Rifampicin 300mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Rifampicin

Available from:

A A H Pharmaceuticals Ltd

ATC code:

J04AB02

INN (International Name):

Rifampicin

Dosage:

300mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010900; GTIN: 5025903003298 5025903089056

Patient Information leaflet

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05 Dec 2019
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Rifampicin 300 mg 100
Label Leaflet
1941704
1618367
1941704
PL 04569/0087
NA
LL0541AC
262
NA
385185
7
United Kingdom
NA
5016695180076
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52 x 110 mm
8 pt
4 pt
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Barcode Info
3D Render ID
05 Dec 2019
II/II
13:10
Varnish
Free
Keyline
Rifampicin 300 mg 100
Label Leaflet
1941704
1618367
1941704
PL 04569/0087
NA
LL0541AC
262
NA
385185
7
United Kingdom
NA
5016695180076
NA
4
Myriad Pro
52 x 110 mm
8 pt
4 pt
Braille
Rifamp-
icin
#300 mg
Capsule
Rifamp-
icin
#300 mg
Capsule
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Non-Print
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TrackWise PR No.
MA No.
Packing Site/Printer
Supplier Code
Sign-offs
v3/July 2017
Pharma Code
SAP No.
Vendor Job No.
Trackwise Proof No.
Client Market
Keyline/Drawing No.
Barcode Info
3D Render ID
05 Dec 2019
1/48
13:10
Rifampicin 300 mg 100
Label Leaflet
1941704
1618367
1941704
PL 04569/0087
NA
LL0541AC
262
NA
385185
7
United Kingdom
NA
5016695180076
NA
4
Black
Myriad Pro
52 x 110 mm
8 pt
4 pt
PMS
7508
PMS
Reflex Blue
PMS
306
1
PEEL HERE BUT DO NOT REMOVE
300
MG
RIFAMPICIN
300 MG
CAPSULES
100 capsules
EACH C

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Rifampicin 300 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 300 mg rifampicin.
Excipients with known effect:
Each capsule contains 31 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
Size no.1 hard gelatin capsules with a pink body and maroon cap,
marked “RN 300” 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 dose should not usually exceed 600mg.
Prophylaxis of Meningococcal Meningit