רוומיצין

ישראל - עברית - Ministry of Health

קנה את זה

עלון מידע עלון מידע (PIL)

30-11-2020

מרכיב פעיל:
SPIRAMYCIN 1.5 MIU
זמין מ:
SANOFI - AVENTIS ISRAEL LTD
קוד ATC:
J01FA02
טופס פרצבטיות:
FILM COATED TABLETS
מסלול נתינה (של תרופות):
PER OS
תוצרת:
FAMAR LYON, FRANCE
קבוצה תרפויטית:
SPIRAMYCIN
סממני תרפויטית:
Respiratory tract infections, infections caused by clamydia, cryptosporidiosis pregnancy toxoplasmosis.
מספר אישור:
046592386800
תאריך אישור:
2010-07-01

מסמכים בשפות אחרות

עלון מידע עלון מידע - אנגלית

30-11-2020

מאפייני מוצר מאפייני מוצר - אנגלית

30-11-2020

עלון מידע עלון מידע - ערבית

30-11-2020

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Æ¥≤μ∞¥ππ†‰È˙†¨∏∞π∞†Æ„Æ˙ ROVA CTAB PL SH 130213

PATIENT PACKAGE INSERTIN ACCORDANCE WITH

THEPHARMACISTS'REGULATIONS(PREPARATIONS)-1986

The dispensing ofthis medicine requires

a doctor's prescription

Read this package insert carefully in its entirety

before using this medicine

The formatofthis leaflet was determined by the

Ministry ofHealth and its content

was checked and approved in April 2013

ROVAMYCIN

Film-Coated Tablets

Composition:Each tablet contains: Spiramycin 1.5 M.I.U.

Inactiveingredients:

Microcrystalline cellulose; Gelifiable maize starch;

Hydroxypropylcellulose; Sodium croscarmellose;

Hypromellose; Magnesium stearate; Macrogol 6000;

Titanium dioxide; Anhydrous colloidal silica.

Therapeutic group:Macrolide antibiotics.

Therapeutic activity:

Antibiotic for the treatment ofsusceptible infections.

When should the preparation not be used?

Do not use this medicine ifyou are sensitive to any

ofits ingredients or to other antibiotics ofthe

macrolide group.

Do not use this medicine ifyou are breastfeeding.

Do not take this medicine without consulting a

doctor before starting treatment:

Ifyou are pregnant, or ifyou are suffering, or have

suffered in the past, from impaired function ofthe liver.

Ifyou have a deficiency ofthe enzyme G6PD.

Warnings:

Ifyou are sensitive to any type offood or medicine,

inform your doctor before commencing treatment with

this medicine.

Ifatthe beginning oftreatment, areas ofredness and

pustules appear on the skin accompanied by fever, a

condition called acute generalized exanthematous

pustulosis should be suspected - stop treatment and

refer to the doctor immediately.

Drug interactions:

Ifyou are taking another drug concomitantly or ifyou

have just finished treatment with another medicine,

inform the attending doctor, in order to prevent hazards

or lack ofefficacy arising from drug interactions. This

is especially important for the following medicines:

levodopa (for treatment ofParkinson’sdisease),

anticoagulants.

Side effects:

In addition to the desired effect ofthe medicine, adverse

reactions may occur during the course oftaking this

medicine, such as:

-Digestion-related reactions: abdominal pain, diarrhea,

nausea, vomiting, in rare cases: a problem with the

intestine, manifested by diarrhea and abdominal pain,

called pseudomembranous colitis.

-Skinreactions: rash, vasculitis (inflammation ofthe

blood vessels) including Henoch-Schonlein purpura.

Side effects that require special attention:

-Allergic reactions such as: itching, urticaria or swelling

ofthe face and neck (rare): refer to the doctor

immediately.

-Appearance ofredness on the skin with pustules

accompanied by fever (very rare): stop treatment and

refer to the doctor immediately.

-Liver function test abnormalities, hepatitis due to

increased bile acid salts or other factors (rare): refer

to the doctor immediately.

-Transient paresthesia (rare): refer to the doctor

immediately.

In the event that you experience side effects not

mentioned in this leaflet, or ifthere 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!

Dosage:

Dosage is according to doctor's instructions only.

This medicine is not usually intended for children

below 6 years ofage because ofthe danger ofchoking.

Directions for use:Do not chew! Swallow the medicine

with a glass ofwater.

How can you contribute to the success ofthe

treatment?

Complete the full course oftreatment as instructed by

the doctor. Even ifthere is an improvement in your

health, do not discontinue use ofthis medicine without

consulting your doctor.

Avoidpoisoning!This medicine, and all other

medicines, must be stored in a safe place out ofthe

reach ofchildren and/or infants, to avoid poisoning.

Ifyou have taken an overdose, or ifa child has

accidentally swallowed the medicine, proceed

immediately to a hospital emergency room and bring

the package ofthe medicine with you.

Donotinducevomiting unless explicitly instructed to

do so by a doctor! This medicine has been prescribed

for the treatment ofyour ailment; in another patient

it may cause harm.Do not givethis medicine to your

relatives,neighbours or acquaintances.

Donottakemedicinesinthedark! Check the label and

the doseeachtime you take your medicine. Wear glasses

ifyou need them.

Storage:Do notstore above 25 o C.Even ifkept in their

original container and stored as recommended, medicines

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

expiry date ofthe medicine! In case ofdoubt, consult

the pharmacist who dispensed the medicine to you.

Do not store different medications in the same package.

License number:465923868

This leaflet does not contain all the information about

your medicine. Ifyou haveany questions or are not

sure about anything, please ask your doctor.

Manufacturer:Famar Lyon, France.

License holder:sanofi-aventis Israel ltd.,

P.O.Box 8090, Netanya 4250499.

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