Skip to Content

GLENSOLUDEX 8 MG SOLUBLE TABLETS

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

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the user

Glensoludex 2 mg, 4 mg and 8 mg soluble tablets
Dexamethasone

Important information about this medicine
• Glensoludex is a steroid medicine,
prescribed for many different conditions
including serious illnesses
• You need to take it regularly to get the
maximum benefit
• Don’t stop taking this medicine without
talking to your doctor – you may need to
reduce the dose gradually
• Glensoludex can cause side effects in some
people (read Section 4: Possible side effects).
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 for more information)
• If you take it for more than 3 weeks you
will get a ‘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. 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 or pharmacist.
• 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 or
pharmacist. This includes any side effects not
listed in this leaflet.
What is in this leaflet:
1. What Glensoludex soluble tablets is and what
it is used for
2. What you need to know before you take
Glensoludex soluble tablets
3. How to take Glensoludex soluble tablets
4. Possible side-effects
5. How to store Glensoludex soluble tablets
6. Contents of the pack and other information
1. W
 hat Glensoludex soluble tablets are and
what they are used for

Glensoludex soluble tablets contain the active
substance dexamethasone. Glensoludex belongs
to a group of medicines called steroids (the full
name is ‘corticosteroids’). Corticosteroids occur
naturally in the body, and help to maintain health
and well-being.
Boosting your body with extra corticosteroid
(such as dexamethasone) is an effective way to
treat various illnesses involving inflammation in
the body.
Glensoludex soluble tablets reduce this
inflammation, which could otherwise go on
making your condition worse. You must take this
medicine regularly to get the maximum benefit
from it.
Glensoludex soluble tablets are used for one of
the following:
• where your natural corticosteroid levels have
been reduced and you need to replace them
• where swelling of the brain has occurred
• if you are having tests for diseases which may
decrease your natural corticosteroid level,
such as Cushing’s syndrome (a hormonal
disorder)

• to reduce inflammation and suppress the
immune system in:
– allergy (hypersensitivity)
– polymyalgia rheumatica (chronic
inflammation of the larger arteries),
polyarteritis nodosa (chronic inflammation
of small and medium arteries)
– blood disorders including haemolytic
anaemia (disorder which breaks down
red blood cells), leukaemia (cancer of the
blood), myeloma (bone marrow tumour)
– Crohn’s disease, ulcerative colitis
(inflammation of the bowel), hepatitis
– polymyositis (inflammation of muscles)
– increased pressure in the head not linked to
tumours, worsening of multiple sclerosis
– inflammation of the eye
– inflammation of the kidney
– breathing problems including chronic
bronchial asthma and chronic obstructive
pulmonary disease (COPD) which may
show as shortness of breath during
exercise, difficulty breathing in and out
deeply and persistent cough. (Disorders
where there is inflammation of the lung).
– rheumatoid arthritis (painful joint disease),
rheumatism, inflammation of a wide area
of the body
– chronic and severe diseases of the skin
(including Stevens-Johnson syndrome
and a rare condition known as mycosis
fungoides)
– leukaemia of the lymphatic system,
Hodgkin’s and Non-Hodgkin’s lymphoma,
breast cancer that has spread around the
body, Kahler’s disease (cancer of blood
cells) and high calcium levels caused by
this disease
– after organ transplants and to prevent
nausea and vomiting following
chemotherapy
You may be using this medicine for a different
reason. Ask your doctor why this medicine has
been prescribed for you.
2. W
 hat you need to know before you take
Glensoludex soluble tablets

Do not take Glensoludex soluble tablets:
• if you are allergic (hypersensitive) to
dexamethasone or any of the other ingredients
of Glensoludex soluble tablets or you
have ever had an unusual reaction to these
substances
• if you have an infection (including fungal
infections) that affects the whole body (unless
you are receiving treatment)
• if you have a stomach or duodenal ulcer
• if you have an infection with worms after
travelling to a tropical area
• to treat a serious lung disease called Acute
Respiratory Distress Syndrome if you have had
this problem for more than 2 weeks.
Warning and precautions
Talk to your doctor or pharmacist before taking
Glensoludex soluble tablets:
• if you have ever had severe depression
or manic depression (bipolar disorder).
This includes having had depression before
or while taking steroid medicines like
Dexamethasone.
• if any of your close family has had these
illnesses.
• if the treatment is for a premature baby.
Glensoludex should not be routinely used in
preterm neonates with respiratory problems.
Mental health problems while taking
Glensoludex soluble tablets
Mental health problems can happen while taking
steroids like Dexamethasone.

• 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 taking this
medicine), show any signs of mental health
problems. This is particularly important if
you are depressed, or might be thinking about
suicide. In a few cases, mental health problems
have happened when doses are being lowered or
stopped.
Talk to your doctor before taking this
medicine if:
• You have a cancer of the blood because you
may be at risk of a very rare, potentially lifethreatening condition resulting from a sudden
breakdown of tumour cells
• you have a bacterial or viral infection (such
as hepatitis, poliomyelitis) or an infection
with parasites.
• you have kidney or liver problems
• you have high blood pressure, heart disease
or you have recently had a heart attack
• you have diabetes or there is a family history
of diabetes
• you have osteoporosis (thinning of the
bones), particularly if you are a female who
has been through the menopause
• you have suffered in the past from muscle
weakness with this or other steroids
• you have glaucoma (raised eye pressure) or
there is a family history of glaucoma
• you have myasthenia gravis (a condition
causing weak muscles)
• you have a bowel disorder (ulcerative
colitis or diverticulitis), have recently had an
operation on your bowel or a stomach ulcer
(peptic or gastrointestinal ulcer)
• you have psychiatric problems or you have
had a psychiatric illness which was made
worse by this type of medicine
• you have epilepsy (condition where you have
repeated fits or convulsions)
• you have migraines
• you have an underactive thyroid gland
• you have tuberculosis (TB) or have recently
had a reaction to a vaccination for TB
• you have septicaemia
• you have a fungal or viral infection in the
eye, an injury to your eye or an ulcer on the
surface of your eye (corneal ulceration)
• you have cerebral malaria
• you have herpes (cold sores or genital
herpes)
• you have asthma
• you have stunted growth
This may affect the dose you are given or your
doctor may want you to take other medicines at
the same time.
More Important Information about taking
this medicine
• Taking this medicine may increase your risk
of getting an infection. It may also mask
the symptoms of an existing or developing
infection and make it harder to find out what
is wrong. If you develop an infection whilst
on this medicine you should talk to your
doctor.
• If you have an accident, are ill, require
surgery (even at the dentists) or you require
a vaccination (particularly with ‘live virus’
vaccines) whilst taking or when you have
finished taking Glensoludex soluble tablets,
you should inform the person treating you that
you are taking or have taken steroids.
• If you have an allergy test, a suppression
test (test for hormone levels) or a test for
an infection, you should inform the person
performing the test that you are taking
Glensoludex as it may interfere with the
results.

• I f you need a vaccination tell your doctor
as it may not be effective or you may have a
greater chance of getting an infection from
a ‘live’ vaccine such as MMR, tuberculosis
(TB), yellow fever or oral typhoid.
• If you have a doping test when taking this
medicine you may get a positive result.
• Your doctor may want to perform regular
check ups on you while you are taking
Glensoludex soluble tablets:
– They may be more frequent if you have
other health problems (such as diabetes or
kidney problems) or if you are elderly as
any side effects may be more serious for
you.
– If a child is taking this medicine, it
is important that their growth and
development is checked at frequent
intervals as Glensoludex can cause
children to grow more slowly.
– If you are taking this medicine for a long
time, regular (every 3 months) checks of
your vision are recommended.
– If you are taking high doses your doctor
may monitor the levels of potassium in
your blood. You may also find that your
doctor will reduce the amount of salt
in your diet and give you a potassium
supplement whilst you are taking this
medicine.
• If you take this medicine for more than 3
weeks, you should always carry a ‘steroid
card’ which gives clear guidance on the
special care to be taken when you are taking
this medicine. Show this to any doctor, dentist
or person who may be giving you treatment.
Even after your treatment has finished you
must tell anyone who is giving you treatment
that you have taken steroids in the past.
• Talk to your doctor if you have symptoms
of tumour lysis syndrome such as muscle
cramping, muscle weakness, confusion,
visual loss or disturbances and shortness of
breath, in case you suffer from haematological
malignancy.
• Chickenpox, shingles and measles.It is
important that whilst you are taking this
medicine you avoid contact with anybody
who has chickenpox, shingles or measles. If
you think you may have had exposure to any
of these diseases, you should consult your
doctor immediately.
– You should also inform your doctor if you
have ever had infectious diseases such as
measles or chickenpox and if you have
had any vaccinations for these diseases in
the past.
Older people
Some of the side effects of Glensoludex may
be more serious in older people. Your doctor
may need to monitor you more closely for the
following:
• diabetes
• getting infections
• thinning of the skin
• high blood pressure
• thinning of the bones (osteoporosis)
• low potassium levels in the blood
(hypokalaemia).
Taking other medicines and Glensoludex
soluble tablets
Please tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines. This includes medicines you
buy without a prescription, including herbal
medicines. This is because some medicines may
increase the effects of Glensoludex and your
doctor may wish to monitor you carefully if
you are taking these medicines (including some
medicines for HIV: ritonavir, cobicistat).
continued overleaf

I n particular, tell your doctor if you are taking
any of the following:
• anticoagulant medicines which thin the blood
(e.g. warfarin, coumarin).
• medicines that control pain or lower
inflammation, such as aspirin or similar
non-steroidal anti-inflammatory drugs
(NSAIDs), such as indometacin,
hydrocortisone, cortisone and other
corticosteroids. You should be carefully
monitored if you are taking NSAIDs at the
same time as taking Dexamethasone because
you are more likely to get stomach or gut
ulcers.
• medicines used to treat diabetes such as
insulin, metformin or sulfonylureas such as
chlorpropamide
• medicines used to treat high blood pressure
such as captopril or verapamil
• diuretics (water tablets)
• amphotericin B injection (used to treat
infections)
• phenytoin, carbamazepine, (epilepsy
medication)
• rifabutin, rifampicin (antibiotics used to treat
tuberculosis)
• antacids or charcoal. You should leave at least
two hours between taking these medicines and
dexamethasone
• barbiturates (medication used to aid sleep and
relieve anxiety and also for epilepsy)
• aminoglutethimide (anti-cancer treatment)
• carbenoxolone (used in the treatment of
stomach ulcers)
• ephedrine (nasal decongestant)
• acetazolamide (used for glaucoma and
epilepsy)
• ketoconazole (for fungal infections)
• medicines for HIV: ritonavir, cobicistat
• antibiotics including erythromycin
• colestyramine (for high cholesterol levels)
• estrogen hormones including the
contraceptive pill
• tetracosactide (used in the test for
adrenocortical function)
• sultopride (used to calm emotions)
• ciclosporin (used to prevent rejection after
transplants)
• thalidomide (anti-cancer treatment and
leprosy)
• praziquantel (given for certain worm
infections)
• isoniazid for tuberculosis
• live vaccines such as MMR, tuberculosis,
yellow fever or oral typhoid
• medicines to treat viral infections and HIV
such as indinavir and saquinavir
• medicines that help muscle movement in
myasthenia gravis, such as neostigmine.
• methotrexate used for cancer or
inflammatory problems.
If you are not sure if any of the above applies
to you, talk to your doctor or pharmacist before
taking Glensoludex.
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice if you
are pregnant, planning to get pregnant or breastfeeding.
Glensoludex soluble tablets should only be
prescribed during pregnancy, particularly in
the first trimester, if the benefit outweighs the
risks for the mother and child. If you become
pregnant during the use of the product, do not
stop using it, but tell your doctor immediately
that you are pregnant.
Glensoludex is excreted in breast milk. It may
influence the growth of your baby or cause other
unwanted effects. Tell your doctor if you intend
to breast-feed while taking Glensoludex.
Driving and using machines
You may experience dizziness when taking this
medicine (see section 4: Possible side effects).
This may affect your ability to drive. If this
happens, do not drive or use tools or machinery.

Important information about some of the
ingredients of Glensoludex soluble tablets
Glensoludex soluble tablets 2 mg contains 14.96
mg of sodium per tablet. Glensoludex soluble
tablets 4 mg contains 29.95 mg of sodium per
tablet. Glensoludex soluble tablets 8 mg contains
60.5 mg of sodium per tablet. This should
be taken into consideration by patients on a
controlled sodium diet.
Glensoludex contains Yellow Sunset (E110).
This colouring agent may cause allergic
reactions.
3. How to take Glensoludex soluble tablets

Glensoludex soluble tablets are only to be taken
by mouth. Your doctor will prescribe the most
appropriate dose to treat your condition.
The tablets should be taken as a drink after
dissolving them in a glass of water. Take your
tablets as a single dose each morning, unless
your doctor has told you otherwise.
Always take this medicine exactly as your doctor
has told you. These instructions will have been
added to the dispensing label by your pharmacist.
You should check with your doctor or pharmacist
if you are not sure.
The recommended dose is:
Adults:
The usual dose of Glensoludex is 0.5 mg to 10
mg each day. If your doctor wishes you to take
less than 2 mg per day, you will be prescribed a
different dexamethasone product.
Children: a single dose on alternate days.
If Glensoludex soluble tablets are being given to
you as part of some hospital tests, the dose given
will be 2 mg, for a short period of time.
Important: If you are unsure how much medicine
to take, please contact your doctor or pharmacist
for advice.
Do not exceed or take less than the stated dose.
Do not take it more or less often than prescribed.
If you take more Glensoludex soluble tablets
than you should
If you take too much medicine contact a doctor
or hospital immediately.
If you forget to take Glensoludex soluble
tablets
If you forget to take a dose, take it as soon as you
remember unless it is almost time for the next
dose.
Do not take a double dose to make up for a
forgotten dose.
If you stop taking Glensoludex soluble tablets
It can be dangerous to stop taking this medicine
abruptly. The symptoms that have been reported
when treatment has been stopped too quickly
include low blood pressure and sometimes,
relapse of the disease for which the medicine
was given. A ‘withdrawal syndrome’ may also
occur which includes fever, muscle and joint
pain, inflammation of the nose lining (rhinitis),
weight loss, itchy skin and inflammation of the
eye (conjunctivitis). If your treatment is to be
stopped follow your doctor’s advice. He/she
may tell you to reduce the amount of medicine
you are taking gradually until you stop taking it
altogether.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. Possible side effects

Like all medicines, this medicine can cause sideeffects, although not everybody gets them.
Serious side effects, tell a doctor straight
away if you experience serious mental health
problems. They can affect people taking
medicines like dexamethasone. These problems
include:
• feeling depressed, including thinking about
suicide
• feeling high (mania) or moods that go up and
down

• feeling anxious or irritable, having problems
sleeping, difficulty in thinking or being
confused and losing your memory
• feeling, seeing or hearing things that do
not exist. Having strange and frightening
thoughts, changing how you act or having
feelings of being alone.
Talk to your doctor immediately or go to
hospital straight away if you experience any
of the following side effects as they are signs of
an allergic reaction:
• any kind of skin rash, flaking skin, boils or
sore lips and mouth
• sudden wheezing, fluttering or tightness of
the chest or collapse.
• puffy, swollen face, tongue or body, which
may cause shortness of breath, shock and
collapse.
Other side effects may include:
• mental health problems: a feeling of
dependence, severe unusual headache with
visual problems usually in children (normally
after treatment has been stopped), worsening
of schizophrenia (where you may sense,
see or hear things that do not exist, become
withdrawn or have mistaken beliefs or
suspicions)
• stomach and bowel problems: nausea,
vomiting, hiccups, increased appetite,
stomach discomfort, swollen abdomen,
bloating, inflammation and ulcers in the
oesophagus, heartburn, stomach ulcers that
may bleed, inflamed pancreas (causing pain in
the back and abdomen), tearing of the bowel
particularly if you have inflammatory bowel
disease, unusual fat deposits
• metabolism and problems with salt levels:
weight gain, salt imbalances, water retention
in the body, potassium loss due to low carbon
dioxide levels (hypokalaemic alkalosis),
loss of protein and calcium balance, unmask
diabetes symptoms, increased need for
diabetic medication, increased cholesterol
levels
• heart and blood problems: blood clots
(signs of this may include redness, pain or
numbness, throbbing, a burning feeling or
swelling), congestive heart failure in people
who are likely to have heart problems,
heart muscle rupture (especially if you have
recently had a heart attack), high blood
pressure, raised or lowered levels of red
and white blood cells, inflammation and
thickening of the veins or arteries
• muscle, bone and skin problems: thinning of
the bones with an increased risk of fractures,
also hip, arm and leg bone problems, ruptured
tendons, muscle wasting, weakness. excess
body hair (particularly in women), slow
wound healing, thinned delicate skin, unusual
marks on the skin, bruising, redness and
inflammation of the skin, stretch marks,
visible swollen capillaries, acne, increased
sweating, impaired reaction to skin tests, skin
rash, thinning of the hair
• immune system problems: greater chance
of picking up infections, recurrence of
tuberculosis if you have already had it, blood
disorders due to infection. You may also get
thrush
• eye problems: cataracts, increased pressure
in the eye, swelling of the eye, thinning of the
eye membranes, worsening of existing eye
infections, protrusion of the eyeballs, visual
disturbances, loss of vision, blurred vision
• reproductive system problems: irregular or
lack of menstruation (periods), impotence
• hormonal problems: impairment of the
body’s regulation of hormones, slow growth
in children and teenagers, swelling and weight
gain of the body and face (Cushingoid state)
• nervous system problems: fits and
worsening of epilepsy, dizziness, headache

• o ther general effect: While taking
Glensoludex your body may not be able
to respond normally to severe stress such
as accidents, surgery or illness withdrawal
effects (fever, muscle and joint pain,
inflammation of the eye or nose, itchy skin
and weight loss). It may make you feel
generally unwell. If you are a man, this
medicine can affect the amount of sperm and
their movement.
If you get any side effects, talk to your doctor
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 Glensoludex soluble tablets

Keep this medicine out of the sight and reach of
children.
This medicinal product does not require any
special temperature storage conditions.
Store in the original package.
Do not use this medicine after the expiry date
printed on the bottle label and carton after EXP.
The expiry date means the last day of that month.
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 Glensoludex soluble tablets contain
The active substance is dexamethasone.
Each 2 mg tablet contains 2 mg of
dexamethasone (as dexamethasone sodium
phosphate).
Each 4 mg tablet contains 4 mg of
dexamethasone (as dexamethasone sodium
phosphate).
Each 8 mg tablet contains 8 mg of
dexamethasone (as dexamethasone sodium
phosphate).
The other ingredients are: sodium bicarbonate,
disodium citrate 1.5 hydrate, povidone K 30,
sodium saccharin, sodium benzoate, yellow
sunset (E110).
What Glensoludex soluble tablets look like
and contents of the pack
Glensoludex 2 mg soluble tablets are salmon,
oblong tablets
Glensoludex 4 mg soluble tablets are salmon,
biconvex, round tablets
Glensoludex 8 mg soluble tablets are salmon,
biconvex, engraved ‘8’, round tablets
Glensoludex soluble tablets are available in
blisters containing 10, 30, 50 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2B Draycott Avenue
Kenton, Middlesex
HA3 0BU
United Kingdom
Manufacturer
RAFARM S.A.
Thesi Pousi-Xatzi, Agiou Louka, Paiania, Attiki,
TK 19002, Greece
This leaflet was last revised in 06/2017

PRODUCT :

Amends :

Glensoludex /Dexamethasone
2 mg, 4 mg and 8 mg soluble
tablets ALL UK

Cutter Guide
Black

Times New Roman ALL 9 pts
body copy (min)

24.7.17

Internal proof approval
Signed (digitally)

GC

GM0150

Artwork Signoff(digitally):

2.5.14
Leaflet (PIL)
330x350 mm

Approval :

16

Y

Indesign CS 5

External proof approval
Signed (digitally)

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.

Hide