Rifampicin 150mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Rifampicin

Available from:

Viatris UK Healthcare Ltd

ATC code:

J04AB02

INN (International Name):

Rifampicin

Dosage:

150mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010900; GTIN: 5016695700021

Patient Information leaflet

V1 Mar 2022
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Rifampicin, 150 mg, 100
21 JUN 2022
12:50
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SUB-28362-01
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N.A.
United Kingdom
McDermott Laboratories Ltd T/A
Gerard Laboratories (Grange Rd :
Dublin - IE)
N.A.
SUB-28362-01
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5016695700021
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V1 Mar 2022
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Rifampicin, 150 mg, 100
21 JUN 2022
12:50
Label Leaflet (All
types)
TBC
N.A.
N.A.
N.A.
N.A.
0
II of II
8 pt
4 pt
SUB-28362-01
1
N.A.
United Kingdom
McDermott Laboratories Ltd T/A
Gerard Laboratories (Grange Rd :
Dublin - IE)
N.A.
SUB-28362-01
N.A.
5016695700021
Myriad Pro
N.A.
52 x 110 mm
Keyline
Varnish
Free Area
Braille
V1 Mar 2022
Colours
Non-Print
Colours
Date:
Time:
Equate CMYK
with
Dimensions
Main Font
Body Text Size
Min Text Size used
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No. of colours
Pharma Code
Viatris SAP No.
Vendor Job No.
Artwork Proof No.
Client Market
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Barcode Info
Description
Component Type
TrackWise/GLAMS Job No
.
MA No
.
Packing Site/Printer
Superseded Supplier Code
Sign-offs
3D Render ID
New Supplier Code
Rifampicin, 150 mg, 100
21 JUN 2022
12:50
Label Leaflet (All
types)
TBC
N.A.
N.A.
N.A.
N.A.
4
Black
PMS
7508
PMS
334
PMS
306
1 of 48
8 pt
4 pt
SUB-28362-01
1
N.A.
United Kingdom
McDermott Laboratories

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Rifampicin 150 mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 150 mg rifampicin.
Excipients with known effect:
Each capsule contains 42 mg of lactose monohydrate.
Each capsule contains a trace (0.015 % w/w of the capsule cap) of
azorubine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
Size 3 hard gelatin capsules with mauve body and maroon cap, marked
“RN 150” and “G”. (The
capsule contents are brick red).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TUBERCULOSIS: Rifampicin, used in combination with other active
anti-tuberculosis drugs, is indicated
in the treatment of all forms of tuberculosis, including fresh,
advanced, chronic and drug-resistant
cases. Rifampicin is also effective against most atypical strains of
mycobacteria.
PROPHYLAXIS OF MENINGOCOCCAL MENINGITIS: Prophylaxis of meningococcal
meningitis in close
contact adult and paediatric patients.
LEPROSY: Rifampicin is indicated in the combination treatment of
multibacillary and paucibacillary
leprosy in patients of all age groups.
HAEMOPHILUS INFLUENZAE: Propylaxis of _Haemophilus influenzae_ _type
b_ disease in close contacts.
OTHER INFECTIONS: Rifampicin is indicated in the treatment of
brucellosis, legionnaires disease, and
serious staphylococcal infections. Rifampicin should be used in
combination with another appropriate
antibiotic to prevent emergence of resistant strains of the infecting
organism.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
Tuberculosis
Rifampicin 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
8-12mg/kg.
Usual daily dose:
Patients weighing less than 50kg – 450mg
Patients weighing 50kg or more – 600mg
_Paediatric patients: _
_Children above 3 months_: Oral doses of 15 (10-20) mg/kg body weight
daily are recommended,
although a total daily d