DEXAMETHASONE 0.5 MG

Israel - English - Ministry of Health

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Active ingredient:
DEXAMETHASONE
Available from:
REKAH PHARMACEUTICAL INDUSTRY
ATC code:
H02AB02
Pharmaceutical form:
TABLETS
Composition:
DEXAMETHASONE 0.5 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
REKAH PHARMACEUTICAL PROD.LTD
Therapeutic group:
DEXAMETHASONE
Therapeutic area:
DEXAMETHASONE
Therapeutic indications:
Anti-inflammatory.
Authorization number:
118 05 22579 00
Authorization date:
2015-02-28

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

27-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

29-08-2016

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

DEXAMETHASONE

DEXAMETHASONE

0.5mg

Tablets Tablets

Composition:

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

joint inflammation.

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.

suffering

from

thinning

bones

(osteoporosis),

particularly if you are a female who has been through the

menopause.

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

strictly followed

- While using this medicine you are susceptible to infections;

therefore

avoid

contact

with

sick

people

(mainly

with

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

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

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.

Dexamethasone

treatment

Acute

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

pharmacist.

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)

Medicines

used

treat

epilepsy,

such

phenytoin,

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

congestion)

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

composition:

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.

chew!

Swallow

medicine

with

water.

Take

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

breathing difficulties.

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

immediately.

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

Feeling

anxious,

having

problems

sleeping,

difficulty

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

or tummy.

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

(chicken pox)

Skin

problems:

wounds

that

heal

more

slowly,

skin

hemorrhages, acne.

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

unable

sleep,

depression,

schizophrenia

become

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

contains also:

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

the content

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.

03/14 5DE1039A

:ט”קמ

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