:

• inflammatory disorders affecting the lungs (including asthma), muscles and joints

(including Rheumatoid Arthritis), bowels, kidneys, blood vessels and heart, eyes, nervous system

• allergies, including severe allergic reactions
• skin conditions
• some cancers, blood disorders and infections
• to help prevent the body rejecting transplants.

They are also given when the body is not making enough of its own natural steroids and to treat high calcium levels. They may also be used to reduce a very high body temperature.

You must talk to a doctor if you do not feel better or if you feel worse.

2. what you need to know before you take prednisolone tablets

Do not take Prednisolone Tablets if you:

• are allergic (hypersensitive) to prednisolone, other steroids, or any other ingredients contained in these tablets (see Section 6)
• have an infection which is not being treated
• have a herpes infection of the eye
• are suffering from galactose or lactose intolerance or glucose-galactose malabsorption.
• If you have ever had severe depression or manic depression (bipolar disorder). This includes having had depression before 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.

Warnings and precautions

Talk to your doctor or pharmacist before you take Prednisolone Tablets if you have:

• diabetes or a history of diabetes in your family
• tuberculosis, or have ever been treated for it
• glaucoma, or a history of glaucoma in your family
• an eye disease affecting your sight due to fluid build-up at the back of the eye
• epilepsy, fits or seizures
• osteoporosis (bone thinning)
• gone through, or are going through, the menopause
• high blood pressure, a heart condition or have recently had a heart attack
• liver or kidney problems
• a stomach ulcer, or have had one in the past
• hypothyroidism (an underactive thyroid gland)
• ever had a blood clot inside a blood vessel, for example a DVT (deep vein thrombosis)
• Cushing’s disease
• ever had muscle weakness caused by treatment with steroids a muscle weakness disorder called Myasthenia Gravis for which you are being treated
• Duchene’s muscular dystrophy a condition that is being treated with medicines that suppress your immune system e.g. for cancer or after a transplant
• Phaeochromocytoma
• attacks causing dramatic increases in blood pressure, heart rate and/or headaches
• 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.

Also talk to your doctor or pharmacist before you take Prednisolone Tablets if you need or are planning to have a vaccination.

If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before you take Prednisolone Tablets.

Children and adolescents

Steroid treatment can slow down the growth of children and adolescents. Your doctor should monitor this and may need to adjust the dose for your child.

Other medicines and Prednisolone Tablets

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines including any preparations you may have purchased yourself.

The following medicines can affect or can be affected by prednisolone:

• medicines for diabetes, including insulin
• medicines to treat epilepsy, such as carbamazepine, phenytoin, phenobarbital, primidone
• anticoagulants, used to thin the blood, e.g. warfarin
• antithyroid medicines, used to reduce the amount of thyroid hormones produced, e.g. carbimazole, thiamazole
• antacid medicines, used for indigestion
• aspirin
• non-steroidal anti-inflammatory drugs, used to treat pain and swelling, e.g. indometacin, ibuprofen
• certain medicines used to treat bacterial infections, including rifampicin, rifabutin, erythromycin
• certain medicines used to treat fungal infections, including amphotericin, ketoconazole
• certain medicines used to treat viral infections, including ritonavir
• certain types of vaccines; tell your doctor or nurse you are taking prednisolone before you are given any vaccinations. You must not be given any live vaccines.
• mifepristone, a drug used to terminate pregnancy and induce labour
• oral contraceptives (the ‘pill’)
• oestrogens, a type of female hormone, e.g. in hormone replacement therapy (HRT)
• medicines to treat high blood pressure
• diuretics (“water tablets”)
• digoxin and related cardiac glycoside drugs, used to treat heart failure and rhythm disorders
• medicines used to relieve asthma, e.g. salbutamol, sameterol, bambuterol, terbutaline,

formoteral, fenoteral, ritodrine

• theophylline
• ciclosporin and other drugs that suppress the immune system
• drugs to treat cancer
• drugs which have anticholinergic effects; these include some medicines for Parkinson’s di­sease, asthma or bronchitis, stomach cramps, motion sickness, bladder problems, allergies, medicines used to relax muscles during surgery. Check with your doctor or pharmacist.

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• methotrexate
• acetazolamide
• carbenoxolone
• aminoglutethimide
• somatropin (growth hormone)
• troleandomycin

When you are first prescribed prednisolone you should be given a Steroid Treatment Card, which you should carry with you at all times to show any doctor, dentist, nurse or anyone else who is giving you medical treatment.

If you are going to have surgery tell your doctor or dentist that you are taking Prednisolone Tablets. Prednisolone Tablets may reduce the effect of some medicines used to relax muscles during surgery, e.g. pancuronium, vecuronium.

Prednisolone with food and drink

Avoid eating liquorice while taking prednisolone.

Pregnancy and breast-feeding

If you are pregnant, 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, tell your doctor before you start taking this medicine. Small amounts of corticosteroid will pass into your breast milk. Your doctor will decide if you should take this 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.

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

Your doctor has decided the dose which is best for you. Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual starting dose depends on the illness being treated and your daily dose may be between 5 and 60 mg. Your doctor might tell you to take it every other day. Your doctor might reduce the dose once your condition starts to get better.

These tablets should be swallowed whole with a glass of water, preferably in the morning after food.

Stopping taking prednisolone: If you feel better whilst taking these tablets do not stop taking them. Rather continue with the course of treatment prescribed by your doctor. For patients receiving long-term treatment, your doctor may wish to monitor your progress closely (especially if you are elderly).

If you have been on a long-term course of treatment your doctor may decide to cut your dose gradually to avoid the serious risks associated with stopping suddenly.

Stopping treatment too quickly or reducing dosage too severely may be life threatening in some patients.

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Use in children and adolescents

Steroids can slow down normal growth. To lessen the effect the doctor may prescribe a dose to be taken every other day.

If any of the following happen while you are taking Prednisolone Tablets tell your doctor straight away:

• If you or a close contact catches chickenpox or develops shingles. This is because you may become very ill if you get chickenpox while taking prednisolone. Avoid contact with people who have chickenpox or shingles while taking prednisolone and for three months after you have stopped taking it.
• If you or a close contact catches measles. Avoid contact with people who have measles.
• If you think you might have an infection. Infections can be worse when taking steroids and need to be treated.

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 take too many tablets, you must seek medical help straight away from your doctor or nearest hospital casualty department. Take any remaining tablets and the container with you. It will help your doctor.

If you forget to take Prednisolone Tablets:

If you forget to take a dose at the right time, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose. If it is almost time for your next dose wait until then, and then carry on as before.

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.

Stop taking Prednisolone Tablets and seek immediate medical help if you develop any of the following: sudden swelling of the face, lips, tongue or body, wheezing or difficulty breathing, feeling faint, shock and collapse. You may be having a severe allergic reaction.

Serious effects: tell a doctor straight away

• severe abdominal pain.

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.

• 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:

• increased susceptibility to infections, worsening of existing infections including eye infections, flare-up of previous infections e.g. tuberculosis
• candida (thrush) infection, causing a sore mouth and throat
• lesser reaction to skin tests e.g. for tuberculosis
• high blood pressure
• heart problems that may cause cough or shortness of breath
• swelling or puffiness, particularly around the ankles and feet
• heart muscle weakness following a heart attack
• slow heart rate
• blood clots inside blood vessels, higher risk of stroke
• putting on weight
• worsening of schizophrenia
• worsening of epilepsy, fits
• increase in blood glucose levels
• upset of diabetes control; showing-up of diabetes
• inability to digest certain carbohydrates (symptoms include diarrhoea, bloating and

flatulence)

• indigestion, pain when swallowing, pain in the chest or abdomen, feeling full or bloated,

diarrhoea

• feeling sick or being sick
• vertigo (a feeling that you or your surroundings are moving)
• loss of eye sight, blurred or double vision, increased pressure inside the eye (glaucoma), bulging eyes, thinning of the eye tissues, eye pain
• buzzing in the ears
• headache
• feeling dizzy, confused, dazed or drowsy
• weakness in arms, legs or down one side of the body
• back pain
• bone, joint or tendon pain; osteoporosis (bone thinning), weakening of the bones, bone fractures, damage to tendons
• muscle disease, causing weakness or wasting, muscle pain
• slower than normal growth of infants, children and adolescents
• Cushing’s Syndrome, (symptoms include sudden weight gain around the trunk and face , the face appears round)
• extra hair growth
• thinning of the skin, slow wound healing, bruising, stripes on the skin, small blood vessels appearing near the surface of the skin, acne
• skin rash, hives, itching
• sweating more than usual
• irregular menstrual periods or periods stopping completely
• feeling hungrier than usual, increased appetite, weight gain
• changes in the balance of minerals in the body, breakdown of body proteins
• increased levels of cholesterol and altered levels of fats in the blood
• increased number of white blood cells
• feeling tired or generally unwell
• feeling dependent on, or addicted to, this medicine
• scleroderma renal crisis in patients already suffering from scleroderma (an autoimmune disorder). Signs of scleroderma renal crisis include increased blood pressure and decreased urine production.

There is an increased risk of stomach bleeding and ulcers when used with aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs). Signs of stomach bleeding can be black tarry stools or vomiting.

In children and adolescents, prolonged high doses can stunt growth.

Reporting of side effects

If you get any side effects, talk to your doctor, 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: or search for MHRA Yellow Card in the Google Play or Apple App Store.

5. how to store prednisolone tablets

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

• Do not use the tablets after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
• Store in a dry place below 25°C and protect from light.

6. contents of the pack and other information

What Prednisolone Tablets contain

The active substance is prednisolone. Each tablet contains 1 mg prednisolone.

The other ingredients are lactose (see section 2 ‘Prednisolone Tablets contain lactose’), starch, magnesium stearate and sodium Iauryl sulphate.

What Prednisolone Tablets look like and contents of the pack

This pack contains small, white, uncoated tablets.

Prednisolone Tablets 1 mg are available in packs containing 50, 100 and 500. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Intrapharm Laboratories Ltd, The Courtyard Barns, Choke Lane, Cookham Dean, Maidenhead, Berkshire SL6 6PT, United Kingdom.

Manufacturer

Norbrook Laboratories Limited, Newry, Co. Down, Northern Ireland.

This leaflet was last revised in April 2021

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