1. Name of the medicinal product

Prednisolone Tablets USP 1mg Taj Pharma
Prednisolone Tablets USP 2.5mg Taj Pharma
Prednisolone Tablets USP 5mg Taj Pharma
Prednisolone Tablets USP 10mg Taj Pharma
Prednisolone Tablets USP 20mg Taj Pharma

  1. Qualitative and quantitative composition

a) Prednisolone Tablets USP 1mg Taj Pharma
Each uncoated tablet contains:
Prednisolone USP 1mg
Excipients: Q.S.

b) Prednisolone Tablets USP 2.5mg Taj Pharma
Each uncoated tablet contains:
Prednisolone USP 2.5mg
Excipients: Q.S.

c) Prednisolone Tablets USP 5mg Taj Pharma
Each uncoated tablet contains:
Prednisolone USP 5mg
Excipients: Q.S.

d) Prednisolone Tablets USP 10mg Taj Pharma
Each uncoated tablet contains:
Prednisolone USP 10mg
Excipients: Q.S.

e) Prednisolone Tablets USP 20mg Taj Pharma
Each uncoated tablet contains:
Prednisolone USP 20mg
Excipients: Q.S.

Excipient with known effect

Contains lactose monohydrate 158mg

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Uncoated Tablet
White, round, biconvex uncoated tablet.

  1. Clinical particulars
  • Therapeutic indications

Prednisolone Taj Pharma is indicated for the treatment and/or suppression of inflammatory and allergic disorders.

  • Posology and method of administration

Posology

In adults and the elderly: The lowest effective dose should be used for the minimum period in order to minimise side effects.

In children: Prednisolone Taj Pharma should be used only when specifically indicated, in a minimum dosage and for the shortest possible time.

The initial dosage of Prednisolone Taj Pharma Tablets may vary from 5mg to 60mg or more depending on the disorder being treated. Divided daily dosage is usually used.

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, initial dosage shall be maintained or adjusted until the anticipated response is observed. 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 dose for systemic corticosteroids (approximately 7.5mg Prednisolone Taj Pharma 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 corticosteroid may be reduced rapidly to physiological doses. Once a daily dose equivalent to 7.5mg of Prednisolone Taj Pharma 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 40mg daily of Prednisolone Taj Pharma, 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 40mg daily of Prednisolone Taj Pharma (or equivalent).
  • patients repeatedly taking doses in the evening. (See section 4.4 and 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 lack of a satisfactory clinical response to Prednisolone Taj Pharma Tablets, the drug should be gradually discontinued and the patient transferred to alternative therapy.

Intermittent dosage regimen A single dose of Prednisolone Taj Pharma 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 5-7.5mg daily during chronic treatment.

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

Collagenosis Initial doses of 20-30mg daily are frequently effective. Those with more severe symptoms may require higher doses.

Rheumatoid arthritis The usual initial dose is 10-15mg daily. The lowest daily maintenance dose compatible with tolerable symptomatic relief is recommended.

Blood disorders and lymphoma An initial daily dose of 15-60mg is often necessary with reduction after an adequate clinical or haematological response. Higher doses may be necessary to induce remission in acute leukaemia.

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 section 4.4). Alternate day dosage is preferable where possible.

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 section 4.4).

Method of administration: Oral

The daily dose should be taken in the morning after breakfast. For further information with reference to dosage see section 4.4 Special warnings and precautions for use.

  • Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Systemic infections unless specific anti-infective therapy is employed.

Patients with ocular herpes simplex due to the possibility of perforation.

One of the excipients of the tablet is lactose; hence patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

  • Special warnings and precautions for use

A patient information leaflet should be supplied with this product. Patients should carry “steroid treatment” cards which give clear guidance on the precautions to be taken to minimise risk and provide details of prescriber, drug, dosage and duration of treatment.

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 systemic steroids, although such reactions have been reported infrequently.

Particular care is required when considering the use of systemic corticosteroids 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.

Caution is necessary when corticosteroids, including Prednisolone Taj Pharma, are prescribed to patients with the following conditions and frequent patient monitoring is necessary:

  • Diabetes mellitus or in those with a family history of diabetes.
  • Glaucoma or in those with a family history of glaucoma.
  • Hypertension or congestive heart failure.
  • Liver failure.
  • Osteoporosis: This is of special importance in post-menopausal females who are at particular risk.
  • Patients with a history of severe affective disorders and particularly those with a previous history of corticosteroid induced psychoses.
  • Peptic ulceration.
  • Previous steroid myopathy.
  • Glucocorticoids should be used cautiously in patients with myasthenia gravis receiving anticholinesterase therapy.
  • Because cortisone has been reported rarely to increase blood coagulability and to precipitate intravascular thrombosis, thromboembolism and thrombophlebitis, corticosteroids should be used with caution in patients with thromboembolic disorders.
  • Renal insufficiency.
  • Tuberculosis: Those with a history of, or X-ray changes characteristic of tuberculosis. The emergence of active tuberculosis can, however, be prevented by the prophylactic use of antituberculous therapy.
  • Recent myocardial infarction (rupture).
  • 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 immunoglobulin (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 special care and urgent treatment. Corticosteroids should not be stopped and the dose may need to be increased.
  • Measles: Patients are advised to avoid exposure to measles, medical advice should be sought if exposure occurs. Prophylaxis with intramuscular normal immunoglobulin may be needed.
  • Suppression of the inflammatory response and immune function increases the susceptibility to 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 advanced stage before being recognised.
  • The effect of corticosteroids may be enhanced in patients with hypothyroidism in those with chronic liver disease with impaired hepatic function.
  • Live vaccines should not be given to individuals with impaired immune responsiveness. The antibody response to other vaccines may be diminished.
  • Adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment.

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

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 Taj Pharma. Blood pressure and renal function (s-creatinine) should therefore be routinely checked. When renal crisis is suspected, blood pressure should be carefully controlled.

Withdrawal

In patients who have received more than physiological doses of systemic corticosteroids (approximately 7.5mg Prednisolone Taj Pharma 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 HPA suppression, the dose of systemic corticosteroid may be reduced rapidly to physiological doses. Once a daily dose equivalent to 7.5mg of Prednisolone Taj Pharma 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 40mg daily of Prednisolone Taj Pharma, 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 40mg daily of Prednisolone Taj Pharma,
  • Patients repeatedly taking doses in the evening.

During prolonged therapy any 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 reintroduced.

Use in children: 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.

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.

  • Interaction with other medicinal products and other forms of interaction

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

Hepatic microsomal enzyme inducers Drugs that induce hepatic enzyme cytochrome P-450 (CYP) isoenzyme 3A4 such as phenobarbital, phenytoin, 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 Taj Pharma 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.

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.

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.

Antibacterials Rifamycins accelerate metabolism of corticosteroids and thus may reduce their effect. Erythromycin inhibits metabolism of methylPrednisolone Taj Pharma and possibly other corticosteroids.

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.

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 Taj Pharma and possibly other corticosteroids.

Antivirals Ritonavir possibly increases plasma concentrations of Prednisolone Taj Pharma and other corticosteroids.

Cardiac Glycosides Increased toxicity if hypokalaemia occurs with corticosteroids.

Ciclosporin Concomitant administration of Prednisolone Taj Pharma and ciclosporin may result in decreased plasma clearance of Prednisolone Taj Pharma (i.e. increased plasma concentration of Prednisolone Taj Pharma). The need for appropriate dosage adjustment should be considered when these drugs are administered concomitantly.

Cytotoxics Increased risk of haematological toxicity with methotrexate.

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

Vaccines Live vaccines should not be given to individuals with impaired immune responsiveness. The antibody response to other vaccines may be diminished.

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.

Somatropin Growth promoting effect may be inhibited.

Sympathomimetics Increased risk of hypokalaemia if high doses of corticosteroids given with high doses of bambuterol, fenoteral, formoteral, ritodrine, salbutamol, salmeterol and terbutaline.

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.

  • Fertility, pregnancy and lactation

Pregnancy

The ability of corticosteroids to cross the placenta varies between individual drugs, however, 88% of Prednisolone Taj Pharma is inactivated as it crosses the placenta. Administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate, intra-uterine growth retardation and effects 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. 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.

Breast-feeding

Corticosteroids are excreted in small amounts in breast milk. However, doses of up to 40mg daily of Prednisolone Taj Pharma are unlikely to cause systemic effects in the infant. Infants of mothers receiving 40mg or more daily should be monitored for signs of adrenal suppression but the benefits of breast-feeding are likely to outweigh any theoretical risk.

  • Effects on ability to drive and use machines

There is no evidence to suggest that Prednisolone Taj Pharma has any affect on the ability to drive or use machines.

  • Undesirable effects

A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations and aggravation of schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances and cognitive dysfunction including confusion and amnesia have been reported. Reactions are common and may occur in both adults and children. In adults, the frequency of severe reactions has been estimated to be 5-6%. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is Not Known.

The incidence of predictable undesirable effects, including hypothalamic pituitary adrenal suppression correlates with the relative potency of the drug, dosage, timing of administration and the duration of treatment (see section 4.4).

System organ classFrequencyUndesirable effects
Infections and infestationsNot knownIncreases susceptibility to and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, recurrence of dormant tuberculosis (see section 4.4).
Blood and lymphatic system disordersNot knownLeucocytosis
Immune system disordersNot knownHypersensitivity including anaphylaxis, fatigue, malaise
Endocrine disordersNot knownCushingoid facies, weight gain, impaired carbohydrate tolerance with increased requirement for antidiabetic therapy, manifestation of latent diabetes mellitus, menstrual irregularity and amenorrhoea.
Metabolism and nutrition disordersNot knownSodium and water retention, hypokalaemic alkalosis, potassium loss, negative nitrogen and calcium balance
Psychiatric disordersNot knownEuphoria, psychological dependence, depression, insomnia, dizziness, headache, vertigo, aggravation of schizophrenia, aggravation of epilepsy
Eye disordersNot knownIncreased intra-ocular pressure, glaucoma, papilloedema, posterior subcapsular cataracts, exophthalmos, corneal or scleral thinning, exacerbation of ophthalmic viral or fungal disease and vision, blurred (see also section 4.4)
Cardiac disordersNot knownCongestive heart failure in susceptible patients, hypertension
Vascular disordersNot knownThromboembolism
Gastrointestinal disordersNot knownDyspepsia, nausea, peptic ulceration with perforation and haemorrhage, abdominal distension, abdominal pain, increased appetite which may result in weight gain, diarrhoea, oesophageal ulceration, oesophageal candidiasis, acute pancreatitis
Skin and subcutaneous tissue disordersNot knownHirsutism, skin atrophy, bruising, striae, telangiectasia, acne, increased sweating, may suppress reactions to skin tests, pruritis, rash, urticaria
Musculoskeletal and connective tissue disordersNot knownProximal myopathy, osteoporosis, vertebral and long bone fractures, avascular osteonecrosis, tendon rupture, myalgia
Renal and urinary disordersNot knownScleroderma renal crisis*
General disorders and administration site conditionsNot knownImpaired healing, withdrawal symptoms**.

*Scleroderma renal crisis

Amongst the different subpopulations the occurrence of scleroderma renal crisis varies. The highest risk has been reported in patients with diffuse systemic sclerosis. The lowest risk has been reported in patients with limited systemic sclerosis (2%) and juvenile onset systemic sclerosis (1%)

**Withdrawal symptoms: Too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death (see section 4.4 and 4.2). A steroid “withdrawal syndrome” seemingly unrelated to adrenocortical insufficiency may also occur following abrupt discontinuance of glucocorticoids. This syndrome includes symptoms such as: anorexia, nausea, vomiting, lethargy, headache, fever, joint pain, desquamation, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules weight loss, and/or hypotension. These effects are thought to be due to the sudden change in glucocorticoid concentration rather than to low corticosteroid levels.

Additional side effects in children and adolescents

Suppression of the hypothalamo-pituitary adrenal axis particularly in times of stress, as in trauma, surgery or illness, growth suppression in infancy, childhood and adolescence.

Raised intracranial pressure with papilloedema (pseudotumor cerebri) in children, usually after treatment withdrawal.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

  • Overdose

Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare. No specific antidote is available; treatment is supportive and symptomatic. Serum electrolytes should be monitored.

  1. Pharmacological properties
    • Pharmacodynamic properties

Pharmacodynamic Group: Corticosteroids for systematic use, plain

Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt- retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.

Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli.

  • Pharmacokinetic properties

Absorption

Prednisolone Taj Pharma is rapidly and apparently almost completely absorbed after oral administration; it reaches peak plasma concentrations after 1-3 hours. There is however wide inter-subject variation suggesting impaired absorption in some individuals. Plasma half-life is about 3 hours in adults and somewhat less in children. Its initial absorption, but not its overall bioavailability, is affected by food. Prednisolone Taj Pharma has a biological half-life lasting several hours, making it suitable for alternate-day administration regimens.

Distribution

Prednisolone Taj Pharma shows dose dependent pharmacokinetics, with an increase in dose leading to an increase in volume of distribution and plasma clearance. The degree of plasma protein binding determines the distribution and clearance of free, pharmacologically active drug. Reduced doses are necessary in patients with hypoalbuminaemia.

Biotransformation

Prednisolone Taj Pharma is metabolised primarily in the liver to a biologically inactive compound. Liver disease prolongs the half-life of Prednisolone Taj Pharma and, if the patient has hypoalbuminaemia, also increases the proportion of unbound drug and may thereby increase adverse effects.

Elimination

Prednisolone Taj Pharma is excreted in the urine as free and conjugated metabolites, together with small amounts of unchanged Prednisolone Taj Pharma.

  • Preclinical safety data

There are no non-clinical data of relevance to the prescriber that are not already covered in other sections of the SmPC.

  1. Pharmaceutical particulars
    • List of excipients

Potato starch

Lactose monohydrate

Talc

Gelatine

Magnesium stearate

  • Incompatibilities

Not applicable.

  • Shelf life

HDPE bottles: 36 months

Once opened: Use within 6 months

Blisters: 20 months

  • Special precautions for storage

HDPE bottles: This medicinal product does not require any special storage precautions.

Blisters: Do not store above 25°C.

  • Nature and contents of container

PVC/PVDC/Aluminium blister pack or HDPE container and LDPE/HDPE cap without desiccant

Pack size: Prednisolone Taj Pharma 1mg, 2.5mg, 5mg, 10mg and 20mg Tablets come in packs of 10, 15, 20, 30  and also comes in 7, 14, 28, 56 or 60 tablets each in blisters or in packs of 10, 14, 25, 28, 50, 56, 60, 100, 200, 300 or 500 tablets in HDPE bottles.

Not all pack sizes may be marketed.

  • Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825) Monday through Saturday 9:00 a.m. to 7:00 p.m. EST E-mail: tajgroup@tajpharma.com

Prednisolone Tablets USP 5mg Taj Pharma

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. Your doctor may have given you this medicine before from another company.

It may have looked slightly different. However, either brand will have the same effect.

The name of your medicine is Prednisolone Taj Pharma 2.5mg Tablets, Prednisolone Taj Pharma 5mg Tablets, Prednisolone Taj Pharma 10mg Tablets, Prednisolone Taj Pharma 20mg Tablets, Prednisolone Taj Pharma 25mg Tablets. It will be referred to as Prednisolone Taj Pharma Tablets for ease hereafter.

Important things you need to know about Prednisolone Taj Pharma Tablets

  • Prednisolone Taj Pharma is a steroid medicine. This can be 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 Taj Pharma can cause side effects in some people (read section 4 for more information). 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 rounder face (read section 4 for more information)
  • 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 Taj Pharma Tablets are and what they are used for
  2. What you need to know before you take Prednisolone Taj Pharma Tablets
  3. How to take Prednisolone Taj Pharma Tablets
  4. Possible side effects
  5. How to store Prednisolone Taj Pharma Tablets
  6. Contents of the pack and other information
  7. WHAT PREDNISOLONE TAJ PHARMA TABLETS ARE AND WHAT THEY ARE USED FOR

Prednisolone Taj Pharma Tablets contain the active ingredient prednisolone. 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 wellbeing. Boosting your body with extra corticosteroid (such as Prednisolone) is an effective way to treat various illnesses such as allergic reactions (for example asthma, eczema) and inflammatory conditions (for example arthritis).

Prednisolone acts by reducing the inflammation caused by these illnesses, which could otherwise go on making your condition worse.

You must take this medicine regularly to get maximum benefit from it.

  1. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PREDNISOLONE TAJ PHARMA TABLETS

Do not take Prednisolone Taj Pharma Tablets:

  • if you are allergic to prednisolone or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
  • if you have an infection that affects your whole body (systemic infection), which is not already being treated (such as measles, chickenpox or shingles)
  • if you are suffering from a herpes infection of the eye.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Prednisolone Taj Pharma Tablets.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Prednisolone Taj Pharma Tablets, especially if:

– you have or have ever had severe depression or manic-depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Prednisolone Taj Pharma Tablets or any of your close family has had these illnesses

  • you have or have ever had mental problems such as ‘depression’ or ‘psychoses’
  • you have epilepsy (fits)
  • you or anyone in your family has diabetes
  • you have high blood pressure
  • you have kidney, liver or heart problems
  • you have brittle or weak bones called osteoporosis
  • you are receiving treatment for a condition called myasthenia gravis (a rare muscular disorder)
  • you have ever had blood clots (deep vein thrombosis or thromboembolism)
  • you or anyone in your family has an eye problem called glaucoma
  • you have or have ever had a stomach ulcer
  • you have or have ever had a bad reaction such as muscle weakness to any steroid
  • you have been in contact with anyone who has chickenpox, shingles or measles. Contact your doctor immediately for advice
  • you have or have ever had ‘tuberculosis’ (TB)
  • you are receiving any vaccines (please see below, “Vaccinations”)
  • you have Scleroderma (also known as systemic sclerosis, an autoimmune disorder) because daily doses of 15mg 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 apply to you, your doctor may want to see you more often during your treatment.

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 Taj Pharma Tablets

Mental health problems can happen while taking steroids like Prednisolone Taj Pharma 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 your 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 Taj Pharma Tablets

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Some medicines may increase the effects of Prednisolone Taj Pharma Tablets and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

Prednisolone Taj Pharma Tablets and some other medicines can affect the way each other work. In particular, tell your doctor if you are taking any of the following:

  • medicines for thinning your blood (such as warfarin)
  • medicines for diabetes (such as insulin)
  • medicines for epilepsy (such as carbamazepine and phenytoin)
  • medicines for high blood pressure (such as furosemide and bendroflumethazide)
  • medicines which contain oestrogens including oral contraceptives
  • medicines to treat infections (such as rifampicin, erythromycin and ketoconazole – used in fungal infections)
  • medicines to treat asthma (such as salbutamol and salmeterol)
  • anti-inflammatory medicines (such as aspirin and ibuprofen)
  • ciclosporin – used to suppress the immune system
  • methotrexate – used to treat a variety of illnesses such as arthritis
  • mifepristone – used for abortion
  • oral contraceptives (the ‘pill’).

Vaccinations

If you have just had any injections or vaccinations, tell your doctor before you take Prednisolone Taj Pharma Tablets. If you are going to have any injections or vaccinations, tell your doctor or nurse that you are taking Prednisolone Taj Pharma Tablets. This includes those needed for a foreign holiday. Some vaccines should not be given to patients taking Prednisolone Taj Pharma Tablets. This is because Prednisolone Taj Pharma Tablets can affect the way some vaccines work. Talk to your doctor if you are not sure.

Pregnancy and breast-feeding

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.

Prednisolone Taj Pharma Tablets contain lactose

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 medicinal product.

  1. HOW TO TAKE PREDNISOLONE TAJ PHARMA TABLETS

If you have been given this medicine for more than three weeks, you will be given a blue ‘steroid card’ by your doctor or pharmacist. It contains information about your medicine, including dose instructions. This is important if you fall ill or are in an accident. You should carry the card with you at all times.

Always take this medicine exactly as your doctor or pharmacist has told you, especially if you are elderly.

Check with your doctor or pharmacist if you are not sure.

Swallow the tablets whole with a glass of water in the morning after breakfast. It is important to take your medicine at the right times.

The recommended doses are

Adults – 20-60mg daily initially (higher doses may be required for specific conditions), reducing to a maintenance dose of 5-20mg daily.

Elderly – doses may be adjusted by the doctor depending of 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 what is the right number of tablets for your child.

Your doctor may change your dose in order to use the lowest effective dose, depending on your response to the medicine.

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

If you take more Prednisolone Taj Pharma Tablets than you should

If you (or someone else) take more tablets than prescribed, or you think a child may have taken any tablets, contact your nearest hospital emergency department or tell your doctor immediately.

If you forget to take Prednisolone Taj Pharma Tablets

If you forget to take a dose, take it as soon as you remember and then take your next dose at the usual time. Do not take a double dose, to make up for a forgotten dose.

If you stop taking Prednisolone Taj Pharma Tablets

If you have been given Prednisolone Taj Pharma Tablets for more than 3 weeks your doctor will ensure that your dose is gradually reduced so as to avoid any withdrawal symptoms. It is important that you complete the course of treatment as per your doctor’s instructions.

If you suddenly stop taking your medicine the following side effects can occur: lack of appetite, feeling sick, being sick, tiredness, skin peeling, inflammation of the inside of the nose, inflammation (swelling and redness) of the conjunctiva (the outermost layer of the eye and the inner surface of the eyelids), muscle or joint pain, fever, headache, weight loss, painful itch skin lumps or low blood pressure. If you notice any of these symptoms please contact your doctor as soon as possible.

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

  1. POSSIBLE SIDE EFFECTS

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

You may experience side effects particularly when you first start taking this medicine. Talk to your doctor or pharmacist if you notice any of the following effects or any effects not listed in this leaflet.

Stop taking Prednisolone Taj Pharma 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 you experience any of the following:

  • inflammation of the pancreas (very severe abdominal pains)
  • steroids including Prednisolone Taj Pharma 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 Taj Pharma 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.

The following side effects have been reported. Tell your doctor if you experience any of the following:

Not known: frequency cannot be estimated from the available data

Heart – high blood pressure, congestive heart failure in those already at risk

Stomach and intestines – increased appetite, indigestion, feeling sick, feeling bloated, weight gain, stomach ulcers which may burst and cause bleeding, diarrhoea, very sore throat and white areas inside your mouth (oral thrush)

Muscles or bones – brittle bones (osteoporosis), muscle weakness and pain

Nervous system – dizziness, headache, difficulty in sleeping, worsening of epilepsy, raised pressure in the skull (causing pain behind the eyes)

Skin – difficult healing of wounds, unusual increase in hair growth on body or face, skin rashes, unusual bruising, thinning of the skin, acne, appearance of reddish purple lines

Hormones – filling or rounding of the face (Cushing’s syndrome), periods become irregular or stop completely, changes in blood glucose levels, weight gain, reduced growth in infancy, childhood and adolescence.

Kidney – water and salt retention, loss of potassium in the urine. 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

Blood – blood clots, increase in the number of white blood cells

Eyes – increase pressure in the eye, cataracts, thinning of the tissue of the eye, bulging of the eye, blurred vision

Other – increased risk to infections, previous infections such as tuberculosis (TB) may reoccur more easily.

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.
By reporting side effects you can help provide more information on the safety of this medicine.

  1. HOW TO STORE PREDNISOLONE TAJ PHARMA 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 and carton. The expiry date refers to the last day of that month.
This medicinal product stored in HDPE bottles does not require any special storage precautions. Do not store above 25°C for tablets stored in blisters. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.

  1. CONTENTS OF THE PACK AND OTHER INFORMATION

What Prednisolone Taj Pharma Tablets contain

  • the active substance is prednisolone. Each tablet contains either 1mg, 2.5mg, 5mg, 10mg, 20mg of prednisolone
  • the other ingredients are: potato starch, lactose, talc, gelatine and magnesium stearate.

What Prednisolone Taj Pharma Tablets look like and contents of the pack

Prednisolone Taj Pharma Tablets are plain white uncoated tablets.
Prednisolone Taj Pharma 1mg, 2.5mg and 5mg are biplane tablets. Prednisolone Taj Pharma 10mg and 20mg tablets are biconvex.
Prednisolone Taj Pharma 1mg, 2.5mg, 5mg, 10mg and 20mg Tablets come in packs of 10, 15, 20, 30  and also comes in 7, 14, 28, 56 or 60 tablets each in blisters or in packs of 10, 14, 25, 28, 50, 56, 60, 100, 200, 300 or 500 tablets in HDPE bottles.

Not all pack sizes may be marketed.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825) Monday through Saturday 9:00 a.m. to 7:00 p.m. EST E-mail: tajgroup@tajpharma.com