Rifadin 300mg capsules

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Rifampicin

זמין מ:

Sanofi

קוד ATC:

J04AB02

INN (שם בינלאומי):

Rifampicin

כמות:

300mg

טופס פרצבטיות:

Oral capsule

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 05010900; GTIN: 5015265300043

עלון מידע

TURN
OVER
_I_
IMPORTANT THINGS YOU NEED TO KNOW ABOUT
RIFADIN 300MG CAPSULES
•
It is very important that you take Rifadin 300mg Capsules
exactly as your doctor has told you. There is a chance of you
having a severe and dangerous allergic reaction if you do
not take Rifadin 300mg Capsules each day as you are told
•
You must keep taking Rifadin 300mg Capsules until your
doctor tells you to stop.
•
If you are taking any other medicines, including medicines
you have bought from the pharmacy or shop, you must
make sure your doctor knows
•
Rifadin 300mg Capsules make all your body fluids an orange
or red colour. Do not worry - this is normal and not harmful
•
Take Rifadin 300mg Capsules on an empty stomach. This
means at least 30 minutes before food or 2 hours after food
•
If you get a temperature, are sick, begin to feel more unwell,
lose your appetite or have yellowing of the skin, gums or
eyes, you must talk to your doctor straight away
READ THE REST OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or your
pharmacist.
•
This medicine has been prescribed for you. Do not pass it to
others. It may harm them, even if their symptoms are the
same as yours.
•
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
WHAT IS IN THIS LEAFLET:
1. What Rifadin 300mg Capsules are and what they are used for
2. What you need to know before you take Rifadin 300mg
Capsules
3. How to take Rifadin 300mg Capsules
4. Possible side effects
5. How to store Rifadin 300mg Capsules
6. Contents of the pack and other information
1. WHAT RIFADIN 300MG CAPSULES ARE AND WHAT THEY
ARE USED FOR
Rifadin 300mg Capsules contain a medicine called rifampicin.
It belongs to a group of medicines called anti-bacterials. It
works by killing the bacteria that cause infections.
Rifadin 300mg Capsules are used to treat the following
bacte

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rifadin 300mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rifampicin Ph Eur 300 mg
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard.
The gelatin capsule is opaque, composed of a scarlet body and cap,
marked R-300.
4.1
THERAPEUTIC INDICATIONS
Indications for use
Tuberculosis: In combination with other active anti-tuberculosis drugs
in the
treatment of all forms of tuberculosis, including fresh, advanced,
chronic and
drug-resistant cases. Rifadin is also effective against most atypical
strains of
Mycobacteria.
Leprosy: In combination with at least one other active anti-leprosy
drug in the
management of multibacillary and paucibacillary leprosy to effect
conversion
of the infectious state to a non-infectious state.
Other Infections: In the treatment of Brucellosis, Legionnaires
Disease, and
serious staphylococcal infections. To prevent emergence of resistant
strains of
the infecting organisms, Rifadin should be used in combination with
another
antibiotic appropriate for the infection.
Prophylaxis of meningococcal meningitis: For the treatment of
asymptomatic
carriers of N. meningitidis to eliminate meningococci from the
nasopharynx.
Haemophilus influenzae: For the treatment of asymptomatic carriers of
H.influenzae and as chemoprophylaxis of exposed children, 4 years of
age or
younger.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Recommended Dosage
For oral administration
The daily dose of Rifadin, calculated from the patient’s body
weight, should
preferably be taken at least 30 minutes before a meal or 2 hours after
a meal to ensure
rapid and complete absorption.
Tuberculosis:
Rifadin should be given with other effective anti-tuberculosis drugs
to prevent the
possible emergence of rifampicin-resistant strains of Mycobacteria.
_Adults_: The recommended single daily dose in tuberculosis is 8-12
mg/kg.
_Usual Daily dose_: Patients weighing less than 50 kg - 450 mg.
Patients weighing 50
kg or more – 600 mg.
_Ch