Dexamethasone Tablets BP 0.5 mg Taj Pharma

1. Name of the medicinal product

Taj Dexamethasone 0.5 mg tablets
Taj Dexamethasone 2 mg tablets

2. Qualitative and quantitative composition

Each uncoated tablet contains
Dexamethasone BP      0.5 mg
Excipients                   q.s

Each uncoated tablet contains
Dexamethasone BP      2 mg
Excipients                   q.s

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Tablet

4. Clinical particulars

4.1 Therapeutic indications

Neurology

Cerebral oedema caused by brain tumours, neurosurgery, bacterial meningitis, brain abscess.

Pulmonary and respiratory diseases

Severe acute asthma attack.

Dermatology

Oral initial treatment of extensive, severe, acute skin diseases that respond to glucocorticoids, such as erythroderma, pemphigus vulgaris, acute eczema.

Autoimmune disorders/rheumatology

Oral initial treatment of autoimmune diseases, such as systemic lupus erythematosus (especially visceral forms).

Severely progressive form of active rheumatoid arthritis, e.g. rapidly destructive forms and/or with extra-articular manifestations.

Infectology

Severe infections with toxic conditions (e.g. tuberculosis, typhoid) only with concomitant anti-infective therapy.

Oncology

Palliative treatment of malignant tumours.

Endocrinology

Congenital adrenogenital syndrome in adulthood.

4.2 Posology and method of administration

Posology

Dosage depends on the nature and severity of the disease and the individual response of the patient to treatment. In general, relatively high initial doses are administered, and they should be significantly higher in acute severe forms than in chronic diseases.

Unless otherwise prescribed, the following dosage recommendations apply:

– Cerebral oedema: Depending on the cause and severity, initial dose of 8–10 mg (up to 80 mg) i.v., followed by 16–24 mg (up to 48 mg)/day orally, divided into 3–4 (up to 6) individual doses for 4–8 days. A longer-term, lower-dose administration of Dexamethasone   may be required during irradiation and in the conservative treatment of inoperable brain tumours.

– Cerebral oedema due to bacterial meningitis: 0.15 mg/kg body weight every 6 hours for 4 days, children: 0.4 mg/kg body weight every 12 hours for 2 days, starting before the first antibiotics.

– Severe acute asthma attack: Adults: 8–20 mg, then, if necessary, 8 mg every 4 hours. Children: 0.15–0.3 mg/kg body weight.

– Acute skin diseases: Depending on the nature and extent of the disease, daily doses of 8–40 mg. Followed by treatment with decreasing doses.

– Active phases of rheumatic systemic diseases: systemic lupus erythematosus 6–16 mg/day.

– Severely progressive form of active rheumatoid arthritis: in rapidly destructive forms 12–16 mg/day, in extra-articular manifestations 6–12 mg/day

– Severe infectious diseases, toxic states (e.g. tuberculosis, typhoid): 4–20 mg for a few days, only with concomitant anti-infective therapy.

– Palliative treatment of malignant tumours: initially 8–16 mg/day, in prolonged treatment 4–12 mg/day.

– Congenital adrenogenital syndrome in adulthood: 0.25–0.75 mg/day as a single dose. If necessary, addition of a mineralcorticoid (fludrocortisone). In cases of particular physical stress (e.g. trauma, surgery), intercurrent infections, etc., a 2- to 3-fold dose increase may be required and under extreme stress (e.g. birth) a 10-fold increase.

The tablets should not be split to adjust doses. If patients need a dose that cannot be provided by one or more tablets of 0.5mg, other appropriate formulations should be used.

Method of administration

The tablets should be taken during or after a meal. They should be swallowed whole, with a sufficient amount of liquid. The daily dose should be administered as a single dose in the morning, if possible (circadian therapy). In patients who require a high-dose therapy because of their disease, multiple daily dosing is often required to achieve maximum effect.

Depending on the underlying disease, clinical symptoms and response to therapy, the dose can be reduced at a faster or slower rate and the therapy stopped, or the patient is stabilised on a maintenance dose as low as possible and, if necessary, adrenal axis monitored. Basically, the dose and duration of treatment should be kept as high and long as necessary, but as low and short as possible. In principle, the dose should be reduced gradually.

In long-term therapy which is deemed necessary following initial treatment, patients should be switched to prednisone/prednisolone, because this leads to lower adrenal suppression.

In hypothyroidism or liver cirrhosis, low doses may be sufficient or a dose reduction may be necessary.

4.3 Contraindications

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

4.4 Special warnings and precautions for use

Depending on the dose and duration of therapy, adrenocortical insufficiency caused by glucocorticoid therapy can continue for several months and in individual cases more than a year after cessation of therapy. In cases of particular physical stress situations (trauma, surgery, childbirth, etc.) during treatment with Dexamethasone  , a temporary increase in dose may be required. Because of the potential risk in stress situations, patients on extended therapy should be issued a steroid card. Also in prolonged adrenal insufficiency after cessation of treatment, the administration of glucocorticoids may be necessary in physical stress situations. In case of intended withdrawal, treatment-induced acute adrenal insufficiency may be minimized by slow dose reduction.

Through immunosuppression, treatment with Dexamethasone   can lead to an increased risk of bacterial, viral, parasitic, opportunistic and fungal infections. It can mask the symptoms of an existing or developing infection, thereby making a diagnosis more difficult. Latent infections, like tuberculosis or hepatitis B, can be reactivated.

Treatment with Dexamethasone   should only be implemented in the event of the strongest indications and, if necessary, additional targeted anti-infective treatment administered for the following illnesses:

– Acute viral infections (Herpes zoster, Herpes simplex, Varicella, herpetic keratitis)

– HBsAG-positive chronic active hepatitis

– Approximately 8 weeks prior to 2 weeks after vaccinations with live vaccines

– Systemic mycoses and parasitoses (e.g. nematodes)

– In patients with suspected or confirmed strongyloidiasis (infection with threadworms), glucocorticoids can lead to activation and mass proliferation of these parasites

– Poliomyelitis

– Lymphadenitis after BCG vaccination

– Acute and chronic bacterial infections

– In a history of tuberculosis (reactivation risk), use only under tuberculostatic protection

In addition, treatment with Dexamethasone   should only be implemented under strong indications and, if necessary, additional specific treatment must be implemented for:

– Gastrointestinal ulcers

– Osteoporosis

– Severe cardiac insufficiency

– High blood pressure that is difficult to regulate

– Diabetes mellitus that is difficult to regulate

– Psychiatric disorders (also in the past), including suicidality: neurological or psychiatric monitoring is recommended

– Narrow- and wide-angle glaucoma, ophthalmic monitoring and adjunctive therapy are recommended

– Corneal ulcerations and corneal injuries, ophthalmic monitoring and adjunctive therapy are recommended

Because of the risk of an intestinal perforation, Dexamethasone   may only be used under urgent indication and under appropriate monitoring for:

– Severe ulcerative colitis with threatened perforation, possibly without peritoneal irritation

– Diverticulitis

– Enteroenterostomy (immediately postoperatively)

Signs of peritoneal irritation after gastrointestinal perforation may be absent in patients receiving high doses of glucocorticoids.

The possibility of a higher need for insulin or oral antidiabetics must be taken into consideration when administering Dexamethasone   to diabetics.

Regular blood pressure monitoring is necessary during treatment with Dexamethasone  , particularly during administration of higher doses and in patients with high blood pressure that is difficult to regulate.

Because of the risk of deterioration, patients with severe cardiac insufficiency should be carefully monitored.

With high doses of dexamethasone bradycardia may occur.

Severe anaphylactic reactions may occur.

The risk of tendon disorders, tendinitis and tendon rupture is increased when fluoroquinolones and glucocorticoids are administered together.

A concurrent myasthenia gravis may initially worsen during treatment with Dexamethasone  .

Vaccinations with inactivated vaccines are generally possible. However, it should be noted that the immune response and thus the vaccine may be compromised at higher doses of corticosteroids.

During long-term therapy with Dexamethasone  , regular medical checkups (including ophthalmologic every three months) are indicated.

At high doses, sufficient calcium intake and sodium restriction should be ensured and serum potassium levels should be monitored.

Depending on the dose and duration of treatment, a negative effect on calcium metabolism can be expected; therefore, the prevention of osteoporosis is recommended. This applies especially to patients with concomitant risk factors, such as familial predisposition, advanced age, postmenopausal period, insufficient protein and calcium intake, heavy smoking, excessive alcohol consumption and lack of physical activity. Prevention consists of sufficient calcium and vitamin D intake and physical activity. In already existing osteoporosis, additional drug therapy should be considered.

Upon termination of long-term administration of glucocorticoids, the following risks must be taken into account: exacerbation or relapse of the underlying disease, acute adrenal insufficiency, cortisone withdrawal syndrome.

Certain viral diseases (chickenpox, measles) may be very severe in patients treated with glucocorticoids. Immunocompromised patients without previous chickenpox or measles infection are particularly at risk. If these patients have contact with people infected with measles or chickenpox while undergoing treatment with Dexamethasone  , a preventative treatment should be introduced, if necessary.

In post marketing experience tumour lysis syndrome (TLS) has been reported in patients with haematological malignancies following the use of dexamethasone alone or in combination with other chemotherapeutic agents. Patient at high risk of TLS, such as patients with high proliferative rate, high tumour burden, and high sensitivity to cytotoxic agents, should be monitored closely and appropriate precaution taken.

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.

Paediatric population

In the growth phase of children, the benefit-risk balance of treatment with Dexamethasone   should be carefully weighed.

Therapy should be of limited duration or in case of long-term therapy, it should be carried out alternatingly.

Preterm neonates: Available evidence suggests long-term neurodevelopmental adverse events after early treatment (< 96 hours) of premature infants with chronic lung disease at starting doses of 0.25mg/kg twice daily.

Elderly patients

Because elderly patients are at an increased risk of osteoporosis, the benefit-risk balance of treatment with Dexamethasone   should be carefully weighed.

Note

The use of Dexamethasone   can lead to positive results in doping controls.

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

4.5 Interaction with other medicinal products and other forms of interaction

Oestrogens (e.g. oral contraceptives): The half-life of glucocorticoids may be prolonged. Therefore, the effect of corticoids may be increased.

Antacids: Concomitant administration of aluminum hydroxide or magnesium hydroxide can lead to a reduction in the absorption of glucocorticoids with reduced efficacy of Dexamethasone  . There should be a 2-hour interval between the intake of one and the other drug.

Drugs that induce CYP3A4, such as rifampicin, phenytoin, carbamazepine, barbiturates and primidone: The effect of corticoids may be reduced.

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.

Drugs that inhibit CYP3A4, such as ketoconazole and itraconazole: The effect of corticoids may be increased.

Ephedrine: The metabolism of glucocorticoids may be accelerated and thus their effectiveness reduced.

ACE inhibitors: Increased risk of blood count changes.

Cardiac glycosides: The effect of glycosides may be increased by potassium deficiency.

Saluretics/laxatives: Potassium excretion may be increased.

Antidiabetics: The hypoglycaemic effect may be reduced.

Coumarin derivatives: The anticoagulant effect may be reduced or increased. Dosage adjustment of the anticoagulant may be necessary when co-administered.

Nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates and indomethacin: The risk of gastrointestinal ulcers and bleeding is increased.

Non-depolarizing muscle relaxants: The muscle-relaxing effect may last longer.

Atropine, other anticholinergics: Additional intraocular pressure increases are possible during concomitant use.

Praziquantel: Corticosteroids may cause a fall in praziquantel concentration in the blood.

Chloroquine, hydroxychloroquine, mefloquine: There is an increased risk of myopathies, cardiomyopathies.

Somatropin: The effect of somatropin may be reduced under long-term therapy.

Protirelin: Reduced increase in TSH may be noted during administration of protirelin.

Immunosuppressive agents: Increased susceptibility to infections and possible aggravation or manifestation of latent infections. Additionally, for ciclosporin: The blood levels of cyclosporine are increased: There is an increased risk of seizures.

Fluoroquinolones may increase the risk of tendon disorders.

Effect on investigation methods: Skin reactions in allergy tests can be suppressed.

4.6 Fertility, pregnancy and lactation

Pregnancy

Dexamethasone crosses the placenta. During pregnancy, especially in the first trimester, the drug should only be administered after careful benefit-risk assessment.

In long-term treatment with glucocorticoids during pregnancy, foetal growth disorders cannot be excluded. 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. See also section 5.3 of the SmPC. If glucocorticoids are administered towards the end of pregnancy, there is a risk of atrophy of the foetal adrenal cortex, which may necessitate replacement therapy in the newborn, which has to be slowly reduced.

Breast-feeding

Dexamethasone is excreted in breast milk. There are no known cases of harm to the infant. Nevertheless, the drug should be strongly indicated during lactation. If the disease requires higher doses, breast-feeding should be discontinued.

Fertility

Dexamethasone decreases testosterone biosynthesis and endogenous ACTH secretion which has an effect on the spermatogenesis and the ovarian cycle.

4.7 Effects on ability to drive and use machines

There have been no studies on the effects on the ability to drive and use machines.

4.8 Undesirable effects

– Very common (≥ 1/10)

– Common (≥ 1/100 to < 1/10)

– Uncommon (≥ 1/1,000 to < 1/100)

– Rare (≥ 1/10,000 to < 1/1,000)

– Very rare (< 1/10,000)

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

Hormone replacement therapy:

Low risk of undesirable effects with the use of recommended doses.

Pharmacotherapy:

The following undesirable effects may occur; they are highly dependent on the dose and duration of treatment, so their frequency cannot be specified:

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

Symptoms

Acute intoxications with dexamethasone are not known. In case of chronic overdosing, an increase in undesirable effects, especially endocrine, metabolic and electrolyte-related effects, can be expected (see section 4.8).

Management

There is no known antidote to dexamethasone.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: corticosteroids for systemic use, glucocorticoids.

Mechanism of action

Dexamethasone is a mono-fluorinated glucocorticoid with pronounced anti-allergic, anti-inflammatory and membrane-stabilizing properties and effects on carbohydrate, protein and fat metabolism.

Dexamethasone has an approximately 7.5 times greater glucocorticoid effect than prednisolone, and compared to hydrocortisone it is 30 times more effective, lacking mineralocorticoid effects.

Glucocorticoids, such as dexamethasone, exert their biological effects by activating the transcription of corticosteroid-sensitive genes. The anti-inflammatory, immunosuppressive and anti-proliferative effects are caused by decreased formation, release and activity of inflammatory mediators, by the inhibition of specific functions and the migration of inflammatory cells. In addition, the effect of sensitized T lymphocytes and macrophages on target cells may be prevented by corticosteroids.

When long-term corticoid treatment is required, the possibility of induction of transient adrenal insufficiency must be considered. The suppression of the hypothalamic-pituitary-adrenal axis also depends on individual factors.

5.2 Pharmacokinetic properties

Absorption and distribution

After oral administration, dexamethasone is rapidly and almost completely absorbed in the stomach and small intestine. Its bioavailability is 80–90%. Maximum blood levels are reached between 60 and 120 minutes. The binding of dexamethasone to plasma albumins is dose-dependent. At very high doses, the largest portion circulates freely in the blood. In hypoalbuminaemia the proportion of the unbound (active) corticoid rises.

Biotransformation

The average (serum) elimination half-life of dexamethasone in adults is 250 minutes (+ 80 minutes). Due to its long biological half-life of more than 36 hours, daily continuous administration of dexamethasone can lead to accumulation and overdosing.

Elimination

The elimination is largely renal in the form of free dexamethasone alcohol. Dexamethasone is partly metabolised, the metabolites are excreted as glucuronates or sulfates, also mainly by the kidneys.

Renal and hepatic impairment

Renal function impairment has no relevant effect on the clearance of dexamethasone. However, the elimination half-life is prolonged in severe liver disease.

5.3 Preclinical safety data

Acute toxicity:

In mice and rats, the LD₅₀ for dexamethasone after a single oral dose is 16 g/kg body and over 3 g/kg body weight, respectively, within the first 7 days. Following a single subcutaneous dose, the LD₅₀ in mice is more than 700 mg/kg body weight and in rats about 120 mg/kg body weight, within the first 7 days.

Over a period of 21 days, these values become lower, which is interpreted as a consequence of serious infectious diseases caused by the hormone-induced immunosuppression.

Chronic toxicity:

There are no data on chronic toxicity in humans and animals. Corticoid-induced intoxications are not known. In longer-term treatment with doses above 1.5 mg/day, pronounced undesirable effects can be expected (see section 4.8).

Mutagenic and tumorigenic potential:

The available study findings for glucocorticoids show no evidence of clinically relevant genotoxic properties.

Reproductive toxicity:

In animal studies, cleft palate was observed in rats, mice, hamsters, rabbits, dogs and primates; not in horses and sheep. In some cases these divergences were combined with defects of the central nervous system and of the heart. In primates, effects in the brain were seen after exposure. Moreover, intrauterine growth can be delayed. All these effects were seen at high dosages.

6. Pharmaceutical particulars

6.1 List of excipients

Lactose monohydrate

Starch, pregelatinised, maize

Silica, colloidal anhydrous

Magnesium stearate

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years

6.4 Special precautions for storage

Store in the original package in order to protect from light and moisture.

This medicinal product does not require any special temperature storage conditions.

6.5 Nature and contents of container

HDPE Bottle: 10, 20, 28, 30, 50, 56, 60, 90, 100.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements for disposal.

Manufactured By:
Taj Pharmaceuticals Ltd.
at: Plot. No. 220, Mahagujarat
Industrial Estate, At & Post-Moraiya,
Tal-Sanand, Dist- Ahmedabad Gujarat (India)

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Taj Dexamethasone 500 microgram Tablets

Dexamethasone 2 mg Tablets

Dexamethasone – Headlines

• Dexamethasone 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 taking this medicine without talking to your doctor – you may need to reduce the dose gradually.
• Dexamethasone 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, keep taking your tablets, but see your doctor straight away.
• Some side effects only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face (read Section 4 for more information).
• If you take it for more than 3 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 might be especially important for you.

Please read all of this leaflet carefully before you start taking the medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

In this leaflet:

1. What this medicine is and what it is used for
   2. Before you take Dexamethasone Tablets
   3. How to take Dexamethasone Tablets
   4. Possible side effects
   5. How to store Dexamethasone Tablets
   6. Further information
2. What this medicine is and what it is used for

Dexamethasone 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 dexamethasone) is an effective way to treat various illnesses involving inflammation in the body. Dexamethasone reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it. Some of the illnesses and conditions that dexamethasone is used for include:

• swelling of the brain and increased pressure in the brain caused by a tumour
• severe allergic reactions
• blood disorders such as leukaemia and haemolytic anaemia (a reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness)
• sarcoidosis, an immune disease that can lead to excessive levels of calcium and vitamin D in the body
• inflammation of the heart in association with heart attack or heart surgery
• intestinal disorders, e.g, Crohn’s disease, ulcerative colitis
• respiratory disorders such as asthma
• tuberculosis (together with appropriate chemotherapy)
• certain inflammatory skin and muscular disorders
• inflammation of the eye
• rheumatoid arthritis
• kidney inflammation caused by SLE, a disease of the immune system.

2. Before you take Dexamethasone Tablets

Do NOT take Dexamethasone Tablets if you

• are allergic to dexamethasone or to any of the other ingredients (see Section 6)
• have an untreated infection affecting your whole body
• have a fungal infection affecting the whole of your body, e.g. thrush
• are to have a ‘live virus’ vaccination.

If any of the above apply to you, speak to your doctor or pharmacist.

Check with your doctor first

• If you have ever had severe depression or manic depression (bipolar disorder). This includes having had depression before while taking steroid medicines like dexamethasone.
• If any of your close family has had these illnesses.

If either of these applies to you, talk to a doctor before taking dexamethasone.

Warnings and Precautions

Before taking the tablets, tell your doctor if you have any of these conditions as additional monitoring may be required:

• recently suffered from a heart attack
• tuberculosis kidney or liver problems, including cirrhosis
• an underactive thyroid
• high blood pressure
• diabetes, or a family history of diabetes, your doctor may need to increase your dose of diabetic treatment
• heart problems
• thinning of the bones (osteoporosis)
• raised pressure in the eye(s) (glaucoma) or a family history of glaucoma
• myasthenia gravis (which causes weakened muscles)
• intestinal or stomach problems
• had muscle weakness with steroids in the past
• an eye infection caused by herpes virus
• malaria affecting the brain
• epilepsy
• severe mental health problems or if you ever had severe depression or manic depression (bipolar disorder) or if a family member has or has ever had these problems. This includes having had depression before while taking steroids
• have symptoms of tumour lysis syndrome such as muscle cramping, muscle weakness, confusion, visual loss or disturbances and shortness of breath, in case you suffer from haematological malignancy

Pay attention when using Dexamethasone

Dexamethasone should not be used routinely in preterm neonates with respiratory problems.

Use in children

Long term use of steroids at high doses may cause slowing of growth in children. Your doctor may check your child’s height at intervals during treatment and reduce the dose if any effects are seen.

Mental problems while taking dexamethasone

Mental health problems can happen while taking steroids like dexamethasone (see also Section 4 Possible side effects)

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

Talk to a doctor if you (or someone taking this medicine), show any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental problems have happened when doses are being lowered or stopped.

Chickenpox, shingles, measles

These infections will become more serious during treatment with steroids, and you will require urgent specialist care if you become exposed to someone with these infections. DO NOT stop taking the tablets.

If you have not had chickenpox, shingles or measles, you should AVOID contact with anyone who has these illnesses.

If you think that you have been exposed to any of these infections, seek immediate medical attention. Do this if you are taking these tablets, or have taken them during the previous 3 months.

Surgery or other treatment by a doctor, dentist or nurse

If you have an accident, become ill, require any surgery (including at the dentist’s), or are to have any ‘live virus‘ vaccinations during or after treatment with Dexamethasone Tablets, you MUST tell the person treating you that you are taking or have taken steroids.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal preparations. Some medicines may be affected by dexamethasone or they may affect how well dexamethasone will work.

Tell your doctor or pharmacist if you are taking:

• aspirin or similar medicines
• phenytoin (to treat epilepsy)
• ephedrine (a nasal decongestant)
• barbiturates (to treat sleeplessness and epilepsy)
• ketoconazole (for fungal infections)
• rifampicin and rifabutin (antibiotics used to treat tuberculosis)
• erythromycin or similar antibiotics
• medicines used to treat HIV, such as ritonavir and cobicistat
• anticoagulants (to thin the blood), such as warfarin
• medicines for diabetes, including insulin; your doctor may need to increase your dose of diabetic treatment
• diuretics (water tablets)
• carbamazepine (for epilepsy, pain, manic depression)
• aminoglutethimide (a cancer medicine)
• thalidomide (to treat leprosy)
• indometacin, as this may affect dexamethasone tests for certain diseases.

Pregnancy and breast-feeding

Dexamethasone may pass to your unborn baby or into breast milk.

DO NOT take dexamethasone if you are pregnant, planning to become pregnant or while breast-feeding unless advised to by your doctor.

Steroids may affect sperm count and movement, in men.

Ask your doctor for advice before taking any medicine.

Driving and using machines

Dexamethasone is unlikely to affect your ability to operate machinery or to drive.

Important information about some of the ingredients of Dexamethasone Tablets

• Lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine

3. How to take Dexamethasone Tablets

Always take Dexamethasone Tablets exactly as your doctor has told you and always read the label. Your doctor will decide on the appropriate dose to suit your condition. Ask your doctor or pharmacist if you are not sure.

• Swallow the tablets with plenty of water, with or immediately after a meal to prevent upset stomach.
• Take the tablets regularly as advised by your doctor to obtain the maximum benefit.

Doses

Adults and the elderly:

The usual dexamethasone starting dose is 500mcg to 9mg per day

Your doctor will tell you the correct dose and when to take it depending on your condition, and may give you the lowest dose to reduce side effects and to control your condition.

Your doctor may change the dose during treatment.

Elderly patients will be monitored more frequently

Children: usually a single dose on alternate days will be given. The doctor will also monitor growth and development at intervals during treatment.

During treatment: because of possible side effects, your doctor may monitor you at intervals during your treatment.

Taking dexamethasone long term

You may be given a blue ‘steroid treatment card‘: always keep it with you and show it to any doctor, pharmacist or nurse treating you.

See your doctor if you develop any new infections while taking these tablets.

Prolonged use may lead to eye problems e.g. cataracts or glaucoma.

Withdrawal symptoms, such as fever, muscle weakness or pain, aching joints or malaise (feeling ill), may occur after stopping long term treatment with dexamethasone.

If you take more than you should

1. Tell your doctor, pharmacist or nearest hospital casualty department immediately.
   2.Take the tablet pack/container and any remaining tablets with you so that people can see what you have taken.
   3. Do this even if you feel well.

If you forget to take

If you forget to take a dose, take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue as usual. Do not take a double dose to make up for a missed dose.

If you stop taking

Stopping this medicine suddenly can be dangerous, and may cause:

• low blood pressure
• a relapse of the disease for which treatment was given.

Keep taking the tablets until your doctor tells you how and when to stop.

Do not let yourself run out of medicine, especially over the weekends or on holidays.

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

4. Possible side effects

Like all medicines, Dexamethasone Tablets can cause side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects. You may not experience any of them. Some side effects only happen after weeks or months.

Seek medical help immediately if you have any of the following allergic reactions:

• difficulty breathing or swallowing, swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or raised lumps.

Also seek immediate medical attention if you have come in contact with anyone suffering from chickenpox, shingles or measles.

Serious effects: tell a doctor straight away

Steroids including dexamethasone can cause serious mental health problems.

These are common in both adults and children. They can affect about 5 in every 100 people taking medicines like dexamethasone.

• Feeling depressed including thinking about suicide
• Feeling high (mania) or moods that go up and down.
• Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory.
• Feeling, seeing or hearing things which do not exist. 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 straight away.

Tell your doctor if you get any of the following symptoms:

• headache
• acne
• a feeling of dizziness or spinning
• increased sweating
• nausea
• changes in vision including visual disturbances or loss of vision
• malaise (feeling ill)
• slow wound healing
• hiccoughs
• thinned, delicate skin
• fits
• difficulty swallowing, sore throat, a feeling of chest pain (which may be signs of a fungal infection in the oesophagus (gullet))
• stomach pain and discomfort, swollen abdomen
• increased appetite
• raised blood pressure
• salt imbalances, fluid retention
• swelling and weight gain of the body and face
• high blood sugar, with symptoms such as excessive thirst
• increased requirement for diabetic medication
• muscle weakness and wasting
• thinning of bone with an increased risk of fractures
• pain behind the ribs radiating towards the back, often worse when lying down, nausea, vomiting, fever. This may be due to inflammation of your pancreas
• bruising and unusual skin markings or rash
• raised pressure in the eye(s) (glaucoma), cataracts
• irregular periods or absence of periods in women
• increase in body and facial hair growth
• slow growth or development in children and adolescents
• increased frequency or severity of infections.

Blood or skin tests: tell the doctor or nurse if you are having blood tests for bacterial infection, or skin tests, as the results may be affected.

If any of the side effects get troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 Dexamethasone Tablets

• Keep out of the reach and the sight of children.
• Do not take after the expiry date which is stated on the blister and carton. 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 it away with your household waste or in water. Return all the unwanted medicine to your pharmacist. This will help to protect the environment.

6. Further information

What Dexamethasone Tablets contain

• The active ingredient is dexamethasone.
• Dexamethasone 500 microgram Tablets contain 500 micrograms of Dexamethasone.
• Dexamethasone 2 mg Tablets contain 2 mg of Dexamethasone.
• The other ingredients are:
  Lactose monohydrate, maize starch, magnesium stearate.
  (See end of Section 2 for further information on lactose).

What Dexamethasone Tablets look like and contents of the pack

Dexamethasone 500 microgram Tablets

Dexamethasone 2 mg Tablets

Manufactured By:
Taj Pharmaceuticals Ltd.
at: Plot. No. 220, Mahagujarat
Industrial Estate, At & Post-Moraiya,
Tal-Sanand, Dist- Ahmedabad Gujarat (India)