Betamethasone Soluble Tablets USP 0.5mg TajPharma

1. Name of the medicinal product
Betamethasone Soluble Tablets USP 0.5mg TajPharma

2. Qualitative and quantitative composition
Each Tablet Contains:
Betamethasone USP                         0.5mg
Excipients                                              q.s.
For a full list of excipients, see section 6.1.

3. Pharmaceutical form
Soluble Tablet
Small, soluble, pink tablets.
The tablets comply with the specification for Betamethasone Sodium Phosphate Tablets.

4. Clinical particulars

4.1 Therapeutic indications
Betamethasone is a glucocorticoid which is about eight to ten times as active as prednisolone on a weight-for-weight basis.
Betamethasone sodium phosphate is very soluble in water and is therefore less likely to cause local gastric irritation than corticosteroids which are only slightly soluble. This is important when high doses are required, as in immune-suppressive therapy.
Betamethasone does not normally cause retention of salt and water and the risk of inducing oedema and hypertension is almost negligible.
A wide variety of diseases may sometimes require corticosteroid therapy. Some of the principal indications are:

Bronchial asthma, severe hypersensitivity reactions, anaphylaxis, rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, mixed connective tissue disease (excluding systemic sclerosis), polyarteritis nodosa;
Inflammatory skin disorders, including pemphigus vulgaris, bullous pemphigoid and pyoderma gangrenosum;
Minimal change nephrotic syndrome, acute interstitial nephritis;
Ulcerative colitis, Crohn’s disease, sarcoidosis, rheumatic carditis;
Haemolytic anaemia (autoimmune), acute and lymphatic leukaemia, malignant lymphoma, multiple myeloma, idiopathic thrombocytopenic purpura;
Immunosuppression in transplantation.

4.2 Posology and method of administration
Posology:
Betamethasone Tablets are best taken dissolved in water, but they can be swallowed whole without difficulty. The lowest dosage that will produce an acceptable result should be used; when it is possible to reduce the dosage, this must be accomplished by stages. During prolonged therapy, dosage may need to be increased temporarily during periods of stress or in exacerbations of illness.
Adults:
The dose used will depend on the disease, its severity and the clinical response obtained. The following regimens are for guidance only. Divided dosage is usually employed.
Short term treatment:
2-3mg daily for the first few days, then reducing the daily dose by 250 or 500mcg (0.25 or 0.5mg) every two to five days, depending upon the response.
Rheumatoid arthritis:
500mcg (0.5mg) to 2mg daily. For maintenance therapy the lowest effective dosage is used.
Most other conditions:
1.5 to 5mg daily for one to three weeks, then reducing to the minimum effective dosage. Larger doses may be needed for mixed connective tissue diseases and ulcerative colitis.
Paediatric population:
A proportion of the adult dosage may be used (e.g. 75% at 12 years, 50% at 7 years and 25% at 1 year) but clinical factors must be given due weight.

Method of Administration: Oral

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
Systemic infections, unless specific anti-infective therapy is employed.

4.4 Special warnings and precautions for use
A patient information leaflet should be supplied with this product.
Undesirable effects may be minimised by using the lowest effective dose for the minimum period and by administering the daily requirement as a single morning dose, or whenever possible as a single morning dose on alternate days. Frequent patient review is required to appropriately titrate the dose against disease activity
Caution is advised with the use of corticosteroids in patients who have suffered a recent myocardial infarction because of the risk of myocardial rupture.
Caution is advised on the use of corticosteroids in patients with hypothyroidism or myasthenia gravis.
Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. The clinical presentation may often be atypical and serious infections such as septicaemia and tuberculosis may be masked and may reach an advanced stage before being recognised.
Chickenpox is of particular concern since this normally minor illness may be fatal in immunosuppressed patients. Patients (or parents of children) without a definite history of chickenpox should be advised to avoid close personal contact with chickenpox or herpes zoster and if exposed they should seek urgent medical attention. Passive immunisation with varicella zoster immunoglobulin (VZIG) is needed by exposed non-immune patients who are receiving systemic corticosteroids or who have used them within the previous 3 months; this should be given within 10 days of exposure to chickenpox. If a diagnosis of chickenpox is confirmed, the illness warrants specialist care and urgent treatment. Corticosteroids should not be stopped and the dose may need to be increased.
Live vaccines should not be given to individuals with impaired immune responsiveness. The antibody response to other vaccines may be diminished.
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.
Adrenal suppression:
Adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment.
In patients who have received more than physiological doses of systemic corticosteroids (approximately 1mg betamethasone or equivalent) for greater than 3 weeks, withdrawal should not be abrupt. How dose reduction should be carried out depends largely on whether the disease is likely to relapse as a 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 1mg betamethasone is reached, dose reduction should be slower to allow the HPA-axis to recover.
Abrupt withdrawal of systemic corticosteroid treatment, which has continued up to 3 weeks is appropriate if it is considered that the disease is unlikely to relapse. Abrupt withdrawal of doses of up to 6mg daily of betamethasone, or equivalent for 3 weeks is unlikely to lead to clinically relevant HPA-axis suppression, in the majority of patients. In the following patient groups, gradual withdrawal of systemic corticosteroid therapy should be considered even after courses lasting 3 weeks or less:
• Patients who have had repeated courses of systemic corticosteroids, particularly if taken for greater than 3 weeks,
• When a short course has been prescribed within one year of cessation of long-term therapy (months or years),
• Patients who have reasons for adrenocortical insufficiency other than exogenous corticosteroids therapy,
• Patients receiving doses of systemic corticosteroid greater than 6mg daily of betamethasone (or equivalent),
• 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 re-introduced.
Special precautions
Particular care is required when considering the use of systemic corticosteroids in patients with the following conditions and frequent patient monitoring is necessary.
A. Osteoporosis (post-menopausal females are particularly at risk).
B. Hypertension or congestive heart failure.
C. Existing or previous history of severe affective disorders (especially previous steroid psychosis).
D. Diabetes mellitus (or a family history of diabetes).
E. History of tuberculosis.
F. Glaucoma (or a family history of glaucoma).
G. Previous corticosteroid-induced myopathy.
H. Liver failure – blood levels of corticosteroid may be increased, (as with other drugs which are metabolised in the liver).
I. Renal insufficiency.
J. Epilepsy.
K. Peptic ulceration.

Patients should carry ‘steroid treatment’ cards which give clear guidance on the precautions to be taken to minimise risk and which provide details of prescriber, drug, dosage and the duration of treatment.
Patients/and or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids. Symptoms typically emerge within a few days or weeks of starting treatment. Risks may be higher with high doses/systemic exposure, although dose levels do not allow prediction of the onset, type, severity or duration of reactions. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary. Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected. Patients/carers should also be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently.
Particular care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or in their first degree relatives. These would include depressive or manic-depressive illness and previous steroid psychosis.
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Paediatric population
Corticosteroids cause dose-related growth retardation in infancy, childhood and adolescence, which may be irreversible. Treatment should be limited to the minimum dosage for the shortest possible time. In order to minimise suppression of the HPA axis and growth retardation, consideration should be given to administration of a single dose on alternate days.
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.

4.5 Interaction with other medicinal products and other forms of interaction
Steroids may reduce the effects of anticholinesterases in myasthenia gravis, cholecystographic X-ray media and non-steroidal anti-inflammatory agents.
Rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone, aminoglutethimide and ephedrine enhance the metabolism of corticosteroids; thus the corticosteroid therapeutic effect may be reduced.
The desired effects of hypoglycaemic agents (including insulin), anti-hypertensives and diuretics are antagonised by corticosteroids, and the hypokalaemic effects of acetazolamide, loop diuretics, thiazide diuretics and carbenoxolone are enhanced.
The efficacy of coumarin anticoagulants may be enhanced by concurrent corticosteroid therapy and close monitoring of the INR or prothrombin time is required to avoid spontaneous bleeding.
The renal clearance of salicylates is increased by corticosteroids and steroid withdrawal may result in salicylate intoxication.
The risk of hypokalaemia is increased with theophylline, ulcer healing drugs such as carbenoxolone and antifungals such as amphotericin B.
Increased toxicity may result if hypokalaemia occurs in patients on cardiac glycosides.
Ritonavir and oral contraceptives may result in increased plasma concentrations or corticosteroids.
The effect of corticosteroids may be reduced for 3-4 days after mifepristone.
The growth promoting effect of somatropin may be inhibited by corticosteroids.
An increase in the incidence of gastrointestinal bleeding may occur if NSAIDS are taken concomitantly with corticosteroids.
Corticosteroids may antagonise the effects of neuromuscular blocking drugs such as vecuronium.
Concurrent use of corticosteroids and fluoroquinolones may result in increased risk of tendon rupture
Concomitant use of betamethasone with quetiapine may result in the increased metabolism of quetiapine and, depending on the clinical response, a higher dose of quetiapine may need to be considered.
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.
Corticosteroids may enhance the metabolism of tretinoin resulting in decreased levels of tretinoin..

4.6 Fertility, pregnancy and lactation
The ability of corticosteroids to cross the placenta varies between individual drugs, however, betamethasone 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. Myocardial hypertrophy and gastroesophageal reflux have been reported in association with in-utero exposure to betamethasone.
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.

Betamethasone, systemically administered to a woman during pregnancy may result in a transient suppression of the foetal heart rate parameters and biophysical activities that are widely used for the assessment of foetal well – being. These characteristics can include a reduction in foetal breathing movements, body movements and heart rate.
Breast-feeding
Corticosteroids may pass into breast milk, although no data are available for betamethasone. Infants of mothers taking high doses of systemic corticosteroids for prolonged periods may have a degree of adrenal suppression.

4.7 Effects on ability to drive and use machines
Not relevant.

4.8 Undesirable effects
The incidence of predictable undesirable effects, including hypothalamic-pituitary-adrenal (HPA) axis suppression correlates with the relative potency of the drug, dosage, timing of administration and the duration of treatment.

N* Negative protein, nitrogen and calcium balance. Increased appetite. Hyperhidrosis. Increased high – density lipoprotein and low – density lipoprotein concentrations in the blood. Fluid and electrolyte disturbance (Sodium and water retention, hypertension, potassium loss, hypokalaemic alkalosis)
** Including affective disorder (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 the 5-6%. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is unknown. Psychological dependence. Increased intra-cranial pressure with papilloedema in children (pseudotumour cerebri), usually after treatment withdrawal. Aggravation of epilepsy.

Withdrawal symptoms and signs
Too rapid reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death (see “Special Warnings and Precautions for Use”).

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

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:
Treatment is unlikely to be needed in cases of acute over dosage.

5. Pharmacological properties

5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Corticosteroids for systemic use, plain, Glucocorticoids
Betamethasone sodium phosphate is an active corticosteroid with topical anti-inflammatory activity.

5.2 Pharmacokinetic properties
Absorption:
The vast majority of corticosteroids, including betamethasone, are absorbed from the gastrointestinal tract.

Biotransformation:
Corticosteroids are metabolised mainly in the liver but also in the kidney, and are excreted in the urine.
Synthetic corticosteroids, such as prednisolone, have increased potency when compared to the natural corticosteroids, due to their slower metabolism and lower protein-binding affinity.

5.3 Preclinical safety data
None stated

6. Pharmaceutical particulars

6.1 List of excipients
Sodium Hydrogen Carbonate (E500) Sodium Acid Citrate
Saccharin Sodium
Povidone
Erythrosine E127
Sodium Benzoate
Croscarmellose sodium, Crospovidone.

6.2 Incompatibilities
Not applicable.

6.3 Shelf life
2 years.

6.4 Special precautions for storage
Do not store above 25°C.

6.5 Nature and contents of container
The tablets are sealed into individual pockets in an aluminium/ polyethylene laminate (30 micron and 38 micron respectively). The tablets are strip-packed in cartons of 100.

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

Betamethasone Soluble Tablets USP 0.5mg TajPharma

Package leaflet: Information for the patient

Betamethasone Soluble Tablets USP 0.5mg TajPharma

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

What is in this leaflet
Your medicine is called either Betamethasone 0.5mg tablets depending on what your doctor has prescribed. It will be known as Betamethasone Tablets for ease hereafter.

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

1. WHAT BETAMETHASONE TABLETS ARE AND WHAT THEY ARE USED FOR
Betamethasone Soluble Tablets belong 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 corticosteroids (such as Betamethasone Soluble Tablets) is an effective way to treat various illnesses involving inflammation in the body.
Betamethasone Soluble Tablets reduce this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.Many different conditions can be improved by the use of corticosteroids, as they reduce inflammation (redness, tenderness, heat and swelling) in the body.
Betamethasone Soluble Tablets are used to treat:
asthma;
severe allergic reactions;
rheumatoid arthritis;
autoimmune diseases such as systemic lupus erythematosus (SLE) and polyarteritis nodosa;
inflammatory conditions of the skin, kidney (such as acute interstitial nephritis or minimal change nephrotic syndrome), bowels (such as ulcerative colitis and Crohn’s disease) and heart;
some connective tissue diseases;
certain conditions of the blood;
some types of cancer, such as malignant lymphoma.
Corticosteroids are also used to help prevent organ transplant rejection following organ transplant surgery.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BETAMETHASONE TABLETS
Do not take Betamethasone Soluble Tablets:
if you are allergic to betamethasone or any of the other ingredients of this medicine
if you have an infection and have not yet started taking medicine (e.g. antibiotics) to treat it.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Betamethasone Soluble Tablets
if you have ever had severe depression or manic depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Betamethasone Soluble Tablets;
if any of your close family has had these illnesses;
if you have or have ever had tuberculosis (TB);
if you have epilepsy (fits), severe mental illness, heart disease, hypertension (high blood pressure), stomach or duodenal ulcers;
if you have osteoporosis (thinning of the bones). Post menopausal women are particularly at risk of this;
if you or any of your family have ever had glaucoma (raised eye pressure);
if you have recently had a heart attack;
if you have recently been in contact with someone who has chickenpox, shingles or measles or recently had chickenpox, shingles or measles yourself. This product may make chickenpox, shingles or measles much worse;
if you or any of your family are diabetic;
if you have an underactive thyroid gland;
if you have myasthenia gravis (a disease which causes muscle weakness);
if you have ever suffered from muscle wasting due to corticosteroids;
if you have liver, kidney or heart disease;
if you have just been or are about to be immunised;
if you have an infection;
if you are pregnant or breast-feeding  
if you experience blurred vision or other visual disturbances.

Other medicines and Betamethasone Soluble Tablets
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some medicines may increase the effects of Betamethasone Soluble Tablets and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat);
Insulin or oral antidiabetic drugs;
Medicines for high blood pressure;
Water tablets (diuretics);
Medicines for thinning the blood e.g. warfarin;
Non-steroidal anti-inflammatory drugs e.g. ibuprofen;
Salicylates e.g. aspirin;
Medicines for myasthenia gravis called anticholinesterases;
Medicines for the heart called cardiac glycosides;
Acetazolamide (used to treat glaucoma);
Rifampicin and rifabutin (antibiotics for tuberculosis) and ephedrine;
Carbamazepine, phenytoin, primidone, phenobarbitone and aminoglutethimide for epilepsy;
Carbenoxolone (an ulcer healing drug), theophylline (used to treat asthma and other breathing difficulties) and amphotericin B (anti-fungal);
Oral contraceptive (the pill);
Mifepristone (anti-progesterone);
Somatropin (growth hormone);
Vecuronium and other muscle relaxants;
Fluoroquinolones (used for some infections);
Quetiapine (improves symptoms of some mental illnesses);
Tretinoin (used for skin problems such as bad acne);
Any other medicine, including medicines obtained without a prescription.
Betamethasone Soluble Tablets may also affect the results of gallbladder X-ray procedures.
Mental problems while taking Betamethasone Soluble Tablets
Mental health problems can happen while taking steroids like Betamethasone Soluble Tablets 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 who is 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 or measles
You should avoid contact with anyone who has either chickenpox, shingles or measles as it could be extremely serious if you caught it from them.
Tell your doctor immediately if you suspect you may have come into contact with a person who has chickenpox, shingles or measles.
However, do not stop taking your tablets, unless your doctor tells you to.

Pregnancy and breast-feeding
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
Taking steroids often or for a long time during pregnancy can slow the baby’s growth in the womb or may temporarily affect the baby’s heart and body movements.
Sometimes the baby may get digestive juices going up into the tube that carries food from the mouth to the stomach. The baby may also make less of its own steroid after birth, but this rarely causes any problems. If you become pregnant whilst taking this medicine, please tell your doctor but DO NOT stop taking the tablets unless told to do so.

Breast-feeding
If you are breast-feeding, the steroid may enter the baby and lower their hormone levels, if you are taking high doses for a long time.

Betamethasone Soluble Tablets contains Sodium
This medicinal product contains 20.9mg sodium per tablet. To be taken into consideration by patients on a controlled sodium diet.

Tell your doctor or pharmacist before taking Betamethasone Soluble Tablets if this applies to you.

3. HOW TO TAKE BETAMETHASONE TABLETS
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Important:
Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not or you are not sure, ask your doctor or pharmacist.
You may have been given a steroid cardwhich also tells you how many tablets to take each day Method of administration:
Your tablets can be swallowed whole, but they are best taken as a drink after allowing them to dissolve in a glass of water.
Do not exceed the stated dose.
Do not suddenly stop taking the tablets even if you feel better unless your doctor tells you to – you could become ill.
The dose used will depend upon the disease, its severity and how quickly you get better. The following doses are a guide only:
The recommended dose is
Adults
Short term treatment:
2000 – 3000 micrograms (4-6 tablets) daily for the first few days, then;
Your doctor may reduce the daily dose by 250 – 500 micrograms (1/2 or 1 tablet) every two to five days, depending upon the response.
Rheumatoid arthritis:
500 – 2000 micrograms (1-4 tablets) daily;
For long-term treatment the dose may be lower.
Most other conditions:
1500 – 5000 micrograms (3-10 tablets) daily for one to three weeks;
Your doctor may then gradually reduce this to a lower dose;
Larger doses may be needed for mixed connective tissue diseases and ulcerative colitis.

If you need to take half a tablet you should break one in half. Use the break line on one side of the tablet to help you snap it.

Use in children and adolescents
A proportion of the adult dose may be used. Your doctor will advise how much.
If you have any queries about the amount of medicine you have been prescribed, ask your doctor.
While you are taking this medicine, your doctor may ask you to have check-ups. These are to make sure that your medicine is working properly and that the dose you are taking is right for you.

If you take more Betamethasone Soluble Tablets than you should
Do not take more Betamethasone Soluble Tablets than you should. If you accidentally take too much, immediately contact the nearest hospital casualty department or your doctor.

If you forget to take Betamethasone Soluble Tablets
Do not take a double dose to make up for a forgotten dose. Take your next dose at the usual time.

If you stop taking Betamethasone Soluble Tablets
Do not stop taking Betamethasone Soluble Tablets without first talking to your doctor.
It is very important that you do not suddenly stop taking Betamethasone Soluble Tablets, even if you feel better from your original illness or are suffering from a side effect, unless your doctor tells you to. If you stop taking your medicine too suddenly, you may suffer from some of the following: Fever, joint and muscle pain, itching eyes, nose or skin, mood changes, loss of weight, low hormone levels and low blood pressure, symptoms of which may include dizziness, headaches or fainting. In extreme cases, this can be fatal.
Your doctor will tell you how to stop taking Betamethasone Soluble Tablets.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious effects: tell a doctor straight away

Steroids including betamethasone 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 betamethasone.
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.
Most people find that using this medicine for a short time causes no problems. If you need to take the tablets for more than two weeks your doctor will prescribe as low as possible, dose.
Not known (Frequency cannot be estimated from the available data)
High doses taken for a long time or repeated short courses, can lead to side effects such as:
low levels of hormones which can cause irregular menstrual periods in women, suppression of growth in adolescents and children, changes in blood sugar, salt or protein levels, extra hair growth and/or weight gain, increased sweating or increases in appetite;
increased levels of cholesterol in your blood;
increased susceptibility to infection, including worsening of tuberculosis (TB) if this is already present;
wasting of muscles, thinning of the bones (osteoporosis) or fractures, breaking of tendons and breakdown of the bone due to lack of blood supply;
water retention (which may cause a bloated feeling) or higher blood pressure (symptoms may include headaches) or changes in blood chemistry due to loss of potassium;
if you have recently had a heart attack, betamethasone can sometimes cause a serious complication of the heart, whereby the tissues can become affected by tears or breaks; mood changes, depression, sleep problems or worsening of epilepsy or schizophrenia if you already have either of these problems;
children may experience swelling and fluid build-up near the eyes and brain (this may result in a throbbing headache which may be worse upon waking up, coughing or sudden movement and patchy vision with blind spots and possible lack of colour vision);
increased pressure in the eye (glaucoma), cataract, worsening of viral or fungal diseases, thinning of the cornea or sclera (the outer membrane of the eye) or other eye problems (which may cause headaches or blurred vision);
heartburn or indigestion, hiccups, nausea bloating of the abdomen, stomach ulcers which may bleed, oesophageal ulcer, thrush in the mouth or throat or pancreas disorders;
bruising, poor wound healing, abscesses, acne, rashes, thinning of the skin, prominent veins, changes in skin colour or blistering of the skin, mouth, eyes and genital;
blood clots or allergic reactions (which can include rashes, breathing difficulties or shock), blood disorders or heart failure;
Blurred vision
Additional care should be taken if this medicine is given to elderly patients, as side effects may be more serious.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE BETAMETHASONE 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 label. The expiry date refers to the last day of that month.
Do not store above 25°C.
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. Further Information

What Betamethasone Soluble Tablets contain
The active substance is betamethasone, as betamethasone sodium phosphate.
Each Tablet Contains:
Betamethasone USP                         0.5mg
Excipients                                              q.s.
The other ingredients are sodium hydrogen carbonate (E500), sodium acid citrate, saccharin sodium, povidone, erythrosine (E127) and sodium benzoate (E211).

What Betamethasone Soluble Tablets look like and contents of the pack
Betamethasone Soluble Tablets are round, pink soluble tablets, scored on one side.
Betamethasone Soluble Tablets are supplied in strip packs of 100 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