Bioflor Capsule 250mg

Nchi: Malta

Lugha: Kiingereza

Chanzo: Medicines Authority

Viambatanisho vya kazi:

SACCHAROMYCES BOULARDII

Inapatikana kutoka:

Biocodex 7 Avenue Gallieni- 94250 Gentilly, France

ATC kanuni:

A07FA02

INN (Jina la Kimataifa):

SACCHAROMYCES BOULARDII 250 mg

Dawa fomu:

CAPSULE

Tungo:

SACCHAROMYCES BOULARDII 250 mg

Dawa ya aina:

OTC

Eneo la matibabu:

ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS

Idhini hali ya:

Authorised

Idhini ya tarehe:

2006-02-27

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BIOFLOR 250MG CAPSULE
_SACCHAROMYCES BOULARDII _CNCM I-745
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 2 days.
WHAT IS IN THIS LEAFLET
1.
What BIOFLOR 250mg capsule is and what it is used for
2.
What you need to know before you take BIOFLOR 250mg capsule
3.
How to take BIOFLOR 250mg capsule
4.
Possible side effects
5.
How to store BIOFLOR 250mg capsule
6.
Contents of the pack and other information
1.
WHAT BIOFLOR 250MG CAPSULE IS AND WHAT IT IS USED FOR
Pharmacotherapeutic group: Anti-diarrhea. Replacement flora. (A:
Digestive system and metabolism).
Therapeutic indications:
•
Treatment of acute infectious diarrhoea of adults and children.
•
Prevention and treatment of antibiotic-associated colitis and
diarrhoea.
•
Addition to vancomycin/metronidazole-treatment to prevent recurrence
of _Clostridium difficile_
diseases.
•
Prevention of tube-feeding associated diarrhoea.
•
Treatment of irritable bowel syndrome.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BIOFLOR 250MG CAPSULE
DO NOT TAKE BIOFLOR 250MG CAPSULE
-
If you are allergic to _Saccharomyces boulardii _CNCM I-745 or any of
the other ingredients of this
medicine (listed in section 6).
-
If you have a central venous catheter.
-
In immunocompromised or hospitalised patients (due to serious illness
or altered/weakened
immune system) (see Warnings and precautions).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Bioflor 250mg capsule.
It is advisable not to ope

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BIOFLOR
® 250MG, CAPSULE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Saccharomyces boulardii_ CNCM I-745
...................................................... 250.00mg
(lyophilized cells of _Saccharomyces boulardii _CNCM I-745)
Excipient with known effect: lactose.
For the full list of excipients: see section 6.1
3.
PHARMACEUTICAL FORM
Capsule.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
-
Treatment of acute infectious (viral or bacterial) diarrhea.
-
Preventive and curative treatment of antibiotic-associated diarrhea
and colitis.
-
Preventive
treatment
of
recurrence
of
_Clostridium _
_difficile_
disease
in
addition
to
vancomycin/metronidazole.
-
Preventive treatment of tube-feeding associated diarrhea.
-
Treatment of irritable bowel syndrome.
BIOFLOR 250mg, capsule is indicated in adults and children above 6
years of age.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY _
1 or 2 capsule once or twice daily.
_METHOD OF ADMINISTRATION _
Oral route.
Swallow the capsules with a glass of water.
In young children under 6 years of age, it is recommended not to
swallow capsules (risk of false passage)
and to use the powder for oral suspension in sachet.
Due to a risk of airborne contamination, capsules should not be opened
in patient rooms. Healthcare
providers should wear gloves during handling of probiotics for
administration, then promptly discard the
gloves and properly wash their hands (see section 4.4).
4.3.
CONTRA-INDICATIONS
-
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
-
Patients with central venous catheter (see section 4.4).
-
Critically ill patients or immunocompromised patients due to a risk of
fungaemia (see section 4.4).
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If symptoms persist for more than 2 days of treatment at usual
posology, the therapeutic approach will be re-
evaluated.
The treatment does not replace rehydration when this is necessary. The
rehydration dose and