E-Z-GAS II

Israel - English - Ministry of Health

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Active ingredient:
CITRIC ACID ANHYDROUS; SIMETHICONE; SODIUM BICARBONATE
Available from:
PROMEDICO LTD
ATC code:
B05XA
Pharmaceutical form:
EFFERVESCENT GRANULES
Composition:
CITRIC ACID ANHYDROUS 38.21 %W/W; SIMETHICONE 1 %W/W; SODIUM BICARBONATE 55.14 %W/W
Administration route:
PER OS
Prescription type:
Not required
Manufactured by:
E-Z-EM INC., USA
Therapeutic group:
ELECTROLYTE SOLUTIONS
Therapeutic indications:
For the relief of heartburn sour stomach acid indigestion upset stomach and gas associated with these symptoms. For use only in X-ray departments: Endoscopic adjunct. Is indicated as an adjunct to contrast media utilized during a double - contrast upper gastro-intestinal (DCUGI) examination.
Authorization number:
125 14 30431 00
Authorization date:
2012-03-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Hebrew

31-08-2016

Patient package insert in accordance with the

pharmacists’ regulations (preparations) - 1986

Read this package insert carefully in its entirety before using this

medicine

E-Z-GAS II

Composition:

Each packet of 4 mg contains:

Active ingredients and their quantity:

Sodium Bicarbonate 2.21g, Citric Acid Anhydrous 1.53g, Simethicone

0.04g.

Inactive ingredients:

Maltodaxtrin, Sodium Saccharin, Orange Flavor.

Therapeutic activity:

This medicine is indicated:

1) For the relief of heartburn, sour stomach, acid indigestion and upset

stomach and gas associated with these symptoms.

2) For use in X-Ray clinics: As an adjunct to contrast media during a

double-contrast gastro-intestinal examination.

When should the preparation not be used?

Do not use this product to dislodge foreign body.

Do not use this medicine if you are sensitive to any of its ingredients.

Do not use in cases of known or suspected esophageal obstruction.

Do not take this medicine without consulting a doctor

before starting treatment:

If you are pregnant.

If you are on a sodium restricted diet.

If you are suffering, or have suffered in the past from impaired function

of: the heart and/or vascular system, the liver, edema, preeclampsia,

bleeding in the digestive system, symptoms of appendicitis (such as

severe stomach ache, fever and vomiting).

Warnings:

Do not take more than the maximum recommended dosage in a 24 hour

period.

Do not use the maximum dosage for more than two weeks, except under

the advice of a physician. If gastro-intestinal symptoms return, consult

your doctor, even if this product relieves the symptoms.

If you are sensitive to any type of food or medicine, inform your doctor

before commencing treatment with this medicine.

If you are about to undergo an examination of gastric juices, do not use

this preparation on the morning before the tests.

Drug interactions:

If you are taking another drug concomitantly, or if you have just finished

treatment with another medicine, inform the attending doctor, in order to

prevent hazards or lack of efficacy arising from drug interactions. This

is especially important for medicines belonging to the following groups:

tetracyclines, ciprofloxacin, norfloxacin (antibiotics), ketoconazole (anti-

fungal).

Side effects

In addition to the desired effect of the medicine, adverse reactions may

occur during the course of taking this medicine, such as: hiccups and

discomfort as a result of bloating.

Side effects that require special attention:

Allergic reactions (urticaria, rash, or anaphylactic reaction), swelling of

the legs, muscle pain, continuous headaches, slow breathing, unpleasant

taste, excessive weakness, frequent urination, loss of appetite (rare):

stop treatment and consult your doctor.

In the event that you experience side effects not mentioned in this

leaflet, or if there is a change in your general health, consult your doctor

immediately.

Adverse reactions and drug interactions in children and

infants:

Parents must inform the attending doctor about any side effects, as well

as any additional medicine being taken by the child!

Recommended

dosage

unless

otherwise

prescribed

by

your doctor:

For endoscopic adjunct:

Adults and elderly: Place the contents of the packet on the back of the

tongue and swallow with 15 ml of water.

Children: The doctor will determine the dosage according to age, weight

and previous experience.

As antacid and antiflatulent:

Place half the contents of the packet on the back of the tongue and

swallow with 15 ml of water. Repeat the procedure with the remaining

contents of the packet.

Adults under the age of 60: One packet every 6 hours or according to

doctor’s instructions. Do not take more than 4 packets within 24 hours.

Adults above the age of 60: One packet every 8 hours. Do not take more

than 3 packets within 24 hours.

Children aged 6-12 years: One packet every 8 hours. Do not take more

than 3 packets within 24 hours.

This medicine is not usually intended for administration to infants and

children under the age of 6 years.

Attention

!

Do not take this medicine with milk or milk products in large amounts.

Allow a lapse of at least 2 hours between taking this medicine and taking

another medicine.

Directions for use:

Do not chew! Swallow the medicine with water.

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.

If you have taken an overdose, or if a child has accidentally swallowed

the medicine, proceed immediately to a hospital emergency room and

bring the package of the medicine with you.

Do not induce vomiting unless explicitly instructed to do so by a doctor!

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.

Storage

:

In a cool and dry place below 25ºC.

Even if kept in their original container and stored as recommended,

medicines may be kept for a limited period only. Please note the expiry

date of the medicine! In case of doubt, consult the pharmacist who

dispensed the medicine to you.

Do not store different medications in the same package.

Registration number:

125 14 30431 00

Manufacturer:

E-Z-EM Inc., USA.

Registration Holder:

Promedico Ltd., P.O box 3340, Petach Tikva.

The format of this leaflet has been determined by the Ministry of Health

and its content has been checked and approved in March 2007.

Code: E-Z-GAS II PIL PB0212-03

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