Hydrocortisone Tablets USP 10mg Taj Pharma

Hydrocortisone Tablets USP 5mg/ 10mg Taj Pharma

1. Name of the medicinal product

Hydrocortisone Tablets USP 5mg/ 10mg Taj Pharma

2. Qualitative and quantitative composition

a) Hydrocortisone Tablets USP 5mg
Each tablet contains:
Hydrocortisone                           5mg
Excipients                                   q.s.

b) Hydrocortisone Tablets USP 10mg
Each tablet contains:
Hydrocortisone                           10mg
Excipients                                   q.s.

Excipient with known effect

Each tablet contains lactose monohydrate.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Tablet.

A white, oval, tablet.

The tablet can be divided into equal doses

4. Clinical particulars

4.1 Therapeutic indications

Corticosteroid

• For use as replacement therapy in congenital adrenal hyperplasia in children.
• Pre-operatively, and during serious trauma or illness in children with known adrenal insufficiency or doubtful adrenocortical reserve.

4.2 Posology and method of administration

Posology

Dosage must be individualised according to the response of the individual patient.

Replacement therapy

Paediatric population: In chronic adrenocortical insufficiency, the dosage should be approximately 0.4 to 0.8mg/kg/day in two or three divided doses, adjusted to the needs of the individual child.

In patients requiring replacement therapy, the daily dose should be given when practicable, in two doses. The first dose in the morning should be larger than the second dose in the evening, thus simulating the normal diurnal rhythm of cortisol secretion.

Use in serious trauma or illness with known adrenal insufficiency or doubtful adrenocortical reserve

Paediatric population: Doses are generally higher than that used for chronic adrenocortical insufficiency and should be selected as appropriate for the clinical situation. Patients should be observed closely for signs that might require dosage adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease, individual drug responsiveness and the effect of stress (e.g. surgery, infection, trauma). During stress it may be necessary to increase the dosage temporarily.

Pre-operative use

Anaesthetists must be informed if the patient is taking corticosteroids or has previously taken corticosteroids.

When long term treatment is to be discontinued, the dose should be gradually reduced over a period of weeks or months, depending on dosage and duration of therapy (see section 4.4).

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.

Method of administration

For oral administration.

4.3 Contraindications

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

Contraindicated in infections including systemic infections where anti-infective therapy has not been started.

High doses of corticosteroids impair the immune response to vaccines. Therefore the concomitant administration of live vaccines with corticosteroids should be avoided.

4.4 Special warnings and precautions for use

Adrenal suppression

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.

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.

Anti-inflammatory / immunosuppressive effects and infection

Suppression of inflammatory response and immune function increases the susceptibility to infections and their severity. The clinical presentation can often be atypical and serious infections such as septicaemia and tuberculosis may be masked and may reach an advanced stage before being recognized. New infections may appear during their use.

Corticosteroids may activate latent amoebiasis or strongyloidiasis or exacerbate active disease. Therefore it is recommended that latent or active amoebiasis and strongyloidiasis be ruled out before initiating corticosteroid therapy in any patient at risk of or with symptoms suggestive of either condition.

Caution should be exercised in immunocompromised patients.

Chickenpox is of particular concern since this normally minor illness may be fatal in immunosuppressed patients. Patients (or parents of children receiving hydrocortisone tablets) without a definite history of chickenpox should be advised to avoid close personal contact with chickenpox or herpes zoster. 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 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 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 caused by high doses of corticosteroids. Killed vaccines or toxoids may be given though their effects may be attenuated.

Corticosteroids should be used with caution in non-specific ulcerative colitis if there is a probability of impending perforation, abscess or other pyogenic infection, diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer.

Particular care is required when prescribing systemic corticosteroids in patients with the following conditions and frequent patient monitoring is necessary:

1. a) osteoporosis (postmenopausal females are particularly at risk);
2. b) hypertension or congestive heart failure;
3. c) existing or previous history of severe affective disorders (especially previous history of steroid psychosis);
4. d) diabetes mellitus (or a family history of diabetes);
5. e) previous history of tuberculosis or characteristic appearance on a chest x-ray. The emergence of active tuberculosis can, however, be prevented by the prophylactic use of anti-tuberculous therapy;
6. f) glaucoma (or family history of glaucoma);
7. g) previous corticosteroid-induced myopathy;
8. h) liver failure;
9. i) renal insufficiency;
10. j) epilepsy;
11. k) peptic ulceration;
12. l) recent myocardial infarction.

During treatment, the patient should be observed for psychotic reactions, weakness, electrocardiographic changes, hypertension and untoward hormonal effects.

Corticosteroids should be used with caution in patients with hypothyroidism.

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 (see section 4.2).

Withdrawal symptoms:

In patients who have received more than physiological doses of systemic corticosteroids (approximately 40 mg cortisone 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 hypothalamic-pituitary adrenal (HPA) suppression, the dose of systemic corticosteroid may be reduced rapidly to physiological doses. Once a daily dose equivalent to 30 mg hydrocortisone 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 160 mg daily hydrocortisone 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 160 mg daily of hydrocortisone;
• patients repeatedly taking doses in the evening.

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.

This medicine contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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.

4.5 Interaction with other medicinal products and other forms of interaction

The metabolism of corticosteroids may be enhanced and the therapeutic effects reduced by certain barbiturates (e.g. phenobarbital) and by phenytoin, rifampicin, rifabutin, primidone, carbamazepine and aminoglutethimide.

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.

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

Erythromycin and ketoconazole may inhibit the metabolism of corticosteroids.

Ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal (see section 4.4).

Ritonavir may increase the plasma concentration of hydrocortisone.

Oestrogens and other oral contraceptives increase the plasma concentration of corticosteroids and dosage adjustments may be required if oral contraceptives are added to or withdrawn from a stable dosage regimen.

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

The desired actions of hypoglycemic drugs (including insulin), antihypertensives and diuretics are antagonised by corticosteroids.

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

Serum levels of salicylates, such as aspirin and benorilate, may increase considerably if corticosteroid therapy is withdrawn, possibly causing intoxication. Concomitant use of salicylates or of non-steroidal anti-inflammatory drugs (NSAIDs) with corticosteroids increases the risk of gastrointestinal bleeding and ulceration.

The potassium-depleting effects of acetazolamide, loop diuretics, thiazide diuretics and carbenoxolone are enhanced by corticosteroids and signs of hypokalaemia should be looked for during their concurrent use. 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 sympathomimetics e.g. bambuterol, fenoterol, formoterol, ritodrine, salbutamol, salmeterol and terbutaline. The toxicity of cardiac glycosides, e.g. digoxin, is increased if hypokalaemia occurs.

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 Pregnancy and lactation

Pregnancy

The ability of corticosteroids to cross placenta varies between individual drugs; however, cortisone readily 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 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 states.

Breast-feeding

Corticosteroids are excreted in breast milk, although no data are available for hydrocortisone. Infants of mothers taking highdoses of systemic corticosteroids for prolonged periods may have a degree of adrenal suppression. Mothers taking pharmacological doses of corticosteroids should be advised not to breast-feed. Any maternal treatment should be carefully documented in the infant’s medical records to assist in follow up.

Fertility

Patients with adrenal insufficiency have been shown to have reduced parity, which is most likely due to the underlying disease, but there is no indication that hydrocortisone in doses for replacement therapy will affect fertility.

4.7 Effects on ability to drive and use machines

Hydrocortisone has minor influence on the ability to drive and use machines. Fatigue and episodes of short lasting vertigo have been reported.

Untreated and poorly replaced adrenal insufficiency may affect the ability to drive and use machines.

4.8 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 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)

4. Increased susceptibility and severity of infections with suppression of clinical symptoms and signs, opportunistic infections and recurrence of dormant tuberculosis (see section 4.4).
5. 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.

Paediatric population

Growth suppression in infancy, childhood and adolescence, increased intracranial pressure with papilloedema in children (pseudotumour cerebri), usually after treatment withdrawal.

Withdrawal symptoms:

Too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute renal 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 weight loss.

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

Symptoms

Overdosage may cause nausea and vomiting, sodium and water retention, hyperglycemia and occasional gastrointestinal bleeding.

Management

Treatment need only be symptomatic although cimetidine (200-400 mg by slow intravenous injection every 6 hours) or ranitidine (50 mg by slow intravenous injection every 6 hours) may be administered to prevent gastrointestinal bleeding.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Systemic Hormonal Preparations (excluding sex hormones and insulins); Corticosteroids for Systemic Use; Plain; Hydrocortisone.

Pharmacodynamic effects

Hydrocortisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally-occurring and synthetic, which are readily absorbed from the gastrointestinal tract.

Hydrocortisone is believed to be the principal corticosteroid secreted by the adrenal cortex. Naturally-occurring glucocorticosteroids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. They are also used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition they modify the body’s immune responses to diverse stimuli.

5.2 Pharmacokinetic properties

Absorption

Hydrocortisone is readily absorbed from the gastrointestinal tract and 90% or more of the drug is reversibly bound to protein.

Distribution

The binding is accounted for by two protein fractions. One, corticosteroid-binding globulin which is a glycoprotein; the other is albumin.

Biotransformation and Elimination

Hydrocortisone is metabolised in the liver and most body tissues to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol which are excreted in the urine, mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone.

Half-life of hydrocortisone is about 1.5 hours.

5.3 Preclinical safety data

Administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate, intra-uterine growth retardation and effects on brain growth and development.

6.Pharmaceutical particulars

6.1 List of excipients

Lactose monohydrate, Maize starch, Magnesium stearate

6.2 Incompatibilities

Not applicable

6.3 Shelf life

30 months

6.4 Special precautions for storage

Do not store above 25° C. Store in the original package in order to protect from light.

6.5 Nature and contents of container

PVC/PVDC blisters lidded with aluminium foil containing 30 tablets.

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

Hydrocortisone Tablets USP 5mg/ 10mg Taj Pharma

Package leaflet: Information for the user

Hydrocortisone 5mg/10 mg Tablets

Hydrocortisone

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only.
  Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Hydrocortisone 5mg/10 mg Tablets. It will be referred to as Hydrocortisone Tablets for ease hereafter.

What is in this leaflet:

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

1.What Hydrocortisone Tablets are and what they are used for

Hydrocortisone 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 Hydrocortisone) is an effective way to treat various illnesses involving inflammation in the body.

Hydrocortisone reduces this inflammation, which could otherwise go on making your condition worse.

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

It is indicated

• for use as replacement therapy for children with congenital adrenal hyperplasia which affects your body’s natural production of steroids.
• pre-operatively and during serious trauma or illness in children with known adrenal insufficiency or doubtful adrenocortical reserve.

Hydrocortisone which is contained in this product is also authorised to treat other sub-groups of patients which are not mentioned in this leaflet. Ask your doctor or pharmacist if you have further questions.

2. What you need to know before you take Hydrocortisone Tablets

Do not take Hydrocortisone Tablets:

• if you are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may be recognised as a rash, itching, swollen face or lips or shortness of breath;
• if you have thrush, Candida or any other fungal infection;
• if you have any other infections;
• if you have been vaccinated recently or are going to have any vaccinations.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Hydrocortisone Tablets:

• if you ever had severe depression or manic depressive illness (bipolar disorder).This includes having had symptoms of depression in the past while taking steroid medicines like Hydrocortisone Tablets;
• if any of your close family has had these illnesses.

Check with your doctor before taking this medicine if you have or have had any of the following:

• tuberculosis (TB);
• liver problems;
• kidney problems;
• high blood pressure;
• heart problems including recent heart attacks;
• diabetes (or a family history of diabetes);
• osteoporosis (thinning of the bones);
• glaucoma (increased pressure in the eye) or family history of glaucoma;
• epilepsy;
• stomach ulcers or other digestive problems;
• muscle weakness with steroids;
• existing or previous history of severe mood-related disorders;
• thyroid problems;
• chickenpox, shingles or measles;
• a weakened immune system;
• amoebic dysentery and an infestation of a gut worm (strongyloidiasis), it may be activated or become worse by Hydrocortisone Tablets.

You should see your doctor if you develop any new infections whilst taking these tablets. Taking hydrocortisone for a long period of time increases your chance of getting infections, which might be worse than normal and may very rarely be fatal.

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

Children and adolescents

It is important that the doctor monitors growth and development at intervals during treatment of children.

If you are taking or have recently taken (within the last 3 months) Hydrocortisone Tablets and you become ill, suffer stress, get injured or are about to have a surgical procedure you must tell your doctor immediately that you are taking Hydrocortisone Tablets. Your dose of hydrocortisone may need to be increased (or you may have to start taking it again for a short time) to prevent a sharp fall in blood pressure.

If you have been on Hydrocortisone Tablets for longer than 3 weeks and wish to stop taking them, do not stop suddenly as this could result in a severe drop in blood pressure which could be fatal. Your doctor will advise on how to reduce the number of tablets you are taking.

It is important to avoid exposure to people who have chickenpox, measles or shingles, especially if you have not already had these illnesses or are not sure if you have had them. Hydrocortisone increases the risk of a severe bout of chickenpox. If exposed you must contact your doctor immediately.

Mental Health Problems while taking hydrocortisone

Mental health problems can occur while taking steroids like hydrocortisone (see also Section 4).

• 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 those 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.

Important-Steroid Treatment Card

All patients taking steroids for more than a few weeks should carry a Steroid Treatment Card, which is available from your doctor or pharmacist. These cards have the details of the medicine you are taking. Always keep it with you and show it to any doctor or nurse treating you.

Other medicines and Hydrocortisone 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 because some medicines can affect or be affected by the use of Hydrocortisone Tablets.

The side effects of this medicine may be increased if certain medicines are taken at the same time. On the other hand, this medicine may increase or decrease the effect of other medicines or increase their side effects when taken at the same time.

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

Please tell your doctor or pharmacist if you are taking:

• anticoagulants such as warfarin (medicines used to thin the blood);
• salicylates such as aspirin;
• non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, diclofenac or naproxen (medicines used to treat mild to moderate pain);
• cough and cold medicines that contain a decongestant called ephedrine;
• medicines for diabetes (including insulin);
• erythromycin (a medicine used to treat bacterial infections);
• an oral contraceptive pill;
• somatropin (a type of growth hormone);
• acetazolamide (a medicine used to treat glaucoma);
• amphotericin or ketoconazole (used to treat fungal infections);
• mifepristone (a medicine used to assist medical termination of pregnancy);
• diuretics (water tablets);
• carbenoxolone (a medicine used to treat ulcers);
• methotrexate (a medicine used to treat rheumatoid arthritis);
• medicines used to treat epilepsy such as phenytoin, phenobarbital, carbamazepine and primidone;
• rifabutin and rifampicin (antibiotics used to treat TB);
• aminoglutethimide (a medicine used in the treatment of cancer);
• cardiac glycosides such as digoxin (used to treat heart failure and irregular heartbeat);
• theophylline and sympathomimetics such as bambuterol, fenoterol, formoterol, ritodrine, salbutamol, salmeterol and terbutaline (used to treat asthma and other breathing problems);
• antihypertensives (medicines used to treat high blood pressure).

Test results while taking Hydrocortisone Tablets

Hydrocortisone Tablets could affect the results of some tests performed by your doctor or in hospital, so tell your doctor or nurse that you are taking these tablets before any tests are carried out.

Hydrocortisone with food, drink and alcohol

Hydrocortisone can be taken with or without food.

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.

Pregnancy

Your doctor will decide whether you should take Hydrocortisone Tablets during this time.

Breast-feeding

Small amounts of hydrocortisone may pass into breast milk. Please ask your doctor for advice before taking these tablets if you are breast-feeding or intend to breast-feed.

Driving and using machines

Hydrocortisone may have minor influence on your ability to drive and use machines. Extreme tiredness and episodes of short-lasting dizziness (vertigo) have been reported. Poorly treated or untreated adrenal insufficiency reduces your ability to concentrate and will affect your ability to drive and use machines. It is therefore important to take this medicine as directed by your doctor when driving or using machines. If you are affected do not drive or use machines, until you have discussed the issue with your doctor.

Hydrocortisone Tablets contains lactose

This medicine contains lactose (a kind of sugar). If you have been told by your doctor, that you have an intolerance to some sugars, contact your doctor, before taking this medicinal product.

3. How to take Hydrocortisone Tablets

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

Remember to always carry a Steroid Treatment Card. Make sure your doctor or pharmacist gives you this and has filled out the details including the dose and how long you will have treatment.

Method of administration

You should take this medicine by mouth. The amount you take each day will depend on your illness. The number of tablets to be taken will be on the label of your medicine. If you are unsure about the dose you should take, you must talk to your doctor or pharmacist. The tablet can be divided into equal doses.

The recommended dose is:

Use in children and adolescents

The recommended dose is 0.4 to 0.8 mg/kg given as two or three doses per day.

Children will be prescribed the lowest possible dose.

The doctor will keep an eye on their growth and development.

If you take more Hydrocortisone Tablets than you should

If you take more Hydrocortisone Tablets than you should, contact your doctor or nearest hospital/emergency department.

If you forget to take Hydrocortisone Tablets

If you forget to take a dose, wait and take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Hydrocortisone Tablets

Do not stop taking this medicine just because you feel better. You must follow your doctor’s instructions on stopping these tablets. Your doctor may want you to reduce gradually the number of tablets before you finally stop taking them. Never let your tablets run out before receiving the next prescription. It may be dangerous to stop treatment without your doctor’s advice (See Section 2).

Stopping Hydrocortisone Tablets may leave you without enough steroid hormones in your body. This may cause withdrawal symptoms such as fever, muscle and joint pain, blocked/runny nose, swelling of the eye, painful itchy skin rash and weight loss.

If you have any further questions on the use of this product, 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 are taking the medicine as a replacement steroid, you should be less likely to get side effects than people taking steroids for other illnesses.

Tell your doctor immediately if you notice:

• itching or skin rashes;
• swelling of the face, lips or throat;
• difficulty in breathing or wheeziness.

These may be signs of an allergic reaction.

Severe side effects:

Steroids including hydrocortisone can cause severe mental health problems. These side effects are common in both adults and children. They can affect about 5 in every 100 people taking medicines like hydrocortisone.

Tell your doctor immediately if you are:

• depressed, including thinking about suicide;
• high (mania) or having moods that go up and down;
• 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;
• suffering from symptoms of reddish stretch marks, rounded red face, weak muscles and bones, mood changes and headache. These could be signs of a condition known as Cushing’s syndrome;
• suffering from symptoms of chest pain and shortness of breath, especially if you have recently had a heart attack. These could be signs of a condition known as myocardial rupture;
• suffering from symptoms of stomach pain, bleeding from the back passage, black stools or being sick with blood present. This could be signs of a bleeding ulcer;
• suffering from symptoms of abdominal pain, stomach pain and discomfort, bloated feeling, infection or ulcers. These could be signs of inflammation of your pancreas;
• suffering from symptoms of broken bones or fractures, hip or shoulder pain due to poor blood circulation, risk of torn tendons, joint inflammation in the knee and groin. These could be signs of a condition known as aseptic necrosis.

Other side effects

Tell your doctor if you experience any of the following:

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

• if you are getting infections more frequently;
• oral thrush;
• an increase in your white blood cell count;
• swelling in your hands and legs;
• increased appetite;
• feeling excited or excessively happy;
• low mood (depression);
• insomnia;
• worsening of another condition known as epilepsy;
• feeling confused;
• anxiety;
• blurred vision;
• cataracts;
• bulging eyes;
• worsening of any eye infections;
• high blood pressure;
• blood clots;
• indigestion;
• feeling sick;
• slow healing of wounds;
• redness on your skin;
• bruising;
• stretch marks;
• hair growth;
• decreased bone strength;
• muscle weakness.

Reporting of side effects

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

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

5. How to store Hydrocortisone 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 blister or carton after EXP. The expiry date refers to the last day of that month.

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

6. Contents of the pack and other information

What Hydrocortisone Tablets contains

• the active substance is hydrocortisone. Each tablet contains 5mg/10 mg of hydrocortisone;
• the other ingredients are lactose monohydrate, maize starch and magnesium stearate.

What Hydrocortisone Tablets looks like and contents of the pack

Hydrocortisone Tablets are white, oval, tablets.

These are available in blister packs containing 30 tablets.

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