Prednisolone 5mg tablets

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:
Prednisolone
Available from:
Genesis Pharmaceuticals Ltd
ATC code:
H02AB06
INN (International Name):
Prednisolone
Dosage:
5mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 01050000; GTIN: 5060014442758
Authorization number:
PL 06453/0055

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Package leaflet: Information for the user

Prednisolone 5 mg Soluble Tablets

(Prednisolone sodium phosphate)

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 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.

Read all of this leaflet carefully before you start using 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.

What is in this leaflet:

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

2. What you need to know 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. Contents of the pack and other information

1. WHAT PREDNISOLONE SOLUBLE TABLETS

ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Prednisolone Soluble Tablets. This

medicine contains the active ingredient prednisolone which belongs to

a group of medicines called corticosteroids or “steroids”.

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. You must take this medicine

regularly to get maximum benefit from it.

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. WHAT YOU NEED TO KNOW BEFORE YOU

TAKE PREDNISOLONE SOLUBLE

TABLETS

Do not take

Prednisolone Soluble tablets:

if you

are allergic to prednisolone or any of the other ingredients

of Prednisolone Soluble Tablets (listed in section 6). (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)

if you have recently had a vaccination or have a vaccination

planned;

if you 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking Prednisolone

5 mg Tablet if you have or 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)

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 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.

Contact your doctor if you experience blurred vision or other visual

disturbances.

Other medicines and Prednisolone Soluble tablets

Tell your doctor if you are taking, have recently taken or might take 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);

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).

some medicines may increase the effects of Prednisolone Soluble

Tablets and your doctor may wish to monitor you carefully if you are

taking these medicines (including some medicines for HIV: ritonavir,

cobicistat)

Pregnancy, breast-feeding and fertility

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.

Driving and using machines

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.

Prednisolone Soluble Tablets contain sodium

This medicinal product contains sodium 27.24 mg per tablet. To be

taken into consideration by patients on a controlled sodium diet.

3. HOW TO TAKE PREDNISOLONE SOLUBLE

TABLETS

Always take Prednisolone Soluble Tablets exactly as your doctor or

pharmacist has told you. Check with your doctor or pharmacist

if you are not sure.

The recommended dose is:

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.

Use in children and adolescents:

To treat asthma attacks:

Children above 2 years – the doctor will decide the most appropriate

dose to treat your child.

Children under 2 years – may be treated in the hospital.

Treatment for up to three days is usually enough, but may be longer.

Method of administration:

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.

If you take more Prednisolone Soluble 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 Prednisolone Soluble tablets

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.

If you stop taking Prednisolone Soluble tablets

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 have any further questions on the use of this medicine, ask your

doctor, pharmacist or nurse.

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:

Not known (frequency cannot be estimated from the available data)

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;

intolerance to carbohydrates;

mood changes, dependence, depression, difficulty sleeping,

worsening of schizophrenia;

severe headaches with blurred vision or temporary visual problems in

children (usually after stopping treatment);

worsening of epilepsy;

raised pressure in the eyes (glaucoma), cataracts, thinning and

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;

blurred vision;

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;

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 consisting of raised, red, purple,

or brown skin lesion) has also been reported to occur in patients

receiving corticosteroids. Stopping treatment may alleviate these

symptoms.

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.

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:

www.mhra.gov.uk/yellowcard

or search for

MHRA Yellow Card in the Google Play or Apple App Store. By

reporting side effects

you can help provide more information on the

safety of

this medicine.

5. HOW TO STORE PREDNISOLONE SOLUBLE

TABLETS

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

Do not use this medicine after the expiry date stated on

the carton

and blister. The expiry date refers to the last

day of that month.

Do not store above 25°C. Store in the original package.

Protect from light.

Do not use this medicine if you notice any visible signs of

deterioration of the blister pack or the tablets. Return it to

your

pharmacist.

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 to protect the environment.

6. FURTHER INFORMATION

What

Prednisolone Soluble Tablets

contain

The active ingredient is prednisolone.

Each tablet contains 5mg

prednisolone as the sodium phosphate ester.

The other ingredients are povidone,

sodium acid citrate, sodium

bicarbonate,

sodium benzoate (E 211), erythrosine (E127) and sodium

saccharin.

What

Prednisolone Soluble Tablets

look like and

contents of

the pack

Pink, round tablets engraved ‘PRED 5’ on one side and a scoreline

on the other. The scoreline allows the tablet to be divided into

equal parts.

The pack contains 30 tablets in blister strips of 10.

Manufactured by Losan Pharma GmbH, Otto-Hahn-Strasse 13,

D-79395, Neuenburg, Germany.

Procured from within the EU by PL Holder PilsCo Ltd, 10-16 Colvilles

Place, East Kilbride, G75 0SN.

PL 39467/0230 Prednisolone Soluble Tablets 5 mg POM

Blind or partially sighted?

Is this leaflet hard to see or read?

Call 0800 198 5000 to obtain the

leaflet in a format suitable for you.

This leaflet was last revised in 24/07/2018.

PIL0230.5

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Prednisolone Tablets BP 5 mg

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 5 mg prednisolone.

Excipients with known effect: each tablet contains lactose (72 mg).

For the full list of excipients see Section 6.1.

3

PHARMACEUTICAL FORM

Uncoated tablets for oral administration.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Allergy and anaphylaxis: bronchial asthma, drug hypersensitivity reactions, serum

sickness, angioneurotic oedema, anaphylaxis.

Arteritis/collagenosis: giant cell arteritis/polymyalgia rheumatica, mixed connective

tissue disease, polyarteritis nodosa, polymyositis.

Blood disorders: haemolytic anaemia (auto-immune), leukaemia (acute and chronic

lymphocytic), lymphoma, multiple myeloma, idiopathic thrombocytopenic purpura.

Cardiovascular disorders: post-myocardial infarction syndrome, rheumatic fever

with severe carditis.

Endocrine disorders: primary and secondary adrenal insufficiency, congenital

adrenal hyperplasia.

Gastro-intestinal disorders: Crohn's disease, ulcerative colitis, persistent coeliac

syndrome (coeliac disease unresponsive to gluten withdrawal), auto-immune chronic

active hepatitis, multisystem disease affecting liver, biliary peritonitis.

Hypercalcaemia: sarcoidosis, vitamin D excess.

Infections (with appropriate chemotherapy): helminthic infestations, Herxheimer

reaction, infectious mononucleosis, miliary tuberculosis, mumps orchitis (adult),

tuberculous meningitis, rickettsial disease.

Muscular disorders: polymyositis, dermatomyositis.

Neurological disorders: infantile spasms, Shy-Drager syndrome, sub-acute

demyelinating polyneuropathy.

Ocular disease: scleritis, posterior uveitis, retinal vasculitis, pseudo-tumours of the

orbit, giant cell arteritis, malignant ophthalmic Graves disease.

Renal disorders: lupus nephritis, acute interstitial nephritis, minimal change

glomerulonephritis.

Respiratory disease: allergic pneumonitis, asthma, occupational asthma, pulmonary

aspergillosis, pulmonary fibrosis, pulmonary alveolitis, aspiration of foreign body,

aspiration of stomach contents, pulmonary sarcoid, drug induced lung disease, adult

respiratory distress syndrome, spasmodic croup.

Rheumatic disorders: rheumatoid arthritis, polymyalgia rheumatica, juvenile

chronic arthritis, systemic lupus erythematosus, dermatomyositis, mixed connective

tissue disease.

Skin disorders: pemphigus vulgaris, bullous pemphigoid, systemic lupus

erythematosus, pyoderma gangrenosum.

Miscellaneous: sarcoidosis, hyperpyrexia, Behçets disease, immunosuppression in

organ transplantation.

4.2

Posology and method of administration

The initial dose may vary up to 60 mg daily depending on the disorder being treated,

taken in the morning after food. The tablets should be taken with a drink of water.

The following therapeutic guidelines should be kept in mind for all therapy with

corticosteroids:

Corticosteroids are palliative symptomatic treatment by virtue of their anti-

inflammatory effects; they are never curative.

The appropriate individual dose must be determined by trial and error and must be re-

evaluated regularly according to activity of the disease.

As corticosteroid therapy becomes prolonged and as the dose is increased, the

incidence of disabling side-effects increases.

In general, the initial dose should be maintained or adjusted until the anticipated

response is noted. The dose should be gradually reduced until the lowest dose which

will maintain an adequate clinical response is reached. Use of the lowest effective

dose may also minimise side-effects (see Section 4.4).

In patients who have received more than physiological doses of systemic

corticosteroids (approximately 7.5 mg prednisolone or equivalent) for greater than 3

weeks, withdrawal should not be abrupt. How dose reduction should be carried out

depends largely on whether the disease is likely to relapse as the dose of systemic

corticosteroids is reduced. Clinical assessment of disease activity may be needed

during withdrawal. If the disease is unlikely to relapse on withdrawal of systemic

corticosteroids but there is uncertainty about hypothalamic-pituitary-adrenal (HPA)

suppression, the dose of systemic corticosteroid may be reduced rapidly to

physiological doses. Once a daily dose equivalent to 7.5 mg of prednisolone is

reached, dose reduction should be slower to allow the HPA-axis to recover.

Abrupt withdrawal of systemic corticosteroid treatment, which has continued up to 3

weeks, is appropriate if it is considered that the disease is unlikely to relapse. Abrupt

withdrawal of doses of up to 40 mg daily of prednisolone, or equivalent for 3 weeks

is unlikely to lead to clinically relevant HPA-axis suppression, in the majority of

patients. In the following patient groups, gradual withdrawal of systemic

corticosteroid therapy should be considered even after courses lasting 3 weeks or less:

patients who have had repeated courses of systemic corticosteroids, particularly if

taken for greater than 3 weeks,

when a short course has been prescribed within one year of cessation of long-term

therapy (months or years),

patients who may have reasons for adrenocortical insufficiency other than

exogenous corticosteroid therapy,

patients receiving doses of systemic corticosteroid greater than 40 mg daily of

prednisolone (or equivalent),

patients repeatedly taking doses in the evening.

(See Section 4.4. and Section 4.8)

During prolonged therapy dosage may need to be temporarily increased during

periods of stress or during exacerbations of the disease (see Section 4.4).

If there is a lack of a satisfactory clinical response prednisolone should be gradually

discontinued and the patient transferred to alternative therapy.

Intermittent dosage regimen A single dose of prednisolone tablets in the morning

on alternate days or at longer intervals is acceptable therapy for some patients. When

this regimen is practical, the degree of pituitary-adrenal suppression can be

minimised.

Specific dosage guidelines

The following recommendations for some corticosteroid-responsive disorders are for

guidance only. Acute or severe disease may require initial high dose therapy with

reduction to the lowest effective maintenance dose as soon as possible. Dosage

reductions should not exceed 5 - 7.5 mg daily during chronic treatment.

Allergic and skin disorders Initial doses of 5-15 mg daily are commonly adequate.

Collagenosis Initial doses of 20-30 mg daily are frequently effective. Those with

more severe symptoms may require higher doses.

Rheumatoid arthritis The usual initial dose is 10-15 mg daily. The lowest daily

maintenance dose compatible with tolerable symptomatic relief is recommended.

Blood disorders and lymphoma An initial daily dose of 15-60 mg is often necessary

with reduction after an adequate clinical or haematological response. Higher doses

may be necessary to induce remission in acute leukaemia.

Special populations

Use in elderly

Treatment of elderly patients, particularly if long-term, should be planned bearing in

mind the more serious consequences of the common side-effects of corticosteroids in

old age (see also Section 4.4).

Use in children

Although appropriate fractions of the actual dose may be used, dosage will usually be

determined by clinical response as in adults (see also Section 4.4 and Section 4.8).

Alternate day dosage is preferable where possible.

4.3

Contraindications

Systemic infections, unless specific anti-infective therapy is used.

Hypersensitivity to prednisolone or any of the excipients (see Section 6.1).

Ocular herpes simplex because of possible perforation.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase

deficiency or glucose-galactose malabsorption should not take this medicine.

4.4

Special warnings and precautions for use

Undesirable effects may be minimised by using the lowest effective dose for

the minimum period and by administering the daily requirement as a single

morning dose on alternate days. Frequent patient review is required to titrate

the dose appropriately against disease activity (see Section 4.2).

Patients and/or carers should be warned that potentially severe psychiatric

adverse reactions may occur with systemic steroids (see Section 4.8).

Symptoms typically emerge within a few days or weeks of starting the

treatment. Risks may be higher with high doses/systemic exposure (see also

section 4.5 pharmacokinetic interactions that can increase the risk of side

effects), although dose levels do not allow prediction of the onset, type,

severity or duration of reactions. Most reactions recover after either dose

reduction or withdrawal, although specific treatment may be necessary.

Patients/carers should be encouraged to seek medical advice if worrying

psychological symptoms develop, especially if depressed mood or suicidal

ideation is suspected. Patients/carers should also be alert to possible

psychiatric disturbances that may occur either during or immediately after

dose tapering/withdrawal of systematic steroids, although such reactions have

been reported infrequently.

Particular care is required when considering the use of systematic

corticosteriods in patients with existing or previous history of severe affective

disorders in themselves or in their first degree relatives. These would include

depressive or manic-depressive illness and previous steroid psychosis.

Psychic derangements may appear when corticosteroids are used, ranging

from euphoria, insomnia, mood swings, personality changes and severe

depression to frank psychotic manifestations (see Section 4.8).

Anti-Inflammatory/Immunosuppressive Effects

Suppression of the inflammatory response and immune function increases the

susceptibility of infections and their severity. The clinical presentation may

often be atypical and serious infections such as septicaemia and tuberculosis

may be masked and may reach an advance stage before being recognised. The

immunosuppresive effects of glucocorticoids may result in activation of latent

infection or exacerbation of intercurrent infections.

Chickenpox: Chickenpox is of particular concern since this normally minor

illness may be fatal in immunosuppressed patients. Patients (or parents of

children) without a definite history of chickenpox should be advised to avoid

close personal contact with chickenpox or herpes zoster and if exposed they

should seek urgent medical attention. Passive immunisation with

varicella/zoster immunogloblin (VZIG) is needed by exposed non-immune

patients who are receiving systemic corticosteroids or who have used them

within the previous 3 months; this should be given within 10 days of exposure

to chickenpox. If a diagnosis of chickenpox is confirmed, the illness warrants

specialist care and urgent treatment. Corticosteroids should not be stopped and

the dose may need to be increased.

Measles: Patients should be advised to take particular care to avoid exposure

to measles, and to seek immediate medical advice if exposure occurs.

Prophylaxis with intramuscular normal immunoglobulin may be needed.

Tuberculosis: Caution is necessary and frequent monitoring required when

prescribing corticosteroids for patients with a history of tuberculosis or X-ray

changes characteristic of tuberculosis. The emergence of active tuberculosis

may, however, be prevented by prophylactic use of anti-tuberculosis therapy

Administration of Live Vaccines: Live vaccines should not be given to

individuals on high doses of corticosteroids, due to impaired immune

response. Live vaccines should be postponed until at least 3 months after

stopping corticosteroid therapy. (See also Section 4.5). The antibody response

to other vaccines may be diminished.

Tumorigenicity: direct tumour-inducing effects of the glucocorticoids are not

known, but the particular risk that malignancies in patients undergoing

immunosuppression with these or other drugs will spread more rapidly is a

well-recognised problem (see Section 4.5).

Adrenocortical Insufficiency

Pharmacologic doses of corticosteroids administered for prolonged periods

may result in hypothalamic-pituitary-adrenal (HPA) suppression (secondary

adrenocortical insufficiency). The degree and duration of adrenocortical

insufficiency produced is variable among patients and depends on the dose,

frequency, time of administration and duration of glucocorticoid therapy.

In addition, acute adrenal insufficiency leading to a fatal outcome may occur if

glucocorticoids are withdrawn abruptly. Drug induced secondary

adrenocortical insufficiency may therefore be minimized by gradual reduction

of dosage. This type of relative insufficiency may persist for months after

discontinuation of therapy; therefore, in any situation of stress occurring

during that period, hormone therapy should be reinstituted. Since

mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid

should be administered concurrently. During prolonged therapy an intercurrent

illness, trauma, or surgical procedure will require a temporary increase in

dosage; if corticosteroids have been stopped following prolonged therapy they

may need to be temporarily re-introduced.

Patients should carry “Steroid treatment” cards which give clear guidance on

the precautions to be taken to minimise risk and which provide details of

prescriber, drug, dosage and the duration of treatment.

Special Precautions

Caution is necessary when oral corticosteroids, including prednisolone tablets,

are prescribed in patients with the following conditions and frequent patient

monitoring is necessary:

Osteoporosis; this is of special importance in post-menopausal females,

who are particularly at risk

Menopausal or post-menopausal women: corticosteroid requirements may

be reduced.

Hypertension.

Congestive heart failure.

Recent myocardial infarction.

Existing or previous history of severe affective disorders, especially

previous steroid-induced psychoses.

Emotional instability or psychotic tendencies; these may be aggravated by

corticosteroids including prednisolone.

Cushing’s Disease; glucocorticoids can produce or aggravate Cushing’s

Syndrome.

Diabetes mellitus or a family history of diabetes.

Previous history of tuberculosis or X-ray changes characteristic of

tuberculosis.

Glaucoma or a family history of glaucoma.

Idiopathic central serious chorioretinopathy; glucocorticoid treatment can

cause severe exacerbation of bullous exudative retinal detachment and

lasting visual loss in some patients (see Section 4.8)

Previous steroid-induced myopathy.

Liver failure.

Hepatic disease. In patients with acute and active hepatitis, protein

binding of glucocorticoids is reduced and peak concentrations of

administered glucocorticoids increased; elimination of prednisolone will

also be impaired. There is an enhanced effect of corticosteroids in patients

with cirrhosis.

Renal insufficiency.

Epilepsy and/or seizure disorders.

Peptic ulceration.

Hypothyroidism; the effect of corticosteroids may be enhanced.

Myasthenia gravis; glucocorticoids should be used carefully in patients

receiving anticholinesterase therapy.

Thromboembolic disorders; corticosteroids should be used with caution

since cortisone has been reported rarely to increase blood coagulability

and to precipitate intravascular thrombosis, thromboembolism and

thrombophlebitis.

Duchene’s muscular dystrophy; transient rhabdomyolysis and

myoglobinuria may occur following strenuous physical activity. It is not

known whether this is due to prednisolone itself or the increased physical

activity.

Phaeochromocytoma. Glucocorticoids should be avoided or administered

with caution in patients previously diagnosed with or currently under

investigation for possible phaeochromocytoma. Phaeochromocytoma

should be recalled as a differential diagnosis whenever patients take a

sudden turn for the worse, or have acute uncontrollable hypertension

following steroid administration.

Prolonged use of corticosteroids may produce posterior subcapsular cataracts

and nuclear cataracts (particularly in children), exophthalmos, or increased

intraocular pressure, which may result in glaucoma with possible damage to

the optic nerves.

Establishment of secondary fungal and viral infections of the eye may also be

enhanced in patients receiving glucocorticoids.

Raised intracranial pressure with papilloedema (pseudotumour cerebri)

associated with corticosteroid treatment has been reported in both children and

adults. The onset usually occurs after treatment withdrawal (See section 4.8).

Inflammatory bowel disease: These tablets are not enteric coated. Symptoms

recurred in a patient with Crohn’s Disease on changing from non-enteric

coated to enteric coated tablets of prednisolone. This was not an isolated

occurrence in the author’s unit, and it was advocated that only non-enteric

coated prednisolone tablets should be used in Crohn’s disease, and that the

enteric coated form should be used with caution in any condition characterised

by diarrhoea or a rapid transit.

Use in the elderly

Treatment of elderly patients, particularly if long term, should be planned

bearing in mind the more serious consequences of the common side-effects of

corticosteroids in old age, especially osteoporosis, diabetes, hypertension,

hypokalaemia, susceptibility to infection and thinning of the skin. Close

clinical supervision is required to avoid life threatening reactions.

Paediatric population

Corticosteroids cause growth retardation in infancy, childhood and

adolescence, which may be irreversible, and therefore long-term

administration of pharmacological doses should be avoided. If prolonged

therapy is necessary, treatment should be limited to the minimum suppression

of the hypothalamo-pituitary adrenal axis and growth retardation. The growth

and development of infants and children should be closely monitored.

Treatment should be administered where possible as a single dose on alternate

days.

There is an increased risk of nuclear cataracts (see Section 4.8).

Scleroderma renal crisis

Caution is required in patients with systemic sclerosis because of an increased

incidence of (possibly fatal) scleroderma renal crisis with hypertension and

decreased urinary output observed with a daily dose of 15mg or more

prednisolone. Blood pressure and renal function (s-creatinine) should therefore

be routinely checked. When renal crisis is suspected, blood pressure should be

carefully controlled.

4.5

Interaction with other medicinal products and other forms of interaction

Vaccines

Live vaccines should not be given to individuals with

impaired immune responsiveness. The antibody response to

other vaccines may be diminished.

Antacids

The absorption of prednisolone may be reduced by large

doses of some antacids such as magnesium trisilicate or

aluminium hydroxide.

Antibacterials

Rifamycins accelerate metabolism of corticosteroids and

thus may reduce their effect. Erythromycin inhibits

metabolism of methylprednisolone and possibly other

corticosteroids.

Anticholinergics

Antimuscarinics Prednisolone has been shown to have

antimuscarinic activity. If used in combination with

another antimuscarinic drug could cause impairment to

memory and attention in the elderly.

Neuromuscular Blocking Agents: Corticosteroids may

antagonise the effects of neuromuscular-blocking agents,

such as pancuronium or vecuronium. Careful monitoring is

needed when neuromuscular blocking agents are used in

patients who have been treated with corticosteroids. An

increase in the dose of the neuromuscular blocker may be

required.

Anticoagulants

Response to anticoagulants may be reduced or, less often,

enhanced by corticosteroids. Close monitoring of the INR or

prothrombin time is required to avoid spontaneous bleeding.

Antidiabetic agents

Glucocorticoids may increase blood glucose levels. Patients

with diabetes mellitus receiving concurrent insulin and/or

oral hypoglycemic agents may require dosage adjustments

of such therapy.

Antiepileptics

Carbamazepine, phenobarbital, phenytoin, and primidone

accelerate metabolism of corticosteroids and may reduce

their effect.

Antifungals

Risk of hypokalaemia may be increased with amphotericin,

therefore concomitant use with corticosteroids should be

avoided unless corticosteroids are required to control

reactions; ketoconazole inhibits metabolism of

methylprednisolone and possibly other corticosteroids.

Antithyroids

Prednisolone clearance increased by the use of carbimazole

and thiamazole.

Cardiac Glycosides

Increased toxicity if hypokalaemia occurs with

corticosteroids.

Ciclosporin

Concomitant administration of prednisolone and ciclosporin

may result in decreased plasma clearance of prednisolone

(i.e. increased plasma concentration of prednisolone). The

need for appropriate dosage adjustment should be

considered when these drugs are administered

concomitantly.

Cytotoxics

Increased risk of haematological toxicity with methotrexate.

Hepatic microsomal

Drugs that induce hepatic enzyme cytochrome P-450 (CYP)

isoenzyme 3A4 such as phenobarbital, phenytoin,

enzyme inducers

rifampicin, rifabutin, carbamazepine, primidone and

aminoglutethimide may reduce the therapeutic efficacy of

corticosteroids by increasing the rate of metabolism. Lack of

expected response may be observed and dosage of

prednisolone tablets may need to be increased.

Hepatic microsomal

enzyme inhibitors

Drugs that inhibit hepatic enzyme cytochrome P-450 (CYP)

isoenzyme 3A4 (e.g. ketoconazole, troleandomycin) may

decrease glucocorticoid clearance. Dosages of

glucocorticoids given in combination with such drugs may

need to be decreased to avoid potential adverse effects.

Hormonal

contraceptives

Oral contraceptives increased prednisolone concentrations

by 131%.

May increase AUC and reduce clearance in oral

contraceptives containing ethinylestradiol, mestranol,

desogestrel, levonorgestrel, norgestrel or norethisterone.

Immunosupressants

Tumorigenicity: direct tumour-inducing effects of the

glucocorticoids are not known, but the particular risk that

malignancies in patients undergoing immunosupression with

these or other drugs will spread more rapidly is a well-

recognised problem.

Liquorice

Glycyrrhizin can delay the clearance of prednisolone.

Mifepristone

Effect of corticosteroids may be reduced for 3-4 days after

mifepristone.

Non-steroidal anti-

inflammatory

drugs

Concomitant administration of ulcerogenic drugs such as

indomethacin during corticosteroid therapy may increase the

risk of GI ulceration. Aspirin should be used cautiously in

conjunction with glucocorticoids in patients with

hypoprothrombinaemia. Although concomitant therapy with

salicylate and corticosteroids does not appear to increase the

incidence or severity of GI ulceration, the possibility of this

effect should be considered.

Serum salicylate concentrations may decrease when

corticosteroids are administered concomitantly.

The renal clearance of salicylates is increased by

corticosteroids and steroid withdrawal may result in

salicylate intoxication. Salicylates and corticosteroids should

be used concurrently with caution.

Patients receiving both drugs should be observed closely for

adverse effects of either drug.

Oestrogens

Oestrogens may potentiate the effects of glucocorticoids and

dosage adjustments may be required if oestrogens are added

to or withdrawn from a stable dosage regimen.

Protease

Inhibitors

Antivirals

Ritonavir possibly increases plasma concentrations of

prednisolone and other corticosteroids by reduction in

clearance of prednisolone through the inhibition of P450

isoenzyme CYP3A4.

Other

The desired effects of hypoglycaemic agents (including

insulin), antihypertensives and diuretics are antagonised by

corticosteroids; and the hypokalaemic effect of

acetazolamide, loop diuretics, thiazide diuretics,

carbenoxolone and theophylline are enhanced.

Somatropin

Growth promoting effect may be inhibited.

Sympathomimetics

Increased risk of hypokalaemia if high doses of

corticosteroids given with high doses of bambuterol,

fenoteral, formoterol, ritodrine, salbutamol, salmeterol and

terbutaline.

4.6

Fertility, pregnancy and lactation

Use in pregnancy

The ability of corticosteroids to cross the placenta varies between individual drugs,

however, 88% of prednisolone is inactivated as it crosses the placenta.

Administration of corticosteroids to pregnant animals can cause abnormalities of

foetal development including cleft palate, intra-uterine growth retardation affects on

brain growth and development. There is no evidence that corticosteroids result in an

increased incidence of congenital abnormalities, such as cleft palate/lip in man.

However, when administered for prolonged periods or repeatedly during pregnancy,

corticosteroids may increase the risk of intra-uterine growth retardation.

Hypoadrenalism may, in theory, occur in the neonate following prenatal exposure to

corticosteroids but usually resolves spontaneously following birth and is rarely

clinically important. Cataracts have been observed in infants born to mothers treated

with long-term prednisolone during pregnancy. As with all drugs, corticosteroids

should only be prescribed when the benefits to the mother and child outweigh the

risks. When corticosteroids are essential however, patients with normal pregnancies

may be treated as though they were in the non-gravid state.

Patients with pre-eclampsia or fluid retention require close monitoring.

Use in lactation

Corticosteroids are excreted in small amounts in breast milk. Corticosteroids

distributed into breast milk may suppress growth and interfere with endogenous

glucocorticoid production in nursing infants. Since adequate reproductive studies

have not been performed in humans with glucocorticoids, these drugs should be

administered to nursing mothers only if the benefits of therapy are judged to outweigh

the potential risks to the infant.

The concentration of the steroid in the milk can be between 5 and 25% of those in the

serum and the two roughly parallel one another after an oral dose.

There are no reports found regarding neonatal toxicity following exposure to

corticosteroids during lactation, however if maternal doses > 40 mg/day of

prednisolone is prescribed, the infant should be monitored for adrenal suppression.

4.7

Effects on ability to drive and use machines

The effect of Prednisolone Tablets on the ability to drive or use machinery has not

been evaluated. There is no evidence to suggest that prednisolone may affect these

abilities.

Read the complete document

MHRA PAR Prednisolone 5 mg Tablets BP, PL 06453/0055

PREDNISOLONE 5 MG TABLETS BP

PL 06453/0055

UKPAR

TABLE OF CONTENTS

Lay summary

Page 2

Scientific discussion

Page 3

Steps taken for assessment

Page 9

Summary of product characteristics

Page 10

Product information leaflet

Page 21

Labelling

Page 23

PREDNISOLONE 5 MG TABLETS BP

PL 06453/0055

LAY SUMMARY

The Medicines and Healthcare products Regulatory Agency granted Athlone

Laboratories Limited a Marketing Authorisation (licence) for the medicinal

product Prednisolone 5mg Tablets BP on 18 July 2006. This product is

available with a prescription only.

Synthetic corticosteroids similar to this product have been available in the

European Union, including the UK, for more than 10 years. Their use is well

established with recognised efficacy and acceptable safety.

Prednisolone 5mg Tablets BP raised no clinically significant safety concerns

and it was therefore judged that the benefits of using this product outweigh the

risks; hence a Marketing Authorisation has been granted.

MHRA PAR Prednisolone 5 mg Tablets BP, PL 06453/0055

PREDNISOLONE 5 MG TABLETS BP

PL 06453/0055

SCIENTIFIC DISCUSSION

TABLE OF CONTENTS

Introduction

Page 4

Pharmaceutical assessment

Page 5

Preclinical assessment

Page 6

Clinical assessment (including statistical assessment)

Page 7

Overall conclusions and risk benefit assessment

Page 8

MHRA PAR Prednisolone 5 mg Tablets BP, PL 06453/0055

INTRODUCTION

Based on the review of the data on quality, safety and efficacy the UK granted

a marketing authorisation for the medicinal product Prednisolone 5mg Tablets

BP (PL 06453/0055) to Athlone Laboratories Limited. This product is a

POM.

This national application for Prednisolone 5mg Tablets BP is submitted under

EC, Article 10c of Directive 2001/83/EC.

Prednisolone

tablets

contain

active

ingredient

prednisolon,

glucocorticoid that reduces inflammation. Prednisolone tablets are, therefore,

indicated in a variety of diseases that cause inflammation; such as bronchial

asthma or rheumatoid arthritis (for a fuller list see Summary of Product

Characteristics on page 10 of this report).

MHRA PAR Prednisolone 5 mg Tablets BP, PL 06453/0055

PHARMACEUTICAL ASSESSMENT

INTRODUCTION

This is an abridged application made under Article 10c of EC Directive

2001/83 and is considered to be an identical product to that of Prednisolone

Tablets 5mg (PL 08215/0006) licensed to Kent Pharmaceuticals Limited. A

letter authorising Athlone to cross-refer to this licence is provided. The

proposed holder of this Marketing Authorisation has

access to all the data

supporting this application.

EXPERT REPORT

Expert statements in relation to the pharmaceutical, preclinical and clinical

aspects of this product confirming that it is identical to the cross-reference

product have been provided from suitably qualified persons.

PRODUCT NAME

The name of the product is Prednisolone 5mg Tablets BP.

MARKETING AUTHORISATION APPLICATION (MAA)

The MAA submitted is satisfactory.

SUMMARY OF PRODUCT CHARACTERISTICS (SPC)

The SPC is in line with the cross-reference product and is satisfactory.

LABELLING

All labelling is satisfactory.

PATIENT INFORMATION LEAFLET (PIL)

The Patient Information Leaflet is in line with the SPC and the requirements

of Directive 2001/83/EC and is satisfactory.

RECOMMENDATION

A grant of a Marketing Authorisation is acceptable.

MHRA PAR Prednisolone 5 mg Tablets BP, PL 06453/0055

PRECLINICAL ASSESSMENT

No new preclinical data have been supplied with this application and none are

required for an application of this type.

MHRA PAR Prednisolone 5 mg Tablets BP, PL 06453/0055

CLINICAL ASSESSMENT

No new clinical data have been supplied with this application and

none are required for an application of this type.

MHRA PAR Prednisolone 5 mg Tablets BP, PL 06453/0055

OVERALL CONCLUSION AND RISK BENEFIT ASSESSMENT

QUALITY

data

this

application

consistent

with

that

previously

assessed for the cross-reference product and, as such, have been

judged to be satisfactory.

PRECLINICAL

No new preclinical data were submitted and none are required

for an application of this type.

EFFICACY

No new or unexpected safety concerns arise from these applications.

The SPC, PIL and labelling are satisfactory and consistent with those

of the cross-reference products.

RISK BENEFIT ASSESSMENT

The quality of the product is acceptable and no new preclinical or

clinical safety concerns have been identified. The applicant’s product

is identical to the cross-reference product. The risk benefit ratio is

considered to be positive.

MHRA PAR Prednisolone 5 mg Tablets BP, PL 06453/0055

PREDNISOLONE 5 MG TABLETS BP

PL 06453/0055

STEPS TAKEN FOR ASSESSMENT

The MHRA received the marketing authorisation application on 27 June

2003

Following assessment of the application, the MHRA requested further

information relating to the quality dossier on 30 October 2003

The applicant responded to the MHRA’s requests, providing further

information on 15 December 2004

Following assessment of the applicant’s response, the MHRA requested

further information relating to the quality dossier on 3 March 2005

The applicant responded to the MHRA’s requests, providing further

information on 29 September 2005

Following assessment of the applicant’s response, the MHRA requested

further information relating to the quality dossier on 24 November 2005

The applicant responded to the MHRA’s requests, providing further

information on 26 April 2006

Following assessment of the applicant’s response, the MHRA requested

further information relating to the quality dossier on 22 May 2006

The applicant responded to the MHRA’s requests, providing further

information on 16 June 2006

The application was determined on 18 July 2006

MHRA PAR Prednisolone 5 mg Tablets BP, PL 06453/0055

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Prednisolone 5mg Tablets BP

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 5mg of prednisolone.

For excipients, see 6.1.

3

PHARMACEUTICAL FORM

Tablet.

White, round tablets scored on one side

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Prednisolone is a glucocorticoid, which is four times as active as

hydrocortisone on a weight for weight basis.

A wide variety of diseases may sometimes require glucocorticoid

therapy. Some of the principle indications are;

Bronchial asthma, severe hypersensitivity reactions, anaphylaxis;

Rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis,

mixed

connective

tissue

disease

(excluding

systemic

sclerosis),

polyarteritis nodosa;

Inflammatory skin disorders, including pemphigus vulgaris, bullous

pemphigoid and pyoderma gangrenosum;

Minimal change nephrotic syndrome, acute interstitial nephritis;

Ulcerative colitis, Crohn’s disease; sarcoidosis; rheumatic carditis;

haemolytic anaemia (auto-immune), acute and lymphatic leukaemia,

malignant lymphoma, multiple myeloma, idiopathic thrombocytopenic

purpura; immunosuppression in transplantation.

4.2

Posology and method of administration

For oral use

The lowest dose to produce an acceptable result should be given; when

it is possible to reduce the dose this must be by stages. In prolonged

treatment, the dose may be increased temporarily during periods of

stress or exacerbation of illness.

MHRA PAR Prednisolone 5 mg Tablets BP, PL 06453/0055

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