BETAMETHASONE TABLETS B.P. 0.5 mg.
Betanem Tablets 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.
Betanem Tablets can cause side effects in some people (read section on side effects 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 medicine, but see your doctor straight away.
Some side effect, only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face (read section on side effects 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 chicken pox or shingles, if you have never had them. They could affect you severely. If you do come into contact with chicken pox 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. If you have any questions about this medicine, ask your doctor or pharmacist.
What is your medicine?
Betanem Tablets are round, pink soluble tablets, scored one side and with ‘Betanem Evans’ engraved on the other.
Each tablet contains 500 micrograms (0.5mg) betamethasone as betamethasone sodium phosphate. The tablets also contain sodium bicarbonate, sodium acid citrate, saccharin sodium, povidone, Erythrosine (E127) and sodium benzoate. Betanem Tablets are supplied in strip packs of 100 tablets.
Betanem Tablets 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 corticosteroids (such as Betanem Tablets is an effective way to treat various illness involving inflammation in the body. Betanem Tablets reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get the maximum benefit.
What is your medicine used for?
Many different conditions can be improved by the use of corticosteroids, as they reduce inflammation (redness, tenderness, heat and swelling) in the body. Some of the main conditions are:
Asthma and severe allergic reactions.
Certain conditions of the blood.
Autoimmune diseases such as systemic lupus erythematosus (SLE) and polyarteritis nodosa.
Inflammatory conditions of the skin, kidney (such as acute interstitial nephritis), bowels (such as ulcerative colitis and Crohn’s disease) and heart.
Some connective tissue disorders.
Some types of cancer, such as malignant lymphoma.
Corticosteroids are also used to help prevent organ transplant rejection following organ transplant surgery.
If you are not sure why you are on these tablets, ask your doctor.
Before using this medicine
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 Betanem Tablets.
If any of your close family had had these illnesses.
If either of these applies to you, talk to a doctor before taking Betanem Tablets.
Have you taken Betanem Tablets before and suffered a reaction to them, or been told that you are allergic to this medicine?
Are you allergic to any of the ingredients in the tablets?
Have you ever had tuberculosis (TB), epilepsy (fits), severe mental illness, glaucoma (raised eye pressure), hypertension (high blood pressure), osteoporosis (thinning of the bones), stomach or duodenal ulcers?
Have you recently had a heart attack?
Have you 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.
Do you have an infection?
Are you diabetic?
Do you have an underactive thyroid gland?
Have you ever suffered from muscle wasting due to corticosteroids?
Do you have liver, kidney or heart disease?
Have you just been or are you about to be immunised?
Are you pregnant, likely to become pregnant, or breast-feeding? (see Special Precautions below)
Are you taking any other medicines either from your doctor or bought in a shop or chemist? In particular; 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. Aspirin; medicines for myasthenia gravis called anticholinesterases, medicines for the heart called cardiac glycosides; carbenoxolone; acetazolamide; rifampicin; rifabutin; carbamazepine, phenobarbitone; primidone; aminoglytethimide; ephedrine; theophylline; amphotericin B (anti-fungal); ritonavir; oral contraceptive (the pill); mifepristone; somatropin (growth hormone).
If the answer to any of these questions is YES, tell your doctor (or pharmacist), before taking this medicine.
What special precautions should be taken?
Mental problems while taking Betanem Tablets
Mental health problems can happen while taking steroids like Betanem Tablets (see also section on 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 problem, go away if the dose is lowered or the medicine is stopped. However if problem do happen they might need treatment.
Talk to a doctor if you (or someone who is taking this medicine), shows 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.
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 rate and body movements. 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 (see Withdrawal Symptoms below). If you are breastfeeding, the steroid may enter the baby and lower their hormone levels if you are taking high doses for a long time.
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.
Advise 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.
How to use your medicine
Look at the label; it should say who should use the tablets, how many should be taken and when. If it does not, or you are not sure, ask your doctor or pharmacist.
You may have been given a STEROID CARD which tells you how many tablets to take each day (see ‘Carrying a steroid card’)
The tablets can be swallowed whole, but they are best taken as a drink after allowing them to dissolve in a glass of water.
If you need to take half a tablet, then use the line on one side of the tablet as a guide. The tablets should be taken EXACTLY as stated on the label.
Do not suddenly stop taking the tablets even if you feel better unless your doctor tells you to – you could become ill.
DO NOT EXCEED THE STATED DOSE
What are the usual doses?
The dose used will depend upon the disease, its severity, and how quickly you get better. The following are for guidance duly.
Short term treatment: 2000-3000 micrograms (4-6 tablets daily for the first few days, then reducing 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) for long-term treatment the lowest effective dosage is used.
Most other conditions: 1500-5000 micrograms (3-10 tablets) daily for one to three weeks, then gradually reducing to the minimum effective dosage. Larger doses may be needed for mixed connective tissue diseases and ulcerative colitis.
A proportion of the adult dosage may be used (e.g. 75% at 12 years, 50% at 7 years and 25% at 1 year).
What to do if you take too much
If you take too many tablets, tell your doctor immediately.
What to do if you miss a dose
If you forget to take a dose, take another as soon as possible, then go on as before. (If you only remember when it is time for your next dose, take a single dose and carry on as before).
It is very important that you do not suddenly stop taking your medicine (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, low blood pressure (symptoms of which may include dizziness, headaches or fainting). In extreme cases this may be fatal.
Are there any side-effects to this medicine?
Serious effects: tells 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 sway.
If you need to take the tablets for more than 2 weeks your doctor will prescribe as low a dose as possible. 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.
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, oesphageal ulcer, thrush in the mouth or throat, or pancreas disorders.
Bruising, poor wound healing, abscesses, acne, rashes, thinning of the skin, prominent veins, or changes in skin colour.
Blood clots, or allergic reactions (which cast include rashes, breathing difficulties or shock), blood disorders, or heart failure.
If you think this medicine has upset you in ANY way, PLEASE TELL YOUR DOCTOR.
Additional care should be taken if this medicine is given to elderly patients, as aide-effects may be more serious.
Storage of your medicine
Do not store above 25oC. Keep the tablets in the original package to protect from light. Do not use this medicine after the expiry date shown on the pack.
KEEP THIS AND ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN
What to do with any unused tablets
If your doctor decides to stop your medicine or you have tablets left at the end of treatment, return any unused tablets to your pharmacist for safe disposal.
Carrying your steroid card
If your doctor asks you to carry a steroid card, be sure to keep it with you always.
Show it to any doctor, dentist, nurse or midwife or anyone else who is giving you treatment.
Even after your treatment has finished tell any doctor, dentist, nurse, midwife or anyone else who is giving you treatment that you have had steroid treatment.
A steroid card may be obtained from your doctor, pharmacist, or local Family Health Service Authority. In Scotland, steroid cards are available from the Scottish Office of Home and Health.
REMEMBER THIS MEDICINE IS ONLY FOR YOU. ONLY A DOCTOR CAN PRESCRIBE IT FOR YOU. NEVER GIVE IT TO SOMEONE ELSE; THERE MAY BE A REASON WHY IT COULD HARM THEM.
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor (or pharmacist), who will have access to further information. Pharmaceutical companies are not allowed to advice about personal medical problems.
YOU MAY WANT TO READ THIS LEAFLET AGAIN. PLEASE DO NOT THROW IT AWAY UNTIL YOU HAVE FINISHED YOUR MEDICINE.
Jay Formulations Ltd.
Unit No.1301 & U-1, G.I.D.C. Kerala (Bavia),
Dist. Ahmedabad, Gujarat, INDIA.
Lifeline Pharmaceuticals Ltd.
30, Umuoji Street Nkpor
Anambra State, Nigeria.