PEPTOLITE CHEWABLE TABLETS

PATIENT PACKAGE INSERT

IN ACCORDANCE WITH THE

PHARMACISTS’ REGULATIONS

(PREPARATIONS) - 1986

The medicine is

dispensed without a

doctor’s prescription

PEPTOLITE

CHEWABLE

TABLETS 262 mg

PEPTOLITE

SUSPENSION

262.5 mg/15 ml

Each tablet contains:

Bismuth Subsalicylate 262 mg

Each 15 ml of suspension contains:

Bismuth Subsalicylate 262.5 mg

*Inactive ingredients in the preparation

- see section 6 in the leaflet.

Read this package insert carefully

in its entirety before using this

medicine. This leaflet contains concise

information about the medicine. If you

have further questions refer to your

physician or pharmacist.

The medicine is intended for adults

and children above 12 years of age.

Below the age of 12, you should refer

to your doctor.

The medicine must be used correctly.

Consult the pharmacist if you need

further information. Stop taking the

medicine and contact the physician

if signs of the illness (symptoms)

get worse or do not improve after

two days. Likewise, if the diarrhea

is accompanied by high fever, if you

experience ringing in the ears or loss

of hearing.

1. WHAT IS THE MEDICINE INTENDED

FOR?

The medicine is intended to relieve

cases of diarrhea, nausea, flatulence,

abdominal cramps, upset stomach

and indigestion.

2. BEFORE USING THE MEDICINE:

Do not use the medicine if:

You are sensitive (allergic) to the

active ingredient or to any other

ingredients contained in the

medicine.

Do not use in children and

adolescents up to 20 years of

age for illnesses accompanied by

fever such as flu and chickenpox

(for fear of Reye’s syndrome).

The medicine contains salicylate.

Do not use the medicine if you are

allergic to salicylates (including

aspirin) or if you are taking

other preparations that contain

salicylate.

You have a stomach ulcer,

bleeding, bloody or black stool.

Special warnings regarding use of

the medicine:

Before starting treatment with

Peptolite tell the doctor if:

you are pregnant or breastfeeding.

you are suffering or have suffered in

the past from impaired function of:

the respiratory system (e.g. asthma),

the kidney/urinary tract, the digestive

system (e.g. stomach ulcer), the

blood system (e.g. coagulation,

etc.), gout, dehydration, if you have

fever.

you have mucus in the stool.

If you are sensitive to any type

of food or medicine, in particular

to aspirin and salicylates, inform

the physician before taking this

medicine.

If behavioral changes, accompanied

with nausea and vomiting occur upon

use of the medicine, consult the

doctor since these symptoms can

be an early sign of Reye’s syndrome,

a rare but serious disease.

Do not give to children or adults for

treatment of nausea of an organic

background.

Do not use the medicine if signs of

the illness (symptoms) get worse or

do not improve after two days.

Do not use this medicine frequently

or for a prolonged period without

consulting the physician.

I

f you are taking or have recently

taken other medicines, including non-

prescription medicines and nutritional

supplements, inform the physician or

pharmacist. You must especially tell

the physician or pharmacist if you

are taking aspirin and salicylates,

anticoagulants, medicines for gout,

probenecid

sulfinpyrazone,

tetracyclines, medicines for diabetes,

medicines for arthritis

Use of the medicine and food:

The medicine can be taken with or

without food.

Use

of

the

medicine

and

consumption of alcohol:

Do not drink wines or alcoholic

beverages during treatment with the

medicine.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding,

consult a physician before using the

medicine.

Important information about some

of the ingredients of the medicine:

The medicine contains salicylate.

Do not use it if you are sensitive to

salicylates, including aspirin, or if you

are taking other preparations that

contain salicylate.

3. HOW SHOULD YOU USE THE

MEDICINE?

Check with the physician or pharmacist

if you are not sure.

The

accepted

dosage

is

generally:

Peptolite, chewable tablets

Adults and children above 12 years

of age: 2 tablets.

As needed, this dosage can be

repeated every half hour to an hour,

up to 8 times (16 tablets) in any 24

hour period. Chew or allow the tablet

to dissolve in the mouth and swallow!

Do not exceed the recommended

dose.

Peptolite, suspension

Adults and children above 12 years

of age:

30 ml = 2 tablespoons (2 TBSP).

As needed, this dosage can be

repeated every half hour to an

hour, up to 8 times (240 ml or

16 tablespoons) in any 24 hour

period.

Children below 12 years of age:

consult the doctor.

Do not use the medicine for more than

two days, unless instructed to do so

by the doctor.

Before use, shake well, then drink

according to the recommended

dosage. Be sure to measure the dose

in the attached measuring cup. Do not

exceed the recommended dose.

If you have accidentally taken a higher

dose: If you have taken an overdose or

if a child has accidentally swallowed

the medicine, refer immediately to a

doctor or to a hospital emergency room

and bring the package of the medicine

with you.

If you forget to take the medicine:

If you forget to take this medicine

at the required time, take a dose as

soon as you remember, but under no

circumstances should two doses be

taken together!

How can you contribute to the

success of the treatment? In case

of diarrhea, drink plenty of caffeine

free fluids in order to make up for the

loss of fluids.

Do not take medicines in the dark!

Check the label and the dose each

time you take a medicine. Wear

glasses if you need them.

If you have further questions regarding

use of the medicine, consult the doctor

or pharmacist.

4. SIDE EFFECTS:

As with any medicine, use of Peptolite

may cause side effects in some users.

Do not be alarmed when reading

the list of side effects. You may not

experience any of them.

Stop use and refer to the physician

immediately if:

The following symptoms occur:

weakness, convulsions, breathing

problems, blurred vision, confusion,

ringing in the ears or loss of hearing,

severe constipation.

Stop use and refer to the physician

as soon as possible if:

Signs of overdose occur, such as

drowsiness, headache.

In case of diarrhea with high fever.

This medicine may cause a change

in the color of your stool or tongue.

These changes are not a cause for

concern.

If any of the side effects worsens, or

if you experience a side effect not

mentioned in the leaflet, consult the

physician.

Reporting side effects:

Side effects can be reported to the

Ministry of Health by clicking on

the link “Reporting Side Effects

from Drug Treatment” found on

the Ministry of Health homepage

(www.health.gov.il), that directs you

to the online form for reporting side

effects, or by entering the link:

https://forms.gov.il/globaldata/getseq

uence/getsequence.aspx?formType=

AdversEffectMedic@moh.gov.il

In addition, you can report to Perrigo

via the following address:

www.perrigo-pharma.co.il

5. HOW SHOULD THE MEDICINE BE

STORED?

Avoid poisoning! This medicine and

any other medicine must be kept

in a closed place out of the reach

of children and/or infants to avoid

poisoning. Do not induce vomiting

unless clearly indicated by the

doctor.

Do not use the medicine after the

expiry date (exp. date) appearing

on the package or the bottle. The

expiry date refers to the last day of

that month.

Store below 25°C.

Suspension: can be used for 3

months after first opening

6. ADDITIONAL INFORMATION:

In addition to the active ingredient, the

medicine also contains:

Tablets:

Calcium

carbonate,

wintergreen

flavor,

magnesium

stearate, mannitol PWD unchil, red

#27 D&C Al lake, sodium saccharin,

stearic acid.

The amount of sodium in each tablet:

0.3 mg

Suspension: Magnesium aluminium

silicate, methylsalicylate, methyl

cellulose, D&C red 22, D&C red 28,

sodium saccharin, salicylic acid,

sodium salicylate, sorbic acid, xanthan

gum, purified water.

The amount of sodium in each 30 ml:

12 mg

The amount of preservative in each

30 ml:

Sorbic acid 11.4 mg

How does the medicine look

and what are the contents of the

package?

Peptolite tablets: a package containing

12 or 24 or 30 pink flat tablets.

Peptolite

suspension:

bottle

containing 237 ml of pink viscous

liquid.

Registration holder and address:

Perrigo Israel Agencies Ltd., 29 Lehi

Street, Bnei-Brak, 51200.

Name

of

manufacturer

and

address:

Perrigo Company, Allegan, Michigan,

USA.

This leaflet was checked and approved

by the Ministry of Health in January

2015.

Drug Registration No. in the National

Drug Registry of the Ministry of

Health:

Peptolite tablets:

14841.33716

Peptolite suspension:

14688.33560