Prednisolone Oral Solution USP 15mg/5ml Taj Pharma

Prednisolone Oral Solution USP 15mg/5ml Taj Pharma

1. Name of the medicinal product

Prednisolone Oral Solution USP 15mg/5ml Taj Pharma

2. Qualitative and quantitative composition

Prednisolone Oral Solution USP 15mg/5ml
Each 1ml of solution contains
Prednisolone                                   3mg
(as prednisolone sodium phosphate)
Excipients                                       q.s.

For the full list of excipients, see section 6.1.

3.Pharmaceutical form

Oral Solution

A clear, colourless to yellowish solution with a characteristic odour.

4. Clinical particulars

4.1 Therapeutic indications

A wide variety of diseases may sometimes require corticosteroid therapy. Some of the principal 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 (autoimmune), acute lymphoblastic and chronic lymphocytic leukaemia, malignant lymphoma, multiple myeloma, idiopathic thrombocytopenic purpura;
• immunosuppression in transplantation.

4.2 Posology and method of administration

Posology

The lowest dosage that will produce an acceptable result should be used (see section 4.4); when it is possible to reduce the dosage, this must be accomplished by stages. 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 re-introduced.

Adults: The dose used will depend upon the disease, its severity and the clinical response obtained. The following regimens are for guidance only. Divided dosage is usually employed.

Short-term treatment: 20mg (2ml) to 30mg (3ml) daily for the first few days, subsequently reducing the daily dosage by 2.5mg (0.25ml) or 5mg (0.5ml) every two to five days, depending upon the response.

Rheumatoid arthritis: 7.5mg (0.75ml) to 10mg (1ml) daily. For maintenance therapy the lowest effective dosage is used.

Most other conditions: 10mg (1ml) to 100mg (10ml) daily for one to three weeks, then reducing to the minimum effective dosage.

Paediatric population: Fractions of the 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 given due weight.

Prednisolone Oral Solution may be given early in the treatment of acute asthma attacks in children. For children over 5 years use a dose of 30-40mg (3-4ml) prednisolone. For children aged 2-5 years use a dose of 20mg (2ml) prednisolone. Those already receiving maintenance steroid tablets should receive 2mg/kg prednisolone up to a maximum dose of 60mg (6ml). The dose of prednisolone may be repeated for children who vomit; but intravenous steroids should be considered in children who are unable to retain orally ingested medication. Treatment for up to three days is usually sufficient, but the length of course should be tailored to the number of days necessary to bring about recovery. There is no need to taper the dose at the end of treatment.

For children under 2 years, Prednisolone Oral Solution can be used early in the management of moderate to severe episodes of acute asthma in the hospital setting, at a dose of 10mg (1ml) for up to three days.

Method of administration: Oral

4.3 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.

– Live virus immunisation.

4.4 Special warnings and precautions for use

In patients who have received more than physiological doses of systemic corticosteroids (approximately 7.5mg prednisolone or equivalent) for greater than three 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 (0.75ml) 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 three 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 three 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 three weeks or less:

• Patients who have had repeated courses of systemic corticosteroids, particularly if taken for greater than three 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, been stopped following prolonged therapy they may need to be temporarily reintroduced.
• Patients receiving doses of systemic corticosteroid greater than 40mg daily of prednisolone (or equivalent).
• Patients repeatedly taking doses in the evening.

Patients should carry ‘steroid treatment’ cards which give clear guidance on the precautions to be taken to minimise risk and which provide details of the prescriber, drug, dosage and the duration of treatment.

Adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment. Withdrawal of corticosteroids after prolonged therapy must therefore always be gradual to avoid acute adrenal insufficiency, being tapered off over weeks or months according to the dose and duration of treatment. 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 re-introduced.

Suppression of the HPA axis and other 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 alternate days. Frequent patient review is required to appropriately titrate the dose against disease activity (see section 4.2).

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.

Chickenpox is of particular concern since this normally minor illness may be fatal in immunosuppressed patients. Patients 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. If the patient is a child parents must be given the above advice. 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 three 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.

Patients should be advised to take particular care to avoid exposure to measles and to seek immediate advice if exposure occurs. Prophylaxis with intramuscular normal immunoglobulin may be needed.

Live vaccines should not be given to individuals with impaired immune responsiveness caused by high doses of corticosteroids. The antibody response to other vaccines may be diminished.

Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission.

Because of the possibility of fluid retention, care must be taken when corticosteroids are administered to patients with renal insufficiency or hypertension or congestive heart failure.

Corticosteroids may worsen diabetes mellitus, osteoporosis, hypertension, glaucoma and epilepsy and therefore patients with these conditions or a family history of them should be monitored frequently.

Care is required and frequent patient monitoring necessary where there is a history of severe affective disorders (especially a previous history of steroid psychosis), previous steroid myopathy, peptic ulceration, hypothyroidism, recent myocardial infarction or patients with a history of tuberculosis.

In patients with liver failure, blood levels of corticosteroid may be increased, as with other drugs which are metabolised in the liver. Frequent patient monitoring is therefore necessary.

Paediatric population: Corticosteroids cause dose-related growth retardation in infancy, childhood and adolescence, which may be irreversible.

Use in the Elderly: The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age, especially osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid life-threatening reactions.

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), although dose levels do not allow prediction of the onset, type, severity or duration of reactions. Most adverse reactions resolve after either dose reduction or withdrawal of the medicine, 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 a 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.

Prednisolone 10mg/ml Oral Solution contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate and may cause allergic reactions (possibly delayed).

It also contains 3mg of sodium per 1ml of oral solution (10mg prednisolone) and 30mg sodium per 10ml of oral solution (100mg prednisolone). To be taken into consideration by patients on a controlled sodium diet.

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 15 mg 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

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.

Rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone, ephedrine and aminoglutethimide enhance the metabolism of corticosteroids and its therapeutic effects may be reduced.

Mifepristone may reduce the effect of corticosteroids for 3-4 days.

Erythromycin and ketoconazole may inhibit the metabolism of some corticosteroids.

Ciclosporin increases plasma concentration of prednisolone. The same effect is possible with ritonavir.

Oestrogens and other oral contraceptives may potentiate the effects of glucocorticoids and dosage adjustments may be required if oral contraceptives are added to or withdrawn from a stable dosage regimen.

The desired effects of hypoglycemic agents (including insulin), anti-hypertensives and diuretics are antagonised by corticosteroids.

The growth promoting effect of somatotropin may be inhibited by the concomitant use of corticosteroids.

Steroids may reduce the effects of anticholinesterases in myasthenia gravis and cholecystographic x-ray media.

The efficacy of coumarin anticoagulants and warfarin may be enhanced by concurrent corticosteroid therapy and close monitoring of the INR or prothrombin time is required to avoid spontaneous bleeding.

Concomitant use of aspirin and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) with corticosteroids increases the risk of gastro-intestinal bleeding and ulceration.

The renal clearance of salicylates is increased by corticosteroids and steroid withdrawal may result in salicylate intoxication.

The hypokalaemic effects of acetazolamide, loop diuretics, thiazide diuretics, and carbenoxolone, are enhanced by corticosteroids. The risk of hypokalaemia is increased with theophylline and amphotericin. Corticosteroids should not be given concomitantly with amphotericin, unless required to control reactions.

The risk of hypokalaemia also increases if high doses of corticosteroids are given with high doses of bambuterol, fenoterol, formoterol, ritodrine, salbutamol, salmeterol and terbutaline. The toxicity of cardiac glycosides is increased if hypokalaemia occurs with corticosteroids.

Concomitant use with methotrexate may increase the risk of haematological toxicity.

High doses of corticosteroids impair the immune response and so live vaccines should be avoided (see also section 4.4).

4.6 Fertility, pregnancy and lactation

Pregnancy

The ability of corticosteroids to cross 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 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 intrauterine 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.

Depression of hormone levels has been described in pregnancy but the significance of this finding is not clear.

Breast-feeding

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 outweigh any theoretical risk.

4.7 Effects on ability to drive and use machines

Not relevant.

4.8 Undesirable effects

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

The following side effects may be associated with the long-term systemic use of corticosteroids with the following frequency:

Not known (cannot be estimated from available data)

1. a) 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 unknown.
2. b) 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).

A ‘withdrawal syndrome’ may also occur including fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and loss of weight.

In some instances, withdrawal symptoms may involve or resemble a clinical relapse of the disease for which the patient has been undergoing treatment.

Other effects that may occur during withdrawal or change of corticosteroid therapy include benign intracranial hypertension with headache and vomiting and papilloedema caused by cerebral oedema.

Latent rhinitis or eczema may be unmasked.

Paediatric population:

Increased intracranial pressure with papilloedema in children (pseudotumour cerebri) -usually after treatment withdrawal.

Growth retardation in infancy, childhood and adolescence.

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.

4.9 Overdose

Treatment is unlikely to be needed in cases of acute overdosage.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Glucocorticoids,

Prednisolone Oral Solution contains the equivalent of 10mg of prednisolone in the form of prednisolone sodium phosphate. Prednisolone sodium phosphate is a synthetic glucocorticoid with the same general properties as prednisolone itself and other compounds classified as corticosteroids. Prednisolone is four times as active as hydrocortisone on a weight for weight basis.

5.2 Pharmacokinetic properties

Absorption

Prednisolone is readily absorbed from the gastrointestinal tract with peak plasma concentrations achieved by 1-2 hours after an oral dose. Plasma prednisolone is mainly protein bound (70-90%), with binding to albumin and corticosteroid-binding globulin. The plasma half-life of prednisolone, after a single dose, is between 2.5-3.5 hours.

Distribution

The volume of distribution and clearance of total and unbound prednisolone are concentration dependent, and this has been attributed to saturable protein binding over the therapeutic plasma concentration range.

Biotransformation

Prednisolone is extensively metabolised, mainly in the liver, but the metabolic pathways are not clearly defined.

Elimination

Over 90% of the prednisolone dose is excreted in the urine, with 7-30% as free prednisolone and the remainder being recovered as a variety of metabolites.

5.3 Preclinical safety data

No additional data of relevance.

6. Pharmaceutical particulars

6.1 List of excipients

Sodium methyl parahydroxybenzoate Sodium propyl parahydroxybenzoate, Glycerol, Sodium saccharin, Disodium edetate, Sodium dihydrogen phosphate dihydrate, flavour (contains propylene glycol), Sodium hydroxide (pH adjuster),Purified Water.

6.2 Incompatibilities

Not applicable

6.3 Shelf life

18 months unopened.

Once the bottle is opened, use within 3 months

6.4 Special precautions for storage

Store in a refrigerator (2°C – 8°C).

Once opened, store below 25°C and use within 3 months.

Keep the container in the outer carton in order to protect from light.

6.5 Nature and contents of container

Amber (Ph. Eur. Type III) glass bottle containing 30ml, with child-resistant, tamper-evident plastic screw cap, a 5ml graduated oral dosing syringe and an adaptor.

6.6 Special precautions for disposal and other handling

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

7. 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 Oral Solution USP 15mg/5ml Taj Pharma

Package leaflet: Information for the user

Read all of this leaflet carefully before you or your child, starts 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 or your child 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 or your child, 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 Oral Solution is and what it is used for

2.What you need to know before you take Prednisolone Oral Solution

3.How to take Prednisolone Oral Solution

4.Possible side effects

5.How to store Prednisolone Oral Solution

6.Contents of the pack and other information

1. What Prednisolone Oral Solution is and what it is used for

Your doctor has decided that you or your child, need this medicine to help treat your or their, condition.

Prednisolone 10mg/ml Oral Solution (called Prednisolone Oral Solution throughout the rest of this leaflet) contains the active ingredient prednisolone. Prednisolone belongs to a group of medicines called steroids (the full name is corticosteroids).

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 involving inflammation in the body.

Prednisolone Oral Solution reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get the maximum benefit from it.

Prednisolone Oral Solution can be used:

• to treat breathing difficulties associated with asthma;
• to treat severe allergic reactions;
• to treat illnesses which cause inflammation of the skin, small and medium sized arteries, muscles and joints (including rheumatoid arthritis);
• to treat problems with your immune system, where the immune system attacks the cells in your body;
• to treat certain kidney problems;
• to treat certain illnesses resulting in inflammation of the bowels

e.g. ulcerative colitis or Crohn’s disease;

1. to treat inflammation of the heart;
2. to treat problems with your blood including haemolytic anaemia (a disorder which breaks down red blood cells) and leukaemia;
3. to prevent rejection following an organ transplant.

2. What you need to know before you take Prednisolone Oral Solution

Do not take Prednisolone Oral Solution:

• if you are allergic to prednisolone or any of the other ingredients of this medicine (listed in section 6). Signs of a severe allergic reaction may include a red and lumpy skin rash, difficulty breathing, swelling of face, mouth, lips or eyelids, unexplained high temperature (fever) and feeling faint. If the swelling affects your throat and makes breathing and swallowing difficult, go to hospital straight away;
• if you have an infection which affects your entire body (unless you are receiving treatment for the infection);
• if you have recently had any “live” vaccinations.

Warnings and precautions

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

• if you have ever had severe depression or manic depression (bipolar disorder). This includes having had depression before or while taking steroid medicines like Prednisolone Oral Solution;
• if any of your close family has had these illnesses;
• if you have Scleroderma (also known as systemic sclerosis, an autoimmune disorder) because daily doses of 15 mg or more may increase the risk of a serious complication called scleroderma renal crisis. Signs of scleroderma renal crisis include increased blood pressure and decreased urine production. The doctor may advise that you have your blood pressure and urine regularly checked.

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

Mental health problems while taking Prednisolone Oral Solution Mental health problems can happen while taking steroids like Prednisolone Oral Solution.

• These illnesses can be serious.
• Usually they start within a few days or weeks of starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is lowered or the medicine is stopped. However, if problems do happen, they might need treatment.

Talk to a doctor if you (or someone taking this medicine) show any signs of mental 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 stopped.

Chickenpox, shingles or measles

• Tell your doctor if you have previously had chickenpox, shingles or measles or if you have been vaccinated against these infections.
• It is important that whilst you are taking this medicine, you avoid contact with anybody who has chickenpox, shingles or measles especially if you have not already had them. If you think you may have come into contact with a person who has chickenpox, shingles or measles, you should contact your doctor immediately.
• If you catch chickenpox, shingles or measles, tell your doctor immediately. Your doctor will advise you on how to take prednisolone. Your doctor may want to change your dose of Prednisolone Oral Solution.

Please also tell your doctor or pharmacist if any of the following apply to you:

• if you have or have ever had, tuberculosis (TB) or blood poisoning (septicaemia);
• if you have liver or kidney problems;
• if you have high blood pressure (or a family history of high blood pressure), heart disease or you have recently had a heart attack;
• if you have or have a family history of the following:

° diabetes

° osteoporosis

° glaucoma (raised eye pressure)

° epilepsy (fits)

• if you have ever previously suffered from muscle weakness when

using prednisolone or any other steroids, in the past;

• if you have or have had, a stomach ulcer;
• if you have an underactive thyroid gland.

If you have any of the above conditions, your doctor may monitor you carefully whilst you are taking this medicine.

Other medicines and Prednisolone Oral Solution

Please tell your doctor or pharmacist 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 Oral Solution and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
• Rifampicin and rifabutin (antibiotics used to treat tuberculosis): taking these medicines with prednisolone may stop prednisolone from working properly.
• Carbamazepine, phenytoin, primidone and phenobarbitone (for epilepsy): taking these medicines with prednisolone may stop prednisolone from working properly.
• Ephedrine (a nasal decongestant): taking ephedrine with prednisolone may stop prednisolone from working properly.
• Aminoglutethimide (anti-cancer treatment): taking this medicine with prednisolone may stop prednisolone from working properly.
• Mifepristone (used for termination of pregnancy): taking mifepristone with prednisolone may stop prednisolone from working properly for several days.
• Erythromycin (an antibiotic, used to treat infections): if taken with prednisolone, your doctor may need to change your dose of prednisolone or you may experience more side effects.
• Ketoconazole (used to treat fungal infections): if taken with prednisolone, your doctor may need to change your dose of prednisolone or you may experience more side effects.
• Ciclosporin (used to prevent rejection after transplants): if taken with prednisolone, your doctor may need to change your dose of prednisolone or you may experience more side effects.
• Oestrogen hormones including the contraceptive pill: if taken with prednisolone, you may experience more side effects and your doctor may need to change your dose of prednisolone.
• Medicines for diabetics (such as insulin): if taken with prednisolone, then these medicines may not work properly.
• Medicines used to treat high blood pressure (e.g. hydralazine): if taken with prednisolone, then these types of medicines may not work properly.
• Diuretics also known as water tablets (e.g. bendrofluazide): if taken with prednisolone, then these types of medicine may not work properly.
• Somatotropin (a growth hormone): if taken with prednisolone, your medicine may no longer work properly.
• Medicines used to treat myasthenia gravis (muscle weakness), such as neostigmine: if taken with prednisolone, these medicines may not work as well.
• Medicines used to make x-rays clearer: if taken with prednisolone, these medicines may not work as well.
• Anticoagulant medicines which thin the blood (e.g. warfarin and coumarin): if taken with prednisolone, you may be at an increased risk of bleeding, therefore your doctor is likely to monitor you more closely.
• Aspirin and Non-Steroidal Anti-Inflammatory Drugs (e.g. ibuprofen): if taken with prednisolone you may be more likely to develop ulcers or bleeding from the stomach.
• Salicylates (e.g. Aspirin): if taken with prednisolone you may experience an increase in side effects of the salicylate once you stop taking prednisolone.
• Methotrexate (anti-cancer treatment): if taken with prednisolone you may experience more severe side effects.

In addition, please tell your doctor or pharmacist if you are taking any of the following medicines, as taking these medicines with Prednisolone Oral Solution may cause you to have a lower level of potassium in your blood than normal (hypokalaemia):

• Acetazolamide (used for glaucoma and epilepsy);
• Diuretics also known as water tablets e.g. furosemide and bendroflumethiazide (used to treat high blood pressure);
• Carbenoxolone (used in the treatment of stomach ulcers);
• Medicines used to treat asthma (e.g. theophylline, bambuterol, fenoterol, formoterol, ritodrine, salbutamol, salmeterol and terbutaline);
• Amphotericin (used to treat fungal infections).

Vaccinations

If you have recently had or are planning to have any vaccinations, tell your doctor before taking Prednisolone Oral Solution. This is because some injections or vaccinations should not be given to people who are taking prednisolone.

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.

Prednisolone Oral Solution contains sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate and sodium:

• Sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate. May cause allergic reactions (possibly delayed).
• Sodium. This medicinal product contains 3mg of sodium per 1ml oral solution (10mg prednisolone) and 30mg of sodium per 10ml of oral solution (100mg prednisolone) daily. To be taken into consideration by patients on a controlled sodium diet.

Carrying a Steroid card

If you take this medicine for more than three weeks, your doctor or pharmacist will give you a Steroid Treatment Card with your prescription or medicine.

• Keep this card with you always.
• Show it to any doctor, dentist, nurse, midwife or anyone else who is giving you treatment.

Even after your treatment has finished, tell any doctor, dentist, nurse, midwife or anyone else who is giving you treatment that you have taken steroids.

3.How to take Prednisolone Oral Solution

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. These instructions will have been added to the dispensing label by your pharmacist.

Your doctor will decide on the most appropriate dose to treat you or your child.

Using the syringe

A 5ml graduated syringe and a syringe/bottle adaptor is provided with your medicine. Use the syringe to withdraw, from the bottle, the amount of Prednisolone Oral Solution that has been prescribed for you by your doctor.

• Insert the bottle adaptor firmly into the neck of the bottle.
• Push the tip of the syringe into the hole in the top of the adaptor and ensure that it is secure.
• Hold the syringe in place and then turn the bottle upside down (refer to Figure 1).
• Still holding the syringe in place, pull the plunger down to the correct mark on the syringe (refer to Figure 1 and Figure 2).
• Turn the bottle the right way up.
• Remove the syringe, from the adaptor, by holding onto the bottle and gently twisting the syringe.
• After use replace the bottle cap and wash the syringe in warm water. Allow to dry.
• Do not remove the adaptor from the bottle.

Each graduation on the syringe provided is equivalent to 0.25ml of solution

Adults

• The usual starting dose is 1ml to 10ml per day
• Your doctor may reduce the dose, after a few days or weeks, depending on how well your condition is responding to the treatment.

For Rheumatoid Arthritis

• The usual starting dose is between 0.75ml and 1ml per day.

Use in children and adolescents

• Your doctor will decide the most appropriate dose to treat your child.
• If Prednisolone Oral Solution has been prescribed for your child, for the treatment of acute asthma attacks the following dosing regime may be given for up to three days:

° For children over 5 years of age, 3 to 4ml may be prescribed;

° For children aged 2-5 years of age, 2ml may be prescribed;

° For children aged under 2 years, 1ml may be prescribed if your child is being treated in a hospital.

Important: If you are unsure how much medicine to take, please contact your doctor or pharmacist for advice.

Method of administration: For oral use only.

If you take more Prednisolone Oral Solution than you should

If you take more oral solution than your doctor has told you to, contact a doctor or your nearest hospital casualty department immediately and take this medicine with you.

If you forget to take Prednisolone Oral Solution

• If you forget to take a dose, take it as soon as you remember unless it is almost time for the next dose.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Prednisolone Oral Solution

Speak to your doctor before you stop taking Prednisolone Oral Solution.

• Do not stop taking this medicine suddenly. Your doctor will tell you how to reduce your dose slowly over a number of weeks or months to help lower the chance of you getting withdrawal symptoms.
• Stopping Prednisolone Oral Solution (particularly if stopped suddenly) can lead to withdrawal symptoms. The most common are:

–        high temperature

–        muscle and joint pain

–        runny nose

–        weight loss

–        itchy skin

–        red, sore and sticky eyes (conjunctivitis)

–        headache

–        being sick

–        blurred vision

–        low blood pressure

• If you get severe withdrawal symptoms tell your doctor straight away. He/she may ask you to start taking your medicine again and then to start coming off it again more slowly.

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

If you experience any of the following side effects after you have been given your medicine, tell your doctor or pharmacist immediately:

• Severe allergic reaction which may include a red and lumpy skin rash, difficulty breathing, swelling of face, mouth, lips or eyelids, unexplained high temperature (fever) and feeling faint. If the swelling affects your throat and makes breathing and swallowing difficult, go to hospital straight away.
• Serious mental health problems. Steroids, including prednisolone, can cause serious mental health problems. These are common in both adults and children. They can affect about five in every 100 people using medicines like prednisolone. The symptoms include:

° feeling depressed, including thinking about suicide;

° feeling high (mania) or moods that can go up and down;

° feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory

° feeling, seeing or hearing things that do not exist. Having strange and frightening thoughts, changing how you act or have feelings of being alone.

• If you have epilepsy and you have more fits than normal.

The following side effects may occur if prednisolone is given for a long period of time:

Not known: frequency cannot be estimated from the available

• if you have had tuberculosis in the past, it may return
• you may get infections more easily than usual
• a rare type of cancer which can affect both the skin and internal organs (Kaposi’s sarcoma)
• raised level of white blood cells
• facial puffiness and weight gain (Cushingoid)
• intolerance to carbohydrates which might result in a requirement for anti-diabetic treatment or you may develop a mild form of diabetes, but without any obvious symptoms
• salt imbalances or water retention in the body
• low levels of potassium in the blood, which may result in tiredness, confusion, muscle weakness or muscle cramps
• increased appetite
• loss of protein and calcium balance
• dizziness
• headache
• increased pressure in the eye, swelling in the eye, cataracts
• detachment of the retina causing visual impairment
• protrusion of the eyeballs
• thinning of the eye membranes, worsening of existing eye infections
• vertigo
• tearing of the heart muscle tissues, particularly if you have recently had a heart attack
• heart failure in susceptible people
• high blood pressure
• blocked blood vessel (embolism)
• hiccups or indigestion
• feeling or being sick
• swollen stomach or stomach ache
• diarrhoea
• ulcers in the oesophagus (gullet)
• thrush
• inflammation of the pancreas causing abdominal pain
• stomach ulcers (which may bleed)
• thin delicate skin, unusual marks on the skin or bruising
• appearance of stretch marks
• acne
• visible swollen capillaries
• increased sweating
• rash, itching skin
• excess body hair (particularly in women)
• muscle wasting, weakness or pain
• thinning of the bones with an increased risk of fractures (osteoporosis)
• bone disease
• irregular periods or your periods may stop altogether
• slow wound healing
• generally feeling unwell
• weight gain
• breaking of tendons. Symptoms can include hearing or feeling a pop or a snap, severe pain, immediate bruising and an inability to put weight on or use, the affected area
• 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.

Additional side effects in children and adolescents Children and teenagers taking this medicine may grow more slowly than normal. If you, as the patient or carer, are worried about the effects of taking this medicine, go back and discuss it with your doctor.

Elderly

If you are elderly, your doctor will monitor you closely whilst you are taking this medicine as you may be more likely to experience side effects.

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

5.How to store Prednisolone Oral Solution

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 and label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C). Once opened, your medicine can be stored at a temperature below 25°C and must be used within 3 months.

Keep this medicine in the original packaging, in order to protect from light.

Do not use this medicine if you notice any visible signs of damage to the bottle or deterioration in your medicine. 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.Contents of the pack and other information

What Prednisolone Oral Solution contains

• The active substance is prednisolone. Each 1ml of oral solution contains 10mg prednisolone (as prednisolone sodium phosphate).
• The other ingredients are sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), glycerol, sodium saccharin, disodium edetate, sodium dihydrogen phosphate dihydrate, sodium hydroxide (as pH adjuster), flavour and purified water (see section 2 What you need to know before you take Prednisolone Oral Solution).

What Prednisolone Oral Solution looks like and contents of the pack

Prednisolone 10mg/ml Oral Solution is a clear colourless to yellowish oral solution with a characteristic odour of orange. It is available in an amber glass bottle containing 30ml of medicine. The pack also contains a 5ml plastic oral dosing syringe and an adaptor.