Skip to Content

BETNESOL 500 MICROGRAMS SOLUBLE TABLETS

Active substance(s): BETAMETHASONE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Betnesol® 500 micrograms Soluble Tablets
(betamethasone sodium phosphate)
Your medicine is known by the above name but will be referred to as
Betnesol through this leaflet.
• Betnesol is a steroid medicine, prescribed for many different conditions,
including serious illnesses.
• You need to take it regularly to get the maximum benefit.
• Do not stop taking this medicine without talking to your doctor – you
may need to reduce the dose gradually.
• Betnesol 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
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 (see section 4).
• If you take it for more than three 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.
Patient Information Leaflet
Read all of this leaflet carefully before you start taking 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1) What Betnesol is and what it is used for
2) What you need to know before you take Betnesol
3) How to take Betnesol
4) Possible side effects
5) How to store Betnesol
6) Contents of the pack and other information

1) What Betnesol is and what it is used for
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) What you need to know before you take Betnesol
Do not take Betnesol:
• 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 medicine (e.g.
antibiotics) to treat it.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Betnesol
• 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 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);
• if you experience blurred vision or other visual disturbances.

Other medicines and Betnesol
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 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 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.
Mental problems while taking Betnesol
Mental health problems can happen while taking steroids like Betnesol (see
also 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 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.
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 taking your tablets, 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 or pharmacist for advice before
taking this medicine.
Pregnancy
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).
Breast-feeding
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.
Betnesol contains Sodium
This medicinal product contains 20.9mg sodium per tablet. To be taken into
consideration by patients 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 this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
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).
Method of administration:
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:
The recommended dose is
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.
Use in children and adolescents
• 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 checkups. 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 forgotten 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 on the use of this medicine, ask your
doctor, pharmacist 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 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 as possible, dose.
Not known (Frequency cannot be estimated from the available data)
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;
• Blurred vision.
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, pharmacist 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 or search for MHRA Yellow Card in the Google
Play or Apple App Store.
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 after the expiry date printed on the carton and blister label after
‘EXP’. 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.
• After first opening of the strip, use within one month.
• Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

6) Contents of the pack and other information
What Betnesol contains:
The active substance is betamethasone. Each tablet contains 500
micrograms of betamethasone (as betamethasone sodium phosphate).
The other ingredients are: sodium hydrogen carbonate, sodium acid citrate,
saccharin sodium, povidone, erythrosine (E127) and sodium benzoate.
What Betnesol looks like and contents of the pack
Betnesol Tablets are round, pink soluble tablets, scored on one side and with
‘Betnesol’ engraved on the other.
They are available in strip packs containing 30 and 100 tablets.
PL 10383/2224

Betnesol 500 micrograms Soluble Tablets

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Sigma-Tau Industrie Farmaceutiche
Riunite S.p.A., Via Pontina KM 30.400, 00071 Pomezia (Rome), Italy.
Procured from within the EU and repackaged by Product Licence Holder:
Primecrown Ltd., 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex, UB5 5QS.
Leaflet date: 22.02.2018
Betnesol® is a registered trademark of Celltech Pharma Europe Limited, 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.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8839 3000 to obtain the
leaflet in a format suitable for you.

Betamethasone 500 micrograms Soluble Tablets
(betamethasone sodium phosphate)
Your medicine is known by the above name but will be referred to as
Betamethasone Soluble Tablets through this leaflet.
• Betamethasone Soluble Tablets are a steroid medicine, prescribed for
many different conditions, including serious illnesses.
• You need to take it regularly to get the maximum benefit.
• Do not stop taking this medicine without talking to your doctor – you
may need to reduce the dose gradually.
• Betamethasone Soluble Tablets 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 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 (see section 4).
• If you take it for more than three 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.
Patient Information Leaflet
Read all of this leaflet carefully before you start taking 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1) What Betamethasone Soluble Tablets are and what they are used for
2) What you need to know before you take Betamethasone Soluble Tablets
3) How to take Betamethasone Soluble Tablets
4) Possible side effects
5) How to store Betamethasone Soluble Tablets
6) Contents of the pack and other information

1) What Betamethasone Soluble Tablets are and what they are
used for
Betamethasone Soluble Tablets 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
Betamethasone Soluble Tablets) is an effective way to treat various illnesses
involving inflammation in the body. Betamethasone Soluble Tablets 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.
Betamethasone Soluble Tablets are 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) What you need to know before you take Betamethasone
Soluble Tablets
Do not take Betamethasone Soluble Tablets:
• 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 medicine (e.g.
antibiotics) to treat it.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Betamethasone
Soluble Tablets
• if you have ever had severe depression or manic depression (bipolar
disorder). This includes having had depression before while taking steroid
medicines like Betamethasone Soluble Tablets;
• 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;
• 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);
if you experience blurred vision or other visual disturbances.

Other medicines and Betamethasone Soluble Tablets
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 Betamethasone Soluble
Tablets 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 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.
Betamethasone Soluble Tablets may also affect the results of gallbladder Xray procedures.
Mental problems while taking Betamethasone Soluble Tablets
Mental health problems can happen while taking steroids like
Betamethasone Soluble Tablets (see also 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 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.
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 taking your tablets, 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 or pharmacist for advice before
taking this medicine.
Pregnancy
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).
Breast-feeding
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.
Betamethasone Soluble Tablets contains Sodium
This medicinal product contains 20.9mg sodium per tablet. To be taken into
consideration by patients on a controlled sodium diet. Tell your doctor or
pharmacist before taking Betamethasone Soluble Tablets if this applies to
you.

3) How to take Betamethasone Soluble Tablets
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.

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).
Method of administration:
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:
The recommended dose is
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.
Use in children and adolescents
• 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 checkups. 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 Betamethasone Soluble Tablets than you should
Do not take more Betamethasone Soluble Tablets than you should. If you
accidentally take too much, immediately contact the nearest hospital casualty
department or your doctor.
If you forget to take Betamethasone Soluble Tablets
Do not take a double dose to make up for a forgotten dose. Take your next
dose at the usual time.

• 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;
• Blurred vision.
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, pharmacist 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 or search for MHRA Yellow Card in the Google
Play or Apple App Store.
By reporting side effects you can help provide more information on the safety
of this medicine.

5) How to store Betamethasone Soluble Tablets
• Keep out of the sight and reach of children.
• Do not use after the expiry date printed on the carton and blister label after
‘EXP’. 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.
• After first opening of the strip, use within one month.
• Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

6) Contents of the pack and other information

If you stop taking Betamethasone Soluble Tablets
Do not stop taking Betamethasone Soluble Tablets without first talking
to your doctor.

What Betamethasone Soluble Tablets contains:
The active substance is betamethasone. Each tablet contains 500
micrograms of betamethasone (as betamethasone sodium phosphate).

It is very important that you do not suddenly stop taking
Betamethasone Soluble Tablets, 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 Betamethasone Soluble Tablets.

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

If you have any further questions on the use of this medicine, ask your
doctor, pharmacist 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 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 as possible, dose.
Not known (Frequency cannot be estimated from the available data)
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;

What Betamethasone Soluble Tablets looks like and contents of the
pack
Betamethasone Soluble Tablets are round, pink soluble tablets, scored on
one side and with ‘Betnesol’ engraved on the other.
They are available in strip packs containing 30 and 100 tablets.
PL 10383/2224

Betamethasone 500 micrograms Soluble Tablets

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Sigma-Tau Industrie Farmaceutiche
Riunite S.p.A., Via Pontina KM 30.400, 00071 Pomezia (Rome), Italy.
Procured from within the EU and repackaged by Product Licence Holder:
Primecrown Ltd., 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex, UB5 5QS.
Leaflet date: 22.02.2018
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.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8839 3000 to obtain the
leaflet in a format suitable for you.

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide