N-ZAREVET

Israel - English - Ministry of Health

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Active ingredient:
CALCIUM CARBONATE
Available from:
PERRIGO ISRAEL AGENCIES LTD, ISRAEL
ATC code:
A12AA04
Pharmaceutical form:
CHEWABLE TABLETS
Composition:
CALCIUM CARBONATE 500 MG
Administration route:
PER OS
Prescription type:
Not required
Manufactured by:
PERRIGO COMPANY, USA
Therapeutic group:
CALCIUM CARBONATE
Therapeutic area:
CALCIUM CARBONATE
Therapeutic indications:
Antacid
Authorization number:
138 45 31624 00
Authorization date:
2013-03-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

18-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

17-08-2016

Use in children:

This medicine is not

intended for infants and

children under 12 years

of age.

Use of N-Zarevet with

food:

If you are sensitive to

any food or medicine,

inform the doctor before

taking the medicine. The

preparation contains sugar

(dextrose) and therefore, if

you suffer from intolerance

to certain sugars, consult

the doctor before taking the

medicine.

If you are taking, or

have recently taken, other

medicines, including non-

prescription medicines and

nutritional supplements,

inform

the

doctor

or

p h a r m a c i s t

b e f o re

commencing treatment,

especially with regard to

medicines from the following

groups:

Tetracyclines, ciprofloxacin

(fluoroquinolones)

(antibiotics), thiazide-type

diuretics, corticosteroids,

vitamin D, bisphosphonates,

digitalis, methenamine,

sodium

polystyrene,

sulfonate,

phenytoin,

m e d i c i n e s

w h i c h

contain: iron, calcium,

phosphate, magnesium,

fluoride,

antifungals

(ketoconazole).

Allow a lapse of 2-3

hours between taking this

medicine and taking other

oral medicines.

Important information

about

some

of

the

ingredients

of

the

medicine:

The orange tablet contains

FD&C Yellow #6 Aluminium

Lake, which may cause

allergic reactions.

3. H O W

S H O U L D

Y O U

U S E

T H E

MEDICINE?

Check with the doctor

or pharmacist if you are

unsure.

This medicine is not

intended for infants and

children under 12 years

of age.

The usual dosage, unless

otherwise instructed by a

doctor, is generally:

For relief of heartburn:

chew 2-4 tablets upon

the onset of symptoms

or as per the doctor’s

recommendation.

If there is no improvement

in the heartburn within

two weeks, refer to the

doctor. Do not use the

medicine for more than

two weeks, except at

the

recommendation

and supervision of the

doctor. Do not exceed

the recommended dose

of 15 tablets per day.

If you are pregnant, do not

take more than 10 tablets

in 24 hours.

Directions for use:

Chew the medicine before

swallowing.

Do not take medicines in

the dark! Check the label

and the dose each time

you take medicine. Wear

glasses if you need them.

have

further

questions regarding use of

this medicine, consult the

doctor or pharmacist.

4. SIDE EFFECTS

As with any medicine, use

of N-Zarevet may cause

side

effects

some

users. Do not be alarmed

when reading the list of

side effects. You may not

experience any of them:

Constipation

Nausea

Flatulence

Belching

If a side effect occurs, if any

of the side effects worsen,

or if you suffer from a side

effect not mentioned in this

leaflet, consult the doctor.

Side effects can be reported

to the Ministry of Health via

the online form for reporting

side effects that can be

found on the Ministry of

Health homepage www.

health.gov.il or via the

following link: https://forms.

gov.il/globaldata/getseque

nce/getsequence.aspx?fo

rmType=AdversEffectMedic

@moh.gov.il

5. H O W

S H O U L D

THE MEDICINE BE

STORED?

Avoid poisoning! This

medicine and any other

medicine must be kept

in a closed place out of

the reach and sight of

children and/or infants to

avoid poisoning. Do not

induce vomiting without

an explicit instruction

from the doctor.

Do not use the medicine

after the expiry date (exp.

date) that is imprinted

on the bottle. The expiry

date refers to the last day

of that month.

Do not store different

medicines in the same

package.

Store in the original

package.

Store below 25°C.

Can be used for 12

months

after

first

opening.

6. FURTHER INFORMATION

In

addition

active ingredient, the

medicine also contains

the following inactive

ingredients:

Red tablet:

Dextrose, Maltodextrin,

Polyethylene glycol, Talc,

Adipic acid, Powdered

cellulose, Art cherry

flavor, Mineral oil, Nat

cream flavor, FD&C RED

#40 Aluminium Lake.

Green tablet:

Dextrose, Maltodextrin,

Polyethylene glycol, Talc,

Adipic acid, Powdered

cellulose, Nat lime flavor,

Mineral oil, FD&C yellow

Aluminium

lake,

FD&C Blue #1 Aluminium

Lake.

Orange tablet:

Dextrose, Maltodextrin,

Polyethylene glycol, Talc,

Adipic acid, Powdered

cellulose, Nat&Art orange

flavor, Mineral oil, FD&C

Yellow #6 Aluminium

Lake.

Yellow tablet:

Dextrose, Maltodextrin,

Polyethylene glycol, Talc,

Adipic acid, Powdered

cellulose, Nat&Art lemon

flavor, Mineral oil, FD&C

Yellow #5 Aluminium

Lake.

The preparation contains

sugar!

Each

tablet

contains about 510 mg

dextrose. Each tablet

also contains between

0.226-0.392 mg sodium

(depending on the color

of the tablet).

What the medicine looks

like and the contents of

the package:

The tablets are packed in a

bottle which contains 150

tablets. The tablets are

PATIENT PACKAGE

INSERT IN

ACCORDANCE WITH

THE PHARMACISTS’

REGULATIONS

(PREPARATIONS) - 1986

The medicine is dispensed

without a doctor’s

prescription.

N-ZAREVET

Chewable

fruit-flavored

tablets

Each tablet contains Calcium

Carbonate 500 mg.

Inactive ingredients: see

section 6 in the leaflet.

Read this leaflet carefully

in its entirety before using

the medicine. This leaflet

contains concise information

about the medicine. If you

have further questions,

refer

doctor

pharmacist.

This

medicine

does

require

doctor’s

prescription. Use it properly.

The medicine is intended for

children above 12 years of

age. Refer to the doctor if

the symptoms worsen or if

they do not improve after

two weeks. Consult the

pharmacist if you need

further information.

1. WHAT IS THE MEDICINE

INTENDED FOR?

Antacid.

2. BEFORE USING THE

MEDICINE

Do

not

use

the

medicine if:

You

have

sensitivity (an allergy)

to calcium carbonate

or to any of the other

ingredients

this

medicine (see section

6 in the leaflet).

You suffer from excess

of calcium in the blood

(hypercalcemia)

excess of calcium in the

urine (hypercalciuria).

You are on a low-

phosphate diet.

You suffer from kidney

stones.

You

suffer

from

impaired function of the

parathyroid glands.

You suffer from Zollinger-

Ellison Syndrome.

You are being treated

with digoxin for a heart

disease.

There

signs

appendicitis

intestinal inflammation,

such as: abdominal

pain,

nausea

vomiting.

Do

medicine in children

under

years

age.

Before treatment with

N-Zarevet, consult the

doctor if:

You are pregnant or

breastfeeding.

You suffer from diabetes

(the preparation contains

sugar).

You

suffer

have

suffered in the past, from

impaired function of the

digestive system, from

liver diseases, heart/

vascular diseases, bone

fractures.

Additional warnings:

Do not use if the inner seal

under the cap is missing or

damaged.

round and imprinted with

“L478” on one side.

Registration

holder

and address: Perrigo

Israel Agencies Ltd., 29

Lehi Street, Bnei-Brak,

51200.

Manufacturer

address: Perrigo Co.,

Michigan, U.S.A.

This leaflet was checked

and approved by the

Ministry of Health in

December 2015.

Registration

number

of the medicine in the

National Drug Registry of

the Ministry of Health:

13845.31624

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