Dexamethasone 4mg tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

Buy It Now

Active ingredient:
Dexamethasone
Available from:
DE Pharmaceuticals
ATC code:
H02AB02
INN (International Name):
Dexamethasone
Dosage:
4mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF:
Authorization number:
PL 33532/0913

PACKAGE LEAFLET: INFORMATION FOR THE USER

Decadron

®

4mg tablets

(dexamethasone)

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 possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Decadron

®

4mg tablets but will be referred

to as Decadron throughout the remainder of this leaflet.

Decadron is also available in other strengths.

What is in this leaflet

1. What Decadron is and what it is used for

2. What you need to know before you take Decadron

3. How to take Decadron

4. Possible side effects

5. How to store Decadron

6. Contents of the pack and other information

1. WHAT DECADRON IS AND WHAT IT IS USED FOR

Decadron is a synthetic glucocorticoid. Glucocorticoids are hormones

produced by the cortex of adrenal glands. The medicine has

anti-inflammatory, analgesic and anti-allergic effects, and suppresses the

immune system.

Decadron is recommended for the treatment of rheumatic and autoimmune

diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, juvenile

idiopathic arthritis, polyarthritis nodosa), diseases of respiratory tract (e.g.

bronchial asthma, croup), skin (e.g. erythroderma, pemphigus vulgaris),

tuberculous meningitis only in conjunction with anti-infective therapy,

diseases of blood (e.g. idiopathic thrombocytopenic purpura in adults),

cerebral oedema, treatment of symptomatic multiple myeloma, acute

lymphoblastic leukemia, Hodgkin’s disease and non-Hodgkin’s lymphoma in

combination with other medicinal products, palliative treatment of neoplastic

diseases, prophylaxis and treatment of nausea and vomiting caused by

chemotherapy and prevention and treatment of vomiting after operation,

within antiemetic treatment.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DECADRON

Do not take Decadron:

if you are allergic to dexamethasone or any of the other ingredients of this

medicine (listed in section 6).

if you have an infection that affects the whole body (unless you are

receiving treatment).

if you have a stomach or duodenal ulcer.

if you are going to have a vaccination by live vaccines.

Warnings and precautions

Talk to your doctor or pharmacist before taking Decadron:

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.

Mental health problems can happen while taking steroids like Decadron.

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 kidney or liver problems (liver cirrhosis or chronic liver failure),

you have a tumour of the adrenal gland (pheochromocytoma),

you have high blood pressure, heart disease or you have recently had a

heart attack (myocardial rupture has been reported),

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 from muscle weakness with this or other steroids in the

past,

you have glaucoma (raised eye pressure) or there is a family history of

glaucoma, cataract (clouding of the lens in the eye leading to a decrease

in vision),

you have myasthenia gravis (a condition causing weak muscles),

you have a bowel disorder or a stomach (peptic) 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 migraine,

you have an underactive thyroid gland,

you have a parasitic infection,

you have tuberculosis, septicaemia or a fungal infection in the eye,

you have cerebral malaria,

you have herpes (cold sores or genital herpes and ocular herpes simplex

because of possible corneal perforation),

you have asthma,

you are treated for a blockage of blood vessels by blood clots

(thromboembolism),

you have corneal ulcerations and corneal injuries.

Treatment with corticosteroid may reduce your body’s ability to fight

infection. This can sometimes lead to infections caused by germs that rarely

cause infection under normal circumstances (called opportunistic

infections). If you get an infection of any kind during treatment with this

medicine, contact your doctor immediately. This is particularly important if

you notice signs of pneumonia: cough, fever, shortness of breath and chest

pain. You may also feel confused, particularly if you are elderly. You should

also tell your doctor if you have had tuberculosis or if you have stayed in

regions where roundworm infections are common.

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 of any vaccinations.

You should tell your doctor if you have any 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.

Contact your doctor if you experience blurred vision or other visual

disturbances.

Treatment with this medicine may cause central serous chorioretinopathy,

an eye disease that leads to blurred or distorted vision. This happens

usually in one of the eyes.

Treatment with this medicine may cause tendon inflammation. In extremely

rare cases, a tendon may rupture. This risk is increased by treatment with

certain antibiotics and by kidney problems. Contact your doctor if you notice

painful, stiff or swollen joints or tendons.

Treatment with Decadron can cause a condition called adrenocortical

insufficiency. This can cause change in effectiveness of the medicine

following stress and trauma, surgery, childbirth or illness and your body may

not be able to respond in the usual way to severe stress such as accidents,

surgery, childbirth or illness.

If you have an accident, are ill, have other specific physical stress

conditions, or require any surgery (even at the dentists) or you require a

vaccination (particularly with ‘live virus’ vaccines) whilst taking or when you

have finished taking Decadron, you should inform the person treating you

that you are taking or have taken steroids.

If you have suppression tests (test for the amount of hormone in the body),

skin test for allergy or test for bacterial infection you should inform the

person performing the test that you are taking dexamethasone as it may

interfere with the results.

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 are elderly, some of the side effects of this medicine may be more

serious, especially thinning of the bones (osteoporosis), high blood

pressure, low potassium levels, diabetes, susceptibility to infection and

thinning of the skin. Your doctor will monitor you more closely.

Children

If a child is taking this medicine, it is important that the doctor monitors their

growth and development at frequent intervals. Decadron should not be used

routinely in preterm neonates with respiratory problems.

Other medicines and Decadron

Tell your doctor or pharmacist if you are taking, have recently taken or

might take any other medicines:

Anticoagulant medicines which thin the blood (e.g. warfarin)

Acetylsalicylic acid or similar (Non-Steroidal Anti-Inflammatory drugs) e.g.

indomethacin

Medicines used to treat diabetes

Medicines used to treat high blood pressure

Medicines used to treat cardiac diseases

Diuretics (water tablets)

Amphotericin B injection

Phenytoin, carbamazepine, primidone (epilepsy medication)

Rifabutin, rifampicin, isoniazid (antibiotics used to treat tuberculosis)

Antacids – particularly those containing magnesium trisilicate

Barbiturates (medication used to aid sleep and relieve anxiety)

Aminoglutethimide (anti-cancer treatment)

Carbenoxolone (used in the treatment of stomach ulcers)

Ephedrine (nasal decongestant)

Acetazolamide (used for glaucoma and epilepsy)

Hydrocortisone, cortisone and other corticosteroids

Ketoconazole, itraconazole (for fungal infections)

Ritonavir (for HIV)

Antibiotics including erythromycin, fluoroquinolones

Medicines that help muscle movement in myasthenia gravis (e.g.

neostigmine)

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 used for e.g. multiple myeloma

Praziquantel given for certain worm infections

Vaccination with live vaccines

Chloroquine, hydroxychloroquine and mefloquine (for malaria)

Somatotropin

Protirelin

Please tell your doctor if you are taking or have recently taken any

other medicines, including medicines obtained without a prescription.

You may be at an increased risk of serious side effects if you take

dexamethasone together with these medicines:

Some medicines may increase the effects of Decadron and your doctor

may wish to monitor you carefully if you are taking these medicines

(including some medicines for HIV: ritonavir, cobicistat)

Acetylsalicylic acid or similar (Non-Steroidal Anti-Inflammatory drugs) e.g.

indometacin

Medicines used to treat diabetes

Medicines used to treat cardiac diseases

Diuretics (water tablets)

Amphotericin B injection

Acetazolamide (used for glaucoma and epilepsy)

Tetracosactide used in the test for adrenocortical function

Carbenoxolone (used in the treatment of stomach ulcers)

Chloroquine, hydroxychloroquine and mefloquine (for malaria)

Medicines used to treat high blood pressure

Thalidomide used for e.g. multiple myeloma

Vaccination with live vaccines

Medicines that help muscle movement in myasthenia gravis (e.g.

neostigmine)

Antibiotics including fluoroquinolones

You must read the package leaflets of all medicinal products to be

taken in combination with Decadron for information related to these

medicines before starting treatment with Decadron. When thalidomide,

lenalidomide or pomalidomide is used, particular attention to

pregnancy testing and prevention requirements is needed.

Decadron with food, drink and alcohol

Decadron should be taken with or after food to minimise irritation to the

gastrointestinal tract. Drinks containing alcohol or caffeine should be

avoided. Eating small, frequent meals is recommended, and possibly taking

of antacids, if recommended by your doctor.

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.

Decadron should be prescribed during pregnancy and particularly in the first

trimester only 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

Decadron, but tell your doctor immediately that you are pregnant.

Corticosteroids may pass into breast milk. A risk to the newborns/infants

cannot be excluded. A decision on whether to continue/discontinue breast

feeding or to continue/discontinue therapy with dexamethasone should be

made taking into account the benefit of breast feeding to the child and the

benefit of dexamethasone therapy to the woman.

Driving and using machines

Do not drive, use any tools or machines or carry out any hazardous tasks if

you experience side effects, such as confusion, hallucinations, dizziness,

tiredness, sleepiness, fainting or blurred vision.

Decadron contains lactose

If you have been told by your doctor that you have an intolerance to some

sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE DECADRON

Always take this medicine exactly as your doctor has told you.

Check with your doctor or pharmacist if you are not sure.

Decadron is in the form of tablets 4mg, 8mg, 20mg and 40mg. The tablet

can be divided into equal halves to provide additional 2mg and 10mg

strengths or to help swallowing.

Decadron is given in usual doses of 0.5 to 10mg daily, depending on the

disease being treated. In more severe disease conditions doses above

10mg per day may be required. The dose should be titrated to the individual

patient response and disease severity. In order to minimize side effects, the

lowest effective possible dose should be used.

Unless otherwise prescribed, the following dosage recommendations

apply:

The below mentioned dosing recommendations are given for guidance

only. The initial and daily doses should always be determined based

on individual patient response and disease severity.

Cerebral oedema: Initial dose and duration of treatment depending on

the cause and severity, 6-16mg (up to 24mg)/day orally, divided into 3-4

individual doses.

Acute asthma: Adults: 16mg/day for two days. Children: 0.6mg/kg body

weight for one or two days.

Croup: Children: 0.15mg/kg - 0.6mg/kg in a single dose.

Acute skin diseases: Depending on the nature and extent of the

disease daily doses of 8-40mg, in some cases up to 100mg, which

should be followed by down titration according to clinical need.

Active phase of rheumatic system disorders: Systemic lupus

erythematosus 6-16mg/day.

Active rheumatoid arthritis with severe progressive course form:

running at fast destructive forms 12-16mg/day, with extra-articular

manifestations 6-12mg/day.

Idiopathic thrombocytopenic purpura: 40mg for 4 days in cycles.

Tuberculous meningitis: Patients with grade II or III disease received

intravenous treatment for four weeks (0.4mg per kilogram per day for

week 1, 0.3mg per kilogram per day for week 2, 0.2mg per kilogram per

day for week 3, and 0.1mg per kilogram per day for week 4) and then oral

treatment for four weeks, starting at a total of 4mg per day and

decreasing by 1mg each week. Patients with grade I disease received

two weeks of intravenous therapy (0.3mg per kilogram per day for week 1

and 0.2mg per kilogram per day for week 2) and then four weeks of oral

therapy (0.1mg per kilogram per day for week 3, then a total of 3mg per

day, decreasing by 1mg each week).

Palliative treatment of neoplastic diseases: Initial dose and duration of

treatment depending on the cause and severity, 3-20mg/day. Very high

doses up to 96mg may also be used for palliative treatment. For optimal

dosing and reduction of the number or tablets the combination of lower

dose strengths (4 and 8mg) and higher dose strengths (20mg or 40mg)

can be used.

Prophylaxis and treatment of emesis induced by cytostatics,

emetogenic chemotherapy within antiemetic treatment: 8-20mg

dexamethasone prior to chemotherapy treatment, then 4-16mg/day on

day 2 and 3.

Prevention and treatment of postoperative vomiting, within

antiemetic treatment: single dose of 8mg before the surgery.

Treatment of symptomatic multiple myeloma, acute lymphoblastic

leukemia, Hodgkin’s disease and non-Hodgkin’s lymphoma in

combination with other medicinal products: the usual posology is

40mg or 20mg once per day.

The dose and administration frequency varies with the therapeutic protocol

and the associated treatment(s). Decadron administration should follow

instructions for dexamethasone administration when described in the

Summary of Product Characteristics of the associated treatment(s). If this is

not the case, local or international treatment protocols and guidelines

should be followed. Prescribing physicians should carefully evaluate which

dose of dexamethasone to use, taking into account the condition and

disease status of the patient.

Long-term treatment

For the long-term treatment of several conditions, after initial therapy,

glucocorticoid treatment should be switched from dexamethasone to

prednisone/prednisolone to reduce suppression on the function of the

adrenal cortex.

Use in children

If a child is taking this medicine, it is important that the doctor monitors their

growth and development at frequent intervals.

If you take more Decadron than you should

If you take too much medicine contact a doctor or hospital immediately.

If you forget to take Decadron

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 tablet.

If you stop taking Decadron

If your treatment is to be stopped follow your doctor’s advice. He may tell

you to reduce the amount of medicine you are taking gradually until you

stop taking it altogether. The symptoms that have been reported when

treatment has been stopped too quickly have included low blood pressure

and in some cases, relapse of the disease for which the treatment 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 you stop treatment too soon

and some of the mentioned symptoms occur, you must talk to your doctor

as soon as possible.

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 side effects, although not

everybody gets them.

Tell a doctor straight away if you experience serious mental health

problems. They can affect about 5 in every 100 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, 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.

Tell a doctor straight away if you experience:

severe abdominal pains, nausea, vomiting, diarrhoea, profound muscle

weakness and fatigue, extremely low blood pressure, weight loss and

fever as these may be signs of adrenocortical insufficiency;

sudden abdominal pain, tenderness, nausea, vomiting, fever and blood in

stool as these may be signs of tearing of the bowel particularly if you

have or have had a bowel disease.

This medicine may worsen your existing heart problem. If you experience

shortness of breath or ankle swelling, consult your doctor straight away.

Other side effects may be (frequency not known):

Greater chance of picking up infections, including viral and fungal

infections e.g. thrush; recurrence of tuberculosis or some other infections,

e.g. eye infections if you have already had it

Reduction in the number of white blood cells or increased number of

white blood cells, abnormal coagulation

An allergic reaction to the medicine, including serious, potentially

life-threatening allergic reaction (which may show as a rash and swelling

of the throat or tongue and in severe cases difficulty in breathing or

dizziness)

Impairment of the body’s regulation of hormones, swelling and weight

gain of the body, full-moon face (Cushingoid state), change in

effectiveness of endocrines following stress and trauma, surgery,

childbirth or illness, your body may not be able to respond in the usual

way to severe stress such as accidents, surgery, childbirth or illness,

stunted growth in children and teenagers, irregular and absence of

menstrual cycles (periods) development of excess body hair (particularly

in women)

Weight gain, loss of protein and calcium balance, increased appetite, salt

imbalances, water retention in the body, potassium loss which can cause

rhythm disorder, increased requirement for diabetic medication, unknown

diabetes becomes evident, high levels of cholesterol and triglycerides in

the blood (hypercholesterolemia and hypertriglyceridaemia)

Extreme mood swings, schizophrenia (mental disorder) may become

worse, depression, inability to sleep

Severe unusual headache with visual disturbances linked with the

withdrawal of treatment, fits and worsening of epilepsy, dizziness

Increased pressure in the eye, papilloedema, thinning of the eye

membranes, increased eye viral, fungal and bacterial infections,

worsening of symptoms associated with corneal ulcers, worsening of

existing eye infections, protrusion of the eyeballs, cataracts, visual

disturbances, loss of vision, blurred vision

Congestive heart failure in susceptible people, cardiac muscle rupture

after a recent heart attack, cardiac decompensation

High blood pressure, blood clots: formation of blood clots that may clog

blood vessels for example in legs or lungs (thromboembolic

complications)

Hiccups

Nausea, vomiting, stomach discomfort and swollen abdomen,

inflammation and ulcers in the oesophagus, peptic ulcers that may split

and bleed, inflamed pancreas (which may show as pain in the back and

abdomen), flatulence, oesophageal candidiasis

Thinned delicate skin, unusual marks on the skin, bruising, redness and

inflammation of the skin, stretch marks, visible swollen, capillaries, acne,

increased sweating, skin rash, swelling, thinning of the hair, unusual fat

deposits, excessive hair growth, water retaining in the body, pigment

disorders, weakened capillaries that rupture easily, observed as bleeding

under the skin (increased capillary fragility), skin irritation around the

mouth (perioral dermatitis)

Thinning of the bone with an increased risk of fractures (osteoporosis),

bone necrosis, tendinitis, ruptured tendons, muscle wasting, myopathy,

muscle weakness, early stoppage of bone growth (premature epiphyseal

closure)

Changes to the number and movement of sperm, impotence

Impaired reaction to vaccination and skin tests, slow wound healing,

discomfort, malaise

A ‘withdrawal syndrome’ may also occur which includes fever, muscle

and joint pain, inflammation of the nose lining (rhinitis), weight loss,

painful itchy skin nodules and inflammation of the eye (conjunctivitis).

Reporting of side effects

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 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 DECADRON

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the

packaging after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage

conditions.

Store in the original package in order to protect from light and moisture.

If your medicine becomes discoloured or shows any sign of deterioration,

return it to your pharmacist.

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 protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Decadron contains

Each tablet contains 4mg dexamethasone.

Also contains: lactose monohydrate, pregelatinised maize starch, colloidal

anhydrous silica and magnesium stearate (E470b).

What Decadron looks like and contents of the pack

White or almost white, round tablets with bevelled edges and scored on one

side. The tablet can be divided into equal doses.

Decadron 4mg tablets are available in boxes containing 10, 30, 50 and 100

tablets in blisters.

Manufactured by

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia.

Procured from within the EU by the Product Licence Holder:

MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way,

Aldridge, Walsall WS9 8ER.

Repackaged by MPT Pharma Ltd.

PL 33532/0913

Leaflet dated 20

June 2019

Leaflet coded xxxxxxxxxx

Decadron

is a registered trademark of Acre Pharma Limited.

request a copy of this leaflet in

Braille, large print or audio please call

01922 745645 and ask for the

Regulatory Department.

POM

PACKAGE LEAFLET: INFORMATION FOR THE USER

Dexamethasone 4mg tablets

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 possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Dexamethasone 4mg tablets but will be

referred to as Dexamethasone throughout the remainder of this leaflet.

Dexamethasone is also available in other strengths.

What is in this leaflet

1. What Dexamethasone is and what it is used for

2. What you need to know before you take Dexamethasone

3. How to take Dexamethasone

4. Possible side effects

5. How to store Dexamethasone

6. Contents of the pack and other information

1. WHAT DEXAMETHASONE IS AND WHAT IT IS USED FOR

Dexamethasone is a synthetic glucocorticoid. Glucocorticoids are hormones

produced by the cortex of adrenal glands. The medicine has

anti-inflammatory, analgesic and anti-allergic effects, and suppresses the

immune system.

Dexamethasone is recommended for the treatment of rheumatic and

autoimmune diseases (e.g. systemic lupus erythematosus, rheumatoid

arthritis, juvenile idiopathic arthritis, polyarthritis nodosa), diseases of

respiratory tract (e.g. bronchial asthma, croup), skin (e.g. erythroderma,

pemphigus vulgaris), tuberculous meningitis only in conjunction with

anti-infective therapy, diseases of blood (e.g. idiopathic thrombocytopenic

purpura in adults), cerebral oedema, treatment of symptomatic multiple

myeloma, acute lymphoblastic leukemia, Hodgkin’s disease and

non-Hodgkin’s lymphoma in combination with other medicinal products,

palliative treatment of neoplastic diseases, prophylaxis and treatment of

nausea and vomiting caused by chemotherapy and prevention and

treatment of vomiting after operation, within antiemetic treatment.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE

DEXAMETHASONE

Do not take Dexamethasone:

if you are allergic to dexamethasone or any of the other ingredients of this

medicine (listed in section 6).

if you have an infection that affects the whole body (unless you are

receiving treatment).

if you have a stomach or duodenal ulcer.

if you are going to have a vaccination by live vaccines.

Warnings and precautions

Talk to your doctor or pharmacist before taking Dexamethasone:

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.

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 kidney or liver problems (liver cirrhosis or chronic liver failure),

you have a tumour of the adrenal gland (pheochromocytoma),

you have high blood pressure, heart disease or you have recently had a

heart attack (myocardial rupture has been reported),

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 from muscle weakness with this or other steroids in the

past,

you have glaucoma (raised eye pressure) or there is a family history of

glaucoma, cataract (clouding of the lens in the eye leading to a decrease

in vision),

you have myasthenia gravis (a condition causing weak muscles),

you have a bowel disorder or a stomach (peptic) 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 migraine,

you have an underactive thyroid gland,

you have a parasitic infection,

you have tuberculosis, septicaemia or a fungal infection in the eye,

you have cerebral malaria,

you have herpes (cold sores or genital herpes and ocular herpes simplex

because of possible corneal perforation),

you have asthma,

you are treated for a blockage of blood vessels by blood clots

(thromboembolism),

you have corneal ulcerations and corneal injuries.

Treatment with corticosteroid may reduce your body’s ability to fight

infection. This can sometimes lead to infections caused by germs that rarely

cause infection under normal circumstances (called opportunistic

infections). If you get an infection of any kind during treatment with this

medicine, contact your doctor immediately. This is particularly important if

you notice signs of pneumonia: cough, fever, shortness of breath and chest

pain. You may also feel confused, particularly if you are elderly. You should

also tell your doctor if you have had tuberculosis or if you have stayed in

regions where roundworm infections are common.

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 of any vaccinations.

You should tell your doctor if you have any 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.

Contact your doctor if you experience blurred vision or other visual

disturbances.

Treatment with this medicine may cause central serous chorioretinopathy,

an eye disease that leads to blurred or distorted vision. This happens

usually in one of the eyes.

Treatment with this medicine may cause tendon inflammation. In extremely

rare cases, a tendon may rupture. This risk is increased by treatment with

certain antibiotics and by kidney problems. Contact your doctor if you notice

painful, stiff or swollen joints or tendons.

Treatment with Dexamethasone can cause a condition called adrenocortical

insufficiency. This can cause change in effectiveness of the medicine

following stress and trauma, surgery, childbirth or illness and your body may

not be able to respond in the usual way to severe stress such as accidents,

surgery, childbirth or illness.

If you have an accident, are ill, have other specific physical stress

conditions, or require any surgery (even at the dentists) or you require a

vaccination (particularly with ‘live virus’ vaccines) whilst taking or when you

have finished taking Dexamethasone, you should inform the person treating

you that you are taking or have taken steroids.

If you have suppression tests (test for the amount of hormone in the body),

skin test for allergy or test for bacterial infection you should inform the

person performing the test that you are taking dexamethasone as it may

interfere with the results.

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 are elderly, some of the side effects of this medicine may be more

serious, especially thinning of the bones (osteoporosis), high blood

pressure, low potassium levels, diabetes, susceptibility to infection and

thinning of the skin. Your doctor will monitor you more closely.

Children

If a child is taking this medicine, it is important that the doctor monitors their

growth and development at frequent intervals. Dexamethasone should not

be used routinely in preterm neonates with respiratory problems.

Other medicines and Dexamethasone

Tell your doctor or pharmacist if you are taking, have recently taken or

might take any other medicines:

Anticoagulant medicines which thin the blood (e.g. warfarin)

Acetylsalicylic acid or similar (Non-Steroidal Anti-Inflammatory drugs) e.g.

indomethacin

Medicines used to treat diabetes

Medicines used to treat high blood pressure

Medicines used to treat cardiac diseases

Diuretics (water tablets)

Amphotericin B injection

Phenytoin, carbamazepine, primidone (epilepsy medication)

Rifabutin, rifampicin, isoniazid (antibiotics used to treat tuberculosis)

Antacids – particularly those containing magnesium trisilicate

Barbiturates (medication used to aid sleep and relieve anxiety)

Aminoglutethimide (anti-cancer treatment)

Carbenoxolone (used in the treatment of stomach ulcers)

Ephedrine (nasal decongestant)

Acetazolamide (used for glaucoma and epilepsy)

Hydrocortisone, cortisone and other corticosteroids

Ketoconazole, itraconazole (for fungal infections)

Ritonavir (for HIV)

Antibiotics including erythromycin, fluoroquinolones

Medicines that help muscle movement in myasthenia gravis (e.g.

neostigmine)

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 used for e.g. multiple myeloma

Praziquantel given for certain worm infections

Vaccination with live vaccines

Chloroquine, hydroxychloroquine and mefloquine (for malaria)

Somatotropin

Protirelin

Please tell your doctor if you are taking or have recently taken any

other medicines, including medicines obtained without a prescription.

You may be at an increased risk of serious side effects if you take

dexamethasone together with these medicines:

Some medicines may increase the effects of Dexamethasone and your

doctor may wish to monitor you carefully if you are taking these

medicines (including some medicines for HIV: ritonavir, cobicistat)

Acetylsalicylic acid or similar (Non-Steroidal Anti-Inflammatory drugs) e.g.

indometacin

Medicines used to treat diabetes

Medicines used to treat cardiac diseases

Diuretics (water tablets)

Amphotericin B injection

Acetazolamide (used for glaucoma and epilepsy)

Tetracosactide used in the test for adrenocortical function

Carbenoxolone (used in the treatment of stomach ulcers)

Chloroquine, hydroxychloroquine and mefloquine (for malaria)

Medicines used to treat high blood pressure

Thalidomide used for e.g. multiple myeloma

Vaccination with live vaccines

Medicines that help muscle movement in myasthenia gravis (e.g.

neostigmine)

Antibiotics including fluoroquinolones

You must read the package leaflets of all medicinal products to be

taken in combination with Dexamethasone for information related to

these medicines before starting treatment with Dexamethasone. When

thalidomide, lenalidomide or pomalidomide is used, particular

attention to pregnancy testing and prevention requirements is needed.

Dexamethasone with food, drink and alcohol

Dexamethasone should be taken with or after food to minimise irritation to

the gastrointestinal tract. Drinks containing alcohol or caffeine should be

avoided. Eating small, frequent meals is recommended, and possibly taking

of antacids, if recommended by your doctor.

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.

Dexamethasone should be prescribed during pregnancy and particularly in

the first trimester only 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 Dexamethasone, but tell your doctor immediately that you are

pregnant.

Corticosteroids may pass into breast milk. A risk to the newborns/infants

cannot be excluded. A decision on whether to continue/discontinue breast

feeding or to continue/discontinue therapy with dexamethasone should be

made taking into account the benefit of breast feeding to the child and the

benefit of dexamethasone therapy to the woman.

Driving and using machines

Do not drive, use any tools or machines or carry out any hazardous tasks if

you experience side effects, such as confusion, hallucinations, dizziness,

tiredness, sleepiness, fainting or blurred vision.

Dexamethasone contains lactose

If you have been told by your doctor that you have an intolerance to some

sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE DEXAMETHASONE

Always take this medicine exactly as your doctor has told you.

Check with your doctor or pharmacist if you are not sure.

Dexamethasone is in the form of tablets 4mg, 8mg, 20mg and 40mg. The

tablet can be divided into equal halves to provide additional 2mg and 10mg

strengths or to help swallowing.

Dexamethasone is given in usual doses of 0.5 to 10mg daily, depending on

the disease being treated. In more severe disease conditions doses above

10mg per day may be required. The dose should be titrated to the individual

patient response and disease severity. In order to minimize side effects, the

lowest effective possible dose should be used.

Unless otherwise prescribed, the following dosage recommendations

apply:

The below mentioned dosing recommendations are given for guidance

only. The initial and daily doses should always be determined based

on individual patient response and disease severity.

Cerebral oedema: Initial dose and duration of treatment depending on

the cause and severity, 6-16mg (up to 24mg)/day orally, divided into 3-4

individual doses.

Acute asthma: Adults: 16mg/day for two days. Children: 0.6mg/kg body

weight for one or two days.

Croup: Children: 0.15mg/kg - 0.6mg/kg in a single dose.

Acute skin diseases: Depending on the nature and extent of the

disease daily doses of 8-40mg, in some cases up to 100mg, which

should be followed by down titration according to clinical need.

Active phase of rheumatic system disorders: Systemic lupus

erythematosus 6-16mg/day.

Active rheumatoid arthritis with severe progressive course form:

running at fast destructive forms 12-16mg/day, with extra-articular

manifestations 6-12mg/day.

Idiopathic thrombocytopenic purpura: 40mg for 4 days in cycles.

Tuberculous meningitis: Patients with grade II or III disease received

intravenous treatment for four weeks (0.4mg per kilogram per day for

week 1, 0.3mg per kilogram per day for week 2, 0.2mg per kilogram per

day for week 3, and 0.1mg per kilogram per day for week 4) and then oral

treatment for four weeks, starting at a total of 4mg per day and

decreasing by 1mg each week. Patients with grade I disease received

two weeks of intravenous therapy (0.3mg per kilogram per day for week 1

and 0.2mg per kilogram per day for week 2) and then four weeks of oral

therapy (0.1mg per kilogram per day for week 3, then a total of 3mg per

day, decreasing by 1mg each week).

Palliative treatment of neoplastic diseases: Initial dose and duration of

treatment depending on the cause and severity, 3-20mg/day. Very high

doses up to 96mg may also be used for palliative treatment. For optimal

dosing and reduction of the number or tablets the combination of lower

dose strengths (4 and 8mg) and higher dose strengths (20mg or 40mg)

can be used.

Prophylaxis and treatment of emesis induced by cytostatics,

emetogenic chemotherapy within antiemetic treatment: 8-20mg

dexamethasone prior to chemotherapy treatment, then 4-16mg/day on

day 2 and 3.

Prevention and treatment of postoperative vomiting, within

antiemetic treatment: single dose of 8mg before the surgery.

Treatment of symptomatic multiple myeloma, acute lymphoblastic

leukemia, Hodgkin’s disease and non-Hodgkin’s lymphoma in

combination with other medicinal products: the usual posology is

40mg or 20mg once per day.

The dose and administration frequency varies with the therapeutic protocol

and the associated treatment(s). Dexamethasone administration should

follow instructions for dexamethasone administration when described in the

Summary of Product Characteristics of the associated treatment(s). If this is

not the case, local or international treatment protocols and guidelines

should be followed. Prescribing physicians should carefully evaluate which

dose of dexamethasone to use, taking into account the condition and

disease status of the patient.

Long-term treatment

For the long-term treatment of several conditions, after initial therapy,

glucocorticoid treatment should be switched from dexamethasone to

prednisone/prednisolone to reduce suppression on the function of the

adrenal cortex.

Use in children

If a child is taking this medicine, it is important that the doctor monitors their

growth and development at frequent intervals.

If you take more Dexamethasone than you should

If you take too much medicine contact a doctor or hospital immediately.

If you forget to take Dexamethasone

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 tablet.

If you stop taking Dexamethasone

If your treatment is to be stopped follow your doctor’s advice. He may tell

you to reduce the amount of medicine you are taking gradually until you

stop taking it altogether. The symptoms that have been reported when

treatment has been stopped too quickly have included low blood pressure

and in some cases, relapse of the disease for which the treatment 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 you stop treatment too soon

and some of the mentioned symptoms occur, you must talk to your doctor

as soon as possible.

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 side effects, although not

everybody gets them.

Tell a doctor straight away if you experience serious mental health

problems. They can affect about 5 in every 100 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, 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.

Tell a doctor straight away if you experience:

severe abdominal pains, nausea, vomiting, diarrhoea, profound muscle

weakness and fatigue, extremely low blood pressure, weight loss and

fever as these may be signs of adrenocortical insufficiency;

sudden abdominal pain, tenderness, nausea, vomiting, fever and blood in

stool as these may be signs of tearing of the bowel particularly if you

have or have had a bowel disease.

This medicine may worsen your existing heart problem. If you experience

shortness of breath or ankle swelling, consult your doctor straight away.

Other side effects may be (frequency not known):

Greater chance of picking up infections, including viral and fungal

infections e.g. thrush; recurrence of tuberculosis or some other infections,

e.g. eye infections if you have already had it

Reduction in the number of white blood cells or increased number of

white blood cells, abnormal coagulation

An allergic reaction to the medicine, including serious, potentially

life-threatening allergic reaction (which may show as a rash and swelling

of the throat or tongue and in severe cases difficulty in breathing or

dizziness)

Impairment of the body’s regulation of hormones, swelling and weight

gain of the body, full-moon face (Cushingoid state), change in

effectiveness of endocrines following stress and trauma, surgery,

childbirth or illness, your body may not be able to respond in the usual

way to severe stress such as accidents, surgery, childbirth or illness,

stunted growth in children and teenagers, irregular and absence of

menstrual cycles (periods) development of excess body hair (particularly

in women)

Weight gain, loss of protein and calcium balance, increased appetite, salt

imbalances, water retention in the body, potassium loss which can cause

rhythm disorder, increased requirement for diabetic medication, unknown

diabetes becomes evident, high levels of cholesterol and triglycerides in

the blood (hypercholesterolemia and hypertriglyceridaemia)

Extreme mood swings, schizophrenia (mental disorder) may become

worse, depression, inability to sleep

Severe unusual headache with visual disturbances linked with the

withdrawal of treatment, fits and worsening of epilepsy, dizziness

Increased pressure in the eye, papilloedema, thinning of the eye

membranes, increased eye viral, fungal and bacterial infections,

worsening of symptoms associated with corneal ulcers, worsening of

existing eye infections, protrusion of the eyeballs, cataracts, visual

disturbances, loss of vision, blurred vision

Congestive heart failure in susceptible people, cardiac muscle rupture

after a recent heart attack, cardiac decompensation

High blood pressure, blood clots: formation of blood clots that may clog

blood vessels for example in legs or lungs (thromboembolic

complications)

Hiccups

Nausea, vomiting, stomach discomfort and swollen abdomen,

inflammation and ulcers in the oesophagus, peptic ulcers that may split

and bleed, inflamed pancreas (which may show as pain in the back and

abdomen), flatulence, oesophageal candidiasis

Thinned delicate skin, unusual marks on the skin, bruising, redness and

inflammation of the skin, stretch marks, visible swollen, capillaries, acne,

increased sweating, skin rash, swelling, thinning of the hair, unusual fat

deposits, excessive hair growth, water retaining in the body, pigment

disorders, weakened capillaries that rupture easily, observed as bleeding

under the skin (increased capillary fragility), skin irritation around the

mouth (perioral dermatitis)

Thinning of the bone with an increased risk of fractures (osteoporosis),

bone necrosis, tendinitis, ruptured tendons, muscle wasting, myopathy,

muscle weakness, early stoppage of bone growth (premature epiphyseal

closure)

Changes to the number and movement of sperm, impotence

Impaired reaction to vaccination and skin tests, slow wound healing,

discomfort, malaise

A ‘withdrawal syndrome’ may also occur which includes fever, muscle

and joint pain, inflammation of the nose lining (rhinitis), weight loss,

painful itchy skin nodules and inflammation of the eye (conjunctivitis).

Reporting of side effects

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 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 DEXAMETHASONE

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the

packaging after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage

conditions.

Store in the original package in order to protect from light and moisture.

If your medicine becomes discoloured or shows any sign of deterioration,

return it to your pharmacist.

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 protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Dexamethasone contains

Each tablet contains 4mg dexamethasone.

Also contains: lactose monohydrate, pregelatinised maize starch, colloidal

anhydrous silica and magnesium stearate (E470b).

What Dexamethasone looks like and contents of the pack

White or almost white, round tablets with bevelled edges and scored on one

side. The tablet can be divided into equal doses.

Dexamethasone 4mg tablets are available in boxes containing 10, 30, 50

and 100 tablets in blisters.

Manufactured by

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia.

Procured from within the EU by the Product Licence Holder:

MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way,

Aldridge, Walsall WS9 8ER.

Repackaged by MPT Pharma Ltd.

PL 33532/0913

Leaflet dated 20

June 2019

Leaflet coded xxxxxxxxxx

request a copy of this leaflet in

Braille, large print or audio please call

01922 745645 and ask for the

Regulatory Department.

POM

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