LORMYX 200 MG

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

RIFAXIMINE

Tilgængelig fra:

MEGAPHARM LTD

ATC-kode:

A07AA11

Lægemiddelform:

FILM COATED TABLETS

Sammensætning:

RIFAXIMINE 200 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

ALFASIGMA S.P.A., ITALY

Terapeutisk gruppe:

RIFAXIMIN

Terapeutisk område:

RIFAXIMIN

Terapeutiske indikationer:

• Casual treatment of diseases of grown-ups and youngsters from 12 years up, caused by bacteria in the gastrointestinal tract, sensitive to Rifaximin:• hepatic encephalopathy • traveller’s diarrhea, caused by not-invasive enteropathogeneous bacteria.• Non-complicated diverticular diseases.

Autorisation dato:

2018-03-31

Indlægsseddel

1
_ _
PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a physician’s prescription only
LORMYX 200 MG
FILM-COATED TABLETS
_ _
ACTIVE INGREDIENT:
Each film-coated tablet contains:
Rifaximin (polymorphic form α) 200 mg
FOR A LIST OF INACTIVE AND ALLERGENIC INGREDIENTS, SEE SECTION 6 -
“ADDITIONAL INFORMATION”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains
concise information about the medicine. If you have further questions,
consult your physician or
pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them even if it seems to you that their illness is similar.
_ _
1.
WHAT IS THIS MEDICINE INTENDED FOR?
LORMYX 200 MG is used for treating infections of the gastrointestinal
tract caused by bacteria
sensitive to the medicine:
•
Traveller's diarrhoea - TD
•
Brain damage due to chronic liver disease allowing toxic substances to
reach the brain as a
result of inability of the liver to remove them from the bloodstream
(hepatic encephalopathy)
•
Non-complicated diverticular diseases (eversion of the intestinal
wall)
THERAPEUTIC GROUP:_ _An antibiotic used for treating gastrointestinal
infections._ _
_ _
LORMYX 200 MG is a broad spectrum antibiotic belonging to the
rifamycin group. The active
ingredient, rifaximin (polymorphic form α), affects bacterial
metabolism by inhibiting a bacterial
enzyme called RNA-polymerase.
LORMYX 200 MG acts mainly in the gastrointestinal tract.
_ _
2.
BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient, rifaximin
(polymorphic form α), other
derivatives of the rifamycin group or to any of the additional
ingredients that the
medicine contains (please see Section 6 "Additional information").
•
If you are suffering from partial or complete intestinal blockage
(ileus).
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TAKING LORMYX 200 MG,

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 ._ _ NAME OF THE MEDICINAL PRODUCT
Lormyx 200 mg
film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet contains: 200 mg Rifaximin (polymorphic form α)
For the full list of excipients, see section 6.1.
3. FHARMACEUTICAL FORM
Film-coated tablet
Visual nature: pink, bi-convex film-coated tablet with a diameter of
10 mm
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS:
>
Causal treatment of illnesses in adults and youths from the age of 12
years up caused by
bacteria in the gastro-intestinal tract, sensitive to Rifaximin:
- Non-complicated diverticular diseases
- Hepatic encephalopathy
- Travellers' Diarrhoea caused by non-invasive enteropathogenic
bacteria
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ADULTS AND YOUNG PEOPLE FROM THE AGE OF 12: _
➢
_Travellers' Diarrhoea_: 2 -
3 times a day 1 - 2 Film-coated tablets Lormyx (corresponding to
400 – 1200 mg Rifaximin (polymorphic form α))
➢
Non-complicated diverticular diseases, _Hepatic encephalopathy: _2 -
3 times per day 2 film-
coated tablets Lormyx (corresponding to 800 - 1200 mg Rifaximin
(polymorphic form α)) per
treatment cycle.
_CHILDREN _
The safety and effectiveness of Rifaximin (polymorphic form α) for
children under the age of 12 has
not been examined.
Currently available data is described in Section 5.1. However, no
recommendation can be made
regarding the dosage.
Method of administration
The film-coated tablets have to be taken with sufficient liquid and
must not be chewed.
Taking the tablets does not depend on meals.
Duration of treatment
_Travellers' Diarrhoea_: _ _
If not otherwise specified by the doctor, the duration of the
treatment for Travellers' Diarrhoea must
not exceed 3 days.
_Non-complicated diverticular diseases_, _Hepatic encephalopathy: _
The duration of a treatment cycle should not exceed 7 - 10 days. For
acute treatment, a single
treatment cycle is sufficient. As maintenance treatment, one cycle per
month is carried out.
Patients with liver and/or kid