BETNESOL 4MG/ML INJECTION

Active substance: BETAMETHASONE SODIUM PHOSPHATE

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Patient Information Leaflet: Betnesol 4mg/mL Injection
Betamethasone sodium phosphate

•Betnesol is a steroid medicine, prescribed
for many different conditions, including
serious illnesses.
•You need to use it regularly to get the
maximum benefit.
•Don’t stop using this medicine without
talking to your doctor – you may need to
reduce the dose gradually.
•Betnesol can cause side effects in some
people (read section 4 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 effects only happen after weeks
or months. These include weakness of arms
and legs, or developing a rounder face (read
section 4 on side effects for more information).
•If you use 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. This leaflet was
last updated November 2011.

Read all of this leaflet carefully before you
start using 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:
1. What Betnesol is for
2. Before you use Betnesol
3. How to use Betnesol
4. Possible side effects
5. How to store Betnesol
6. Further information.

Many different conditions can be improved
by the use of corticosteroids, as they reduce
inflammation (redness, tenderness, heat and
swelling) in the body.
Betnesol Injection is used to treat:
• Asthma
• Severe allergic reactions including reactions
to drugs
• Local inflammation eg. of joints, tendons
or the eye
• As replacement for the body’s naturally
occurring corticosteroid hormones when
these are reduced or absent
• Severe shock, (collapse) due to surgery,
injury or overwhelming infection.
Corticosteroids are also used to help prevent
organ transplant rejection following organ
transplant surgery.

1. What Betnesol is for

2. Before you use Betnesol

Betnesol Injection 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 use this medicine regularly
to get maximum benefit from it.

Do not use 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
ulcersulcers, diverticulitis (inflammation of
the bowel), or a herpes infection of the eye
• 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 had a stroke, or if there is a
history of this in your family
• If you have recently had a head injury
• 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 using 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 using this
medicine, 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 using Betnesol Injection.
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
treatment unless told to do so (see section 3
“If you stop taking Betnesol” below).

W 07-6214
Code 214

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 Injection contains sodium
metabisulphite (0.1% w/v) as a preservative
and should not be used to treat patients with
known hypersensitivity to bisulphite or
metabisulphite. It also contains sodium 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 use Betnesol
Always use 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 injections you need
each day (see section 6 “Carrying your steroid
card” below).
Betnesol Injection can be given slowly into a
vein, deep into a muscle or locally at the site of
inflammation. It should not be injected directly
into tendons. Your doctor will decide where,
how much and how often you should have
Betnesol Injection.

The dose used will depend upon the disease, its
severity, and how quickly you get better.
Betnesol Injection is not intended for long term
use. The following are for guidance only:
Local injections excluding eye:
Adults: 4 - 8mg (1-2ml), repeated up to 3 times.
Children may have a smaller dose
Eye injections:
Adults and children: 2 - 4mg (0.5 - 1ml)
Other injections: Adults: 4 - 20mg (1 - 5ml)
Children 6 - 12 years: 4mg (1ml)
Children 1 - 5 years: 2mg (0.5ml)
Children up to 1 year: 1mg (0.25ml)
These doses can be repeated up to 4 times a
day.
If you have any queries about the amount of
medicine you have been prescribed, ask your
doctor.
While you are using 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 use more Betnesol Injection than you
should
If you think you have been given too much of
the injection, immediately tell your doctor or
nurse. The dose may be reduced slowly over
time to minimise any effects.
If you forget to use Betnesol Injection
If you forget to have a dose, i.e. miss your
doctor’s appointment; see your doctor as soon
as possible.

If you stop using Betnesol
Do not stop using Betnesol without first talking
to your doctor.
It is very important that you do not suddenly
stop using 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
using Betnesol Injection.
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 injections 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 any of the side effects gets serious, or if you
• If you have recently had a heart attack,
betamethasone can sometimes cause a serious notice any side effects not listed in this leaflet,
complication of the heart whereby the tissues please tell your doctor or pharmacist.
can become affected by tears or breaks.
5. How to store Betnesol
• Mood changes, depression, sleep problems,
Keep out of the reach and sight of children.
or worsening of epilepsy or schizophrenia if
you already have either of these problems.
Do not use Betnesol after the expiry date on the
label. The expiry date refers to the last day of
• Children may experience swelling and fluid
that month.
build-up near the eyes and brain (this may
result in a throbbing headache which may be
Do not store above 30°C. Store in the original
worse upon waking up, coughing, or sudden
package to protect from light.
movement, and patchy vision with blind
Medicines should not be disposed of via
spots and possible lack of colour vision).
wastewater or household waste. Return any
• Increased pressure in the eye (glaucoma)
medicine you no longer need to your
cataract, worsening of viral or fungal
pharmacist.
diseases, thinning of the cornea or sclera (the
6. Further information
outer membrane of the eye) or other eye
problems (which may cause headaches or
What Betnesol Injection contains
blurred vision).
The active substance is betamethasone sodium
• Heartburn or indigestion, hiccups, nausea,
phosphate at a concentration of 4 milligrams
bloating of the abdomen, stomach ulcers
(mg) betamethasone in 1 millilitre (mL) of
which may bleed, oesophageal ulcer, thrush
sterile solution in water.
in the mouth or throat, or pancreas
The other ingredients are disodium edetate,
disorders.
sodium metabisulphite, sodium chloride,
• Bruising, poor wound healing, abscesses,
sodium hydroxide, hydrochloric acid and water
acne, rashes, thinning of the skin, prominent
for injection.
veins, changes in skin colour, or blistering of
the skin, mouth, eyes and genitals.
What Betnesol Injection looks like
• Blood clots, or allergic reactions (which can
Betnesol Injection is a solution supplied in
include rashes, breathing difficulties or
ampoules containing 1ml, in boxes of 5.
shock), blood disorders, or heart failure.
Marketing Authorisation Holder
Additional care should be taken if this medicine
RPH Pharmaceuticals AB, Lagervägen 7,
is given to elderly patients, as side-effects may
136 50 Haninge, Sweden.
be more serious.
Distributed by Focus Pharmaceuticals Ltd.

Manufacturer
Recipharm Ltd, Vale of Bardsley,
Ashton-under-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 November 2011.

If this leaflet is difficult to see or
read or you would like it in a
different format, please contact
RPH Pharmaceuticals AB,
Lagervägen 7,
136 50 Haninge,
Sweden.

W 07-6214
Code 214

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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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