PREDNISOLONE TABLETS

NAME OF THE MEDICINAL PRODUCT

Prednisolone Tablets IP 5 mg,

Prednisolone Tablets IP 10 mg,

Prednisolone BpTablets 5 mg

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg of Prednisolone.

Excipient with known effect
Each 5mg tablet contains 60.00mg of Lactose Monohydrate PhEur.

PHARMACEUTICAL FORM
Tablets.

 CLINICAL PARTICULARS

Therapeutic indications
Prednisolone is indicated in the management of all conditions deemed likely to benefit from short or long term glucocorticoid therapy. These include:

Allergic states
Severe, incapacitating allergies unresponsive to conventional treatment; asthma serum sickness; drug hypersensitivity reactions.

Collagen disorders
Eg systemic lupus erythematosus, polymyositis, polymyalgia rheumatica and temporal (giant cell) arteritis, mixed connective tissue disease syndrome, acute rheumatic carditis.

Rheumatic disorders
Usually given as an adjunctive therapy for short term administration during an acute episode or exacerbation of rheumatoid arthritis, psoriatic arthritis.

Skin conditions
Life-threatening or incapacitating skin conditions such as pemphigus and exfoliative dermatitis.

Neoplastic disease
Leukaemias and lymphomas in adults, acute leukaemia of childhood.

Gastro-Intestinal disease
During acute exacerbation in ulcerative colitis and regional ileitis (Crohn’s Disease).

Respiratory disease
Sarcoidosis (especially with hypercalcaemia), fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculosis chemotherapy.

Haematological disorders
Various blood dyscrasias eg selected cases of haemolytic anaemia, thrombocytopenic purpura.

Miscellaneous
Nephrotic syndrome.

Posology and method of administration


Posology

Adults
20-40mg daily (acute conditions up to 80mg daily) reducing gradually to maintenance level when symptoms have subsided. Maintenance dosage is usually 5-20mg daily reached in about two weeks by reduction of the daily dosage by 5mg or 2.5mg, two or three times a week.

Peadiatric population
Fractions of adult dosage may be used (e.g. 75% at 12 years, 50% at 7 years and 25% at 1 year), but clinical factors must be taken into consideration.

Corticosteroids cause growth retardation in infancy, childhood and adolescence which may be irreversible. Treatment should be limited to the minimum dosage for the shortest possible time. In order to minimise suppression of the hypothalamo-pituitary adrenal axis and growth retardation, treatment should be administered where possible as a single dose on alternate days.

Elderly

Treatment of elderly patients, especially if long-term, should be planned bearing in mind the more serious consequences of the common side-effects of corticosteroids in old age, particularly diabetes, hypertension, hypokalaemia, osteoporosis, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid life-threatening reactions.

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

Method of Administration

For oral administration

CONTRAINDICATION


Hypersensitivity to the active substance or to any of the excipients
Systemic infections unless specific anti-infective therapy is employed.
Patients with ocular herpes simplex due to the possibility of perforation.

SPECIAL PRECAUTIONS & WARNINGS


General:


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. Symptoms typically emerge within a few days or weeks of starting the treatment. Risks may be higher with high doses/systemic exposure  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.

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.
Caution is necessary when corticosteroids, including prednisolone, 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.
• Epilepsy.
• 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.
• 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. Propylaxis 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.

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.

Withdrawal

In patients who have received more than physiological doses of systemic corticosteroids (approximately 7.5mg 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 HPA suppression, the dose of systemic corticosteroid may be reduced rapidly to physiological doses. Once a daily dose equivalent to 7.5mg 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 40mg 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 40mg daily of prednisolone,
• 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.

Excipients

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

 Interaction with other medicinal products and other forms of interaction


• Antacids can reduce the absorbtion of prednisolone if given in high doses. Indigestion remedies should not be taken at the same time of day as Prednisolone.
• Rifampicin, rifabutin, carbamazepine, phenobarbital, phenytoin, primidone, carbimazole and aminoglutethimide enhance the metabolism of corticosteroids and its therapeutic effects may be reduced. Therefore it may be necessary to adjust the dose of prednisolone accordingly.
• The desired effects of hypoglycaemic agents (including insulin), antihypertensives and diuretics are antagonised by corticosteroids.
• The hypokalaemic effects of acetazolamide, loop diuretics, thiazide diuretics, beta-2-agonists, theophylline and carbenoxolone are enhanced.
• The efficacy of coumarin anticoagulants may be enhanced by concurrent corticosteroid therapy and close monitoring of the INR or prothrombin time is required to avoid spontaneous bleeding.
• Ciclosporin increases the plasma concentration of prednisolone.
• The renal clearance of salicylates is increased by corticosteroids and steroid withdrawal may result in salicylate intoxication.
• NSAIDs such as indometacin may increase the risk of GI ulceration. The possiblity of GI ulceration should be considered with concomitant use with any other NSAIDs.
• Aspirin should be used cautiously in conjunction with glucocorticoids in patients with hypoprothrombinaemia. Concurrent use of aspirin and prednisolone may result in an increased risk of gastrointestinal ulceration and subtherapeutic aspirin serum concentrations.
• Antifungals: Increased risk of hypokalaemia with amphotericin. Avoid concomitant use. Ketoconazole reduces the metabolic and renal clearances of methylprednisolone, this may also occur with prednisolone.
• Mifepristone reduces the effect of corticosteroids for 3-4 days after administration.
• Methotrexate may have a steroid sparing effect. There is evidence that the toxicity of methotrexate is increased.
• Etoposide metabolism may be inhibited by corticosteroids in vitro. This may lead to an increase in both efficacy and toxicity of the etoposide. Monitoring would be prudent.
• Corticosteroids should not be used concurrently with retinoids and tetracyclines due to increased intracranial pressure.
• Oestrogens and progestogens increase plasma concentrations of corticosteroids.
• 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.

Fertility, pregnancy and lactation


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 and 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 intrauterine growth retardation. Hypoadrenalism may occur in the neonate following prenatal exposure to corticosteroids but usually resolves spontaneously following birth and is rarely clinically important. Cataracts have also been rarely reported. 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 abnormal pregnancies may be treated as though they were in the non-gravid state.
Patients with pre-eclampsia or fluid retention require close monitoring.                Lactation
Corticosteroids are excreted in small amounts in breast milk. However doses of up to 40mg daily of prednisolone are unlikely to cause systemic effects in the infant. Infants of mothers taking higher doses than this may have a degree of adrenal suppression but the benefits of breast feeding are likely to out-weigh any theoretical risk. Monitoring of the infant for adrenal suppression is advised.

Effects on ability to drive and use machines


If insufficient sleep occurs, the likelihood of impaired alertness may be increased, patients should make sure they are not affected before driving or operating machinery.

UNDESIRABLE EFFECTS

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 “other special warnings and precautions”). 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 or whenever possible as a single morning dose on alternative days. Frequent patient review is required to appropriately titrate the dose against disease activity.

*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 “other special warnings and precautions”. A “withdrawal syndrome” may also occur including arthralgia, conjunctivitis, fever, loss of weight, myalgia, painful itchy skin nodules and rhinitis.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Overdose


In the event of an overdosage, supportive and symptomatic therapy is indicated.
Serum electrolytes should be monitored.

Undesirable effects
MedDRA system organ class
Blood and lymphatic system disorders Leucocytosis
Immune system disorders Increased susceptibility and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, recurrence of dormant tuberculosis. See “other special warnings and precautions”.
Endocrine disorders Cushingoid facies, growth suppression in infancy, childhood and adolescence, hirsutism, impaired carbohydrate tolerance with increased requirement for antidiabetic therapy, negative protein and calcium balance, suppression of the hypothalamo-pituitary adrenal axis, and weight gain. Although the frequency is not known, there is a risk for Cushing Syndrome.
Metabolism and nutrition disorders Hypokalaemic alkalosis, potassium loss, sodium and water retention.
Psychiatric disorders 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), marked euphoria leading to dependence; aggravation of epilepsy, behavioural disturbances, irritability, nervousness, 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 unknown. Psychological dependence.
Nervous system disorders Intracranial pressure with papilloedema in children (pseudotumour cerebri) usually after treatment withdrawal.
Eye disorders Corneal or scleral thinning, scleral perforation, exacerbation of ophthalmic viral or fungal disease, glaucoma, increased intra-ocular pressure, papilloedema, posterior subcapsular cataracts, central serous chorioretinopathy (frequency not know known), vision, blurred (see also section 4.4) (frequency not known).
Cardiac disorders Risk of congestive heart failure in susceptible patients.
Vascular disorders Hypertension, thromboembolism.
Gastrointestinal disorders Abdominal distension, acute pancreatitis, dyspepsia, nausea, increased appetite, oesophageal candidiasis, oesophageal ulceration, peptic ulceration with perforation and haemorrhage, perforation of the small bowel, particularly in patients with inflammatory bowel disease.
Skin and subcutaneous tissue disorders Acne, bruising, impaired healing, skin atrophy, striae, telangiectasia.
Musculoskeletal and connective tissue disorders Avascular osteonecrosis, osteoporosis, proximal myopathy, tendon rupture, vertebral and long bone fractures, muscle weakness, wasting and loss of muscle mass.
Renal and urinary disorders Nocturia, scleroderma renal crisis* (frequency unknown).
Reproductive system and breast disorders Menstrual irregularity and amenorrhoea.
General disorders and administration site conditions Hypersensitivity including anaphylaxis, malaise.

Pharmacological particulars

Pharmacodynamic properties
Pharmacotherapeutic group: Corticosteriods for systematic use, plain
ATC CODE: H02A B06

Mechanism of action

Prednisolone is one of the highly potent glucocorticoid steroids having anti-inflammatory, hormonal and metabolic effects qualitatively similar to those of hydrocortisone.
Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli.

 Pharmacokinetic properties


Absorption


Prednisolone is readily and almost completely absorbed from the GI tract after oral administration.

Distribution


Peak plasma concentrations are obtained 1-2 hours after oral administration. Prednisolone is extensively bound to plasma proteins, although less so than hydrocortisone. Prednisolone crosses the placenta and small amounts are excreted in breast milk.

Biotransformation

Prednisolone is mainly metabolised in the liver and has a usual plasma half-life of 2-3 hours. It has a biological half-life lasting several hours which makes it suitable for the alternate-day administration regimens which have been found to reduce the risk of adrenocortical insufficiency, yet provide adequate corticosteroid coverage in some disorders.
Its initial absorption, but not its overall bioavailability, is affected by food, hepatic or renal impairment and certain drugs.

Elimination

It is excreted in the urine as free and conjugated metabolites, together with an appreciable proportion of unchanged prednisolone.

Preclinical safety data
Not applicable.

Pharmaceutical particulars

List of excipients
Lactose monohydrate, maize starch, povidone, purified talc, colloidal anhydrous silica, magnesium stearate.

Incompatibilities
Not applicable.

 Shelf life

Blister pack : 3 years from the date of manufacture
Propylene container & glass bottle : 5 years from the date of manufacture

 Special precautions for storage
Blister pack: Store below 25°C in a dry place. Protect from light.
Polypropylene container: Store below 25°C. Protect from light.
Glass bottle: Protect from light.

 Nature and contents of container
Blister Pack : 28, 56, 84, 98

Propylene Container & Glass Bottle : 28, 56, 84, 500, 1000
Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements for disposal.

MARKETING AUTHORISATION HOLDER

TAJ PHARMA CIS LTD.
Marksistsky lane 6, office 221, Moscow, 109147, Russia

MANUFACTURER:

Manufactured in India by:
TAJ PHARMACEUTICALS LTD,
220, Mahagujarat Ind. Estate,  Moraiya,

Tal. Sanand , Dist. Ahmedabad,

Gujarat, INDIA.

Package leaflet:

Information for the patient

PREDNISOLONE 5MG  tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
– Keep this leaflet. You may need to read it again.
 – If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

What is in this leaflet
1. What PREDNISOLONE Tablets are and what they are used for
2. What you need to know before you take PREDNISOLONE Tablets
3. How to take PREDNISOLONE Tablets
4. Possible side effects
5. How to store PREDNISOLONE Tablets
6. Contents of the pack and other information

 WHAT PREDNISOLONE TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Prednisolone 5mg 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. Steroids work by reducing inflammation, which could otherwise go on making your condition worse and lowering the body’s immune response. You must take this medicine regularly to get maximum benefit from it. 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.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE PREDNISOLONE TABLETS

Do not use Prednisolone Soluble Tablets:
if you are allergic to prednisolone or any of the other ingredients of this medicine. 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 Soluble Tablets 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.
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 or pharmacist 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. Prednisolone 5mg Soluble Tablets prednisolone sodium phosphate Package leaflet: Information for the user Continued top of next column Continued over page * Please note that only Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date Proof Round UK-Eire-Artwork-Support@Actavis.com Technical Approval Colours Non Printing Colours Date sent: Date received: Item no: Originator: Origination Date: Revision Date: Revised By: Dimensions: Min Body Text Size: Supplier: 1. 2. 3. 4. 5. 6. 1. 2. 3. Prednisolone 5mg 30 Soluble Tablets PIL – UK Black Profile BBBA1330 S.Anson 28.09.17 210 x 297 9pts Wasdell 28.09.17 29.09.17 1 HEAD 02970210X01480035L00-M050UWASS Prednisolone Soluble Tablets contain sodium This medicinal product contains 1.18mmol (or 27.22mg) sodium per tablet. To be taken into consideration by patients on a controlled sodium diet.


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

HOW TO TAKE PREDNISOLONE TABLETS

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

Use in Adults The recommended dose will depend on the condition you are being treated for and can vary between 10mg and 100mg 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.

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.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine 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:
• 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
• 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
• 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 blurred vision
• heart attack (sudden severe chest pains)
• changes in body chemistry
• an increase in the number of white blood cells • formation of blood clots
• 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 lesions) 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 chickenpox 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 Website: 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.

HOW TO STORE PREDNISOLONE TABLETS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or foil blister. The expiry date refers to the last day of that month. Store below 30°C.
Store in the original packaging in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Further Information

What Prednisolone Soluble Tablets contain
The active substance is
prednisolone (as prednisolone sodium phosphate).
Each tablet contains 5mg of prednisolone.
• The tablet also contains, povidone, sodium acid citrate, sodium bicarbonate, sodium carbonate, sodium benzoate (E211), and saccharin sodium.
What Prednisolone Soluble Tablets look like and contents of the pack White, 7mm, round, with a score line on one side, imprinted with “A” and “615” respectively on each side of the score. They are available in aluminum foil blister packs containing 30 soluble tablets.

Manufactured by:
Taj Pharmaceuticals Limited
220, Mahagujarat Ind. Estate, Moraiya, Tal. Sanand, Dist. Ahmedabad, Gujarat, INDIA

Marketing Authorization Holder:
Regal sun co., Ltd.Myanmar

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