Israel - English - Ministry of Health
The format of this leaflet was set by the ministry of health and its
content was checked and approved by it in March 2014
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The dispensing of the medicine requires a doctor’s prescription
Each tablet contains:
Each tablet contains:
Dexamethasone 0.5 mg
Dexamethasone 2 mg
Inactive ingredient: see the chapter 6- further information.
Read this package insert carefully in its entirety before
using this medicine. This leaflet contains essential information
of this medicine. If you have any further questions, ask your
doctor or pharmacist.
Take this medicine regularly to get the maximum benefit
from the treatment.
This medicine has been prescribed for you. Do not pass it
on to others. It may harm them, even if their symptoms are
the same as yours.
1. For what is intended this medicine?
For the treatment and relief in cases of inflammation,
swelling, itching, severe allergies, skin conditions and
Therapeutic group: Potent synthetic glucocorticoid.
2. Before use this medicine:
Do not take this medicine
- If you are allergic (hypersensitive) to dexamethasone or
any other ingredients in this medicine (listed in Section 6).
The signs of an allergic reaction include a rash, itching or
shortness of breath
If you are about to receive any vaccination (especially
attenuated live virus vaccine)
- If you are suffering from infection that affects whole body.
Do not take this medicine without consulting a doctor
before starting treatment if you:
Are suffering, or have suffered from severe depression or
maniac depression (bipolar disorder), or if any of you close
family has had these illnesses.
Are suffering, or have suffered in the past, from impaired
function of: the heart and/or vascular system (e.g. high blood
pressure), the liver, the kidney.
Are suffering from diabetes or there is a family history of diabetes.
particularly if you are a female who has been through the
Are suffering from muscle weakness with steroids administration
in the past.
Are suffering from an increased eye pressure (glaucoma) or
there is a family history of glaucoma.
Are suffering from stomach ulcers (ulcers)
Use of this medicine may worsen your condition if you suffer or
have suffered from mental disorders (psychosis due to steroid use)
Are suffering from epilepsy.
Are suffering from migraines.
Have an underactive thyroid gland.
Are suffering from infection with parasites.
Are suffering from tuberculosis.
Are suffering from growth disorder (delay)
Special warnings concerning the medicine use:
- Do not use this medicine frequently, or for a long period, without
consulting a doctor. If you are sensitive to any type of food or
medicine, inform your doctor before commencing treatment
with this medicine.
- Inform your doctor (including your dentist) if you are about to
undergo skin tests or a surgery.
- Inform your doctor, dentist or medical staff if you took or have
taken in the past as a steroid like dexamethasone.
- Inform your doctor if you develop an infection during the treatment
with this medicine.
- Prolonged use of this medicine may slow growth in children
and adolescents. Therefore, the doctor’s instructions must be
- While using this medicine you are susceptible to infections;
chickenpox or measles).
- Patient should report signs/symptoms of increased blood sugar
levels (hyperglycemia). Diabetic patients may need to closely
monitor blood glucose.
- Patients should avoid sudden discontinuation of drug.
- Mental health problems may happen while taking steroids like
Dexamethasone (see also Section 4: side effects):
These illnesses can be serious.
Usually they start within a few days or weeks of starting the
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
If you take or someone take this medicine, inform a doctor from
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.
Respiratory Distress Syndrome (ARDS; a serious lung disease)
if you have been diagnosed with this condition for over 2 weeks.
If you are taking or have recently taken other
medicines, including non-prescription medicines
and dietary supplement, inform the doctor or the
Specially, refer to the doctor or pharmacist if you
take medicines of the following:
Medicines used to prevent blood clotting (such warfarin)
High blood pressure medicine
Water tablets (diuretics)
Rifampicin and rifabutin (antibiotic to treat the tuberculosis)
carbamazepine, phenobarbitone and primidone
Medicines used to treat stomach problems, such as antacids
Carbenoxolone, sometimes used for ulcers
Medicines used to treat pain and inflammation, such as aspirin,
ibuprofen or similar non-steroidal anti-inflammatories (NSAIDs)
Medicines used to treat diabetes
Medicines used to increase lower potassium levels
Medicines used to treat myasthenia
Ritonavir, indinavir or saquinavir used to treat HIV
Oral contraceptives containing oestrogen and progestogen
Anti-cancer treatments, such as aminoglutethimide
Methotrexate used to treat cancer or inflammatory problems
Ephedrine used to relieve symptoms of a stuffy nose (nasal
Acetazolamide used for glaucoma
Use of this medicine and food:
Take the medicine before
the meal with glass of water
Use of this medicine and alcohol:
Do not drink wine or
alcoholic beverages while under treatment with this medicine.
Pregnancy and breast-feeding:
Do not take this medicine
during pregnancy, whilst breast-feeding, or you are planning to
become pregnant unless advised by your doctor.
Driving and using machines:
Dexamethasone tablet is not
likely to affect you being able to drive.
Important information on the Dexamethasone tablets
Each Dexamethasone 0.5 mg tablets contains
47.7 mg of lactose and Each Dexamethasone 2 mg tablets
contains 80 mg.
If you are allergic to lactose, consult your doctor before
commencing the treatment.
3. How use this medicine?
Always take this medicine exactly as instructed by the attending
doctor. If you are unsure how to use this medicine, you
should consult your doctor or your pharmacist. Do not
exceed the recommended dose.
This medicine is to be taken at specific time intervals as determined
by the attending doctor.
medicine with a meal.
It is possible to crush or halve the tablet if necessary.
If you forget to take this medicine, take the dose as soon as
you remember, but never take a double dose to compensate for
a missed one! Take the next dose at the usual time and consult
your doctor or pharmacist.
If you have accidentally taken an overdose, or if a child has
accidentally swallowed the medicine, contact immediately the
doctor or proceed immediately to a hospital emergency room
and bring the package of the medicine with you. You may
experience swelling in the throat, skin allergic reactions and
Do not stop taking this medicine, even if you are feeling
well, unless your doctor tells you. This medicine may cause
dependence; therefore you could get a withdrawal reaction
[headache, problems with your vision (including pain or swelling
in the eye), vomiting and nausea, fever, pain in your muscles and
joints, swelling in the inside of nose, weight loss, itchy skin and
conjunctivitis]. You must stop the treatment gradually according
to your doctor’s recommendation.
Do not take medicines in the dark! Check the label and the dose
each time you take your medicine. Wear glasses if you need them.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.
4. Side Effects:
Like all medicine, Dexamethasone tablets use can cause side
effects, although not everybody gets them.
Do not be alarmed by this list of possible events. You may not
have any of them.
Severe side effects: Consult your doctor immediately:
Steroids including Dexamethasone can cause serious mental
health problems in adults and children. Consult your doctor
They can affect about 5 in every 100 people taking medicines
like Dexamethasone. These include:
Feeling depressed, including thinking about suicide
Feeling high (mania) or moods that go up and down
thinking or being confused and losing your memory
Hallucination, feeling afraid.
If you have an allergic reaction to Dexamethasone, consult
your doctor immediately. An allergic reaction may include:
Any kind of skin rash or itching of the skin
Difficulty in breathing or collapse
If you get any of the following side effects see your doctor
as soon as possible:
Stomach and intestinal problems: ulcers in the throat,
stomach ulcers, which may perforate or bleed, indigestion,
nausea vomiting, a swollen stomach, having more of an
appetite than usual, hiccups, diarrhoea.
Inflamed pancreas: this may cause severe pain in the back
Problems with Electrolyte balance in your blood such as
increased level of sodium or low level potassium or calcium
that may cause edema.
Heart and blood problems: high blood pressure, blood clots,
problems with heart after a recent heart attack.
Bone problems: thinning of the bones (osteoporosis) with an
increased risk of fractures, bone disease.
Recurring infections like fungal infections or viral infection
Eye problems: increased pressure in the eye including
glaucoma, eye disorders such as cataracts, eye infections.
Hormone problems: irregular or missing periods, stunted
growth in children and teenagers, swelling of the face (called
‘Cushingoid’ or ‘moon’ face), it may affect your diabetes and
you may notice you start needing higher doses of the medicine
you take for diabetes, your body may not be able to respond
normally to severe stress such as accidents, surgery or illness,
growth of extra body hair (particularly in women), increased
appetite or weight gain.
Nervous system problems: fits or epilepsy may become
worse, severe unusual headache with visual problems, being
worse, pain or swelling in the eyes.
General problems: may make you feel generally unwell or tired.
If one of the side effects gets worse, or in the event that
you experience side effects not mentioned in this leaflet,
consult your doctor immediately
5. How to store this medicine?
Avoid poisoning! This medicine, and all other medicines, must be
stored in a safe place out of the reach of children and/or infants, to
avoid poisoning. Do not induce vomiting unless explicitly instructed
to do so by a doctor.
Do not take medicines in the dark! Do not use this medicine after
the expiry date stated on the label/carton/bottle. The expiry date
refers to the last day of that month.
Store below 25°C in a dark and a dry place.
Do not throw this medicine into dustbin. This medicine have to be
returned to the pharmacy.
6. Further information:
In addition of active ingredient (substance) this medicine
Dexamethasone 0.5 mg: Starch, lactose, avicel, talc, PVP
K-30, stearic acid, aerosil.
Dexamethasone 2 mg: Lactose, starch 1500, microcrystalline
cellulose (Avicel PH 102), talc, stearic acid, colloidal silicone
dioxide (Aerosil 200), croscarmellose sodium (Ac-Di-Sol)
What does the medicine look like and what is
of the package:
Dexamethasone 2 mg: not coated white tablet with R engraved on
one side, plain on the other. 50 tablets into white bottle.
Dexamethasone 0.5 mg: not coated white tablet with R engraved
on one side, scored in half on other side. 30 tablets into white bottle.
Manufacturer and Holder: Rekah Pharmaceutical Prod. Ltd., 30
Hamelacha St., Holon, Israel
This leaflet was checked and approved it in March 2014
License number: Dexamethasone 0.5 mg: 118-05-22579-00
Dexamethasone 2 mg: 036-08-22562-00
For simplicity and easier to read, this leaflet is formulated male,
however, the medicines is intended for members of both sex.