BETNESOL 500 MICROGRAM SOLUBLE TABLETS

Active substance: BETAMETHASONE SODIUM PHOSPHATE

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Patient Information Leaflet: Betnesol 500 microgram Soluble Tablets
Betamethasone sodium phosphate

Now read the rest of this leaflet. It includes
•Betnesol is a steroid medicine, prescribed
other important information on the safe and
for many different conditions, including
effective use of this medicine that might be
serious illnesses.
especially important for you. This leaflet was
•You need to take it regularly to get the
last updated February 2012.
maximum benefit.
Read all of this leaflet carefully before you
•Don’t stop taking this medicine without
start taking this medicine.
talking to your doctor – you may need to
• Keep this leaflet. You may need to read it
reduce the dose gradually.
again.
•Betnesol can cause side effects in some people
• If you have any further questions, ask your
(read section 4 on side effects below). Some
doctor or pharmacist.
problems such as mood changes (feeling
• This medicine has been prescribed for you.
depressed or ‘high’), or stomach problems
Do not pass it on to others. It may harm
can happen straight away. If you feel unwell
them, even if their symptoms are the same
in any way, keep taking your medicine, but
as yours.
see your doctor straight away.
• In this leaflet, Betnesol 500 microgram
•Some side effects only happen after weeks
Soluble Tablets will be called Betnesol.
or months. These include weakness of arms
and legs, or developing a rounder face (read
In this leaflet:
section 4 on side effects for more information).
1. What Betnesol is for
•If you take it for more than 3 weeks, you
2. Before you take Betnesol
will get a blue ‘steroid card’: always keep it
with you and show it to any doctor or nurse 3. How to take Betnesol
treating you.
4. Possible side effects
•Keep away from people who have chicken
5. How to store Betnesol
pox or shingles, if you have never had them. 6. Further information.
They could affect you severely. If you do
come into contact with chicken pox or
1. What Betnesol is for
shingles, see your doctor straight away.
Betnesol 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 Betnesol) is an
effective way to treat various illnesses

involving inflammation in the body. Betnesol
reduces 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 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. 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
• 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
• 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), 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.
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 breastfeeding, 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 contains 20.9 mg 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 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 uch 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 genitals.
• 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.
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.

5. How to store Betnesol
Keep out of the reach and sight 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. Store in the original
package to protect from light.
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 contains
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 looks 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, Unit 5, Faraday
Court, First Avenue, Centrum 100, Burton upon
Trent, Staffordshire, DE14 2WX, UK.
Manufacturer
Recipharm Ltd., Vale of Bardsley, Ashtonunder-Lyne, OL7 9RR, UK.

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 updated February 2012.

If this leaflet is difficult to see
or read or you would like it in
a different format, please
contact
Focus Pharmaceuticals Limited,
Unit 5, Faraday Court,
First Avenue, Centrum 100,
Burton upon Trent,
Staffordshire, DE14 2WX, UK.

MU

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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