לופרקס

ישראל - עברית - Ministry of Health

קנה את זה

עלון מידע עלון מידע (PIL)

29-11-2020

מרכיב פעיל:
LOPERAMIDE HYDROCHLORIDE 2 MG
זמין מ:
PERRIGO ISRAEL AGENCIES LTD
קוד ATC:
A07DA03
טופס פרצבטיות:
CAPLETS
מסלול נתינה (של תרופות):
PER OS
תוצרת:
PERRIGO COMPANY, USA
קבוצה תרפויטית:
LOPERAMIDE
סממני תרפויטית:
Control and symptomatic relief of acute diarrhea.
מספר אישור:
139913191500
תאריך אישור:
2008-12-01

מסמכים בשפות אחרות

עלון מידע עלון מידע - אנגלית

29-11-2020

עלון מידע עלון מידע - ערבית

29-11-2020

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microcrystalline cellulose, polyethylene glycol 400,

polyethylene glycol 8000, pregelatinized starch.

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PATIENT PACKAGE INSERT IN ACCORDANCE

WITHTHE PHARMACISTS' REGULATIONS

(PREPARATIONS)-1986

Read this package insert carefully in its entirety

before using this medicine

The format of this leaflet was determined by

the Ministry of Health and its content

was checked and approved in September 2009

LOPREX

Caplets

Composition:

Each caplet contains:Loperamide HCl 2 mg

Each caplet also contains:Lactose 118.73 mg

Inactive ingredients:

Carnauba wax, yellow #10 D&C lake,blue #1 FD&C

lake,hypromellose, magnesium stearate,

microcrystalline cellulose, polyethylene glycol 400,

polyethylene glycol 8000, pregelatinized starch.

Therapeutic group:Antidiarrheal.

Indications:

For the treatment of acute diarrhea.

When should the preparation not be used?

Do not use this medicine if you are sensitive to

any of its ingredients.

This medicine must not be used when constipation

should be avoided or during intestinal blockage

or if there is chronic intestinal disease.

Do not use this medicine if you suffer from colitis

or if the diarrhea was caused byantibiotic

treatment.

Do not use this medicine if the diarrhea is

accompanied byfever or bloody or mucosal

secretion.

Do not use this medicine if you are breastfeeding.

Do not take this medicine without consulting

a doctor before starting treatment:

If you are pregnant, if you are suffering, or have

suffered in the past, from impaired liver function, if

you suspect that the diarrhea is caused byfood

poisoning or bybacteria, in case of rectal bleeding

or unusual abdominal distention, if you are suffering

from dysentery or dehydration, manifested by

symptoms such as:dizziness, reduction in urination,

wrinkled skin, excessive thirst.

How will this medicine affect your daily life?

Use of this medicine may impair alertness and

therefore caution should be exercised when

engaging in activities such as driving a car,

operating dangerous machinery and in any other

activity which requires alertness.

Warnings:

Do not use this medicine frequently, or for a long

period, without consulting a doctor.See also

"Dosage" section below.

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

inform your doctor before commencing treatment

with this medicine.

The medicine contains lactose and may cause

sensitivity in people sensitive to lactose.

Drug interactions:

If you are taking another drug concomitantly or if

you havejust 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:narcotic analgesics,

medicines that slow down stomach or intestinal

activity (e.g.anticholinergics).

Side effects:

In addition to the desired effect of the medicine,

adverse reactions may occur during the course of

taking this medicine, for example:dryness of the

Side effects that require special attention:

Skin rash, unusual abdominal distention, strong

abdominal pains accompanied bynausea and

vomiting (rare), increased tiredness, drowsiness or

increased thirst (rare):stop treatment and refer to

the doctor immediately.

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:

Parents must inform the attending doctor about any

side effects, as well as any additional medicine

being taken bythe child!

See abovefor details of special side effects and

drug interactions.

Dosage:

Unless otherwise instructed bythe doctor the

recommended dosage is:2 caplets as a first dose

and thereafter one caplet after every loose stool.

The recommended dosage is 3-4 caplets a day.Do

not take more than 8 caplets in one day (24 hours).

Dosageforchildren:Use of this medicine in children

6-12 years of age must be with a doctor's prescription

and medical surveillance.

This medicine is not usually intended for

administration to infants and children under 6

years of age.

If there is no improvement in your condition within

2 days, refer to your doctor.

Directions for use:

Do not chew! Swallow the medicine with water.

The caplet may be halved or crushed and then

taken in a single dose.

How can you contribute to the success of the

treatment?

This medicine stops diarrhea, but does not treat

the reason causing it.The cause of the diarrhea

should be treated if possible.

Diarrhea causes increased loss of fluids.Drink

plenty of liquids (non-caffeinated) in order to restore

fluids to your body and prevent dehydration.Avoid

drinking alcoholic beverages.

As for food, eating easily digested foods is

recommended.It is advisable to avoid fried or spiced

food or any kind of food that may irritate the

intestines, such as fruits and vegetables.

Avoidpoisoning!

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 havetaken 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, even

if you or your child feels well since there is a risk of

damage to the liver.

Donotinducevomiting unless explicitly instructed

to do so bya doctor!

Donottakemedicinesinthedark! Check the label

and the doseeachtime you take your medicine.

Wear glasses if you need them.

Storage:

Store below 25 0 C.

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.

License number:13991.31915

Manufacturer:Perrigo Co., Allegan, Michigan, USA.

Importer and registration holder:

Agis Commercial Agencies (1989) Ltd.,

29 Lehi Street, Bnei-Brak 51200.

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