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Package leaflet: Information for the user

Betnesol 500 microgram Soluble Tablets

Betamethasone sodium phosphate

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.

Read all of this leaflet carefully before you start taking this 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    In this leaflet, Betnesol 500 microgram Soluble Tablets will be called Betnesol.

In this leaflet

1.    What Betnesol is for

2.    Before you take Betnesol

3.    How to take Betnesol

4.    Possible side effects

5.    How to store Betnesol

6.    Further information

1. What Betnesol is for

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

Betnesol is 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 interstitiall 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. Before you take Betnesol Do not take Betnesol if

•    you are allergic to betamethasone or any of the other ingredients of Betnesol (see section 6);

•    you have an infection and have not yet started taking medicine (e.g. antibiotics) to treat it.

If any of the above applies to you talk 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 Betnesol;

•    if any of your close family has had these illnesses.

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

Talk to your doctor:

•    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 (see “Pregnancy and breast-feeding” section below).

Tell your doctor if you are taking any of the following medicines:

•    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)

•    Ritonavir (anti-viral for infections) and 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.

Betnesol may also affect the results of gallbladder X-ray procedures.

If any of the above applies to you, talk to your doctor before taking Betnesol.

Mental problems while taking Betnesol

Mental health problems can happen while taking steroids like Betnesol (see also section 4 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 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.

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.

Pregnancy and breast-feeding

If you are pregnant, trying to become pregnant or breast-feeding ask your doctor or pharmacist for advice before taking Betnesol.

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 (see section 3 “If you stop taking Betnesol” below).

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.

Warnings about the ingredients in Betnesol

Betnesol contain 20.9mg sodium per tablet and may not be suitable for people on a controlled sodium diet. Tell your doctor or pharmacist before taking Betnesol if this applies to you.

3. How to take Betnesol

Always take Betnesol exactly as your doctor has told you.

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 card which also tells you how many tablets to take each day (see section 6 “Carrying your steroid card” below).

Remember: 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:

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.

Children

•    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 Betnesol than you should

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

If you forget to take Betnesol

Do not take a double dose to make up for a missed dose. Take your next dose at the usual time.

If you stop taking Betnesol

Do not stop taking Betnesol without first talking to your doctor.

It is very important that you do not suddenly stop taking Betnesol, 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 Betnesol.

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

4. Possible side effects

Like all medicines Betnesol 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 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

•    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

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, dentist or pharmacist. 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 Betnesol

Keep out of the sight and reach of children.

Do not use Betnesol after the expiry date on the label. The expiry date refers to the last day of that month.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.

6.    Further information What Betnesol contain

The active substance is 500 micrograms of betamethasone, as betamethasone sodium phosphate.

The other ingredients are sodium hydrogen carbonate (E500), sodium acid citrate, saccharin sodium, povidone, erythrosine (E127) and sodium benzoate (E211).

What Betnesol look like

Betnesol Tablets are round, pink soluble tablets, scored on one side and with ‘Betnesol Evans’ engraved on the other. Betnesol Tablets are supplied in strip packs of 100 tablets.

Marketing Authorisation Holder

Focus Pharmaceuticals Limited

Capital House, 85 King William Street, London EC4N 7BL, UK.

Tel: 00 44 (0)1283 495280    Fax: 00 44 (0)1283 495290

Email: medinfo@focuspharma.co.uk

Manufacturer

Recipharm Limited, Vale of Bardsley, Ashton-under-Lyne, OL7 9RR, UK.

For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided above.

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.

This leaflet was last revised in April 2016.

For information in large print, audio CD or Braille please telephone 00 44 (0)1283 495 280 or email medinfo@focuspharma.co.uk.

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