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BETNESOL 4MG/ML INJECTION

Active substance(s): BETAMETHASONE SODIUM PHOSPHATE / BETAMETHASONE SODIUM PHOSPHATE / BETAMETHASONE SODIUM PHOSPHATE

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Package leaflet: Information for the user
Betnesol 4mg/mL Solution for Injection
Betamethasone sodium phosphate









Betnesol Injection 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 Injection can cause side effects in some people (see section 4). 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 using 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 (see section 4).
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 chickenpox or shingles, if you have never had
them. They could affect you severely. If you do come into contact with chickenpox or
shingles, see your doctor straight away.

Read all of this leaflet carefully before you are given 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 nurse.
 If you get any side effects, talk to your doctor or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
In this leaflet Betnesol 4mg/mL Solution for Injection will be called Betnesol Injection.
What is in this leaflet
1.
2.
3.
4.
5.
6.

What Betnesol Injection is and what it is used for
What you need to know before you are given Betnesol Injection
How you will be given Betnesol Injection
Possible side effects
How to store Betnesol Injection
Contents of the pack and other information

1. What Betnesol Injection is and what it is used for

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 Injection) is an effective way
to treat various illnesses involving inflammation in the body. Betnesol Injection reduces this
inflammation, which could otherwise go on making your condition worse. You must use 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 Injection is used:
 to treat asthma
 to treat severe allergic reactions including reactions to drugs
 to treat local inflammation e.g. of joints, tendons or the eye
 as replacement for the body’s naturally occurring corticosteroid hormones when these are
reduced or absent
 to treat severe shock, (collapse) due to surgery, injury or overwhelming infection.
Corticosteroids are also used to help prevent organ transplant rejection following organ
transplant surgery.
2. What you need to know before you are given Betnesol Injection
Do not use Betnesol Injection:
 if you are allergic to betamethasone or any of the other ingredients of this medicine (listed
in section 6)
 if you have an infection and have not yet started taking any medicine (e.g. antibiotics) to
treat it.
Warnings and precautions
Talk to your doctor or nurse before you are given Betnesol Injection
 If you have ever had severe depression or manic depression (bipolar disorder). This
includes having had depression before while using steroid medicines like Betnesol
Injection
 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, 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 stroke 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
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).

Other medicines and Betnesol Injection
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 Betnesol Injection 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 contraceptives (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 Injection may also affect the results of gall-bladder X-ray procedures.
Mental problems while using Betnesol Injection
Mental health problems can happen while using steroids like Betnesol Injection (see section
4).
 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 occur they may need treatment.
Talk to a doctor if you (or someone who is using 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 any of these 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 using this
medicine, 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 for advice before using this medicine.
Pregnancy:
Taking steroids often or for a long period of 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 using this medicine, please tell
your doctor but DO NOT stop treatment unless told to do so (see section 3).
Breast-feeding:
If you are breast-feeding, the steroid may enter the baby and lower their hormone levels if
you are using high doses for a long period of time.
Betnesol Injection contains sodium metabisulphite and sodium
Betnesol Injection contains sodium metabisulphite (0.1% w/v) as a preservative, it may rarely
cause severe hypersensitivity reactions and bronchospasm. This medicinal product contains
less than 1 mmol sodium (23 mg) per 1ml, i.e. essentially ‘sodium- free’. Tell your doctor or
nurse before you are given Betnesol Injection if this applies to you.

3. How you will be given Betnesol Injection
Always use this medicine exactly as your doctor has told you. Check with your doctor if you
are not sure.
Important: Your doctor will choose the dose that is right for you.
You may have been given a steroid card which also tells you how many injections you need
each day (see section 6).
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:
The recommended doses are:
Local injections (excluding eye):
Adults: 4 – 8mg (1 – 2ml), repeated up to 3 times.
Use in children and adolescents:
Children may have a smaller dose

Eye injections:
Adults and children: 2 – 4mg (0.5 – 1ml)
Other injections: Adults: 4 – 20mg (1 – 5ml)
Use in children and adolescents:
Children 6 – 12 years: 4mg (1ml)
Children 1 – 5 years: 2 mg (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.
Method of administration:
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 be given Betnesol Injection.
If you are given 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 Injection
Do not stop using Betnesol Injection without first talking to your doctor.
It is very important that you do not suddenly stop using Betnesol Injection, 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 using your medicine too suddenly, you may suffer from some
of the following: fever, joint and muscle pain, itchy eyes, nose or skin, mood changes, loss of
weight, low hormone levels or 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 on the use of this medicine, ask your doctor 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 may affect up to 1 in 10 people taking medicines
like betamethasone.
If you notice any of the following problems, talk to a doctor straight away:









Feeling depressed, including thinking about suicide.
Allergic reactions (which can include rashes, breathing difficulties or shock), blood
disorders or heart failure.
Changes in skin colour or blistering of the skin, mouth, eyes and genitals.
Symptoms of cramping pain, redness, warmth or swelling in your arms or legs or
shortness of breath. These could be a sign of a blood clot.
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.
Worsening of epilepsy or schizophrenia, if you already have either of these
problems.
Feeling, seeing or hearing things which do not exist. Having strange and frightening
thoughts, changing how you act or having feelings of being alone.







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 eye pressure (glaucoma).
Mouth and/or stomach ulcers, oesophageal ulcers (which may bleed)
Symptoms of severe pain in your stomach, nausea and vomiting, diarrhoea, fever,
loss of appetite and yellowing of your skin (jaundice). These could be a sign of acute
pancreatitis.

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 as possible, dose.
Not known (Frequency cannot be estimated from the available data)
High doses taken for a long period of 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 increase 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), 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.
 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, thrush in the mouth
or throat.
 Bruising, poor wound healing, abscesses, acne, rashes, thinning of the skin, prominent
veins.
Additional care should be taken if this medicine is given to elderly, as side-effects may be
more serious.
Reporting of side effects
If you get any side effects, talk to your doctor 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 Betnesol Injection
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 carton and label. The
expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package in order to protect from light.
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. Contents of the pack and other information
What Betnesol Injection contains
-The active substance is betamethasone sodium phosphate. Each ampoule contains 5.3mg of
betamethasone sodium phosphate equivalent to 4mg betamethasone in 1ml of sterile aqueous
solution.
-The other ingredients are disodium edetate, sodium metabisulphite, sodium chloride, sodium
hydroxide, hydrochloric acid and water for injection.
What Betnesol Injection looks like and contents of the pack
Betnesol Injection is a clear, colourless or pale yellow solution, supplied in ampoules
containing 1ml, in boxes of 5.
Marketing Authorisation Holder
Focus Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK.
Manufacturer
Wasserburger Arzneimittelwerk GmbH, Herderstraße 2, D-83512 Wasserburg, Germany.
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, 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, nurse 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 02/2017.

Expand Transcript

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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