1. Name of The Medicinal Product

Prednisolone 25 mg/ml Suspension for Injection Taj Pharma

2. Qualitative and Quantitative Composition

Each ampoule contains 25 mg Prednisolone Acetate

For the full list of excipients, see section 6.1.

3. Pharmaceutical Form

Suspension for Injection

A white or almost white suspension.

4. Clinical Particulars

4.1 Therapeutic indications

This medicine is indicated in adults for the local treatment, by intra-articular or periarticular injection, of the following conditions: rheumatoid arthritis; osteoarthritis; synovitis not associated with infection; tennis elbow; golfer’s elbow, and bursitis.

This medicine is also suitable for administration by the intramuscular route in conditions requiring systemic corticosteroids, e.g. suppression of inflammatory and allergic disorders such as bronchial asthma, anaphylaxis, ulcerative colitis and Crohn’s disease.

4.2 Posology and method of administration

Posology

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 titrate the dose against disease activity.

Paediatric Population

This medicine is not suitable for use in children.

Elderly

Steroids should be used cautiously in the elderly since adverse effects are enhanced by old age (see section 4.4).

Method of administration

Intra-articular, periarticular or intramuscular injection.

Adults

For articular use: 5-25mg depending upon the size of the joint. The injections may be repeated when relapse occurs. No more than three joints should be treated in one day.

For intramuscular use: The dosage may vary from 25 to 100mg, given once or twice per week, as needed. It will depend upon the disease and its severity and the clinical response to this medicine. The maximum dosage should not exceed 100mg twice weekly.

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.

Vaccination with live vaccines (see section 4.4).

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

Intra-articular and periarticular injections of this medicine, when the joint or surrounding tissues are infected.

Injection into tendon sheaths and bursae when infection is present.

Injection directly into tendons.

Injection into spinal or other non-diarthrodial joints.

4.4 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.

Anti-inflammatory/ immunosuppression effects and infection:

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

Chronic immunosuppression (e.g. in the setting of organ transplantation), has been associated with an increased risk of malignancy.

Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. The resultant opportunistic infections may be fatal. 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. New infections may appear during their use.

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 three 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.

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

Live vaccines should not be given to individuals with impaired immune responsiveness. Killed vaccines or toxoids may be given though their effects may be attenuated.

Others

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).
• The effect of corticosteroids may be enhanced in patients with hypothyroidism in those with chronic liver disease with impaired hepatic function.
• Adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment.
• Patients with a history of severe affective disorders and particularly those with a previous history of corticosteroid induced psychoses.

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.

Withdrawal

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 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 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,
• 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.

This medicine contains sodium

This medicinal product contains less than 1mmol sodium (23mg) per dose, i.e. essentially sodium free.

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.

Use in 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 (see section 4.2).

Paediatric population

Corticosteroids cause growth retardation in infancy, childhood and adolescence; this 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 (HPA) axis and growth retardation (see section 4.2).

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.

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

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 sub therapeutic aspirin serum concentrations.

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

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.

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

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.

Antifungals: There is an increased risk of hypokalaemia with amphotericin, and concomitant use should be avoided. Ketoconazole reduces the metabolic and renal clearance of methylprednisolone and this may also occur with prednisolone.

Erythromycin may inhibit the metabolism of some corticosteroids.

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

Rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone, ephedrine 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.

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

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 hypokalaemic effects of acetazolamide, loop diuretics, thiazide diuretics, and carbenoxolone are enhanced by corticosteroids.

There is also an increased risk of hypokalaemia with the simultaneous use of theophylline and 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.

Etoposide metabolism may be inhibited by corticosteroids in vitro. This may lead to an increase in both efficacy and toxicity of etoposide. Monitoring would be prudent.

Corticosteroids should not be used concurrently with retinoids and tetracyclines due to increased intracranial pressure.

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

4.6 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 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 pre-natal 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. Monitoring of the infant for adrenal suppression is advised.

4.7 Effects on ability to drive and use machines

This medicine has no or negligible influence on the ability to drive and use machines.

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)

System organ class	Frequency	Undesirable effects
Infections and infestations	Not known	Increased susceptibility and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, recurrence of dormant tuberculosis (see section 4.4).
Neoplasms benign, malignant and unspecified (including cysts and polyps)	Not known	Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission.
Blood and lymphatic system disorders	Not known	Leukocytosis.
Immune system disorders	Not known	Hypersensitivity including anaphylaxis has been reported.
Endocrine disorders	Not known	Suppression of the HPA axis. Cushingoid. Impaired carbohydrate intolerance with increased requirement for anti-diabetic therapy, manifestation of latent diabetes mellitus.
Metabolism and nutrition disorders	Not known	Sodium and water retention, hypokalaemia, hypokalaemic alkalosis, increased appetite, negative protein and calcium balance.
Psychiatric disordersa	Not known	Euphoric mood, psychological dependence, depressed mood, insomnia, aggravation of schizophrenia.
Nervous system disorders	Not known	Dizziness, headache. Aggravation of epilepsy.
Eye disorders	Not known	Glaucoma, papilloedema, posterior subcapsular cataracts, central serous chorioretinopathy, exophthalmos, corneal or scleral thinning, exacerbation of ophthalmic viral or fungal diseases and vision, blurred (see also section 4.4).
Ear and labyrinth disorders	Not known	Vertigo.
Cardiac disorders	Not known	Myocardial rupture following recent myocardial infarction. Congestive cardiac failure (in susceptible patients).
Vascular disorders	Not known	Hypertension, embolism.
Respiratory, thoracic and mediastinal disorders	Not known	Hiccups.
Gastrointestinal disorders	Not known	Dyspepsia, nausea, vomiting, abdominal distension, abdominal pain, diarrhoea, oesophageal ulceration, candidiasis, pancreatitis acute. Peptic ulceration with perforation and haemorrhage.
Skin and subcutaneous tissue disorders	Not known	Skin Atrophy, skin striae, acne, telangiectasia, hyperhidrosis, rash, pruritus, urticaria, hirsutism.
Musculoskeletal and connective tissue disorders	Not known	Myopathy, osteoporosis, vertebral and long bone fractures, avascular osteonecrosis, myalgia.
Renal and urinary disorders	Not known	Scleroderma renal crisis*
Reproductive system and breast disorders	Not known	Menstruation irregular, amenorrhoea.
General disorders and administration site conditions	Not known	Impaired healing, malaise.
Investigations	Not known	Weight increased.
Injury, poisoning and procedural complications	Not known	Tendon rupture, contusion (bruising).

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.

*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.

4.9 Overdose

Management

Overdosage is unlikely with this medicine but there is no specific antidote available. Treatment should be symptomatic.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Glucocorticoids

Prednisolone is a glucocorticoid which has anti-inflammatory activity.

5.2 Pharmacokinetic properties

Absorption

Absorption following intramuscular injection is relatively slow. Systemic absorption occurs slowly after local, intra-articular injection.

Distribution

Prednisolone is extensively bound to plasma proteins.

Elimination

Excretion takes place via the urine as free and conjugated metabolites, together with an appreciable proportion of unchanged prednisolone.

5.3 Preclinical safety data

There is no pre-clinical data of relevance to a prescriber which is additional to that already included in other sections of the SmPC.

6. Pharmaceutical particulars

6.1 List of excipients

Water for injections, sodium chloride for injections, benzyl alcohol, sodium carboxymethylcellulose, polysorbate 80, with sodium hydroxide and/or sterile sodium hydroxide and/or hydrochloric acid as pH adjusters.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Store at 15°C -25°C and protect from light.

6.5 Nature and contents of container

1ml flint neutral glass ampoules.

10 ampoules are packed in a polystyrene pack within a cardboard sleeve.

6.6 Special precautions for disposal and other handling

Shake the ampoule well before use.

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 25 mg/ml Suspension for Injection Taj Pharma

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of medicine is Prednisolone acetate 25mg/ml Suspension for Injection. It will be referred to as Prednisolone Injection for ease of use hereafter.

• Prednisolone Injection is a steroid medicine, prescribed for many different conditions, including serious illnesses.
• You need to take it regularly to get the maximum benefit.
• Don’t stop receiving this medicine without talking to your doctor – you may need to reduce the dose gradually.
• Prednisolone Injection can cause side effects in some people (read section 4 below). Some problems such as mood changes (feeling depressed or ‘high’) or stomach problems can happen straight away. If you feel unwell in any way, see your doctor straight away.
• Some side effects only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face (read section 4 for more information).
• If you take this medicine for more than three weeks, you will get a blue ‘steroid card’: always keep it with you and show it to any doctor or nurse treating you.
• Keep away from people who have chickenpox or shingles, if you have never had them. They could affect you severely. If you do come into contact with chickenpox or shingles, see your doctor straight away.

Now read the rest of this leaflet. It includes other important information

on the safe and effective use of this medicine that may be especially important for you.

Prednisolone – benefit information

Prednisolone belongs to a group of medicines called steroids. Their full name is corticosteroids. These corticosteroids occur naturally in the body and help to maintain health and well-being. Boosting your body with extra corticosteroid (such as prednisolone) is an effective way to treat various illnesses involving inflammation in the body. Prednisolone reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.

What is in this leaflet

1. What Prednisolone Injection is and what it is used for
2. What you need to know before you are given Prednisolone Injection
3. How Prednisolone Injection is given to you
4. Possible side effects
5. How to store Prednisolone Injection
6. Contents of the pack and other information

 

1. WHAT PREDNISOLONE INJECTION IS AND WHAT IT IS USED FOR

The name of your medicine is Prednisolone Injection. Prednisolone Injection contains the active ingredient prednisolone acetate which belongs to a group of medicines called corticosteroids or ‘steroids. Steroids work by reducing inflammation and lowering the body’s immune response.

Prednisolone Injection is used to treat adults. This medicine is used to treat swollen, painful joints and tendons in conditions such as arthritis, tennis elbow and golfer’s elbow.

Prednisolone Injection can also be used to treat conditions such as asthma, severe allergic reactions, ulcerative colitis and Crohn’s disease.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PREDNISOLONE INJECTION

Prednisolone Injection is not suitable for use in children.

You should not be given Prednisolone Injection:

• if you are allergic to prednisolone or any of the other ingredients of this medicine (listed in section 6) (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing);
• if you just 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 nurse before you are given Prednisolone Injection.

• If you have severe depression or manic-depressive illness (bipolar disorder). This includes having had depression before while taking steroid medicines like Prednisolone Injection or if anyone in your family has suffered from these illnesses;
• If you have TB (tuberculosis);
• If you have diabetes;
• If you have epilepsy;
• If you have an eye disease caused by a rise of pressure within the eye (glaucoma);
• If you have osteoporosis (thinning of the bones);
• If you have muscle problems when steroids have been taken before;
• If you have stomach ulcers;
• If you have high blood pressure or heart failure;
• If you have any liver or kidney problems;
• If you have an under-active thyroid (hypothyroidism);

If you are elderly your doctor may need to monitor you closely;

• If you are going to receive an organ transplant;
• 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.

If any of the above applies to you or you are not sure please tell your doctor or nurse before you use this medicine. Mental health problems while receiving prednisolone

Mental health problems can occur while being given steroids like prednisolone (see also section 4 Possible Side Effects).

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

Talk to a doctor if you (or someone is given 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.

Other medicines and Prednisolone Injection

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

This is especially important if you are taking:

• Some medicines may increase the effects of Prednisolone Injection and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat);
• Medicines for epilepsy such as carbamazepine, phenobarbitone, phenytoin or primidone;
• Antibiotics such as rifampicin, rifabutin;
• 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;
• Non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin;
• 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);
• Etoposide (used to treat 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);
• Aminoglutethimide (used to treat Cushing’s disease or some breast cancers);

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 for advice before you are given this medicine.

Driving and using machines

This medicine should not affect your ability to drive or use machines.

Carrying a Steroid card

Your doctor or pharmacist will have given you a Steroid Treatment Card with your prescription or medicine.

YOU SHOULD ALWAYS CARRY THIS CARD WITH YOU as it must be shown to any of the following persons:

Doctor or Nurse	–   before  having  any  surgery  or
	emergency treatment or if any new
Dentist	treatment is prescribed.
	–   before having any dental surgery.
Pharmacist	–   before buying any medicine.
Optician	–   it is advisable to have regular eye tests.

Prednisolone Injection contains sodium and benzyl alcohol

Sodium- This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially ‘sodium-free’.

Benzyl alcohol- Must not be given to premature babies or neonates. May cause toxic reactions and allergic reactions in infants and children up to 3 years old.

3. HOW PREDNISOLONE INJECTION IS GIVEN TO YOU

This medicine will be given to you by a doctor or nurse. The doctor will decide upon the most suitable dose for you, but the recommended doses are:

Adults:

For joint injections: Between 5 mg and 25 mg depending on the size of the joint. Not more than 3 joints will be treated in one day. The injections may be repeated if needed.

For muscle (systemic) injections: Between 25 mg and 100 mg once or twice a week, depending on your condition.

Elderly:

Your doctor will use the lowest dose for the shortest period of time to treat

your condition. This is important to reduce the possible side effects.

Method of administration:

Prednisolone Injection will be injected into or around a joint or into a muscle, depending on the condition being treated.

If you think you have been given more Prednisolone Injection than you should have

Overdosing is unlikely. If it does happen the doctor will treat any symptoms that follow.

If you stop taking Prednisolone Injection

If treatment is stopped too quickly it can lead to severe problems of the adrenal gland, low blood pressure and death.

You may also experience ‘withdrawal symptoms’ which include fever, muscular pain, joint pain, runny nose, an eye infection (conjunctivitis), painful itchy skin lumps, loss of weight, increased pressure in the brain with headache and vomiting, reappearance of your disease symptoms and swelling eye nerve.

Children may also experience swelling of the nerves in the eyes due to increase in pressure in and around the brain. The normal growth of infants, children and adolescents can slow down.

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

4. 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.

Tell your doctor immediately. These may be signs of an allergic reaction.

If you are having injections into a joint, the most likely side effect is increased pain and swelling after the injection. This usually goes away after a few hours and you should rest the joint as much as possible.

If you are having muscle (systemic) injections the steroid will enter your system.

The side effects which can occur if steroids are given in high doses for a long time are:

Not known: frequency cannot be estimated from the available data

• generally feeling unwell;
• feeling sick (nausea);
• hiccups;
• indigestion or stomach discomfort;
• stomach ulcer (which can rupture and bleed) or ulcer in the oesophagus (gullet);
• small bowel perforation;
• hrush;
• 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 motion, pain and muscle spasms;
• fluid retention causing swelling;
• feeling dehydrated;
• high blood pressure;
• slow healing of wounds, thinning of the skin, bruising, marks which look like stretch marks and acne;
• small red, purple or blue spots found along the surface of the skin (caused by blood vessels under the skin);
• low adrenal gland function;
• 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;
• worsening of epilepsy;
• raised pressure in the eyes (glaucoma), cataracts, thinning and inflammation of the cornea (part of the eye), worsening of viral or fungal eye diseases and visual impairment;
• heart attack;
• changes in blood chemistry;
• an increase in the number of white blood cells in the blood;
• 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;
• 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.

Kaposi’s sarcoma (a type of cancer) has also been reported to occur in patients receiving corticosteroids. However, once the treatment has been stopped, this may go away.

Injections like these 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.

Additional side effects in children and adolescents

• slowed growth in infants, children and teenagers;
• severe headaches with blurred vision or temporary visual problems in children (usually after stopping treatment).

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.

5. HOW TO STORE PREDNISOLONE INJECTION

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

Prednisolone Injection ampoules will be stored at the healthcare centre.

They should be stored at 15°C -25°C and kept in the carton in order to protect from light.

The doctor or nurse will check that the expiry date on the label has not passed before you are given the injection.

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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Prednisolone Injection contains

– The active substance is Prednisolone Acetate. Each 1ml Prednisolone Injection ampoule contains 25 mg of the active ingredient Prednisolone Acetate.

– The other ingredients are water for injections, sodium chloride, benzyl alcohol, sodium carboxymethylcellulose, polysorbate 80, with sodium hydroxide and/or hydrochloric acid as pH adjusters.

What Prednisolone Injection looks like and the contents of the pack

Prednisolone Injection is a white or almost white suspension.

Prednisolone injection is available in 1 ml clear glass ampoules.

It is available in packs containing 10 x 1 ml ampoules.

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